Remote Patient Management for Cardiac Implantable Electronic Devices (RPM-CIED)

Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:

1. Long, expensive travel for patients
2. Morbidity to patients due to delay in receiving appropriate treatment
3. Efficiency in health care delivery
4. Patient satisfaction

Study Overview

• Status: Completed
• Conditions: Arrhythmia, Cardiac
• Intervention / Treatment: Device: Remote CIED Management

Detailed Description

Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.

While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QEII HSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
2. Able to provide consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote CIED Management; Patients with a CIED will undergo remote monitoring with information technology.	Device: Remote CIED Management; Information Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers		6 months
Compliance (number of received remote transmissions divided by the number of expected remote transmissions)	Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.	12 months

Collaborators and Investigators

• Sponsor: Ratika Parkash
• Collaborators: Medtronic; Cardiac Arrhythmia Network of Canada
• Investigators: Principal Investigator: Ratika Parkash, MD, FRCPC, Nova Scotia Health Authority

Publications and helpful links

General Publications

• Sapp JA, Gillis AM, AbdelWahab A, Nault I, Nery PB, Healey JS, Raj SR, Lockwood E, Sterns LD, Sears SF, Wells GA, Yee R, Philippon F, Tang A, Parkash R. Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study. CMAJ Open. 2021 Jan 25;9(1):E53-E61. doi: 10.9778/cmajo.20200041. Print 2021 Jan-Mar.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac Implantable Electronic Devices
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: RP-002

Plan for Individual participant data (IPD)

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