Clinical trial NCT02623517: A Novel Healthcare Information Technology Tool to Improve Care in Patients With Atrial Fibrillation
Official title: A Novel Healthcare Information Technology Tool to Improve Care in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: CIED
AF
arrhythmia
atrial fibrillation
cardiac device
pacemaker
defibrillator
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2015-12-07
Enrollment: 75
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: Patients with cardiovascular implantable electronic devices (CIED), including pacemakers, defibrillators, and cardiac resynchronization therapy devices

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of atrial fibrillation in patients with CIEDs
timeFrame: two years
measure: The prevalence of cardiac electrophysiology referrals from the E.D
timeFrame: two years
measure: The patient population with AF that are treated with catheter ablation
timeFrame: two years
measure: The patient population with AF that are treated with rate-control therapy
timeFrame: two years
measure: The patient population with AF that are treated with rhythm control drug therapy
timeFrame: two years
measure: The patient population with AF that are treated with oral anticoagulation for stroke prophylaxis
timeFrame: two years
measure: The prevalence of device and lead malfunctions in patients with CIEDs.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Sulpizio Cardiovascular Center
state: California
Study officials:
affiliation: UC San Diego School of Medicine; Sulpizio Cardiovascular Center
name: Jonathan Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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