Introduction
Chronic pain is continual ache patients suffer for an extended period, which harms the individuals’ health and well-being. Healthcare professionals prescribe opioids to treat persistent pain in adults. However, the narcotic drug causes addiction and dependency, consequently leading to drug misuse and overdose (Gorfinkel et al., 2018). Therefore, there is a quest to get alternative medication with fewer side effects. It necessitates comparing opioids prescription and acupuncture use in adults aged 40 to 60 years diagnosed with chronic pain. The pilot project uses Kurt Lewin’s three-stage model to facilitate opioid and acupuncture interventions implementation. Besides, it uses behavioral counseling techniques to promote engagement and conducts a feasibility study. The trial also utilizes CONSORT-SPI 2018 as the practice guideline for the intervention. The paper aims to describe the problem, the PICOT question, the pilot project, and stakeholders’ roles. Moreover, it proposes two strategies for promoting engagement, discusses specific guidelines, identifies primary organizational resources, and explains intervention outcomes.
The Problem, the PICOT Question, and the Intervention
Patient/Population (P): Adults aged 40 to 60 years diagnosed with persistent pain.
Intervention/Indicator (I): A randomized controlled trial with opioids and acupuncture as complementary medicines.
Compare/Control (C): The research equates the effects of prescribed opioids on the health and well-being of adults with chronic pain with those of acupuncture.
Outcome (O): Prolonged opioid use causes dependency on the drug, whereas acupuncture has no significant side effect on users. Acupuncture is more effective than prescribed opioids in relieving pain.
Time (T): Twelve months
Opioid abuse and addiction are notable concerns in hospitals treating patients with persistent aches. They are addictive medications with potential negative effects on the health of people who use them inappropriately (Gorfinkel et al., 2018). Another problem is that patients develop tolerance and need an escalating amount of opioids to relieve chronic pain. A randomized controlled trial has to account for adverse effects and opioid dependence risk when prescribing the medication.
The PICOT question is “how does acupuncture medication compare with opioid narcotic treatment over a year in adults aged 40 to 60 years diagnosed with chronic pain?” The question’s objective is to treat chronic pain and match opioid use in pain control with acupuncture as complementary medicine. The design relates to the negative impact of treating adults aged 40 to 60 years diagnosed with persistent pain. The research involves assessing and evaluating the sampled patient’s pain intensity in the entire trial for twelve months.
Opioid use to manage elevated pain is consequential to the patients. The therapeutic payback of the narcotic as an intervention for chronic pain comes with limitations. The benefit-risk ratio reduces as a patient prolongs opioid medications because side effects rise. On the other hand, acupuncture reduces pain without significant consequences (Urits et al., 2020). Besides, it relieves pain for approximately twelve months after the end of the trial. Therefore, acupuncture is more effective than opioids in managing chronic pain.
Pilot Project for the Intervention
The Who
Adults with chronic pain aged 40 to 60 years will participate in the pilot project.
The What
The trial will compare the effects of prescribed opioids with acupuncture on treating persistent pain.
The Why
The pilot research aims at determining the best alternative medication for chronic pain and the benefits-risks ratio of prescribed opioid and acupuncture use.
The Where
The pilot project will occur in Kansas, New Mexico, North Carolina, and Kentucky.
The When
The trial will take one year, starting from April 20, 2021, to April 21, 2022.
The How
The research will use a randomized controlled approach to sample six participants in each of the study sites. Four Clinical and Transitional Science Award (CTSA) hubs will collaborate with the research team. They will evaluate multi-site research procedures and advice on the best practices for recruiting, retaining participants, and collecting data.
The Model of Change Used to Facilitate the Intervention Implementation
The pilot project will use Kurt Lewin’s three-stage model of change to implement opioids and acupuncture interventions for treating chronic pain among adults (Diab et al., 2018). The objective of unfreezing stage is to create awareness of the way the status quo affects the well-being of people with persistent pain. Overprescription of opioids for adults with chronic pain is increasingly resulting in an overdose crisis in the US. The problem necessitates a comparison of the effects of opioids and acupuncture to determine the best alternative medication. The changing step will ensure the real implementation of acupuncture intervention. Participants will learn new behaviors, processes, and perspectives (Diab et al., 2018). The randomized controlled pilot will happen in rural areas of New Mexico, North Carolina, Kansas, and Kentucky. The refreezing stage entails reinforcement, stabilization, and solidification of the new state (Diab et al., 2018). There will be follow-up activities, and semi-structured interviewees will occur after the intervention.
The Stakeholders and their Roles in the Pilot Project
Four CCTSA hubs will form part of the pilot project team and help in the investigation. Their roles are evaluating multi-site research procedures, advising on the best practices for recruiting and retaining participants, and collecting data (Daudelin et al., 2020). ClinicalTrials.gov will register the test project. Rural primary care practitioners (PCP) will be vital stakeholders in the study sites, namely, North Carolina, Kentucky, Kansas, and New Mexico. One master’s level behavioral therapist per study area will monitor the intervention (Daudelin et al., 2020). The target sample size is six respondents per site, making them twenty-four participants.
Two Strategies for Promoting Engagement of Stakeholders in the Project
First, the pilot project will employ acceptance and commitment therapy (ACT). It is a behavioral counseling technique, which helps stakeholders and patients engage and focus on their current situation with chronic pain and find coping skills (Lin et al., 2019). The second strategy will be conducting a feasibility study to pan the trial’s effectiveness. It will also investigate the proposed method and determine the viability of the pilot project.
Practice Guideline Supporting the Intervention
The pilot study will use the Consolidated Standards of Reporting Trials (CONSORT-SPI 2018) because it enables medical, behavioral, and social experts to report research transparently. The guideline is vital in reporting RCTs, conducting clinical tests, and evaluating complex interventions (Mohiuddin et al., 2020). The CONSORT-SPI 2018 has nine checklists, twenty-five items, and 14 sub-items. Furthermore, it has a modified flow diagram, stakeholders’ involvement, and interventions.
Major Organizational Resources Needed for the Pilot Project
The CTSA hubs in New Mexico, Kentucky, North Carolina, and Kansas will be fundament as integrated academic centers for translational practice. The CTSA hubs’ resources will enable the team and researchers working on the pilot project to apply new techniques and knowledge to patients diagnosed with chronic pain (Daudelin et al., 2020). The consortiums’ goals include developing national transitional study capacity, offering training, and enhancing career development. The organization also translates laboratory discoveries into clinical trials.
Approaches for Measuring the Intervention
The pilot project will measure comorbidity behavioral health, opioid abnormal behavior, and pain outcome. It will use the Brief Pain Inventory (BPI) to assess pain severity and impact the functioning of sampled adults (Rhyne et al., 2020). The intervention items are mood, general activity, sleep, life enjoyment, and routine work. Second, the Short Form Health Survey (SF-36) will measure the quality of life, including well-being and functional health. It depends on the participants’ self-reporting, and care organizations use it to examine adult patients’ health results (Rhyne et al., 2020). Likewise, Patient Health Questionnaire (PHQ-8) will assess depressive disorders and determine depression comparability. Lastly, the Current Opioid Misuse Measure (COMM) will quantify abnormal opioid medication risk among people with chronic pain (Rhyne et al., 2020). The strategy complements opioid misuse screeners and enhances the ability of clinicians to sample patients with persistent pain.
Conclusion
The trial will use a randomized controlled method to sample six adults in each of the study sites. It is notable the therapeutic returns of opioids as a remedy for chronic pain come with restrictions. The benefit-risk ratio lessens as a patient lengthens opioid medications because side effects upsurge. On the contrary, acupuncture eases pain without significant concerns. Accordingly, the first barrier to the pilot project implementation is the lack of clarity regarding opioids prescription guidelines. Adults with chronic pain experience varying intensity; therefore, they require different drug doses. The second obstacle is the ethical standard of benevolence to the respondents. The pilot study should act against the hurdles by recruiting participants with no opioid abuse history. Likewise, it should obtain informed consent from the respondents and give them the freedom to leave the trial when they are uncomfortable.
References
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