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
| 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
| 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 monthsOutcome 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 monthsOutcome 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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place