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

• ClinicalTrials.gov Identifier: NCT05390411
• Recruitment Status: Enrolling by invitation
• First Posted: May 25, 2022
• Last Update Posted: April 16, 2024
• Sponsor: Indiana University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA, Indiana University

Tracking Information

• First Submitted Date: March 21, 2022
• First Posted Date: May 25, 2022
• Last Update Posted Date: April 16, 2024
• Actual Study Start Date: March 6, 2023
• Estimated Primary Completion Date: February 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2023)

• Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies. [ Time Frame: Up to 3 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) [ Time Frame: Month 2, up to 2 years, and 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.

Original Primary Outcome Measures (submitted: May 19, 2022)

• Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies. [ Time Frame: Up to 3 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) [ Time Frame: Month 2, up to 2 years, and 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.

Current Secondary Outcome Measures (submitted: March 14, 2023)

• 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) [ Time Frame: Baseline, 2 months, and 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.
• Discussion themes during allocation meetings across patient race/ethnicity and gender [ Time Frame: Baseline, 2 months, and up to 2 years ]
  Transcriptions of meetings will be qualitatively evaluated over time.
• Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years) [ Time Frame: Baseline, 2 months, and 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.
• Adoption of SOCIAL HF [ Time Frame: 2 months ]
  Proportion of eligible advanced therapy professionals who participate in training
• Reach of SOCIAL HF [ Time Frame: From 2 months up to 2 years ]
  Proportion of patients evaluated using any parts of SOCIAL HF
• Implementation of SOCIAL HF [ Time Frame: From 2 months up to 2 years ]
  Proportion of patients evaluated using all parts of SOCIAL HF

Original Secondary Outcome Measures (submitted: May 19, 2022)

• 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) [ Time Frame: Baseline, 2 months, and 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.
• Discussion themes during allocation meetings across patient race/ethnicity and gender [ Time Frame: Baseline, 2 months, and up to 2 years ]
  Transcriptions of meetings will be qualitatively evaluated over time.
• Change from baseline sum group function scores at 2 months and time at which study target has been reached (up to 2 years) [ Time Frame: Baseline, 2 months, and 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.
• Adoption of SOCIAL HF [ Time Frame: 2 months ]
  Proportion of eligible advanced therapy professionals who participate in training
• Reach of SOCIAL HF [ Time Frame: From 2 months up to 2 years ]
  Proportion of patients evaluated using any parts of SOCIAL HF
• Implementation of SOCIAL HF [ Time Frame: From 2 months up to 2 years ]
  Proportion of patients evaluated using all parts of SOCIAL HF

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Pragmatic randomized controlled cluster trial

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition

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

Intervention

Behavioral: SOCIAL HF

participate in SOCIAL HF training

Study Arms

• No Intervention: Control Sites
  No Intervention
• Experimental: Sites Randomized to SOCIAL HF
  SOCIAL HF is composed of evidence-based bias reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.
  Intervention: Behavioral: SOCIAL HF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: May 19, 2022): 1463
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2027
• Estimated Primary Completion Date: February 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05390411
• Other Study ID Numbers: 13943; R56HL159216 ( U.S. NIH Grant/Contract ); R01HL159216 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA, Indiana University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Khadijah Breathett, MD, MS; Indiana University

• PRS Account: Indiana University
• Verification Date: April 2024