The ORIENT study: Testing the effect of a nurse-led model of care in general practice on uptake of long-acting reversible contraception and access to medical abortion for women in rural and regional Australia

We will undertake a five-year pragmatic cluster randomised controlled trial with a stepped-wedge approach to assess the effect of a complex intervention comprising delivery of a nurse-led model of care (involving task-sharing, and where appropriate implant insertion by nurses and use of telehealth) in general practice for improving women’s uptake of long-acting reversible contraception (LARC) and access to medical abortion (MA) in rural and regional Australia. The delivery of this complex intervention will be supported by a set of implementation activities consisting of online education and clinical upskilling, educational outreach and participation in a digital community of practice (CoP). These activities will be made available to all participating practices; however, the start time will be staggered based on the intervention step to which the practices are randomly assigned to. Once practices enter the intervention phase, they will be invited to complete the clinical upskilling (activities 1-3) and educational outreach session (activity 4) within an eight-week period. Practices will be enrolled into the AusCAPPS CoP (activity 5) during this time. Engagement in the CoP will continue through to the end of the trial period. Intervention support activities: (1) Training in contraceptive implant insertion and removal: Practice nurses (PNs) and general practitioners (GPs) who have not previously undertaken implant training will participate in an online accredited implant insertion and removal training program. The training format will include an education (theory) component, the expected duration of which is 1.5 hours, and a separate simulation practice component of approximately 20 minutes. Participants will be encouraged to complete both components over four weeks. The theory component will be delivered as an interactive, self-paced online course consisting of four modules. The first module will introduce contraceptive options, including implants and considerations for contraceptive initiation. The second module will include features of the contraceptive implant, clinical assessment, side effects, contraindications and patient information provision to facilitate and support informed decision-making. The third module will include Implanon procedures such as positioning of the patient, insertion information, local anaesthetic administration, and removal procedures. The fourth module will include contraception resources, and a summary slide-set of content covered in the theory component. The simulation practice component will be delivered through a Zoom “virtual classroom”. In advance of this session, participants will receive a simulation equipment pack. During the session, participants will practice insertions and receive feedback from a credentialed clinical educator. The usual format is one trainer to one participant, or on occasion one trainer to two participants. This format provides a highly time efficient and individualised approach to simulation practice. The course is RACGP accredited for 4 Category 2 points, and participants will receive a certificate upon completion. (2) MS-2 Step prescriber training: GPs will complete the mandatory MS Health online medical abortion training to become certified prescribers of MS-2 Step, which is the composite pack containing the mifepristone-misoprostol combination regimen indicated for medical abortion. The layout of the training includes an introduction to the active ingredients in MS-2 Step (mifepristone and misoprostol), the mechanisms of action and history of use, and an overview of clinical literature. Participants are taken through the process of informed consent, patient eligibility, product administration, patient follow-up and aftercare, and management of complications. The training module also includes case studies to apply knowledge gained through participation in the module. Participants will be encouraged to complete the training over a four-week period. (3) Online education on LARC and medical abortion: PNs will complete online modules on LARC and medical abortion, developed by the Centre for Excellence in Rural Sexual Health (CERSH). The module on medical abortion will take approximately three hours to complete and includes identifying the elements required for setting up a rural medical abortion service system, and clinical pathways for service provision within the practice. The module also covers the barriers and enablers to establishing and managing medical abortion service delivery. The duration of the online module on LARCs is approximately three hours in length. The learning objectives include identifying patients best suited for LARCs, implementing a person-centred approach to patient education on how LARCs work, and the benefits and considerations of using LARC methods for contraception. Both modules have a set of reinforcing activities as the final learning component to apply key concepts covered in each module. Participants will be encouraged to complete both modules over a four-week period. Each module attracts 6 Category 2 points for RACGP and 4 ACRRM professional development program (PDP) points. (4) Academic detailing/educational outreach: Each participating practice will receive a single online educational outreach session lasting 60 minutes, modelled on the successful approach adopted by the National Prescribing Service (NPS) to encourage evidence-based practice. The hour-long session will be scheduled near the end of the eight-week intervention period once all clinical upskilling activities are completed. It will be co-facilitated by a NPS educational visitor, a GP opinion leader and a nurse opinion leader. The opinion leaders will be selected in advance based on their experience providing sexual and reproductive health services in primary care settings. NPS educational visitors will be responsible for running the session, including facilitating discussions amongst participants. The GP and nurse opinion leaders will offer peer-to-peer guidance on practical strategies for model implementation, drawing upon their experience providing sexual and reproductive healthcare services, specifically provision of implant and medical abortion services. This will include tailored advice to navigate and overcome logistical and clinical challenges that practices may anticipate in implementing the nurse-led model of care. At least two weeks prior to the delivery of each session, GP and nurse participants will each receive a pre-session pack containing: (1) a “detailing aid” with a customisable work plan to document how the model of care will be implemented in each practice, a summary billing options informational sheet and an infographic of the model of care for easy reference, and (2) a brief three-minute video introducing the nurse-led model of care and the steps involved for setting up and delivering LARC and medical abortion services using the model. The delivery of the educational outreach sessions will be guided by a handbook specifically designed by the ORIENT research team to provide (a) background evidence underpinning the model, (b) an overview of the content to be covered in session, (c) the key messages that will be delivered, (d) the nurse-led model and considerations for implementation and (e) information on the AusCAPPS community of practice. (5) Participation in an online Community of Practice: A national online Community of Practice (CoP) called the Australian Contraception and Abortion Primary Care Practitioner Support Network (hereafter referred to as AusCAPPS) has been developed under the guidance of partners from clinical professional groups and academia with interests in women’s sexual and reproductive health in primary care. AusCAPPS, hosted by Monash University, provides resources, training, and online clinical support for provision of LARC and medical abortion services. It contains interactive elements to inform, educate and support CoP members. These elements include: • A discussion forum where members interact with each other by posting and/or responding to clinical questions, sharing practice tips, relevant news or research articles that spark discussion. • Webinars and podcasts that take the form of instructional presentations, discussions and/or demonstrations that can be attended in real-time or viewed/listened to on-demand. • Case studies of clinical issues in the context of realistic patient encounters to solicit member input on clinical decision-making that also considers social, financial, and environmental factors pertaining to the specific case relevant to the diagnostic and treatment process. • A directory of members by state and the types of LARC and medical abortion services (e.g., MS-2Step prescriber or dispenser) that they provide, which will facilitate regional level peer networking and relationship-building across providers to support partnerships and referral pathways for improving delivery of LARC and medical abortion services • A resource library that serves as a repository of relevant resources and information such as clinical guidelines, patient consent forms, treatment checklists and procedures, patient informational booklets etc., to support delivery of LARC and medical abortion services. • Information on LARC and medical abortion training courses and modules for clinical upskilling The ORIENT research implementation team will facilitate the logistics of participation across the various implementation support activities and monitor and encourage completion of each component. Verification of training completion for implant, MS-2Step and CERSH LARC and medical abortion training will occur by participants providing a copy of their certificates of completion and/or by the implementation team liaising directly with the training providers. Participation in the educational outreach session will be recorded by the NPS co-facilitator.