Implantable Cardioverter-Defibrillator Use in the VA System

NCT ID: NCT01217827

Last Updated: 2021-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiomyopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Reminder

Intervention Type BEHAVIORAL

Control

This group does not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical Reminder

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Paul A. Heidenreich

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul A. Heidenreich

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24319096 (View on PubMed)

Other Identifiers

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IRB 15312

Identifier Type: -

Identifier Source: secondary_id

SU-08102010-6708

Identifier Type: -

Identifier Source: org_study_id

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