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.

抽象的 标准化协议可以减少隐式偏见的影响，但没有充分利用。自从研究所 医学的报告“不平等的治疗”，多项研究证实了决策的标准化 - 进行过程减少了偏见，但是尚未解决高级疗法分配的偏见。 使用基于证据的行为改变框架[能力，机会和行为动机 更改/行为变更轮（com-b/bcw）]，我们制定了标准化的协议策略，寻求 分配晚期心力衰竭（社会HF）的客观性，该问题解决了公平的重大障碍 高级疗法：1）偏见，2）评估社会支持和依从性的主观性，3）贫穷的群体 动力学。那就是社会HF包括：1）针对HF量身定制的基于证据的偏见培训，2）限制 对社会支持和依从性的客观评估，以及3）环境修复和建模 开会设置，包括匿名电子投票和公平的座位安排。复杂 包括个人和团体在内的决策，我们的标准化协议策略，社会HF，具有 在高级HF中实现健康公平的最大可能性。我们的目标是评估现实世界的有效性 （目标1）和社会HF的实施（目标2）用于分配高级HF疗法，心脏移植 和心室辅助装置植入。我们将使用簇随机设计来测试 社会HF策略。我们将使用混合方法评估跨研究网站的社会HF的实施 为了学习实现公平的最佳实施策略。我们将使用归一化过程理论 评估社会HF如何影响对高级HF中心重要的过程和结果（例如 保真度/变化）。我们将使用RE-AIM框架（覆盖，有效性，采用，实施，并且 维护）评估促进实施所需的覆盖范围，采用和资源的因素。 我们拥有执行该项目的关系，基础架构和专业知识；我们的多学科团队 包括HF专家，基于证据的偏见培训，临床试验，混合方法和 实施科学。