Implantable Cardioverter-Defibrillator Use in the VA System
2 other identifiers
interventional
89
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
December 7, 2016
CompletedMay 19, 2021
April 1, 2021
9 months
October 7, 2010
October 13, 2016
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Referral for Implantable Cardioverter Defibrillator
Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
6 months
Study Arms (2)
Clinical Reminder
EXPERIMENTALReminder 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.
Control
NO INTERVENTIONThis group does not receive an intervention.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Medtroniccollaborator
- VA Palo Alto Health Care Systemcollaborator
Study Sites (2)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 24319096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Heidenreich
- Organization
- VA Palo Alto HCS
Study Officials
- PRINCIPAL INVESTIGATOR
Paul A. Heidenreich
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
October 7, 2010
First Posted
October 8, 2010
Study Start
April 1, 2010
Primary Completion
January 1, 2011
Study Completion
December 1, 2013
Last Updated
May 19, 2021
Results First Posted
December 7, 2016
Record last verified: 2021-04