Electronic Intervention for Heart Failure

(TAILORD-HF Trial)

Recruiting at 3 trial locations

Overseen By Neal W Dickert, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Guideline-directed medical therapy

Disqualifiers: Hypertrophic cardiomyopathy, End-stage HF, others

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

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an electronic checklist can help doctors more frequently use the best heart failure treatments. The checklist, integrated into electronic medical records, ensures that patients with heart failure receive guideline-recommended treatments, potentially improving their care and health outcomes. The trial includes different groups: some will use the checklist, while others will continue with standard care to assess the checklist's impact. Suitable participants have heart failure with an ejection fraction of 40% or less from a recent test. As an unphased trial, this study offers a unique opportunity to contribute to improving heart failure care practices.

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 focuses on increasing the use of specific heart failure medications, so you may need to continue or adjust your current treatment as part of the study.

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

Research has shown that electronic tools, such as the EPIC-HF checklist, are safe for patients with heart failure. Past studies have demonstrated that these tools help doctors use important heart medications more effectively.

One study assessed safety by examining changes in patients' heart rate, potassium levels, or kidney function after using an electronic alert system. The results revealed no major safety concerns, indicating that the tool was well-tolerated.

Overall, this personalized electronic tool appears safe for people with heart failure and may assist doctors in providing better care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Intervention for Heart Failure because it leverages technology to enhance patient care. Unlike traditional heart failure treatments that rely on medication and lifestyle changes, this trial explores how an electronic checklist can support both patients and clinicians. By integrating decision-support tools within electronic medical records, the intervention aims to improve communication and decision-making during clinical visits. This innovative approach could lead to more personalized and efficient care for heart failure patients, potentially transforming how the condition is managed.

What evidence suggests that this electronic intervention is effective for increasing the use of guideline-directed medical therapy in heart failure?

Research has shown that electronic tools can improve heart failure treatment. In this trial, participants may receive the EPIC-HF Checklist, sent to patients before their heart doctor visit through their electronic medical record (EMR) portal. This tool aims to improve the prescribing of recommended medications for a specific type of heart failure. Another arm of the trial involves an optimized version of the EPIC-HF Checklist, which also seeks to enhance treatment plans. Overall, digital tools like checklists and alerts can help doctors follow best practices for heart failure care, potentially leading to better treatment and improved health outcomes for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Neal W Dickert, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with heart failure who have a specific condition called reduced ejection fraction (HFrEF). It's designed to see if certain tools can help doctors prescribe the best combination of medications more often. Participants should be currently receiving treatment for heart failure.

Inclusion Criteria

Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in the prior 18 months

I have been diagnosed with heart failure.

Exclusion Criteria

I need constant medication for heart failure or need a heart transplant or device.

My kidney function is severely reduced.

Any conditions other than HF that are likely to alter the patient's status over 6 months, indicated by active hospice status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Period 1

Patients receive the EPIC-HF checklist prior to their clinic appointment via EMR message

6 months

Regular clinic visits

Intervention Period 2

Clinician-facing decision support for GDMT intensification is added

6 months

Regular clinic visits

Follow-up

Participants are monitored for safety and effectiveness after intervention

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Electronic Intervention

Trial Overview

The study tests whether an optimized version of the EPIC-HF Checklist and clinician-facing decision support tools can increase the use of guideline-directed medical therapy in cardiology clinics, compared to standard care.

How Is the Trial Designed?

Group I: Optimized version of the EPIC-HF Checklist Experimental Treatment 1 Intervention

Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal.

Group II: EPIC-HF Checklist for Patients and Clinician-facing Decision Support Experimental Treatment 2 Interventions

Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR.

Group III: Standard of Care Active Control 1 Intervention

Patients of clinics that are randomized to the standard of care will not have the EPIC-HF checklist available for viewing in their electronic medical record (EMR).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

A pilot study involving 71 heart failure patients demonstrated that using a smartphone app and wearables for 3 months led to stable or improved clinical status, as indicated by the New York Heart Association class.

While most health indicators showed positive trends, such as improvements in walking distance and self-care behaviors, these changes were not statistically significant, suggesting that while the app-based intervention may be beneficial, further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting patients with heart failure with digital therapeutics-A pilot study in Germany. Reif, S., Schubert, S., Stiefel, J., et al.[2023]

Tailoring heart failure self-management interventions to individual patients may improve their effectiveness, as current interventions often lack sufficient customization beyond content.

Certain patient characteristics, such as low income, literacy, and education, are associated with a higher likelihood of success in self-management interventions, while factors like age and disease severity do not significantly impact effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring of self-management interventions in patients with heart failure. Bos-Touwen, I., Jonkman, N., Westland, H., et al.[2022]

In a study of 754 heart failure patients, 50% reported experiencing dizziness and 44% reported a dry cough, with these adverse effects leading to a 38% increased likelihood of medication changes.

Among the reported adverse effects, a dry cough was associated with the highest risk of medication change (1.83 times more likely), while patients reporting gout had a fourfold increase in the likelihood of starting or intensifying alleviating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of perceived adverse effects on medication changes in heart failure patients. De Smedt, RH., Jaarsma, T., Haaijer-Ruskamp, FM., et al.[2013]

The Heart Messages intervention, designed to improve self-care compliance in heart failure patients, was found to be useful for patient education and feasible for implementation in both printed and web-based formats.

Initial evaluations suggest that this tailored message program could enhance adherence to self-care regimens, but larger randomized trials are needed to confirm its effectiveness in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Messages: a tailored message intervention for improving heart failure outcomes. Bennett, SJ., Hays, LM., Embree, JL., et al.[2019]

Despite advancements in heart failure treatments, significant gaps in clinical practice lead to high rates of morbidity and mortality, indicating that many patients are not receiving optimal care.

The failure to intensify treatment to evidence-based targets is influenced by three main factors: healthcare providers' actions in medication management, patient engagement, and systemic healthcare barriers, highlighting the need for targeted initiatives to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perfect Storm: Barriers to Heart Failure Treatment Optimization. Davidson, BT., Dunham, S.[2022]

A systematic review of 49 studies highlighted that effective self-care for heart failure patients relies on their ability to integrate self-care practices into their daily lives and recognize symptoms promptly.

To enhance the effectiveness of heart failure self-care interventions, it is crucial to involve family members and align the interventions with patients' normal routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of effective heart failure self-care: a systematic review of patients' and caregivers' perceptions. Clark, AM., Spaling, M., Harkness, K., et al.[2022]

The study involved 38 older adults with heart failure, comparing a sensor-controlled digital game (SCDG) intervention to a sensors-only approach over 12 weeks, showing that the SCDG was feasible and well-accepted for encouraging daily weight monitoring and physical activity.

Participants using the SCDG demonstrated a strong correlation between app engagement and adherence to weight monitoring and physical activity, suggesting that gamification can effectively motivate health behaviors in older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. Radhakrishnan, K., Julien, C., Baranowski, T., et al.[2022]

Therapeutic education programs delivered through digital health significantly enhance patient knowledge and self-care in heart failure patients, as evidenced by a systematic review of 8 randomized clinical trials from 6 countries.

These programs also contribute to a reduction in hospital readmissions and improvements in functional status, highlighting their effectiveness as a complementary tool to traditional nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education interventions in heart failure using m-Health: Systematic review]. Camino Ortega, E., Baroja Gil de Gómez, A., González Gamarra, A., et al.[2023]

The review proposes a new framework called 'Digital Phenotypes in HF' to better utilize wearable and digital health devices for managing heart failure (HF) by guiding treatment and predicting disease trajectories.

It emphasizes the need for a systematic approach to evaluate the effectiveness of remote patient monitoring (RPM) technologies, addressing key questions about patient participation, device accuracy, and integration into clinical workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framework for Digital Health Phenotypes in Heart Failure: From Wearable Devices to New Sensor Technologies. Khedraki, R., Srivastava, AV., Bhavnani, SP.[2022]

Wearable electronic devices (WEDs) show potential in enhancing self-care and health behaviors in patients with heart failure, as indicated by improvements in exercise habits and reduced symptoms like fatigue and dyspnea in some studies.

However, the overall effectiveness of WEDs is mixed, with some studies showing that increased motivation to exercise did not translate into actual exercise adherence, highlighting the need for higher-quality research focused specifically on WEDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care Practices of Patients With Heart Failure Using Wearable Electronic Devices: A Systematic Review. Patel, HA., Hayden, KA., Raffin Bouchal, S., et al.[2023]

Patient-reported outcomes (PROs) are essential for understanding heart failure (HF) from the patient's perspective, as they capture the impact of the disease on daily life and can improve treatment adherence.

Despite their proven effectiveness in evaluating disease status and correlating with prognosis in clinical trials, the use of PROs in everyday clinical practice for heart failure remains limited, highlighting the need for strategies to integrate patient perspectives into care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. Savarese, G., Lindenfeld, J., Stolfo, D., et al.[2023]

In a study of 151 patients with systolic heart failure followed for about 10 months, treatment-related serious adverse events (SAEs) were common, but there was no significant difference in SAEs between those receiving NT-proBNP-guided care and standard care.

Patients who experienced SAEs had poorer quality of life and less improvement in heart function, and a risk score was developed to help predict which patients might be at higher risk for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and prediction of adverse events from intensive chronic heart failure management and effect on quality of life: results from the pro-B-type natriuretic peptide outpatient-tailored chronic heart failure therapy (PROTECT) study. Gandhi, PU., Szymonifka, J., Motiwala, SR., et al.[2015]

In a study of 4977 heart failure outpatients, nearly half (47.9%) met the eligibility criteria for implantable defibrillator or cardiac resynchronization therapy based on the SCD-HeFT trial, indicating a significant number of patients who could benefit from these devices.

The one-year mortality rate for patients who did not receive device treatment was 1.5 to 2 times higher than those in the control groups of the corresponding trials, suggesting that real-world patients may have worse outcomes compared to trial participants, despite similar pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial-generated profiles for implantation of electrical devices in outpatients with heart failure: real-world prevalence and 1-year outcome. Boriani, G., Rapezzi, C., Diemberger, I., et al.[2010]

Citations

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A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT.

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Electronic Intervention for Heart Failure (TAILORD-HF Trial)

Research suggests that tailoring self-management interventions to individual patient needs can improve their effectiveness in managing heart failure.

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Electronic Alerts to Improve Heart Failure Therapy in ...

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Digital Health Interventions for Heart Failure Management ...

This systematic review aims to identify randomized trials of digital health interventions for individuals living in underserved rural areas with heart failure.

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Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or ...

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Electronic Alerts to Improve Heart Failure Therapy in ...

Safety outcomes included the proportion of patients with potassium >5.5 mEq/L, heart rate <60 beats/min, or a 50% increase in creatinine at 30 days after ...

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Results From Phase 1 of ALLEVIATE‐HF

A personalized medication intervention based on insertable cardiac monitor risk score can be safely instituted in patients with HF, irrespective of symptoms.