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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05062434
Recruitment Status : Not yet recruiting
First Posted : September 30, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patient Safety Other: Academic detailing and audit and feedback intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study for cardiac electrophysiologists at 3 Veterans Integrated Service Networks.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Safety of Cardiovascular Implantable Electronic Devices in Veterans (CDA 21-057)
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion of cardiovascular implantable electronic device leads that are of the lead model with the lowest failure rate [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062434


Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Contact: Sanket S Dhruva, MD MHS    (415) 221-4810 ext 26139    sanket.dhruva2@va.gov   
Principal Investigator: Sanket Shishir Dhruva, MD MHS         
Sponsors and Collaborators
VA Office of Research and Development
University of California, San Francisco
Investigators
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Principal Investigator: Sanket Shishir Dhruva, MD MHS San Francisco VA Medical Center, San Francisco, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05062434    
Other Study ID Numbers: CDX 21-007
1IK2HX003357-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Defibrillators, Implantable
Pacemaker, Artificial