The PROMPPT Trial
Research type
Research Study
Full title
Improving care for patients living with persistent non-cancer pain and taking opioid medicines long-term: A multicentre cluster randomised controlled trial of proactive clinical review led by practice pharmacists in primary care. The PROMPPT Trial.
IRAS ID
305174
Contact name
Christian Mallen
Contact email
Sponsor organisation
Keele University
ISRCTN Number
ISRCTN45616481
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
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. Persistent pain affects almost half of UK adults.
Use of opioids (morphine-like medicines) for persistent pain has dramatically increased in the last 20 years, but most people with persistent pain do not benefit from opioids long-term. In addition, they often experience side effects and are at increased risk of serious harm including bone fractures, addiction and overdose. Guidelines say patients on long-term opioids should be reviewed regularly but often this does not happen, putting patients at risk of continuing or increasing medicines that may be harming rather than helping them.
This study is the third and final stage of a 5-year research programme (funded by the National Institute for Health Research) to develop and test a practice pharmacist-led intervention (PROMPPT) and an associated pharmacist training package. The PROMPPT intervention and training were developed in earlier stages of this research. PROMPPT involves pharmacists working in GP practices proactively reviewing patients with persistent pain who have been prescribed opioids and aims to support them to reduce opioids (where appropriate) and to live well with persistent pain.
This cluster randomised trial, which follows a feasibility study (PROMPPT FS), will investigate, in patients with persistent non-cancer pain who are prescribed opioids long-term (for at least 6 months), whether providing the PROMPPT intervention is more likely to reduce opioid use, without increasing pain/pain-related interference, at 12-months follow-up compared with usual primary care review. A linked health economic evaluation will assess the cost-effectiveness of providing PROMPPT compared to usual care and a process evaluation will explore potential factors influencing trial results and help us understand how PROMPPT was used and perceived by patients and clinicians.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0044
Date of REC Opinion
23 Mar 2022
REC opinion
Favourable Opinion