Cardiomyopathies
Conditions
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.
Interventions
BEHAVIORALClinical Reminder
Sponsors
Medtronic
VA Palo Alto Health Care System
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Referral for Implantable Cardioverter Defibrillator | 6 months | Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 46 |
| Control This group does not receive an intervention. | 43 |
| Total | 89 |
Baseline characteristics
| Characteristic | Clinical Reminder | Control | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 8 | 65 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 46 participants | 43 participants | 89 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 43 Participants | 43 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 43 |
| serious Total, serious adverse events | 1 / 46 | 4 / 43 |
Outcome results
Primary
Referral for Implantable Cardioverter Defibrillator
Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Reminder | Referral for Implantable Cardioverter Defibrillator | 11 participants |
| Control | Referral for Implantable Cardioverter Defibrillator | 1 participants |