Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF
NCT03334188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306
Last updated 2021-10-06
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.
Conditions
- Patient Engagement
- Medication Optimization
- Heart Failure With Reduced Ejection Fraction
- Patient Activation
Interventions
- BEHAVIORAL
-
Patient engagement materials
The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
- BEHAVIORAL
-
No Intervention--Usual Care
Control for intervention--patient receives care as usual from provider to contrast against intervention arm.
Sponsors & Collaborators
- collaborator OTHER
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Larry A Allen, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-11
- Primary Completion
- 2020-11-11
- Completion
- 2021-04-13
Countries
- United States
Study Locations
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