Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Barakaldo, Spain
Biocruces Bizkaia Health Research Institute, Barakaldo, Spain.
BMJ Open. 2024 Apr 17;14(4):e078692. doi: 10.1136/bmjopen-2023-078692.
This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.
A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45-74 years and men aged 40-74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR<7.5%), who attend at least one appointment with any of the participating FPs (May 2022-May 2023), and will be followed until May 2024. We use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes. The main outcome will be the change in the incidence rate of PIP of statins and healthy lifestyle counselling in the study population 12 and 24 months after FPs' exposure to the strategies. Moreover, FPs' perception of their feasibility and acceptability, and patient experience regarding the quality of care received will be evaluated.
The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.
NCT04022850.
本研究旨在减少心血管疾病（CVD）一级预防中低危患者他汀类药物的潜在不适当处方（PIP），并促进健康生活方式的推广。为此，我们将比较几种基于行为改变车轮结构设计过程开发的实施策略的有效性和可行性，这些策略针对 CVD 预防临床决策过程的关键决定因素。
将开展一项包含额外对照组的集群随机实施试验，涉及来自 2021 年存在他汀类药物 PIP 非零发生率的 13 个综合医疗组织（IHO）的家庭医生（FPs）。所有 FPs 将接触到基于提醒和决策支持工具的非反射性决策辅助策略。此外，两个 IHO 的 FPs 将被随机分配到两种越来越强化的去实施策略之一：添加基于知识传播的决策信息策略和通过审计/反馈的反射决策结构策略。目标人群包括年龄在 45-74 岁的女性和 40-74 岁的男性，他们胆固醇水平中度升高，但没有诊断出 CVD 和低心血管风险（REGICOR<7.5%），并且至少与参与的 FPs 中的一位医生预约（2022 年 5 月-2023 年 5 月），并将随访至 2024 年 5 月。我们使用 Reach、Effectiveness、Adoption、Implementation 和 Maintenance（RE-AIM）框架评估结果。主要结果将是在 FPs 接触策略后 12 和 24 个月，研究人群中他汀类药物 PIP 和健康生活方式咨询的发生率变化。此外，还将评估 FPs 对其可行性和可接受性的看法，以及患者对所接受护理质量的体验。
该研究得到了巴斯克地区临床研究伦理委员会的批准，并在 ClinicalTrials.gov 上注册（NCT04022850）。结果将在科学同行评议期刊上发表。
NCT04022850。
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