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Trial registered on ANZCTR


Registration number
ACTRN12614000595617
Ethics application status
Approved
Date submitted
29/05/2014
Date registered
4/06/2014
Date last updated
11/02/2021
Date data sharing statement initially provided
6/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of removing financial incentives and/or audit and feedback on preventive care activities in general practice: A cluster randomised controlled trial (ACCEPt-able)
Scientific title
The impact of removing financial incentives and/or audit and feedback on preventive care activities in general practice: A cluster randomised controlled trial (ACCEPt-able)
Secondary ID [1] 284380 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACCEPt-able
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chlamydia 291547 0
Condition category
Condition code
Infection 291928 291928 0 0
Sexually transmitted infections
Public Health 292412 292412 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Factorial cluster RCT design - 3 intervention groups groups and one control (see below)
1) Incentive payments: This group will continue to receive incentive for each chlamydia test done for 16 to 29 year old men or women. These payments will range from $5 per eligible test for up to 20% coverage to $8 per test for over 40% coverage. The intervention period is up to 2 years.

2) Audit+feedback only: Provision of quarterly chlamydia testing reports to each GP. The report lists the number of patients aged 16 to 29 years the GP has tested during the quarter, his/her chlamydia testing rate for the quarter and for the previous 12 months. The reports will be given both verbally and in writing to the clinic in a quarterly face to face meeting where a study Research Officer will explain the results and discuss how the clinic can further improve their rates. The intervention period is up to 2 years.

3) None: GPs and clinics will NOT receive any incentive payments or audit+feedback on their chlamydia testing performance. The intervention period is up to 2 years.
Intervention code [1] 289109 0
Prevention
Intervention code [2] 289506 0
Behaviour
Comparator / control treatment
The control group will continue to receive incentive payments and audit plus feedback for chlamydia testing among 16 to 29 year old men and women.
Control group
Active

Outcomes
Primary outcome [1] 291832 0
Chlamydia testing proportion: Numerator = total number of unique individuals aged 16 to 29 years who have had at least one test in the last 12 months. Denominator = total number of unique individuals who have had a consultation with a participating GP at least once in the last 12 months.
Timepoint [1] 291832 0
24 months
Secondary outcome [1] 307641 0
Acceptability of incentives and/or audit+feedback for chlamydia testing in general practice. This will be assessed by semi-structured interviews with GPs.
Timepoint [1] 307641 0
24 months

Eligibility
Key inclusion criteria
General Practitioners and Practice nurses who work in a general practice that has been participating in the intervention group of ACCEPt are eligible to participate.
ACCEPt is a cluster RCT of a chlamydia testing intervention. We propose to re-randomised intervention clinics at the conclusion of the trial to evaluate the importance of incentive payments and audit+feedback. The ACCEPt protocol has been accepted as a Lancet published protocol: Hocking JS, Low N, Guy R, Law M, Donovan B, Kaldor J, Temple-Smith M, Gunn J, Fairley CK. 12 PRT 09010: Australian Chlamydia Control Effectiveness Pilot (ACCEPt): a cluster randomised controlled trial of chlamydia testing in general practice (ACTRN1260000297022) Lancet protocol. Published May 2013.
ACCEPt has been registered on the ANZCTR - 1260000297022.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
When the ACCEPt trial is finished, practices in the intervention group will be invited by Research Officers to participate in ACCEPt-able. All General Practitioners and Practice nurses will be invited to participate. They will receive a presentation, plain language statement outlining the trial and will be encouraged to ask questions. They will be required to sign an consent form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation is a general practice and these will be randomised using a minimisation approach to ensure key variables are evenly distributed across 4 groups. These variables are testing rates, size of practice population and gender of GP. The trial statistician is located at a site away from the participating practices. Allocation of practice to 1 or the 4 groups is according to the computer-generated algorithm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis was by intention to treat at the patient level. The primary analyses investigated the effects of removal versus retention of incentive payments and of audit and feedback on chlamydia testing, exploiting the factorial study design (‘factorial analysis’). For each intervention, we fitted generalised linear models, using a generalised estimating equation approach to account for clustering at clinic level. This modelling approach is consistent with our analysis of the ACCEPt study. A logistic model provided the odds ratios and absolute differences were obtained from a model with an identify link function with binomial error distribution. These models also provided associated 95% confidence intervals and p-values. We also obtained the results of an adjusted model which included sex and age-group of the patient and socio-economic status quintile of the clinic. Our protocol did not explicitly state the reporting of absolute differences, but these are included as good reporting practice in addition to the planned odds ratios.

In addition to our pre-specified analyses, we undertook the following analyses: i) tested the assumption that there is no interaction effect between the two interventions before conducting the analyses per factorial design; ii) an analysis by randomised group whereby the group which retained audit and feedback and incentive payment was the control group (‘intervention group analysis’); iii) subgroup analyses based on the factorial study design by sex and age group (16–19 years vs 20–24 years vs 25–29 years) using interaction tests to explore intervention heterogeneity between the subgroups; iv) finally, we performed additional analyses i) and ii) for chlamydia test positivity. The output was generated during SAS software, Version 9.4 of the SAS System for Windows Version 6.1.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2014
Actual
14/07/2014
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
62
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 289245 0
Government body
Name [1] 289245 0
NHMRC
Country [1] 289245 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
3/207 Bouverie Street
Carlton 3053
Victoria
Country
Australia
Secondary sponsor category [1] 288025 0
None
Name [1] 288025 0
Address [1] 288025 0
Country [1] 288025 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291014 0
RACGP National Research and Evaluation Ethics Committee
Ethics committee address [1] 291014 0
Ethics committee country [1] 291014 0
Australia
Date submitted for ethics approval [1] 291014 0
12/03/2014
Approval date [1] 291014 0
07/04/2014
Ethics approval number [1] 291014 0
NREEC14-004

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

Contacts
Principal investigator
Name 47242 0
Prof Jane Hocking
Address 47242 0
Centre for Epidemiology and Biostatistics
University of Melbourne
3/207 Bouverie St
Carlton
Victoria 3053
Country 47242 0
Australia
Phone 47242 0
+61 3 8344 0762
Fax 47242 0
Email 47242 0
[email protected]
Contact person for public queries
Name 47243 0
Anna Wood
Address 47243 0
Centre for Epidemiology and Biostatistics
University of Melbourne
3/207 Bouverie St
Carlton
Victoria 3053
Country 47243 0
Australia
Phone 47243 0
+61 3 9035 4574
Fax 47243 0
Email 47243 0
[email protected]
Contact person for scientific queries
Name 47244 0
Jane Hocking
Address 47244 0
Centre for Epidemiology and Biostatistics
University of Melbourne
3/207 Bouverie St
Carlton
Victoria 3053
Country 47244 0
Australia
Phone 47244 0
+61 3 8344 0762
Fax 47244 0
Email 47244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient and GP consent for making medical records data available at the conclusion of the trial was not obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5569Study protocolCan preventive care activities in general practice be sustained when financial incentives and external audit plus feedback are removed? ACCEPt-able: a cluster randomised controlled trial protocol. Hocking JS1, Temple-Smith M2, van Driel M3, Law M4, Guy R4, Bulfone L5, Wood A6, Low N7, Donovan B4, Fairley CK8, Kaldor J, Gunn J. Implement Sci. 2016 Sep 13;11(1):122https://implementationscience.biomedcentral.com/articles/10.1186/s13012-016-0489-0 



Results publications and other study-related documents

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