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

Not Applicable

Not yet recruiting

• Conditions: Patient Safety
• Interventions: Other: Academic detailing and audit and feedback intervention

• Registration Number: NCT05062434
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Study Start: 2025-10-01
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Academic detailing and audit and feedback intervention	VA cardiac electrophysiologists receiving the intervention

Primary Outcome Measures

Name	Time	Method
Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate	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.

Trial Locations

Locations (1)

San Francisco VA Medical Center, San Francisco, CA; 🇺🇸 San Francisco, California, United States