Heart FailureNCT06065761
Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure
An observational study of Heart Failure, run by Kaiser Permanente at 21 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Comprehensive ED heart failure management tool
- How many people
- 17,459 participants
- Where
- 21 sitesUnited States
- Study dates
- 16 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to KPNC emergency departments with eligibility criteria
Who may be able to join
- Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure
Who cannot join
- Children (<18y).
- Patients who left against medical advice or eloped prior to ED physician evaluation.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites
Kaiser Permanente Antioch Emergency Department
Antioch, California, 94531
Kaiser Permanente Fremont Emergency Department
Fremont, California, 94538
Kaiser Permanente Fresno Medical Center
Fresno, California, 93720
Kaiser Permanente Manteca Medical Center
Manteca, California, 95337
Kaiser Permanente Modesto Medical Center
Modesto, California, 95356
Kaiser Permanente Oakland Emergency Department
Oakland, California, 94611
Kaiser Permanente Redwood City Emergency Department
Redwood City, California, 94063
Kaiser Permanente Richmond Emergency Department
Richmond, California, 94801
Kaiser Permanente Roseville Emergency Department
Roseville, California, 95661
Kaiser Permanente South Sacramento Emergency Department
Sacramento, California, 95823
Kaiser Permanente Sacramento Emergency Department
Sacramento, California, 95825
Kaiser Permanente San Francisco Emergency Department
San Francisco, California, 94115
Kaiser Permanente San Jose Emergency Department
San Jose, California, 95119
Kaiser Permanente San Leandro Emergency Department
San Leandro, California, 94577
Kaiser Permanente San Rafael Emergency Department
San Rafael, California, 94903
Kaiser Permanente Santa Clara Emergency Department
Santa Clara, California, 95051
Kaiser Permanente Santa Rosa Emergency Department
Santa Rosa, California, 95403
Kaiser Permanente South San Francisco Emergency Department
South San Francisco, California, 94080
Kaiser Permanente Vacaville Medical Center
Vacaville, California, 95688
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
About this study
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
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).
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Comprehensive ED heart failure management tool
- Keywords
- Emergency Department, Risk Prediction
- Medical subject headings
- Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive ED heart failure management toolOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with risk-stratified appropriate disposition
Risk-stratified appropriate disposition is defined as the proportion of ED encounters with concordant risk-based disposition (admission of high-risk patients and discharge of low-risk patients), assessed using STRATIFY risk calculator
Measured: 24 hours
Secondary outcomes (3)
Number of patients with all-cause mortality
Measured: 30 days from index ED visit
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)
Measured: 30 days from index ED visit
Number of patients with readmissions
Measured: 30 days from index ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start16 Jan 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,459 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065761
- Sponsor's protocol ID
- 1719171
- Status last verified
- May 2026
- First submitted
- 26 Sep 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06065761
- Acronym / sponsor ID
- 1719171
- Conditions
- Heart Failure
- Keywords
- Emergency Department, Risk Prediction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17,459 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to KPNC emergency departments with eligibility criteria
Key inclusion criteria (1 listed)
- Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure
Key exclusion criteria (2 listed)
- Children (<18y).
- Patients who left against medical advice or eloped prior to ED physician evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive ED heart failure management toolThe 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). | Other | – |
Primary outcome
Number of patients with risk-stratified appropriate disposition
Time frame: 24 hours
Risk-stratified appropriate disposition is defined as the proportion of ED encounters with concordant risk-based disposition (admission of high-risk patients and discharge of low-risk patients), assessed using STRATIFY risk calculator
3 secondary outcomes
Number of patients with all-cause mortality
Time frame: 30 days from index ED visit
Number of patients with serious adverse events
Time frame: 30 days from index ED visit
Number of patients with readmissions
Time frame: 30 days from index ED visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Kaiser Permanente at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with risk-stratified appropriate disposition (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.