Elsevier

American Heart Journal

Volume 229, November 2020, Pages 144-155
American Heart Journal

Trial Design
An 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

https://doi.org/10.1016/j.ahj.2020.08.013Get rights and content

Background

Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.

Hypothesis

Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies.

Design

The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools—a 3-minute video and 1-page checklist—delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy.

Summary

The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

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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    ClinicalTrials.gov identifier: NCT03334188.

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