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

Heart Failure Clinical Trial

— REVeAL-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845660
• Other study ID #: 2000025000
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3124
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Ahmad T, O'Brien EC, Schulte PJ, Stevens SR, Fiuzat M, Kitzman DW, Adams KF, Kraus WE, Piña 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 Fai — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality	All cause mortality will be monitored and reported.	1 Year
Primary	Heart failure Re-hospitalization	30-day risk of heart failure re-hospitalization will be assessed and reported.	30 Days Post Discharge
Secondary	Length of stay	Average length of stay will be collected in Days	1 Year
Secondary	Discharge doses of heart failure therapies	Discharge doses of guideline recommended heart failure therapies in milligrams (mg)	1 Year
Secondary	Palliative care referral	Palliative care referrals will be collected and counted (Number)	1 Year
Secondary	Advanced therapies referral	Referrals for advanced therapies like transplant or mechanical circulatory support will be collected and counted (number)	1 Year
Secondary	Electrophysiology referral	Referrals to electrophysiology will be collected and counted (number)	1 Year
Secondary	Weight Change	Weight change is defined as the change in weight during hospitalization (kg)	1 Year