Clinical trial NCT02989090: Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™
Official title: Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Cardioverter-Defibrillator
Health Information Exchange
Electronic Health Records
Patient Participation
Keywords: Patient Engagement
Defibrillators
Health Records, Personal
Patient Portal
Lead sponsor: Parkview Health
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-12-12
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Engagement evaluated through Patient Activation Measure (PAM)
timeFrame: Baseline, 3 months, and 6 months
measure: Change in health outcomes and healthcare utilization
timeFrame: 6 months retrospective and 6 months prospective
Secondary outcomes:
measure: Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)
timeFrame: Baseline, 3 months, and 6 months
measure: Providers' attitudes and perceptions evaluated through survey
timeFrame: At study conclusion (approximately 1 year post deployment)
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Health
state: Indiana
Study officials:
affiliation: Parkview Health
name: Michael J Mirro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.