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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Implementation Science, Heart Transplant, Decision Making, Bias, Racial, Health Equity, Bias, Sex

Intervention / Treatment
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* Behavioral: SOCIAL HF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized controlled cluster trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Sites<br>No Intervention | |
| Experimental: Sites Randomized to SOCIAL HF<br>SOCIAL HF is composed of evidence-based bias reduction training, employment of objective measures of social support, and changes to facilitate group dynamics. | Behavioral: SOCIAL HF<br>* participate in SOCIAL HF training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies. |  | Up to 3 years | 
| Change in SOCIAL HF fidelity from time of training completion (month 2) to time study target has been reached (up to 2 years) and 6 months after reaching study target (up to 2.5 years) | Evaluated as barriers, facilitators, and variability in adoption, reach, implementation and maintenance through structured interviews. Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies per center. | Month 2, up to 2 years, and up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline knowledge, attitudes, and self-reported behavior change among clinicians at 2 months and time at which study target has been reached (up to 2 years) | Multiple survey responses by participants will indicate knowledge, attitudes, and self-reported behavior changes over time. Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies. | Baseline, 2 months, and up to 2 years | 
| Discussion themes during allocation meetings across patient race/ethnicity and gender | Transcriptions of meetings will be qualitatively evaluated over time. | Baseline, 2 months, and up to 2 years | 
| Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years) | The de Groot Critically Reflective Diagnoses protocol objectively measures categories associated with group function including challenging groupthink, critical opinion sharing, research utilization, openness to mistakes, asking and giving feedback, and experimentation. Each category is scaled from 1-4 (high-low), 1 = demonstrating interaction and reflection, 2 = reflective on an individual basis, 3 = non-reflective and non-interactive, and 4 = restricted. Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies per center. | Baseline, 2 months, and up to 2 years | 
| Adoption of SOCIAL HF | Proportion of eligible advanced therapy professionals who participate in training | 2 months | 
| Reach of SOCIAL HF | Proportion of patients evaluated using any parts of SOCIAL HF | From 2 months up to 2 years | 
| Implementation of SOCIAL HF | Proportion of patients evaluated using all parts of SOCIAL HF | From 2 months up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthcare Disparities