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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Emergencies
• Heart Failure

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