- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077293
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure (BETTER CARE-HF)
BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed Description
An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.
This is a feasibility study using cross-over design at two outpatient clinics in a large health system to implement and compare a best practice alert (BPA) and an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cardiologist visit
- Transthoracic echocardiogram with the most recent EF >= 40%
Exclusion Criteria:
- Hypotension: SBP < 95
- Hyperkalemia: most recent K > 5.1, or any K >5.5
- Renal dysfunction: eGFR < 30
- Ventricular assist device
- Hospice care
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Best Practice Alert group
Providers will receive a BPA at the time of visit for patients with HFrEF who are not on MRA (and who do not have contraindication to MRA).
This alert will be visible on the first screen displayed in the electronic health record and will display the patient's current HFrEF therapies, EF, blood pressure, potassium, and glomerular filtration rate.
The alert will give access to an outpatient heart failure order set, and also provide links to the most recent guidelines.
|
A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.
|
|
In-Basket Message group
Providers will receive a biweekly in-basket messages linking to a list of patients who have been seen in the past year with HFrEF who are not on MRA (and who do not have contraindication to MRA).
This list will display each patient's current hFrEF therapies, EF, blood pressure, potassium, glomerular filtration rate, and date of last visit.
From the list, providers can access the patient's chart, order medications, and document communication with the patient.
|
An In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure
|
|
Control group
Patients who will receive the current standard practice of care (no alerts)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients prescribed MRA
Time Frame: 14 days after alert
|
14 days after alert
|
|
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Incidence of provider engagement with each alert type
Time Frame: 14 days after alert
|
Provider engagement is reported when the provider clicks on links or buttons within each alert.
|
14 days after alert
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QI-BETTER CARE-HF PS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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