Electronic Intervention for Heart Failure
(TAILORD-HF Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byNeal W Dickert, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Must be taking: Guideline-directed medical therapy
Disqualifiers: Hypertrophic cardiomyopathy, End-stage HF, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.
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 data supports the effectiveness of the treatment Tailored Electronic Intervention for heart failure?
Research suggests that tailoring self-management interventions to individual patient needs can improve their effectiveness in managing heart failure. Additionally, a similar tailored message intervention called Heart Messages showed promise in improving patient compliance with self-care regimens, which could lead to better outcomes.12345
Is the electronic intervention for heart failure safe for humans?
How is the Tailored Electronic Intervention treatment for heart failure different from other treatments?
Eligibility Criteria
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
See 1 more
Trial Timeline
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
Treatment Details
Interventions
- Tailored Electronic Intervention (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Optimized version of the EPIC-HF ChecklistExperimental Treatment1 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 SupportExperimental Treatment2 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 CareActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University HospitalAtlanta, GA
Emory Saint Joseph's HospitalAtlanta, GA
Emory University Hospital MidtownAtlanta, GA
Emory Johns Creek HospitalJohns Creek, GA
Loading ...
Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
Heart Messages: a tailored message intervention for improving heart failure outcomes. [2019]Heart failure is a major health problem in the United States leading to high rates of mortality and morbidity and impaired quality of life. Assisting patients to improve compliance with their self-care regimen, including medications, dietary sodium restrictions, and self-monitoring (daily weights, edema assessment), may improve these poor outcomes. This article describes the development and initial evaluation of Heart Messages, a theory-based, tailored message intervention to improve compliance with the self-care regimen recommended for patients with heart failure. The project involved four phases, each of which is described in this article. The Heart Messages tailored message intervention program is available in both printed and Web-based formats. In a pilot study and clinical evaluation project, the program was found to be useful for patient education and feasible for implementation. Larger randomized trials are now warranted to evaluate the effectiveness of the intervention in improving compliance with the self-care regimen and thereby improving outcomes among patients with heart failure.
Tailoring of self-management interventions in patients with heart failure. [2022]The effectiveness of heart failure (HF) self-management interventions varies within patients suggesting that one size does not fit all. It is expected that effectiveness can be optimized when interventions are tailored to individual patients. The aim of this review was to synthesize the literature on current use of tailoring in self-management interventions and patient characteristics associated with self-management capacity and success of interventions, as building blocks for tailoring. Within available trials, the degree to which interventions are explicitly tailored is marginal and often limited to content. We found that certain patient characteristics that are associated with poor self-management capacity do not influence effectiveness of a given intervention (i.e., age, gender, ethnicity, disease severity, number of comorbidities) and that other characteristics (low: income, literacy, education, baseline self-management capacity) in fact are indicators of patients with a high likelihood for success. Increased scientific efforts are needed to continue unraveling success of self-management interventions and to validate the modifying impact of currently known patient characteristics.
The Perfect Storm: Barriers to Heart Failure Treatment Optimization. [2022]Despite advances in heart failure therapies with proven positive outcomes, treatment gaps in clinical practice persist and heart failure morbidity and mortality remain high. The lack of treatment intensification to evidence-based targets accounts for a significant portion of unattained treatment goals and has been characterized to involve 3 main elements: the provider initiating and titrating the medication(s), the patient themselves, and the system that serves as the gatekeeper and facilitator for health care needs. This article will examine the mechanisms and impact of these 3 factors, and present targeted initiatives to help improve patient outcomes and quality of care.
Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. [2023]Heart failure (HF) is a complex syndrome that affects mortality/morbidity and acts at different levels in the patient's life, resulting in a drastic impairment in multiple aspects of daily activities (e.g. physical, mental/emotional, and social) and leading to a reduction in quality of life. The definition of disease status and symptom severity has been traditionally based on the physician assessment, while the patient's experience of disease has been long overlooked. The active participation of patients in their own care is necessary to better understand the perception of disease and the multiple aspects of life affected, and to improve adherence to treatments. Patient-reported outcomes (PROs) aim to switch traditional care to a more patient-centred approach. Although PROs demonstrated precision in the evaluation of disease status and have a good association with prognosis in several randomized controlled trials, their implementation into clinical practice is limited. This review discusses the modalities of use of PROs in HF, summarizes the most largely adopted PROs in HF care, and provides an overview on the application of PROs in trials and the potential for their transition to clinical practice. By discussing the advantages and the disadvantages of their use, the reasons limiting their application in daily clinical routine, and the strategies that may promote their implementation, this review aims to foster the systematic integration of the patient's standpoint in HF care.
Determinants of effective heart failure self-care: a systematic review of patients' and caregivers' perceptions. [2022]Disease management interventions for heart failure (HF) are inconsistent and very seldom incorporate the views and needs of patients and their caregivers into intervention design.
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. [2015]Serious adverse events (SAEs) from heart failure (HF) therapy are frequent; however, techniques to identify at-risk patients are inadequate. Furthermore, the relationship between SAEs, quality of life (QOL), and cardiac structure are unknown.
Self-care Practices of Patients With Heart Failure Using Wearable Electronic Devices: A Systematic Review. [2023]Heart failure (HF) is the fastest growing cardiovascular condition globally; associated management costs and hospitalizations place an immense burden on healthcare systems. Wearable electronic devices (WEDs) may be useful tools to enhance HF management and mitigate negative health outcomes.
Trial-generated profiles for implantation of electrical devices in outpatients with heart failure: real-world prevalence and 1-year outcome. [2010]Randomized controlled trials have generated strong evidence on the efficacy of electrical device therapy in selected patients with heart failure (HF). The enrolment criteria of these three trials generated patient profiles that helped to shape current guidelines on chronic heart failure (CHF) treatment and sudden cardiac death (SCD) prevention. We investigated the prevalence of trial-generated profiles for implantable defibrillator or cardiac resynchronization therapy candidacy among HF outpatients; we explored differences between real-world and trial populations and we evaluated 1-year survival without device treatment.
The impact of perceived adverse effects on medication changes in heart failure patients. [2013]Given the importance of patient safety and well-being, we quantified the likelihood and type of medication changes observed after 5 possible adverse effects (AE) perceived by heart failure (HF) patients.
[Education interventions in heart failure using m-Health: Systematic review]. [2023]To provide the best scientific evidence available on the effectiveness of therapeutic education programs through digital health in patients with heart failure.
Supporting patients with heart failure with digital therapeutics-A pilot study in Germany. [2023]Continuous monitoring and targeted behavioral interventions have been shown to improve health status and quality of life for heart failure patients. Digital therapeutics offer the possibility to make more frequent monitoring and targeted behavioral interventions available for more people.
Framework for Digital Health Phenotypes in Heart Failure: From Wearable Devices to New Sensor Technologies. [2022]Consider these 2 scenarios: Two individuals with heart failure (HF) have recently established with your clinic and followed for medical management and risk stratification. One is a 62-year-old man with nonischemic cardiomyopathy due to viral myocarditis, an ejection fraction (EF) of 40%, occasional rate-limiting dyspnea, and comorbidities of atrial fibrillation and hypertension. The other is a 75-year-old woman with ischemic cardiomyopathy, an EF of 35%, a prior hospitalization 6 months ago, and persistent symptoms of edema and orthopnea. Both have expressed interest in remote patient monitoring (RPM) with wearable and digital health devices that are commercially available such as a smartwatch-ECG, weight scales, and blood pressure monitoring technologies. While there is enthusiasm from both patients and their clinical teams to engage in a technology-driven approach to care, important questions arise such as "What are the patient requirements for participation in digital health programs?", "Can we anticipate improvements in HF status and lower the risk of future HF events including hospitalizations?", "Do the same type of devices in different patients provide accurate information on physiologic changes toward individualized risk assessments?", and "What are the systematic approaches to integrate digital health workflows and datasets from RPM into clinical HF programs?". Given the importance of such questions, embracing new technologies, as a core competency of a modern health care system requires a deeper understanding of how effective digital health programs can be designed to meet the needs of patients and their clinical teams. In this review, we propose a new framework of "Digital Phenotypes in HF" for how new devices and sensors and their respective datasets can be used to guide treatment and to predict disease trajectories within the heterogeneity of HF. Our objectives are to generate a systematic approach to evaluate digital health devices as they relate to the next phase of RPM in HF, to critically analyze the literature, and to apply the lessons learned from digital devices through present-day, real-world evidence examples.
Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. [2022]Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF.