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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve care for people with serious heart failure, a condition where the heart doesn't pump blood effectively, by integrating home-based support and palliative care. The researchers aim to determine if a "nudge" to doctors, using a clinician nudge or opt-out approach for AHCAH liaison visits, can increase patient enrollment in a home care program, potentially reducing hospital visits and costs. Eligible participants include those with heart failure who have been admitted to certain hospitals and live within a specific area. The trial investigates whether encouraging doctors to enroll patients in home care can improve outcomes and make care more efficient for those nearing the end of life. As an unphased trial, it offers participants the chance to contribute to innovative care strategies that could enhance 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 prior data suggests that this method is safe for heart failure patients?

Research has shown that using gentle reminders, or "nudges," to encourage doctors to enroll heart failure patients in home care is safe. One study found that this method might help reduce hospital visits and costs for patients with serious heart issues. Secure messages sent to doctors remind them that a patient is at high risk and could benefit from special care at home.

While there is limited research on this specific nudge method, home care strategies, in general, have proven to be safe and often more cost-effective than hospital stays. These findings suggest that this approach is well-received. No reports of negative effects linked to these nudges have emerged, indicating a positive safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home-Based Integrated Care Nudge for heart failure because it introduces a proactive communication strategy that could significantly improve patient outcomes. Unlike standard treatments, which primarily focus on medication and lifestyle changes, this approach uses secure text messages to alert clinicians about high-risk patients. This method ensures timely intervention and encourages enrollment in the AHCAH (Acute Hospital Care at Home) program, potentially reducing hospital visits and improving patient care. By incorporating technology to enhance communication, this method could provide a more personalized and efficient care plan for heart failure patients.

What evidence suggests that this nudge approach is effective for heart failure patients?

In this trial, clinicians of participants in the "AHCAH Nudge" arm will receive gentle reminders, or "nudges," to encourage enrollment in home-based heart care programs. Research has shown that such nudges can help heart failure patients feel better and avoid hospital visits. In a previous project, these nudges helped seriously ill patients spend less time in the hospital and reduced their medical costs. Studies also indicate that these strategies can increase the use of hospice care, which is crucial for support at the end of life. By notifying doctors about patients at high risk and encouraging enrollment in special care programs, this approach aims to combine heart failure treatment with palliative care, ensuring patients receive the support they need. Participants in the control arm will receive usual care without these nudges. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03724695

Advanced Heart Care At Home (AHCAH) End-of-life (EOL) care for heart failure (HF) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal HF ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930280/

Nudging Health Behavior Change Among Home-Based ... In many studies, HBCR practices for patients with heart disease benefited from a series of nudge strategies. However, the research and ...

3. withpower.com withpower.com/trial/phase-heart-failure-10-2018-ad8c5

Home-Based Integrated Care Nudge for Heart Failure 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1071916424007607

Closing The Gap In Heart Failure Care Using Nudge ... Closing The Gap In Heart Failure Care Using Nudge Interventions For Clinicians ... : Anticipated outcomes involve evaluating the effectiveness of a multicomponent ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2023.02.047

Team-Based Virtual Nudges to Overcome Clinician Inertia ... These have included use of specialized HF clinics, multidisciplinary HF disease-management programs, transitional-care interventions, ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.122.010456

Hospital at Home as a Treatment Strategy for Worsening ... To date, limited research in HF and other disease states has supported HaH as being safe and lower cost than traditional inpatient admission.