Home-Based Integrated Care Nudge for Heart Failure

(AHCAH Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Incarceration, Homelessness, others

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

Compensation: Varies

Number of Visits: 1

700 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if encouraging doctors to sign up very sick heart failure patients for a special home care program can reduce hospital visits and costs. The program combines heart treatment with comfort care, aiming to improve patient quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Clinician nudge or opt out approach for AHCAH liaison visit for heart failure?

The study on just-in-time e-mail reminders in home health care suggests that timely information-based interventions can improve self-care management and outcomes for heart failure patients, which may support the effectiveness of a clinician nudge approach. ^{1 2 3 4 5}

Is the Home-Based Integrated Care Nudge for Heart Failure safe for humans?

The research on similar approaches, like the multidisciplinary heart failure management program, suggests that structured patient education and home monitoring by trained nurses are generally safe and may even improve survival rates for heart failure patients. ^{1 6 7 8 9}

How does the Home-Based Integrated Care Nudge for Heart Failure treatment differ from other treatments for heart failure?

This treatment is unique because it integrates home-based care with technology to provide timely reminders and support for self-care management, which can improve patient outcomes and reduce mortality. It involves a multidisciplinary approach with structured education, home monitoring by trained nurses, and automatic alerts for healthcare providers, making it more personalized and proactive compared to traditional heart failure management. ^{1 2 5 9 10}

Eligibility Criteria

This trial is for adults over 18 with heart failure who live in a specific area and have had a related health care visit within the last year. They must be hospitalized during the study period, not pregnant, incarcerated, homeless, or without a primary physician.

Inclusion Criteria

Your Palliative Connect score is higher than 0.3.

I was diagnosed with heart failure in the last year.

You were admitted to the hospital while the study is happening.

Exclusion Criteria

You live outside the area where Caring Way can provide services.

Patients without an identifiable primary physician for AHCAH staff to communicate with as determined by the AHCAH liaison via EPIC

Prior hospitalization during study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Intervention

Clinicians receive 'nudges' to enroll high-risk heart failure patients in the AHCAH program, with an AHCAH liaison visiting to discuss and facilitate enrollment

6-12 months

Ongoing visits as needed

Follow-up

Participants are monitored for clinical, utilization, and cost outcomes, including emergency department visits and hospice enrollment

6-12 months

Treatment Details

Interventions

• Clinician nudge or opt out approach for AHCAH liaison visit

Trial Overview The trial tests if 'nudging' clinicians to discuss and enroll seriously ill heart failure patients into an at-home care program can reduce healthcare use and costs while improving end-of-life care compared to usual practices.

Participant Groups

Group I: AHCAH Nudge Experimental Treatment 1 Intervention

The investigators have developed methods for sending "nudges" to clinicians via secure text messages to primary teams to alert them that their patient was identified as high-risk for 6-month mortality and that an AHCAH liaison would visit their patient to discuss the AHCAH program and to facilitate enrollment if the patient was amenable. The investigators propose that these secure text messages would be sent to the teams of patients randomized to the intervention by the AHCAH liaison within 72 hours of eligibility identification (to allow for the liaison not being available over the weekend). The investigator team will track all aspects of messaging and timing. Clinicians can choose to opt out a patient from the liaison visit and AHCAH enrollment within a two-hour timeframe.

Group II: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Independence Blue Cross

Collaborator

Trials

5

Recruited

126,000+

Penn Medicine Center for Health Care Innovation

Collaborator

Trials

1

Recruited

700+

Independence Blue Cross

Collaborator

Trials

7

Recruited

126,000+

Findings from Research

In a study involving 902 patients with mild to moderate heart failure, adding self-management counseling to heart failure education did not significantly reduce the rates of death or hospitalization due to heart failure compared to education alone.

The trial, which followed patients for a median of 2.56 years, found no differences in secondary outcomes such as overall hospitalization rates or quality of life, suggesting that simply enhancing education with self-management strategies may not improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. Powell, LH., Calvin, JE., Richardson, D., et al.[2022]

Heart failure disease management (HFDM) programs can improve patient outcomes and reduce hospitalizations, but implementing these programs results in significant financial losses for healthcare providers, with estimated losses of $179,549 for physicians, $464,132 for integrated health systems, and $652,643 for hospitals in the first year.

While third-party payers can save approximately $713,661 annually for managing 350 patients in HFDM programs, the lack of financial incentives for providers limits the adoption of these beneficial programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives. Whellan, DJ., Reed, SD., Liao, L., et al.[2019]

The PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failure involved 1,012 hospitalized patients with heart failure with reduced ejection fraction (HFrEF) to test an electronic health record system that alerts providers about necessary but unprescribed guideline-directed medical therapy (GDMT).

The study aims to increase the prescription of GDMT at discharge, addressing the common issue of underutilization, which can lead to higher risks of cardiovascular death and hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. Ghazi, L., O'Connor, K., Yamamoto, Y., et al.[2023]

In a pilot study with 213 primary care patients, providing quantitative information about colorectal cancer screening significantly increased the likelihood of patients getting screened compared to those who did not receive this information.

While a nudge towards stool testing (FIT) increased perceived risk of colorectal cancer, it did not lead to a higher screening uptake, suggesting that simply nudging patients may not be as effective as providing clear quantitative data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. Schwartz, PH., Perkins, SM., Schmidt, KK., et al.[2018]

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

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. [2022]

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

Just-in-time evidence-based e-mail "reminders" in home health care: impact on patient outcomes. [2019]

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

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives. [2019]

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

Heart Failure Spending Function: An Investment Framework for Sequencing and Intensification of Guideline-Directed Medical Therapies. [2022]

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

Healthcare resource use among heart failure patients in a randomized pilot study of a cognitive training intervention. [2023]

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

Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. [2023]

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

A controlled trial of including symptom data in computer-based care suggestions for managing patients with chronic heart failure. [2018]

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

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. [2018]

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

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

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

Patient preferences and willingness-to-pay for a home or clinic based program of chronic heart failure management: findings from the Which? trial. [2022]