Secure mental health pathways are complex. They are typically based around secure hospitals, but also interface with justice agencies and other clinical services, including in the community. Consideration of risk is fundamental to clinical care and to decisions relating to a patient’s stepwise journey through the pathway. Patient autonomy and involvement in decision-making are policy priorities for health services. However, improving collaboration in risk-related decisions in secure services is complicated by potential issues with insight and capacity and the necessary involvement of other agencies. In addition, although some collaborative approaches are feasible and effective, their impact, mechanisms and the contexts in which they work are not well understood. Therefore, using realist methodology, this review will outline what works, for whom, why and under what circumstances in terms of collaborative risk assessment and management in secure services.

The review will consist of four stages: (1) Development of an initial programme theory to explain how and why collaborative risk assessment and management works for different groups of people, (2) search for evidence, (3) data selection and extraction and (4) evidence synthesis and development of a final programme theory. Our initial programme theory will be informed by an informal search of the literature and consultation with experts and patient and public involvement and engagement representatives. Following this, our formal literature search will include both the published and unpublished literature. During full text screening, each document will be assessed according to the principles of rigour and relevance and, if included, data will be extracted and synthesised to refine the programme theory.

This protocol is for a review of published literature and so does not require ethical approval. The main output will be the final programme theory. Remaining gaps will inform planned future work to further refine the theory using mixed methods. Our dissemination strategy will be codeveloped with our public and patient involvement group and will include publishing findings in a peer-reviewed journal and presenting findings at relevant professional conferences, as well as engaging patient, carer and clinician groups directly.

The current diagnostic pathway for patients with a suspected inherited bleeding disorder is long, costly, resource intensive, emotionally draining for patients and often futile, as half of patients will remain without a diagnosis and be labelled ‘bleeding disorder of unknown cause’. Advances in understanding the genetic basis of the inherited bleeding disorders, coupled with both increasing infrastructure for genetic/genomic testing and decreasing costs, have increased the feasibility of introducing genomic testing into the clinical diagnostic pathway as a potential solution to improve the care of these patients. Yet, there remain evidence gaps on the optimal integration of genomic analysis into the diagnostic pathway.

Using a multicentre randomised-controlled trial design, we will evaluate an early genomic testing strategy for the diagnosis of newly referred patients with a suspected inherited bleeding disorder. Eligible participants will be randomised to early genomic testing diagnostic pathway (intervention) or standard diagnostic pathway (control) and will be followed for a 12-month period. Patients in the control group who remain undiagnosed at study end will be offered identical early genomic testing to ensure equitable access to the intervention. The study will follow a parallel fixed design with waitlist control group and a 1:1 allocation ratio. The study will be conducted at three tertiary care centres in Ontario, Canada, with a target sample size of 212 participants. Clinical utility will be evaluated via the primary outcome of diagnostic yield, as well as the secondary outcome of time to diagnosis. Additional secondary outcomes will allow for assessment of patient impact via health-related quality of life and patient burden measures, as well as evaluation of economic impact through a cost-effectiveness analysis and budget impact analysis.

This investigator-initiated study was approved by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board through Clinical Trials Ontario (CTO-4909). Participant informed consent/assent is required. Findings will be disseminated through academic publications.

ClinicalTrials.gov, NCT06736158.