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

Decision Making Clinical Trial

— SOCIAL HF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05390411
• Other study ID #: 13943
• Secondary ID: R56HL159216R01HL
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1463
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bias, Racial
• Bias, Sex
• Decision Making
• Health Equity
• Heart Failure
• Heart Transplant
• Implementation Science

Intervention

Behavioral:
• SOCIAL HF
participate in SOCIAL HF training

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.		Up to 3 years
Primary	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	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)	Multiple survey responses by participants will indicate knowledge, attitudes, and self-reported behavior changes over time.; Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies.	Baseline, 2 months, and up to 2 years
Secondary	Discussion themes during allocation meetings across patient race/ethnicity and gender	Transcriptions of meetings will be qualitatively evaluated over time.	Baseline, 2 months, and up to 2 years
Secondary	Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years)	The de Groot Critically Reflective Diagnoses protocol objectively measures categories associated with group function including challenging groupthink, critical opinion sharing, research utilization, openness to mistakes, asking and giving feedback, and experimentation. Each category is scaled from 1-4 (high-low), 1 = demonstrating interaction and reflection, 2 = reflective on an individual basis, 3 = non-reflective and non-interactive, and 4 = restricted.; Study target is defined as time 50 patients of color and 50 women have been evaluated for advanced heart failure therapies per center.	Baseline, 2 months, and up to 2 years
Secondary	Adoption of SOCIAL HF	Proportion of eligible advanced therapy professionals who participate in training	2 months
Secondary	Reach of SOCIAL HF	Proportion of patients evaluated using any parts of SOCIAL HF	From 2 months up to 2 years
Secondary	Implementation of SOCIAL HF	Proportion of patients evaluated using all parts of SOCIAL HF	From 2 months up to 2 years

External Links

•   NIH Reporter
•   NIH Reporter