Clinical and Economic Impact of an Organized Treatment Pathway on AFib Patient Management From the ER (ER2EP)

February 2, 2021 updated by: Kansas City Heart Rhythm Research Foundation

Clinical and Economic Impact of an Organized Treatment Pathway on Atrial Fibrillation Patient Management From the Emergency Room

Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Management variation such as selecting rate vs rhythm control, timing and need for thromboembolic treatment, ER vs inpatient treatment and cardiology consultation could lead to disparate care of patients. Therefore, there is a need for future studies to standardize practice leading to improved management, decreased rates of hospitalization and overall cost. Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

i) Study arm: Patients > 18 years of age (both males and females) who present with AF as the primary diagnosis to the ER will have their chart reviewed.

ii) Historical control arm:Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex. All patients > 18 years of age (both males and females) who presented with AF as primary diagnosis to the ER of the participating centers within last 2 years will be selected if they meet the inclusion/exclusion criteria mentioned below

Description

Inclusion Criteria:

  • Consecutive patients > 18 years of age who comes to the ER with AF as the primary diagnosis and is treated according to study protocol.

Exclusion Criteria:

  • Patients with established cardiology or electrophysiology care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Arm
Patients who present with AF as the primary diagnosis to the ER will have their chart reviewed
Other: Quality improvement
All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.
Other Names:
  • All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER.
Historical Cohort
Historical control arm will be selected from chart review of emergency department prior to the commencement of this study after propensity matching with age and sex.
Other: Quality improvement
All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.
Other Names:
  • All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative resource utilization in dollars
Time Frame: 15 months
Primary Outcome
15 months
Time to definitive therapy (AAD and or Ablation)
Time Frame: 15 months
Primary Outcome
15 months
Number of Hospital/clinic visits
Time Frame: 15 months
Primary Outcome
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRF-ER2EP-0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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