Evaluating a primary care pharmacist-led intervention to reduce opioid use for persistent non-cancer pain: the PROMPPT cluster randomised controlled trial protocol

Background Addressing the need for evidence-based interventions to reduce opioid use for persistent pain, we developed the PROMPPT intervention (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams), a primary care pharmacist-led review and associated training package. This trial will evaluate whether, in patients prescribed long-term opioids for persistent pain, PROMPPT is more likely to reduce opioid use, without increasing pain/pain-related interference, compared with usual primary care and will examine the cost-effectiveness of PROMPPT from healthcare and societal perspectives. MethodsPatient and Public Involvement (PPI) A group of public contributors from Keele University’s Research User Group (RUG) with experience of persistent pain and opioids was convened to support the development of the PROMPPT research programme, the NIHR funding application, and subsequently to advise on delivery of the programme. As RUG members, all members of the PROMPPT PPI group have received an induction, a plain English glossary of research terms and have access to training resources (e.g. contributing assertively to meetings), are supported by a dedicated PPI support worker, and they are offered payment according to NIHR guidelines <ext-link xmlns:ns4="http://www.w3.org/1999/xlink" ext-link-type="uri" ns4:href="https://www.nihr.ac.uk/nihr-public-contributor-payment-policy">https://www.nihr.ac.uk/nihr-public-contributor-payment-policy</ext-link>. To support the development of the PROMPPT intervention, the pharmacist training package and the feasibility study, this group attended 5 formal workshops (between Mar 2019 and July 2021). Patients were also represented in the consultation of stakeholders by 2 further RUG members, who attended 3 mixed stakeholder workshops, which informed design of the intervention ¹⁷ . More recently, patient advisors have influenced the design of this trial by:

• Co-producing revised pain medicines questionnaires in light of findings from the feasibility study.

• Co-producing patient-facing information with the research team including participant information sheets, invitation letters, the “Getting Ready for Your Pain Review” leaflet and self-management leaflets developed as part of the PROMPPT intervention.

• Advising on strategies to improve follow-up questionnaire response rates during the trial, including sending text notifications ahead of Minimum Data Collection (MDC) calls to non-responders and advising on the wording of text messages to participants and a Thank You Flyer to accompany follow-up questionnaires.

Further PPI group meetings are planned to discuss the findings of the main trial and the process evaluation, and to generate the key messages to disseminate these to patients and the wider public. Design and setting: cluster randomised controlled trial, with internal pilot, in 38 general practices across England. Participants: patients ≥18 years prescribed one or more opioids ≥ 6 months for persistent pain who consent to participate in a questionnaire study. Practices are randomly allocated (1:1 ratio) to either: invite participants for a PROMPPT review with the practice pharmacist, and follow-up as needed, or continue usual primary care arrangements for reviewing patients who are prescribed opioids. Co-primary outcomes, measured at 12 months, are (1) reduction in self-reported opioid use (≥25% reduction in daily morphine equivalent dose from their baseline) and (2) non-inferiority of the Brief Pain Inventory total score. The trial includes an economic evaluation (within trial and longer-term cost-utility analyses) and a mixed methods process evaluation. Analysis of consultation audio-recordings, case report forms (including an intervention delivery template), acceptability questionnaires and semi-structured interviews will explore how PROMPPT was delivered and received, and how context affected implementation and outcomes. Conclusion The PROMPPT trial will provide important new evidence about the effectiveness of a practice pharmacist-led primary care intervention to reduce opioid use for persistent pain. Trial registration ISRCTN 45616481, 13/05/2022 <ext-link xmlns:ns4="http://www.w3.org/1999/xlink" ext-link-type="uri" ns4:href="https://doi.org/10.1186/ISRCTN45616481">https://doi.org/10.1186/ISRCTN45616481</ext-link>