Clinical trial NCT05390411: Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
Official title: Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Implementation Science
Heart Transplant
Decision Making
Keywords: Healthcare Disparities
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-05-25
Enrollment: 1463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled cluster trial
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to achieve equity 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 bias, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. This rigorously designed trial may 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.

Detailed description: Standardized protocols can reduce the impact of implicit bias but are underused. Since the Institute of Medicine's report, "Unequal Treatment", multiple studies have confirmed that standardization of decision- making processes reduces bias, but bias in the allocation of advanced therapies has not been addressed. Using an evidence-based framework for behavior change \[Capability, Opportunity, and Motivation for Behavior Change/Behavior Change Wheel (COM-B/BCW)\], a standardized protocol strategy Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) was developed, that addresses significant barriers to equity in advanced therapies:1) bias, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based bias training 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 equitable seating arrangement. In complex decision-making that includes individuals and groups, the standardized protocol strategy, SOCIAL HF, has the greatest likelihood of achieving health equity in advanced HF. The 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. A randomized controlled cluster design will be used to test the effectiveness of SOCIAL HF strategy. Investigators will evaluate Implementation of SOCIAL HF across study sites using mixed-methods in order to learn optimal implementation strategies to achieve equity. Investigators will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). Investigators will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation.

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

Primary outcomes:
measure: Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.
timeFrame: Up to 3 years
measure: 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)
timeFrame: Month 2, up to 2 years, and up to 2.5 years
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 2 months, and up to 2 years
measure: Discussion themes during allocation meetings across patient race/ethnicity and gender
timeFrame: Baseline, 2 months, and up to 2 years
measure: Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years)
timeFrame: Baseline, 2 months, and up to 2 years
measure: Adoption of SOCIAL HF
timeFrame: 2 months
measure: Reach of SOCIAL HF
timeFrame: From 2 months up to 2 years
measure: Implementation of SOCIAL HF
timeFrame: From 2 months up to 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Khadijah Breathett, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: