N/A
N=306
Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF
Patient Engagement · Medication Optimization · Heart Failure With Reduced Ejection Fraction · Patient Activation
Bottom Line
View on ClinicalTrials.gov: NCT03334188 ↗Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT) — 29.7; 49.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient engagement materials (Behavioral); No Intervention--Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT) |
29.7; 49.0 | — |
| SECONDARY Self-Reported Patient Engagement Around HFrEF Medications |
81; 73; 53; 51; 83; 74 | — |
| SECONDARY Number of Participants With Initiation/Intensification of Key Heart Failure Medications |
42; 61; 45; 73; 10; 17 | — |
| SECONDARY Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient |
0.36; 0.61; 0.38; 0.63 | — |
| SECONDARY Safety Outcomes |
4; 6; 5; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Most recent cardiology imaging study showing left ventricular ejection fraction (LVEF) <=40%
- A plan for ambulatory clinic appointments in the UCHealth system
Exclusion Criteria
- Patients who have clinic appointments more than 12 months apart
- Under 18 years of age
- Non-English speaking (decision tools and study assessments are in English only)
- Unable to consent (this would include patients with conditions such as moderate-to- severe dementia)
- Prisoners
- Patients who are enrolled in hospice (increasing curative medications is often not appropriate in these patients)
- Patients who are expected to live < 6 months as documented in the patient's chart by treating clinician.
- Continuous IV inotropic support (e.g. dobutamine or milrinone)
- Glomerular filtration rate (GFR) < 15 mL/min or chronic renal disease
- Patients who have neither an email address nor a phone to which text messages may be sent
- Patients with an left ventricular assist device (LVAD) implant
- Patients who have neither an email address nor a phone to which text messages may be sent
Data sourced from ClinicalTrials.gov (NCT03334188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.