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

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to reduce disparities 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 unequal and unethical decision-making towards patients, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. Our rigorously designed trial will 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 across populations.

Study Overview

• Status: Enrolling by invitation
• Conditions: Implementation Science; Decision Making; Heart Transplant
• Intervention / Treatment: Behavioral: SOCIAL HF

Detailed Description

Standardized protocols can reduce the impact of unfair and unequal treatment but are underused. Since the Institute of Medicine's report, "Unequal Treatment", multiple studies have confirmed that standardization of decision-making processes reduces unequal treatment, but unequal and unethical perceptions in decision-making 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 the most significant barriers to equality in advanced therapies: 1) unequal and unethical perceptions that influence decision-making, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based training to reduce disparities 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 more fair-minded seating arrangement. In complex decision-making that includes individuals and groups, our standardized protocol strategy, SOCIAL HF, has the greatest likelihood of reducing health disparities 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. As a type 2 effectiveness-implementation hybrid study, 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 to learn optimal implementation strategies to reduce disparities in accessing life-saving therapies. 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 training in reducing unequal and unethical perceptions in decision-making, clinical trials, mixed-methods, and implementation science.

• Study Type: Interventional
• Enrollment (Estimated): 1463
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.		Up to 2 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
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
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
Discussion themes during allocation meetings across patient race/ethnicity and sex	Transcriptions of meetings will be qualitatively evaluated over time.	Baseline, 2 months, and up to 2 years

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Khadijah Breathett, MD, MS, Indiana University

Publications and helpful links

Helpful Links

• NIH Reporter
• NIH Reporter

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Healthcare Disparities
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 13943; R56HL159216 (U.S. NIH Grant/Contract); R01HL159216 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No