Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 191
- Locations
- 2
- Primary Endpoint
- Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
Study Overview
Brief Summary
Remote monitoring of implantable cardioverter-defibrillators (ICDs) for patients has led to efficient, safe, and satisfying analysis of their device and cardiac status; resulting in an overall improvement in the quality of care for such patients. Despite the efficacy of remote monitoring of ICDs and the satisfaction of patients and providers with the process, there is a desire from patients to have access and view ability of the data their ICD is transmitting. However, methods for making ICD device data directly available to the patients are not currently in place. This study aims to elicit the impact of standardized remote monitoring ICD data to patients through an electronic personal health record (ePHR) on patient engagement, healthcare utilization, and patient-provider communication. For this study, patients with an ICD manufactured by St. Jude Medical and that are undergoing remote monitoring through the remote management system, Merlin.net™, will receive a standardized format of their electronic remote monitoring ICD data in MyChart, the ePHR used at Parkview Health. The standard format for the electronic remote monitoring ICD data, as it is delivered to the patient, will be termed the ICD Patient Notification Summary. Additionally, provider attitudes and perceptions regarding the value of the Patient Notification Summary, its impact on clinic workflow, and patient-provider communication will be collected.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years of age and older
- •Physically and mentally capable of providing an informed consent
- •Patient of PPG-Cardiology
- •Implanted with a St. Jude Medical ICD
- •Undergoing remote monitoring by the Merlin.net™ system
- •Ability to read, write and understand English
- •Have access to computer and/or Internet (Group A and B only)
- •Patient has a scheduled ICD download within the study period at the time of enrollment.
Exclusion Criteria
- •Does not meet inclusion criteria
- •Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing an ePHR such as; blindness, loss of function of arms, cognitive impairments (per chart review) that would interfere in learning a new task
- •Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- •Currently participating in another Parkview study that involves other ePHR use.
Arms & Interventions
Group A (Intervention Group)
Receive Detailed ICD Information-electronic: Receive ICD Patient Notification Summary via MyChart Patient Portal Account - Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey
Intervention: Receive Detailed ICD Information-electronic (Other)
Group C (Control Group)
Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey
Group B (Intervention Group)
Receive Detailed ICD Information-paper: Receive ICD Patient Notification Summary via paper Receive training to familiarize yourself with using the ePHR, MyChart Complete baseline, 3 month and 6 months survey
Intervention: Receive Detailed ICD Information-paper (Other)
Outcomes
Primary Outcomes
Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
Time Frame: Baseline, 3 months, and 6 months
This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
Change in health outcomes and healthcare utilization
Time Frame: 6 months retrospective and 6 months prospective
The number of and reason for ER visits, Hospitalization, Office Visits, and Calls to Clinic will be recorded to evaluate patient health outcomes and healthcare utilization before and during the study.
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)
Investigators
Michael Mirro
Chief Academic-Research Officer : Parkview Health System
Parkview Hospital, Indiana