Remote Interrogation in Rural Emergency Departments
REM RED
Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care. Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 4, 2019
January 1, 2019
1.1 years
April 13, 2015
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Clinical Specialist Treatment Decision
ED check in time to time of clinical specialist treatment decision.
1 day
Secondary Outcomes (1)
Health Care Utilization Rate
Within 30 days of initial ED visit
Other Outcomes (1)
Time to Device Interrogation
1 day
Study Arms (2)
Interrogation with unpaired remote monitoring transmitter
ACTIVE COMPARATORInterrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Interrogation with Programmer
NO INTERVENTIONInterrogation with programmer Interrogation with programmer according to usual standard of care
Interventions
Eligibility Criteria
You may qualify if:
- Presents to Emergency Department with an implanted pacemaker or defibrillator.
- Are 18 years of age or older.
- Are willing and able to provide informed consent for study participation.
- Are willing and able to complete a 30-60 day follow up phone call.
You may not qualify if:
- \. Are unwilling to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross Downey, MD
New Mexico Heart Institute, PA
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 20, 2015
Study Start
December 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 4, 2019
Record last verified: 2019-01