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Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

Sponsor
Kaiser Permanente (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065761
Collaborator
(none)
17,459
Enrollment
21
Locations
26
Anticipated Duration (Months)
831.4
Patients Per Site
32
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Comprehensive ED heart failure management tool

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
17459 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Number of patients with serious adverse events [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)

  2. Number of patients with all-cause mortality [30 days from index ED visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Antioch Emergency Department Antioch California United States 94531
2 Kaiser Permanente Fremont Emergency Department Fremont California United States 94538
3 Kaiser Permanente Fresno Medical Center Fresno California United States 93720
4 Kaiser Permanente Manteca Medical Center Manteca California United States 95337
5 Kaiser Permanente Modesto Medical Center Modesto California United States 95356
6 Kaiser Permanente Oakland Emergency Department Oakland California United States 94611
7 Kaiser Permanente Redwood City Emergency Department Redwood City California United States 94063
8 Kaiser Permanente Richmond Emergency Department Richmond California United States 94801
9 Kaiser Permanente Roseville Emergency Department Roseville California United States 95661
10 Kaiser Permanente South Sacramento Emergency Department Sacramento California United States 95823
11 Kaiser Permanente Sacramento Emergency Department Sacramento California United States 95825
12 Kaiser Permanente San Francisco Emergency Department San Francisco California United States 94115
13 Kaiser Permanente San Jose Emergency Department San Jose California United States 95119
14 Kaiser Permanente San Leandro Emergency Department San Leandro California United States 94577
15 Kaiser Permanente San Rafael Emergency Department San Rafael California United States 94903
16 Kaiser Permanente Santa Clara Emergency Department Santa Clara California United States 95051
17 Kaiser Permanente Santa Rosa Emergency Department Santa Rosa California United States 95403
18 Kaiser Permanente South San Francisco Emergency Department South San Francisco California United States 94080
19 Kaiser Permanente Vacaville Medical Center Vacaville California United States 95688
20 Kaiser Permanente Vallejo Medical Center Vallejo California United States 94589
21 Kaiser Permanente Walnut Creek Medical Center Walnut Creek California United States 94596

Sponsors and Collaborators

  • Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT06065761
Other Study ID Numbers:
  • 1719171
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaiser Permanente
Emergency Department
Risk Prediction
Additional relevant MeSH terms:
Heart Failure
Emergencies

Study Results

No Results Posted as of Oct 4, 2023