BACKGROUND De-implementation or abandonment of ineffective or low-value healthcare is becoming a priority research field globally due to the growing empirical evidence of the high prevalence of such care and its impact in terms of patient safety and social inefficiency. Little is known, however, about the factors, barriers, and facilitators involved or about interventions that are effective in promoting and accelerating the de-implementation of low-value healthcare. The De-imFAR study seeks to carry out a structured, evidence-based, and theory-informed process involving the main stakeholders (clinicians, managers, patients, and researchers) for the design, deployment, and assessment of de-implementation strategies for reducing low-value pharmacological prescribing. METHODS A phase I formative study using a systematic and comprehensive framework based on theory and evidence for the design of implementation strategies-specifically, the Behavior Change Wheel (BCW)-will be conducted to design and model de-implementation strategies to favor reductions in low-value pharmacological prescribing of statins in primary prevention of cardiovascular disease (CVD) by main stakeholders (clinicians, managers, patients, and researchers) in a collegiate way. Subsequently, a phase II comparative hybrid trial will be conducted to assess the feasibility and potential effectiveness of at least one active de-implementation strategy to reduce low-value pharmacological prescribing of statins in primary prevention of CVD compared to the usual procedures for dissemination of clinical practice guidelines ("what-not-to-do" recommendations). A mixed-methods evaluation will be used: quantitative for the results of the implementation at the professional level (e.g., adoption, reach and implementation or execution of the recommended clinical practice); and qualitative to determine the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and patients' experiences related to the clinical care received. DISCUSSION The DE-imFAR study aims to generate valid scientific knowledge about the design and development of de-implementation strategies using theory- and evidence-based methodologies suggested by implementation science. It will explore the effectiveness of these strategies and their acceptability among clinicians, policymakers, and patients. Its ultimate goal is to maximize the quality and efficiency of our health system by abandoning low-value pharmacological prescribing. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT04022850. Registered 17 July 2019.

中文翻译：

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通过结构化的基于证据和理论依据的流程来设计和测试去实现策略，从而解决CVD一级预防中的低价值药理处方：DE-imFAR研究。

背景技术由于越来越多的经验证明这种护理的普遍性及其对患者安全和社会低效的影响，越来越多的经验证据表明，取消或放弃无效或低价值的医疗保健正在成为全球的优先研究领域。但是，对于所涉及的因素，障碍和促进者，或者对于有效促进和加速低价值医疗保健的取消实施的干预措施知之甚少。De-imFAR研究旨在进行一个结构化，基于证据和理论的流程，让主要利益相关者（临床医师，管理人员，患者和研究人员）参与到设计，部署和评估减少实施策略的过程中。低价药理处方。方法将使用基于理论和证据的系统，全面框架进行实施阶段I的形成性研究，以设计实施策略，具体而言，将进行行为改变轮（BCW）的设计和建模，以实现降低实施成本的策略。主要利益相关者（临床医生，管理人员，患者和研究人员）以合议的方式对他汀类药物进行心血管疾病一级预防的有价值的药理处方。随后，将进行II期比较性混合试验，以评估与常规的临床散布程序相比，至少一种主动去实施策略以减少他汀类药物在心血管疾病一级预防中的低价值药理处方的可行性和潜在有效性。实践准则（“不做什么” 建议）。将使用混合方法评估：在专业级别量化实施结果（例如，推荐的临床实践的采用，达到和实施或执行）；并从临床医生的角度以及从患者所接受的与临床护理相关的经验中定性地确定取消实施策略的可行性和可感知的影响。讨论DE-imFAR研究旨在使用实施科学提出的基于理论和证据的方法，来生成有关实施策略设计和开发的有效科学知识。它将探讨这些策略的有效性及其在临床医生，政策制定者和患者中的接受度。它的最终目标是通过放弃低价值的药理处方来最大化我们的卫生系统的质量和效率。试验注册Clinicaltrials.gov标识符：NCT04022850。注册于2019年7月17日。