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Completed

NCT Number: NCT03845660

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Electronic Alert

Behavioral

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: REVeAL-HF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2019
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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