Implementation of a patient-centred complex intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): a mixed-methods process evaluation.

IF 5.6 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Carmen Corral-Partearroyo, Alba Sánchez-Viñas, María Teresa Peñarrubia-María, Montserrat Gil-Girbau, Ignacio Aznar-Lou, Claudia Palma-Vasquez, Carmen Gallardo-González, María Del Carmen Olmos-Palenzuela, Maria Rubio-Valera
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引用次数: 0

Abstract

Introduction: The initial medication adherence (IMA) intervention aims to improve adherence to cardiovascular disease (CVD) and diabetes treatments in primary care (PC) through standardised shared decision-making (SDM) and healthcare professional (HCP) collaboration (general practitioners (GPs), nurses and pharmacists). This study assessed the intervention's implementation (strategies, fidelity and integration into routine practice-based on the Normalisation Process Theory), mechanisms of action and the role of context.

Methods: The IMA-cRCT was an effectiveness-implementation cluster-Randomised Controlled Trial involving 24 Spanish PC centres (>300 HCP; >3000 patients) based on real-world evidence. This nested process evaluation used quantitative (monitoring data; HCP questionnaires) and qualitative methods (field diaries; 36 semistructured individual interviews and two focus groups (19 patients, 28 HCPs)). Quantitative data explored implementation and context and were analysed descriptively, while qualitative data examined implementation, mechanisms of action and context and were analysed using framework analysis. Both analyses were integrated for interpretation.

Results: Intervention implementation fidelity (6.5/10) and normalisation into clinical practice (7.6/10) were adequate, particularly regarding SDM and use of decision aids. HCPs recognised the importance of SDM, although some assumed it was already part of routine practice. The anticipated mechanisms of action were moderately supported. HCPs' knowledge and attitudes towards SDM improved as they acknowledged its relevance to practice. Some patients reported participation in decision-making, while others preferred the GP to decide on their behalf. Patients found leaflets helpful for understanding information. Contextual factors influencing the intervention were mainly organisational, such as lack of time and familiarity with SDM.

Conclusions: The interprofessional SDM-based IMA intervention was considered beneficial for patients and HCPs, with adequate implementation fidelity and normalisation into practice. The intervention was important for HCPs, and patients accepted it. However, greater effort is needed to extend SDM throughout healthcare, moving towards patient-centred care. These results have enhanced understanding of SDM interventions and support their refinement for future implementation.

Trial registration number: ClinicalTrials.gov, NCT05026775.

实施以患者为中心的复杂干预措施,提高初级保健中心血管疾病和糖尿病治疗的初始服药依从性(IMA-cRCT研究):一项混合方法过程评估。
初始药物依从性(IMA)干预旨在通过标准化的共享决策(SDM)和医疗保健专业人员(HCP)合作(全科医生(gp)、护士和药剂师)提高初级保健(PC)中心血管疾病(CVD)和糖尿病治疗的依从性。本研究评估了干预措施的实施(基于正常化过程理论的策略、保真度和融入日常实践)、作用机制和情境的作用。方法:IMA-cRCT是一项有效性实施集群随机对照试验,涉及24个西班牙PC中心(bb0 300 HCP;(3000名患者)基于真实世界的证据。这种嵌套过程评估使用了定量(监测数据;HCP问卷调查)和定性方法(实地日记;36个半结构化的个人访谈和两个焦点小组(19名患者,28名HCPs))。定量数据探讨了实施和背景,并进行了描述性分析,而定性数据检查了实施、行动机制和背景,并使用框架分析进行了分析。两种分析综合起来进行解释。结果:干预实施的保真度(6.5/10)和临床实践的规范化(7.6/10)是足够的,特别是在SDM和决策辅助工具的使用方面。医护人员认识到SDM的重要性,尽管有些人认为它已经是常规实践的一部分。预期的作用机制得到适度支持。由于认识到SDM与实践的相关性,医护人员对SDM的知识和态度有所改善。一些患者报告参与决策,而另一些患者更喜欢全科医生代表他们做决定。患者发现传单有助于理解信息。影响干预的背景因素主要是组织性的,如缺乏时间和对SDM的熟悉程度。结论:基于sdm的跨专业IMA干预被认为对患者和HCPs有益,具有足够的实施保真度和规范化。干预对HCPs很重要,患者也接受了。然而,需要更大的努力将SDM扩展到整个医疗保健领域,朝着以患者为中心的护理方向发展。这些结果增强了对SDM干预措施的理解,并支持对其进行改进,以便将来实施。试验注册号:ClinicalTrials.gov, NCT05026775。
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来源期刊
BMJ Quality & Safety
BMJ Quality & Safety HEALTH CARE SCIENCES & SERVICES-
CiteScore
9.80
自引率
7.40%
发文量
104
审稿时长
4-8 weeks
期刊介绍: BMJ Quality & Safety (previously Quality & Safety in Health Care) is an international peer review publication providing research, opinions, debates and reviews for academics, clinicians and healthcare managers focused on the quality and safety of health care and the science of improvement. The journal receives approximately 1000 manuscripts a year and has an acceptance rate for original research of 12%. Time from submission to first decision averages 22 days and accepted articles are typically published online within 20 days. Its current impact factor is 3.281.
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