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Trial registered on ANZCTR


Registration number
ACTRN12611000076976
Ethics application status
Approved
Date submitted
19/01/2011
Date registered
20/01/2011
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting Treatment decisions to Optimise stroke Prevention in AF- the Stop-Stroke in AF tria (STOP-STROKE in AF trial).
Scientific title
Effect of academic detailing plus expert decisional support compared with academic detailing on general practitioners use of anticoagulation for the management of stroke risk in atrial fibrillation.
Secondary ID [1] 253309 0
NA
Universal Trial Number (UTN)
Trial acronym
STOP-STROKE IN AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 258841 0
Condition category
Condition code
Cardiovascular 258981 258981 0 0
Other cardiovascular diseases
Stroke 259141 259141 0 0
Ischaemic
Public Health 259142 259142 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One academic detailing session (30 minutes to 60 minutes in duration, tailored to GP needs) delivered by a medically trained peer to general practitioners via a phone session followed by expert feedback on the management of patients with atrial fibrillation. During the academic detailing session, GPs' identify patients with AF for which they wish to receive expert feedback. The medically trained peer proceeds through a standardised proforma collecting de-identified information about the presence of comorbidities, stroke risk factors, current anti-thrombotic treatments and records GPs' concerns/questions about the patient's management. The de-identified proforma is returned to the research staff who forward a one-page summary to experts in stroke medicine (specifically Neurologists and Cardiologists) who reply to GP's queries. The completed one-page summary is then returned to the GPs.
Intervention code [1] 257761 0
Behaviour
Intervention code [2] 257896 0
Prevention
Comparator / control treatment
One academic detailing session delivered by a medically trained peer to general practitioners via a phone session as for the intervention group. The medically trained peer also completes de-identified patient proformas with the GPs and forwards these to the research team who then returns a one-page summary to GPs. GPs allocated to the "control" arm therefore receive the same academic detailing session GPs allocated to the intervention arm (as allocation occurs after this session).
Control group
Active

Outcomes
Primary outcome [1] 259835 0
GP prescribing of anti-coagulation for patients with atrial fibrillation, measured by self-report questionnaire (ie whether GP indicates patient is receiving anti-coagulation or not).
Timepoint [1] 259835 0
One-off post-test measurement scheduled for within 8-12 weeks.
Secondary outcome [1] 268689 0
"Appropriateness" of anticoagulation:
-GP prescribing of anti-coagulation for patients with atrial fibrillation, measured by self-report questionnaire (ie whether GP indicates patient is receiving anti-coagulation or not) in the presence of a CHADS2 score of 2+; OR
-GP prescribing of aspirin for patients with a CHADS2 score of 0; OR
-GP prescribing of anticoagulation or aspirin for patients with a CHADS2 score of 1+
Timepoint [1] 268689 0
One-off post-test measurement scheduled for within 8-12 weeks.
Secondary outcome [2] 268925 0
"Appropriateness" of anticoagulation, with quality control measure incorporated into the definision. Specifically,

-GP prescribing of anti-coagulation for patients with atrial fibrillation, measured by self-report questionnaire (ie whether GP indicates patient is receiving anti-coagulation or not) in the presence of a CHADS2 score of 2+; OR
-GP prescribing of aspirin for patients with a CHADS2 score of 0; OR
-GP prescribing of anticoagulation or aspirin for patients with a CHADS2 score of 1+

AND, where anticoagulation is prescribed, at least monthly INR checks with 67% of INR levels within therapeutic range (2.0-3.0).
Timepoint [2] 268925 0
One-off post-test measurement scheduled for within 8-12 weeks.
Secondary outcome [3] 268926 0
GP decisional conflict, measured by an adapted version of Dolan's Provider Decision Process Assessment Instrument (1999)
Timepoint [3] 268926 0
One-off post-test measurement scheduled for within 8-12 weeks.

Eligibility
Key inclusion criteria
GPs must be in active practice during the study period.
GPs must nominate at least one patient with AF to refer for expert feedback on their management of stroke prevention.
Minimum age
25 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GPs working as locums or who are on extended leave (eg maternity or sick leave) or who work exclusively in a sub-specialty area not involving elderly patients or patients managed for general health issues (eg travel medicine).
GPs failing to nominate a patient with AF during baseline academic detailing session.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs are randomly selected from across Australia using a commercially available data-base.

Randomly selected GPs are first contacted via mail and asked to register their interest via a faxed or emailed form in a QA&CPD education program about stroke prevention. GPs are then mailed an information sheet and consent form. Consenting GPs are sent educational materials and receive a phone call from a medically trained GP to complete an academic detailing session and nominate patients with AF for referral to an expert in stroke medicine (ie Neurologist or Cardiologist) for feedback about their management of patients. All GPs completing this process are then randomised to receive expert decision support either before or after post-test assessment has been completed.

A statistician external to the study team is responsible for randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
GPs are ordered according to the date and time of completed academic detailing session and randomisation is stratified according to the number of patients GPs have referred to the study team (less than or equal to two patients versus 3 or more). Block randomisation is used, block size is unknown to the study investigators; the statistician has not advised the study investigators.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a cluster randomised controlled trial as outcomes are assessed at the patient level and randomisation is at the GP level.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 258226 0
Government body
Name [1] 258226 0
Department of Health and Ageing (Research Fellowship to Chief Investigator)
Address [1] 258226 0
GPO Box 9848,
Canberra ACT 2601, Australia
Canberra

Central Office street addresses in Woden, ACT
Sirius Building: Furzer Street, Woden Town Centre
Penrhyn House: Bowes Street, Woden Town Centre
Scarborough House: Atlantic Street, Woden Town Centre
Country [1] 258226 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bupa Health Foundation
Address
50 Bridge St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 257518 0
None
Name [1] 257518 0
Address [1] 257518 0
Country [1] 257518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260342 0
The University of New South Wales HREC
Ethics committee address [1] 260342 0
The University of New South Wales HREC
UNSW SYDNEY NSW 2052
Ethics committee country [1] 260342 0
Australia
Date submitted for ethics approval [1] 260342 0
Approval date [1] 260342 0
03/04/2007
Ethics approval number [1] 260342 0
07067

Summary
Brief summary
This study aims to improve GPs' management of atrial fibrillation to prevent stroke.
Trial website
NA
Trial related presentations / publications
Gattellari M, Worthington JM, Leung D, Zwar N. Study protocol. Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial. Implementation Science, 2012;7:63.

Gattellari M, Worthington J, Leung D, Zwar N. Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial. International Journal of Stroke, 2015; 10(S3):27.
Public notes

Contacts
Principal investigator
Name 32025 0
Dr Melina Gattellari
Address 32025 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 32025 0
Australia
Phone 32025 0
61 2 8738-9281
Fax 32025 0
Email 32025 0
melina.gattellari@sswahs.nsw.gov.au
Contact person for public queries
Name 15272 0
Dr Dr Melina Gattellari
Address 15272 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 15272 0
Australia
Phone 15272 0
61 2 87389281
Fax 15272 0
NA
Email 15272 0
Melina.Gattellari@sswahs.nsw.gov.au
Contact person for scientific queries
Name 6200 0
Dr Dr Melina Gattellari
Address 6200 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 6200 0
Australia
Phone 6200 0
61 2 8738 9281
Fax 6200 0
None
Email 6200 0
Melina.Gattellari@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary