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Clinical Trials/NCT06065761
NCT06065761Enrolling By InvitationNot Applicable

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

Kaiser Permanente42 sites in 1 country17,459 target enrollmentStarted: January 16, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
17,459
Locations
42
Primary Endpoint
Number of patients with serious adverse events

Study Overview

Brief Summary

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).

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Number of patients with serious adverse events

Time Frame: 30 days from index ED visit

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)

Number of patients with all-cause mortality

Time Frame: 30 days from index ED visit

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (42)

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