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

NCT05390411 | Enrolling By Invitation DMC

• 3 other identifiers: 13943R56HL159216R01HL159216
• Study Type: interventional
• Target: 1,463
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implementation Science; Heart Transplant; Decision Making

Keywords

Healthcare Disparities

Outcome Measures

Primary Outcomes (2)

• Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.

  Up to 2 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 Outcomes (6)

• 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

• Discussion themes during allocation meetings across patient race/ethnicity and sex

  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)

  Baseline, 2 months, and up to 2 years

• Adoption of SOCIAL HF

  2 months

• Reach of SOCIAL HF

  From 2 months up to 2 years

Study Arms (2)

Control Sites

NO INTERVENTION

No Intervention

Sites Randomized to SOCIAL HF

EXPERIMENTAL

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

Interventions

SOCIAL HF BEHAVIORAL

participate in SOCIAL HF training

Sites Randomized to SOCIAL HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Links

• NIH Reporter
• NIH Reporter

Study Officials

• Khadijah Breathett, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: tenured Associate Professor of Medicine

Model Details: Pragmatic randomized controlled cluster trial

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 25, 2022
• Study Start: March 6, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)