Trial Outcomes & Findings for Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) (NCT NCT05275920)

NCT ID: NCT05275920

Last Updated: 2024-10-09

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2211 participants

Primary outcome timeframe

Through study completion, an average of 6 months

Results posted on

2024-10-09

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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
Control Group
Patients who will receive the current standard practice of care (no BPA or in-basket message)
Overall Study
STARTED
755
812
644
Overall Study
COMPLETED
755
812
644
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Best Practice Alert Group
n=755 Participants
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.
In-Basket Message Group
n=812 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
Control Group
n=644 Participants
Patients who will receive the current standard practice of care (no BPA or in-basket message)
Total
n=2211 Participants
Total of all reporting groups
Age, Continuous
73.0 years
n=99 Participants
73.0 years
n=107 Participants
74.0 years
n=206 Participants
73.0 years
n=7 Participants
Sex: Female, Male
Female
220 Participants
n=99 Participants
209 Participants
n=107 Participants
204 Participants
n=206 Participants
633 Participants
n=7 Participants
Sex: Female, Male
Male
535 Participants
n=99 Participants
603 Participants
n=107 Participants
440 Participants
n=206 Participants
1578 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
103 Participants
n=99 Participants
82 Participants
n=107 Participants
66 Participants
n=206 Participants
251 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
600 Participants
n=99 Participants
668 Participants
n=107 Participants
532 Participants
n=206 Participants
1800 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
52 Participants
n=99 Participants
62 Participants
n=107 Participants
46 Participants
n=206 Participants
160 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
4 Participants
n=7 Participants
Race (NIH/OMB)
Asian
28 Participants
n=99 Participants
28 Participants
n=107 Participants
27 Participants
n=206 Participants
83 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
4 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
78 Participants
n=99 Participants
57 Participants
n=107 Participants
56 Participants
n=206 Participants
191 Participants
n=7 Participants
Race (NIH/OMB)
White
490 Participants
n=99 Participants
586 Participants
n=107 Participants
448 Participants
n=206 Participants
1524 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
75 Participants
n=99 Participants
75 Participants
n=107 Participants
46 Participants
n=206 Participants
196 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
81 Participants
n=99 Participants
66 Participants
n=107 Participants
62 Participants
n=206 Participants
209 Participants
n=7 Participants
Region of Enrollment
United States
755 participants
n=99 Participants
812 participants
n=107 Participants
644 participants
n=206 Participants
2211 participants
n=7 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 6 months

Outcome measures

Outcome measures
Measure
Best Practice Alert Group
n=755 Participants
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.
In-Basket Message Group
n=812 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
Control Group
n=644 Participants
Patients who will receive the current standard practice of care (no BPA or in-basket message)
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
224 Participants
127 Participants
75 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 6 months

Outcome measures

Outcome measures
Measure
Best Practice Alert Group
n=755 Participants
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.
In-Basket Message Group
n=812 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
Control Group
n=644 Participants
Patients who will receive the current standard practice of care (no BPA or in-basket message)
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
94 Participants
85 Participants

Adverse Events

Best Practice Alert Group - Prescribed MRA

Serious events: 0 serious events
Other events: 35 other events
Deaths: 2 deaths

In-Basket Message Group - Prescribed MRA

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Control Group - Prescribed MRA

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Best Practice Alert Group - Not Prescribed MRA

Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths

In-Basket Message Group - Not Prescribed MRA

Serious events: 0 serious events
Other events: 44 other events
Deaths: 5 deaths

Control Group - Not Prescribed MRA

Serious events: 0 serious events
Other events: 31 other events
Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Best Practice Alert Group - Prescribed MRA
n=224 participants at risk
Participants in the Best Practice Alert group who were prescribed MRA.
In-Basket Message Group - Prescribed MRA
n=127 participants at risk
Participants in the In-Basket Message group who were prescribed MRA.
Control Group - Prescribed MRA
n=75 participants at risk
Participants in the control group who were prescribed MRA.
Best Practice Alert Group - Not Prescribed MRA
n=531 participants at risk
Participants in the Best Practice Alert group who were not prescribed MRA.
In-Basket Message Group - Not Prescribed MRA
n=685 participants at risk
Participants in the In-Basket Message group who were not prescribed MRA.
Control Group - Not Prescribed MRA
n=569 participants at risk
Participants in the control group who were not prescribed MRA.
Renal and urinary disorders
Hyperkalemia
13.4%
30/224 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
9.4%
12/127 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
10.7%
8/75 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
7.0%
37/531 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
6.3%
43/685 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
5.4%
31/569 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
Renal and urinary disorders
Significant Hyperkalemia
5.4%
12/224 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
6.3%
8/127 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
4.0%
3/75 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
2.6%
14/531 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
2.2%
15/685 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
2.1%
12/569 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
General disorders
Newly documented adverse reaction/intolerance to MRA
2.7%
6/224 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
0.00%
0/127 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
0.00%
0/75 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
0.00%
0/531 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
0.15%
1/685 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.
0.00%
0/569 • Up to 90 days after intervention completion, an average of 6 months
Assessed using electronic health record (EHR) data.

Additional Information

Amrita Mukhopadhyay, MD

NYU Langone Health

Phone: 212-263-7751

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place