Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
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About
The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to achieve equity in the allocation rate of advanced heart failure therapies, heart transplants and ventricular assist devices. This study proposes to implement evidence-based strategies that reduce bias, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. This rigorously designed trial may inform national guidelines for advanced heart failure therapy allocation, and data are likely to be generalizable to other organ replacement treatments and advanced chronic disease decision-making processes.
Full description
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)], a standardized protocol strategy Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) was developed, 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, the standardized protocol strategy, SOCIAL HF, has the greatest likelihood of achieving health equity in advanced HF. The 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. A randomized controlled cluster design will be used to test the effectiveness of SOCIAL HF strategy. Investigators will evaluate Implementation of SOCIAL HF across study sites using mixed-methods in order to learn optimal implementation strategies to achieve equity. Investigators will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). Investigators will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Active United Network for Organ Sharing heart transplant and ventricular assist device center
- Centers that routinely evaluate at least 50 minoritized racial/ethnic patients and 50 women for advanced heart failure therapies (heart transplant and ventricular assist device) over 2 years
- Advanced therapy professionals from participating centers (i.e., coordinators, physicians, pharmacists, nurses, social workers)
- Participants for the interview portion will be a subset of otherwise eligible advanced therapy professionals who are included on selection meeting attendance sheets at an included center
Exclusion criteria
- Centers unable to fully participate in the training and evaluation measures
- If the center ceases to be an active heart failure/transplant center
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,463 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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