PROMPPT-FS [COVID-19]
Research type
Research Study
Full title
PROMPPT-FS: Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams. A non-randomised Feasibility Study with mixed methods process evaluation.
IRAS ID
275857
Contact name
Christian Mallen
Contact email
Sponsor organisation
Keele University
ISRCTN Number
ISRCTN87628403
Clinicaltrials.gov Identifier
NIHR, RP-PG-0617-20005
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Research Summary
Persistent pain affects almost half of UK adults. Use of opioids (morphine-like painkillers) for persistent pain has dramatically increased but opioids do not help most patients and often cause side-effects. People taking regular opioids are also more likely to suffer bone fractures, addiction and overdose. Guidelines say patients on long-term opioids should be reviewed regularly, but often this does not happen.
This study is the second stage of a 5-year National Institute for Health Research funded research programme. The programme comprises of three linked workstreams to develop and test a clinical pharmacist-led primary care intervention (PROMPPT), and an associated clinical pharmacist training package which aims to reduce opioid use for people with persistent pain (where appropriate) and support self-management for those with persistent pain in primary care.
This is the second work stream which is a non-randomised feasibility study including a mixed methods(qualitative and questionnaire data) evaluation of the process. This will inform the refinement of the PROMPPT intervention, clinical pharmacist training package and the main trial design in workstream 3 of the programme.Summary of Results
Background and study aims Opioids are commonly prescribed for persistent non-cancer pain (‘persistent pain’) but they do not help most patients and there are important safety concerns. Guidelines say patients on long-term opioids should be reviewed regularly, but often this does not happen. This study looked at a new way to review patients taking opioids for persistent pain, using pharmacists who work in GP practices (‘practice pharmacists’).
People with persistent pain and a range of healthcare professionals helped design the new review, which is called PROMPPT (Proactive clinical Review of patients taking Opioid Medicines Pain led by clinical Pharmacists in primary care Teams). PROMPPT aims to support patients with persistent pain to safely reduce opioids, where appropriate, without making pain worse.
This study aimed to answer the following questions:
(1) How acceptable is PROMPPT to patients, practice pharmacists and GPs?
(2) How practical is it to deliver PROMPPT in general practices?
(3) How well does the study design work and is it possible to collect the information that would be needed in a future clinical trial.Who participated in the study?
148 adult patients (aged over 18 years) with persistent pain who had been prescribed an opioid medicine for at least six months were recruited from four general (GP) practices across Staffordshire and Nottinghamshire.What did the study involve?
Study participants completed questionnaires at the start of the study and after 3 months. A sample of participants also had a PROMPPT review with the practice pharmacist from their GP surgery. After the review, participants were asked to complete a questionnaire about the review and 15 participants were interviewed. The practice pharmacist and one GP from each of the four practices in the study were also interviewed.
What were the results of the study?
A sample of 88 patients who took part in the questionnaire study were invited for a PROMPPT review. 80 of these took part in the review. Most reviews (78 out of 80) were completed by telephone because of the COVID-19 pandemic.
Nine out of ten patients rated the review ‘acceptable’ or ‘completely acceptable’ on the questionnaire. Overall, patients, pharmacists and GPs interviewed thought the PROMPPT reviews were a good idea and felt it was appropriate for practice pharmacists to conduct them. Patients and pharmacists said they would prefer a face-to-face review where possible. Although patients liked the review overall, some patients said they felt worried about what would happen before the review. Most patients who had agreed to make changes to their opioids were happy with the plan and found the review helpful, but some patients felt confused about what medicines to take. Patients were more likely to be satisfied with the plan when clear arrangements for a follow-up appointment had been made.
How has this study helped patients and researchers?
The study team discussed the study results with a patient group who advised on how to improve the invitation letter and patient information to make the purpose of the PROMPPT review clearer and to explain what would happen. Changes were also made to the pharmacist training, for example to help improve discussions about the management plan and arrangements for follow-up.
The results of this study have also been used to improve the design of the participant questionnaires and the next step is a large trial to find out whether the updated PROMPPT review 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.
Where was the study run from?
Keele University Clinical Trials Unit (UK) When did the study take place?
November 2020 to September 2021
Who funded the study?
National Institute for Health and Care Research (NIHR) (UK) Where can I learn more about the study?
https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.promppt.co.uk%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C4332762130cb40b8d6f008dbb7928c8e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638305612290211790%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3kCPKi3r3FDgPTJgn4miNArChYAiRxuLcm08vjMKAY0%3D&reserved=0REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0067
Date of REC Opinion
29 May 2020
REC opinion
Favourable Opinion