Postcards to Improve Remote Monitoring Connectivity Among Patients With Cardiovascular Implantable Electronic Devices and Disconnected Monitors: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,726
- 试验地点
- 1
- 主要终点
- Median time to monitor reconnection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Address outside of United States or Puerto Rico
- •Previously included in the present RCT or a complementary RCT (VANCDSP Disconnected CIED). Once a patient reconnects but then becomes disconnected again, cannot be included again
研究组 & 干预措施
Postcards
Participants who received tailored postcard
干预措施: Tailored Postcard (Other)
Controls
Participants who did not receive a postcard (usual care)
结局指标
主要结局
Median time to monitor reconnection
时间窗: 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.
次要结局
- Binary adherence to next scheduled transmission(From intervention (mailing) to at least 100 days after intervention.)
研究者
Sanket Dhruva, MD, MHS
Staff Physician
San Francisco VA Health Care System