Postcards to Improve Remote Monitoring Adherence Among Veterans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-02-28

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.

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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.

Conditions

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ICD Pacemaker DDD Adherence, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Postcards

Participants who received a postcard.

Group Type EXPERIMENTAL

Postcard

Intervention Type OTHER

Participants received a postcard asking them to address non-adherence to remote monitoring.

Controls

Participants did not receive a postcard (usual care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Postcard

Participants received a postcard asking them to address non-adherence to remote monitoring.

Intervention Type OTHER

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)