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Trial registered on ANZCTR
Registration number
ACTRN12619000607178
Ethics application status
Approved
Date submitted
12/04/2019
Date registered
23/04/2019
Date last updated
18/08/2020
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
18/08/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Should we CHECK it? Assessing interrogation of cardiac implantable electronic devices in the Emergency Department
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Scientific title
Should we CHECK it? Assessing interrogation of Cardiac Implantable Electronic Devices (CIEDs) in the Emergency Department; implications for service planning and care delivery.
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Secondary ID [1]
297993
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
CHECK-ED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrhythmia Management
312349
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cardiac implantable electronic devices
312381
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Condition category
Condition code
Cardiovascular
310937
310937
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0
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Other cardiovascular diseases
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Emergency medicine
310979
310979
0
0
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Other emergency care
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
No intervention/exposure. This is a retrospective audit study which will review all Cardiac Implanted Electronic Device checks performed in the Royal Adelaide Hospital Emergency Department over a defined twelve month period to assess how often these checks identify relevant clinical data for the each patient's presentation. The audit period will be 4th September 2016 to 3rd September 2017, inclusive.
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Intervention code [1]
314191
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Not applicable
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Comparator / control treatment
No treatment intervention.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
319752
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Incidence of Remarkable Issues (RI) for all checks performed in the ED over the audit period. The composite endpoint of "Remarkable Issues" is comprised of;
a) CIED malfunction which required urgent reprogramming (ie; lead dislodgment or battery issue), or;
b) Significant arrhythmia responsible for presentation, or;
d) Tachyarrhythmia therapy intervention since last device check (ie; AICD shock or Anti Tachycardia Pacing).
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Assessment method [1]
319752
0
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Timepoint [1]
319752
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Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive)
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Secondary outcome [1]
369418
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Burden of after-hours device checks performed in the ED. After Hours occasion of service is defined as;
a) CIED check being performed on occasions outside of 8am to 5pm during Monday to Friday.
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Assessment method [1]
369418
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Timepoint [1]
369418
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Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive).
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Secondary outcome [2]
369419
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Differential burden of Remarkable Issues (RI) for checks performed in the ED by device type. The CIED types consisting of;
a) Permanent Pacemaker (PPM).
b) Implanted Cardioverter Defibrillator (ICD).
c) Implanted Loop Recorder (ILR).
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Assessment method [2]
369419
0
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Timepoint [2]
369419
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Retrospective Audit study of Hospital medical records over 12month period (4th September 2016 to 3rd September 2017, inclusive).
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Eligibility
Key inclusion criteria
Inclusion in the audit will be evaluated by the following criteria:
a. The patient presented to the Royal Adelaide Hospital ED and had a CIED interrogation performed during ED admission.
b. The CIED was either a PPM, ICD or implanted Loop Recorder (ILR).
c. The CIED check was documented in the patient’s medical records.
d. At least 18 years of age.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
"None"
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
All data will be analyzed retrospectively. The nominal data will be presented as number of events (n) and percentage (%). Normally distributed continuous data will be expressed as mean ± standard deviation. The difference between groups will be analyzed using chi-squared comparisons for the nominal data and the normal continuous data tested with unpaired t-tests between groups. Clinical predictors of remarkable issues will be evaluated.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
12/04/2019
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Date of last participant enrolment
Anticipated
31/07/2019
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Actual
31/07/2019
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Date of last data collection
Anticipated
31/12/2019
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Actual
31/12/2019
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Sample size
Target
354
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Accrual to date
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Final
354
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
13618
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
26283
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
302472
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Nil
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Address [1]
302472
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Nil
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Country [1]
302472
0
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Primary sponsor type
University
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Name
The University of Adelaide
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Address
North Terrace, ADELAIDE, SOUTH AUSTRALIA, 5000
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Country
Australia
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Secondary sponsor category [1]
302430
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None
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Name [1]
302430
0
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Address [1]
302430
0
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Country [1]
302430
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303134
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
303134
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Royal Adelaide Hospital
Port Road, ADELAIDE, SA 5000
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Ethics committee country [1]
303134
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Australia
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Date submitted for ethics approval [1]
303134
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26/03/2019
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Approval date [1]
303134
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10/04/2019
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Ethics approval number [1]
303134
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HREC/19/CALHN/162
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Summary
Brief summary
The purpose of this study is to investigate the outcomes of Cardiac Implantable Electronic Device (CIED) interrogations performed in the Emergency Department (ED). Patients who present to the Royal Adelaide Hospital’s (RAH) ED whom have an Implanted Cardiac Electronic Device (CIED) currently have their device interrogated upon request by the attending ED physician. These device interrogations are performed by Cardiac Physiologists, often requiring call-backs at the expense of the hospital, who use specialised computer systems which can interact with the device by telemetry. The performance of the CIED can be assessed during these interrogations to exclude device malfunction as a contributing factor to the patient’s clinical presentation. Furthermore, clinical data trends stored in the device can assist in diagnostics for the ED physician. It is not known how frequently significant issues are detected from these device checks. We hypothesize that there is a low yield of significant issues identified by CIED checks performed in the ED. The outcomes of this study can be used to develop evidence-based triaging methods to reduce the number of unnecessary checks and call-backs being performed.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Dennis Lau
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Address
92590
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Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
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Country
92590
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Australia
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Phone
92590
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+61 8 8313 9000
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Fax
92590
0
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Email
92590
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[email protected]
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Contact person for public queries
Name
92591
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A/Prof Dennis Lau
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Address
92591
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Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
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Country
92591
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Australia
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Phone
92591
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+61 8 8313 9000
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Fax
92591
0
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Email
92591
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[email protected]
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Contact person for scientific queries
Name
92592
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A/Prof Dennis Lau
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Address
92592
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Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
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Country
92592
0
Australia
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Phone
92592
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+61 8 8313 9000
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Fax
92592
0
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Email
92592
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Majority of Cardiac Implanted Electronic Device ch...
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Documents added automatically
No additional documents have been identified.
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