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.
LAY SUMMARY:
Award Title: Improving care for patients living with persistent pain and taking opioid medicines long-term: Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams (PROMPPT)Chief Investigator: Professor Christian D Mallen
Associate Investigator: Dr Julie Ashworth
Contracting Organisation: NHS Staffordshire and Stoke-on-Trent Integrated Care Board
Funder: National Institute for Health and Care Research (RP-PG-0617-20005)
Plain Language Summary
Background
Persistent pain (long-lasting pain not caused by cancer) affects almost 28 million adults in the United Kingdom. Around one in three are prescribed opioid medicines, but opioids don’t work well for long-term pain and increase the risk of serious harm. Guidelines say opioid use should be reviewed regularly and reduced slowly if harms outweigh benefits. In practice, this does not happen as often as it should.
The PROMPPT research programme developed a new approach to reviewing people with persistent pain who are prescribed long-term opioids. This involves pharmacists who work in GP practices (practice pharmacists) carrying out personalised reviews for patients with persistent pain who are prescribed opioids. These PROMPPT reviews are supported by a structured toolkit and a dedicated pharmacist training package to ensure consistent and safe delivery of the review.
Aims
This trial aimed to test whether the PROMPPT approach is more likely to help people with persistent pain safely reduce their opioid use, without making their pain or daily life worse, compared to usual GP care, and whether it offers value for money.
What did the researchers do?
A cluster randomised controlled trial was conducted in 38 general practices across England.
Who was invited to take part?
Adult patients who had been taking opioids for at least 6 months were invited to take part in a questionnaire study.
Patients were not invited if they were taking opioids for short-term or cancer-related pain, receiving end-of-life care, considered vulnerable by their GP, or being treated for any drug misuse.
Trial groups: PROMPPT vs usual care
GP practices were randomly allocated to either offer questionnaire study participants a PROMPPT review with a trained pharmacist or continue with usual care. PROMPPT training for pharmacists included an e-learning course and two online workshops.
In PROMPPT practices, pharmacists met with participants to talk about their pain, how opioids affected them and whether changes were needed, and they developed a personalised plan together. Follow-up appointments were arranged as needed, and participants received a written summary and were signposted to information about managing pain and reducing opioids.
What was measured?
The researchers compared the two groups over 12 months, looking at what proportion of participants reduced their opioid use by at least 25%, and average scores for pain and impact of pain on daily functioning (Brief Pain Inventory (BPI) Total Score).
The researchers also looked at other pain medicines use, side effects, mental health, confidence in managing pain, quality of life, healthcare use and whether people were working. They collected feedback through questionnaires, interviews and recordings of some reviews to understand how PROMPPT was delivered and experienced.
What did the study find?
The PROMPPT trial recruited 907 people, of whom 604 (67%) responded at 12-month follow-up. The average age of participants was 63 years, around two-thirds were women, and 97% described their ethnicity as white. Both groups were similar at the start of the study. Of those invited for a PROMPPT review, 63% attended.
Main outcome
In the PROMPPT group 147 out of 311 participants (47%) reduced their opioid use by at least 25%, compared to 86 out of 291 (29%) in the usual care group. This shows a clear difference between the groups that is unlikely to have happened by chance. Average BPI scores (pain and the impact of pain) remained similar in both groups.
Other outcomes
On average, people in the PROMPPT group reduced their opioid use by almost14%, while those in usual care increased theirs by over 6%, a difference of almost 20%. There were no differences between the groups in mental health, confidence to manage pain, or use of other pain medicines. Nausea was lower in the PROMPPT group after 12 months.
Overall, patients interviewed found the PROMPPT review acceptable, appreciated the opportunity to discuss their pain and often felt more informed and better supported afterwards.
Pharmacists reported that the PROMPPT training helped them build rapport, understand patients’ experiences of pain, support dose reductions, and feel more confident in their role.
Although healthcare costs were slightly lower in the PROMPPT group than usual care, the economic evaluation found no meaningful difference in healthcare use, overall costs, or health outcomes during the study period.
What does this mean?
The PROMPPT trial showed that pharmacist-led pain reviews can safely help people reduce their opioid medicines. Almost half of the people offered a PROMPPT review reduced their opioid dose by at least 25%, compared with fewer than one in three receiving usual care. Importantly, reducing opioids in this way did not make people’s pain or daily life worse.
Overall, PROMPPT is an effective and acceptable approach that can support safer and more personalised prescribing for people living with persistent pain. While the intervention did not
lead to clear differences in healthcare costs or overall health outcomes compared with usual care, it achieved meaningful reductions in opioid use without causing harm. For general practices, PROMPPT offers a proactive way to review long-term opioid prescribing that aligns with current NHS priorities on patient safety and medicines optimisation.
Involving patients and the public
A Patient Advisory Group comprising people with experience of persistent pain and opioids supported the PROMPPT research throughout. Working alongside patient representatives in the mixed stakeholder group, they helped design the PROMPPT approach, ensuring it was shaped by real patient experience and what matters most to people living with persistent pain.
The advisory group also supported research delivery by:
· Helping to design the online study,
· advising on recruitment,
· reviewing patient-facing information to ensure clarity and accessibility,
· guiding changes in response to the COVID-19 pandemic,
· helping to refine questionnaires, invitation letters and leaflets,
· advising on text message reminders to improve main trial follow-up
· co-designing the patient-facing website
· helping to interpret study findings
· advising on how to share the results with the wider public.
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