Electronic Patient Notification of Remote ICD Data: Impact of Patient Engagement on Outcomes in the Merlin.Net™

NCT02989090 | Completed

• 1 other identifier: PRC13-0113 ePHR-ICD SJM
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Implantable Cardioverter-Defibrillator; Health Information Exchange; Electronic Health Records; Patient Participation

Keywords

Patient Engagement; Defibrillators; Health Records, Personal; Patient Portal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Technology Acceptance evaluated through Technology Acceptance Model (TAM)

  Baseline, 3 months, and 6 months

• Providers' attitudes and perceptions evaluated through survey

  At study conclusion (approximately 1 year post deployment)

Study Arms (3)

Group A (Intervention Group)

EXPERIMENTAL

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

Group B (Intervention Group)

ACTIVE COMPARATOR

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

Group C (Control Group)

NO INTERVENTION

Receives Standard of Care-No Report Complete baseline, 3 month and 6 months survey

Interventions

Receive Detailed ICD Information-electronic OTHER

Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control

Group A (Intervention Group)

Receive Detailed ICD Information-paper OTHER

Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control

Group B (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parkview Hospital, Indiana: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Parkview Health

Fort Wayne, Indiana, 46845, United States

Location

Related Publications (5)

• 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.

  PMID: 23242192 BACKGROUND

• 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.

  PMID: 22626743 BACKGROUND

• 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.

  PMID: 20530358 BACKGROUND

• 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.

  PMID: 23381514 BACKGROUND

• 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.

  PMID: 15230939 BACKGROUND

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael J Mirro, MD

  Parkview Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Academic-Research Officer : Parkview Health System

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 12, 2016
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)