Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial (SOCIAL HF)
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ClinicalTrials.gov Identifier: NCT05390411 |
Recruitment Status :
Enrolling by invitation
First Posted : May 25, 2022
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Implementation Science Heart Transplant Decision Making Bias, Racial Health Equity Bias, Sex | Behavioral: SOCIAL HF | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1463 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Pragmatic randomized controlled cluster trial |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial |
Actual Study Start Date : | March 6, 2023 |
Estimated Primary Completion Date : | February 2027 |
Estimated Study Completion Date : | February 2027 |
Arm | Intervention/treatment |
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No Intervention: Control Sites
No Intervention
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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.
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Behavioral: SOCIAL HF
participate in SOCIAL HF training |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Active United Network for Organ Sharing heart transplant and ventricular assist device center
- 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
- Advanced therapy professionals from participating centers (i.e., coordinators, physicians, pharmacists, nurses, social workers)
- 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:
- Centers unable to fully participate in the training and evaluation measures
- If the center ceases to be an active heart failure/transplant center
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390411
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Khadijah Breathett, MD, MS | Indiana University |
Responsible Party: | Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA, tenured Associate Professor of Medicine, Indiana University |
ClinicalTrials.gov Identifier: | NCT05390411 |
Other Study ID Numbers: |
13943 R56HL159216 ( U.S. NIH Grant/Contract ) R01HL159216 ( U.S. NIH Grant/Contract ) |
First Posted: | May 25, 2022 Key Record Dates |
Last Update Posted: | April 16, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Healthcare Disparities |
Heart Failure Heart Diseases Cardiovascular Diseases |