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Enrolling By Invitation
NCT05390411
Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
Conditions: Implementation Science, Heart Transplant, Decision Making
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1463
Sponsor: Indiana University
Location: Indiana University Indianapolis Indiana
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05390411). StuddyBuddy aggregates publicly available trial information.