Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF)
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ClinicalTrials.gov Identifier: NCT03845660 |
Recruitment Status :
Completed
First Posted : February 19, 2019
Last Update Posted : April 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure | Behavioral: Electronic Alert | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3124 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Subjects will be recruited when electronically identified. The inclusion criteria will be all adults ≥18 years who have an NTproBNP levels of >500 pg/mL and received intravenous diuretics within 24 hours of admission within the YNHS. Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when providers accesses a patient record to enter a progress note. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | The REVeAL-HF Trial: Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure |
Actual Study Start Date : | January 1, 2020 |
Actual Primary Completion Date : | December 30, 2021 |
Actual Study Completion Date : | December 30, 2021 |

Arm | Intervention/treatment |
---|---|
No Intervention: Usual Care
Providers taking care of patients randomized to this arm will have no alert related to the patients prognosis.
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Experimental: Electronic Alert
Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when the provider accesses a patient record to enter a progress note after the definitions for inclusions into the study have been registered.
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Behavioral: Electronic Alert
Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a "pop-up" when the provider accesses a patient record to enter a progress note after the definitions for inclusions into the study have been registered. |
- All-Cause Mortality [ Time Frame: 1 Year ]All cause mortality will be monitored and reported.
- Heart failure Re-hospitalization [ Time Frame: 30 Days Post Discharge ]30-day risk of heart failure re-hospitalization will be assessed and reported.
- Length of stay [ Time Frame: 1 Year ]Average length of stay will be collected in Days
- Discharge doses of heart failure therapies [ Time Frame: 1 Year ]Discharge doses of guideline recommended heart failure therapies in milligrams (mg)
- Palliative care referral [ Time Frame: 1 Year ]Palliative care referrals will be collected and counted (Number)
- Advanced therapies referral [ Time Frame: 1 Year ]Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)
- Electrophysiology referral [ Time Frame: 1 Year ]Referrals to electrophysiology will be collected and counted (number)
- Weight Change [ Time Frame: 1 Year ]Weight change is defined as the change in weight during hospitalization (kg)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18
- NTproBNP levels of >500pg/mL within 24 hours of admission
- Intravenous diuretics within 24 hours of admission
Exclusion Criteria:
• None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845660
United States, Connecticut | |
Yale New Haven Hospital | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Tariq Ahmad, MD MPH | Yale University | |
Principal Investigator: | Nihar R Desai, MD MPH | Yale University | |
Principal Investigator: | Francis P Wilson, MD MS | Yale University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT03845660 |
Other Study ID Numbers: |
2000025000 |
First Posted: | February 19, 2019 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data will be housed at Yale University. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Failure Prognosis Electronic Alerts |
Heart Failure Heart Diseases Cardiovascular Diseases |