A Novel Healthcare Information Technology Tool to Improve Care in Patients With Atrial Fibrillation (AFCare)

August 4, 2022 updated by: Jonathan Hsu, University of California, San Diego

A Novel Healthcare Information Technology Tool to Improve Care in Patients

Patients with implantable heart devices including pacemakers, defibrillators, and cardiac monitors may not seek regular medical care related to their implanted devices. These devices are capable of detecting abnormal heart rhythms or other device abnormalities that may benefit from clinical action or oversight. A novel healthcare information technology has been developed and is being implemented clinically for screening of patients with cardiac rhythm devices who seek care in the emergency room setting. This study seeks to examine differences in detection of cardiac rhythm disturbances including atrial fibrillation (AF) with utilization of this new screening technology, and how often treatment plans change in patients who have a heart rhythm abnormality detected.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a prospective, observational study designed to evaluate the use of the Geneva Healthcare Patient Population Management platform to detect AF (atrial fibrillation) in patients with CIEDs (cardiovascular implantable electronic devices) in the emergency room setting, and assess the feasibility of sub-specialty cardiac electrophysiology (EP) care of these patients. This is a PI-initiated study and there are currently no plans to conduct this study at any other sites.

The investigators plan to use the Geneva Healthcare Patient Population Management platform to detect AF in patients with CIEDs and will utilize a clinical excellence team of nurse practitioners and research assistants to ensure that appropriate treatment of AF is pursued. UCSD (University of California, San Diego) has used the Geneva Patient Population Management Platform for clinical purposes since September, 2012 at both emergency room sites at Hillcrest and Thornton. The platform is not an experimental device.

After the patient's device is interrogated in the usual fashion by placing a wand over the patient, with downloading of information to each device manufacturers interrogator, the information is uploaded to the Geneva platform, where it is organized for a physician to interpret. After the data has been processed and organized on the password protected system, the data retrieved from the CIED will be uploaded to UCSD's electronic medical record system, EPIC, by the hospital personnel. For the purposes of this study, the Geneva Healthcare PPM (Patient Population Management) platform is simply a tool used to collect relevant device data in the ER setting.

The investigators plan to clinically screen all patients who are evaluated in either of two UCSD emergency departments who have any cardiac rhythm device. This ER screening will be incorporated into standard clinical practice and will be conducted by EP staff. The goal will be to detect all patients with AF and to refer them for direct electrophysiology evaluation. Patients with AF will have data captured from physiologic and arrhythmia data collected by the Geneva Healthcare PPM platform from the point-of-care interrogation in the ER (emergency room) or by home monitoring.

A Clinical Excellence Team of physicians, nurse practitioners, and nurses will direct identified patients with AF to appropriate treatment by referral to an EP subspecialist for treatment considerations including rate control, rhythm control, stroke prophylaxis therapy, and ablation therapy. The patient will be offered a clinic appointment with an EP subspecialist. Patients who have been identified with atrial fibrillation will be referred to research staff. If the patient is interested in participation in the main trial, informed consent will be obtained by one of the study investigators or research coordinators. Patients who are enrolled in the trial will be followed through their course of standard clinical treatment for atrial fibrillation for 12 months, including both ablation and medication therapy. Outcomes including morbidity, mortality, hospitalization, healthcare utilization, and recurrent AF will be evaluated in all patients (including those who are taken to ablation vs. those who are not). If a patient refuses to be referred to an EP subspecialist, the patient will not be approached for research. The patient will be encouraged to follow-up with any previous physician they have recently seen, including a primary care physician and/or cardiologist for standard clinical care.

The investigators propose a pilot clinical excellence study leveraging innovative healthcare information technology tools to capture patients with AF and CIEDs, and efficiently route these patients for guideline-based treatment with a goal for appropriate radiofrequency catheter ablation of AF and/or medical therapy. The investigators' mission is to evaluate the ability to detect AF in patients with cardiac rhythm devices with this novel healthcare technology, increase access to proper medical and procedural therapy for AF, and evaluate a centralized repository for follow-up of clinical results and outcomes in this patient population.

Study Type

Observational

Enrollment (Actual)

75

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
    • California
      • La Jolla, California, United States, 92037
        • Sulpizio Cardiovascular Center

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

Patients with cardiovascular implantable electronic devices (CIED), including pacemakers, defibrillators, and cardiac resynchronization therapy devices

Description

Inclusion Criteria:

  • Patients with Atrial Fibrillation
  • Patients presented in the UCSD E.D with a CIED
  • Patient willingness to participate

Exclusion Criteria:

  • Any medical condition that may prevent patient's ability to participate
  • No indication of Atrial Fibrillation
  • Patient unable to follow-up at UCSD or follow research instructions

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Enrolled Subjects
The Enrolled Subjects group will comprise of 75 individuals who will be followed for 12 months for their atrial fibrillation condition. Data will be collected from subjects' devices for 12 months, and any needed changes or additions to therapy will be done. (ie: ablation, pacemaker setting changes, medication control).
Registry Subjects
The Registry Subjects group will comprise of screened patients who do not exhibit symptoms of atrial fibrillation at the time of screening. The already collected data from the patient's device during the screening visit will be kept and put into a registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of atrial fibrillation in patients with CIEDs
Time Frame: two years
To establish the prevalence of device detected atrial tachyarrhythmia episodes (most commonly AF) in patients who have device interrogations performed in the Emergency Room by the Geneva Healthcare Patient Population Management Platform
two years
The prevalence of cardiac electrophysiology referrals from the E.D
Time Frame: two years
To establish the prevalence of cardiac electrophysiology referral in a population of patients with cardiac rhythm devices but no Geneva Healthcare Patient Population Management Platform routine interrogation versus routine interrogation in the emergency room.
two years
The patient population with AF that are treated with catheter ablation
Time Frame: two years
two years
The patient population with AF that are treated with rate-control therapy
Time Frame: two years
two years
The patient population with AF that are treated with rhythm control drug therapy
Time Frame: two years
two years
The patient population with AF that are treated with oral anticoagulation for stroke prophylaxis
Time Frame: two years
two years
The prevalence of device and lead malfunctions in patients with CIEDs.
Time Frame: two years
To investigate the prevalence of device and lead malfunction in a population of patients with cardiac rhythm devices undergoing interrogation by the Geneva Healthcare Patient Population Management Platform.
two years

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Jonathan Hsu, MD, UC San Diego School of Medicine; Sulpizio Cardiovascular Center

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

May 1, 2016

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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