An interventional study of Best Practice Alert (BPA) and In-Basket Message in Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 2,211 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
Patients who will receive the current standard practice of care (no BPA or in-basket message)
A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.
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
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
Time frame: Through study completion, an average of 6 months
Number of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study
Time frame: Through study completion, an average of 6 months
| Milestone | Best Practice Alert Group | In-Basket Message Group | Control Group |
|---|---|---|---|
| Started | 755 | 812 | 644 |
| Completed | 755 | 812 | 644 |
| Not completed | 0 | 0 | 0 |
| Participants | Best Practice Alert Group | In-Basket Message Group | Control Group |
|---|---|---|---|
| Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | 224 | 127 | 75 |
| Participants | Best Practice Alert Group | In-Basket Message Group | Control Group |
|---|---|---|---|
| Number of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study | 87 | 94 | 85 |
Collected over Up to 90 days after intervention completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Best Practice Alert Group - Prescribed MRA | 2/224 (0.9%) | 0/224 (0%) | 35/224 (15.6%) |
| In-Basket Message Group - Prescribed MRA | 0/127 (0%) | 0/127 (0%) | 12/127 (9.4%) |
| Control Group - Prescribed MRA | 0/75 (0%) | 0/75 (0%) | 8/75 (10.7%) |
| Best Practice Alert Group - Not Prescribed MRA | 0/531 (0%) | 0/531 (0%) | 37/531 (7%) |
| In-Basket Message Group - Not Prescribed MRA | 5/685 (0.7%) | 0/685 (0%) | 44/685 (6.4%) |
| Control Group - Not Prescribed MRA | 5/569 (0.9%) | 0/569 (0%) | 31/569 (5.4%) |
| Event | Best Practice Alert Group - Prescribed MRA | In-Basket Message Group - Prescribed MRA | Control Group - Prescribed MRA | Best Practice Alert Group - Not Prescribed MRA | In-Basket Message Group - Not Prescribed MRA | Control Group - Not Prescribed MRA |
|---|---|---|---|---|---|---|
| HyperkalemiaRenal and urinary disorders | 30/224 | 12/127 | 8/75 | 37/531 | 43/685 | 31/569 |
| Significant HyperkalemiaRenal and urinary disorders | 12/224 | 8/127 | 3/75 | 14/531 | 15/685 | 12/569 |
| Newly documented adverse reaction/intolerance to MRAGeneral disorders | 6/224 | 0/127 | 0/75 | 0/531 | 1/685 | 0/569 |
| Age, Continuous(years) | Best Practice Alert Group | In-Basket Message Group | Control Group | Total |
|---|---|---|---|---|
| Median | 73.0 (64.0 to 81.0) | 73.0 (65.0 to 83.0) | 74.0 (63.0 to 81.0) | 73.0 (64.0 to 82.0) |
| Sex: Female, Male(Participants) | Best Practice Alert Group | In-Basket Message Group | Control Group | Total |
|---|---|---|---|---|
| Female | 220 | 209 | 204 | 633 |
| Male | 535 | 603 | 440 | 1578 |
| Ethnicity (NIH/OMB)(Participants) | Best Practice Alert Group | In-Basket Message Group | Control Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 103 | 82 | 66 | 251 |
| Not Hispanic or Latino | 600 | 668 | 532 | 1800 |
| Unknown or Not Reported | 52 | 62 | 46 | 160 |
| Race (NIH/OMB)(Participants) | Best Practice Alert Group | In-Basket Message Group | Control Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 3 | 4 |
| Asian | 28 | 28 | 27 | 83 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 | 4 |
| Black or African American | 78 | 57 | 56 | 191 |
| White | 490 | 586 | 448 | 1524 |
| More than one race | 75 | 75 | 46 | 196 |
| Unknown or Not Reported | 81 | 66 | 62 | 209 |
| Region of Enrollment(participants) | Best Practice Alert Group | In-Basket Message Group | Control Group | Total |
|---|---|---|---|---|
| United States | 755 | 812 | 644 | 2211 |
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