Patton D E, Pearce C J, Cartwright M, Smith F, Cadogan C A, Ryan C, Clark E, Francis J J, Hughes C M
School of Pharmacy, Queen's University Belfast, Belfast, UK.
School of Health Sciences, City University of London, London, UK.
Pilot Feasibility Stud. 2021 Jan 7;7(1):18. doi: 10.1186/s40814-020-00762-3.
Older patients prescribed multiple medications commonly experience difficulties with adherence. High-quality evidence on interventions targeting older patients is lacking. Theory is rarely used to tailor adherence solutions. This study aimed to pilot test a novel intervention, developed using the Theoretical Domains Framework, which guides community pharmacists in identifying adherence barriers and delivering tailored solutions (behaviour change techniques). Key study procedures (e.g. recruitment, data collection) for a future randomised controlled trial (cRCT) were also assessed.
Using purposive sampling, this non-randomised pilot study aimed to recruit 12 community pharmacies (six in Northern Ireland; six in London, England). Pharmacists were trained to deliver the intervention to non-adherent older patients (maximum 10 per pharmacy; target n = 60-120) aged ≥ 65 years (reduced to 50 years due to recruitment challenges) and prescribed ≥ 4 regular medicines. The intervention, guided by an iPad web-application, was delivered over 3-4 face-to-face or telephone sessions, tailored to specific barriers to adherence. We assessed the feasibility of collecting adherence data (primary outcome: self-report and dispensing records), health-related quality of life (HRQOL) and unplanned hospitalisations (secondary outcomes) at baseline and 6-months. The final decision on progressing to a cRCT, using pre-defined 'stop-amend-go' criteria, is presented.
Fifteen pharmacists from 12 pharmacies were recruited and trained. One pharmacy subsequently dropped out. Sixty patients were recruited (meeting the 'Amend' progression criteria), with 56 receiving the intervention. Adherence barriers were identified for 55 patients (98%) and a wide range of behaviour change solutions delivered (median: 5 per patient). Self-report and dispensing adherence data were available for 37 (61.7%) and 44 (73.3%) patients, respectively. HRQOL data were available for 35 (58.3%) patients. GP-reported and self-reported hospitalisations data were available for 47 (78.3%) and 23 (38.3%) patients, respectively. All progression concepts were met (nine 'Go' and three 'Amend' criteria).
This study demonstrates the feasibility of key study procedures (e.g. pharmacy recruitment) and delivery of a tailored adherence intervention in community pharmacies. However, modifications are required to enhance issues identified with patient recruitment, retention and missing data. A future definitive cRCT will explore the effectiveness of the intervention.
ISRCTN, ISRCTN73831533 , Registered 12 January 2018.
开具多种药物的老年患者通常在坚持服药方面存在困难。针对老年患者干预措施的高质量证据尚缺。理论很少被用于定制坚持服药的解决方案。本研究旨在对一种新型干预措施进行试点测试，该措施是使用理论领域框架开发的，可指导社区药剂师识别坚持服药的障碍并提供定制化解决方案（行为改变技巧）。还评估了未来随机对照试验（cRCT）的关键研究程序（如招募、数据收集）。
采用立意抽样法，这项非随机试点研究旨在招募12家社区药房（北爱尔兰6家；英格兰伦敦6家）。药剂师接受培训，为年龄≥65岁（因招募困难降至50岁）且开具≥4种常规药物的不坚持服药的老年患者（每家药房最多10名；目标n = 60 - 120）提供干预措施。该干预措施由iPad网络应用程序引导，通过3 - 4次面对面或电话会议提供，针对特定的坚持服药障碍进行定制。我们评估了在基线和6个月时收集坚持服药数据（主要结局：自我报告和配药记录）、健康相关生活质量（HRQOL）和非计划住院（次要结局）的可行性。使用预定义的“停止 - 修改 - 继续”标准，给出了推进至cRCT的最终决定。
招募并培训了来自12家药房的15名药剂师。随后有一家药房退出。招募了60名患者（符合“修改”推进标准），其中56名接受了干预。为55名患者（98%）识别出了坚持服药的障碍，并提供了广泛的行为改变解决方案（中位数：每位患者5种）。分别有37名（61.7%）和44名（73.3%）患者提供了自我报告和配药坚持服药数据。35名（58.3%）患者提供了HRQOL数据。分别有47名（78.3%）和23名（38.3%）患者提供了全科医生报告和自我报告的住院数据。所有推进标准均得到满足（9项“继续”标准和3项“修改”标准）。
本研究证明了关键研究程序（如药房招募）以及在社区药房提供定制化坚持服药干预措施的可行性。然而，需要进行修改以改善在患者招募、留存和数据缺失方面发现的问题。未来确定性的cRCT将探索该干预措施的有效性。
ISRCTN，ISRCTN73831533，2018年1月12日注册。
