Clinical trial NCT06065761: Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Keywords: Emergency Department
Risk Prediction
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 17459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to KPNC emergency departments with eligibility criteria

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.

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.

Primary outcomes:
measure: Number of patients with serious adverse events
timeFrame: 30 days from index ED visit
measure: Number of patients with all-cause mortality
timeFrame: 30 days from index ED visit
Secondary outcomes:
Other outcomes:
Locations:
city: Antioch
country: United States
facility: Kaiser Permanente Antioch Emergency Department
state: California
city: Fremont
country: United States
facility: Kaiser Permanente Fremont Emergency Department
state: California
city: Fresno
country: United States
facility: Kaiser Permanente Fresno Medical Center
state: California
city: Manteca
country: United States
facility: Kaiser Permanente Manteca Medical Center
state: California
city: Modesto
country: United States
facility: Kaiser Permanente Modesto Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Emergency Department
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente Redwood City Emergency Department
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Richmond Emergency Department
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Emergency Department
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Emergency Department
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose Emergency Department
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro Emergency Department
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente San Rafael Emergency Department
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Emergency Department
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Santa Rosa Emergency Department
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Emergency Department
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Vacaville Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
Study officials:
References: