Pilot of a novel co-produced supported and shared decision-making model relating to medication for early psychosis (Choices)

This study will be conducted at two headspace Early Psychosis program sites (Bentleigh and Narre Warren), which are governed by Bayside Health (Alfred Care Group) in Victoria, Australia. Participants will be young people, aged 12-25, who have been diagnosed with a psychotic disorder and are currently receiving mental health treatment at headspace. This is a cluster randomised pilot randomised controlled trial. This means that sites (not participants) will be randomised to the intervention groups. The aim of this study is to evaluate the acceptability, feasibility, and possible effectiveness of a supported and shared decision-making model related to decisions about medication in early psychosis care (i.e., the Choices model). Decisions may relate to commencing medication, changing medication (dose or type), and safely reducing or discontinuing medication. The Choices model will be compared to standard care (control). We will recruit 56 people into this study (i.e., 28 participants in each group). Participants in both groups will receive the 16 core components of the Australian early psychosis treatment model (EPPIC) as part of standard care. Participants in Choices will also have access to essential decision-support tools, such as patient decision aids, advance statements, nominated person forms, and structured frameworks for eliciting values and preferences (which are expected to be used less frequently in standard care). The Choices protocol will not dictate the exact type of treatment that young people will receive in their group. This will remain a clinical decision. However, there is an expectation that young people in Choices will receive treatment that is more closely aligned with shared/supported decision making principles (including access to specific decision-making tools) than participants in standard care (e.g., young people will be explained the benefits and harms of each treatment including not taking medication, they will know they can seek advice from trusted others to help them decide about treatment, they will know they can nominate another person to help them make decisions if they become unwell and be given options to do so, etc.). Clinicians who are based at the site allocated to Choices will receive training in shared/supported decision making prior to recruitment of the first participant, with the model to be supported by senior management at that site. We expect that most participants will attend headspace face-to-face every 1-2 weeks, but frequency of clinical contacts and the format (face-to-face vs telehealth) will remain a decision for the young person and their treating team. The Choices model will be delivered to participants over 12-months by their clinical team at headspace Early Psychosis during standard consultation sessions at headspace. Fidelity to the model will be evaluated throughout the trial using a study-specific fidelity tool. This trial will also explore the acceptability and feasibility of implementation strategies trialled in this study (e.g., proposed clinician training model) as well as facilitators and barriers to the delivery of Choices in the real-world as part of an exploratory implementation study. These objectives will be explored using a semi-structured qualitative interview with key stakeholders (e.g., young people, caregivers, clinicians, service leaders), which will be led by approved interview guides. Qualitative interviews will be audio-recorded and may take up to 90 minutes to complete. This component of the trial is optional and will involve a separate consent process.