Heart FailureBETTER CARE-HFNCT05275920
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
A study testing Best Practice Alert (BPA) and In-Basket Message in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Best Practice Alert (BPA) and In-Basket Message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,211 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiologist visit
- Transthoracic echocardiogram with the most recent EF >= 40%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Best Practice Alert (BPA), In-Basket Message
- Keywords
- Best Practice Alert [BPA], In-Basket message, Mineralocorticoid Receptor Antagonists [MRA], guideline-directed medical therapy [GDMT], Clinical decision support
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
In-Basket MessageOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice Alert (BPA) |
| 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. Receives: Other: In-Basket Message |
| Control group | No intervention | Patients who will receive the current standard practice of care (no BPA or in-basket message) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
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
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start28 Apr 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amrita Mukhopadhyay, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275920
- Sponsor's protocol ID
- 21-00644
- Acronym
- BETTER CARE-HF
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2022
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38043045Mukhopadhyay 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.
PubMed 36882134Mukhopadhyay 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.
PubMed 36640860
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
- ClinicalTrials.gov ID
- NCT05275920
- Acronym / sponsor ID
- BETTER CARE-HF / 21-00644
- Keywords
- Best Practice Alert [BPA], In-Basket message, Mineralocorticoid Receptor Antagonists [MRA], guideline-directed medical therapy [GDMT], Clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,211 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best Practice Alert group | Experimental | Other: Best Practice Alert (BPA)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. |
| In-Basket Message group | Experimental | Other: In-Basket MessageProviders 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. |
| Control group | No intervention | –Patients who will receive the current standard practice of care (no BPA or in-basket message) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiologist visit
- Transthoracic echocardiogram with the most recent EF >= 40%
Key exclusion criteria (6 listed)
- Hypotension: SBP < 95
- Hyperkalemia: most recent K > 5.1, or any K >5.5
- Renal dysfunction: eGFR < 30
- Ventricular assist device
- Hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Best Practice Alert group |
| In-Basket MessageAn In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure | Other | In-Basket Message group |
Primary outcome
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
Time frame: Through study completion, an average of 6 months
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38043045Mukhopadhyay 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.
- Derived from this study: PubMed 36882134Mukhopadhyay 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.
- Derived from this study: PubMed 36640860Mukhopadhyay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrita Mukhopadhyay, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Alert (BPA) and In-Basket Message in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275920, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.