Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275920
Collaborator
(none)
1,600
1
3
7
228.6

Study Details

Study Description

Brief Summary

Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (CDS) intervention tools (best practice alert (BPA) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (HFrEF) is not on appropriate medical therapy, as compared to usual care.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice Alert (BPA)
  • Other: In-Basket Message
N/A

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.

BETTER CARE - HF is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted CDS intervention tools (BPA and automated in-basket message) as compared to usual care on the primary outcome of MRA prescription at end of study period.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Oct 27, 2022
Anticipated Study Completion Date :
Nov 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 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.

Other: 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.

Experimental: In-Basket Message group

Providers will receive a monthly in-basket messages linking to a list of patients who have been seen in the past 2 months or will be seen in the upcoming month 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, date of last visit, and date of next visit. From the list, providers can access the patient's chart, order medications, and document communication with the patient.

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

No Intervention: Control group

Patients who will receive the current standard practice of care (no BPA or in-basket message)

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients prescribed MRA [through study completion, 1 year]

Secondary Outcome Measures

  1. Incidence of provider engagement with each alert type [through study completion, 1 year]

    Provider engagement is reported when the provider clicks on links or buttons within each alert.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Cardiac amyloid

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Amrita Mukhopadhyay, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05275920
Other Study ID Numbers:
  • QI-BETTER CARE-HF
First Posted:
Mar 11, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NYU Langone Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022