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

Not Applicable

• Conditions: Implementation Science; Heart Transplant; Decision Making
• Interventions: Behavioral: SOCIAL HF

• Registration Number: NCT05390411
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Start: 2023-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1463

Inclusion Criteria

1. Active United Network for Organ Sharing heart transplant and ventricular assist device center
2. 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
3. Advanced therapy professionals from participating centers (i.e., coordinators, physicians, pharmacists, nurses, social workers)
4. 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

1. Centers unable to fully participate in the training and evaluation measures
2. If the center ceases to be an active heart failure/transplant center

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sites Randomized to SOCIAL HF	SOCIAL HF	SOCIAL HF is composed of evidence-based bias reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.

Primary Outcome Measures

Name	Time	Method
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)	Month 2, up to 2 years, and 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.
Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Reach of SOCIAL HF	From 2 months up to 2 years	Proportion of patients evaluated using any parts of SOCIAL HF
Implementation of SOCIAL HF	From 2 months up to 2 years	Proportion of patients evaluated using all parts of SOCIAL HF
Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years)	Baseline, 2 months, and 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.
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)	Baseline, 2 months, and 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.
Discussion themes during allocation meetings across patient race/ethnicity and gender	Baseline, 2 months, and up to 2 years	Transcriptions of meetings will be qualitatively evaluated over time.
Adoption of SOCIAL HF	2 months	Proportion of eligible advanced therapy professionals who participate in training

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States