NCT06065761

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17,459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

21 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

September 26, 2023

Last Update Submit

April 22, 2024

Conditions

Keywords

Emergency DepartmentRisk Prediction

Outcome Measures

Primary Outcomes (2)

  • 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

  • Number of patients with all-cause mortality

    30 days from index ED visit

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting to KPNC emergency departments with eligibility criteria

You may qualify if:

  • Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure

You may not qualify if:

  • Children (\<18y).
  • Patients who left against medical advice or eloped prior to ED physician evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Kaiser Permanente Antioch Emergency Department

Antioch, California, 94531, United States

Location

Kaiser Permanente Fremont Emergency Department

Fremont, California, 94538, United States

Location

Kaiser Permanente Fresno Medical Center

Fresno, California, 93720, United States

Location

Kaiser Permanente Manteca Medical Center

Manteca, California, 95337, United States

Location

Kaiser Permanente Modesto Medical Center

Modesto, California, 95356, United States

Location

Kaiser Permanente Oakland Emergency Department

Oakland, California, 94611, United States

Location

Kaiser Permanente Redwood City Emergency Department

Redwood City, California, 94063, United States

Location

Kaiser Permanente Richmond Emergency Department

Richmond, California, 94801, United States

Location

Kaiser Permanente Roseville Emergency Department

Roseville, California, 95661, United States

Location

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, 95825, United States

Location

Kaiser Permanente San Francisco Emergency Department

San Francisco, California, 94115, United States

Location

Kaiser Permanente San Jose Emergency Department

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro Emergency Department

San Leandro, California, 94577, United States

Location

Kaiser Permanente San Rafael Emergency Department

San Rafael, California, 94903, United States

Location

Kaiser Permanente Santa Clara Emergency Department

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Santa Rosa Emergency Department

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente South San Francisco Emergency Department

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Vacaville Medical Center

Vacaville, California, 95688, United States

Location

Kaiser Permanente Vallejo Medical Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Heart FailureEmergencies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dana R Sax, MD, MPH

CONTACT

Adina S Rauchwerger, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 4, 2023

Study Start

October 1, 2024

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations