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Completed

NCT Number: NCT05077293

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Alert (BPA)

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

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

Primary outcomes

  1. Percentage of patients prescribed MRA

    Time frame: 14 days after alert

  2. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study

Acronym: BETTER CARE-HF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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