The COVID-19 pandemic is expected to have a disproportionate burden on people with psychosis related to anticipated adverse physical and mental health consequences, compounded by barriers to accessing quality care [1-6]. Psychosis, characterized by delusions, hallucinations, disorganization, and negative symptoms, typically occurs during adolescence or early adulthood, an age at which the pandemic may be particularly detrimental for mental health [7,8]. Early, time-limited, team-based comprehensive treatment in the form of early psychosis intervention (EPI) has become the standard of care for youth with psychosis, with demonstrated evidence of superior outcomes including reduced mortality, improved access to psychiatric care, reduced risk of relapse, fewer hospital readmissions, and increased employment rates [9-13]. There is additional evidence that a manualized package of EPI services called NAVIGATE results in improved functional outcomes relative to usual care [14]. NAVIGATE is a form of coordinated specialty care developed for early-phase psychosis that has shown greater improvement in symptoms, social functioning, and engagement in educational and vocational training compared to usual care [14-16]. EPI programs were designed to deliver care in person, emphasizing frequent contacts and community outreach. Amid the COVID-19 pandemic, EPI programs have had to transition to virtual delivery to adhere to public health physical distancing measures; however, with little prior knowledge about the effectiveness of virtual delivery of EPI care [17-20].

Virtual mental health care is generally defined as mental health care delivered via any form of information and communication technology, such as the telephone, the internet, teleconferencing, or SMS text messaging [21]. In the past, virtual care has been commonly utilized to improve access to health care, especially in underserved and remote areas [22]. There is a robust literature on the effectiveness of telehealth for mental disorders, although most of this research has focused on anxiety and mood disorders [21,23]. Regarding telehealth interventions for people with schizophrenia, a review in 2014 [24] yielded initial promising results in the limited number of studies that utilized telehealth technology at that time. A recent scoping review on videoconferencing with people with schizophrenia [20] showed that implementation was feasible and acceptance was high, but noted a lack of studies on videoconferencing interventions for individuals at clinical high risk or at the early stages of psychosis. Studies of youth with psychosis suggest that they have favorable attitudes toward videoconferencing [25] and receiving mental health information on the internet [26]. Additionally, most youth have access to smartphones or other devices with a webcam [25], suggesting that virtual care is likely to be acceptable and feasible for youth with psychosis. Barriers to implementation of virtual mental health services in general include acceptance by clinicians and clients, technology, organizational/regulatory policies, and funding to support virtual care [23]. Furthermore, digital literacy and access to technology (internet and devices), as well as the availability of private space to receive services in this manner may present barriers to specific populations and have the potential to increase health disparities [27]. Psychotic symptoms may pose further barriers to client acceptance of videoconferencing [20].

The COVID-19 pandemic compelled many mental health services to rapidly transition to virtual care [28,29]. Understanding what adaptations to the intervention are needed and how they occur over time is a vital aspect of their effective implementation because the core components of the intervention must be retained for effectiveness [30]. Adaptations that focus on improving interventions fit with the target population can lead to improved engagement and acceptability, particularly when working with diverse populations [31-33]. However, modifications that alter or remove core components of an intervention, or fail to align with population needs may impact effectiveness and be less sustainable [30]. We propose exploring the adaptations required to deliver NAVIGATE virtually and to evaluate the implementation effectiveness of virtual delivery of NAVIGATE.

The objectives of this study are as follows:

We propose a pragmatic mixed methods implementation and evaluation study, with a focus on adaptations needed for the implementation of virtual NAVIGATE care and evaluation of the implementation. Virtual delivery of NAVIGATE started in March 2020 with additional adaptations and ongoing data collection. The StaRI (Standards for Reporting Implementation Studies) Statement and Checklist is used as a standard for describing the implementation strategy and intervention (Multimedia Appendix 1) [34].

The Centre for Addiction and Mental Health (CAMH) in Toronto, Ontario, is home to the largest EPI program in Canada, providing assessment and ongoing services to people aged 16-29 years with any mental health disorder that can manifest as early psychosis (schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, or unspecified psychotic disorder) [35]. Located in downtown Toronto, the EPI program is staffed by approximately 40 clinicians and assesses over 600 new clients annually. The CAMH EPI program implemented NAVIGATE in late 2017 and is currently the coordinating center for a multisite implementation effectiveness study of NAVIGATE in diverse EPI programs across the province of Ontario (Early Psychosis Intervention-Spreading Evidence-based Treatment or “EPI-SET,” trial registration number: NCT03919760) [36].

Of importance, CAMH has a dedicated Virtual Mental Health and Outreach Team. Previously, this service primarily supported telepsychiatry to clients in remote and rural areas; however, during the COVID-19 pandemic, they have supported other CAMH programs to deliver care virtually, including the EPI service. Throughout the pandemic, the bulk of EPI care has transitioned to virtual delivery, although a small number of clients have continued to access some CAMH EPI services in person; these are mainly clients who are receiving intramuscular injections, have increased symptoms, or are in a crisis and may require a hospital admission, who are at risk of disengaging, who do not have access to the technology needed for virtual care, or for whom adequate assessment is not feasible remotely. Staff have been rotating onsite approximately 1-2 days per week to ensure a small continuous onsite presence and otherwise working remotely from home.

NAVIGATE is a highly structured model of coordinated specialty care with clearly defined roles for staff. The original model is described with four core services: individual resiliency training (IRT), supported employment and education (SEE), family education program, and individualized medication management [16]. For our context, we distilled additional core components that are fundamental to the NAVIGATE program, including the following: a team leader who facilitates monitoring, practice feedback and training, and caseloads small enough to allow for the intensity and frequency of required contact. In addition to these core components of NAVIGATE, CAMH’s EPI program also incorporates peer support. Manualized protocols are used to operationalize current EPI standards, and all clients are systematically offered all treatment components, with regular team reviews to assess client progress, fidelity, and need for adjustments. The core components of NAVIGATE are described in Figure 1.

In March 2020, clinicians at CAMH rapidly transitioned to delivering NAVIGATE virtually using videoconferencing and telephone calls. Over time, clinicians have supplemented NAVIGATE delivery with group videoconferencing, interactive worksheets, and web-based videos prepared collaboratively with CAMH Education Services. This conversion to primarily virtual care delivery has been supported by policies and processes established by CAMH Virtual Mental Health, including client tools, training videos, podcasts, and a Digital Mental Health Certificate Program [37,38]. These early NAVIGATE adaptations are described in Table 1.

The implementation evaluation plan for this study is described in Table 2. By engaging youth and family members with lived experience in accordance with current best practices [39-41], as well as frontline clinicians, administrators, and a policy maker, we aim to continue to adapt and refine the virtual delivery of NAVIGATE in a facilitated, stepwise process and to describe the nature of these adaptations using the Framework for Reporting Adaptations and Modifications for Evidence-Based Interventions (FRAME) [42]. We will explore to what extent virtual delivery of NAVIGATE retains its core components and describe adaptations in how the core components are delivered. We will also consider whether additional core components are warranted to specifically support virtual delivery of this model. We will explore implementation barriers and facilitators to virtual delivery using the Consolidated Framework for Implementation Research (CFIR) [43,44]. This approach will allow us to adjust our implementation approach in accordance with feedback and clinical outcomes [45,46].

Integration of qualitative and quantitative data will occur at the data collection, interpretation, and reporting level with a convergent design [62]. Qualitative and quantitative data collection occurs iteratively, with recurrent linking at multiple points for each of the evaluation objectives. For example, the fidelity assessment integrates findings from both reviews of medical records and individual interviews. Additionally, early quantitative results from the VCES on satisfaction with virtually delivered NAVIGATE will be used to guide adaptations of the client and family qualitative interviews, probing emergent quantitative findings. Similarly, findings from the qualitative interviews on service engagement may highlight the need for additional variables to be extracted in the reviews of medical records. Data sources will be woven together at the interpretation and reporting level through narrative integration and joint display methods [62]. We will explore coherence of the quantitative and qualitative findings by reporting on “fit” of data integration [62].

The onset of the COVID-19 pandemic has led to rapid transition of mental health services to virtual delivery, with little evidence to guide the transition from in-person mental health care to delivery via virtual care for young people with psychosis. Adaptations to the delivery of NAVIGATE core components have occurred organically and iteratively, requiring evaluation of how NAVIGATE may best be delivered to provide an effective intervention in a virtual setting. This study will identify how NAVIGATE core components are best delivered and provide essential knowledge on the fidelity, facilitators and barriers, and satisfaction with virtual NAVIGATE. Results will guide future program implementation in other EPI sites to better customize virtual NAVIGATE delivery to meet the needs and preferences of clients, family members, and care providers. Data on service engagement will improve early identification of youth likely to benefit from a virtual approach and those who may require an in-person component, either owing to digital equity issues, personal preference, or other factors. Insights into the barriers and facilitators to virtual NAVIGATE will guide further adaptations, future scale up, and identify health disparities that require further attention.

In addition to supporting the delivery of high-quality care to youth with psychosis in the near future, the virtual delivery of EPI care may also be more accessible to youth and adaptable to low-resource and geographically remote settings well beyond the COVID-19 pandemic [63].

Individuals in rural communities tend to experience poorer health, greater disability, and higher mortality related to poor access to health care and limited availability of specialized health providers [64]; Ontario has a population of approximately 14 million people spread across 1 million km² with mental health services concentrated in urban settings. If implementation of virtual NAVIGATE at CAMH results in high fidelity to the EPI model and demonstrates acceptability and feasibility, spread would first be coordinated across additional programs in Ontario through our existing collaboration with the EPI-SET study network of providers [36]. These programs have similarly transitioned to virtual delivery; however, without the support of a dedicated virtual care program or evaluation tools to guide iterative adaptations. The EPI-SET study sites cover a large geographical region of Ontario and suburban, rural, and Northern regions. Because of their geographic spread, these sites have even more to gain from establishing effective ways to deliver high-quality EPI services virtually.

We will also disseminate our results by preparing a manual on what is required to transition from in-person to virtual delivery of NAVIGATE. Additionally, we will engage in traditional knowledge translation activities by publishing manuscripts in open access journals and presenting our findings at conferences.

The initial adaptations to NAVIGATE virtual delivery were organic, unplanned, and reactive, having been prompted by public health guidance for the COVID-19 pandemic. Emergent needs are being addressed iteratively and some additional tools, including provider satisfaction surveys, are still being validated as of this writing. Exposure to the intervention is dynamic over time not only because the intervention has evolved with additional supports but also because clients have received their care in different modalities, in part reflective of the changes in public health recommendations. It will be challenging to distinguish the impacts of the transition to virtual delivery on outcomes, including service engagement, from the impacts of the pandemic itself.

Out of necessity, mental health care has rapidly transitioned to virtual delivery in the absence of intentional and explicit guidance and evidence of quality outcomes. This study leverages existing clinical evidence and implementation science in the context of an emergent global pandemic to evaluate how best to adapt and deliver NAVIGATE virtually toward lasting improvements to quality and accessibility of services for youth with psychosis.