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

Indiana University

Status: Invitation-only

Conditions: Decision Making; Implementation Science; Heart Transplant

Treatments: Behavioral: SOCIAL HF

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05390411

R01HL159216 (U.S. NIH Grant/Contract)

R56HL159216 (U.S. NIH Grant/Contract)

13943

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,463 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,463 participants in 2 patient groups

Control Sites

No Intervention group

Description:

No Intervention

Sites Randomized to SOCIAL HF

Experimental group

Description:

SOCIAL HF is composed of evidence-based disparities reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.

Treatment:

Behavioral: SOCIAL HF