Clinical trial NCT05009225: Clinical Decision Support for Atrial Fibrillation and Flutter
Official title: Reducing Variation in Hospitalization and Processes of Care in Emergency Department Patients With Atrial Fibrillation: A Stepped Wedge Cluster Randomized Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation and Flutter
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 4000
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: 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.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18y) KPNC members presenting to the ED with a primary ED diagnosis of atrial fibrillation/flutter (AF/FL). Subjects who meet criteria will be identified electronically within the CDSS tool in the electronic health record.

Exclusion Criteria:

* Children (\<18y).
* Non-members of KPNC.
* Patients who were prisoners, pregnant, receiving hospice or palliative care, or who left against medical advice at the index encounter for AF/FL.

Primary outcomes:
measure: Number of patients who were hospitalized
timeFrame: Through emergency department visit, an average of 8 hours
measure: Number of patients who received sustained rate-reduction medications
timeFrame: Through emergency department visit, an average of 8 hours
measure: Number of patients who received stroke prevention interventions
timeFrame: Through emergency department visit, an average of 8 hours
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: 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: 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: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Emergency Department
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
Study officials:
References: