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: 10440891
• 负责人: Khadijah Breathett
• 金额: $ 74.57万
• 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/10440891
• 关键词: Address; Adherence; Adoption; Affect; Attitude; Chronic Disease; Clinical Trials; Cluster randomized trial; Color; Complex; Data; Decision Making; Effectiveness; Ethnic Origin; Evaluation; Gender; Goals; Guidelines; Heart; Heart Transplantation; Heart failure; Individual; Infrastructure; Institute of Medicine (U.S.); Knowledge; Lead; Learning; Life; Maintenance; Measures; Methods; Modeling; Motivation; Organ; Outcome; Patients; Persons; Phenotype; Population; Process; Protocols documentation; Race; Randomized; Reach Effectiveness Adoption Implementation and Maintenance; Reporting; Research; Resources; Savings; Site; Social support; Standardization; Surveys; Testing; Therapy trial; Training; Treatment Failure; Variant; Voting; Woman; behavior change; behavior change wheel; design; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness testing; 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 and ethnic; 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 标准化的协议可以减少隐性偏见的影响，但未得到充分利用。自研究所 医学的报告，“不平等的待遇”，多项研究已经证实，标准化的决定- 制定流程减少了偏差，但先进疗法分配中的偏差尚未得到解决。 使用基于证据的行为改变框架[行为的能力、机会和动机 改变/行为改变轮（COM-B/BCW）]，我们开发了一种标准化的协议策略， 晚期心力衰竭分配的客观性（社会HF），解决了公平分配的重大障碍， 先进疗法：1）偏倚，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HF包括：1）针对HF量身定制的循证偏倚培训，2）限制 社会支持和坚持的客观评价，3）环境重建和建模， 会议设置包括匿名电子投票和公平座位安排。在复杂 决策，包括个人和团体，我们的标准化协议策略，社会HF，具有 最有可能在晚期HF中实现健康公平。我们的目标是评估现实世界的有效性 (Aim 1）和实施（目标2）用于分配高级HF治疗、心脏移植的社会HF 和心室辅助装置植入。我们将采用整群随机设计来测试 社会HF战略。我们将使用混合方法评价各研究中心的社会HF实施情况 以便学习实现公平的最佳执行战略。我们将使用规范化过程理论 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（覆盖范围、有效性、采用率、实施和 维护），以评估促进普及和采用的因素以及实施所需的资源。 我们拥有执行该项目的关系、基础设施和专业知识;我们的多学科团队 包括HF专家，循证偏倚减少培训，临床试验，混合方法， 执行科学。