CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 306 enrolled
Drug / intervention
Patient engagement materials +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03334188
NCT03334188N/ACompleted

A Clinical Trial of an Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for Heart Failure (EPIC-HF)

University of Colorado, Denver·interventional·Posted Nov 7, 2017·Updated Oct 6, 2021

In Brief

A clinical study evaluating Patient engagement materials and No Intervention--Usual Care for Patient Engagement and 3 related conditions. Completed, enrolled 306 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartJan 11, 2018
Primary CompletionNov 11, 2020
Study CompletionApr 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.7 years ago

Interventions

Patient engagement materialsbehavioral

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.

No Intervention--Usual Carebehavioral

Control for intervention--patient receives care as usual from provider to contrast against intervention arm.