Clinical trial NCT03334188: Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF
Official title: A Clinical Trial of an Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for Heart Failure (EPIC-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
Medication Optimization
Heart Failure With Reduced Ejection Fraction
Patient Activation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2017-11-07
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The EPIC-HF study will test the effectiveness of a patient empowerment and activation for optimization of Heart Failure with reduced Ejection Fraction (HFrEF) medication plans. Three main regional centers in the University of Colorado Health (UCHealth) system will participate in a two-arm, randomized study design. In this design, each site participates in both control and intervention, with members of the sites eligible patient population randomly enrolled in either the intervention or the control arm. All eligible patients who agree to participate in the study will complete the Baseline Survey, the Follow-Up Survey, and will have information collected from their medical record at baseline, 1 month after the first clinic appointment post-enrollment, and 1 year after enrollment. Enrollment will take place at three UCHealth locations: UCHealth University of Colorado Hospital (Metro), UCHealth Medical Center of the Rockies and UCHealth Poudre Valley Hospital (North), and UCHealth Memorial Central and Memorial North (South). Study personnel at the North and South sites will carry out enrollment and Baseline Surveys with patients for those locations; all other study procedures will be conducted by study personnel at the University of Colorado (UC) School of Medicine (SOM) (UCSOM) at UCHealth University of Colorado School of Medicine.

Patients enrolled in the intervention arm will receive, by email and/or text, a link to 1) a short patient engagement video around HFrEF medications, and 2) a link to an online portable document format (PDF) of a HFrEF medication checklist. Patients in the intervention arm will receive these materials after enrollment and one week prior to their next scheduled clinic appointment. The materials will be delivered in a second communication, three days after the first, via text, as well as a third communication on the day of the clinic appointment. Patients enrolled in the control arm will not receive any materials at any point of time and will receive their usual care.

For both arms, medication changes in patient medical records will be assessed before and after clinic visits to measure the effectiveness of the intervention on aim 1; surveys will be compared before and after clinic visits to determine the effectiveness of the intervention on aim 2.

Detailed description: Multiple medications improve left ventricular remodeling, quality of life, and survival in patients with heart failure with reduced ejection fraction (HFrEF). Unfortunately, the real-world use of HFrEF medications is suboptimal, particularly for more recently approved agents such as aldosterone antagonists. The introduction of sacubitril/valsartan and ivabradine add to already complex HFrEF treatment regimens. Without novel mechanisms to improve medication use, the benefits of advances in HF treatment will be largely unrealized.

Efforts to optimize HFrEF medication delivery have focused primarily on 1) provider decision support around prescribing and 2) patient education around adherence. An important gap is the failure to empower patients to engage more directly in HFrEF prescribing efforts. Patients have a direct stake in making sure they are getting efficacious treatments, want to be involved in decisions about their treatments, and if engaged are more likely to adhere to them. Direct-to-consumer marketing and proliferation of shared decision making reflect a culture where patients are increasingly involved in medication prescribing.

Within this context, the American Heart Association (AHA) has funded four centers across the United States to examine ways in which heart failure treatment and prevention may be optimized. The University of Colorado, Denver is one of these sites; The Development and Trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure Tool (EPIC-HF) is the population-focused arm of study. Inspired by the gap in HFrEF medication optimization, this study aims to develop a patient-centered intervention in order to 1) activate and engage patients with HFrEF in their prescribing regimen, 2) empower them to initiate discussions with their provider about ways in which their medication plan could be improved, which will result in 3) a superior HFrEF medication plan. The investigators modeled this tool with the previous success of flipped classrooms and patient empowerment initiatives in mind. The intervention was iteratively developed with the input of both clinician and patient stakeholders, and is innovative in its emphasis on patient self-actualization and role as an equal with their healthcare provider in the discussion around medication prescribing. This study applies the intervention in a two-arm, randomized controlled trial across three sites (UCHealth metro, Memorial, and Medical Center of the Rockies) in the UCHealth medical system.

Aim 1: Assess the effectiveness of the EPIC-HF intervention on HFrEF medication optimization Hypothesis 1: Compared to usual care, EPIC-HF will increase the number of HFrEF medication optimizations (i.e., dose changes for beta-blockers (βB), Angiotensin-converting enzyme inhibitors (ACE-I)/Angiotensin receptor blockers (ARB)/sacubitril, Aldosterone Receptor Antagonists (AldaA), Ivabradine, etc.) without compromising secondary outcomes including safety and healthcare provider satisfaction.

Aim 2: Assess the effectiveness of the EPIC-HF intervention on patient empowerment and activation around their HFrEF medication plan Hypothesis 2: Compared to usual care, EPIC-HF will result in increased patient empowerment and activation around their HFrEF medication plan as measured through patient self-assessment

Eligibility criteria: Inclusion Criteria:

1. Most recent cardiology imaging study showing left ventricular ejection fraction (LVEF) \<=40%
2. A plan for ambulatory clinic appointments in the UCHealth system

Exclusion Criteria:

1. Patients who have clinic appointments more than 12 months apart
2. Under 18 years of age
3. Non-English speaking (decision tools and study assessments are in English only)
4. Unable to consent (this would include patients with conditions such as moderate-to- severe dementia)
5. Prisoners
6. Patients who are enrolled in hospice (increasing curative medications is often not appropriate in these patients)
7. Patients who are expected to live \< 6 months as documented in the patient's chart by treating clinician.
8. Continuous IV inotropic support (e.g. dobutamine or milrinone)
9. Glomerular filtration rate (GFR) \< 15 mL/min or chronic renal disease
10. Patients who have neither an email address nor a phone to which text messages may be sent
11. Patients with an left ventricular assist device (LVAD) implant
12. Patients who have neither an email address nor a phone to which text messages may be sent

Primary outcomes:
measure: Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT)
timeFrame: Enrollment, 1 month (30 days) after enrollment
Secondary outcomes:
measure: Self-Reported Patient Engagement Around HFrEF Medications
timeFrame: 1 month after delivery of intervention materials.
measure: Number of Participants With Initiation/Intensification of Key Heart Failure Medications
timeFrame: Enrollment, 1 month (30 days) after enrollment
measure: Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient
timeFrame: Enrollment, 1 month (30 days) after enrollment
measure: Safety Outcomes
timeFrame: Enrollment, 1-month (30 days) after Enrollment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Larry A Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen LA, Venechuk G, McIlvennan CK, Page RL 2nd, Knoepke CE, Helmkamp LJ, Khazanie P, Peterson PN, Pierce K, Harger G, Thompson JS, Dow TJ, Richards L, Huang J, Strader JR, Trinkley KE, Kao DP, Magid DJ, Buttrick PM, Matlock DD. An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial. Circulation. 2021 Feb 2;143(5):427-437. doi: 10.1161/CIRCULATIONAHA.120.051863. Epub 2020 Nov 17.
citation: Venechuk GE, Khazanie P, Page RL 2nd, Knoepke CE, Helmkamp LJ, Peterson PN, Pierce K, Thompson JS, Huang J, Strader JR, Dow TJ, Richards L, Trinkley KE, Kao DP, McIlvennan CK, Magid DJ, Buttrick PM, Matlock DD, Allen LA. 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. Am Heart J. 2020 Nov;229:144-155. doi: 10.1016/j.ahj.2020.08.013. Epub 2020 Aug 28.