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Enrolling by invitation NCT06065761

Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive ED heart failure management tool.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Comprehensive ED heart failure management tool
    The investigators plan a regional implementation of an electronic health record-based heart failure decision support tool across 21 EDs of Kaiser Permanente Northern California (KPNC).

Primary outcome measures

  • Number of patients with risk-stratified appropriate disposition [Time frame: 24 hours]
Secondary outcome measures (3)
  • Number of patients with all-cause mortality [Time frame: 30 days from index ED visit]
  • Number of patients with serious adverse events [Time frame: 30 days from index ED visit]
  • Number of patients with readmissions [Time frame: 30 days from index ED visit]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 21 centers
  • Kaiser Permanente Antioch Emergency Department — Antioch
  • Kaiser Permanente Fremont Emergency Department — Fremont
  • Kaiser Permanente Fresno Medical Center — Fresno
  • Kaiser Permanente Manteca Medical Center — Manteca
  • Kaiser Permanente Modesto Medical Center — Modesto
  • Kaiser Permanente Oakland Emergency Department — Oakland
  • Kaiser Permanente Redwood City Emergency Department — Redwood City
  • Kaiser Permanente Richmond Emergency Department — Richmond
  • … and 13 more centers

Identifiers

NCT: NCT06065761 · 1719171

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗