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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
Objective: To determine the effect on remote monitoring (RM) connectivity of mailing informational postcards to patients with CIEDs who have lost continuous RM connectivity because of a disconnected monitor.
Design: Parallel prospective randomized controlled trial (RCT).
Setting: Veterans Health Administration.
Participants: Randomized selection of all patients with CIEDs whose bedside or smartphone monitor had become disconnected for ≥16 but ≤40 days from the manufacturer's RM service.
Exposure: We developed postcards that notified patients about RM disconnection, described RM's clinical benefits, and provided the customer service number of their CIED manufacturer. Twice monthly, we randomized patients to either receive or not receive the postcard.
Main Outcomes and Measures: Primary outcome was median time to reconnection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postcards | Experimental | Participants who received tailored postcard |
|
| Controls | No Intervention | Participants who did not receive a postcard (usual care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Postcard | Other | Participants received a postcard with a tailored notice that their home monitor was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to monitor reconnection | Time to reconnection using median survival time and assessing differences in each group through log-rank test. Assess relative difference across two groups through Cox proportional hazards regression. | From intervention (mailing) to at least 100 days after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Binary adherence to next scheduled transmission | Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression. | From intervention (mailing) to at least 100 days after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Clinic staff was not informed as to which patients were sent postcards and which patients were not sent postcards. Only the study staff had access to randomization data and and the individuals mailing the postcards (who were not involved in patient-level remote monitoring adherence efforts) had access to mailing data.
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