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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 15312 |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| VA Palo Alto Health Care System | FED |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Reminder | Experimental | 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. |
|
| Control | No Intervention | This group does not receive an intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Reminder | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Referral for Implantable Cardioverter Defibrillator | Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation. | 6 months |
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Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system
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| Name | Affiliation | Role |
|---|---|---|
| Paul A. Heidenreich | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24319096 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Clinical Reminder |
| FG001 | Control | This group does not receive an intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Clinical Reminder |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Referral for Implantable Cardioverter Defibrillator | Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation. | Posted | Number | participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Clinical Reminder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Heidenreich | VA Palo Alto HCS | 650-849-1205 | paul.heidenreich@va.gov |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Stanford |
| California |
| 94305 |
| United States |
This group does not receive an intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 46 |
| 0 |
| 46 |
| EG001 | Control | This group does not receive an intervention. | 4 | 43 | 0 | 43 |
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