Summary

Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Sanket Shishir Dhruva, MD MHS
Photo of Sanket Shishir Dhruva
Sanket Shishir Dhruva

Description

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.

Official Title

Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)

Details

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 facilities 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.

Keywords

Patient Safety Defibrillators, Implantable Pacemaker, Artificial Academic detailing and audit and feedback intervention

Eligibility

You can join if…

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

You CAN'T join if...

  • Not willing to participate in the study

Location

  • San Francisco VA Medical Center, San Francisco, CA
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Sanket Shishir Dhruva, MD MHS
    Assistant Professor, Medicine. Authored (or co-authored) 120 research publications. Research interests: Medical Device and Drug Safety · Medical Device Regulation and Insurer Coverage · Real-World Evidence · Medicare Formulary Coverage · High-Value Care · Research with Digital Technologies.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT05062434
Study Type
Interventional
Last Updated