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

NCT03845660 | Completed DMC

• 1 other identifier: 2000025000
• Study Type: interventional
• Target: 3,124
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Prognosis; Electronic Alerts

Outcome Measures

Primary Outcomes (2)

• All-Cause Mortality

  All cause mortality will be monitored and reported.

  1 Year

• Heart failure Re-hospitalization

  30-day risk of heart failure re-hospitalization will be assessed and reported.

  30 Days Post Discharge

Secondary Outcomes (6)

• Length of stay

  1 Year

• Discharge doses of heart failure therapies

  1 Year

• Palliative care referral

  1 Year

• Advanced therapies referral

  1 Year

• Electrophysiology referral

  1 Year

Study Arms (2)

Usual Care

NO INTERVENTION

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

Electronic Alert

EXPERIMENTAL

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

Interventions

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.

Electronic Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (7)

• 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.

  PMID: 30071528 RESULT

• 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.

  PMID: 29622668 RESULT

• 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.

  PMID: 30537243 RESULT

• 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.

  PMID: 30165979 RESULT

• 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.

  PMID: 26034004 RESULT

• 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.

  PMID: 35947362 DERIVED

• 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.

  PMID: 33992566 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tariq Ahmad, MD MPH

  Yale University

  PRINCIPAL INVESTIGATOR

• Nihar R Desai, MD MPH

  Yale University

  PRINCIPAL INVESTIGATOR

• Francis P Wilson, MD MS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 19, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)