Title: Improving outcomes for patients with opioid-treated persistent non-cancer pain: a proactive clinical pharmacist-led primary care intervention (PROMPPT intervention).ACRONYM: Pharmacist-led intervention to Reduce inappropriate use of Opioid Medicines and optimise Persistent Pain Therapy (PROMPPT)
Funder: Department of Health and Social Care

Abstract: Background: Opioid prescribing for persistent pain has increased despite limited evidence of long-term effectiveness and important safety concerns. Clinical pharmacists play an increasing role in managing patients on long-term medicines in general practice. Aim: Develop and test a clinical pharmacist&ndash;led intervention (PROMPPT) to support patients with persistent pain to safely reduce opioids, without increasing pain/pain-related interference. Workstream 1: Development of PROMPPT intervention and training. Objectives: Determine PROMPPT intervention components, clinical pharmacist training needs and potential barriers to delivery using best practice guidelines, stakeholder engagement, qualitative methods and theory. Co-design prototype PROMPPT intervention with stakeholders and refine through cycles of in-practice testing. Qualitative methods: Investigate experiences and perspectives regarding opioids for persistent pain and potential barriers/facilitators in delivering a clinical pharmacist-led intervention to reduce opioids using: Semi-structured interviews with opioid-treated patients, clinical pharmacists and GPs (each group, n=15 or until category saturation achieved). Netnography/online qualitative research, via researcher-administered blog generating 12 (weekly) online discussions (informed by themes emerging from interviews and extant online data) among people with persistent pain. Clinical pharmacist focus groups (n=2) to identify clinical pharmacist training needs and barriers/facilitators in delivering PROMPPT. In-practice testing of prototype PROMPPT reviews including cognitive think-aloud interviews (n=3 practices, n=3 clinical pharmacists, n=3 cycles, 15 patients). Analysis: Framework approach. Output: Finalised prototype PROMPPT intervention. Workstream 2: Non-randomised feasibility study with mixed methods process evaluation Objectives: Investigate acceptability/feasibility of PROMPPT and main trial design. Methods: Eligible patients, prescribed opioids &ge;6months, identified from electronic records (n=80, from 4 practices across 2 centres), invited to participate in evaluation of primary care pain management ( research evaluation ) and, separately, to attend clinical pharmacist (PROMPPT) review (around 30 minutes, personalised, multifaceted, follow-up and GP collaboration as needed). Data collection: self-reported participant questionnaires (baseline, 3-months), PROMPPT template, audio-recorded consultations (n=20), qualitative interviews (n=15 patients, all clinical pharmacists, n=4 GPs). Quantitative analysis: Rates of intervention uptake/follow-up attendance and acceptability/credibility scores. Research evaluation recruitment/retention. PROMPPT uptake by patients not providing study data. Qualitative analysis: Framework approach. Outputs: Refinement/modification of intervention and/or trial processes for main trial. Workstream 3: Pragmatic multicentre, cluster RCT incorporating internal pilot, health economic and process evaluations. Objectives: Determine clinical and cost-effectiveness of providing PROMPPT in reducing opioid use, without increasing pain/pain-related interference, compared with usual care. Methods: Eligible patients (n=1040) identified from n=24 GP practices (3 centres). Practices randomised 1:1 intervention/control. Eligible patients (both arms) sent identical research evaluation study pack. Intervention practices: patients invited for PROMPPT. Control practices: usual care. Primary outcomes: (1) Reduction in opioid use (&ge;25% reduction daily morphine-equivalent dose), (2) Non-inferiority on Brief Pain Inventory score (at 12 months). Secondary outcomes include pain, pain-related interference, quality of life, side-effects, self-efficacy, medication use, healthcare utilisation. Practice-level analgesic prescribing. Primary intention-to-treat analysis: multilevel logistic (opioid reduction) and linear (BPI) regression. Health economic evaluation will determine cost-effectiveness and cost-utility of PROMPPT (NHS perspective) and model long-term cost-effectiveness. Process evaluation (PROMPPT template, audio-recorded consultations, interviews) investigating quantity/quality of intervention delivery and contextual factors affecting delivery and outcomes. Outputs: Evidence on PROMPPT clinical/cost effectiveness and factors affecting NHS implementation.

Lay abstract: This research aims to help people with persistent pain, which means long-lasting pain due to a range of conditions, for example osteoarthritis and back pain, but not pain caused by cancer. Nearly 8 million UK adults suffer with moderate or severe persistent pain. Most are managed by their family doctor (GP), using medicines. Use of opioid (morphine-like) painkillers has dramatically increased. Twice as many people used weak opioids (e.g. codeine) and five times more used strong opioids (e.g. morphine) in 2012 compared to 2005. Most people start with weak opioids but almost one-quarter move up to strong opioids after 2 years. People with persistent pain who take long-term opioids tend to have worse quality of life than those who do not, and are more likely to suffer bone fractures, addiction and overdose, especially at high doses. Guidelines say GPs should review people taking long-term opioids regularly but often this does not happen, mainly because GPs are too busy. This research programme will test an alternative approach, recommended in a recent report, which is to train clinical pharmacists working in GP surgeries to help manage these people. Our programme has three workstreams: Workstream 1: We will use a range of methods to gain in-depth understanding of patients, clinical pharmacists and GPs experiences and views about reducing opioids and the role of clinical pharmacists in helping people with persistent pain. Patients and expert clinicians will use the results, together with published evidence-based guidelines, to develop the PROMPPT intervention. This will support patients to reduce or stop opioids (where appropriate) and to self-manage their pain. Repeated testing, with feedback from patients, GPs, and clinical pharmacists, will help to improve the intervention and training. Workstream 2: A study of 80 patients taking long-term opioids for pain will test how well clinical pharmacists deliver the PROMPPT intervention, whether it is acceptable and practical to deliver, and what proportion of patients agree to take part. We will make improvements based on the results. Workstream 3: A trial of approximately 1040 patients will test whether the PROMPPT intervention leads to less opioid use, without making patients pain worse, and whether this results in better use of NHS resources compared to usual GP care. If successful, this research will benefit patients and the NHS by: Improving patient safety by reducing opioid use. Helping people with persistent pain improve their quality of life. Reducing costs of prescribing opioids and treating side-effects. Allowing GPs to focus on complex cases. We will involve patients throughout this research to: Advise on developing the PROMPPT intervention. Help design study documents. Oversee the running and reporting of the studies. Advise on easily understandable messages to publicise study findings.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL;NEUROLOGICAL