Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001890224
Ethics application status
Approved
Date submitted
15/11/2018
Date registered
21/11/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A review of hospital based management of atrial fibrillation
Scientific title
A review of the inpatient and emergency department management of atrial fibrillation
Secondary ID [1] 296622 0
None
Universal Trial Number (UTN)
Trial acronym
REVIEW-AF
Linked study record
This study is linked to the Home Based Education and Learning Package for atrial fibrillation study (HELP AF). ACTRN12611000607976. Participants for the current trial were individuals who underwent preliminary screening for eligibility in the HELP AF study.

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 310435 0
Condition category
Condition code
Cardiovascular 309150 309150 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to characterise hospital based health care resource utilisation in a cohort of individuals with atrial fibrillation. The cohort of individuals comprises of participants who presented to the emergency departments of three hospitals over a one year period (2013-2014) primarily due to atrial fibrillation. Emergency department presentations and hospital admissions over an approximate four year follow up period (ranging from 2013-2018) will be recorded with a view towards characterising reasons for re-presentations to the emergency department and hospital admissions. This information will be obtained retrospectively by electronic medical review. The management of atrial fibrillation will be explored including the use of rate and rhythm control therapies and appropriate use of oral anticoagulation to reduce stroke risk. Factors predictive of re-presentation and hospitalisation will be examined.
Intervention code [1] 312925 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308129 0
The primary outcome measure will be to characterise reasons for emergency department re-presentations and/or hospital admissions in a cohort of individuals with AF. These will be characterised as related to: 1: atrial fibrillation 2: other cardiovascular causes 3: all other causes. This is a composite endpoint. Data will be collected by retrospective electronic medial review.
Timepoint [1] 308129 0
Over an approximate four year follow up time period. This time period ranges from 2013-2018.
Primary outcome [2] 308172 0
To determine factors predictive of re-hospitalisation for atrial fibrillation
Timepoint [2] 308172 0
Over an approximate four year follow up period (ranging from 2013-2018).
Secondary outcome [1] 354148 0
To determine hospital based management of atrial fibrillation, including the use of rate and rhythm control strategies, and the appropriate use of oral anticoagulation to reduce stroke risk.
Timepoint [1] 354148 0
Over an approximate four year follow up period (ranging from 2013-2018).

Eligibility
Key inclusion criteria
Individuals presenting to the emergency department of three public hospitals in South Australia with a principal diagnosis, by ICD-9 or ICD-10 coding, of atrial fibrillation and/or atrial flutter.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals residing in states other than South Australia, overseas visitors, individuals presenting to hospital for elective AF related procedures, individuals presenting to hospitals which do not publish their emergency department or hospital admission correspondence on electronic health databases.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The study sample consists of all individuals presenting to the emergency department of participating hospitals (for the HELP AF study) over a one year period. All individuals with a principal diagnosis of atrial fibrillation were eligible for inclusion. Descriptive analyses will be used to examine reasons for emergency department re-presentations and admissions over the follow up period. A logistic regression model will be used to examine factors predictive of re-presentation or admission to hospital. Descriptive analyses will be employed to examine the use of rate and rhythm control therapies and appropriate use of oral anticoagulation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2016
Date of last participant enrolment
Anticipated
Actual
19/07/2018
Date of last data collection
Anticipated
Actual
19/07/2018
Sample size
Target
400
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12428 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 12429 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 12430 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 24702 0
5000 - Adelaide
Recruitment postcode(s) [2] 24703 0
5011 - Woodville
Recruitment postcode(s) [3] 24704 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 301199 0
University
Name [1] 301199 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 301199 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
Centre for Heart Rhythm Disorders
c/-Royal Adelaide Hospital
Department of Cardiology
Port Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 300826 0
None
Name [1] 300826 0
None
Address [1] 300826 0
N/A
Country [1] 300826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301940 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 301940 0
Ethics committee country [1] 301940 0
Australia
Date submitted for ethics approval [1] 301940 0
06/10/2015
Approval date [1] 301940 0
06/11/2015
Ethics approval number [1] 301940 0
HREC/15/RAH/447

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88634 0
Prof Prashanthan Sanders
Address 88634 0
Centre for Heart Rhythm Disorders
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 88634 0
Australia
Phone 88634 0
+61 8 83139000
Fax 88634 0
Email 88634 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 88635 0
Celine Gallagher
Address 88635 0
Centre for Heart Rhythm Disorders
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 88635 0
Australia
Phone 88635 0
+61 8 8313 9000
Fax 88635 0
Email 88635 0
celine.gallagher@adelaide.edu.au
Contact person for scientific queries
Name 88636 0
Prashanthan Sanders
Address 88636 0
Centre for Heart Rhythm Disorders
c/- Department of Cardiology
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Country 88636 0
Australia
Phone 88636 0
+61 8 83139000
Fax 88636 0
Email 88636 0
prash.sanders@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applicable


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.