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OpenTrials
Enrolling by Invitation

NCT Number: NCT06065761

Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Antioch Emergency Department, Antioch, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive ED heart failure management tool

Other

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 outcomes

  1. Number of patients with risk-stratified appropriate disposition

    Time frame: 24 hours

    Risk-stratified appropriate disposition is defined as the proportion of ED encounters with concordant risk-based disposition (admission of high-risk patients and discharge of low-risk patients), assessed using STRATIFY risk calculator

Secondary outcomes

  1. Number of patients with all-cause mortality

    Time frame: 30 days from index ED visit

  2. 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)

  3. Number of patients with readmissions

    Time frame: 30 days from index ED visit

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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