Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000655741
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
4/05/2022
Date last updated
4/05/2022
Date data sharing statement initially provided
4/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The AusCAPPS Network: A community of practice to support the provision of long acting reversible contraception and medical termination of pregnancy in primary care
Scientific title
AusCAPPS: The Australian Contraception and Abortion Primary Care Practitioner Support Network
Secondary ID [1] 306912 0
Nil Known
Universal Trial Number (UTN)
U1111-1265-5758
Trial acronym
AusCAPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual and reproductive health 326017 0
abortion 326018 0
contraception 326019 0
Condition category
Condition code
Public Health 323324 323324 0 0
Health service research
Reproductive Health and Childbirth 323325 323325 0 0
Abortion
Reproductive Health and Childbirth 323326 323326 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name
The AusCAPPS (The Australian Contraception and Abortion Primary Care Practitioner Support Network)
Why
Long-acting reversible contraception (LARC) utilisation rates by Australian women remains very low, despite guidelines recommending increased use (Richters et al 2016). General practitioners (GPs) and women continue to preference the oral contraceptive pill and there has been little utilisation of practice nurses and pharmacists to promote LARC uptake. In addition, expanding the numbers of primary care practitioners willing to provide early medical abortion (EMA) (using mifepristone followed by misoprostol to end an early pregnancy up to 9 weeks), which is a more accessible and less invasive option than surgical termination that can be provided in primary care settings, has proven challenging. Very few GPs provide these services (Black et al 2017) and there remains great inequity in access to EMA, particularly for young and rural and remote women (Shankar et al 2017).
AusCAPPS will empower the primary care workforce to deliver best practice, evidence-based care to women of reproductive age who are trying to prevent or manage an unintended pregnancy. This project will increase the availability of LARC methods (i.e. intrauterine devices (IUDs) and implants) and access to safe, affordable EMA, including for women from the most vulnerable populations.
What
The AusCAPPS community of practice is an online network designed to connect and develop skills of GPs, PNs and CPs in LARC and EMA. Whilst the overall project will run for 3.5years, participant evaluation will be undertaken following 2 years engagement in the site.

Modelled on a successful Canadian online community of practice (the Canadian Abortion Providers Support-Communauté de pratique canadienne sur l’avortement)(CAPS_CPCA), the AusCAPPS community of practice will provide support for health professionals by helping them create networks and implement new models of care. CAPS-CPCA is an interactive online community of practice for health professionals who are interested in providing EMA. AusCAPPS was designed by the project team in conjunction with primary care and sexual health stakeholders, through a knowledge exchange workshop held in February 2021. Linking LARC and EMA together in AusCAPPS made sense as the provision of these services and the need for them are often linked, and resources supporting LARC and EMA are currently dispersed across numerous providers, making it difficult for busy practitioners to locate and identify them. Partners emphasised that making AusCAPPS specific to the issues of LARC and EMA would emphasise the importance of these issues, make AusCAPPS easily identifiable, and ensure that AusCAPPS provided focused attention to this area of real need.

Who provided
All CIs and AIs are investigators in the SPHERE CRE and, together, have a strong history of collaboration in women's sexual and reproductive health research over many years and have made significant contributions to clinical practice, advocacy, translation into practice and policy, and guideline development and implementation.
CI Mazza has an outstanding track record of leading and delivering large collaborative projects with national and international partners and is an international leader in women's health in primary care and knowledge translation. She is CIA of the SPHERE CRE, a CI on two NHMRC trials and leads the general practice arms of two other NHMRC CREs and one NHMRC Dementia Team Research Grant. She has led or contributed to many GP guidelines and represents her discipline as a GP and women's health implementation expert on government and non- government committees.
CI Norman, Canada's Chair of Family Planning Public Health Research brings her international networks and experience and skills in knowledge translation gained from her community of practice on EMA that resulted in policy changes and increased access to EMA.
CI Black chairs RANZCOG's special interest group in sexual and reproductive health that sets national training standards in contraception and abortion. She brings extensive clinical, research and policy expertise to the project.
CI Taft is a leading Australian translational researcher in the areas of unplanned pregnancy, reproductive rights and domestic violence and has led national, competitively-funded studies in primary care and emergency contraception.
CI Bateson, Medical Director at Family Planning NSW, is a key national opinion leader in contraception and abortion who is actively involved in research and guideline and policy development.
CI McGeechan is a highly experienced biostatistician and is actively involved in many women's health research projects.
AI Goldstone, Medical Director at Marie Stopes Australia, has devoted his clinical career to the provision of pregnancy termination and contraceptive services, including the establishment of EMA in Australia.
AI Tomnay is Director of the Centre for Excellence in Rural Sexual Health, which designs, implements, and evaluates programs aimed at improving sexual and reproductive health services in rural Victoria. She brings expertise in nurse-led models of care for EMA in rural primary care.
How
AusCAPPS is a multidisciplinary online platform created to support practice in LARC and EMA. Our nationally-focused project targets all practicing GPs, PNs and CPs working in metropolitan, regional and rural settings and amongst marginalised populations (including migrant and Aboriginal and Torres Strait Islander groups).

When and How Much
Participation in AusCAPPS will be based on practitioner availability therefore we cannot forecast participant engagement in AusCAPPS nor have requirements/expectations around this. However, a robust engagement plan has been developed to both track and follow up with practitioners on their engagement in AusCAPPS and keep them interested. AusCAPPS was launnched July 2021 and is actively recruiting participants until July 2022. However, the intervention’s duration will be until 2023.

Tailoring
Based on a practitioner needs analysis, a range of existing international and national patient and practitioner resources will be housed on the site. In addition, engagement and learning activities will be developed on AusCAPPS based on the needs analysis and input from experts in the field. These will include:
• Case studies, quizzes, practice tips
• Discussion of practice service set up advice and models of best practice
• “Ask the expert” questions and answers
• Regional level networking
• Ability to assist General Practitioners (GPs) and Practice Nurses (PNs) to identify community pharmacists (CPs) who they can partner with to improve access to LARC and EMA
• Regular emails/newsletters with items of interest
• Webinars and podcasts
• Polls that will posted from time to time asking the community for their views on what content is the most useful, what aspects of the platform are the most informative, and how AusCAPPS could be improved.
Content on AusCAPPS will be reviewed by an expert advisory group and clinical experts will moderate the online content over the intervention period. Resources on AusCAPPS will be reviewed and updated frequently to make sure AusCAPPS material is current.
Intervention code [1] 323362 0
Treatment: Other
Comparator / control treatment
MBS and PBS data from GPs and eligible nurses from Services Australia for the year before participation in AusCAPPS will be compared to data from the year after participation in AusCAPPS. For example, data from August 2020 would be collected if enrolment in AusCAPPS occurred in August 2021.
Control group
Historical

Outcomes
Primary outcome [1] 331064 0
Women's access to LARC and EMA services in primary care through an online community of practice (AusCAPPS). This will be assessed through:
- Baseline and endline surveys of 500 GPs, 500 practice nurses and 500 pharmacists in the general community to assess knowledge, attitudes and practices in LARC and EMA service provision. These surveys are based on those previously used by the ACCORd study.
Timepoint [1] 331064 0
We will assess the primary outcomes at 24-months following the launch of AusCAPPS.
Secondary outcome [1] 408613 0
The number of GPs certified to prescribe EMA as measured by data from MSHealth on current numbers of GPs registered to prescribe EMA.
Timepoint [1] 408613 0
12 months pre- to 12 months post-intervention
Secondary outcome [2] 408614 0
The number of pharmacists certified to dispense MS-2-Step measured by data from MSHealth on current numbers of pharmacists registered to dispense MS-2-Step.
Timepoint [2] 408614 0
12 months pre- to 12 months post-intervention
Secondary outcome [3] 408615 0
The rates of prescription of intrauterine devices (IUDs), implants and MS-2-Step as measured by aggregated data from Medicare on PBS dispensed prescriptions for Implanon (item no: 8487Q), Mirena (item no: 8633J) (Copper IUDs are not currently available on the PBS) and Mifepristone (MS-2-Step) (item no: 10211K) and MBS-funded LARC insertions (Implanon (item 14206) and IUD (item 35503)) within GPs participating in AusCAPPS.
Timepoint [3] 408615 0
12 months pre- to 12 months post-intervention
Secondary outcome [4] 409106 0
Women's access to LARC and EMA services in primary care through an online community of practice (AusCAPPS). This will be assessed through audio-recorded, structured one-on-one post-intervention interviews with GPs, PNs and CPs. New perspectives and concepts gained through participation; implementation of advice, solutions, insights and innovations; whether AusCAPPS facilitated new collaborative arrangements and professional connections; and use of new tools and documents to inform practice will be assessed. The interview tool will be developed for the purpose of the study.
Timepoint [4] 409106 0
We will assess outcomes 24 months following the launch of AusCAPPS.
Secondary outcome [5] 409285 0
Women's access to LARC and EMA services in primary care through an online community of practice (AusCAPPS). This will be assessed through audio-recorded, structured one-on-one interviews with the research team. Namely:.
• Post-intervention interviews with project staff and partner investigators to identify the barriers and enablers to establishing and delivering AusCAPPS. The interview tool will be developed for the purpose of the study.
Timepoint [5] 409285 0
We will assess outcomes 24 months following the launch of AusCAPPS.
Secondary outcome [6] 409303 0
Women's access to LARC and EMA services in primary care through an online community of practice (AusCAPPS). This will be assessed through:

- Registration data collected when participants sign up to AusCAPPS to gauge the number of participants, their geographic location as well and other, demographic characteristics.
Timepoint [6] 409303 0
We will assess outcomes at 24-months following the launch of AusCAPPS
Secondary outcome [7] 409304 0
Women's access to LARC and EMA services in primary care through an online community of practice (AusCAPPS). This will be assessed through:
- Google analytics of participant website activity.
Timepoint [7] 409304 0
We will assess outcomes 24 months following the launch of AusCAPPS

Eligibility
Key inclusion criteria
GPs, PNs, and CPs who are registered with the Australian Health Practitioner Regulation Agency (AHPRA) and working in primary care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Family planning services provided outside of the general practice or community pharmacy setting.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA - not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA – not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Historical data comprises of:
-Baseline KAP survey responses
-MBS/PBS data in the year prior to enrolment in AusCAPPS
-MS Health data on numbers of prescribers and dispensers of EMA prior to AusCAPPS launch
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will conduct analysis using the Realist Evaluation model5 involving quantitative and qualitative methods to establish, implement and evaluate AusCAPPS. A baseline and endline knowledge, attitudes and practices survey will also be conducted nationally. This will identity changes that occur during the intervention.
Consenting AusCAPPS participant posts will be used to analyse various aspects of the site, including patterns of use, content, effectiveness and innovations.
We will compare the rate of LARC and EMA provision in consenting GPs participating in AusCAPPS in the year before and in the year after registration using Poisson regression. We will also assess whether there is a difference in the impact by gender or location of participant. Data will be analysed separately for GPs (PBS and MBS items), and where available nurses (PBS items), providing objective measures of the impact of the intervention on individual practice.

We will compare the current numbers of GPs registered to prescribe and pharmacists registered to dispense EMA to that of one-year prior to AusCAPPS implementation.

We will recruit a minimum of 500 each of GPs, pharmacists and PNs for the baseline and endline knowledge, attitudes and practice surveys. This will allow us to estimate the proportion with key characteristics (currently provide, adequate knowledge of and positive attitudes towards LARCs/EMA) in each professional group with a precision of ±5%. Data from KAP surveys will be summarised for each professional group using counts and proportions, or means and standard deviations where appropriate. We will also use logistic and linear regression models to explore the factors associated with knowledge, attitudes and practice.

Thematic analysis of telephone interviews of 20 GPs, 20 PNs and 20 CPs will be conducted to gain feedback on their experience participating in AusCAPPS. Interviews with project staff and partner investigators will also be conducted to identify the barriers and enablers to establishing and delivering AusCAPPS.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/07/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
20/07/2024
Actual
Sample size
Target
3000
Accrual to date
738
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311223 0
Government body
Name [1] 311223 0
NHMRC
Country [1] 311223 0
Australia
Funding source category [2] 311226 0
Commercial sector/Industry
Name [2] 311226 0
Sexual Health Victoria
Country [2] 311226 0
Australia
Funding source category [3] 311227 0
Commercial sector/Industry
Name [3] 311227 0
Bayer
Country [3] 311227 0
Australia
Funding source category [4] 311228 0
Commercial sector/Industry
Name [4] 311228 0
RACGP
Country [4] 311228 0
Australia
Funding source category [5] 311229 0
Commercial sector/Industry
Name [5] 311229 0
RANZCOG
Country [5] 311229 0
Australia
Funding source category [6] 311230 0
Commercial sector/Industry
Name [6] 311230 0
APNA
Country [6] 311230 0
Australia
Funding source category [7] 311231 0
Commercial sector/Industry
Name [7] 311231 0
SHQ
Country [7] 311231 0
Australia
Funding source category [8] 311232 0
Commercial sector/Industry
Name [8] 311232 0
AWHNA
Country [8] 311232 0
Australia
Funding source category [9] 311233 0
Commercial sector/Industry
Name [9] 311233 0
ASHNNA
Country [9] 311233 0
Australia
Funding source category [10] 311234 0
Commercial sector/Industry
Name [10] 311234 0
Organon
Country [10] 311234 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Department of General Practice, 1/270, Ferntree Gully Road, Notting Hill, VIC 3168
Country
Australia
Secondary sponsor category [1] 312593 0
None
Name [1] 312593 0
Address [1] 312593 0
Country [1] 312593 0
Other collaborator category [1] 282249 0
University
Name [1] 282249 0
University of British Columbia
Address [1] 282249 0
Suite 930, 1125 Howe Street, Vancouver, BC Canada V6Z 2K8
Country [1] 282249 0
Canada
Other collaborator category [2] 282252 0
University
Name [2] 282252 0
La Trobe University
Address [2] 282252 0
Level 3, George Singer Building, Bundoora, VIC, 3086
Country [2] 282252 0
Australia
Other collaborator category [3] 282253 0
University
Name [3] 282253 0
The Sydney University
Address [3] 282253 0
Johns Hopkins Dr, Camperdown NSW 2050
Country [3] 282253 0
Australia
Other collaborator category [4] 282254 0
University
Name [4] 282254 0
Centre for Excellence in Rural Sexual Health (CERSH), University of Melbourne
Address [4] 282254 0
696, University of Melbourne, Shepparton Campus, 49 Graham St, Shepparton VIC 3630
Country [4] 282254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310750 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310750 0
Monash Graduate Research Office, 26 Sports Walk, Clayton VIC 3168
Ethics committee country [1] 310750 0
Australia
Date submitted for ethics approval [1] 310750 0
Approval date [1] 310750 0
21/04/2021
Ethics approval number [1] 310750 0

Summary
Brief summary
This project seeks to enhance women’s access to primary care provision of LARC and EMA by addressing healthcare practitioner barriers and integrating these aspects of reproductive health into locally-available, community-based services. Lack of familiarity with LARC among health professionals and misperceptions about their use (e.g. many GPs falsely believe that IUDs are contraindicated in nulliparous women) have a profound effect on the advice given to women and limit women’s options. Lack of education and training for GPs and other health professionals and lack of follow-up support after training (e.g. supervision, mentoring) are also real issues. Further to this, integration of EMA into general practice has recognised barriers – some GPs feel EMA is beyond their scope of practice or that they would be stigmatised. Many feel isolated and speak of the need for peer support and referral pathways to assist them.
It is anticipated with this intervention that primary care clinicians will benefit from the increased support and education, enhanced teamwork and networking with colleagues in the community, and connection to services and service providers to help women achieve their reproductive goals.
Trial website
https://www.spherecre.org/the-auscapps-project
Trial related presentations / publications
Public notes
Our partners will participate on the project Steering Group and Intervention Advisory Group. Their ongoing involvement in the design and roll out of the intervention will assist us in developing an intervention that is ultimately scalable.

In addition, we will hold two major events: a knowledge translation workshop at the start of AusCAPPS and a stakeholder forum in the final 6 months that will bring together our partners, other key stakeholders, consumers, and policymakers from state and federal governments to review and disseminate the outcomes from the project. A key focus of the forum will be the development of a detailed plan agreed upon by all partners for the future sustainability of AusCAPPS.

Contacts
Principal investigator
Name 118734 0
Prof Danielle Mazza
Address 118734 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 118734 0
Australia
Phone 118734 0
+610399024512
Fax 118734 0
Email 118734 0
danielle.mazza@monash.edu
Contact person for public queries
Name 118735 0
Prof Danielle Mazza
Address 118735 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 118735 0
Australia
Phone 118735 0
+610399024512
Fax 118735 0
Email 118735 0
danielle.mazza@monash.edu
Contact person for scientific queries
Name 118736 0
Prof Danielle Mazza
Address 118736 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 118736 0
Australia
Phone 118736 0
+610399024512
Fax 118736 0
Email 118736 0
danielle.mazza@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the research, individual participant data will not be publicly available. Ethics approval did not include sharing participant data with external parties.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15751Ethical approval    383919-(Uploaded-12-04-2022-13-41-37)-Study-related document.pdf



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 availability of long-acting reversible contraception and medical abortion in primary care: the Australian Contraception and Abortion Primary Care Practitioner Support Network (AusCAPPS) cohort study protocol2022https://doi.org/10.1136/bmjopen-2022-065583
N.B. These documents automatically identified may not have been verified by the study sponsor.