Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure

NCT ID: NCT05077293

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 596 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-01-01

Brief Summary

This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with 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 pilot 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).

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).

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Best Practice Alert (BPA)

Intervention Type: OTHER

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.

In-Basket Message

Intervention Type: OTHER

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)

No interventions assigned to this group

Interventions

Best Practice Alert (BPA)

A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.

Intervention Type: OTHER

In-Basket Message

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

QI-BETTER CARE-HF PS

Identifier Type: -

Identifier Source: org_study_id