Social Services Support for Heart Failure

Recruiting at 2 trial locations

Overseen By Stacy Farr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Luke's Health System

Disqualifiers: Under 18, Over 99

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the support patients receive after hospital discharge for heart failure, a condition where the heart struggles to pump blood effectively. It tests whether coordinating social services, such as in-home assessments and community connections, aids recovery more than standard medical follow-up. Managed Services, a type of IT support service, will enhance coordination. Individuals currently hospitalized for heart failure in Missouri or Kansas may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance recovery for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for heart failure patients?

Research has shown that services like remote monitoring and telehealth are generally safe for people with heart failure. Studies have found that these services effectively track patients' symptoms and manage their care. For instance, a remote monitoring program significantly reduced hospital visits for heart failure patients, indicating it was well-received and safe.

Telehealth, which includes video calls and online health records, is widely used for managing heart conditions. It helps ensure that patients adhere to their treatment plans without introducing new risks. While these services aren't physical treatments like medications, they support patients at home and connect them with necessary care. Overall, using these services in heart failure management is considered safe and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support heart failure patients after they leave the hospital. Unlike standard care, which typically involves routine follow-ups and medication management, this approach offers personalized in-home assessments and connects patients with community resources. This method aims to improve patient outcomes by providing tailored support and addressing social determinants of health, which can significantly impact recovery and quality of life.

What evidence suggests that managed services are effective for heart failure?

Research has shown that managed services can benefit patients with heart failure. In this trial, some participants will receive managed services after discharge, including in-home assessment and care coordination with community resources. Studies have found that digital health tools and remote monitoring, key components of managed services, can lower hospital costs for heart failure patients recently discharged. This approach results in fewer hospital visits and potentially more stable health. Remote monitoring tracks a patient's health from a distance, helping to identify early warning signs and improve care. Additionally, these managed services have saved money and reduced hospital stays over time compared to standard care, which is another arm of this trial. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Missouri or Kansas residents aged 18-99 who are currently hospitalized due to acute heart failure. It's not open to those under 18 or over 99.

Inclusion Criteria

I am currently hospitalized for sudden heart failure.

Resident of Missouri or Kansas

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard medical care or managed services after discharge, including in-home assessment and care coordination

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Managed Services

Trial Overview The study is testing a program designed to improve the coordination of social services after patients with heart failure leave the hospital, aiming to reduce rehospitalization rates.

How Is the Trial Designed?

Group I: Managed Services After Discharge Experimental Treatment 1 Intervention

Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge

Group II: Standard Of Care - No Managed Services Active Control 1 Intervention

Subjects receive standard medical care and follow-up after hospital discharge

Who Is Running the Clinical Trial?

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+

Truman Medical Center

Collaborator

Trials

10

Recruited

301,000+

University of Missouri, Kansas City

Collaborator

Trials

73

Recruited

34,600+

Mid America Regional Council

Collaborator

Trials

1

Recruited

320+

Published Research Related to This Trial

There is an urgent need for a National Service Framework specifically designed for heart failure, indicating a gap in current healthcare provisions.

Implementing such a framework could improve the management and treatment of heart failure, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary interventions in heart failure. Clark, AL., Cleland, JG.[2018]

A systematic review of 12 studies found that adherence to heart failure performance measures, particularly the use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and beta-blockers at discharge, is strongly associated with improved patient outcomes.

While discharge instructions also positively impacted outcomes, their effect was weaker compared to medication adherence, highlighting the importance of specific treatment measures in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based heart failure performance measures and clinical outcomes: a systematic review. Maeda, JL.[2018]

Chronic heart failure poses a significant public health challenge due to its poor prognosis and high rates of hospital readmissions, leading to substantial healthcare costs.

Establishing a specialized service for heart failure patients can address these issues by providing targeted care and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic heart failure: New challenges and new perspectives]. Tereshchenko, SN., Zhirov, IV.[2018]

The establishment of an Integrated Heart Failure Service (IHFS) at a district general hospital led to a significant increase in the quality of care for heart failure patients, including higher rates of cardiologist consultations and echocardiography, as well as improved initiation of essential heart failure medications.

Patients with heart failure with preserved ejection fraction (HFpEF) experienced a notable reduction in 30-day post-discharge mortality and readmission rates, highlighting the effectiveness of the IHFS in improving outcomes for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an integrated heart failure service in a medium-sized district general hospital. Hawley, A., He, J., Crabtree, A., et al.[2020]

In a randomized controlled trial involving heart failure patients, a reciprocal peer support program did not show any significant improvement in rehospitalization rates or quality of life compared to standard nurse care management, despite the program's design to enhance patient engagement.

Only 55% of participants in the peer support program actively engaged in the intended peer communication, suggesting that low participation may have contributed to the lack of observed benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled effectiveness trial of reciprocal peer support in heart failure. Heisler, M., Halasyamani, L., Cowen, ME., et al.[2022]

The implementation of an outpatient inotropic infusion unit and case management at a community hospital led to a significant reduction in hospital admissions and inpatient length of stay for patients with congestive heart failure.

Alongside decreased healthcare costs, patient satisfaction and functional status improved, demonstrating the effectiveness of the new care model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure management. Warner, PM., Hutchinson, C.[2019]

Hospital-initiated case management (CM) for heart failure patients significantly reduces unplanned readmissions by 26% and decreases the length of hospital stay by an average of 1.28 days compared to usual care, based on a systematic review of 22 studies involving over 8,600 participants.

Community-initiated CM showed limited effectiveness, with only non-randomized trials indicating a reduction in admissions, suggesting that hospital-based interventions may be more beneficial for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does case management for patients with heart failure based in the community reduce unplanned hospital admissions? A systematic review and meta-analysis. Huntley, AL., Johnson, R., King, A., et al.[2021]

Effective disease management programs for heart failure can significantly improve patient outcomes by focusing on coordinated care, patient education, and monitoring, which helps keep patients out of the hospital and reduces mortality.

The main challenges in implementing these programs are changing physician practices and ensuring patient compliance, highlighting the need to effectively utilize existing technologies rather than just developing new ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure and disease management. Leider, HL.[2019]

A nurse-led service was established in the UK to manage chronic heart failure, addressing the needs of 880,000 individuals affected by this condition.

The initiative is part of a national priority to improve heart failure management, highlighting the importance of specialized care in enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of setting up a nurse-led heart failure service. Ayers, N.[2007]

Nurse-led follow-up care for heart failure patients after hospital discharge significantly lowers the risk of mortality, highlighting the importance of ongoing support in managing this condition.

This review of case management interventions indicates that structured follow-up by nurses can improve patient outcomes and potentially enhance the quality of care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse support is most effective follow-up for heart failure patients. [2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9795268/

Digital health technology in the prevention of heart failure and ... Multiple forms of noninvasive mobile digital technology are now available to assist in the optimal management of heart failure patients.

2. withpower.com withpower.com/trial/phase-heart-failure-5-2022-f4f53

Social Services Support for Heart Failure What data supports the effectiveness of the treatment Managed Services, IT Managed Services, Outsourced IT Services, IT Service Management, IT Operations ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10896481/

Effectiveness of Telemonitoring in Reducing Hospitalization ... The results suggest that the telemonitoring solution can reduce hospital-related costs for patients with HF with a recent hospital admission.

4. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs.

5. jheor.org jheor.org/article/130066-cost-effectiveness-analysis-of-a-heart-failure-management-system-in-the-united-states

Cost-Effectiveness Analysis of a Heart Failure ... The use of HFMS is expected to save costs and reduce hospitalizations over a 5-year period compared with the current SOC.

6. ajmc.com ajmc.com/view/remote-monitoring-program-cuts-heart-failure-readmissions-in-half

Remote Monitoring Program Cuts Heart Failure ... A remote monitoring program launched by UMass Memorial Health–Harrington led to a 50% reduction in 30-day readmissions for patients with congestive heart ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001107

An Overview of Telehealth in the Management ... Telehealth has been used to facilitate the management of many CVDs, such as arrhythmia detection, heart failure, hypertension, coronary artery ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7058493/

Heart Failure Management Innovation Enabled by Electronic ... In this article we describe how appropriate use of technologies offered by EHRs can help standardize CHF care, promote adherence to evidence-based guidelines, ...