Back to resultsImplantable Cardioverter-Defibrillator Use in the VA System
Primary Purpose
Cardiomyopathies
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Clinical Reminder
Sponsored by
About this trial
This is an interventional health services research trial for Cardiomyopathies
Eligibility 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
Sites / Locations
- VA Palo Alto Health Care System
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Clinical Reminder
Control
Arm Description
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.
This group does not receive an intervention.
Outcomes
Primary Outcome Measures
Referral for Implantable Cardioverter Defibrillator
Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Secondary Outcome Measures
Full Information
NCT ID
NCT01217827
First Posted
October 7, 2010
Last Updated
April 30, 2021
Sponsor
Stanford University
Collaborators
Medtronic, VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT01217827
Brief Title
Implantable Cardioverter-Defibrillator Use in the VA System
Official Title
Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Medtronic, VA Palo Alto Health Care System
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group does not receive an intervention.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Reminder
Primary Outcome Measure Information:
Title
Referral for Implantable Cardioverter Defibrillator
Description
Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A. Heidenreich
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24319096
Citation
Gupta A, Gholami P, Turakhia MP, Friday K, Heidenreich PA. Clinical reminders to providers of patients with reduced left ventricular ejection fraction increase defibrillator referral: a randomized trial. Circ Heart Fail. 2014 Jan;7(1):140-5. doi: 10.1161/CIRCHEARTFAILURE.113.000753. Epub 2013 Dec 6.
Results Reference
derived
Learn more about this trial
Implantable Cardioverter-Defibrillator Use in the VA System
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