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方案文件:采用逐步楔形集群随机试验将 ABCS 转化为优化艾滋病毒感染者心血管护理。

Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.

机构信息

Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, NY.

Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY.

出版信息

Prog Cardiovasc Dis. 2020 Mar-Apr;63(2):125-133. doi: 10.1016/j.pcad.2020.02.003. Epub 2020 Feb 5.

Abstract

People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.

摘要

与未感染人群相比,艾滋病毒感染者(PWH)患心血管疾病(CVD)和中风的风险更高。ABCs(阿司匹林-血压控制-胆固醇控制-戒烟)降低了普通人群的动脉粥样硬化性心血管疾病(ASCVD)风险,但对于促进 PWH 采用 ABCs 的策略知之甚少。本研究以实施研究综合框架(CFIR)为指导,设计了针对 PWH 及其临床医生的多层次实施策略,根据 10 年 ASCVD 风险,促进 ABCS 的合理使用。实施策略包括患者辅导、自动短信、同行电话支持、学术详细信息以及患者临床医生的审核和反馈。我们正在通过基于扩展有效性-可接受性-适用性-维持性/定性评估-系统翻译(RE-AIM/QuEST)混合方法框架的阶梯式楔形集群随机试验评估实施情况,该框架综合了定量和定性评估。主要结局是 ASCVD 风险的变化。研究结果对于降低 PWH 患 ASCVD 风险的策略具有重要意义。

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