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Implantable Cardioverter-Defibrillator Use in the VA System

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01217827
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : December 7, 2016
Last Update Posted : May 19, 2021
Sponsor:
Collaborators:
Medtronic
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Paul A. Heidenreich, Stanford University

Study Description
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Brief Summary:
Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.

Condition or disease Intervention/treatment Phase
Cardiomyopathies Behavioral: Clinical Reminder Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population
Study Start Date : April 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Clinical Reminder
Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
 Behavioral: Clinical Reminder
No Intervention: Control
This group does not receive an intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Referral for Implantable Cardioverter Defibrillator [ Time Frame: 6 months ]
    Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system
Contacts and Locations
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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): NCT01217827


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Medtronic
VA Palo Alto Health Care System
Investigators
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Principal Investigator: Paul A. Heidenreich Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paul A. Heidenreich, Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01217827    
Other Study ID Numbers: SU-08102010-6708
IRB 15312
First Posted: October 8, 2010    Key Record Dates
Results First Posted: December 7, 2016
Last Update Posted: May 19, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases