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Trial registered on ANZCTR


Registration number
ACTRN12615000839505
Ethics application status
Approved
Date submitted
29/07/2015
Date registered
12/08/2015
Date last updated
12/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Providing testing reports to general practitioners as an intervention to increase chlamydia screening
Scientific title
An RCT examining the impact of providing audit and feedback reports of chlamydia screening to Australian general practitioners on the general practitioners' subsequent chlamydia screening rates, compared to control.
Secondary ID [1] 287175 0
Nil
Universal Trial Number (UTN)
U1111-1172-6602
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia 295743 0
Condition category
Condition code
Infection 296022 296022 0 0
Sexually transmitted infections
Public Health 296093 296093 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testing report containing information of chlamydia screening coverage and positivity rates, associated demographic breakdowns, comparison to clinic-wide and trial-wide averages in the April 2014 to March 2015 12 month period. Report also shows testing rates change for the two years prior, as well as relevant information about screening guidelines and appropriate management. The report is sent once, by regular mail. The data for these reports are sourced from all consultations by a non-locum doctor at an ACCESS PHC (The Australian Collaboration for Coordinated Enhanced Sentinel Surveillance of Sexually Transmitted Infections (STIs) and Blood Borne Viruses (BBVs) Primary Health Clinic network) site ,excluding Gay and Bisexual Men subnetwork practices, and Family Planning practices. This report is prepared by a member of the ACCESS PHC research team.
Intervention code [1] 292448 0
Early detection / Screening
Intervention code [2] 292449 0
Behaviour
Comparator / control treatment
No report sent
Control group
Active

Outcomes
Primary outcome [1] 295691 0
% of patients aged 15-29 tested at least once for chlamydia in the past 12 months, as calculated from consultation and testing data collected as part of the ACCESS PHC network.
Timepoint [1] 295691 0
baseline, 3 and 6 months after provision of report.
Secondary outcome [1] 316234 0
% of patients tested who test positive for chlamydia in the past 12 months, as calculated from consultation and testing data collected as part of the ACCESS PHC network.
Timepoint [1] 316234 0
baseline, 3 and 6 months after provision of report.

Eligibility
Key inclusion criteria
General practitioner practicing at clinic enrolled in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance Primary Health Clinic (ACCESS PHC) network, having seen at least 1 patient in the 15-29 age range over April 2014-March 2015
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
locum doctors, family planning site, site designated as high gay and bisexual men (GBM) caseload clinic by ACCESS PHC

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)
Allocation was completed at a central site by computer. Limited disclosure was used to conceal allocation, that is, at the time of report sending participants are unaware that only half of eligible practitioners are receiving reports during the trial period (as part of the broader ACCESS PHC network all practitioners have agreed for their testing practice to be monitored and reports of their testing practice to be sent to them), but at the conclusion of the trial period all practitioners will be informed of the project and given the opportunity to exclude their results from analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation by site and by number of consultations April 2014-March 2015 (in quartiles).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Of the total 227 eligible practitioners, assuming a control coverage of 8.9% and an ICC of 0.02, and an average patient cluster size of 309, the minimum detectable RR was calculated to be 1.19, which would detect most statistically significant increases reported for comparable interventions. Data will be analysed initially using chi-squared tests and then a multivariate logistic regression using a multi-level mixed effects analysis to adjust for confounders and clustering will be conducted.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/06/2015
Actual
12/06/2015
Date of last participant enrolment
Anticipated
12/06/2015
Actual
12/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
237
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 291740 0
Other
Name [1] 291740 0
Burnet Institute
Country [1] 291740 0
Australia
Funding source category [2] 291741 0
University
Name [2] 291741 0
Monash University
Country [2] 291741 0
Australia
Funding source category [3] 291742 0
Government body
Name [3] 291742 0
Victorian Department of Health and Human Services
Country [3] 291742 0
Australia
Funding source category [4] 291743 0
Government body
Name [4] 291743 0
New South Wales Ministry of Health
Country [4] 291743 0
Australia
Primary sponsor type
Other
Name
Burnet Institute
Address
Burnet Institute
GPO Box 2284
MELBOURNE VIC 3001
Country
Australia
Secondary sponsor category [1] 290413 0
University
Name [1] 290413 0
Monash University
Address [1] 290413 0
Monash University
MONASH UNIVERSITY VIC 3800
Country [1] 290413 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293261 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 293261 0
Office of Ethics & Research Governance
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 293261 0
Australia
Date submitted for ethics approval [1] 293261 0
22/04/2015
Approval date [1] 293261 0
12/06/2015
Ethics approval number [1] 293261 0
6/14

Summary
Brief summary
General practitioners enrolled in the trial will be randomised to either the "intervention" or the "control" group. The intervention group general practitioners will then be sent reports of their chlamydia screening and test positivity data, that compare their performance to the relevant guidelines and to their peers. The sub-project will then monitor and compare testing rates and patterns between the intervention and control groups over the next six months
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59150 0
Dr Megan Lim
Address 59150 0
Burnet Institute
GPO Box 2284
MELBOURNE VIC 3001
Country 59150 0
Australia
Phone 59150 0
+61 3 8506 2403
Fax 59150 0
Email 59150 0
[email protected]
Contact person for public queries
Name 59151 0
Megan Lim
Address 59151 0
Burnet Institute
GPO Box 2284
MELBOURNE VIC 3001
Country 59151 0
Australia
Phone 59151 0
+61 3 8506 2403
Fax 59151 0
Email 59151 0
[email protected]
Contact person for scientific queries
Name 59152 0
Megan Lim
Address 59152 0
Burnet Institute
GPO Box 2284
MELBOURNE VIC 3001
Country 59152 0
Australia
Phone 59152 0
+61 3 8506 2403
Fax 59152 0
Email 59152 0
[email protected]

No information has been provided regarding IPD availability


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.