Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

寻求晚期心力衰竭 (SOCIAL HF) 治疗试验分配的客观性

• 批准号: 10617805
• 负责人: Khadijah Breathett
• 金额: $ 63.99万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617805
• 关键词: Address; Adherence; Adoption; Affect; Attitude; Chronic Disease; Clinical Trials; Cluster randomized trial; Color; Complex; Data; Decision Making; Effectiveness; Electronics; Eligibility Determination; Equity; Ethnic Origin; Evaluation; Gender; Goals; Guidelines; Heart; Heart Transplantation; Heart failure; Hospitalization; Individual; Infrastructure; Institute of Medicine (U.S.); Knowledge; Learning; Life; Maintenance; Measures; Methods; Modeling; Motivation; Organ; Outcome; Patients; Persons; Phenotype; Population; Process; Protocols documentation; Race; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Resources; Site; Social support; Standardization; Surveys; Testing; Therapy trial; Training; Treatment Failure; Variant; Voting; Woman; behavior change; behavior change wheel; cluster randomized design; effectiveness evaluation; effectiveness testing; effectiveness/implementation trial; evidence base; health equity; implantation; implementation evaluation; implementation outcomes; implementation science; implementation strategy; implicit bias; improved; medication compliance; meetings; multidisciplinary; people of color; programs; racial minority; self reported behavior; theories; trial design; ventricular assist device

ABSTRACT Standardized protocols can reduce the impact of implicit bias but are underused. Since the Institute of Medicine’s report, “Unequal Treatment”, multiple studies have confirmed that standardization of decision- making processes reduces bias, but bias in the allocation of advanced therapies has not been addressed. Using an evidence-based framework for behavior change [Capability, Opportunity, and Motivation for Behavior Change/Behavior Change Wheel (COM-B/BCW)], we developed a standardized protocol strategy, Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF), that addresses significant barriers to equity in advanced therapies: 1) bias, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based bias training tailored for HF, 2) restriction to objective evaluations of social support and adherence, and 3) environmental restructuring and modeling of meeting settings to include anonymous electronic voting and equitable seating arrangement. In complex decision-making that includes individuals and groups, our standardized protocol strategy, SOCIAL HF, has the greatest likelihood of achieving health equity in advanced HF. Our goal is to assess real-world effectiveness (Aim 1) and implementation (Aim 2) of SOCIAL HF for allocation of advanced HF therapies, heart transplant and ventricular assist device implantation. We will use a cluster randomized design to test the effectiveness of SOCIAL HF strategy. We will evaluate implementation of SOCIAL HF across study sites using mixed-methods in order to learn optimal implementation strategies to achieve equity. We will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). We will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation. We have the relationships, infrastructure, and expertise to execute this project; our multidisciplinary team includes experts in HF, evidence-based bias reduction training, clinical trials, mixed-methods, and implementation science.

摘要 标准化方案可以减少隐性偏见的影响，但没有得到充分利用。自该研究所成立以来 医学报告《不平等待遇》的多项研究证实，决策的标准化-- 制造过程减少了偏见，但先进疗法分配中的偏见尚未得到解决。 使用基于证据的框架改变行为[能力、机会和行为动机 Change/Behavior Change Wheels(COM-B/BCW)]，我们开发了标准化协议策略，寻求 在晚期心力衰竭(社会性心力衰竭)分配中的客观性，解决了公平的重大障碍 先进疗法：1)偏见，2)社会支持和依从性评价的主观性，3)贫困群体 动力学。因此，社会性HF包括：1)针对HF量身定做的循证偏见训练；2)限制 对社会支持和依从性的客观评价，以及3)环境重组和建模 会议设置包括匿名电子投票和公平的座位安排。在复合体中 包括个人和团体在内的决策，我们的标准化协议策略，社交HF，具有 在进展性心衰中实现健康公平的可能性最大。我们的目标是评估现实世界的有效性 (目标1)和实施(目标2)社会性心力衰竭，用于分配先进的心力衰竭疗法、心脏移植 以及植入脑室辅助装置。我们将使用整群随机设计来测试 社交高频战略。我们将使用混合方法评估跨研究站点的社会HF的实施情况 以学习最佳实施策略，以实现公平。我们将使用标准化过程理论 评估社会性心力衰竭如何影响对先进心力衰竭中心非常重要的过程和结果(例如 保真度/变化)。我们将使用RE-AIM框架(覆盖范围、有效性、采用、实施和 维护)评估促进覆盖和采用的因素以及实施所需的资源。 我们拥有执行该项目所需的关系、基础设施和专业知识；我们的多学科团队 包括心衰专家、基于证据的减少偏见培训、临床试验、混合方法和 实施科学。