Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected CIED

San Francisco VA Health Care System1,312 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,312

Conditions

ICD Pacemaker Implanted Loop Recorder Remote Monitoring Adherence, Patient

Interventions

Tailored PostcardsOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

San Francisco VA Medical Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Median time to CIED 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.

Time frame: From intervention (mailing) to at least 100 days after intervention.

Secondary Outcomes

Binary adherence to next scheduled transmission

Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression.

Time frame: From intervention (mailing) to at least 100 days after intervention.

Data from ClinicalTrials.gov

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