Sluggett Janet K, Hughes Georgina A, Ooi Choon Ean, Chen Esa Y H, Corlis Megan, Hogan Michelle E, Caporale Tessa, Van Emden Jan, Bell J Simon
UniSA Allied Health and Human Performance, University of South Australia, Adelaide, SA 5001, Australia.
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC 3052, Australia.
Int J Environ Res Public Health. 2021 May 27;18(11):5778. doi: 10.3390/ijerph18115778.
Complex medication regimens are highly prevalent, burdensome for residents and staff, and associated with poor health outcomes in residential aged care facilities (RACFs). The SIMPLER study was a non-blinded, matched-pair, cluster randomized controlled trial in eight Australian RACFs that investigated the one-off application of a structured 5-step implicit process to simplify medication regimens. The aim of this study was to explore the processes underpinning study implementation and uptake of the medication simplification intervention. A mixed methods process evaluation with an explanatory design was undertaken in parallel with the main outcome evaluation of the SIMPLER study and was guided by an established 8-domain framework. The qualitative component included a document analysis and semi-structured interviews with 25 stakeholders (residents, family, research nurses, pharmacists, RACF staff, and a general medical practitioner). Interviews were transcribed verbatim and reflexively thematically content analyzed. Descriptive statistics were used to summarize quantitative data extracted from key research documents. The SIMPLER recruitment rates at the eight RACFs ranged from 18.9% to 48.6% of eligible residents (38.4% overall). Participation decisions were influenced by altruism, opinions of trusted persons, willingness to change a medication regimen, and third-party hesitation regarding potential resident distress. Intervention delivery was generally consistent with the study protocol. Stakeholders perceived regimen simplification was beneficial and low risk if the simplification recommendations were individualized. Implementation of the simplification recommendations varied between the four intervention RACFs, with simplification implemented at 4-month follow-up for between 25% and 86% of residents for whom simplification was possible. Good working relationships between stakeholders and new remunerated models of medication management were perceived facilitators to wider implementation. In conclusion, the one-off implicit medication simplification intervention was feasible and generally delivered according to the protocol to a representative sample of residents. Despite variable implementation, recommendations to simplify complex regimens were valued by stakeholders, who also supported wider implementation of medication simplification in RACFs.
复杂的药物治疗方案非常普遍，给养老院居民和工作人员带来负担，并且与老年护理机构（RACF）中不良的健康结果相关。SIMPLER研究是一项在澳大利亚8家RACF中进行的非盲、配对、整群随机对照试验，该试验调查了采用结构化的5步隐性流程一次性简化药物治疗方案的情况。本研究的目的是探讨支持研究实施和药物简化干预措施采用的过程。在SIMPLER研究的主要结局评估的同时，采用了具有解释性设计的混合方法过程评估，并以既定的8领域框架为指导。定性部分包括对25名利益相关者（居民、家属、研究护士、药剂师、RACF工作人员和一名全科医生）进行文件分析和半结构化访谈。访谈逐字记录，并进行反思性主题内容分析。描述性统计用于总结从关键研究文件中提取的定量数据。8家RACF的SIMPLER招募率在符合条件居民的18.9%至48.6%之间（总体为38.4%）。参与决策受到利他主义、可信赖之人的意见、改变药物治疗方案的意愿以及第三方对潜在居民痛苦的犹豫的影响。干预措施的实施总体上与研究方案一致。利益相关者认为，如果简化建议是个性化的，那么方案简化是有益且风险较低的。四个干预RACF之间简化建议的实施情况各不相同，在4个月随访时，对于可能进行简化的居民，有25%至86%实施了简化。利益相关者之间良好的工作关系以及新的有偿药物管理模式被视为更广泛实施的促进因素。总之，一次性隐性药物简化干预措施是可行的，并且通常按照方案提供给具有代表性的居民样本。尽管实施情况存在差异，但简化复杂方案的建议受到利益相关者的重视，他们也支持在RACF中更广泛地实施药物简化。
