Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001346561
Ethics application status
Approved
Date submitted
30/11/2015
Date registered
10/12/2015
Date last updated
21/10/2021
Date data sharing statement initially provided
5/12/2018
Date results provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of training general practitioners in structured contraceptive counselling for increasing use of long-acting reversible contraception (LARC): The Australian Contraceptive ChOice pRoject (ACCORd)
Scientific title
Training general practitioners to deliver ‘LARC First’ structured contraceptive counselling (LARC: Long-Acting Reversible Contraception) and implement rapid referral pathways for LARC insertion, compared with providing "usual care", to increase LARC insertions amongst 16-45 year old women.
Secondary ID [1] 286531 0
NHMRC ID: APP1081743
Universal Trial Number (UTN)
Nil
Trial acronym
ACCORd

(Increasing the use of long-acting reversible contraception: The Australian Contraceptive ChOice pRoject (ACCORd))
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-Acting Reversible Contraception (LARC) uptake 294759 0
Condition category
Condition code
Reproductive Health and Childbirth 295038 295038 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will occur over a duration of 10 months.

a. Training GPs: GPs in the intervention arm will complete a 6 hour interactive online training program about delivering structured contraceptive counselling with an emphasis on the effectiveness of LARCs. The training is an Australian adaption of materials from the 'LARC first' online training site of the successful US Contraceptive CHOICE study. Modules within the training program include:
* The problem of unintended pregnancies
* What are long-acting reversible contraceptives?
* Learn the advantages and disadvantages of available birth control options
* Learn how to expedite access to chosen contraceptive
* Long-acting reversible contraceptive insertion and removal
* Addressing patient and GP concerns
* Scenarios depicting the delivery of structured contraceptive counselling

The online training module will be available to GPs from March 2016 until December 2016. While it is recommended that GPs complete the training in one session. If required, GPs may pause their training and return to continue the program at a later time.
When a GP in the intervention group completes the online training he or she will receive face-to-face training from a project coordinator regarding enrolling patient participants in the study. Additional practice visits, email and telephone support will be available to GPs in the intervention arm, as requested by the GP.
To ensure fidelity of the counselling, random visits to GPs in the intervention arm will be conducted and all GPs will be asked to complete a checklist of items related to the counselling they have provided to participating women.

b. Facilitating rapid referral to LARC insertion: Rapid referral pathways to study specific LARC insertion clinics will be established for GPs in the intervention arm who do not undertake LARC insertions in their own rooms.
GPs will book online appointments for women to have a LARC insertion at a study-specific LARC insertion clinic provided in the rooms of local gynaecologists.
Women seeking contraception, or a change in contraceptive method, will be recruited to each arm – they will all be able to choose their preferred method of contraception.
Intervention code [1] 291622 0
Behaviour
Comparator / control treatment
Control arm comprises GPs who will provide usual care concerning contraceptive counselling and prescribing to women in this arm.
Control group
Active

Outcomes
Primary outcome [1] 294864 0
Number of LARCs inserted by participating GPs or specialists at study-specific LARC-insertion clinics. These are data that will be recorded by participating GPs and specialists using a standardized data collection form.
Timepoint [1] 294864 0
LARC insertion within 4 weeks of contraceptive counselling consultation,
Secondary outcome [1] 314075 0
Women’s choice of contraceptive method recorded by the GP or at LARC insertion clinic
Timepoint [1] 314075 0
LARC insertion within 4 weeks of contraceptive counselling consultation,
Secondary outcome [2] 314076 0
Women’s Quality of Life as measured by the SF-36
Timepoint [2] 314076 0
(a) at baseline, (b) 6 months after the first GP consultation and (c) at 12 months after the first GP consultation (d) at 36 months after the first GP consultation.
Secondary outcome [3] 314077 0
Cost effectiveness – direct costs i.e. medical services and pharmaceutical products (contraceptive) as measured by Medicare (MBS and PBS) record; indirect costs i.e. travel time and time away from work as measure by patient reporting (survey).

The patient survey is adapted for this study from the US Contraceptive CHOICE Project. Secura GM, Allsworth JE, Madden T, et al. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol 2010;203:115.e1-7.
Timepoint [3] 314077 0
12 months after the first GP consultation.
Secondary outcome [4] 354670 0
LARC use at 6 months, as noted in either the Standardised Data Collection Form (SDCF) from the GP or in the participant six month survey, if SDCF form unavailable.
Timepoint [4] 354670 0
This outcome was in the original protocol as 'Contraception use at 6 & 12 months' and clarified further, specifically 'LARC use at 6 months', six months after recruitment commenced 17/12/16
Secondary outcome [5] 354671 0
LARC use at 12 months as noted in either the Standardised Data Collection Form (SDCF) from the GP or in the participant six month survey, if SDCF form unavailable.
Timepoint [5] 354671 0
12 months after enrolment
Secondary outcome [6] 371264 0
Contraceptive continuation rates at 36 months, as noted in the participant 36 month survey
Timepoint [6] 371264 0
36 months after enrolment

Eligibility
Key inclusion criteria
GP’s: eligible if they work three or more sessions per week, are based at a computerised practice in Melbourne, Australia, and have a receptionist who can assist with the recruitment of women.

Women: eligible if they are aged between 16 - 45 years, have been sexually active with a male partner in the past six months or anticipate sexual activity in the next six months, have not undergone a tubal ligation or hysterectomy, have partner(s) who have not undergone a vasectomy, are not pregnant or have no desire to become pregnant in the next year, are not currently using a contraceptive method or are interested in starting a new, reversible contraceptive method, are proficient in English and are registered with Medicare.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP’s: participation is restricted to one GP per practice.

Women: excluded if aged <16 years or >45 years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individual GPs will be the unit of randomisation.

After recruitment each GP will be randomly allocated to one of two arms: (1) intervention arm and be trained to deliver ‘LARC First’ structured contraceptive counselling and have access to rapid referral pathways, or (2) control arm and deliver usual contraceptive care.

A statistician not directly involved with the recruiting process, and blinded to the identity of the GPs, will generate and hold a randomization list. As each GP is recruited, the statistician will be notified and they will allocate the GP to the intervention or control arm according to the next spot on the randomization list.

Women who are patients of participating GPs, and who visit the participating GP during the study enrolment period, will be recruited for each arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using permuted blocks stratified by whether or not the GP inserts LARCs (IUDs or implants). The computer program Rand.exe (ref: S Piantadosi. Clinical Trials: A Methodologic Perspective) will be used to generate the randomization sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial requires 24 GPs and 14 women per GP in each of the two study arms (intervention and control) to detect a change in the LARC insertion rate from 10% to 20%, with 80% power and a significance level of 5%. This will allow for the stratification by whether or not the GP inserts LARCs (IUD or Implants) and a clustering effect (intra-cluster correlation (ICC)) of 0.05. Accordingly, the study will attempt to recruit 27 GPs and 27 women per GP in each of the two study arms to allow for up to a 10% drop-out among GPs (based on researcher experience) and a 5% drop-out among women. A low drop-out rate among the women has been assumed because the primary outcome (i.e. LARC insertion) will be scheduled soon after the consultation, and the data for this outcome will be derived from GP and clinic records rather than through participant follow up.
The Chi-square test adjusted for clustering will be used for the primary analysis (to compare the proportion of women who have had a LARC inserted) and the binary secondary outcomes. Exploratory analyses of possible mediating variables will be carried out using binary regression models with generalised estimating equations and robust standard errors to account for clustering.
The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis. The economic evaluation will utilise a trial-based analysis followed by the construction of a decision model to extrapolate future costs and benefits beyond the completion of the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2016
Actual
28/04/2016
Date of last participant enrolment
Anticipated
5/06/2017
Actual
14/07/2017
Date of last data collection
Anticipated
30/07/2020
Actual
1/08/2018
Sample size
Target
672
Accrual to date
Final
740
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291091 0
Government body
Name [1] 291091 0
National Health and Medical Research Council
Country [1] 291091 0
Australia
Primary sponsor type
Individual
Name
Professor Danielle Mazza
Address
Department of General Practice
School of Primary Health Care
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill, Victoria 3168
Country
Australia
Secondary sponsor category [1] 289843 0
Individual
Name [1] 289843 0
Associate Professor Kirsten Black
Address [1] 289843 0
Discipline of Obstetrics, Gynaecology & Neonatology
Sydney Medical School
Edward Ford Building A27
The University of Sydney, NSW 2006
Country [1] 289843 0
Australia
Secondary sponsor category [2] 291183 0
Individual
Name [2] 291183 0
Professor Angela Taft
Address [2] 291183 0
Judith Lumley Centre
School of Nursing and Midwifery
College of Science, Health and Engineering
La Trobe University
215 Franklin Street, Melbourne
Vic 3000
Country [2] 291183 0
Australia
Other collaborator category [1] 278713 0
Individual
Name [1] 278713 0
Professor Jayne Lucke
Address [1] 278713 0
Australian Research Centre in Sex, Health and Society
School of Psychology and Public Health
College of Science, Health and Engineering
La Trobe University
215 Franklin Street, Melbourne
Vic 3000
Country [1] 278713 0
Australia
Other collaborator category [2] 278714 0
Individual
Name [2] 278714 0
Doctor Kevin McGeechan
Address [2] 278714 0
School of Public Health
Sydney Medical School
Edward Ford Building A27
The University of Sydney,
NSW 2006
Country [2] 278714 0
Australia
Other collaborator category [3] 278715 0
Individual
Name [3] 278715 0
Professor Marion Haas
Address [3] 278715 0
Centre for Health Economics Research and Evaluation
University of Technology Sydney
PO Box 123 Broadway,
NSW 2007
Country [3] 278715 0
Australia
Other collaborator category [4] 278716 0
Individual
Name [4] 278716 0
Professor Jeffrey Peipert
Address [4] 278716 0
Indiana University School of Medicine, Department of Obstetrics & Gynecology, 550 N. University Blvd., UH 2440, Indianapolis, IN 46202
Country [4] 278716 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292673 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 292673 0
Ethics committee country [1] 292673 0
Australia
Date submitted for ethics approval [1] 292673 0
Approval date [1] 292673 0
12/01/2015
Ethics approval number [1] 292673 0
CF14/3990 - 2014002066

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

Contacts
Principal investigator
Name 56542 0
Prof Danielle Mazza
Address 56542 0
Department of General Practice
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 56542 0
Australia
Phone 56542 0
+61 3 99024496
Fax 56542 0
Email 56542 0
[email protected]
Contact person for public queries
Name 56543 0
Danielle Mazza
Address 56543 0
Department of General Practice
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 56543 0
Australia
Phone 56543 0
+61 3 99024496
Fax 56543 0
Email 56543 0
[email protected]
Contact person for scientific queries
Name 56544 0
Danielle Mazza
Address 56544 0
Department of General Practice
School of Primary Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 56544 0
Australia
Phone 56544 0
+61 3 99024496
Fax 56544 0
Email 56544 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
Ethics approval did not include sharing participant data with external parties


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIIncreasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial protocol2016https://doi.org/10.1136/bmjopen-2016-012491
EmbaseIncreasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-035895
EmbaseCurrent contraceptive use in women with a history of unintended pregnancies: Insights from the Australian Contraceptive ChOice pRoject (ACCORd) trial.2021https://dx.doi.org/10.31128/AJGP-06-20-5464
EmbaseInfluences on condom use: A secondary analysis of women's perceptions from the Australian Contraceptive ChOice pRoject (ACCORd) trial.2021https://dx.doi.org/10.31128/AJGP-06-20-5489
Dimensions AIWomen’s satisfaction with and ongoing use of hormonal long-acting methods compared to the oral contraceptive pill: Findings from an Australian general practice cluster randomised trial (ACCORd)2021https://doi.org/10.1111/ajo.13319
N.B. These documents automatically identified may not have been verified by the study sponsor.