Opioid prescribing in UK general practice will be cut using a system that automatically adjusts the intensity of feedback to doctors based on whether they change their behaviour. This matters because the UK is following North America’s opioid crisis trajectory, with rapidly rising opioid-related deaths. Both patients and GPs are dissatisfied with current opioid prescribing for chronic non-cancer pain. Existing audit-and-feedback interventions reduce prescribing but with variable effects, and adding extra support like facilitated feedback is costly. This project builds an adaptable intervention that uses decision rules to determine when and how to increase support—only for practices that need it. If successful, the approach could reduce the number of patients prescribed opioids by an estimated 30,000. It would give the NHS a reproducible, cost-effective method for targeting high-impact prescribing recommendations without blanket spending on expensive co-interventions. The SMART trial design itself is innovative: it tests not just whether feedback facilitation works, but when and for whom it is worth the extra cost. This could change how the NHS designs implementation strategies for other prescribing problems, quietly improving patient safety and reducing harm from overprescribing.
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BACKGROUND: Opioid prescribing is an internationally recognised threat to population health and poses significant challenges for healthcare services. The UK is following the 'opioid crisis' trend in North America, with rapidly rising opioid-related mortality. Both patients and physicians are dissatisfied with opioid prescribing in chronic pain management. System-level interventions, such as audit and feedback (A&F), are effective at reducing opioid prescribing in primary care, with variable effects. The addition of co-interventions, such as feedback facilitation, may increase A&F effectiveness but with additional costs of delivery. An adaptable intervention uses individually-tailored decision rules to specify how, when and whether to increase the intensity of the intervention at critical decision points. AIM AND OBJECTIVES To develop and optimise an adaptable implementation strategy to reduce prescribing of opioids for chronic non-cancer pain in primary care using a clustered, sequential, multiple-assignment randomised trial (SMART). To adapt and refine two interventions that reduce prescribing of opioids, A&F and feedback facilitation; To evaluate the feasibility and acceptability of delivering the interventions in general practice; To evaluate the adaptable intervention using a SMART design to determine whether feedback facilitation increases (cost-) effectiveness, when and for whom to intervene; To evaluate intervention acceptability, adoption, appropriateness, feasibility, fidelity, penetration and sustainability. METHODS: WS1: User-centred design. Two workshops with the project team, followed by 3-5 rounds of design and evaluation with stakeholders to adapt and design A&F and feedback facilitation interventions, using think-aloud and semi-structured interviews. WS2: Feasibility study. Four practices will receive A&F alone and four with additional feedback facilitation to assess feasibility. Semi-structured interviews with practice staff and routinely-collected data will assess acceptability, feasibility of delivery, changes in prescribing and fidelity of intervention components. WS3: SMART. 285 practices in West Yorkshire will receive the A&F intervention over 18 months. Non-responders to A&F alone will be randomised at 6- and 12-months to receiving additional feedback facilitation. Primary outcome will be a reduction in patients prescribed opioids. Health economics evaluation to identify incremental cost-effectiveness ratios. Further analyses will assess timing of feedback facilitation and baseline tailoring variables that moderate effectiveness. WS4: Process evaluation. Ten practices will be recruited for in-depth, mixed-methods theory-informed analysis. Routinely collected data, surveys, interviews and observations. Methodological triangulation will integrate qualitative and quantitative analyses. TIMELINE FOR DELIVERY: I will complete the Fellowship over 60 months (0.8FTE) to allow opportunities for development outside the Fellowship, and to accommodate trial follow-up. Set-up: Months 1-3 WS1: Months 4-18 Workshops (M7-8) User-centred design (M9-12) WS2: Months 13-27 Feasibility testing (M16-21) Analysis and refinement (M19-24) WS3: Months 25-60 SMART delivery (M31-48) Interim analyses (M36, M42) (Cost-)effectiveness analysis (M46-54) WS4: Months 25-60 Qualitative and quantitative data collection and analysis (M31-54) Triangulation (M52-57) Dissemination and impact: Months 12-60 ANTICIPATED IMPACT AND DISSEMINATION: Increased effectiveness of practices to reduce opioid prescribing, with estimated 30,000 fewer patients prescribed opioids. Demonstration of an innovative, systematic and hence reproducible approach to targeting high impact recommendations to improve patient care and outcomes at an acceptable cost.
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