NCT05077293

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
596

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 28, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

October 3, 2021

Last Update Submit

October 27, 2022

Conditions

Keywords

Best Practice AlertIn-Basket messageMineralocorticoid Receptor AntagonistsMRAguideline-directed medical therapyGDMT

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients prescribed MRA

    14 days after alert

  • Incidence of provider engagement with each alert type

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

    14 days after alert

Study Arms (3)

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.

Other: Best Practice Alert (BPA)

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.

Other: In-Basket Message

Control group

Patients who will receive the current standard practice of care (no alerts)

Interventions

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

Best Practice Alert group

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

In-Basket Message group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Langone cardiology outpatients

You may qualify if:

  • Cardiologist visit
  • Transthoracic echocardiogram with the most recent EF \>= 40%

You may not qualify if:

  • Hypotension: SBP \< 95
  • Hyperkalemia: most recent K \> 5.1, or any K \>5.5
  • Renal dysfunction: eGFR \< 30
  • Ventricular assist device
  • Hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 14, 2021

Study Start

September 9, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

October 28, 2022

Record last verified: 2022-02

Locations