Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System

Brief Summary

Detailed Description

Currently, patients receive a letter by postal mail from their physician's office with a statement about their ICD status. The St. Jude Medical ICD data is managed by the Merlin.net™ remote monitoring system and maintained in the database with periodic transfer to the healthcare providers EHR system. This is the first large study that will evaluate the impact of transferring information from the ICD manufacturer's remote monitoring system directly into a patient's ePHR for the purpose of making select information readily available to patients in the form of a report, called the ICD Patient Notification Summary. The ICD Patient Notification Summary will be transmitted to the healthcare providers' EHR system (Epic) from Merlin.net™ as part of the data flow pathway to the patients' ePHR (MyChart). This will ensure that the Arrhythmia Diagnostic Center (ADC) clinic and other healthcare providers will be able to view the same information that the patients will receive. Baseline: Patients from the intervention group and control groups will answer a baseline survey. The baseline survey will assess socio-demographic characteristics, patient engagement, and patient satisfaction with the current standard of care as well as patient perceptions about receiving remote monitoring ICD data in their ePHR. The survey will be administered either paper-based or online, using a secure online survey program, Survey Monkey. Patient engagement will be assessed using the short form Patient Activation Measure (PAM) survey copyrighted by Insignia Health. The Patient Activation Measure (PAM) is a validated survey tool developed by Judith Hibbard, PhD, MPH of the University of Oregon, which assesses the degree a patient acts as an active agent in their own health care. PAM is associated with improved health outcomes6. Follow-up: Patients will respond to two follow up surveys in approximately 3 months and 6 months from the baseline survey. The follow up surveys will assess patient engagement, patient satisfaction and perceptions with the ICD Patient Notification Summary or current standard of care as well as technology acceptance, depending on the group randomization. Technology acceptance will be assessed using the Technology Acceptance Model as a framework and will explore patient attitudes regarding ease of use, usefulness and intentions to use the ePHR and ICD Patient Notification Summary. The Technology Acceptance Model is a commonly used model, originally developed by Fred Davis and Richard Bagozzi, which predicts technology acceptance based on the user's perceived usefulness and perceived ease of use of the technology for a specific purpose 7,8. Data Collection: Chart review will be performed to collect past and current data regarding patient's socio-demographic characteristics, comorbidities, laboratory and interventions, and healthcare utilization. These data points will help provide background and descriptive information to supplement the other components of the study. ICD-related data and events as well as measurement and classification of clinic calls will be assessed starting six months prior to the study period and continuing throughout the study period. The amount and type of healthcare utilization in relation to cardiac care will be collected. Data related to the use of MyChart will also be collected.

Primary Outcomes

Secondary Outcomes

• Providers' attitudes and perceptions evaluated through survey(At study conclusion (approximately 1 year post deployment))
• Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)(Baseline, 3 months, and 6 months)