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NCT06065761 Clinical Trial

Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06065761
Other study ID # 1719171
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2024
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source Kaiser Permanente
Contact Dana R Sax, MD, MPH
Phone 510-891-3400
Email dana.r.sax@kp.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 17459
Est. completion date December 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
United States Kaiser Permanente Antioch Emergency Department Antioch California
United States Kaiser Permanente Fremont Emergency Department Fremont California
United States Kaiser Permanente Fresno Medical Center Fresno California
United States Kaiser Permanente Manteca Medical Center Manteca California
United States Kaiser Permanente Modesto Medical Center Modesto California
United States Kaiser Permanente Oakland Emergency Department Oakland California
United States Kaiser Permanente Redwood City Emergency Department Redwood City California
United States Kaiser Permanente Richmond Emergency Department Richmond California
United States Kaiser Permanente Roseville Emergency Department Roseville California
United States Kaiser Permanente Sacramento Emergency Department Sacramento California
United States Kaiser Permanente South Sacramento Emergency Department Sacramento California
United States Kaiser Permanente San Francisco Emergency Department San Francisco California
United States Kaiser Permanente San Jose Emergency Department San Jose California
United States Kaiser Permanente San Leandro Emergency Department San Leandro California
United States Kaiser Permanente San Rafael Emergency Department San Rafael California
United States Kaiser Permanente Santa Clara Emergency Department Santa Clara California
United States Kaiser Permanente Santa Rosa Emergency Department Santa Rosa California
United States Kaiser Permanente South San Francisco Emergency Department South San Francisco California
United States Kaiser Permanente Vacaville Medical Center Vacaville California
United States Kaiser Permanente Vallejo Medical Center Vallejo California
United States Kaiser Permanente Walnut Creek Medical Center Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Number of patients with all-cause mortality 30 days from index ED visit
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