Clinical trial NCT03919760: Early Psychosis Intervention - Spreading Evidence-based Treatment
Official title: Enhancing Evidence-Based Practice for Youth and Emerging Adults With Early Psychosis: Implementation and Evaluation in Diverse Service Settings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: First Episode Psychosis
Schizophrenia, Childhood
Psychosis
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Bipolar I Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Affective Disorders, Psychotic
Psychotic Disorder Due to Unspecified Substance
Keywords: Implementation Science
Youth and Emerging Adults
First Episode Psychosis
Schizophrenia
Mental Health
Psychiatric Services
NAVIGATE
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Institute for Clinical Evaluative Sciences
name: North Bay Regional Health Centre
name: Health Sciences North
name: Niagara Region Public Health
name: Lakeridge Health Corporation
name: Canadian Mental Health Association - Waterloo Wellington
name: Canadian Mental Health Association - Thunder Bay
First posted: 2019-04-18
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive referrals to the Early Psychosis Intervention (EPI) programs participating in the study will be recruited, with representation from three geographic regions of Ontario respectively: the south, central-east, and north-east.

Brief summary: Implementation of 'NAVIGATE' in Ontario aims to help youth and emerging adults suffering from a first episode of psychosis. Although Ontario already has early psychosis intervention programs, the team's recent work has identified major challenges of delivering coordinated care, particularly those elements of care that enhance recovery. These challenges also exist nationally and internationally. By building on the already existing early psychosis intervention community of practice through the Early Psychosis Intervention Ontario Network, the investigators will implement NAVIGATE with the help of CAMH's Provincial System Support Program facilitators. The use of tele-videoconferencing through ECHO Mental Health Ontario and ECHO processes and protocols provide us with an opportunity to ensure sustainability. Using health administrative data held at the Institute for Clinical Evaluative Sciences (ICES), the investigators can examine system-level outcomes, including hospitalizations, emergency department visits, and outpatient physician visits of youth and emerging adults suffering from a first episode psychosis who are treated with NAVIGATE compared with those treated in early psychosis intervention programs without NAVIGATE and those who are not treated in early psychosis intervention programs. In addition, the investigators can also evaluate health care costs. Prior to initiating this project, the investigators obtained the input of youth and emerging adults with a first episode psychosis and family members. The investigators will also continue to measure engagement across the study.

Hypotheses:

1. Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve.
2. Compared to patients not receiving NAVIGATE, those who receive NAVIGATE through this implementation study will have fewer days in hospital, fewer emergency department visits, fewer suicide attempts, lower mortality, and lower healthcare costs.
3. Improvements in functioning and symptoms will be comparable to the RAISE study (an earlier study assessing NAVIGATE); improvement may be influenced by demographic, socio-economic, geographic, and clinical factors.
4. The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.

Detailed description: The emergence of early psychosis intervention (EPI) programs has provided tremendous hope for individuals experiencing psychosis by providing early intervention. Work by the team shows that youth who access an EPI program in Ontario, Canada receive faster psychiatric follow-up, better coordination of care between inpatient and outpatient services, reduced burden on the emergency department, and reduced all-cause mortality. The team's system-level data support EPI programs as a critical life-saving intervention. Internationally, EPI has demonstrated significant benefits compared to treatment as usual with respect to engagement, service utilization, and suicide.

Despite the initial life-saving benefits of EPI services, provincial, national and international data show that consistent delivery of high-quality, evidence-based care in EPI programs is a major challenge. Recovery rates in EPI programs remain low, and associated disability has not improved under routine clinical care. One explanation for these disappointing facts is that a low proportion of patients receive recovery-based services, namely, case management including individualized psychosocial interventions, family education and intervention, and supported education and employment. Even in clinical service delivery trials, recovery-based service is received by 15-56% of patients, with only 18% receiving comprehensive EPI services. While EPI standards across jurisdictions recommend coordinated and comprehensive recovery-based care, effective implementation and sustainability of such care in real-world settings remains poor.

The team's work in Ontario has uncovered a startling gap between the evidence-based standard of care, and real-world delivery of care, even in a jurisdiction (Ontario) that has prioritized EPI services. The results of the team's Ontario survey were mirrored in a national survey of 11 Canadian EPI programs. This study is designed to improve the delivery of recovery-oriented evidence-based EPI care in Ontario, and improve person-, system-, and economic-level outcomes for youth and emerging adults (YEA) suffering from a first episode psychosis (FEP), offering a potential roadmap for the rest of Canada.

In 2004, the province of Ontario allocated funding for EPI programs based on early evidence of efficacy. Between 2005 and 2007, this funding led to a major EPI program expansion in Ontario, but the absence of provincial standards led to program development in an ad-hoc manner, drawing upon general service delivery experience and advice from established programmes. Concomitantly, the Early Psychosis Intervention Ontario Network (EPION) was established, which has now grown to 52 EPI sites. The establishment of EPI program standards in Ontario in 2011, informed by existing international and national standards, but also by input from clinicians, patients, family-members, and policy makers was a crucial first step toward standardizing care. However, the release of standards alone is not sufficient to ensure effective implementation, practice change, and ongoing quality practice.

Key findings from the first survey by the Ontario Standards Implementation Steering Committee (SISC) of 52 EPI program sites in Ontario (92% participation) demonstrated important challenges in delivering evidence-based EPI care. A follow-up survey also identified opportunities for addressing these challenges. Building on the two surveys, the investigators conducted a study to measure fidelity to current EPI standards using the First Episode Psychosis Service - Fidelity Scale. The most notable finding was lack of delivery of consistent recovery-oriented care, with no structured or manualized process for these elements of care. Through site visits, and in-person interviews with nine Ontario EPI programs, the investigators obtained a richer and clearer picture of the current state, creating an opportunity to implement solutions that can address the major challenges identified in the fidelity study.

The investigators want to address these challenges in Ontario EPI settings by implementing NAVIGATE, a coordinated and comprehensive multidisciplinary treatment program for FEP that is deliverable in community mental health settings. NAVIGATE is manualized and measurement-based. To maximize affordability, adaptability, spread, and sustainability, the investigators will utilize the already-established EPION community of practice, the implementation science expertise of PSSP (Provincial System Support Program), and the sustainability and capacity building approach of The Extension of Community Health Outcomes (ECHO) Ontario Mental Health at CAMH and the University of Toronto (ECHO-ONMH).

NAVIGATE was developed in consultation with clinical and research experts, biostatisticians, health economists, consumers, family members, advocacy groups, and government officials. It is a form of coordinated specialty care for FEP consisting of 4 key intervention components: (i) individualized medication management using a decision support tool, (ii) a package of psychoeducation and a blend of evidence-based psychotherapies called "individual resiliency training" (IRT); (iii) supported employment and education (SEE); and (iv) a family education program. NAVIGATE was evaluated from 2009-2014 in a cluster randomized controlled trial involving 404 individuals with an FEP in 34 community mental health centers across the United States. Notably, it was delivered by re-allocating existing community mental health resources with no new funding for clinical care. Compared to usual care, NAVIGATE treatment provided greater improvement in symptoms, but more importantly, as prioritized by patients, significantly greater improvement in real-world functioning, including social functioning and engagement in educational and vocational training. NAVIGATE was also readily implementable across a broad range of community-based mental health settings, with enhanced engagement and delivery of multidisciplinary care to YEA presenting with psychosis and their families compared to standard care, and with longer and more consistent receipt of mental health services. A recent economic analysis revealed that NAVIGATE treatment was more cost-effective compared to standard community care, driven by the anticipated enhanced health benefits and improvements in quality of life. NAVIGATE implementation addresses the major challenges identified in the previously mentioned SISC fidelity study, as follows:

Challenge 1: NAVIGATE operationalizes current EPI standards using manualized protocols, ensuring consistency and reducing variability in care. The four NAVIGATE components (individualized medication management, IRT, SEE, and family education program) are systematically applied in collaboration with the patient. There is an overarching emphasis on the coordinated delivery of these elements of care. Every patient is offered these elements of care, and modules are completed in a systematic time-oriented fashion that reduces variability in care among sites and team-members within a site. At each patient visit, a contact/progress note is completed, including the modules delivered, that the team reviews to assess patient progress, fidelity, and determine need for adjustments.

Challenge 2. Ontario EPI sites have learned about NAVIGATE through didactic sessions and conferences offered through EPION. Because translation and implementation of evidence-based practice remains a challenge, training, implementation expertise, and other resources are required. The mandate of the CAMH PSSP is to support system change in Ontario by providing implementation, evaluation, knowledge exchange, engagement and information management expertise to organizations and networks across the province. PSSP operates regional offices throughout Ontario and their implementation teams work closely with local communities and key partners to implement and sustain system improvements. For this project, regional PSSP teams will support implementation and work closely with NAVIGATE content experts from the Slaight Centre (CAMH's EPI program), and community site leads, who are members of EPION.

Challenge 3. EPION has identified use of technology to transfer knowledge, and equitable application of the provincial standards as key priorities. ECHO consists of specialist hubs that connect with multiple learner teams in remote areas through televideo-conferencing technology, and thus can bridge the geographic gap required to bolster the Ontario EPI community of practice. The goal of ECHO clinics is to extend the reach of best practices in academic settings to the chronic and complex illnesses seen in local settings, thereby reducing variation, increasing access to specialist mentoring and services, and monitoring and improving patient outcomes. Initial evaluation data in Ontario has shown high provider satisfaction and engagement with ECHO, and increased knowledge and self-efficacy in managing mental health and addictions in rural and remote settings.

How is this Study Further Enhanced?

i) This project includes Patient and Family Engagement. In the direct planning and design of the present study, one of the team's Principal Investigators with lived experience was present at each team meeting, and was an equal partner in decisions regarding all of the outcome measures. A co-applicant family member (her son experienced an FEP) also joined the team, and she provided input, further refining the research objectives. The Advisory Committees will grow to include patient/family representation from each site, and will provide ongoing guidance to the research team in implementation, evaluation, analyses, and dissemination. The investigators will also continue qualitative work with patients and families to further evaluate NAVIGATE at the participating sites.

ii) Using data from ICES, which captures all physician and hospital-provided insured services in Ontario, the investigators will compare population-based outcomes (hospitalizations, emergency department visits, suicide attempts and mortality) with two comparison groups: 1) all EPI program FEP patients who have not been part of the NAVIGATE trial; and 2) all FEP patients who are not attached to EPI programs. All EPI programs in Ontario report their service utilization data through the Ontario Common Assessment of Need (OCAN) dataset (OCAN is linked to ICES data). The investigators can accurately ascertain the initiation date of all EPI patients by sex within Ontario through ICES linkage. The ability to link NAVIGATE's primary clinical and implementation data with ICES data, and the capacity to identify all FEP patients in Ontario (whether treated in EPI programs or not) allows for a meaningful, valid, and highly generalizable comparison of outcomes. The use of propensity score methods will address confounding associated with observational studies, and mimics some of the characteristics of a randomized controlled trial.

Primary Study Hypotheses:

1. Following the implementation of NAVIGATE, program fidelity to the Ontario EPI standard will improve.
2. Compared to patients not receiving NAVIGATE, those who receive NAVIGATE through this implementation study will have fewer days in hospital, fewer ED visits, fewer suicide attempts, lower mortality, and lower costs.
3. Improvements in functioning and symptoms will be comparable to the RAISE study; improvement may be influenced by demographic, socio-economic, geographic, and clinical factors.
4. The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.

Eligibility criteria: Early psychosis intervention (EPI) programs from specific geographic regions of Ontario will be included. Investigators will recruit consecutive referrals to the EPI programs participating in the study. All of the EPI sites follow people experiencing a first episode psychosis.

Individual inclusion criteria:

* Age range of 14-35 years;
* any DSM-diagnosis 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);

Exclusion Criteria:

- Absence of psychosis

Primary outcomes:
measure: Hypothesis 1: Fidelity/Adaptability
timeFrame: Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and end of study [approx. year 4]
measure: Hypothesis 1: Penetration/Scalability
timeFrame: Month 48
measure: Hypothesis 1: Contextual Factors
timeFrame: End of study [approx. year 4]
measure: Hypothesis 1: Sustainability
timeFrame: Ongoing throughout study [years 2-4 inclusive]
measure: Hypothesis 1: Sustainability
timeFrame: Prior to ECHO participation [approx. year 2] and end of study [approx. year 4]
measure: Hypothesis 1: Affordability
timeFrame: End of study [approx. year 4]
measure: Hypothesis 2: System-Level: Number of psychiatric hospitalization days in the year following NAVIGATE admission
timeFrame: End of study [approx. year 4]
measure: Hypothesis 2: System-Level: Time to first psychiatric hospitalization
timeFrame: End of study [approx. year 4]
measure: Hypothesis 3: Assessment for diagnosis
timeFrame: Admission to clinic [month 0]
measure: Hypothesis 3: Assessment of clinical psychopathology [BPRS]
timeFrame: Admission to clinic [months 0, 6, 12, 18, 24]
measure: Hypothesis 3: Assessment of clinical psychopathology [PHQ-9]
timeFrame: Admission to clinic [month 0, 6, 12, 18, 24]
measure: Hypothesis 3: Assessment of clinical psychopathology [QLS]
timeFrame: Admission to clinic [month 0, 6, 12, 18, 24]
measure: Hypothesis 3: Assessment of illness severity and improvement
timeFrame: Admission to clinic [month 0, 6, 12, 18, 24]
measure: Hypothesis 3: Assessment of functioning [WHODAS 2.0]
timeFrame: Admission to clinic [month 0, 6, 12, 18, 24]
measure: Hypothesis 3: Assessment of parental socio-economic status
timeFrame: Admission to clinic [month 0]
measure: Hypothesis 3: Measurement of Service Utilization
timeFrame: Month 6, 12, 18, 24
measure: Hypothesis 4: Engagement
timeFrame: End of implementation [approx. year 2], Study end [approx. year 4]
measure: Hypothesis 4: Engagement [PPEET/PCORI]
timeFrame: After the first engagement [approx. year 1]. end of implementation [approx. year 2]
measure: Hypothesis 4: Engagement [Interview]
timeFrame: After first engagement [approx. year 1], End of the implementation [approx. year 2], study end [approx. year 4]
Secondary outcomes:
measure: Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts
timeFrame: End of study [approx. year 4]
measure: Hypothesis 3: Demographics
timeFrame: Admission to clinic [month 0]
Other outcomes:
Locations:
city: North Bay
country: Canada
facility: North Bay Regional Health Centre
state: Ontario
city: Oshawa
country: Canada
facility: Durham Amaze- Lakeridge Health
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Thorold
country: Canada
facility: Niagara Region Public Health
state: Ontario
city: Thunder Bay
country: Canada
facility: First Place Clinic and Regional Resource Centre
state: Ontario
city: Waterloo
country: Canada
facility: CMHA Waterloo Wellington
state: Ontario
Study officials:
affiliation: Centre for Addiction & Mental Health
name: Aristotle Voineskos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction & Mental Health
name: George Foussias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction & Mental Health
name: Paul Kurdyak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction & Mental Health
name: Janet Durbin, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction & Mental Health
name: Sanjeev Sockalingam, MD
role: PRINCIPAL_INVESTIGATOR
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