Clinical trial NCT05062434: An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
Official title: Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Safety
Keywords: Defibrillators, Implantable
Pacemaker, Artificial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2021-09-30
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study for cardiac electrophysiologists at 3 Veterans Integrated Service Networks.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.

Detailed description: This study will identify Department of Veterans Affairs (VA)-based cardiac electrophysiologists at three Veterans Integrated Service Networks (VISNs). Each cardiac electrophysiologist will participate in a videoconference during which time an academic detailing and audit and feedback intervention will be implemented, which will include details and recommendations about lead selection for implantation, based on cardiovascular implantable electronic device (CIED: pacemaker and implantable cardioverter-defibrillator \[ICD\]) lead-specific failure rates for lead models currently available in clinical practice. The cardiac electrophysiologist will also be presented with quantitative data about the individual physician's facility's implants and national data on implants over the past year. These data will be shared in advance, with time for questions and discussion. The electrophysiologist will be asked if anything can be done to facilitate selection of CIED lead models with the statistically and clinically significantly lower failure rates.

Then, over the subsequent 3 months, a quantitative evaluation of the CIED lead models implanted will be evaluated, comparing changes in lead model selection among the electrophysiologists receiving the intervention to a control group of all VA cardiac electrophysiologists who do not receive the intervention. Subsequently, semi-structured interviews will be conducted to assess reasons for changes, or lack thereof, in CIED lead model selection - including barriers and facilitators. Finally, quantitative data will be included to each of the cardiac electrophysiologists, with additional feedback.

Eligibility criteria: Inclusion Criteria:

* Department of Veterans Affairs-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks (VISNs)

Exclusion Criteria:

* Not willing to participate in the study

Primary outcomes:
measure: Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Sanket Shishir Dhruva, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: