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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334188
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : September 17, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Colorado, Denver

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.


Condition or disease Intervention/treatment Phase
Patient Engagement Medication Optimization Heart Failure With Reduced Ejection Fraction Patient Activation Behavioral: Patient engagement materials Behavioral: No Intervention--Usual Care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Trial of an Electronic Health Record-leveraged, Patient-centered, Intensification of Chronic Care for Heart Failure (EPIC-HF)
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : April 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Active Comparator: Intervention
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
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.




Primary Outcome Measures :
  1. Percent of Participants Who Experienced an Initiation or Intensification of Their Guideline-Directed Medical Therapy (GDMT) [ Time Frame: Enrollment, 1 month (30 days) after enrollment ]
    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.


Secondary Outcome Measures :
  1. Self-Reported Patient Engagement Around HFrEF Medications [ Time Frame: 1 month after delivery of intervention materials. ]
    The investigators were interested in whether the patient engagement tool (a 3-minute video and 1-page checklist-delivered electronically 1 week prior, 3 days prior and 24 hours prior to the enrollment cardiology clinic visit) led to an increase in patient sense of engagement around their HFrEF medication prescribing, prompting patients to begin a dialogue with their clinician about their medication plan. This was assessed among the Intervention group by comparing answers from a self-reported survey at 1 month after delivery of intervention materials. Participants were sent the survey and asked if they received and reviewed the intervention materials. Survey measures were included as well as a series of questions asking about how and when medications were discussed during clinical interactions.

  2. Number of Participants With Initiation/Intensification of Key Heart Failure Medications [ Time Frame: Enrollment, 1 month (30 days) after enrollment ]
    Initiation or intensification of key heart failure medications was determined by medical chart review conducted at immediately following the cardiology clinic appointment (enrollment) and for the clinic visit closest to 1 month (30 days) after the enrollment visit. Raw numbers of participants were analyzed.

  3. Guideline-directed Medical Therapy (GDMT) Intensifications Per Patient [ Time Frame: Enrollment, 1 month (30 days) after enrollment ]

    Guideline-directed medical therapy (GDMT) intensifications per patient from the pre-clinic visit (enrollment) to 1-month (30 days) after enrollment. This was measured by medical chart reviewing of the pre-clinic visit appointment and the closest clinic appointment preceding the 30 day mark after enrollment.

    Key: guideline directed medical therapy (GDMT); evidence-based beta blocker (EVBB); angiotensin converting enzyme inhibitors (ACE-I); angiotensin receptor blockers (ARB); angiotensin receptor neprilysin inhibitors (ARNI); mineralocorticoid receptor agonists (MRA); hydralazine/isosorbide dinitrate (H/ISDN); Ivabradine (Iva)


  4. Safety Outcomes [ Time Frame: Enrollment, 1-month (30 days) after Enrollment ]
    Unplanned hospitalizations or emergency department visits without hospitalization from the cardiology clinic visit (enrollment) to 1-month (30 days) after enrollment. Hospitalization and emergency department visits were obtained via medical chart review and were analyzed as yes/no per patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334188


Locations
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United States, Colorado
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80209
Sponsors and Collaborators
University of Colorado, Denver
American Heart Association
Investigators
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Principal Investigator: Larry A Allen, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03334188    
Other Study ID Numbers: 17-1249
First Posted: November 7, 2017    Key Record Dates
Results First Posted: September 17, 2021
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases