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

基本信息

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
项目类别：
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

项目摘要

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性偏见的影响，但自成立以来并未得到充分利用。医学报告“不平等待遇”，多项研究证实决策标准化制作过程减少了偏差，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] Change/Behavior Change Wheel (COM-B/BCW)]，我们制定了标准化协议策略，寻求晚期心力衰竭 (SOCIAL HF) 分配的客观性，解决了公平分配的重大障碍先进疗法：1）偏见，2）社会支持和依从性评估的主观性，3）贫困群体因此，社交心力衰竭包括：1）针对心力衰竭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。包括个人和团体的决策，我们的标准化协议策略 SOCIAL HF 具有在晚期心力衰竭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。社会心力衰竭（目标 1）和实施（目标 2），用于分配先进的心力衰竭治疗、心脏移植我们将使用整群随机设计来测试心室辅助装置植入的有效性。我们将使用混合方法在各个研究地点实施社交高频策略。为了学习实现公平的最佳策略实施，我们将使用标准化过程理论。评估社交心力衰竭如何影响对先进心力衰竭中心很重要的流程和结果（例如我们将使用 RE-AIM 框架（范围、有效性、采用、实施和）。维护）来评估促进影响范围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；包括 HF、基于证据的偏差减少培训、临床试验、混合方法和实施科学。