Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure: Building and Testing a Machine-learning Platform for Personalized, Accurate, Real-time Risk Prediction

The primary goal is to build and test a previously developed and validated risk model and clinical decision support tool embedded within the electronic health record to improve risk stratification of emergency department (ED) patients with acute heart failure (AHF).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Comprehensive ED heart failure management tool

Detailed Description

The study team will build an electronic health record-embedded clinical decision support tool using a recently developed risk prediction model that curates patient-specific data in real-time, accurately estimates short-term patient risk, and presents tailored clinical recommendations. This will be a regional implementation study in which the tool is turned on at 21 emergency departments (ED) across Kaiser Permanente Northern California (KPNC). The study team will validate risk predictions and study key clinical outcomes as part of this trial.

• Study Type: Observational
• Enrollment (Estimated): 17459

Contacts and Locations

• Study Contact: Name: Adina S Rauchwerger, MPH; Phone Number: 510-891-3400; Email: adina.s.rauchwerger@kp.org
• Study Contact Backup: Name: Dana R Sax, MD, MPH; Phone Number: 510-891-3400; Email: dana.r.sax@kp.org

Study Locations

• United States
  • California
    • Antioch, California, United States, 94531
      • Kaiser Permanente Antioch Emergency Department
    • Fremont, California, United States, 94538
      • Kaiser Permanente Fremont Emergency Department
    • Fresno, California, United States, 93720
      • Kaiser Permanente Fresno Medical Center
    • Manteca, California, United States, 95337
      • Kaiser Permanente Manteca Medical Center
    • Modesto, California, United States, 95356
      • Kaiser Permanente Modesto Medical Center
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Emergency Department
    • Redwood City, California, United States, 94063
      • Kaiser Permanente Redwood City Emergency Department
    • Richmond, California, United States, 94801
      • Kaiser Permanente Richmond Emergency Department
    • Roseville, California, United States, 95661
      • Kaiser Permanente Roseville Emergency Department
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento Emergency Department
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento Emergency Department
    • San Francisco, California, United States, 94115
      • Kaiser Permanente San Francisco Emergency Department
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose Emergency Department
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro Emergency Department
    • San Rafael, California, United States, 94903
      • Kaiser Permanente San Rafael Emergency Department
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara Emergency Department
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente Santa Rosa Emergency Department
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente South San Francisco Emergency Department
    • Vacaville, California, United States, 95688
      • Kaiser Permanente Vacaville Medical Center
      • Contact: Dana R Sax, MD, MPH
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Vallejo Medical Center
      • Contact: Dana R Sax, MD, MPH
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente Walnut Creek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to KPNC emergency departments with eligibility criteria

Description

Inclusion Criteria:

• Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure

Exclusion Criteria:

• Children (<18y).
• Patients who left against medical advice or eloped prior to ED physician evaluation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with serious adverse events	Serious adverse events include mortality, cardiopulmonary resuscitation (CPR), intubation/ventilation, new end-stage renal disease (ESRD), balloon pump placement, or percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG)	30 days from index ED visit
Number of patients with all-cause mortality		30 days from index ED visit

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department; Risk Prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies
• Other Study ID Numbers: 1719171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No