Is it feasible to recruit to a cluster randomised-controlled trial to evaluate a practice pharmacist-led intervention to reduce opioid overprescribing in primary care?
Problem
New primary care interventions to address opioid overprescribing for persistent non-cancer pain (‘persistent pain’) are needed. This trial, funded by the National Institute for Health and Care Research, aims to evaluate a practice pharmacist-led primary care intervention (PROMPPT review and pharmacist training) for patients prescribed long-term opioids for persistent pain, which aims to reduce opioid use, where appropriate, without increasing pain/pain-related interference. The intervention was co-designed with stakeholders (patients and healthcare professionals), using a person-based approach combined with best practice guidance and theory, and refined following a feasibility study.
Approach
This pragmatic multicentre cluster randomised controlled trial aimed to recruit 896 patients from GP practices across England. Eligible patients were identified from electronic healthcare records, screened according to inclusion/ exclusion criteria, and invited to participate in the Management of Opioids and Persistent Pain (MOPP) questionnaire study. Inclusions: Adults prescribed any opioid continuously for ≥6 months. Exclusions: acute pain, cancer pain, terminal illness, vulnerable patients, current substance misuse treatment. GP practices were randomised into two groups: the intervention group invited MOPP participants for a practice-pharmacist-led review (personalised, holistic 30-minute assessment with signposting and follow-up according to clinical need/patient preference), and the control group continued usual primary care for patients prescribed opioids for persistent pain. Two co-primary outcomes: (1) reduction in opioid use (≥25% reduction in daily morphine equivalent dose (MED) from baseline) and (2) Brief Pain Inventory (BPI) total score, tested for superiority and non-inferiority respectively. Secondary outcomes: pain severity, pain interference, opioid/ non-opioid pain-related medicines use, opioid-related side-effects, depression, anxiety, pain self-efficacy, health-related quality of life and practice-level prescribing (opioids, non-opioid analgesics, gabapentinoids, antidepressants, benzodiazepines, Z drugs). Participant follow-up was at 3,6 and 12-months, with a primary endpoint of 12 months. A mixed-methods process evaluation will examine fidelity of delivery, investigate experiences of the review and explore contextual factors in both groups. An economic evaluation will be undertaken to calculate cost per quality-adjusted life year from an NHS/personal social services perspective. Full ethical approval (Ref: 22/NE/0044).
Findings
An internal pilot (May-Dec 2022) recruited n=388 participants. Progression criteria were met for GP practice recruitment (n=14 recruited; target n=12), participant recruitment (mean ≥50/month), and fidelity of intervention delivery (89%; target ≥ 80% delivered consistent with training). Pain review uptake was slightly lower than anticipated; with 62% (target 70%) of those invited attending. Four further waves of recruitment yielded a total of 38 participating practices (19 in each group). As of 02/01/2024, 901 eligible participants had been recruited and 68% of participants invited for a PROMPPT review had attended.
Consequences
The PROMPPT Trial has recruited to target. Pain review uptake has improved with batching of invitations according to pharmacist availability. Follow-up data collection will be completed by 07/02/2025.