An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans (Veteran CIEDs)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Safety
• Intervention / Treatment: Other: Academic detailing and audit and feedback intervention

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanket S Dhruva, MD MHS; Phone Number: 26139 (415) 221-4810; Email: sanket.dhruva2@va.gov

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121-1563
      • San Francisco VA Medical Center, San Francisco, CA
      • Contact: Sanket S Dhruva, MD MHS; Phone Number: 26139 (415) 221-4810; Email: sanket.dhruva2@va.gov
      • Principal Investigator: Sanket Shishir Dhruva, MD MHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; VA cardiac electrophysiologists receiving the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Sanket Shishir Dhruva, MD MHS, San Francisco VA Medical Center, San Francisco, CA

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Defibrillators, Implantable; Pacemaker, Artificial
• Other Study ID Numbers: CDX 21-007; 1IK2HX003357-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No