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

April 20, 2022 updated by: Yale University

The REVeAL-HF Trial: Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 1 Year
All cause mortality will be monitored and reported.
1 Year
Heart failure Re-hospitalization
Time Frame: 30 Days Post Discharge
30-day risk of heart failure re-hospitalization will be assessed and reported.
30 Days Post Discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 1 Year
Average length of stay will be collected in Days
1 Year
Discharge doses of heart failure therapies
Time Frame: 1 Year
Discharge doses of guideline recommended heart failure therapies in milligrams (mg)
1 Year
Palliative care referral
Time Frame: 1 Year
Palliative care referrals will be collected and counted (Number)
1 Year
Advanced therapies referral
Time Frame: 1 Year
Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)
1 Year
Electrophysiology referral
Time Frame: 1 Year
Referrals to electrophysiology will be collected and counted (number)
1 Year
Weight Change
Time Frame: 1 Year
Weight change is defined as the change in weight during hospitalization (kg)
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Nihar R Desai, MD MPH, Yale University
  • Principal Investigator: Francis P Wilson, MD MS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

December 30, 2021

Study Completion (ACTUAL)

December 30, 2021

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (ACTUAL)

February 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000025000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be housed at Yale University.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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