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NCT05062434 Clinical Trial

An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans

Patient Safety Clinical Trial

— Veteran CIEDs  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05062434
Other study ID # CDX 21-007
Secondary ID 1IK2HX003357-01A
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date November 30, 2026

Study information
Verified date July 2023
Source VA Office of Research and Development
Contact Sanket S Dhruva, MD MHS
Phone (415) 221-4810
Email sanket.dhruva2@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date November 30, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Academic detailing and audit and feedback intervention
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.

Locations
Country Name City State
United States San Francisco VA Medical Center, San Francisco, CA San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
VA Office of Research and Development University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate 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. 3 months
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