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

<ns3:p> Background Opioids offer limited long-term benefits and carry significant risks. We developed the PROMPPT intervention to address challenges in implementing effective person-centred review and safe opioid tapering in UK primary care. PROMPPT comprises a primary care review, led by clinical pharmacists working in general practices as part of the multidisciplinary team, and an associated training package. This trial will evaluate (1) the effectiveness of PROMPPT in supporting people with persistent non-cancer pain to safely reduce opioids, where appropriate, without increasing pain/pain-related interference, and (2) cost-effectiveness compared with usual primary care. Methods 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. Exclusions: acute pain, cancer pain, end-of-life care, dementia, severe mental illness or otherwise vulnerable, and current substance misuse treatment. Practices are randomly allocated (1:1) to either: invite participants for a PROMPPT review with a trained practice pharmacist, and follow-up as needed, or continue usual primary care review for 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 assess whether review by trained clinical pharmacists working in general practices can support safe opioid reduction without compromising pain management and quality of life. Trial registration ISRCTN 45616481, 13/05/2022 <ns3: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</ns3:ext-link> </ns3:p>