Heart Failure, Heart Failure With Reduced Ejection Fraction
Conditions
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | Through study completion, an average of 6 months |
Secondary
| Measure | Time 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 Study | Through study completion, an average of 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 2,211 |
Baseline characteristics
| Characteristic | Best Practice Alert Group | Total | Control Group | In-Basket Message Group |
|---|---|---|---|---|
| Age, Continuous | 73.0 years | 73.0 years | 74.0 years | 73.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 103 Participants | 251 Participants | 66 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 600 Participants | 1800 Participants | 532 Participants | 668 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 52 Participants | 160 Participants | 46 Participants | 62 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 28 Participants | 83 Participants | 27 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants | 191 Participants | 56 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 75 Participants | 196 Participants | 46 Participants | 75 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 81 Participants | 209 Participants | 62 Participants | 66 Participants |
| Race (NIH/OMB) White | 490 Participants | 1524 Participants | 448 Participants | 586 Participants |
| Region of Enrollment United States | 755 participants | 2211 participants | 644 participants | 812 participants |
| Sex: Female, Male Female | 220 Participants | 633 Participants | 204 Participants | 209 Participants |
| Sex: Female, Male Male | 535 Participants | 1578 Participants | 440 Participants | 603 Participants |
Adverse events
| Event type | EG000 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 / 224 | 0 / 127 | 0 / 75 | 0 / 531 | 5 / 685 | 5 / 569 |
| other Total, other adverse events | 35 / 224 | 12 / 127 | 8 / 75 | 37 / 531 | 44 / 685 | 31 / 569 |
| serious Total, serious adverse events | 0 / 224 | 0 / 127 | 0 / 75 | 0 / 531 | 0 / 685 | 0 / 569 |
Outcome results
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
Time frame: Through study completion, an average of 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Best Practice Alert Group | Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | 224 Participants |
| In-Basket Message Group | Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | 127 Participants |
| Control Group | Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | 75 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Best Practice Alert 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 Participants |
| In-Basket Message 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 | 94 Participants |
| 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 | 85 Participants |