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ACTIVE NOT RECRUITING

Clinical Decision Support for Atrial Fibrillation and Flutter

NCT05009225 · View on ClinicalTrials.gov ↗

Study Summary

Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.

Interventions

  • OTHER Comprehensive ED AF management tool

Study Locations (16)

California

  • Kaiser Permanente Antioch Emergency Department — Antioch
  • Kaiser Permanente Fremont Emergency Department — Fremont
  • Kaiser Permanente Manteca Medical Center — Manteca
  • Kaiser Permanente Modesto Medical Center — Modesto
  • Kaiser Permanente Oakland Emergency Department — Oakland
  • Kaiser Permanente Richmond Emergency Department — Richmond
  • Kaiser Permanente Roseville Emergency Department — Roseville
  • Kaiser Permanente South Sacramento Emergency Department — Sacramento
  • Kaiser Permanente Sacramento Emergency Department — Sacramento
  • Kaiser Permanente San Francisco Emergency Department — San Francisco
  • Kaiser Permanente San Jose Emergency Department — San Jose
  • Kaiser Permanente San Leandro Emergency Department — San Leandro
  • Kaiser Permanente San Rafael Emergency Department — San Rafael
  • Kaiser Permanente Santa Clara Emergency Department — Santa Clara
  • Kaiser Permanente South San Francisco Emergency Department — South San Francisco
  • Kaiser Permanente Walnut Creek Medical Center — Walnut Creek

Trial Details

FieldValue
Enrollment Target 4,000 participants
Start Date 2021-10-01
Est. Completion 2024-06-30

Sponsor

Kaiser Permanente

132 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05009225

The ClinicalTrials.gov registry entry for NCT05009225 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Atrial Fibrillation and Flutter appearing as the primary indexed condition, and to 1 intervention — of which Comprehensive ED AF management tool is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05009225 reports 16 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05009225 about?

NCT05009225 is a clinical study titled "Clinical Decision Support for Atrial Fibrillation and Flutter". Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) an...

What is the current status of trial NCT05009225?

This trial is currently active not recruiting. The enrollment target is 4,000 participants. The study started on 2021-10-01. Estimated completion is 2024-06-30.

What conditions does trial NCT05009225 study?

This clinical trial studies the following conditions: Atrial Fibrillation and Flutter. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05009225?

The interventions under investigation include: Comprehensive ED AF management tool (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05009225?

This trial is sponsored by Kaiser Permanente, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05009225 being conducted?

This trial has 16 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial