Implementation ScienceSOCIAL HFNCT05390411
Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
A study testing SOCIAL HF in people with Implementation Science and Heart Transplant, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implementation Science, Heart Transplant, Decision Making
- What is being tested?
- SOCIAL HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,463 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Centers unable to fully participate in the training and evaluation measures
- If the center ceases to be an active heart failure/transplant center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Standardized protocols can reduce the impact of unfair and unequal treatment but are underused. Since the Institute of Medicine's report, "Unequal Treatment", multiple studies have confirmed that standardization of decision-making processes reduces unequal treatment, but unequal and unethical perceptions in decision-making 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)], we developed a standardized protocol strategy, Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF), that addresses the most significant barriers to equality in advanced therapies: 1) unequal and unethical perceptions that influence decision-making, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based training to reduce disparities 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 more fair-minded seating arrangement. In complex decision-making that includes individuals and groups, our standardized protocol strategy, SOCIAL HF, has the greatest likelihood of reducing health disparities in advanced HF. Our 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. As a type 2 effectiveness-implementation hybrid study, we will use a cluster randomized design to test the effectiveness of SOCIAL HF strategy. We will evaluate implementation of SOCIAL HF across study sites using mixed-methods to learn optimal implementation strategies to reduce disparities in accessing life-saving therapies. We will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). We will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation. We have the relationships, infrastructure, and expertise to execute this project; our multidisciplinary team includes experts in HF, evidence-based training in reducing unequal and unethical perceptions in decision-making, clinical trials, mixed-methods, and implementation science.
- Conditions
- Implementation Science, Heart Transplant, Decision Making
- Being tested
- SOCIAL HF
- Keywords
- Healthcare Disparities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCIAL HFBehavioural
participate in SOCIAL HF training
| Study group | Role | What they receive |
|---|---|---|
| Control Sites | No intervention | No Intervention |
| Sites Randomized to SOCIAL HF | Experimental | SOCIAL HF is composed of evidence-based disparities reduction training, employment of objective measures of social support, and changes to facilitate group dynamics. Receives: Behavioral: SOCIAL HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.
Measured: Up to 2 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)
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.
Measured: Month 2, up to 2 years, and up to 2.5 years
Secondary outcomes (6)
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.
Measured: Baseline, 2 months, and up to 2 years
Discussion themes during allocation meetings across patient race/ethnicity and sex
Transcriptions of meetings will be qualitatively evaluated over time.
Measured: Baseline, 2 months, and up to 2 years
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.
Measured: Baseline, 2 months, and up to 2 years
Adoption of SOCIAL HF
Proportion of eligible advanced therapy professionals who participate in training
Measured: 2 months
Reach of SOCIAL HF
Proportion of patients evaluated using any parts of SOCIAL HF
Measured: From 2 months up to 2 years
Implementation of SOCIAL HF
Proportion of patients evaluated using all parts of SOCIAL HF
Measured: From 2 months up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start6 Mar 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled cluster trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,463 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA, Indiana University
- Investigators
- Khadijah Breathett, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390411
- Sponsor's protocol ID
- 13943
- Other IDs
- R56HL159216, R01HL159216
- Acronym
- SOCIAL HF
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial
- ClinicalTrials.gov ID
- NCT05390411
- Acronym / sponsor ID
- SOCIAL HF / 13943
- Conditions
- Implementation Science, Heart Transplant, Decision Making
- Keywords
- Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,463 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standardized protocols can reduce the impact of unfair and unequal treatment but are underused. Since the Institute of Medicine's report, "Unequal Treatment", multiple studies have confirmed that standardization of decision-making processes reduces unequal treatment, but unequal and unethical perceptions in decision-making 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)], we developed a standardized protocol strategy, Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF), that addresses the most significant barriers to equality in advanced therapies: 1) unequal and unethical perceptions that influence decision-making, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based training to reduce disparities 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 more fair-minded seating arrangement. In complex decision-making that includes individuals and groups, our standardized protocol strategy, SOCIAL HF, has the greatest likelihood of reducing health disparities in advanced HF. Our 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. As a type 2 effectiveness-implementation hybrid study, we will use a cluster randomized design to test the effectiveness of SOCIAL HF strategy. We will evaluate implementation of SOCIAL HF across study sites using mixed-methods to learn optimal implementation strategies to reduce disparities in accessing life-saving therapies. We will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). We will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation. We have the relationships, infrastructure, and expertise to execute this project; our multidisciplinary team includes experts in HF, evidence-based training in reducing unequal and unethical perceptions in decision-making, clinical trials, mixed-methods, and implementation science.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled cluster trial
| Arm | Type | Receives |
|---|---|---|
| Control Sites | No intervention | –No Intervention |
| Sites Randomized to SOCIAL HF | Experimental | Behavioral: SOCIAL HFSOCIAL HF is composed of evidence-based disparities reduction training, employment of objective measures of social support, and changes to facilitate group dynamics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Centers unable to fully participate in the training and evaluation measures
- If the center ceases to be an active heart failure/transplant center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOCIAL HFparticipate in SOCIAL HF training | Behavioural | Sites Randomized to SOCIAL HF |
Primary outcome
Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies.
Time frame: Up to 2 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.
6 secondary outcomes
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
Discussion themes during allocation meetings across patient race/ethnicity and sex
Time frame: Baseline, 2 months, and up to 2 years
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
Adoption of SOCIAL HF
Time frame: 2 months
Reach of SOCIAL HF
Time frame: From 2 months up to 2 years
Implementation of SOCIAL HF
Time frame: From 2 months up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- NIH ReporterLink provided by the sponsor.
- NIH ReporterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khadijah Breathett, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCIAL HF in people with Implementation Science and Heart Transplant, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of evaluated minoritized racial/ethnic patients and women patients receiving advanced therapies. (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.