Better Access to and Integration of Mental Health and Addiction Services Through Navigation: A Mixed-Methods Adaptive Pragmatic Clinical Trial

Background and Objectives: The Family Navigation Project (FNP) is navigation service for youth ages 11 to 29 with mental health and/or addictions (MHA) concerns and their family of choice. FNP is expanding to northern Ontario by setting up a new site in the Sudbury-Manitoulin region (including Sudbury, Greater Sudbury, and Manitoulin). Following the implementation of FNP in Sudbury-Manitoulin, the service will be evaluated through an adaptive pragmatic mixed-methods clinical trial, which will assess whether access to navigation support leads to improved outcomes and more efficient healthcare utilization for youth and families, specifically in terms of:

1. access to care (primary outcome),
2. appropriateness and continuity of care (primary outcome),
3. quality of life (primary outcome),
4. healthcare utilization (exploratory outcome), and
5. wellbeing (exploratory outcome).

Research Design: This project uses a community-based participatory research approach, ensuring that community members and local partners are actively involved in shaping the study's development, implementation, and interpretation. Embedded within this framework is an adaptive pragmatic clinical trial to assess whether access to navigation support leads to improved outcomes and more efficient healthcare utilization for youth and families. An adaptive design will allow for planned modifications in response to data being collected, which will lead to improved efficiency in the conduct of clinical trials. A pragmatic approach will allow for the evaluation of the effectiveness of navigation in routine clinical practice. Mixing methods to include a concurrent descriptive qualitative approach will allow for an exploration of youth and families' experiences in relation to the outcomes, to help elucidate their perceptions of particular aspects of the navigation process or self-navigation which led to observed outcomes. This is an open clinical trial with a quasi-experimental design (i.e., participants act as their own control). There is no control group or randomization, so that any youth/family in need of and seeking navigation will receive navigation, which was a stipulation made by local partners.

Participants: Participants will be those who meet the client criteria for FNP. That is, youth ages 11 to 29 experiencing a MHA concern and/or their family of choice, who reside in the geographical catchment area of Sudbury-Manitoulin.

Navigation Procedure: Potential clients can reach out to FNP via phone or email. FNP is a free service, with no diagnosis, referral, or OHIP/IFHP required. After reaching out to FNP, they will be contacted for an intake assessment, where a navigator will discuss what FNP is, determine eligibility, and gather preliminary information. Within two business days of completing intake, the client will be contacted by their assigned navigator. During the initial assessment with the navigator, the client (youth or caregiver/family of choice) will describe the youth's service history, social history, functioning, and family background. The navigator will then present the case to the navigation team, which involves other navigators and a psychiatrist. The team will generate a "navigation plan," including potential treatment and resource options for the youth and/or supports, coaching, counselling, and other services for the family. In almost all cases, the navigator will contact resources identified in the navigation plan to explain the clinical situation of the client and ensure appropriate fit. The navigator will present these options to the youth/family and address any questions or concerns they may have. If or when the youth/family decides to move forward with any options, the navigator will support them in making contact with services, compiling documentation, and letting them know what to expect. Navigators then check in with clients to learn whether the resource(s) was/were a good fit and if they are satisfied, or if they would like to explore other options. Clients may also be connected with peer support at FNP. FNP Sudbury-Manitoulin will employ one Youth Advocate with Lived Experience and one Caregiver Advocate with Lived Experience, who will draw on their lived experience to offer emotional support, validation, hope, and practical, real-world insights about services and systems to clients. Navigation can last anywhere from a few weeks to a few months, with an average length of stay of four months. Clients will be able to contact their navigator to re-engage with FNP services at any time, as long as they remain within the eligibility criteria.