Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ (ePHR-ICD-SJM)

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Participation; Electronic Health Records; Implantable Cardioverter-Defibrillator; Health Information Exchange
• Intervention / Treatment: Other: Receive Detailed ICD Information-electronic; Other: Receive Detailed ICD Information-paper

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.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age and older
2. Physically and mentally capable of providing an informed consent
3. Patient of PPG-Cardiology
4. Implanted with a St. Jude Medical ICD
5. Undergoing remote monitoring by the Merlin.net™ system
6. Ability to read, write and understand English
7. Have access to computer and/or Internet (Group A and B only)
8. Patient has a scheduled ICD download within the study period at the time of enrollment.

Exclusion Criteria:

1. Does not meet inclusion criteria
2. 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
3. Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
4. Currently participating in another Parkview study that involves other ePHR use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Receive Detailed ICD Information-electronic; Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control
Active Comparator: 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	Other: Receive Detailed ICD Information-paper; Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control
No Intervention: Group C (Control Group); Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Engagement evaluated through Patient Activation Measure (PAM)	This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.	Baseline, 3 months, and 6 months
Change in health outcomes and healthcare utilization	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.	6 months retrospective and 6 months prospective

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)	This validated survey instrument will be utilized in the patient survey to evaluate technology acceptance.	Baseline, 3 months, and 6 months
Providers' attitudes and perceptions evaluated through survey	This survey will be utilized to evaluate providers' attitudes and perceptions of the intervention	At study conclusion (approximately 1 year post deployment)

Collaborators and Investigators

• Sponsor: Parkview Hospital, Indiana
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Michael J Mirro, MD, Parkview Health

Publications and helpful links

General Publications

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
• Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.
• Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
• Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Health Aff (Millwood). 2010 Jun;29(6):1214-9. doi: 10.1377/hlthaff.2010.0503.
• Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Patient Engagement; Patient Portal; Defibrillators; Health Records, Personal
• Other Study ID Numbers: PRC13-0113 ePHR-ICD SJM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO