Background Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory ('a systematic way of understanding events or situations') can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Methods As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3-4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient's underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention's mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Discussion Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients' adherence behaviour and guide further refinement of the intervention and study procedures. Trial registration This study is registered at ISRCTN: 10.1186/ISRCTN73831533.

中文翻译：

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S-MAP（药物依从性问题解决方案）干预的试点研究，用于初级保健中规定的老年人多药治疗：研究方案。

背景 对于老年患者（≥ 65 岁）来说，坚持多种药物处方是一项挑战，而且行为也难以改善。以前旨在解决这一问题的干预措施在本质上非常复杂，但效果有限，并且很少在设计中使用理论。人们已经认识到，理论（“理解事件或情况的系统方法”）可以指导干预措施的发展，并帮助研究人员更好地了解复杂的依从性干预措施是如何工作的。这项试点研究旨在测试一种新的基于社区药学的干预措施，该干预措施已使用行为改变的理论域框架（12 域版本）系统开发。方法 作为非随机试点研究的一部分，北爱尔兰（n = 6）和伦敦 12 家社区药房的药剂师，英格兰（n = 6）将接受培训，以向开具 ≥ 4 种常规药物且不依从（自我报告）的老年患者提供干预。每个药房将招募 10 名患者（n = 120），并在 3-4 个月的时间内在药房或通过电话提供最多四次量身定制的一对一课程。在 iPad 上的电子应用程序（应用程序）的指导下，干预内容将根据每位患者不依从的根本原因进行定制，并使用已建立的行为改变技术映射到最合适的解决方案。本研究将评估收集有关药物依从性（自我报告和配药数据）和次要结果（与健康相关的生活质量和计划外住院）的主要结果数据的可行性。嵌入式过程评估将评估药房工作人员的培训保真度、干预保真度、患者和药剂师的可接受性以及干预措施的作用机制。过程评估数据将包括培训研讨会、干预会议、反馈访谈和患者调查的录音。分析将主要是描述性的。讨论 使用预先定义的进展标准，这项试点研究的结果将指导决定是否进行集群随机对照试验，以测试 S-MAP 干预与社区药房常规护理相比的有效性。该研究还将探讨干预成分如何改变老年患者的依从行为，并指导干预和研究程序的进一步完善。