A Novel Healthcare Information Technology Tool to Improve Care in Patients With Atrial Fibrillation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2016 |
| End Date: | July 2018 |
| Contact: | Maylene Alegre |
| Email: | malegre@ucsd.edu |
| Phone: | 858-657-5397 |
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.
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.
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.
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.
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
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