What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, and diuretics. ACE inhibitors can cause side effects like cough, elevated blood potassium levels, and low blood pressure. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. Diuretics can result in electrolyte imbalances, dehydration, and kidney dysfunction. Behavioral interventions and home-based palliative care, as part of an integrated approach, generally have fewer direct side effects but may involve challenges such as adherence to treatment plans and the emotional impact of managing a chronic condition at home.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including ACE inhibitors (e.g., enalapril), beta-blockers (e.g., carvedilol), and ARNI (e.g., sacubitril/valsartan). These medications help manage symptoms and improve survival rates. Additionally, the FDA has approved devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. While these treatments are pharmacological and device-based, the trial on clinician 'nudges' focuses on integrating home-based palliative care with heart failure management, aiming to reduce healthcare utilization and costs, and improve hospice utilization.

What other types of research exist?

Promising alternatives to clinician 'nudges' for encouraging enrollment in home-based integrated HF and palliative care programs include: 1) Digital health applications for remote monitoring and patient engagement, 2) AI-driven predictive analytics for personalized care recommendations, 3) Telehealth services for continuous patient support, and 4) Community-based interventions to increase awareness and accessibility of care programs.

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Home-Based Integrated Care Nudge for Heart Failure (AHCAH Trial)

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Admitted to a cardiology or hospitalist service

Must not have

Less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves healthcare management rather than medication or procedures, traditional side effects are not applicable. However, changes in care may affect patient comfort and satisfaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently under the care of a cardiology or hospitalist service.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute care days

Secondary study objectives

Hospice enrollment

Mortality

Pennsylvania emergency department visits

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AHCAH NudgeExperimental Treatment1 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: ControlActive Control1 Intervention

Usual Care

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure (HF) include medications and behavioral interventions. ACE inhibitors and beta-blockers reduce the workload on the heart by lowering blood pressure and heart rate, improving heart function. Diuretics help remove excess fluid, reducing symptoms like swelling and shortness of breath. Aldosterone antagonists prevent fluid retention and reduce heart strain. Behavioral interventions, such as home-based palliative care, focus on symptom management and improving quality of life. These treatments are crucial as they not only alleviate symptoms but also slow disease progression, reduce hospitalizations, and enhance overall well-being for HF patients.

Effects of mindfulness-based interventions on health-related outcomes for patients with heart failure: a systematic review.