Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for HF

NCT03334188 | Completed Results

• 1 other identifier: 17-1249
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Engagement; Medication Optimization; Heart Failure With Reduced Ejection Fraction; Patient Activation

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT)

  The investigators were interested in whether the patient engagement tool led to an increase in the optimization of HFrEF medications for patients. This was measured through medical record review of all medications and doses immediately preceding the cardiology clinic visit (enrollment) to 30 days after enrollment.

  Enrollment, 1 month (30 days) after enrollment

Secondary Outcomes (4)

• Self-Reported Patient Engagement Around HFrEF Medications

  1 month after delivery of intervention materials.

• Number of Participants With Initiation/Intensification of Key Heart Failure Medications

  Enrollment, 1 month (30 days) after enrollment

• Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient

  Enrollment, 1 month (30 days) after enrollment

• Safety Outcomes

  Enrollment, 1-month (30 days) after Enrollment

Study Arms (2)

Control

OTHER

Patients will receive care-as-usual. The only study procedures patients will be exposed to will be a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment.This arm will include 'No Intervention--Usual Care'.

Behavioral: No Intervention--Usual Care

Intervention

ACTIVE COMPARATOR

Patients will receive the patient engagement video and HFrEF medication checklist by email one week prior to their next clinic appointment after enrollment. Patients in the intervention arm will also receive a baseline survey at time of enrollment about their sense of engagement around their HFrEF medication prescribing, as well as a follow-up survey with the same general content one month after their next clinic appointment. Medical record review will occur at baseline (enrollment), 1 month after the next clinic appointment post-enrollment, and at 12 months from enrollment. This arm will include the 'Intervention :Behavioral: Patient engagement materials.'

Behavioral: Patient engagement materials

Interventions

Patient engagement materials BEHAVIORAL

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.

Intervention

No Intervention--Usual Care BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Heart Association: collaborator

Study Sites (1)

UCHealth University of Colorado Hospital

Aurora, Colorado, 80209, United States

Location

Related Publications (2)

• 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.

  PMID: 33201741 RESULT

• 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.

  PMID: 32866454 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

We did not measure intolerance and contraindications to GDMT. Randomization occurred at the patient-level rather than the clinician- or site-level, which allowed for potential contamination. Only cardiology specialists were included in this study. The use of a single, regional health system may further limit generalizability. However University of Colorado Health is a diverse system spanning a range of local care approaches, and we over-enrolled under-represented patient groups where possible.

Results Point of Contact

• Title: Dr. Larry Allen, Professor of Medicine
• Organization: University of Colorado | School of Medicine | ACCORDS

larry.allen@cuanschutz.edu

303-724-4713

Study Officials

• Larry A Allen, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: January 11, 2018
• Primary Completion: November 11, 2020
• Study Completion: April 13, 2021
• Last Updated: October 6, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)