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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Alert
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart Failure, Prognosis, Electronic Alerts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• None

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Electronic Alert

Arm Description

Providers taking care of patients randomized to this arm will have no alert related to the patients prognosis.

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.

Outcomes

Primary Outcome Measures

All-Cause Mortality
All cause mortality will be monitored and reported.
Heart failure Re-hospitalization
30-day risk of heart failure re-hospitalization will be assessed and reported.

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2019
Last Updated
April 20, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03845660
Brief Title
Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure
Acronym
REVeAL-HF
Official Title
The REVeAL-HF Trial: Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Prognosis, Electronic Alerts

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Providers taking care of patients randomized to this arm will have no alert related to the patients prognosis.
Arm Title
Electronic Alert
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Alert
Intervention Description
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 Outcome Measure Information:
Title
All-Cause Mortality
Description
All cause mortality will be monitored and reported.
Time Frame
1 Year
Title
Heart failure Re-hospitalization
Description
30-day risk of heart failure re-hospitalization will be assessed and reported.
Time Frame
30 Days Post Discharge
Secondary Outcome Measure Information:
Title
Length of stay
Description
Average length of stay will be collected in Days
Time Frame
1 Year
Title
Discharge doses of heart failure therapies
Description
Discharge doses of guideline recommended heart failure therapies in milligrams (mg)
Time Frame
1 Year
Title
Palliative care referral
Description
Palliative care referrals will be collected and counted (Number)
Time Frame
1 Year
Title
Advanced therapies referral
Description
Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)
Time Frame
1 Year
Title
Electrophysiology referral
Description
Referrals to electrophysiology will be collected and counted (number)
Time Frame
1 Year
Title
Weight Change
Description
Weight change is defined as the change in weight during hospitalization (kg)
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tariq Ahmad, MD MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nihar R Desai, MD MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis P Wilson, MD MS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be housed at Yale University.
Citations:
PubMed Identifier
30071528
Citation
Wilson FP, Greenberg JH. Acute Kidney Injury in Real Time: Prediction, Alerts, and Clinical Decision Support. Nephron. 2018;140(2):116-119. doi: 10.1159/000492064. Epub 2018 Aug 2.
Results Reference
result
PubMed Identifier
29622668
Citation
Martin M, Wilson FP. Utility of Electronic Medical Record Alerts to Prevent Drug Nephrotoxicity. Clin J Am Soc Nephrol. 2019 Jan 7;14(1):115-123. doi: 10.2215/CJN.13841217. Epub 2018 Apr 5.
Results Reference
result
PubMed Identifier
30537243
Citation
Ahmad T, Freeman JV, Asselbergs FW. Can advanced analytics fix modern medicine's problem of uncertainty, imprecision, and inaccuracy? Eur J Heart Fail. 2019 Jan;21(1):86-89. doi: 10.1002/ejhf.1370. Epub 2018 Dec 10. No abstract available.
Results Reference
result
PubMed Identifier
30165979
Citation
Ahmad T, Wilson FP, Desai NR. The Trifecta of Precision Care in Heart Failure: Biology, Biomarkers, and Big Data. J Am Coll Cardiol. 2018 Sep 4;72(10):1091-1094. doi: 10.1016/j.jacc.2018.07.009. No abstract available.
Results Reference
result
PubMed Identifier
26034004
Citation
Ahmad T, O'Brien EC, Schulte PJ, Stevens SR, Fiuzat M, Kitzman DW, Adams KF, Kraus WE, Pina IL, Donahue MP, Zannad F, Whellan DJ, O'Connor CM, Felker GM. Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure. Circ Heart Fail. 2015 Jul;8(4):709-16. doi: 10.1161/CIRCHEARTFAILURE.114.001996. Epub 2015 Jun 1.
Results Reference
result
PubMed Identifier
35947362
Citation
Ahmad T, Desai NR, Yamamoto Y, Biswas A, Ghazi L, Martin M, Simonov M, Dhar R, Hsiao A, Kashyap N, Allen L, Velazquez EJ, Wilson FP. Alerting Clinicians to 1-Year Mortality Risk in Patients Hospitalized With Heart Failure: The REVEAL-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Sep 1;7(9):905-912. doi: 10.1001/jamacardio.2022.2496.
Results Reference
derived
PubMed Identifier
33992566
Citation
Ahmad T, Yamamoto Y, Biswas A, Ghazi L, Martin M, Simonov M, Hsiao A, Kashyap N, Velazquez EJ, Desai NR, Wilson FP. REVeAL-HF: Design and Rationale of a Pragmatic Randomized Controlled Trial Embedded Within Routine Clinical Practice. JACC Heart Fail. 2021 Jun;9(6):409-419. doi: 10.1016/j.jchf.2021.03.006. Epub 2021 May 12.
Results Reference
derived

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Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure

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