Adherence, Patient, ICD, Implanted Loop Recorder, Pacemaker, Remote Monitoring
Conditions
Keywords
Remote Monitoring Adherence, cardiovascular implantable electronic devices
Brief summary
The investigators tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices (CIED) who have lost continuous RM connectivity because their home monitor had become disconnected from their CIED.
Detailed description
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 their home monitor had become disconnected from their CIED. Design: Parallel prospective randomized controlled trial (RCT). Setting: Veterans Health Administration. Participants: Randomized selection of all patients with CIEDs that had become disconnected from their home monitor for ≥16 but ≤40 days from the manufacturer's RM service. Exposure: The investigators 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, the investigators randomized patients to either receive or not receive the postcard. Main Outcomes and Measures: Primary outcome was median time to reconnection.
Interventions
OTHERTailored Postcards
Participants received a postcard with a tailored notice that their CIED was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic.
Sponsors
San Francisco VA Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients followed by the VA National Cardiac Device Surveillance Program for CIED remote monitoring care with a wireless-capable CIED (i.e., does not require manual transmission). * CIEDs: pacemakers, implantable cardioverter-defibrillators, and implantable loop recorders * Patients had a remote monitoring transmission received by VA National Cardiac Device Surveillance Program within past 100 days (representing standard 90-day interval plus additional 10-day buffer in case of travel) * Data from Abbott merlin.net, Biotronik Home Monitoring, Medtronic Carelink, or Boston Scientific Latitude indicating patient disconnected from remote monitoring for ≥16 days but ≤40 days
Exclusion criteria
* Address outside of United States or Puerto Rico * Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected Monitor). Once a patient reconnects but then becomes disconnected again, cannot be included again
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median time to CIED reconnection | From intervention (mailing) to at least 100 days after intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary adherence to next scheduled transmission | From intervention (mailing) to at least 100 days after intervention. | Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression. |
Countries
United States
Outcome results
None listed