Trial DesignAn Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial
Section snippets
Rationale
Advances in therapy have revolutionized the care of patients with heart failure with reduced ejection fraction (HFrEF). Multiple classes of HFrEF medications—angiotensin converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs)/neprilysin inhibitors (ARNIs), β-blockers (BBs), mineralocorticoid receptor agonists (MRAs), sodium glucose transport 2 inhibitors (SGLT2Is), and ivabradine—plus numerous devices have been shown to markedly improve survival and quality of life. Reflective
Methods
The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF, ClinicalTrials.gov Identifier: NCT03334188) is an American Heart Association–funded, Heart Failure Strategically Focused Research Network study designed to develop patient-activation tools around HFrEF medication prescribing optimization and then test their implementation, effectiveness, and safety in practice. EPIC-HF occurs in phases: (1)
Trial cohort characteristics
Enrollment of 306 patients was completed January 2020, with 134 patients from the academic metropolitan Denver region and 171 patients from the community-practice regions in northern and southern Colorado. At the Enrollment visit, 31.7% were female, 31.05% were under age 59 years, 10.8% identified as black or African American, 2.6% identified as another race or multiracial, and 6.5% identified as Hispanic. Mode LVEF was 30%-34%. All Enrollment characteristics may be found in Table II.
Baseline use of guideline-directed medical therapies
At
Discussion
Engaging patients in their health care treatment decisions has emerged as a major priority in American health care. Since the 2001 publication of the Institute of Medicine's 6 domains of health care quality, which include patient centeredness, multiple policy decisions have explicitly engaged patients in treatment decisions. These include Patient Centered Outcomes Research Institute's research agenda,34 as well as Medicare national coverage decisions requiring the use of patient decision aids
Conclusions
Although myriad therapies for HFrEF patients now exist, they remain widely underused. Given that millions of people are affected by heart failure, it is crucial that the barriers preventing optimal prescribing and adherence of HFrEF medications are addressed. The EPIC-HF study is designed to address issues of suboptimal prescribing and adherence in HFrEF patients by using principles of shared decision making combined with aspects of DTCA to create a practical yet novel tool which encourages
Funding
This work was funded entirely by a grant from the American Heart Association's Strategically Focused Research Network, Award #16SFRN29640000, https://professional.heart.org/professional/ResearchPrograms/StrategicallyFocusedResearchPrograms/UCM_454438_Strategically-Focused-Research-Networks.jsp.
Conflicts of interest
Dr Knoepke is supported by a career development award from the American Heart Association (AHA).
Dr Allen has received grant funding from AHA, National Institutes of Health (NIH), and Patient-Centered Outcomes Research Institute and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis.
Dr Kao has received grant funding from NIH, AHA, and Centers for Disease Control and Prevention and has an advisory agreement with Codex, Inc.
Dr. Magid has received grant
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Trust and activation in defining patient-clinician interactions for chronic disease management
2023, Patient Education and CounselingCitation Excerpt :All study procedures were approved by the Colorado Multiple Institution Review Board (COMIRB) and registered with ClinicalTrials.gov (ID: NCT03334188). EPIC-HF randomized patients with HFrEF to either usual care or a novel pre-clinic activation tool intended to foster patient-clinician discussion regarding optimization of the patient’s HFrEF medication plan [6,10]. After enrollment but shortly before their next clinic visit, patients enrolled in the intervention arm received via email or text a short video and medication checklist, encouraging them to discuss their HF medication plan with their clinician.
Electronic Health Record Embedded Strategies for Improving Care of Patients With Heart Failure
2023, Current Heart Failure ReportsHeart Failure Strategically Focused Research Network: Summary of Results and Future Directions
2022, Journal of the American Heart AssociationThe use of multidisciplinary teams, electronic health records tools, and technology to optimize heart failure population health
2022, Current Opinion in CardiologySacubitril/valsartan initiation among veterans who are renin-angiotensin-aldosterone system inhibitor naïve with heart failure and reduced ejection fraction
2021, Journal of the American Heart Association
ClinicalTrials.gov identifier: NCT03334188.