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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05390411
Status
Enrolling By Invitation

Conditions

  • Decision Making
  • Heart Transplant
  • Implementation Science

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SOCIAL HF — BEHAVIORAL
    participate in SOCIAL HF training

Study Details

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.

Key Dates

Start date
Mar 6, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
1,463 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies. [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By research site
Indiana University· Indianapolis, IN

Related Studies