EPIC-HF intervention results in intensification of guideline-recommended HFrEF therapy
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After an educational intervention, patients with HF and reduced ejection fraction improved their dialogue with their doctors about their medications, resulting in intensification of guideline-recommended therapy, a speaker reported.
The EPIC-HF intervention involved a short educational video and subsequent medication checklist for patients with HFrEF that was brought to a clinical visit and discussed with their provider.
This study was simultaneously published in Circulation.
“We are all aware of gaps in prescribing evidence-based medications to patients with heart failure, and there are significant efforts that have been made to close that gap,” Larry Allen, MD, professor of medicine and cardiology, associate head of clinical affairs and cardiology and medical director of advanced heart failure at the University of Colorado School of Medicine, said during a press conference at the virtual American Heart Association Scientific Sessions. “Primarily, there are two approaches: One is to focus on providers and decision support around their prescribing; the other is to focus on patients and try to educate them about adherence and self-care. This has been held up by clinical inertia on the provider side and disempowerment on the patient side. We believe that an activated patient who participates in shared decision-making around prescribing decisions could help overcome these problems.
“We developed the EPIC-HF intervention, which postulated that patients activated prior to a clinic appointment will be more likely to engage their clinician around their medication plan, which will prompt greater prescribing of medications known to improve outcomes,” Allen said.
For this analysis, investigators enrolled 306 patients in the University of Colorado Health system, who were then randomly assigned to the intervention or the control arm. Participants received the 3-minute intervention video and a PDF checklist via email or smartphone. After viewing the educational video, participants filled out the checklist, marking each of HF medication they are prescribed and the dose, and brought the checklist to their next visit to be discussed with their medical provider or doctor. The primary endpoint was intensification of guideline-recommended medical therapy for HF.
At baseline, a majority of participants were on beta-blockers and ACE inhibitors/angiotensin receptor blockers, but at less than 50% of the target dose. In addition, investigators noted there was very limited use of sacubitril/valsartan (Entresto, Novartis) and about half of patients were on spironolactone or eplerenone.
Among participants in the intervention arm of the study, 67% reported receiving the video, of which 91% viewed the video and 74% reported they found the informational video helpful in understanding their treatment.
Moreover, of those who also received the checklist (70%), approximately 89% reviewed it, and of those, 82% brought the checklist to their appointment with their doctor. This translated to approximately half of the intervention arm bringing their checklist to their visit and discussing their HF medications.
For the primary endpoint of intensification of guideline-recommended medical therapy for HF, researchers observed a 19.3 percentage point increase among patients who utilized the EPIC-HF intervention compared with the control group (49% vs. 29.7%; P = .001).
Allen reported that the main driver for HF medication intensification was the up-titration of the medication patients were already on, and not the addition of new therapies.
The guideline-recommended treatment most frequently intensified was beta-blockers, according to the presentation.
“A 3-minute patient activation video, plus a one-page medication checklist delivered to patients with HFrEF immediately before a cardiology visit resulted in an increase from 30% to 49% of patients who had an intensification in their guideline-directed medical therapy,” Allen said during the press conference. “The majority of these changes involved a dose increase in generic beta-blockers. Clinical inertia accounts for some portion of underuse of guideline-directed medical therapies and HFrEF. And this can be partially overcome by engaging patients in prescribing decisions.”
Although this trial was not powered to assess differences in clinical outcomes between groups, there were no deaths in either arm, and the composite safety endpoint of death, hospitalization or ED visit at 30 days was 10.3% in the intervention group and 6.2% in the control group (P = .29).
Discussant Erica S. Spatz, MD, MHS, associate professor of cardiovascular medicine in the Center for Outcomes Research and Evaluation at Yale School of Medicine, said after the press conference: “Digital therapeutics are tools that use evidence-based, clinically validated information and support for chronic disease management. You can imagine that there is a sea of apps to help people manage their disease, and finding ones that are effective is an important goal to advance outcomes. But these tools have a challenge and they need to address many of the underlying [challenges]. One is the challenge of clinical inertia, which is the failure for providers to either initiate or intensify, or sometimes even deescalate therapy.
“In EPIC-HF, among patients who received the tool, many had an intensification of their medication therapy. But important questions remain as we continue to clinically validate these digital therapeutics,” Spatz said. “Do these interventions result in improved adherence? Do they create greater self-efficacy? Do they reduce the burden of work for a patient that affects their quality of life? Can these tools be freshened or personalized so that they continue to be relevant for the challenges of managing a chronic disease?”