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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Practice Alert group | Experimental | 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. |
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| In-Basket Message group | Experimental | 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. |
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| Control group | No Intervention | Patients who will receive the current standard practice of care (no BPA or in-basket message) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | Through study completion, an average of 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amrita Mukhopadhyay, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38043045 | Derived | Mukhopadhyay A, Reynolds HR, King WC, Phillips LM, Nagler AR, Szerencsy A, Saxena A, Klapheke N, Katz SD, Horwitz LI, Blecker S. Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care. JACC Heart Fail. 2024 Apr;12(4):665-674. doi: 10.1016/j.jchf.2023.11.002. Epub 2023 Nov 15. | |
| 36882134 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | Control Group | Patients who will receive the current standard practice of care (no BPA or in-basket message) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
|
Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Best Practice Alert Group - Prescribed MRA | Participants in the Best Practice Alert group who were prescribed MRA. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amrita Mukhopadhyay, MD | NYU Langone Health | 212-263-7751 | amrita.mukhopadhyay@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2023 | Oct 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
|
| Mukhopadhyay A, Reynolds HR, Phillips LM, Nagler AR, King WC, Szerencsy A, Saxena A, Aminian R, Klapheke N, Horwitz LI, Katz SD, Blecker S. Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care. J Am Coll Cardiol. 2023 Apr 11;81(14):1303-1316. doi: 10.1016/j.jacc.2023.02.005. Epub 2023 Mar 5. |
| 36640860 | Derived | Mukhopadhyay A, Reynolds HR, Xia Y, Phillips LM, Aminian R, Diah RA, Nagler AR, Szerencsy A, Saxena A, Horwitz LI, Katz SD, Blecker S. Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists. Am Heart J. 2023 Apr;258:38-48. doi: 10.1016/j.ahj.2022.12.016. Epub 2023 Jan 11. |
| BG001 | 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 |
| BG002 | Control Group | Patients who will receive the current standard practice of care (no BPA or in-basket message) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
| OG002 | Control Group | Patients who will receive the current standard practice of care (no BPA or in-basket message) |
|
|
| 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 | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
|
|
|
| 2 |
| 224 |
| 0 |
| 224 |
| 35 |
| 224 |
| EG001 | In-Basket Message Group - Prescribed MRA | Participants in the In-Basket Message group who were prescribed MRA. | 0 | 127 | 0 | 127 | 12 | 127 |
| EG002 | Control Group - Prescribed MRA | Participants in the control group who were prescribed MRA. | 0 | 75 | 0 | 75 | 8 | 75 |
| EG003 | Best Practice Alert Group - Not Prescribed MRA | Participants in the Best Practice Alert group who were not prescribed MRA. | 0 | 531 | 0 | 531 | 37 | 531 |
| EG004 | In-Basket Message Group - Not Prescribed MRA | Participants in the In-Basket Message group who were not prescribed MRA. | 5 | 685 | 0 | 685 | 44 | 685 |
| EG005 | Control Group - Not Prescribed MRA | Participants in the control group who were not prescribed MRA. | 5 | 569 | 0 | 569 | 31 | 569 |
| Significant Hyperkalemia | Renal and urinary disorders | Systematic Assessment |
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| Newly documented adverse reaction/intolerance to MRA | General disorders | Systematic Assessment |
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