Increasing Medication Adherence in Sickle Cell Patients Dissertation

Abstract

Hydroxyurea-based therapy is a requested treatment of sickle cell disease (SCD), and it is exciting to know what interventions can improve this medication adherence for efficient management of the disease. The purpose of this quantitative quasi-experimental quality improvement project was to determine if the research by Nevitt et al., Hosseini et al., and Keikhaei et al. on the implementation of hydroxyurea-based therapy facilitated by the use of a pill packaging system discussed in the studies by Telen, Conn et al., and Lorenzini and Hellström and the Mango Health mobile application that is the new intervention part would impact medication adherence among patients with SCD in a North Carolina medical center over four weeks. Ajzen’s theory of planned behavior was used as the theoretical underpinning of the project. Data on medication adherence were measured by the medication adherence questionnaire by Huang in 18-30-year-old patients (n=75) at baseline and four weeks post-implementation of pill packaging systems and the mobile application. A chi-square test showed that there was a statistically significant difference in medication adherence (X2 (1, N = 75) = 17.6389, p =.05) following the intervention. Therefore, the findings suggest that continuous utilization of hydroxyurea-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would improve patients’ medication adherence. Recommendations include implementing the proposed intervention and possible repetition of the project at another medical site over a more extended period of time and larger sample size.

Introduction to the Project

The problem of sickle cell disease (SCD) has been developing exponentially, causing multiple fatal outcomes in patients and making them vulnerable to numerous infectious diseases (Badawy et al., 2017). The issue must be addressed as a global concern that affects vulnerable and disadvantaged groups in remote areas. Applying hydroxyurea-based therapy (HU therapy) combined with the use of a pill packaging system and Mango Health, a mobile application, to instances of SCD provides one approach to treating the disease and preventing the further spread of SCD, at the same time catering to the needs of people that have been affected by SCD. In this context, a pill packaging system is associated with pillboxes, blister packs, unit-dose systems, or blended systems to organize taking a required dose of medications regularly (Conn et al., 2015; Lorenzini & Hellström, 2017). The application of these systems during HU therapy is viewed as a beneficial intervention for patients with SCD.

To understand the gravity of the problem, it is significant to consider the nature of the malady. The development of SCD is linked to decreased levels of hemoglobin in red cells. Thus, SCD is “a group of inherited red blood cell disorders” when “red blood cells become hard and sticky and … die early, which causes a constant shortage of red blood cells” (Centers for Disease Control and Prevention, 2017, para. 1). When red blood cells move through small and narrow blood vessels, they become stuck and prevent normal blood flow, causing pain as well as other health problems (Adams-Graves & Bronte-Jordan, 2016). Therefore, it is vital to ensure that SCD patients adhere to their medication to relieve their state. The project is aimed at analyzing how and whether the combination of applying HU along with a pill packaging system and a mobile application increases medication adherence in SCD patients.

Numerous approaches toward managing SCD exist, and HU therapy is among them. HU is defined as an antimetabolite drug that increases important fetal hemoglobin (Hb F) in individuals’ red blood cells. Furthermore, HU inhibits ribonucleoside diphosphate reductase, preventing changes in the red blood cells (Hosseini et al., 2016; Keikhaei, Yousefi, & Bahadoram, 2016). As a result of HU effects, the red blood cells do not change their shape and form and remain flexible not to affect the blood flow in vessels (Keikhaei et al., 2016). This effect leads to preventing the development of the pain syndrome in patients with SCD outcomes; it is necessary to take HU for several weeks (Araujo et al., 2016; Wilson & Nelson, 2015). Therefore, patients’ adherence to this medication is critical to prevent or relieve pain and improve their quality of life (Badawy et al., 2017).

When designing a treatment method based on HU’s use, it is vital to keep in mind that adhering to HU is a complex therapy that requires proper patient perceptions (Badawy et al., 2017). Since HU therapy implies direct collaboration between medical professionals and the patient’s active education, designing a communication channel that will enable a nurse to administer HU-based treatment is essential. HU-based therapy will help patients with SCD manage a pain crisis because of preventing clots in blood vessels that cause pain (McGann et al., 2016). Patient outcomes can also be improved by utilizing a pill packaging system that implies arranging the necessary pills in boxes for each intake for patients’ convenience (Conn et al., 2015). It is noteworthy that HU-based therapy’s effectiveness, supported by a pill packaging system when treating SCD, has not received much attention among researchers.

Chapter 1 includes a synopsis of the background of this project and the problem statement. The purpose of the current project and the clinical question will be further provided in this chapter. Chapter 1 also overviews the potential advancement of scientific knowledge this project can offer, its significance, and the rationale for the chosen methodology. This chapter describes the project design and methodology and provides the definitions of the employed terms and concepts. Chapter 1 outlines the project’s assumptions, limitations, and delimitations.

Background of the Project

SCD has been studied in-depth, yet no treatment can remove all symptoms and cure patients completely has been found to date. In the United States, approximately 100,000 people currently suffer from SCD (Centers for Disease Control and Prevention, 2017). While on a global scale, the problem might not seem drastic, in some areas, including most of the African continent, the rates of SCD reach as high as 30% of the population (Badawy et al., 2017; Kutlar et al., 2019). Studies show that the cause of SCD lies in the genetic mutation of hemoglobin (Badawy et al., 2017; Kutlar et al., 2019). Addressing the problem of SCD and curing the disease would necessitate performing a meticulous genome study, which is currently impossible (Badawy et al., 2017).

In the present and past, SCD is primarily treated with HU as the main approved drug to address this state. To support HU-based therapy, supportive care measures were proposed to patients (Adams-Graves & Bronte-Jordan, 2016). Furthermore, for the past two decades, patients with SCD received such options as for chronic blood transfusions and stem cell transplantation that are rather costly compared to taking HU (Badawy et al., 2017). Therefore, it is important to focus on improving compliance to increase pain control for patients (McGann et al., 2016). The use of pill packaging systems and mobile applications as reminders is important in increasing adherence to HU in patients (Huang, Maguire, Miller, & Appel, 2000; McGann et al., 2016; Telen, 2016). The reason is that those patients, who take HU regularly, suffer from pain crises rarely (Badawy et al., 2017; Hosseini et al., 2016; Huang et al., 2000).

Problem Statement

It is unknown if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. Although SCD might seem a minor concern globally, especially compared to other disorders and diseases, its scope is significant for the United States because SCD is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017). Developing an intervention for managing SCD is a necessary step in meeting the needs of SCD patients. Although numerous strategies have been designed to address SCD, little progress has been made so far in terms of SCD prevention and control. Furthermore, the use of such pill packaging systems as pill organizers to simplify the process of taking drugs and increase adherence to minimize pain episodes also needs examination in the context of HU therapy (Badawy et al., 2017; Conn et al., 2015).

HU is one of a few therapies that have delivered promising outcomes to date, suggesting that its effects on SCD patients and populations vulnerable to SCD should be explored in depth. It is believed that HU’s application will allow for alleviating the painful experiences typical of SCD patients (Badawy et al., 2017). A lack of information on the positive and negative aspects of using HU presents an additional obstacle to managing the problem and makes the further study of HU an urgent measure (Lê et al., 2015). The use of pill packaging systems needs detailed investigation since only some aspects of pill intake management were previously examined by researchers, including Huang et al. (2000) and Kopelowicz et al. (2015).

The need for this project is in the fact that it is necessary to determine the potential of taking HU in combination with using pill packaging systems and a mobile application for reminders for increasing medication adherence and addressing pain crises. Sufficient studies have not been conducted regarding the effects of taking HU with the help of pill packaging systems or mobile applications on patients’ medication adherence and possible pain experiences (Badawy et al., 2017; McGann et al., 2016). It is essential to evaluate the combination of HU-based therapy and a pill packaging system and use a mobile application to identify the relationship between this approach and medication adherence affecting the patients’ quality of life.

This project will help solve patients’ pain episodes providing information on opportunities for improving the peoples’ well-being with SCD to affect their adherence to HU. The limited amount of evidence supporting HU’s combined with the use of a pill packaging system and facilitated by using a mobile app signifies the need for immediate research. A recent article has indicated that HU’s application deserves scrutiny as a potential strategy to ameliorate the conditions of current SCD patients (Badawy et al., 2017).

Purpose of the Project

The purpose of this quantitative quasi-experimental project was to determine if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The independent variables of using a pill packaging system and a mobile application will be measured regarding the application or not of this intervention by patients with SCD. The medication adherence as a dependent variable will be measured about the regularity of taking HU. It is expected that the promotion of the pill packaging system will lead to increased medication adherence. Huang et al. (2000) developed this self-administered questionnaire to determine how often the study’s participants forgot or skipped taking pills as it had been prescribed to them.

The discussion of positive and negative outcomes of the proposed therapy combined with the pill packaging intervention contributes to creating strategies that may help to address pain episodes associated with the disease in question. The project explores the opportunities for the management of SCD in patients, especially African Americans (Lê et al., 2015). The examination of interventions, such as the combination of HU therapy with pill packaging systems and a mobile application-oriented toward improving the adherence to HU, is important to determine the effectiveness of these interventions to decrease such effects of SCD as pain crises.

The low quality of life and the physical discomfort afflicting SCD patients and pain associations must be managed as an evident concern. The application of an approach based on HU may lead to vast improvements among people with SCD when coupled with using convenient pill packaging systems and a mobile application (Badawy et al., 2017). The opportunities that HU combined with a pill packaging system provides must be examined to enhance the current quality of nursing care and ensure that the level of awareness rises among SCD patients, their parents, at-risk groups, and general audiences.

To address the problem, it is necessary to explore the nature of SCD and the effects that HU therapy facilitated by a pill packaging system and a mobile app produces on patients. The current approach to the effort to cure SCD associated with blood transfusions and transplantations allows for helping only a small group of patients due to the high costs of procedures (Wilson & Nelson, 2015). An analysis of the advantages and disadvantages of an HU-based pill packaging system contributes to problem-solving and providing an opportunity to design a framework for managing any SCD patient or a group of patients. Consequently, the problem refers to the fact that SCD patients fail to benefit from their treatment because of insufficient medication adherence, and this situation needs improvement.

Clinical Question

The question guiding this project was: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks? The project in question strives to determine whether HU therapy enhanced by a pill packaging system and a mobile application can be associated with higher medication adherence levels to prevent pain episodes in patients with SCD. Therefore, this project determined how the specified strategy contributes to increasing medication adherence among patients and enables nurses to increase their competency levels. The opportunity for using pill packaging systems and a mobile application can also serve as a method of sustaining the high quality of life in SCD patients because of addressing pain.

HU therapy based on using pill packaging systems and a mobile app as independent variables was defined by following SCD patients’ intervention. Possible changes in medication adherence in patients with SCD are the dependent variable, and the data on it was collected with the help of a questionnaire to assess the dependent variable. It is important to determine whether the proposed intervention promotes medication adherence in SCD patients aged 18-30 years.

Advancing Scientific Knowledge

It is critical to encourage the advancement of scientific knowledge associated with the management of SCD to address and prevent pain episodes or crises observed when HU is taken irregularly, and medication adherence is low. When considering the rationale for the project, it is important to mention the lack of studies that handle the topic of HU in combination with pill packaging and other systems to increase medication adherence as a possible solution to SCD-related pain. Currently, a significant gap exists in the scientific knowledge of HU as a tool for improving the quality of SCD patients’ lives by increasing their adherence to HU and relieving their pain, as well as promoting patient education concerning the use of mobile applications as reminders (Kopelowicz et al., 2015; Lê et al., 2015). The findings of the currently available studies provide reasons to believe that the application of HU therapy can facilitate patient control, which will lead to a drop in the levels of pain common in SCD patients (Centers for Disease Control and Prevention, 2017). The focus must be on studying the opportunities that HU and pill packaging systems, and mobile app reminders, provide for SCD patients.

The application of the proposed strategy based on HU, pill packaging systems, and a mobile app is likely to lead to a change in medication adherence and pain cycles observed in SCD patients (Badawy, Thompson, & Liem, 2016; Badawy et al., 2017). According to Wilson and Nelson (2015), HU therapy provides a relatively cheap and possibly effective alternative to existing approaches, most of which are quite costly. Stettler, McKiernan, Adejoro, and Walczak (2015) made the following specific claim: “Despite evidence demonstrating the benefits of HU in patients with SCD and frequent pain crises, this analysis suggests that more than 3 of 4 patients who might benefit were not treated with this safe and inexpensive drug” (p. 1671). The current barriers to treatment include the refusal to acknowledge that HU therapy delivers impressive results and that significant outcomes can be achieved through high-level medication adherence (Badawy et al., 2017).

The few studies that explore the link between HU and the quality of SCD patients’ lives prove that HU can potentially benefit people suffering from SCD. The opportunities under consideration occur due to the presence of elements that help to address the vaso-occlusive crisis (VOC) in HU (Centers for Disease Control and Prevention, 2017). A few studies that do serve to tackle the pain management in patients having SCD with the help of HU and delve into the mechanics of the process have proven HU’s efficacy (Badawy et al., 2017). These studies have provided reasons to believe that adherence to HU can reduce the pain experienced by patients with SCD. HU can counteract platelets’ activation in SCD patients that typically leads to inflammation and further aggravation of the SCD condition (Kutlar et al., 2019). The use of HU, in turn, will help to reduce inflammation and alleviate negative experiences (Lorenzini & Hellström, 2017; Zhang, Xu, Manwani, & Frenett, 2016). The described intervention focusing on combining HU therapy with a pill packaging system and a mobile app can improve medication adherence and address pain (Badawy et al., 2017). Although the impact of the provision of HU therapy facilitated by a pill packaging system is unknown, recent research on the effects of pill packaging systems in treating similar conditions suggests improved patient outcomes (Lorenzini & Hellström, 2017). Using a pill packaging system and mobile reminders in HU-based therapy apps is expected to improve patients’ lives by increasing HU adherence.

The theory of planned behavior is a theoretical model that supports the project and explains how pill packaging systems and mobile applications can lead to medication adherence changes in patients. This theory was developed by Icek Ajzen, who determined particular factors affecting changes in people’s individual behaviors. Ajzen (1985) claimed that people’s attitudes, behavioral control, and subjective norms should be viewed as predictors of an individual’s decision to choose a behavior. The process of decision making and selecting a behavior (in this project, the behavior is adherence or not to medications) is based on a person’s evaluation influenced by the mentioned predictors. The project adds to explaining how this theoretical model can be applied to the topic of taking medications regularly to improve health outcomes and advances the approach to modeling patients’ behavior with the help of proposing some instruments, like pill packaging or a mobile app (Rich, Brandes, Mullan, & Hagger, 2015). The given project will demonstrate whether a mobile application works as a behavioral control, leading changes in people’s individual behaviors.

Significance of the Project

The problem of poor medication adherence is severe in the health care industry. According to Vrijens, Antoniou, Burnier, de la Sierra, and Volpe (2017), the World Health Organization reported that this issue became of striking magnitude in 2003. The current statistics demonstrate 30%-50% of medications are not taken as prescribed, leading to more than 100,000 deaths in the USA (Kini & Ho, 2018, p. 2461). These data mean that there is a necessity to find a practical way to improve medication adherence among patients to achieve better health outcomes.

This project is not unique in addressing the issue of poor medication adherence, meaning that many other scholarly articles try to promote this behavior among patients. For example, the retrospective observational study by Wiecek, Torres-Robles, Cutler, Benrimoj, and Garcia-Cardenas (2020) shows that a mobile app can improve medication adherence over time. Simultaneously, Lorenzini and Hellström (2017) argue that specific packaging can promote medication adherence among older patients. However, there is a gap in research associated with the lack of literature on how the combination of pill packaging systems and mobile applications can relate to medication adherence (Haywood et al., 2014). Thus, the present project is significant because it is going to demonstrate whether the use of these effective interventions can lead to better results in relation to specific population (Conn et al., 2015; Rich et al., 2015).

Furthermore, the project completion is significant for clinicians and practitioners working with SCD patients because the project provides an important opportunity to advance the understanding of the intervention and the practice of taking pills by patients (Huang et al., 2000; Nevitt, Jones, & Howard, 2017). This project’s results will be significant for professionals who work with patients with SCD who take HU as there were no other studies on the relationship between HU therapy, pill packaging, using a mobile app, and medication adherence (Lin et al., 2016). Therefore, it will be possible to improve the practice of providing HU therapy to regularly guarantee taking pills.

Rationale for Methodology

This project implemented a quantitative methodology. A quantitative methodology allows for focusing on data provided in a numerical form, applying statistical tests to analyzing these data to make results more objective (Cokley & Awad, 2013). The quantitative method is effective when findings need to be generalized for a wider population, as it is typical in clinical practice (LibGuides, 2018; Trochim et al., 2015). Furthermore, the given design will contribute to fast data processing.

Simultaneously, the qualitative method is used under different conditions. According to Rutberg and Bouikidis (2018), this methodology is employed “when the problem is not well understood and there is an existing desire to explore the problem thoroughly” (p. 211). Typically, this approach relies on open-ended questions and interviews, which makes it more challenging to involve many participants and analyze the data quickly. It cannot determine any statistical relationship between different variables.

A quantitative methodology was chosen for the project to address the clinical question and determine the effects of applying HU therapy combined with pill packaging systems and a mobile application on medication adherence in SCD patients. This methodology is appropriate for conducting this project because it adds to finding the relationships between independent and dependent variables (Trochim, Donnelly, & Arora, 2015). The collection of quantitative data regarding pill packaging systems in patients with SCD and further statistical analysis of data allows for concluding about the combined intervention’s effectiveness. Badawy et al. (2017) and Lê et al. (2015) applied a quantitative method to examine different outcomes and effects of various interventions, including HU therapy, in patients with SCD. Since the nature of the project is quantitative, it was possible to use a large sample size to represent all target groups and embrace as many members of the SCD population as possible (Adesina, Brunson, Keegan, & Wun, 2017; Cokley & Awad, 2013). The proposed methodology helps find the relationship between applying HU therapy and pill packing systems, a mobile app, and adherence to the medication in SCD patients.

Nature of the Project Design

The design that can be suitable to answer the clinical question is quasi-experimental. Researchers use this design to establish a cause-and-effect relationship among different variables. This approach implies a significant advantage that refers to the ease of conducting such studies, but it implies lower internal validity compared to true experiments because quasi-experiments do not have randomization. Nevertheless, the given design implies higher validity compared to other non-experimental designs, which justifies the popularity of this approach in the research field.

A correlational design identifies a relationship between variables. It peculiar feature refers to the fact that the research does not control any of them. This type of descriptive research is used to identify positive, negative, or zero correlation between the variables. This information denotes that the given approach aims to identify correlation that is not the same as causation. The presence of strong correlation between the variables does not guarantee that one of them causes the other.

A descriptive design is also popular in medical research, and it is reasonable to consider using this approach. Doyle, McCabe, Keogh, Brady, and McCann (2020) stipulate that this design implies simplicity and flexibility. However, it is only applicable in particular conditions when it is necessary to describe a phenomenon or identify its long-term development. It means that the given approach will not help determine and assess the correlation between variables.

The quasi-experimental design effectively determines the intervention outcomes based on HU therapy and using pill packaging and a mobile app for medication adherence in other scholarly articles (Bell, Bryman, & Harley, 2018). It is the best choice to address the problem of using effective HU-based interventions for increasing medication adherence and addressing the pain crises (Bell et al., 2018; Cokley & Awad, 2013). According to the given design, it is necessary to collect a sufficient sample size, and the given project will rely on 75 patients with SCD who were asked to take HU with pill packaging systems and utilize the Mango Health mobile application for reminders. The quasi-experimental design stipulates that the project will not have randomization. The data on the sample was collected with the help of a questionnaire developed by Huang et al. (2000) to determine possible changes in patients’ medication adherence due to applying the intervention.

Definition of Terms

The following terms are used operationally in this project:

SCD. Sickle cell disease (SCD) is defined as a genetic red blood cell disorder caused by an autosomal recessive mutation that is likely to cause anemia unless appropriate measures are taken (Kutlar et al., 2019).

HU (Hydroxycarbamide, HU). It is a medication that allows for decreasing the number of pain episodes in patients with SCD due to affecting the red blood cells to make them round and rather flexible through increasing fetal hemoglobin and preventing blockages of blood vessels (Kutlar et al., 2019).

Pill packaging systems. A pill package system implies using some packages (such as blister packs or pillboxes) to help patients arrange their regular medication (Conn et al., 2015).

Mango Health mobile application. Mango Health is a mobile application that offers users information on their medication schedules and regimens and provides reminders (Kitty, 2020; Singh et al., 2016). Users of the app receive different rewards for taking their pills regularly (Haase, Farris, & Dorsch, 2017).

Medication adherence. Adherence to the medication is an extent to which patients take pills correctly, regularly, or according to a prescribed regimen with a focus on following directions strictly and taking pills on time (Badawy et al., 2017).

Assumptions, Limitations, Delimitations

The project has several limitations, most of which are linked directly to the methodology to be employed. The first limitation is associated with examining the results related to participants only in North Carolina. The second limitation is associated with the quantitative methodology, and a quasi-experimental design as incomplete records and questionnaire answers can affect the quality of statistical analysis, and incomplete data should be excluded. Furthermore, due to the focus on obtaining complete and valid quantitative results, an important piece of information might be lacking. The limitations of the quantitative methodology do not allow for exploring qualitative changes in patients’ adherence to medication. The specified issues may be reviewed in a follow-up project addressing qualitative aspects of using a combination of HU and a pill packaging system and using a mobile application. The timeframe in one month can also influence the project results, and further studies can be longer to receive more detailed information.

The key assumption that can be made is that the adoption of the proposed intervention can positively affect medication adherence, consequently improving the quality of patients’ lives. Due to the changes in patients’ perception of taking pills regularly, individuals can have the likelihood of significantly changing their adherence to the medication. The integration of the specified pill packaging systems and a mobile application can reduce the discomfort that SCD patients experience daily. As for delimitations, the strategies for making the samples as diverse as possible and introducing methods for generalizing the results should be used. It is believed that the selected approach leads to creating a comprehensive intervention for improving medication adherence in SCD patients.

Summary and Organization of the Remainder of the Project

The problem of SCD remains an unceasing threat to the well-being of people all over the world, including the population in the United States. The specific problem identified for this project is that it is unknown if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The reason is that the scope of SCD is large in the United States, as this condition is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017). The purpose of this quantitative quasi-experimental project was to determine if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The use of a pill packaging system and a mobile application is an independent variable, and medication adherence is a dependent variable. The clinical question formulated for this project is the following: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks.?

The project has theoretical and practical significance for improving medication adherence in patients with SCD because of addressing the gaps in research and improving clinical practice (Kutlar et al., 2019). A quantitative methodology and a descriptive design were chosen for the project to address the clinical question and the purpose and determine the effects of applying the intervention on medication adherence in SCD patients. The intervention’s enhancement will enable patients to control their regular taking of HU to improve their state and achieve positive results in addressing pain (Zhang et al., 2016).

This project is organized to investigate the problem in depth by progressing from an overview of the issue with an analysis of the latest studies on the topic to a detailed consideration of the project methodology. Chapter 2 will provide an overview of the current literature on HU’s use when in SCD patient treatment. Chapter 3 will present the methodology that will be employed to address the set clinical question. Chapter 4 will include the graphic and written presentation of the results of this project. Chapter 5 outlines the assessment of the findings along with the discussion. Finally, the evaluation of the project results, recommendations for implementing SCD management practice, and considerations for further projects will be added. The chapters’ layout will be provided in the natural progression from the discussion of the problem to assessing the suggested solutions to the implications of the project results.

Literature Review

Sickle cell disease (SCD) affects many people, reduces the quality of their lives, and drastically increases mortality rates (Badawy et al., 2017; Hosseini et al., 2016). The problem of managing the disorder is fraught with numerous challenges that range from the necessity to address severe pain experienced by patients to the need of managing possible complications (Hosseini et al., 2016). Among the methods of managing the problem of SCD, taking HU should be mentioned as a method of improving patients’ life quality by introducing a more elaborate pain management approach. Implementing an HU-based approach toward the management of SCD requires focusing on several aspects of the disease management simultaneously (McGann et al., 2016). One of these aspects is adherence to the medication in SCD patients that can depend on various factors, including the type of pill packaging systems used. The purpose of this quantitative descriptive project was to determine to what degree HU therapy combined with using a pill packaging system and a mobile application could affect possible changes in the adherence of SCD patients to their medication. This chapter presents a review of the literature to determine the role of pill packaging and mobile applications in treating SCD with HU’s help to improve medication adherence.

Recent studies on the topic have been searched in such databases as PubMed, Cochrane, Google Scholar, and ProQuest with the help of the following keywords: sickle cell disease, hydroxyurea, pill packaging, Mango Health, and medication adherence. Consequently, 218 articles were retrieved, and 37 articles were selected for further review. The need for conducting this project is supported by the review of articles that indicate the absence of studies on the relationship between the use of pill packaging in SCD patients and their adherence to HU. Past and current studies represent only the findings on the application of HU in SCD patients (Hosseini et al., 2016; McGann et al., 2016; Telen, 2016), or only the results of research on the relationship between pill-taking systems and medication adherence (Haywood et al., 2014; Huang et al., 2000; Smaldone et al., 2016). It is necessary to identify further gaps in researching the role of using pill packaging in treating SCD patients taking HU. This chapter provides a review of the literature organized according to two large themes, such as HU for treating SCD and pill packaging systems and a mobile application for medication adherence and related subtopics. These subtopics include HU, other SCD therapies, pain management, complications, comorbid issues, pill packaging systems, patient education on taking medications, and medication adherence.

Background

The issue of poor medication adherence has not always been on the same scale. It was not until 2003 when the World Health Organization stated that this problem was of striking magnitude (Vrijens, Antoniou, Burnier, de la Sierra, & Volpe, 2017). Consequently, this problem became acute in the early 21^st century, and the modern state of affairs is not better. For example, Kini and Ho (2018) admit that 30%-50% of medications are not taken as prescribed, leading to more than 100,000 deaths in the United States (p. 2461). This information means that it is necessary to find effective ways to improve medication adherence to achieve better health outcomes.

Theoretical Foundations

The theoretical model that can support the current DPI project oriented toward identifying how pill packaging systems and a mobile application can be associated with medication adherence changes is the theory of planned behavior. This theoretical framework was proposed and developed by Icek Ajzen, who concentrated on specific factors and conditions that can influence people’s behaviors. According to Ajzen’s (1985) seminal work, people’s attitudes, behavioral control, and subjective norms are the key predictors of an individual’s decision to demonstrate or not a certain behavior. After evaluating the behavior from the personal perspective (attitude), from other people’s positions (norms), and from the analysis of resources to be able to perform in a certain way (control), individuals make decisions regarding this or that behavior.

This theory can be applied to this project directly to provide the background for understanding how patients’ medication adherence is formed about the above-mentioned assumptions. It is so because the theory aligns with the clinical question. It refers to the fact that the theory focuses on what assumptions make patients take medications, why the clinical question tries to identify whether specific measures encourage patients to follow the required behavior. Patients make decisions on taking pills regularly when assess their attitude to this practice and available pill packaging systems, refer to prescribed regimens as norms, and try to adhere to medication in terms of their control over their behavior. Patients choose to use medications according to a certain schedule or a prescribed regimen to assess their behavior outcomes from several perspectives. Some people have positive attitudes toward taking drugs regularly, but other people can perceive this practice as ineffective to help them cope with their health condition (Kopelowicz et al., 2015; Lin, Updegraff, & Pakpour, 2016). Research on patients’ adherence to medications by Kopelowicz et al. (2015), who applied the theory of planned behavior to improve medication adherence in patients with schizophrenia, and Lin et al. (2016), who studied the theory of planned behavior with adherence in patients with epilepsy, among other studies, is based on Ajzen’s theory. This aspect supports the idea regarding the appropriateness of this model for being used in the current project.

The decision regarding applying the theory of planned behavior to this project is based on previous studies on the topic. Researchers referred to this model to explain why some patients chose to take medications regularly, and other groups of patients ignored their regimens (Lin et al., 2016; Rich, Brandes, Mullan, & Hagger, 2015). Lin et al. (2016) argue that the theory of planned behavior promoted behavioral control leads to enhanced medication adherence. Simultaneously, Rich et al. (2015) show that planned behavior theory implies a small-to-medium impact on medication adherence. In this context, the research focuses on analyzing patients’ motivation and intentions influenced by their attitudes, subjective norms, and behavioral control in combination with the proposed intervention. Therefore, this theory provides a framework for addressing the clinical question of applying medication adherence interventions in patients with SCD.

Review of the Literature

In this section, two wide topic areas related to this project, such as the use of HU for treating SCD and the use of pill packaging systems to affect medication adherence, are discussed in detail. These themes have been identified after reviewing the relevant literature on the problem. In this section, a review of recent studies on the topics is provided to analyze gaps in the current research on the problem.

Hydroxyurea in treating SCD

In SCD patients, HU is actively applied among other therapies to treat the condition because it can improve patient outcomes by minimizing the possibility of pain episodes. Researchers have studied specifics of using this medication in SCD patients, and they are actively analyzed in the reviewed articles (Savage et al., 2015; Zhang et al., 2016). The following subtopics are identified in this context: the use of HU, among other SCD therapies, HU in pain management, and SCD complications.

Hydroxyurea, among other SCD therapies

It is critical to provide SCD patients with an opportunity for pain alleviation since red blood cells in these patients have a specific shape that interrupts blood flow in vessels, causing pain episodes. The comparison between the available approaches toward managing pain and the reduction of unpleasant experiences focusing on HU has to be incorporated into the analysis (Sins, Mager, Davis, & Biemond, 2017). The assessment results have to be integrated into creating a patient-specific treatment approach to improve the overall quality of their lives and build a more comfortable environment for them (Benenson & Porter, 2018). An HU-based strategy will help avoid painful experiences due to its effects on the target population’s hemoglobin levels by making red blood cells round and flexible to avoid blockages in vessels.

In their quantitative study, Stettler et al. (2015) presented an analysis of HU’s effects on SCD patients. The clinical question was to find the effects of HU on the treatment of SCD in adult patients because of harrowing experiences. The hypothesis stated that HU allows for reducing pain in SCD patients. The authors used the term “pain crisis” and provided a very brief overview of the literature. The sample included 2086 adult SCD patients, and the database search was used to retrieve the data with no supplementary procedures included. The researchers found that HU can significantly improve patient outcomes (18.2% (95% CI, 15.0%-21.8%)), leading to overcoming pain crises. The research supported the idea that HU is required for pain alleviation and improved outcomes in SCD patients. Future research may be needed to address the problems of the HU application.

Keikhaei et al. (2016) conducted a cohort study to explore different aspects of HU therapy’s impact on SCD patients. The researchers evaluated both clinical, pain alleviation, and hematological, such as HbF levels change and alterations in patients with SCD. The sample of the research included 48 adult patients with SCD. The drastic effect of poor pain management in the target population was the key rationale for the project. The hypothesis stated that HU has a positive effect on clinical and hematological changes in patients. The key concepts of the study include HbF levels, MCV, MCH. Forty-eight participants were enrolled in the research. The cohort study involved obtaining data with the help of questionnaires. Also, basic demographic data such as patients’ sex, age, and the duration of their SCD were collected. The research outcomes indicate a direct connection between the application of HU treatment and the extent of pain alleviation in SCD patients. Specifically, the article supports the hypothesis that 10 mg/kg/day can help patients reduce painful experiences due to a rise in hemoglobin levels (Keikhaei et al., 2016). The article results indicate that the application of HU-based therapy allows for reducing pain in patients with SCD. The integration of HU-based treatment strategies into managing SCD patients’ needs should be seen as necessary.

Nevitt et al. (2017) studied the contrast between HU and a placebo application to manage SCD patients’ pain. The authors intended to compare the application of HU-based therapy for managing pain to using a placebo. The review study was concerned with the low quality of SCD patients’ lives due to poor management of their condition. The notion of HU is rendered in the course of the analysis. The authors offered a profound review of the literature, and 74 samples were selected for the analysis. The study represented a large review of the literature concerning the management of SCD-related pain with HU and with the help of a placebo. The study outcomes supported the idea that the adoption of HU is beneficial to patients’ needs compared to a placebo. The data were collected via the database search and organized in multiple tables. The analysis results stated that HU provides more pain management opportunities than a placebo (Nevitt et al., 2017). The study shows that HU’s use reduces pain and improves the physical and psychological state in SCD patients. The study’s outcomes point to the further research question, which may include the methods of administering HU to patients.

In their quantitative research, Hosseini et al. (2016) also formulated the clinical question to examine HU’s mechanisms on patients with SCD. The research hypothesized that there are specific cellular biophysical properties that can be determined at the normoxia level. The authors did not specify the sample yet mentioned that the required information was gathered with the Excess Human Material Protocol’s help. The study findings showed that the biophysical properties of SCD patients could be identified can be determined at the normoxia level. The analysis of the data supported the initially stated hypothesis. The study aimed at determining common patterns in SCD patients to enhance the efficacy of HU, and the results of the research supported the view that these characteristics are visible at the normoxia level. This study also demonstrates the specifics of using HU in patients with SCD to improve the quality of life.

Adopting an HU-based intervention as the method for reducing pain is critical for patients who suffer from SCD. The integration of the proposed tool leads to the successful prevention of numerous infections and helps patients avoid multiple threats to which they become vulnerable after the development of SCD (Keikhaei et al., 2016; Smith et al., 2015). Indeed, since the use of the tool in question reduces inflammation and a drop in the negative effects thereof on a patient, the threat of acquiring an infection is reduced (Zempsky et al., 2017). The possibility of hospital-acquired infection (HAI) can, in turn, be lowered with the adoption of a strategy aimed at improving nurses’ schedule and removing the threat of workplace burnout that can cause a medical error and a subsequent HAI in SCD patients (Nevitt et al., 2017). A strategy that involves several approaches is required in the case of analysis.

Pain management

The problem of pain management in patients suffering from SCD remains a concern for most medical workers and nurses. Due to the drop in hemoglobin levels and the consequent changes in a patient’s tissue, blood clots and ruptures become very common, thus, causing intense pain and reducing the quality of life extensively (Stettler et al., 2015). Strategies for managing pain in SCD patients are a critical step toward handling the problem of SCD on an epidemiological level (Savage et al., 2015). When considering pain management opportunities in patients with SCD, one should mention that HU’s application does not allow for alleviating it completely. The analysis of recent articles on the topic must examine this area in detail and identify possible gaps.

In their case study, Brandow, Zappia, and Stucky (2017) examined the effects of a natural pain management model on children with SCD. Although the article aimed to study the underlying mechanisms of pain development in teenage patients based on a case study of a 19-year-old patient, its findings are important to contribute to the analysis. The research was restricted to a single case, with the hypothesis concerning the cause of pain and its intensity. The researchers viewed the target patient as the study population, the sample being one. The analysis of the patient’s records was the key data collection tool. Other procedures included a general analysis of recent SCD cases. The analysis results supported the assumption that the intensity and extent of pain could increase with a patient’s age, the progression of the SCD, and the increase in the opioid dosage (40% of children experience chronic pain, and 35% report everyday pain). The study indicates that pain increases as SCD progresses, with opioids enhancing the negative experiences of SCD patients. What tools can be used for pain alleviation is the question for future research.

Savage et al. (2015) discussed the current lack of information for building a comprehensive SCD management strategy in the study, with a summary of essential findings and a commentary on them regarding 22 trials. From this point, the study focused on addressing the existing knowledge gaps so that a more elaborate approach toward addressing SCD issues could be designed, and improved strategies could be introduced. The authors hypothesized that health maintenance currently remains a grey area, mentioning “all immunization” (Savage et al., 2015). Since the data collection tool used in the study was a qualitative review, no participants were included in the study. The authors concluded that the existing guidelines for SCD management are often based on rather scarce data; therefore, the creation of coordinated databases was suggested. The study supported the view that there are significant gaps in the research of SCD management. As a result, a thorough analysis of the existing databases is required. These databases will show the key question for future research, although it was actively discussed in other articles.

Kara fin et al. (2018) conducted a cross-sectional cohort study on the effects of opioids on pain management in patients with sickle cell disease. The purpose of the research was to analyze the effects of opioids on SCD patients’ health-related quality of life (HRQOL). The study’s scope was restricted to analyzing the effects that opioids as the means of pain management could produce on people with SCD. The study’s rationale included the need to alleviate pain experienced by SCD patients and assess opioids as pain management medication. The authors asserted that the increase in the opioid dose leads to the aggravation of patients’ condition. The authors selected the population, including 99 adults with SCD and a median age of 30. HRQOL questionnaires were incorporated for effective data collection. Additional procedures included counting the amount of morphine administered to patients daily. The analysis results indicated that the use of opioids affects patients’ perception of pain in the long term by intensifying it. From this perspective, data analysis supported the view that there was a correlation between pain perception and the opioid dose in SCD patients (Kara fin et al. 2018). The study can be summarized as research that identified the link between pain intensity and the opioid dose administered to SCD patients. The main question for future research is what options for pain-alleviation, except opioids, can be used for SCD.

Not all authors primarily referred to HU-related therapies as the major approach to overcoming pain in SCD patients. Sins et al. (2017) explored pain management techniques outside the use of HU therapy. The authors of the research sought to understand how pain can be alleviated in patients suffering from SCD, aside from using the HU technique. Having conducted the literature review of 63 sources, they found that other strategies that may include changes in dietary supplements and the introduction of the gardos channel blocker senicapoc may reduce the threat of painful experiences in the target demographic. Zempsky et al. (2017) explored phenotype’s influence as a factor defining SCD patients’ propensity toward experiencing severe pain. The research goal was to define whether the experience of pain associated with SCD was linked to a specific phenotype in SCD patients. The scope of the paper was limited to the study of child patients. It was found that the extent of pain experienced by an SCD patient is not linked directly to their WSP phenotype. The research supported the idea that the WSP phenotype of patients with SCD did not define the extent of pain that they suffer.

Benenson and Porter (2018) also provided an overview of the types of pain experienced by SCD patients. Their research aimed to represent the nature and causes of pain that SCD patients could feel. The scope of the study allowed the authors to embrace the notion of SCD in general. The paper represented a review of literature focused on the concepts of HU and pain management. Since the research implied a literature review, no samples were included. The data collection was based on the analysis of the recent studies and cases of SCD pain management. The findings show that the nature of pain experienced by SCD patients stems from bone demineralization. The analysis of the data supported the idea that positive changes can be introduced into SCD management. The study also indicates that pain is an inevitable aspect of SCD due to bone demineralization.

HU used to manage pain in SCD patients is viewed by researchers as an effective tool. The propensity among SCD patients to experience severe pain is inversely proportional to their hemoglobin levels (Savage et al., 2015). Strategies for increasing hemoglobin levels in patients should be regarded as a valid approach to managing pain intensity and SCD patients (Telen, 2016). On the other hand, incorporating other treatment options, including opioid medications, is often suggested (Brandow et al., 2017). The studies show that HU is not the only solution to pain management in SCD patients; thus, this aspect needs to be examined in detail. Due to the detrimental side effects that opioids have on patients suffering from pain, one may need to reconsider applying opioids and, instead, view a combination of HU and medicinal marijuana as a possible method of handling the concern (Kara fin et al., 2018). The integration of the specified strategy will increase the chances of bettering patients’ lives while maintaining their response to pain alleviation strategies and preventing the situations that will require a consistent increase in the dose of the medication.

Complications and comorbid issues

In order to understand the significance of using an HU-based therapy when meeting the needs of SCD patients as opposed to deploying traditional approaches, one will need to consider the phenomenon of a painful crisis in SCD patients. The specified notion, also known as the vaso-occlusive crisis, implies highly unpleasant experiences caused by sickle-shaped red blood cells in patients’ bloodstream (Hernigou et al., 2018). The specified process requires introducing the approach that will help reduce the inflammation caused by sickle-shaped cells and increase the amount and effects of positive acute-phase proteins in patients (McGann et al., 2016). A thorough analysis of the available evidence is critical.

McGann et al. (2016) conducted a clinical trial to point at the lack of awareness about SCD in certain areas, leading to numerous complications, including infections, thus, reducing patients’ chances for survival. The researchers focused on the sample from sub-Saharan Africa, formulating the hypothesis that HU can lead to significant improvements as long as gaps in knowledge are remedied. The concepts, such as hematological toxicities and other infection-associated terms, were studied in detail. Six hundred children were enrolled in the clinical trial, with a sample amounting to 120 people. The data were gathered by inspecting clinical events records, and other procedures included interviews with patients. The outcomes of the analysis were that using an HU-based treatment could reduce the probability of an infection-related complication in patients. Patient education is strongly encouraged to reduce the threat even more. Preventing infections in SCD patients becomes possible with a combination of HU and patient education. The researchers concluded that patient education and staff training, coupled with HU, produces impressive results.

Hankins et al. (2016), in their quantitative study, analyzed the propensity among SCD children toward the Parvovirus B19 infection, as well as described strategies for its prevention. The study’s purpose was to evaluate the possibility of children with SCD having a natural parvovirus B19 infection during HU therapy. The researchers assumed a link between B19 and HU, introducing the notion of a myelosuppressive agent. Accordingly, 120 patients were sampled for a clinical trial. The analysis of medical records was used as the key data collection tool, with no other methods mentioned. The research outcomes indicated that SCD patients have higher risks of acquiring the parvovirus B19 based on the record analysis outcomes used as a data collection tool. The authors noted that HU’s application could reduce the threat of B19, which affected SCD patients’ lives significantly. The use of HU-based therapy helps to avoid the contraction of B19. For that reason, HU should be incorporated into the treatment framework.

The purpose of the research performed by Hernigou et al. (2018) was to determine the probability of different health complications associated with osteoporosis occurring in SCD patients with specific levels of Tetrahydroaminoacridine (THA) in the target population. The quantitative study was limited to the analysis of 312 arthroplasties, and the authors sought to answer whether the levels of THA in patients could define their propensity toward osteoporosis and, therefore, increased levels of pain. Two hundred and forty-four patients represented the sample, and THA is the key term used in the study. The study’s information was collected by analyzing the medical records of the patients involved in the case. Personal interviews were also utilized as methods for retrieving critical data. Medical complications were observed after 27% of operations. The research results proved a direct link between THA levels and the levels of pain experienced by SCD patients. Controlling TRA can be seen as an important step in addressing SCD patients’ needs. A connection between THA rates and the propensity toward pain in SCD patients has been identified, which means that the specified complication has to be addressed.

It is also important to focus on alternative views presented in the literature regarding the topic. Guery et al. (2018) conducted a chart review and set expectations for analyzing the threats that Non-typhoidal salmonellosis (NTS) contains for SCD patients and focused on covering the challenges associated with diagnosing the disease in SCD patients. The authors limited the scope of the study to the assessment of NTS in adult patients. The research hypothesized that the clinical presentation of NTS is unnoticeable in adult SCD patients. The data collection primarily involved a chart review, with the historical data from 2006 to 2016 was gathered (3500 individuals). The researchers determined significant challenges associated with the diagnosis of NTS in adult SCD patients. The study outcomes suggested that the current approach toward managing the NTS issue should be improved. The information analysis implies the need to incorporate tools for preventing and addressing NTS in SCD patients. Patients with SCD are exposed to an NTS threat due to the drop in the immune system’s levels. As a result, the study indicates that nurses should be particularly aware of NTS’ comorbidities.

Lee et al. (2018) went further and explained the effects that the development of asthma had on patients with SCD and the methods for avoiding and managing the specified comorbidity. They defined the impact that HU has on SCD child patients with respiratory infections such as asthma being their comorbid disease regarding the results related to 200 patients aged 2-20 years old. The researchers used patients’ records during the clinical trial and referred to a questionnaire to gather the required information. According to the research analysis findings, young patients with SCD were particularly exposed to the threat of respiratory infection in vitamin D deficiency. These results indicate that respiratory infections remain a threat to SCD patients aged 2-20 years old. Ogu and Billett (2018) provided a general overview of the key comorbidities that may occur in SCD patients. The study’s weakness is its broad scope, focusing on the research question being geared toward the study of SCD comorbidities, in general. Providing a general review of the existing literature, the study did not include any samples.

According to the key findings, several comorbidities are associated with SCD. These include musculoskeletal deformation, vaso-occlusive episodes, hyperuricemia, and other health issues that require a combined therapy. The researchers stated that, in order to address SCD patients’ needs, one has to combine several strategies to manage comorbid issues along with basic SCD-related concerns (Lee et al., 2018). In their turn, Adesina et al. (2017), in their quantitative study, determined the degree of risk that SCD patients could face regarding the development of osteonecrosis. The research scope was limited to assessing patients with SCD and the ONFH diagnosis who have recently undergone a hip replacement surgery. The sample included 1356 participants, and patient records were scrutinized closely. The study results indicated that ONFH affects patients with SCD, with the surgery changing the quality of their lives drastically.

DeBaun and Kirkham (2016) also hypothesized that HU could improve the treatment of SCD-related central nervous system complications. The authors offered a general review of the recent studies as the only data collection tool, and the results of the analysis supported the idea that the use of HU reduces the propensity among patients to develop CNS-related issues. The possibility of CNS-related problems in SCD patients was observed, and HU’s application as a prevention tool was recommended.

Given the nature of the HU-based treatment, the researchers considered utilizing it to manage inflammation and the related concerns in SCD patients. Since the use of HU leads to a reduction in the number of white blood cells and the rise in the levels of mean hemoglobin in SCD patients, the specified approach has to be tested as a plausible solution to the pain crisis and the increase in the levels of comfort among SCD patients (Hankins et al., 2016; DeBaun & Kirkham, 2016). Managing the needs of SCD patients implies building a pain management strategy based on a detailed analysis of the nature of painful crises and their development. Because of the increase in white cell count and the drop in hemoglobin levels, a pain crisis during an SCD requires the application of an HU-based intervention that leads to an increase in the number of red blood cells and alleviates the pain caused by vessel and tissue rupture in SCD patients (Minniti & Kato, 2016). Adopting an HU-based approach is highly recommended to solve the pain crisis in HU patients and associated complications.

The problem of SCD and its comorbidities need to be studied in-depth in terms of the outcomes that the latter has on patients’ well-being and the increase in the quality of life. In most SCD patients, comorbid health issues are inevitable due to the disorder (Guery et al., 2018). With the application of specific management techniques, the negative impact of comorbidities o patients with SCD can be minimized.

It is crucial to inspect different ways in which SCD affects the functions of a patient’s organism. While the impact that SCD has on the propensity toward acquiring infections and the associated comorbidities is necessary to study, other systems apart from immune and nervous ones require an analysis (Lee et al., 2016). For instance, the effects that SCD produces on patients’ musculoskeletal system also need a profound analysis with HU’s assessment as a possible treatment method. It is worth noting that the negative impact of SCD on the musculoskeletal system also contributes to an increased level of discomfort and pain experienced by SCD patients, which means that appropriate tools for minimizing the painful experiences have to be incorporated into the treatment process (Ogu & Billett, 2018). Patients will have their quality of life improved systematically with the help of regular HU therapy sessions.

Other impacts also need to be explored to sustain HU-based therapy’s efficacy and integrate new components into it. Opportunities for a comprehensive model to be designed will appear. For instance, it is important to know that certain comorbidities add to the risk of developing a stroke in adult SCD patients (Adesina et al., 2017). Creating an environment in which patients are shielded from as many negative factors as possible should be the goal of a health management strategy. The introduction of an HU-based therapy is expected to reduce the specified risks, including the risk of a stroke, yet, in many cases, additional resources such as the provision of vitamin D are required (Adams-Graves & Bronte-Jordan, 2016). A nurse must compose a comprehensive treatment plan based on a combination of HU and other treatment methods.

Pill packaging systems and medication adherence

In addition to reviewing the literature on the use of HU in SCD patients, it is also important to examine the information presented in studies regarding the application of pill packaging systems and the connection of this approach to medication adherence in patients. The reason is that, if medication adherence is inadequate, it is more problematic to cope with complications of SCD (Conn et al., 2015; Hughes, Cadogan, Patton, & Ryan, 2016). On the one hand, pill packing systems and special boxes are highly recommended by healthcare professionals. On the other hand, there is limited research on the topic (Lorenzini & Hellström, 2017). Subtopics that have been identified after reviewing the literature on the problem are pill packaging systems, education of patients, and medication adherence.

Pill packaging systems

In healthcare organizations, nurses often propose SCD patients to use special pillboxes to organize their medications. Researchers focused on different packaging interventions in their studies while examining the correlation of using these systems and expected patient outcomes (Boeni, Spinatsch, Suter, Hersberger, & Arnet, 2014; Lorenzini & Hellström, 2017). Even though the examined studies do not present the information on packaging systems to be used in SCD patients with HU therapy, the reviewed sources are still important to be analyzed to identify potential research gaps.

Telen (2016) concentrated on schedules and systems in using pills when comparing HU to traditional and innovative methods of SCD treatment. The article’s main aim was to compare the efficacy of different methods of SCD treatment, including the HU approach. The researcher assumed that HU and new drugs could improve the well-being of patients compared to traditional medications. The qualitative research examined the effects of different treatment methods in SCD patients regarding eight studies’ results. The research results indicated that the adoption of HU and innovative treatment strategies helped reduce the number of negative experiences in patients and raise the quality of their lives significantly, and the use of a certain system in taking pills contributed to that. The current management of SCD patients’ needs is quite poor concerning alleviating pain when drugs are misused.

Conn et al. (2015) studied the specifics of applying pill packaging interventions to increase medication adherence in patients. The researchers used a systematic review and meta-analysis for testing their assumptions (52 reports). The overall mean in effect size was 0.593, which is related to 71% adherence for treatment subjects compared to 63% in control subjects. The findings demonstrated that different packaging interventions could effectively increase adult patients’ adherence to drugs, especially if pillboxes and simple blister packs are applied. This study supports the view that, by utilizing certain packing systems, it is possible to improve patient outcomes associated with well-organized medication therapy.

In their systematic review, Lorenzini and Hellström (2017) examined how older patients can appropriately use pill packaging. The study was focused on finding a relationship between the application of senior‐friendly medication packaging and positive outcomes for older people. The search for analysis sources was conducted in Scopus, Medline, Web of Science, and Engineering Village. The authors selected 34 articles, and their review indicated that the application of specific pill packing devices and systems is beneficial for patients, especially for older ones, because they can easily use these devices and follow a schedule of taking their drugs.

The review of the articles on the topic of using pill packing in patients indicates that there are no studies to examine SCD patients’ experience, and this gap needs to be addressed with the help of the current project. The researchers of reviewed articles are concentrated on finding the relationship between using different packing systems and changes in patients’ medication adherence (Lorenzini & Hellström, 2017; Telen, 2016). Additional research is required to study the relationship with a focus on SCD patients taking HU and using pill packaging systems to improve their drug adherence.

Patient education on taking medications

When it comes to addressing the needs of patients with SCD and the related comorbidities with the help of the HU therapy, one must keep in mind that the specified process implies the direct and consistent communication between a patient and a nurse, as well as other healthcare staff members, regarding their medication therapy (Brennan-Cook, Bonnabeau, Aponte, Augustin, & Tanabe, 2018). Also, integrating strategies that allow for improving communication between a patient and a nurse suggests a significant rise in patient education quality. Although the specified issue is often taken for granted during the provision of HU treatment for SCD patients, it is critical to ensure that the target demographic is aware of the means of maintaining positive health levels with the help of adhering to taking drugs (HU) (Sinha, Bakshi, Ross, & Krishnamurti, 2018). Patient education and the promotion of patient agency and independence are critical components of HU therapy and the process of patient care (Badawy et al., 2016). With the help of a consistent patient education process, SCD patients will learn how to take HU appropriately.

Brennan-Cook et al. (2018) conducted a descriptive study and tested certain patient education techniques to provide SCD patients with opportunities to overcome their condition’s negative outcomes. The research goal was to study the available SCD patient education tools focusing on the scope of embracing 200 SCD patients. The research hypothesis concerned the integration of nurse-patient communication to improve their approach to applying medication therapy. The authors found out that communication is critical for SCD patients’ education, and patient education is critical in SCD cases, with further studies for education techniques being required. Smaldone et al. (2016) received similar results when they aimed at showing that the incorporation of patient education approaches that involve transformative nursing leadership could contribute to faster patient education. Transformative leadership was recommended to improve patient education.

Sinha et al. (2018) studied HU’s use in adult SCD patients and found out that patient education through nurse-patient communication is essential for successful pain management. The researchers supported the importance of patient-nurse communication during SCD management regarding the sample of 95 patients. Earlier, Hsu et al. (2016) defined SCD patients’ education opportunities regarding different interventions, including pill packing. The study showed that patients’ lack of awareness about SCD might lead to lethal outcomes, necessitating introducing a program for patient awareness. Record analysis was used to collect the data, and it was concluded that creating an awareness program is the key to improving SCD patients’ education. There is a significant lack of awareness among SCD patients, which needs to be managed with an improved communication strategy to inform about medication therapy rules.

Nagalla and Ballas (2016) represented reducing painful experiences in SCD patients by using different interventions, including medication therapies. A sample of three studies out of 51 selected ones was included in the analysis. The results of the research demonstrated that the current strategies for changing red cell parameters lack consistency. Despite improved approaches toward managing the needs of SCD, the nature of change in red cell count is still vague, which does not allow modifying the pain management framework successfully. Little attention can be paid to educating patients regarding the specifics of their condition to improve their living. In their turn, Minniti and Kato (2016) discussed patient education and medication therapies when focusing on managing and preventing leg ulcers in SCD patients. The research scope allowed for embracing the global community’s needs since the analysis of separate cases is provided.

The research hypothesized that a combination of HU and supportive care, as well as patient education, could reduce the probability of leg ulcers or the aggravation of an already existing issue. The authors introduced terms such as chronic transfusions and provided a short literature review in the introduction section. The authors reduced the sample to five clinical cases. It is possible to state that the study provided an analysis of several clinical cases as the main data collection tool. According to the analysis findings, the adoption of HU helps reduce the threat of leg ulcer development and manage the ones that already exist. In this case, much attention is also paid to patients’ adherence to medication and regimens (Minniti & Kato, 2016). Leg ulcers are a common complication observed in SCD patients due to disruptions in blood vessels’ functioning. As a part of a larger therapy, HU should be seen as a method of managing leg ulcers and preventing them from occurring at earlier stages of SCD.

The reviewed articles demonstrate that the lack of a patient-nurse dialogue regarding the management of SCD and medication therapies is especially common in the setting that involves either severe overstaffing or patients living in remote areas that cannot be accessed by healthcare providers (Hsu et al., 2016). A strategy for encouraging a patient-nurse dialogue in unfavorable conditions is required. The specified issue can be addressed by utilizing digital tools for maintaining the dialogue consistent to ensure effective patient education. Monitoring tools that allow nurses to concentrate on outpatients’ needs and address the concerns of SCD inpatients in an understaffed environment are needed.

Several gaps in the contemporary literature address HU’s effects on SCD patients in alleviating their pain regarding taking such pills as HU. Specifically, the opportunities for combining the HU approach with a framework that encourages communication between a patient and a healthcare expert or a nurse are examined in studies. The specified issue is particularly important for SCD patients, who require nurses and healthcare experts’ assistance and support throughout their life (Smaldone et al., 2016). The lack of insight into the communication and patient education can create a platform for successful pain management is a reason for concern (Nagalla & Ballas, 2016). With the insight gained from the studies mentioned above, one can construct the patient education strategy and the communication framework for nurses to utilize when administering HU therapy to SCD patients. As a result, a drop in medical errors and a rise in pain management efficacy are expected.

Medication adherence

Huang et al. (2000) admits that it is possible to use a specific questionnaire to define medication adherence. The scientist stated that his questionnaire effectively determined pill-taking patterns in patients to conclude regarding possible differences in their medication compliance. This information means that the questionnaire by Huang et al. (2000) can be used for this project to identify the changes in patients’ medical adherence.

There are indications that the application of HU and pill packaging systems can assist in managing most of the instances of pain crisis in SCD patients by addressing some of the changes within their bloodstream and the opportunities for managing the issues associated with the patients’ musculoskeletal system (Checchi, Huybrechts, Avorn, & Kesselheim, 2014). The existing studies support the view that integrating the proposed approaches will introduce opportunities for alleviating pain based on a process of healing in a patient’s tissue, and medication adherence will increase (Adams-Graves & Bronte-Jordan, 2016; Smith et al., 2015). New mechanisms in managing painful sensations in SCD patients can be introduced successfully (Zempsky et al., 2017). Currently, the use of opioids is being regarded as important, yet the increase in dosage and the propensity toward developing dependency in SCD patients are rather troubling signs signaling that there is a necessity to change the treatment approach and use appropriate regimens (Boeni et al., 2014; Hosseini et al., 2016; Zhang et al., 2016). The researchers pay much attention to studying the relationship between regimens, medication therapy, and medication adherence leading to positive patient outcomes.

Smith et al. (2015) conducted a quantitative study and assessed the effects that HU has on alleviating pain in SCD patients in general and focusing on medication adherence. The article’s goals were to determine the connection between the use of an HU approach and the extent of pain experienced by people with SCD depending on their adherence to the regimen. The research rationale was to reduce painful experiences in SCD patients, the key concepts being analgesics and HU. A sample of 134 patients was used in the research, and it was found that the use of HU has an analgesic effect on the pain experienced by SCD patients when applied appropriately. The study set in a clinical environment was expected to prove that HU positively affects pain management in patients. The initial hypothesis was supported by future studies having to focus on how patient-nurse communication can be enhanced. This communication is reported to play an important role in influencing medication adherence in patients.

In a cross‐sectional survey, Badawy et al. (2016) studied how technologies can contribute to medication adherence in patients with SCD. They discussed modern devices and technologies, along with education techniques in SCD patients. The research involved 107 participants and indicated that patient-nurse communication and certain applications should be supported with innovative solutions for better training. IT and ICT tools are believed to be essential in enhancing the quality of care for SCD patients when focusing on patients’ adherence to taking drugs, including HU. It was concluded that innovative communication tools should be integrated into the promotion of patient education. Hoppe et al. (2017) analyzed Simvastatin’s effects on VOC in SCD patients experiencing vaso-occlusive pain. The study’s rationale was that the drug’s assessment in question would allow for alleviating pain more actively and effectively. The researchers found out the management of pain in SCD patients should be improved by introducing Simvastatin as the primary medication and incorporating it into the pain management strategy, but the focus is also on controlling how patients adhere to using their drugs.

In their review research, Adams-Graves and Bronte-Jordan (2016) discussed the issues associated with access to SCD patients’ care. The study’s goal was to inspect the factors that impede patients with SCD from accessing healthcare services. The study’s rationale was to provide people with SCD with access to care and improve the quality thereof. The research question was how to improve the existing strategies with the help of an HU-based framework. In addition to that, the researchers also discussed the role of medication adherence in influencing the quality of treatment for SCD patients. The Registry and Surveillance System for Hemoglobinopathies (RuSH) program was used to collect data, and the results of the research proved that there are significant impediments in access to care for SCD patients. Due to the lack of healthcare access, patients with SCD and comorbidities suffer extensively because of the impossibility of getting prescriptions and taking pills appropriately. Many factors can prevent SCD patients from taking their drugs regularly in order to improve their physical state.

Zhang et al. (2016) reviewed cellular and molecular factors that define a pain management intervention’s success. The purpose of the research was to review the factors that could lead to vaso-occlusive crises (VOC) and define the approaches that may improve patients’ well-being and quality of life. In this context, much attention should be paid to the following regimens. The study’s scope was rather broad, with the rationale being to address diverse cases of SCD and pain management. The key concepts reviewed were VOC, pain management in SCD patients, and medication adherence. Since the entire study was an overview of the existing factors, it can be regarded as a comprehensive literature review. The findings indicate that the factors contributing to a rise in pain levels in SCD patients include hemolysis that causes inflammation and the following rise in pain intensity. Patients need to adhere to their medications in order to overcome VOC. In other cases, it is possible to experience significant pain and negative effects on everyday life.

The literature review indicates a limited number of studies covering the problem of medication adherence regarding the sample of SCD patients taking HU. The studies discussed in this section seem to indirectly address the question of adherence to drugs, such as HU, to overcome SCD symptoms and associated pain (Badawy et al., 2016). As a method of inhibiting pain and restoring some of the functions of an SCD patient’s body, the HU therapy should be regarded as one of the most promising frameworks for improving the quality of SCD patients’ lives (Nagalla & Ballas, 2016). Combined with an elaborate somatosensory system for identifying the causes of pain and reducing the impact thereof, HU will serve as an innovative approach toward addressing the needs of people with SCD (Boeni et al., 2014; Haywood et al., 2014). From this perspective, more research is required to determine how certain strategies in taking pills (pill packaging systems, for example) can increase adherence to medications in SCD patients.

Summary

In this chapter, available literature on this topic has been discussed. Two major themes and six related subtopics have been identified: HU, other SCD therapies, pain management, complications, comorbid issues, pill packaging systems, patient education on taking medications, and medication adherence. It has been found that researchers are inclined to actively discuss the effectiveness of using HU in patients with SCD, but limited research is available on using packaging systems in patients with SCD or patients taking HU. Many studies describe testing the relationship between taking pills and using different regimens and medication adherence to influence patients’ outcomes. There is a gap in the literature on possible relations between pill packaging systems for patients taking HU and their medication adherence. The literature review indicates the necessity of conducting the current project to provide evidence regarding the possible relationship between applying packaging pills and medication adherence changes in a specific group of SCD patients taking HU.

In addition to synthesizing and analyzing the articles on using HU in patients with SCD focusing on their adherence to medications, the chapter also includes the information on the theoretical model to be applied in this project. A suitable theoretical model to use is Ajzen’s theory of planned behavior to explain what factors influence patients’ adherence to medications. The analysis of retrieved articles indicates that the focus on in-depth reviews of records provided by hospitals and other healthcare organizations regarding SCD patients’ regimens and medication adherence is appropriate for this current project. As a result, after performing this DPI project, it is possible to expect that effective evidence of using pill packing for increasing adherence to medications will appear to be used by healthcare providers in their practice. In this case, the focus is on improving patients’ experiences with SCD taking HU and using certain pill packaging systems. In Chapter 3, the methodology applied to this project will explain what procedures will be followed to determine how the use of pill packaging systems and a mobile application can affect changes in the adherence to medications in patients with SCD who take HU.

Methodology

The purpose of this quantitative quasi-experimental project was to determine if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. This project is supported by the data indicating patients fail to follow a medication prescription, which exposes them to adverse health outcomes. This project’s focus is on determining the patients’ increased abidance by the prescribed medication intake of using pill compliance packaging and a mobile application on HU therapy for SCD patients in the context when non-compliance packaging approaches proved to be ineffective. As a result, it is essential to examine how pill packaging systems and mobile apps can improve medication adherence. The methodology described in this chapter is proposed to address how HU therapy combined with applying pill packaging systems and a mobile app can affect medication adherence in patients with SCD.

In this chapter, the problem, clinical question, appropriate methodology, design, population, and sample are described. The chapter presents the applied instruments focusing on their validity and reliability and the description of data collection and analysis procedures, ethical considerations, and limitations. This information is necessary to show that the proposed project aims at addressing the topical problem and achieving significant outcomes.

Statement of the Problem

It is unknown if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The literature demonstrates, the application of HU and pill packaging systems, as well as appropriate mobile applications, can potentially prevent the development of complications associated with SCD, but the research on the role of this therapy in increasing medication adherence is still limited (Badawy et al., 2017; Wang, 2016). Taking HU is discussed as one of the most effective therapies in patients with SCD. However, there is still a high non-adherence to this medication and a lack of research on the problem.

The specific problem investigated in this project is that, although HU is actively used to treat SCD, healthcare providers have difficulty finding alternatives to increase medication adherence in patients. The use of pill packaging systems in SCD patients requires more detailed investigation because limited pill intake management aspects were only researched previously (Telen, 2016). A lack of data on applying pill packaging systems and mobile apps in combination with HU therapy illustrates the necessity of more research in the field to examine all potential outcomes of using HU and pill packaging systems for SCD patients in terms of their medication adherence.

Clinical Question

The clinical question guiding the project was: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks? In this question, the independent variable is HU therapy based on using pill packaging systems and a mobile application measured regarding the intervention’s presence or absence. The dependent variable includes changes in medication adherence in patients with SCD, the data collected with the help of a survey, and measured referring to the provided figures. The focus on the cause-and-effect relationship between these variables accentuates the necessity of selecting the project’s quantitative methodology.

The quasi-experimental design selected for this project was determined to be the best approach due to its ability to identify the effect of an intervention on the population. Thus, the independent variable was the use of pill packaging systems with a mobile app in the context of HU therapy, and the dependent variable was medication adherence. Since it was necessary to collect data regarding patients’ medication adherence, Huang et al. (2000) questionnaire was applied. This questionnaire can demonstrate whether individuals regularly take their medication and follow doctors’ prescriptions.

Project Methodology

A quantitative methodology is the most appropriate option for conducting this project compared to a qualitative approach. The reason is that a quantitative method applies surveys and statistical tests for finding the relationships between variables regarding collecting numerical data, and these tests include chi-square tests, t-tests, Pearson correlation coefficient, and regression tests, among others (Bell et al., 2018; Trochim et al., 2015). A qualitative methodology helps a clinician understand specific details regarding the phenomenon, concentrate on subjects’ visions, and formulate the theory referring to collected data (Trochim et al., 2015). This approach cannot lead to addressing the set clinical question in this project. On the contrary, a quantitative method can be considered appropriate for applying the selected theory to explain the studied relationship and test hypotheses.

For this project’s purpose, a quantitative methodology covers the questions asked, and the application of mixed methods can seem unrequired. Applying a survey (questionnaire) proposed in the context of quantitative methods, it was possible to collect data regarding the use of compliance pill packaging and a mobile app in patients with SCD in the numerical form and analyze them to conclude about the effectiveness of the combined intervention for individuals with SCD (Bell et al., 2018). Referring to the existing literature on the problem where a quantitative method was applied, it is possible to predict positive outcomes of using the intervention in persons with SCD (Badawy et al., 2017; Lê et al., 2015). From this perspective, a quantitative methodology is selected as appropriate to examine the efficacy of pill packaging systems and a mobile application to improve medication adherence in patients with SCD.

Project Design

The project design applied in this project was quasi-experimental to answer the clinical question on to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks. The reason for selecting a quasi-experimental approach was the necessity of applying the intervention (HU therapy combined with a pill packaging system and a mobile app) and then describe whether the intervention has resulted in significant changes regarding the dependent variable.

A quasi-experimental approach is viewed in the academic literature as useful in answering cause-and-effect questions. This design is appropriate for determining the intervention outcomes based on HU therapy and using pill packaging and a mobile app for medication adherence (Bell et al., 2018; Trochim et al., 2015). Compared to the correlational, case study, or descriptive designs, this approach is practical and does not require significant resources (Siedlecki, 2020). It is also more time-efficient. It can be regarded as the best choice to address the problem of using effective HU-based interventions to increase medication adherence and manage the pain crises (Bell et al., 2018; Cokley & Awad, 2013). However, it is necessary to remember that the absence of randomization is a limitation of this design, influencing its findings.

A quasi-experimental design effectively supports the offered intervention based on using pill packaging systems and a mobile app to solve the practice problem of low medication adherence in SCD patients. This project sample included 75 patients with SCD who were asked to take HU with pill packaging systems and utilize the Mango Health mobile application. The independent variable was the use of pill packaging systems with a mobile app in the context of HU therapy, and the dependent variable was medication adherence. The sample data was collected with a questionnaire developed by Huang et al. (2000) to determine possible changes in patients’ medication adherence due to applying the intervention.

Population and Sample Selection

This project’s total population covers all individuals with SCD treated by HU (1,018 individuals) in the community. The project population covers those medical center patients with SCD who received medications at the local North Carolina pharmacy (512 individuals). The total population is contacted in the context of the purposive sampling procedure with managers’ help at the local pharmacy and a medical center to involve in the project. The project deals with an urban population that has sufficient access to medical services.

The pharmacy is a community medical facility that provides a wide range of medical services to patients of different origins, genders, and age groups. North Carolinians can access this medical establishment to receive qualified and evidence-based assistance. The medical center is recognized by MAGENT, which means that its staff members are devoted to providing patients with sufficient care to achieve the best possible health outcomes.

The following inclusion criteria were formulated for the potential participants: living in North Carolina, being diagnosed with SCD, taking HU, and having a smartphone to use applications. Exclusion criteria included taking other medications in addition to HU and using other therapies. The population was attained referring to the pharmacy databases: potential participants were selected depending on being prescribed HU on a regular basis.

The selected medical center authorities were contacted to receive access to records on patients with SCD and medications they take. Their approval and supervision were required to gather all the needed data for analysis in this project. Furthermore, nurse practitioners were contacted to acquire data regarding patient medication compliance. These medical professionals should provide recruited patients with questionnaires to identify their medication adherence behaviors. At the recruiting stage, the participants addressing inclusion criteria were provided with the details regarding the project and an informed consent form. It was stated that their confidentiality would be guaranteed. Those participants who agreed to participate in the project provided their signed informed consent forms before starting the data collection procedures.

Instrumentation or Sources of Data

This project’s primary source of data is the questionnaire completed as the participants’ reaction to the following intervention: applying HU therapy combined with pill packaging systems and a mobile application (Mango Health).

Pill packaging systems. Some patients using the services of Premier Pharmacy and Wellness Center use bottles for keeping their medication, and others use pill packaging systems, such as labeled blisters, unit-dose and multi-dose organizers, and pillboxes with dates. According to Huang et al. (2000) and Boeni et al. (2014), the type of containers for organizing pills can influence medication adherence. Those participants who agreed to join the project were asked whether they used a pill packaging system (a free option) referring to the information from the records on SCD patients’ prescription fill history and pill pack counts from the local pharmacy in Charlotte, North Carolina, as well as their medical records from Wellness Center within the pharmacy. Similar records were also used by Wickson-Griffiths, Kaasalainen, Ploeg, and McAiney (2014) and Van Melle et al. (2018) in their studies.

The Mango Health mobile application. This app provides patients with regular reminders regarding the number of pills to take and refill alerts (Haase et al., 2017). The application motivates the users to take their medication on time by offering in-game currency for the right behavior. This application is expected to increase adherence to medications in multiple patients (Kitty, 2020; Singh et al., 2016). The application is free, and it can be downloaded to be used with Android and iOS. The participants were asked to use this application when receiving their HU therapy regardless of the type of pill organizers they utilize.

Medication adherence questionnaire. The project adapted the freely available medication adherence questionnaire developed for patients using pill packaging systems (Appendix B). The questionnaire was designed for the study by Huang et al. (2000) regarding the data self-reported by participants. The questionnaire includes eight main items on patients’ adherence to pill-taking and additional questions to collect demographic data. Huang et al. (2000) reported that this tool effectively determined pill-taking patterns in patients to conclude possible medication adherence differences. Since a medication questionnaire is involved, the patient population was asked to express their consent to participate in the intervention.

Validity

The validity of data collected after applying pill packaging systems, a mobile application, and using a survey, is measured regarding the validity coefficient using the SPSS software. When it comes to the questionnaire validity, it is reasonable to focus on the study by Huang et al. (2000). The researchers attempted to identify whether the use of pill packaging and blister packs can increase medication adherence. For this purpose, they conducted a randomized trial of 184 individuals who were divided in intervention and control groups. The self-reported questionnaire was used to collect the data from the participants. According to Huang et al. (2000), the desired degree of validity for the instrument measuring medication adherence is.30 -.40; this value is regarded as high. The given instrument allowed the researchers to find that blister packs were more effective in improving medication adherence compared to pill organizers.

Reliability

Agala et al. (2020) have demonstrate reliability, validity, and measurement invariance of the self-reported medication adherence questionnaire. The given research instrument made the participants answer whether they forgot to take their medicine, how they assess their medication adherence. Agala et al. (2020) performed a quasi-experimental study to identify the reliability and focused on 926 female individuals. The scholars made the participants complete the questionnaire both at the baseline and follow-up. In conclusion, Agala et al. (2020) used Cronbach’s alpha to measure reliability and identified that the research instrument had the values of 0.6-0.8 that are considered adequate.

Data Collection Procedures

It is essential to introduce the project to the clinic staff. The explanation of every step of the planned implementation process to the staff is necessary before getting the institutional review board approval. Following approval from the institutional review board at Grand Canyon University (Appendix A), patients were contacted to participate in the project. All the patients gave voluntary consent to participate in this research (Appendix C) (Trochim et al., 2015).

The participating sample was contacted via mobile phones; the medication center agreed to provide the patients’ phone numbers for the purpose of this research. Those who agreed to participate were invited to an organizational meeting at the health center, where they were educated on using pill packs. A researcher demonstrated the possibilities of pill packs by assorting the medication to them in front of all the participants. Participants were asked to download the application and showed a PowerPoint presentation explaining how to use the application and adjust it to personal needs.

In a month after the intervention, the participants were invited to another organizational meeting at the same health center to ensure that the participants completed two questionnaires under the same external conditions. They were given a questionnaire to complete to retrieve information on the participants’ use of pill packaging systems and the regularity of taking medicines. The specific questionnaire is the primary procedure to collect the data regarding the intervention’s impact on the dependent variable, medication adherence. The participants were gathered in a single room to answer the questions. No time limits were used to ensure that the participants had sufficient time to think about the questions thoroughly.

Every patient’s questionnaire was coded to ensure individual anonymity. A chief researcher provided the participants with codes to use them instead of personal details. The codes and the completed records should be stored in a locked cabinet that can only be accessed by the chief researcher. This step was necessary to motivate the patients to answer the questions fairly and without any bias. The answers should not be uploaded to any web clouds because this approach cannot guarantee safety. The data should be kept for three years after the study has been completed. When this period is over, the materials will be destroyed to prevent any misuse of this information per organizational policy.

Data Analysis Procedures

The clinical question that guided the data analysis procedures was: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks? For the independent variable of using a pill packaging system and a mobile application, the categorical data were collected after conducting the intervention regarding the participants’ medical records and their answers to the questionnaire items. The collected categorical data (raw data) were converted into figures for inferential analysis with a chi-square test. Thus, a chi-square test was utilized to accentuate the changes in medication adherence (a dependent variable) depending on the presence of HU therapy with or without pill packaging systems supported by the use of a mobile application (an independent variable).

The participants’ answers (Yes/No) to the questionnaire by Huang et al. (2000) were converted into figures (1/0) organized in tables to be used in SPSS (Statistical Package for Social Sciences) for a chi-square test. A chi-square test was selected for this project as a tool applied typically in a quantitative methodology (Trochim et al., 2015). SPSS software was used for conducting a chi-square test to evaluate the assumptions formulated for this project. A significance level of p < 0.05 was chosen to ensure that the obtained results are statistically significant and minimize the effect of chance. This step is necessary to justify that the results are scientifically valuable.

Descriptive analysis was applied to demographic data and descriptive data collected with the help of the questionnaire. The participants’ demographic data, including their age, race, and ethnicity, were collected from their medical records at the recruitment stage. The following data were collected and measured regarding the percentage: the regularity of taking HU, the use of Mango Health, problems with remembering taking HU, and the interest in pill packaging systems. Percentages can be viewed as the most recognized variant of descriptive statistics for quantitative projects about analyzing collected data. Percentages for the collected data were calculated by dividing the frequency into categories by the total number of participants.

A chi-square independence test will be conducted using SPSS software (Version 27) to determine possible statistically significant differences for the variables in both determined groups (those using pill packaging and the mobile application and those not using them). A chi-square independence test was conducted for groups to determine any statistically significant difference in the level of medication adherence self-reported by participants depending on the application of HU with or without using pill packaging systems and a mobile application, where p < 0.05. The conducted chi-square independence test helped provide the data significant for answering the set clinical question on finding a possible difference between HU’s application supported by pill packaging systems and a mobile app and medication adherence in patients with SCD.

Ethical Considerations

The ethical issue related to the project is associated with retrieving medical records on patients with SCD from the local pharmacy and the medical center. The challenge refers to the fact that they include protected health information according to the Health Insurance Portability and Accountability Act (HIPAA) and the protection of received data. To guarantee that all the ethical issues are addressed, it is necessary to ask for and receive the authorities’ permission regarding access to clinical data for this project (Trochim et al., 2015). The patients’ data were coded to protect it from any possible disclosure.

According to the Belmont Report, beneficence, respect, and justice were guaranteed through protecting patients’ confidentiality when disclosing project results. Beneficence was guaranteed at the stages of data collection and analysis when risks of disclosing personal information were minimized for the participants. Respect was guaranteed at the stages of recruiting participants and collecting data as they could withdraw from the project at any stage. Justice was ensured through the ethical process of selecting participants according to inclusion criteria without biasing potential respondents. The approval for conducting such a project should be received from the Institutional Review Board, and it was obtained.

The current project also addresses the privacy interests of the participants. It relates to the fact that the participants are free to choose any convenient time of a specific day to come to the medical center to complete the post-test questionnaire. This condition is necessary because some individuals from the sample size are employed, meaning that a fixed date and time can result in some difficulties for them. Furthermore, the participants are told that researchers can only receive and use their information.

The participants will also be offered solid confidentiality principles to ensure that their private health information will be protected. The participants will disclose their information by filling in the printed questionnaires, meaning that these papers only represent a threat. That is why the respondents will use codes instead of their full names. A chief researcher will only have these codes, which minimizes the danger of disclosing personal details. The codes and the completed records will be stored in a locked cabinet that can be accessed by the chief researcher.

As has been mentioned, the data will be stored in a locked cabinet. The chief researcher will only have access to the participant’s records and codes that can be used to identify the completed questionnaires’ authors. The data will be kept for three years after the study has been completed. When this period is over, the materials will be destroyed to prevent any misuse of this information. This approach is necessary to meet the institutional review board requirements.

Limitations

One of the major limitations is the necessity to limit the project scope to the settings located in North Carolina, which makes the project more specific. Other critical limitations in this project are associated with the use of the quantitative methodology. Depending on the specifics of available medical records and answers to questionnaires, one of the limitations is the lack of access to accurate records presenting all the required information. It is important to note that, if the documentation and participants’ answers to questionnaires are incomplete, it is almost impossible to receive statistically significant results when conducting specific analyses to test hypotheses and assumptions. This limitation was addressed in the project while selecting only those patients whose medical records included all the necessary data, and questionnaires were checked for providing the answers to all questions.

One more limitation was associated with the application of a quantitative method. It was almost impossible to examine the trends in treating patients with SCD regarding the figures gathered for this quantitative project because of its descriptive nature (Trochim et al., 2015). Further research on the topic is recommended based on a qualitative methodology to examine patient outcomes after receiving HU therapy in detail to support this project’s findings. It is so because the quantitative method does not allow for exploring qualitative changes in patients’ adherence to medication. The timeframe in one month could also influence the results of the project. This limitation was addressed during the analysis of the results to avoid potentially inaccurate generalizations and interpretations. Another limitation refers to the design of the given research. As has been mentioned, a quasi-experimental design lacks randomization. It means that the sample population does not represent society’s different qualities, meaning that the results cannot be generalized.

Summary

This chapter has articulated the statement of the problem and the clinical question of the project. It has also presented detailed and comprehensive information on the methodology selected for examining how the application of HU therapy combined with pill packaging and a mobile app in individuals with SCD can predict changes in medication adherence. For this project, a quantitative method has been selected as more suitable to address the project’s purpose than a qualitative method or mixed methods. A quasi-experimental design was proposed as a specific research design that allows for analyzing the cause-and-effect relationship between the variables. The project sample included 75 patients aged 18-30 years old with SCD receiving services in a medical center in North Carolina.

Data collection and analysis procedures typical for a descriptive project were described in this chapter with much detail to present the steps to be made by the author to realize the purpose of this project. A questionnaire was used to collect data on the intervention’s application based on HU therapy, pill packaging, and a mobile app. A chi-square statistical test was chosen to examine the differences in medication adherence after applying the intervention. The process of preparing the data for analysis has also been covered. The chapter also includes information on the validity and reliability of using instruments, and it was stated that the proposed instruments were reliable and valid. Finally, this chapter’s ethical issues, including the participants’ privacy interests, confidentiality, and data management, as well as limitations, were also described in this chapter to inform the reader about all the quantitative project details.

The given chapter has presented a comprehensive description of all the necessary details to conduct a quantitative study. That is why the following chapters will show the exact calculations and statistical information. For example, the results of applying for a review and a questionnaire to address this project’s clinical question will be presented in Chapter 4. In turn, Chapter 5 will summarize the entire project and offer reasonable conclusions regarding the whole research.

Data Analysis and Results

The purpose of this quantitative quasi-experimental project was to determine if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The clinical question guiding the project was: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks?

The methodology selected for this project to address the clinical question is quantitative, focusing on applying a quasi-experimental research design and data analysis based on a chi-square test. This chapter describes the data analysis procedure and presents the actual results of the given project. Therefore, in this chapter, descriptive data related to the project results, data analysis procedures, findings, and the summary will be provided in detail. That is why the subheadings, including Descriptive Data, Data Analysis Procedures, and Results, will be used.

Descriptive Data

All the participants addressed the following inclusion criteria: living in North Carolina, being diagnosed with SCD, taking HU, and having a smartphone to use applications. The demographic data presents that 64% (N= 48) of the participants with SCD and taking HU, who are aged 18-30 years, are men. The project did not present a demographic form to separate out the ages in smaller ranges. All the project participants are African Americans, and 77 percent (N= 58) of them are employed.

Table 1:Descriptive Demographic Data

Data Analysis Procedures

The following data were collected from the completed questionnaire to be used in a chi-square test: adherence to taking pills by patients compared to a prescribed number of pills per day and problems in taking pills regularly and using a mobile application. A chi-square independence test was conducted using SPSS software (Version 27) to determine possible statistically significant differences for the variables in both determined groups (those using pill packaging and a mobile application and those receiving the standard of care). Thus, a chi-square independence test was conducted for groups to determine any statistically significant difference in the level of medication adherence self-reported by participants depending on the application of HU with or without using pill packaging systems and a mobile application, where p< 0.05.

The conducted chi-square independence test helped to provide the data significant for answering the set clinical question on finding a possible difference between HU’s application supported by pill packaging systems and a mobile app and medication adherence in patients with SCD. The selected data analysis is aligned with the set clinical question and is appropriate for a quantitative descriptive project. The sources of error were associated with the self-reported medication adherence. To ensure the patients’ levels of medication adherence were reported accurately, these data were compared with the number of pills taken by patients per day compared to a prescribed schedule.

Referring to reliability and validity issues, the collected data were checked several times to minimize errors; Cohen’s kappa is 0.7, and Cronbach’s alpha equals 0.79-0.89 (Conn et al., 2015; Singh et al., 2016). Cohen’s kappa indicates that there is a substantial agreement between the variables under analysis, while Cronbach’s alpha demonstrates an acceptable internal consistency of the data. The reliability and validity of data related to a chi-square test were checked with the help of SPSS, and they were also determined to be high. Descriptive data were analyzed to calculate the percentages for the collected data by dividing the frequency into categories by the total number of participants.

Results

The project aimed to answer the following clinical question:

Q1: In patients with SCD, would the combined implementation of HU therapy with a pill packaging system and a mobile application increase medication adherence?

Statistical data related to the percentages associated with this project’s variables are summarized in Table 2. Data demonstrates that the same number of patients (N= 75, 100%) participated in both pre- and post-test questionnaires. All 75 individuals (100%) reported difficulties with remembering to take HU medication regularly. This state of affairs results in the fact that 27 members (36%) only take their medication regularly pre-test. However, the post-test results show that 71 individuals (94%) report adhering to their prescribed medication entirely.

Table 2: Pre- and Post-Intervention Results

Table 3 introduces the results of a chi-square test to see a degree of relationship between two variables, referring to the proposed intervention and medication adherence. Since the task is to find a confidence interval for the specific sample, the degree of freedom is 1. The chi-square result of 17.6389 shows that the correlation between the variables is present. Table 3 shows that p =.000027 is present between the use of pill packaging combined with a mobile application and medication adherence. The test result is significant at p =.05; thus, it is possible to state a statistically significant difference in HU adherence between the two groups of participants.

Table 3:Chi-Square Test Results

Summary

In summary, examining the relationship between the variables to address the clinical question was provided. The chi-square test results (X2 (1, N = 75) = 17.6389, p =.000027, at p <.05) indicated there was a statistically significant difference in medication adherence between those patients who used a pill packaging system combined with a mobile application and those who received the standard of care. Consequently, the clinical question is answered because the intervention under analysis leads to a fewer number of individuals who forget taking HU medication regularly.

In Chapter 5, the interpretation and analysis of the received findings will be presented regarding how the obtained results effectively address the set clinical question and how these findings are correlated with the previous findings on the problem and topic. Furthermore, Chapter 5 will summarize the entire project, comment on what useful implications can be articulated based on the project, and offer further research recommendations.

Summary, Conclusions, and Recommendations

Chapter 5 summarizes the project focusing on interpreting the received findings, conclusions, implications for theory and practice, and recommendations. The project’s completion of examining how pill packaging systems and HU-based therapy and a mobile application in individuals with SCD can affect their medication adherence has important implications for both theorists and practitioners. The reason is that the project results helped determine what interventions can be regarded as beneficial for patients with SCD. It was identified that there was a statistically significant difference (p=.05) in medication adherence between the participants who used a pill packaging system in combination with a mobile application and those who did not use a pill packaging system. The detailed interpretation of the results presented in this chapter and supported by the discussion of implications and recommendations will inform health care providers and theorists regarding the effectiveness of applying pill packaging systems for patients with SCD who use HU-based therapy to improve their adherence to medications.

Summary of the Project

The purpose of this quantitative quasi-experimental project was to determine if or to what degree the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD in a North Carolina medical center. The formulated clinical question focused on the issue that insufficient medication adherence resulted in adverse health outcomes.

The project advances scientific knowledge by offering a practical solution of how to promote medication adherence among SCD patients. This scientific work is significant because it addresses the essential topic of poor medication adherence behavior among SCD patients. This problem is acute, and the project demonstrates that it is possible to improve the outcomes in this area with specific interventions that can improve public health.

The literature review helped identify that there was a lack of knowledge on how the use of different types of pill packaging systems combined with a mobile application can influence the effectiveness of treatment of sickle cell disease in patients regarding their adherence to the prescribed medication (Badawy et al., 2017). To address this issue, it was necessary to refer to the theoretical framework based on Icek Ajzen’s planned behavior theory. According to the theoretical assumptions, people’s specific attitudes, their ability for behavioral control, and their knowledge of subjective norms can predict their decision to demonstrate certain behaviors in different situations (Rich et al., 2015). This theory can explain why patients with SCD can choose to adhere or not to their medication regimens. The theory can also explain how additional tools like pill packaging systems and a mobile application can affect patients’ decisions regarding HU’s regular consumption and whether they can change their attitude to taking pills and view this behavior as a routine.

The information denotes that it was necessary to choose a suitable methodology to research the issue under consideration. The pre- and post-test quasi-experimental design of the project demonstrated that patients required behavioral control measures to follow the prescription regulations. The sample size included 75 African Americans aged 18-30 years old because this population significantly suffers from SCD in the US, in general, and in the community, in particular. This information means that specific measures are needed to improve patients’ medication compliance. The specific questionnaire by Huang et al. (2000) was used to assess the pill packaging systems and mobile application impact on the patients’ medication adherence. Thus, this chapter is going to present the main findings and conclusions of the given project.

Summary of Findings and Conclusion

The project aimed to answer the clinical question: To what degree does the implementation of HU-based therapy facilitated by the use of a pill packaging system and the Mango Health mobile application would impact medication adherence when compared to standard treatment plan among patients with SCD patients in a North Carolina medical center over four weeks?

The project’s results have demonstrated that there was a statistically significant difference (X2 (1, N = 75) = 17.6389, p =.000027) in medication adherence between the patients with SCD who used pill packaging in combination with a mobile application and those who received the standard of care. The obtained data demonstrate that the post-intervention group reported higher medication adherence of 94% (N= 71) compared to 36% (N= 27) for the pre-intervention group. This statistical evidence presents the answer to the clinical question, mentioning that the intervention under analysis leads to a statistically significant increase in SCD patients’ medication adherence.

These findings are in line with the theoretical findings of other researchers. For example, the results are supported by the findings of Conn et al. (2015) and Lorenzini and Hellström (2017), who stated that pill packaging systems are helpful to stimulate patients’ medication adherence. These findings were also in line with the results of studies by Boeni et al. (2014), Huang et al. (2000), and Haywood et al. (2014), who found a positive correlation and relationship between using different types of pill packaging systems and similar interventions and medication adherence in patients. Furthermore, results were reported by Boeni et al. (2014), who noted that drug reminder packaging effectively helps patients remember taking pills, and their adherence to medications increases. These findings confirm that pill packaging systems can be somehow related to stimulating medication adherence in patients. Finally, the results concerning the effectiveness of a mobile app refer to the article by Badawy et al. (2016), who accentuated smartphone apps’ effectiveness for stimulating medication adherence.

The project’s results also highlight its significance by addressing the existing gap in the literature. It relates to the fact that the findings demonstrate that a combination of pill packaging systems and a mobile application positively impacts SCD patients’ medication adherence. It is possible to conclude that the project advances scientific knowledge by offering a practical method to promote improved adherence to HU-medication among young African Americans.

Implications

It is important to discuss the contribution of this project’s results to the theoretical discussion of medication adherence in the context of applying HU in patients with SCD and the clinical practice of treating individuals with this disease. Therefore, this section presents the theoretical implications of conducting this project and important practical implications to understand how the findings can change the process of treating patients with SCD with the help of HU-based therapy. Future implications are also described in this section to show how this project can contribute to further projects on the problem.

The results can be effectively discussed in the context of Ajzen’s (1985) theory of planned behavior chosen as a basis for a theoretical framework in this project. Thus, individual beliefs of patients with SCD regarding the usefulness of pill packaging and their assessment of their personal ability to follow a medication regimen could influence and explain their results in this project and certain social pressure they felt or not after receiving the patient education on this aspect. Furthermore, patients’ perceptions of their ability to control their behavior and adhere to the regimen could also explain their further results after using pill packaging. From this perspective, participants’ medication adherence changes could significantly depend on their attitude to using pill packaging systems, and a mobile application explained the theory of planned behavior. However, this project’s limitations do not analyze this aspect in detail, and qualitative projects can be required. The conclusions are still credible, depending on the quantitative descriptive methodology’s appropriate application using a chi-square test to measure categorical data.

In addition, the research’s results indicate that the use of a mobile application leads to improved medication adherence. This finding complies with planned behavior theory, stating that some barriers make people restrain from actions. These barriers refer to the fact that patients need regular reminders and motivation to follow the prescriptions. Consequently, the mobile application provides its users with the required resources to overcome these barriers.

Practical implications. The completed project has many implications for clinicians and practitioners in the sphere of health care. It is possible to note that this project’s results can be easily applied by professionals who work with patients with SCD if these patients take HU in the context of their basic therapy. There were no similar projects or studies reported in the existing literature on the topic; that is why this project’s results are essential in their implications for practice to be actively used by practitioners (Lin et al., 2016). Healthcare professionals can promote pill packaging systems and mobile applications to improve patients’ adherence to medications depending on this project’s results.

A significant weakness of the project refers to its design because the absence of randomization in a quasi-experimental study means that the findings cannot be generalized to the entire population. Furthermore, the absence of randomization and small sample size also resulted in the fact that the intervention group included few individuals, which is another weakness. Simultaneously, the project also implies a significant strength that refers to offering a practical solution to improve medication adherence among the specific population. Considering the information above, the methodology, and the selected project design, one can admit that the project’s findings are of limited credibility, meaning that further research is necessary.

Future implications. The project’s findings indicated a statistically significant difference in medication adherence between the participants using pill packaging and the participants who do not use this method. Further examination is necessary to understand how the type of SCD and the type of pill packaging systems could influence the results to determine whether the current findings can be easily applied to a broader range of situations associated with HU-based therapy.

Another type of future implications is associated with the results that were not achieved or identified with the project’s help. In the context of future projects, it is possible to refer to the examination of patients with SCD who take medications other than HU in order to understand whether the use of pill packaging and medication adherence can depend on the type of drugs to take.

Recommendations

This section summarizes the recommendations that should be viewed from the completed project and discussed implications for theory and practice and future implications. Therefore, in this section, recommendations for future projects on a similar topic and problem are presented in detail. Additionally, the chapter provides critical implications for implementing the change in a facility where practitioners work with patients with SCD and taking HU.

Recommendations for future projects. When referring to the project results and discussed implications, it is possible to formulate four future project recommendations. Firstly, it is important to test how pill packaging systems can be related to medication adherence with correlation and regression tests. This project results indicated only the significant difference in findings. Secondly, it is necessary to investigate patients’ feedback regarding pill packaging systems and outcomes. Finally, it is vital to examine the relationship between pill packaging and medication adherence compared to other systems, such as calendar-based organizers for pills. The proposed recommendations contribute to making the next steps in the clinical research and practice on medication adherence to address patients with SCD in terms of preventing their pain episodes.

Practice recommendations. Outcomes of this project identify recommendations for future practice in treating patients with SCD to influence their adherence to such medication as HU and health outcomes. This section will demonstrate that the project has the potential to results in better delivery of care in healthcare organizations. Furthermore, the following recommendations will show that the project contributes to achieving the best possible health outcomes referring to the specific population.

First, practitioners must integrate pill packaging systems supported by mobile applications to improve health outcomes in their daily practice. Healthcare providers and nurses will quickly educate patients with SCD on how to adhere to their regimen. This approach has the potential to introduce a significant improvement to the standard of care because patients will have additional stimuli and assistance to abide by the prescribed medication to the full extent.

Second, it is necessary to promote different pill organizers to analyze their effectiveness depending on patients’ feedback (Smaldone et al., 2016). Healthcare providers will be able to choose pill packaging systems depending on their patients’ needs. Medical professionals should consider using various pill organizers to ensure that their patients’ needs and preferences are satisfied, which is critical for achieving the best outcomes in a healthcare organization.

Third, it is essential to maximize pill packaging systems’ effect by using a mobile application since they are safe for patients to improve medication adherence and take HU easier and regular for patients. If healthcare providers encourage convenient pill packaging among patients, it is possible to increase their medication adherence, referring to the project results. In addition to that, a mobile application will be a supportive tool to notify patients of the necessity to take pills.

The benefits of implementing this project’s results in practice will be received by both health care practitioners and patients with SCD. The reason is that health care providers can decide on whether to educate patients with SCD taking HU on using pill packaging systems in order to improve their medication adherence if some problems with following a regimen are observed. Patients taking HU also receive an opportunity to change their health outcomes when deciding whether to use blisters of pills or other packaging systems to organize their prescribed HU pills.

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Appendix A

Grand Canyon University Approval Letter

Appendix B

Medication Adherence Questionnaire

Please circle correct answer or give short answers where applies.

Age: 18-30 years old/Other (Specify).

Gender: Male/Female.

Race: White/Non-White.

Employment: YES/NO.

1. Do you take your Hydroxy Urea Medication everyday as prescribed? YES/NO.
2. Do you have difficulty remembering to take your Hydroxy Urea Medication? YES/NO.
3. Do you skip pills? YES/NO.
4. Do you take more pills than assigned? YES/NO.
5. Do you mistake pills due to carelessness? YES/NO.
6. Is your Hydroxy Urea Medication filled in pill bottles? YES/NO.
7. Is your Hydroxy Urea Medication filled in a pill packaging system? YES/NO.
8. Are you interested in using pill packaging systems?
9. Do you use a mobile application for reminders (Mango Health)?

Appendix C

Mango Health Application

Appendix D

Pill Packaging System

Using the pill packaging tool is a service that does not need permission to use, just a provider order or patient request. Information via www.pillpack.com