Postcards to Improve Remote Monitoring Adherence Among Veterans

Study Overview
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Brief Summary
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We tested the effect of informational postcards on improving remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators in a stepped-wedge randomized controlled trial.

Detailed Description
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Objective: To test the effect of informational postcards on remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators (ICDs). Design/Patients: Stepped-wedge randomized controlled trial among Veterans with pacemakers and ICDs. Intervention: In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: 1) a warning postcard describing risks of non-adherence or 2) an encouraging postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send a remote monitoring transmission within 1 month were mailed a second, identical postcard. Main Measures: Proportion of patients who sent a transmission within 70 days.

Official Title
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Informational Postcards to Improve Remote Monitoring Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators

Conditions
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ICD, Pacemaker DDD, Adherence, Patient

Intervention / Treatment
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* Other: Postcard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran patients with wireless RM-capable pacemakers and ICDs followed by the VA National Cardiac Device Surveillance Program (VANCDSP) Sent at least 1 remote transmission within the past 2 years but had become non-adherent (defined as missing their last scheduled transmission by at least 10 days) Exclusion Criteria: Veteran patients without a wireless RM-capable device Had not sent a remote transmission in the past 2 years
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This was a stepped-wedge randomized controlled trial with two waves. In wave 1, Veterans who had sent at least 1 transmission within the past 2 years but had become non-adherent were randomly assigned to receive a postcard or no postcard. Those receiving postcards were randomized to 1 of 2 messages: 1) a warning postcard describing risks of non-adherence or 2) an encouraging postcard describing benefits of adherence. In wave 2, Veterans who had either not received a postcard in wave 1 or had since become non-adherent were mailed a postcard (again, randomized to 1 of 2 messages). Patients who did not send a RM transmission within 1 month were mailed a second, identical postcard.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postcards<br>Participants who received a postcard. | Other: Postcard<br>* Participants received a postcard asking them to address non-adherence to remote monitoring.<br>|
| No Intervention: Controls<br>Participants did not receive a postcard (usual care). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remote monitoring transmission | Proportion of patients who sent a transmission within 70 days | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transmission after first postcard | Proportion of patients who sent a transmission after the first postcard | 70 days |