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Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845660
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
Heart failure is a complex and heterogenous disease with mortality and morbidity that equals more cancers. Numerous studies have examined the ability to improve prognostication from heart failure, ranging from basic statistical methodologies to machine learning, with impressive improvements in both predictive indices. However, no study to date has examined, in a randomized fashion, the impact of providing prognostic information on provider behavior and downstream clinical outcomes. It is for this reason that the investigators plan to perform the Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF) Trial within the Yale New Haven Health System. REVeAL-HF is a randomized, single-blind intervention trial that is testing the clinical impact of providing prognostic information to the provider on heart failure outcomes in the inpatient settings. The study hypothesis is that electronic alerting about prognostic information on heart failure patients along with links to guidelines will lead to reductions in all-cause mortality and 30-day HF hospitalizations via improved use of guideline directed medical therapy and more adequate decongestion.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Electronic Alert Not Applicable

Detailed Description:
Heart failure is the major cause of mortality and morbidity in the United States and Western Europe and prognosis in individual patients is highly variable. Quantifying a patient's survival prospects based on their overall risk profile has the potential to help identify those patients in need of more intensive monitoring and help target appropriate populations for therapies. In fact, several comprehensive risk scores in patients with heart failure are currently available for both reduced and preserved ejection fraction but their applicability to contemporary heart failure populations is unknown. Additionally, the impact of knowing a patient's prognostic information on treatment decisions in heart failure has never been studied. Therefore, guidelines do not recommend using risk assessments to decide on therapeutic decision making in heart failure due to a lack of data for this strategy. The investigators have proposed a randomized controlled trial be conducted of an electronic alert system that informs practitioners about their patients risk of inpatient mortality and 1-year predicted mortality using data from the electronic health record (EHR). The primary outcome for the trial will be a composite of all-cause mortality and 30-day risk of heart failure rehospitalization. The secondary outcomes will be length of stay, discharge doses of heart failure therapies, palliative care referral, referral for advanced therapies like transplant or mechanical circulatory support, referral to electrophysiology, and change in weight during hospitalization (aggressiveness of diuresis). The investigators will enroll into the trial across the hospitals that comprise the Yale New Haven Health System.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 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
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 1 Year ]
    All cause mortality will be monitored and reported.

  2. Heart failure Re-hospitalization [ Time Frame: 30 Days Post Discharge ]
    30-day risk of heart failure re-hospitalization will be assessed and reported.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 1 Year ]
    Average length of stay will be collected in Days

  2. Discharge doses of heart failure therapies [ Time Frame: 1 Year ]
    Discharge doses of guideline recommended heart failure therapies in milligrams (mg)

  3. Palliative care referral [ Time Frame: 1 Year ]
    Palliative care referrals will be collected and counted (Number)

  4. Advanced therapies referral [ Time Frame: 1 Year ]
    Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)

  5. Electrophysiology referral [ Time Frame: 1 Year ]
    Referrals to electrophysiology will be collected and counted (number)

  6. Weight Change [ Time Frame: 1 Year ]
    Weight change is defined as the change in weight during hospitalization (kg)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18
  • NTproBNP levels of >500pg/mL within 24 hours of admission
  • Intravenous diuretics within 24 hours of admission

Exclusion Criteria:

• None

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Tariq Ahmad, MD MPH 2038431667 tariq.ahmad@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Tariq Ahmad, MD MPH    203-843-1667    tariq.ahmad@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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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
More Information
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Publications of Results:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03845660    
Other Study ID Numbers: 2000025000
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be housed at Yale University.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
Heart Failure
Prognosis
Electronic Alerts
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases