San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
Location contact
Sanket S Dhruva, MD MHS
CONTACT
(415) 221-4810 ext. 26139
Sanket Shishir Dhruva, MD MHS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05062434
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.
Trial opening soon.
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Interventional
Not applicable
San Francisco, California, 94121-1563, United States
Sanket S Dhruva, MD MHS
CONTACT
(415) 221-4810 ext. 26139
Sanket Shishir Dhruva, MD MHS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An academic detailing and audit and feedback intervention will be presented to VA cardiac electrophysiologists, and will include quantitative data about the individual physician's facilities cardiovascular implantable electronic device lead implants and national data on lead implants over the past year.
Time frame: 3 months
This outcome will be the proportion of cardiovascular implantable electronic device leads implanted in the 3 months post-intervention that are of the lead model with the lowest failure rate. The failure rates for the lead models will be available from VA data.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)
Acronym: Veteran CIEDs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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