Implantable Cardioverter-Defibrillator Use in the VA System

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01217827
• Collaborator: Medtronic (Industry), VA Palo Alto Health Care System (U.S. Fed)
• Enrollment: 89
• Locations: 2
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 44.5
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathies	Behavioral: Clinical Reminder	Phase 3

Study Design

• Study Type: Interventional
• 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: Apr 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. Referral for Implantable Cardioverter Defibrillator [6 months]

   Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304
2	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• Medtronic
• VA Palo Alto Health Care System

Investigators

• Principal Investigator: Paul A. Heidenreich, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul A. Heidenreich, Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01217827
• Other Study ID Numbers: SU-08102010-6708; IRB 15312
• First Posted: Oct 8, 2010
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Cardiomyopathies

Study Results

Participant Flow

Arm/Group Title	Clinical Reminder	Control
Arm/Group 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. Clinical Reminder	This group does not receive an intervention.
Period Title: Overall Study
STARTED	46	43
COMPLETED	46	43
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Clinical Reminder	Control	Total
Arm/Group 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. Clinical Reminder	This group does not receive an intervention.	Total of all reporting groups
Overall Participants	46	43	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (8)	64 (8)	65 (8)
Sex: Female, Male (Count of Participants)
Female	3 6.5%	0 0%	3 3.4%
Male	43 93.5%	43 100%	86 96.6%
Region of Enrollment (participants) [Number]
United States	46 100%	43 100%	89 100%

Outcome Measures

1. Primary Outcome

Title	Referral for Implantable Cardioverter Defibrillator
Description	Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clinical Reminder	Control
Arm/Group 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. Clinical Reminder	This group does not receive an intervention.
Measure Participants	46	43
Number [participants]	11 23.9%	1 2.3%

Adverse Events

Arm/Group Title	Clinical Reminder		Control
Arm/Group 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. Clinical Reminder		This group does not receive an intervention.
All Cause Mortality
	Clinical Reminder		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Clinical Reminder		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/46 (2.2%)		4/43 (9.3%)
Cardiac disorders
Death	1/46 (2.2%)	1	4/43 (9.3%)	4
Other (Not Including Serious) Adverse Events
	Clinical Reminder		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.