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。

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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
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引用次数: 0

摘要

背景:鉴于阿片类药物对持续性非癌性疼痛的长期疗效不佳,及其潜在的危害,需要循证干预措施来解决阿片类药物对持续性疼痛的过度处方。本研究旨在探讨初级保健实践药剂师主导的干预(PROMPPT审查)的可接受性和可行性,为处方阿片类药物治疗持续性疼痛的患者和可行性评估PROMPPT在一个明确的试验。方法:在四个英国初级保健实践中进行单臂研究,采用混合方法进行过程评估。处方阿片类药物≥6个月的成年人被邀请参加阿片类药物和持续性疼痛管理(MOPP)研究,完成基线和3个月的随访问卷。实践邀请了一个有代表性的MOPP参与者样本来安排PROMPPT审查,其中8个是录音的。审查结束后,药剂师完成干预交付模板,并向参与者发送可接受性问卷,并邀请他们同意接受采访。结果:在2020年11月至2021年5月期间,148名参与者被招募到MOPP研究中。其中123例(83%)完成了3个月的随访。在88名MOPP参与者中,有80人(91%)参加了PROMPPT审查。在90%(45/50)的可接受问卷中,评价被评为完全可接受或可接受。总体而言,受访的参与者(n = 15)认为评论是一个好主意,并将其推荐给其他人;他们更喜欢面对面的协商。在审查之前,他们报告了复杂的感受,包括对被邀请感到“高兴”和“感激”有人感兴趣,以及对审查期间会发生的事情的担忧,包括阿片类药物被停止和变化是有害的。在审查之后,那些有明确的随访计划/可以接触药剂师的人对改变他们的止痛药感到放心,而那些被建议根据需要安排随访的人则不太满意,更有可能对计划感到困惑。结论:PROMPPT的评价对患者来说是可以接受的,评价的接受度很高,研究证明了进行大型决定性试验来评价PROMPPT的可行性。回顾邀请、患者信息和药剂师培训是基于大型集群随机对照试验之前的发现而改进的。试验注册:ISRCTN, ISRCTN87628403,注册日期为2020年7月31日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
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.
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