Allocation Method for Advanced Heart Failure

(SOCIAL HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Inactive centers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1463 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment SOCIAL HF for advanced heart failure?

The research suggests that social support can improve the quality of life for heart failure patients, which may indirectly support the effectiveness of SOCIAL HF if it includes social support components. Additionally, a multidisciplinary heart failure management program, which may share elements with SOCIAL HF, was shown to reduce mortality in heart failure patients. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial aims to test SOCIAL HF, a set of guidelines to ensure fair allocation of advanced heart failure treatments. It targets patients needing heart transplants or special heart pumps. SOCIAL HF works by reducing bias, using objective criteria, and improving decision-making processes.

Research Team

Khadijah Breathett, MD, MS

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for heart transplant and ventricular assist device centers that see at least 50 minority patients and 50 women over two years. It includes professionals like coordinators, physicians, pharmacists, nurses, social workers involved in advanced therapy decisions. Centers not fully able to participate or no longer active are excluded.

Inclusion Criteria

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

My center sees many patients from diverse backgrounds and women for advanced heart failure treatments.

You are currently on the waiting list for a heart transplant or have a ventricular assist device.

Exclusion Criteria

My treatment center is not equipped for the study's required training and evaluations.

If the center ceases to be an active heart failure/transplant center

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Implementation

SOCIAL HF strategy is implemented, including bias reduction training and objective evaluations of social support

2 months

Multiple training sessions

Evaluation and Monitoring

Evaluation of SOCIAL HF implementation and monitoring of group function scores and clinician behavior changes

Up to 2 years

Regular monitoring and evaluation sessions

Follow-up

Participants are monitored for long-term outcomes and effectiveness of SOCIAL HF strategy

6 months after reaching study target

Treatment Details

Interventions

• SOCIAL HF

Trial Overview The SOCIAL HF trial tests a strategy aimed at equitable allocation of heart failure therapies by reducing bias and using objective criteria over subjective judgment. The study's design may influence national guidelines on how advanced therapies for chronic diseases are allocated.

Participant Groups

Group I: Sites Randomized to SOCIAL HF Experimental Treatment 1 Intervention

SOCIAL HF is composed of evidence-based bias reduction training, employment of objective measures of social support, and changes to facilitate group dynamics.

Group II: Control Sites Active Control 1 Intervention

No Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Despite advancements in heart failure (HF) treatments over the past 15-20 years, many patients are still not receiving optimal doses of medications, which can hinder their recovery and overall health outcomes.

The proposed practical approach algorithm aims to help physicians better implement guideline-directed therapies for HF patients, ensuring both safety and efficacy in treatment, as current guidelines lack detailed recommendations for inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. Abdin, A., Bauersachs, J., Soltani, S., et al.[2023]

A multicenter study involving 1816 heart failure patients showed that a community-based multidisciplinary disease management program (DMP) significantly reduced 1-year all-cause mortality, with a hazard ratio of 0.65, indicating a 35% lower risk of death compared to standard care.

The DMP included structured patient education, home monitoring by trained nurses, and alerts for significant clinical changes, demonstrating that coordinated care can improve survival outcomes for heart failure patients after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. Laborde-Castérot, H., Agrinier, N., Zannad, F., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Quality of life, social support and cognitive impairment in heart failure patients without diagnosed dementia. [2017]

2. England pubmed.ncbi.nlm.nih.gov

A survey-based triage tool to identify patients potentially eligible for referral to an advanced heart failure centre. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A practical approach to the guideline-directed pharmacological treatment of heart failure with reduced ejection fraction. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Socioeconomic Disparities in Referral for Invasive Hemodynamic Evaluation for Advanced Heart Failure: A Nationwide Cohort Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary heart failure disease management programme on 1-year mortality: Prospective cohort study. [2022]