Julie Ashworth, Nicola Cornwall, Sarah A Harrisson, Charlotte Woodcock, Elaine Nicholls, Gillian Lancaster, Simon Wathall, Libby Laing, Toby Helliwell, Sue Jowett, Jesse Kigozi, Christian D Mallen, Anthony Avery, Roger Knaggs, Tamar Pincus, Simon White, Clare Jinks
{"title":"由初级保健团队临床药师领导的长期服用阿片类药物治疗持续性疼痛患者的前瞻性临床回顾(PROMPPT):一项非随机混合方法可行性研究。","authors":"Julie Ashworth, Nicola Cornwall, Sarah A Harrisson, Charlotte Woodcock, Elaine Nicholls, Gillian Lancaster, Simon Wathall, Libby Laing, Toby Helliwell, Sue Jowett, Jesse Kigozi, Christian D Mallen, Anthony Avery, Roger Knaggs, Tamar Pincus, Simon White, Clare Jinks","doi":"10.1186/s40814-025-01636-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial.</p><p><strong>Methods: </strong>A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview.</p><p><strong>Results: </strong>Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83%) completed 3-month follow-up. Of 88 MOPP participants invited for a PROMPPT review, 80 (91%) attended. The review was rated completely acceptable or acceptable in 90% (45/50) of acceptability questionnaires returned. Overall, participants interviewed (n = 15) perceived the review as a good idea and recommended it to others; they preferred face-to-face consultations. Prior to the review, they reported mixed feelings, including feeling 'pleased' to be invited and 'grateful' someone was taking an interest, alongside concerns about what would happen during the review, including opioids being stopped and changes being detrimental. Following the review, those with a clear plan for follow-up/access to the pharmacist felt reassured about making changes to their pain medicines, whilst those advised to arrange follow-up as needed were less satisfied and more likely to report confusion about the plan.</p><p><strong>Conclusions: </strong>PROMPPT reviews appeared acceptable to patients, review uptake was high, and the study demonstrated the feasibility of a large definitive trial to evaluate PROMPPT. The review invitation, patient information, and pharmacist training were refined based on the findings ahead of a large cluster randomised controlled trial.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN87628403 , registered 31 July 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"53"},"PeriodicalIF":1.5000,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023653/pdf/","citationCount":"0","resultStr":"{\"title\":\"Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study.\",\"authors\":\"Julie Ashworth, Nicola Cornwall, Sarah A Harrisson, Charlotte Woodcock, Elaine Nicholls, Gillian Lancaster, Simon Wathall, Libby Laing, Toby Helliwell, Sue Jowett, Jesse Kigozi, Christian D Mallen, Anthony Avery, Roger Knaggs, Tamar Pincus, Simon White, Clare Jinks\",\"doi\":\"10.1186/s40814-025-01636-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial.</p><p><strong>Methods: </strong>A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview.</p><p><strong>Results: </strong>Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83%) completed 3-month follow-up. Of 88 MOPP participants invited for a PROMPPT review, 80 (91%) attended. The review was rated completely acceptable or acceptable in 90% (45/50) of acceptability questionnaires returned. Overall, participants interviewed (n = 15) perceived the review as a good idea and recommended it to others; they preferred face-to-face consultations. Prior to the review, they reported mixed feelings, including feeling 'pleased' to be invited and 'grateful' someone was taking an interest, alongside concerns about what would happen during the review, including opioids being stopped and changes being detrimental. Following the review, those with a clear plan for follow-up/access to the pharmacist felt reassured about making changes to their pain medicines, whilst those advised to arrange follow-up as needed were less satisfied and more likely to report confusion about the plan.</p><p><strong>Conclusions: </strong>PROMPPT reviews appeared acceptable to patients, review uptake was high, and the study demonstrated the feasibility of a large definitive trial to evaluate PROMPPT. The review invitation, patient information, and pharmacist training were refined based on the findings ahead of a large cluster randomised controlled trial.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN87628403 , registered 31 July 2020.</p>\",\"PeriodicalId\":20176,\"journal\":{\"name\":\"Pilot and Feasibility Studies\",\"volume\":\"11 1\",\"pages\":\"53\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-04-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023653/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pilot and Feasibility Studies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40814-025-01636-2\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01636-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study.
Background: Given the poor long-term effectiveness of opioids for persistent non-cancer pain, and their potential for harm, evidence-based interventions to address opioid overprescribing for persistent pain are needed. This study aimed to explore the acceptability and feasibility of a primary care practice pharmacist-led intervention (PROMPPT review) for patients prescribed opioids for persistent pain and the feasibility of evaluating PROMPPT in a definitive trial.
Methods: A single-arm study, with mixed methods process evaluation, was conducted in four English primary care practices. Adults prescribed opioids for ≥ 6 months were invited to participate in the Management of Opioids and Persistent Pain (MOPP) study by completing baseline and 3-month follow-up questionnaires. Practices invited a representative sample of MOPP participants to schedule a PROMPPT review, eight of which were audio-recorded. Following the review, pharmacists completed intervention delivery templates, and participants were sent an Acceptability Questionnaire and invited to consent to an interview.
Results: Between November 2020 and May 2021, 148 participants were recruited to the MOPP study. Of these, 123 (83%) completed 3-month follow-up. Of 88 MOPP participants invited for a PROMPPT review, 80 (91%) attended. The review was rated completely acceptable or acceptable in 90% (45/50) of acceptability questionnaires returned. Overall, participants interviewed (n = 15) perceived the review as a good idea and recommended it to others; they preferred face-to-face consultations. Prior to the review, they reported mixed feelings, including feeling 'pleased' to be invited and 'grateful' someone was taking an interest, alongside concerns about what would happen during the review, including opioids being stopped and changes being detrimental. Following the review, those with a clear plan for follow-up/access to the pharmacist felt reassured about making changes to their pain medicines, whilst those advised to arrange follow-up as needed were less satisfied and more likely to report confusion about the plan.
Conclusions: PROMPPT reviews appeared acceptable to patients, review uptake was high, and the study demonstrated the feasibility of a large definitive trial to evaluate PROMPPT. The review invitation, patient information, and pharmacist training were refined based on the findings ahead of a large cluster randomised controlled trial.
Trial registration: ISRCTN, ISRCTN87628403 , registered 31 July 2020.
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.