Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05275920
Acronym
BETTER CARE-HF
Enrollment
2211
Registered
2022-03-11
Start date
2022-04-28
Completion date
2022-10-26
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Failure With Reduced Ejection Fraction

Keywords

Best Practice Alert [BPA], In-Basket message, Mineralocorticoid Receptor Antagonists [MRA], guideline-directed medical therapy [GDMT], Clinical decision support

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.

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.

Interventions

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During StudyThrough study completion, an average of 6 months

Secondary

MeasureTime frame
Number of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During StudyThrough study completion, an average of 6 months

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
755
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. 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
812
Control Group
Patients who will receive the current standard practice of care (no BPA or in-basket message)
644
Total2,211

Baseline characteristics

CharacteristicBest Practice Alert GroupTotalControl GroupIn-Basket Message Group
Age, Continuous73.0 years73.0 years74.0 years73.0 years
Ethnicity (NIH/OMB)
Hispanic or Latino
103 Participants251 Participants66 Participants82 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
600 Participants1800 Participants532 Participants668 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
52 Participants160 Participants46 Participants62 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants4 Participants3 Participants0 Participants
Race (NIH/OMB)
Asian
28 Participants83 Participants27 Participants28 Participants
Race (NIH/OMB)
Black or African American
78 Participants191 Participants56 Participants57 Participants
Race (NIH/OMB)
More than one race
75 Participants196 Participants46 Participants75 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants4 Participants2 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
81 Participants209 Participants62 Participants66 Participants
Race (NIH/OMB)
White
490 Participants1524 Participants448 Participants586 Participants
Region of Enrollment
United States
755 participants2211 participants644 participants812 participants
Sex: Female, Male
Female
220 Participants633 Participants204 Participants209 Participants
Sex: Female, Male
Male
535 Participants1578 Participants440 Participants603 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
2 / 2240 / 1270 / 750 / 5315 / 6855 / 569
other
Total, other adverse events
35 / 22412 / 1278 / 7537 / 53144 / 68531 / 569
serious
Total, serious adverse events
0 / 2240 / 1270 / 750 / 5310 / 6850 / 569

Outcome results

Primary

Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study

Time frame: Through study completion, an average of 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Alert GroupNumber of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study224 Participants
In-Basket Message GroupNumber of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study127 Participants
Control GroupNumber of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study75 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Best Practice Alert GroupNumber of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study87 Participants
In-Basket Message GroupNumber of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study94 Participants
Control GroupNumber of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study85 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026