Early Psychosis Intervention - Spreading Evidence-based Treatment (EPI-SET)
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ClinicalTrials.gov Identifier: NCT03919760 |
Recruitment Status :
Recruiting
First Posted : April 18, 2019
Last Update Posted : July 29, 2021
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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:
- Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve.
- 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.
- 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.
- The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.
Condition or disease | Intervention/treatment |
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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 | Behavioral: NAVIGATE |

Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Enhancing Evidence-Based Practice for Youth and Emerging Adults With Early Psychosis: Implementation and Evaluation in Diverse Service Settings |
Actual Study Start Date : | January 3, 2020 |
Estimated Primary Completion Date : | May 31, 2023 |
Estimated Study Completion Date : | May 31, 2024 |

Group/Cohort | Intervention/treatment |
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NAVIGATE EPI
This group of first episode psychosis patients is receiving NAVIGATE early psychosis intervention (EPI) as their regular clinical standard of care. The project team is implementing NAVIGATE at several early psychosis intervention (EPI) programs in different geographic regions of Ontario. The team will recruit consecutive referrals to these programs in order to determine longitudinal change in functioning and symptoms (hypothesis #3). Additionally, the primary data collected for these patients will be linked deterministically to data sources held at the Institute for Clinical Evaluative Sciences (ICES) via their unique health card number. Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts). |
Behavioral: NAVIGATE
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 first episode psychosis consisting of 4 key intervention components:
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Non-NAVIGATE EPI
This group of first episode psychosis patients received early psychosis intervention other than NAVIGATE as their regular clinical standard of care. The data already collected for these patients (not as a part of study/recruitment) is held at the Institute for Clinical Evaluative Sciences (ICES). Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts). |
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Non-EPI
This group of first episode psychosis patients did not receive early psychosis intervention as their regular clinical standard of care. The data already collected for these patients (not as a part of study/recruitment) is held at the Institute for Clinical Evaluative Sciences (ICES). Routine system-level outcome measurements will be compared among NAVIGATE subjects and two control populations (hypothesis #2 - see other groups/cohorts). |
- Hypothesis 1: Fidelity/Adaptability [ Time Frame: Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and end of study [approx. year 4] ]
First Episode Psychosis Service-Fidelity Scale (FEPS-FS) will be used to assess fidelity of service delivery to the current standard of early psychosis intervention in relation to 32 program-specific items (individual and team practices) on a 5-point scale from "1=not implemented" to "5=fully implemented". Ratings for each site will be made through a remote assessment process that includes a review of site administrative data, data abstracted from client health records, and phone interviews with site staff.
Site will be the unit of analysis. Descriptive statistics (percentages, means, medians, range) will be reported for the total scale score and for subscale scores that align with NAVIGATE components. Fidelity scores will be calculated per site in relation to the four core NAVIGATE interventions using measurements of service utilization. Total and subscale scores will be an average of item scores, reported out of 5.
- Hypothesis 1: Penetration/Scalability [ Time Frame: Month 48 ]To determine whether implementation of NAVIGATE is associated with improvement in fidelity to the EPI standard, program staff will document delivery of core modules for each of the four interventions. We will calculate the percentage of core modules completed per intervention per patient to assess penetration and to identify variations in delivery both within sites and across sites. Additionally, we will calculate frequency of team activities (e.g., weekly meetings, direct supervision) and assess staff perceived competence in delivery of NAVIGATE using the Readiness Monitoring Tool and the competency assessment questionnaires completed at the conclusion of each ECHO cycle.
- Hypothesis 1: Contextual Factors [ Time Frame: End of study [approx. year 4] ]The Consolidated Framework for Implementation Research (CFIR) will be used to systematically assess contextual factors that are associated with effective implementation. The CFIR constructs are organized within five major domains: intervention characteristics (e.g., complexity, relative advantage); outer setting (e.g., external policy, patient needs); inner setting (e.g., resources, fit, leadership); staff characteristics (e.g., knowledge, beliefs); and implementation process (e.g., facilitation, planning, coaching). The CFIR will be used to develop a semi-structured interview to guide data collection. Interviews will be conducted with stakeholders at each site (EPI staff, organization leaders) at the end of the study, recorded, and transcribed.
- Hypothesis 1: Sustainability [ Time Frame: Ongoing throughout study [years 2-4 inclusive] ]Staff attendance during ECHO sessions will indicate ECHO engagement and retention.
- Hypothesis 1: Sustainability [ Time Frame: Prior to ECHO participation [approx. year 2] and end of study [approx. year 4] ]
A competency assessment questionnaire will be administered to staff to assess changes in attitudes, knowledge and self-efficacy (self-reported competence) in delivering NAVIGATE components.
Question domains will include Likert scales assessing self-reported knowledge and skill domains specific to the NAVIGATE model. Self-efficacy questions will focus on key competency domains of NAVIGATE and assess confidence in delivering these components in their local settings.
- Hypothesis 1: Affordability [ Time Frame: End of study [approx. year 4] ]The investigators will employ a costing algorithm developed in SAS®, and available at ICES, to estimate all direct patient-level health care costs incurred by the public third-party payer (Ontario Ministry of Health and Long-Term Care) across the three comparison groups. Included will be costs of hospitalizations (both non-psychiatric and psychiatric); ED visits; physician services (i.e. primary care, psychiatry and other care) and diagnostics tests; outpatient prescription drugs for individuals covered under the provincial public drug insurance plan only (for individuals under 65 who receive social assistance and for individuals under age 25 who lack private insurance coverage); home care; and other care (this includes other ambulatory care, such as same-day surgery/procedures, cancer and dialysis clinic visits, and other hospital-based care, such as rehabilitation and complex continuing care).
- Hypothesis 2: System-Level: Number of psychiatric hospitalization days in the year following NAVIGATE admission [ Time Frame: End of study [approx. year 4] ]
Propensity scores will be used to compare NAVIGATE participants with 2 groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.
The primary outcome is days in hospital (psychiatric hospitalizations) in the year following NAVIGATE admission.
- Hypothesis 2: System-Level: Time to first psychiatric hospitalization [ Time Frame: End of study [approx. year 4] ]
Propensity scores will be used to compare NAVIGATE participants with 2 comparison groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.
Hospitalization-based outcomes assessed include time to first psychiatric hospitalization.
- Hypothesis 3: Assessment for diagnosis [ Time Frame: Admission to clinic [month 0] ]Psychiatric diagnosis/diagnoses will be confirmed using the Structured Clinical Interview for DSM-5 (SCID-5). Information from the SCID-5 will be supplemented by information from family informants, any previous psychiatrist, and medical records.
- Hypothesis 3: Assessment of clinical psychopathology [BPRS] [ Time Frame: Admission to clinic [months 0, 6, 12, 18, 24] ]The Brief Psychiatric Rating Scale (BPRS) (24 item) will be used to assess the severity of positive symptoms, psychosis, negative symptoms, and general psychopathology. Scores range from 2-7 for each item (7 indicates worse symptoms). Total score is a sum ranging from 48-168.
- Hypothesis 3: Assessment of clinical psychopathology [PHQ-9] [ Time Frame: Admission to clinic [month 0, 6, 12, 18, 24] ]The self-report Patient Health Questionnaire - 9 (PHQ-9) will be used to characterize the presence and severity of depressive symptoms. Higher score = worse symptoms (range 0-27).
- Hypothesis 3: Assessment of clinical psychopathology [QLS] [ Time Frame: Admission to clinic [month 0, 6, 12, 18, 24] ]The Intrinsic Motivation Factor of the Quality of Life Scale (QLS) will serve as a specific measure of motivation to augment the above psychopathology measures. Semi-structured interview (subscale item) score range 0-6 (higher score = higher intrinsic motivation).
- Hypothesis 3: Assessment of illness severity and improvement [ Time Frame: Admission to clinic [month 0, 6, 12, 18, 24] ]The Clinical Global Impressions Scale (CGI) will be administered to characterize overall illness severity. It rates both illness severity and improvement. It takes into account all available information, including knowledge of the patient's history, psychological circumstances, symptoms, behaviour, and the impact of the symptoms on the patient's ability to function. Structured interview, illness and improvement score range 0-7 (higher = worse severity/least improvement).
- Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Admission to clinic [month 0, 6, 12, 18, 24] ]WHO Disability Assessment Schedule 2.0: assessment of functioning to provide an assessment of health and disability. Scoring will be done using item-response theory. It takes the coding for each item response as "none", "mild", "moderate", "severe" and "extreme" separately, and then uses an algorithm to determine the summary score by differentially weighting the items and the levels of severity. Domain and total scores will be produced (total score range 0 to 100, where 0 = no disability; 100 = full disability).
- Hypothesis 3: Assessment of parental socio-economic status [ Time Frame: Admission to clinic [month 0] ]Parental and participant education will be used as indicator of SES.
- Hypothesis 3: Measurement of Service Utilization [ Time Frame: Month 6, 12, 18, 24 ]The Service Use and Resource Form (SURF) will be used to measure utilization of mental health and other medical services across residential, inpatient, and outpatient treatment settings. This will be administered by research staff either over the phone or via email survey, based on participant preference.
- Hypothesis 4: Engagement [ Time Frame: End of implementation [approx. year 2], Study end [approx. year 4] ]The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. Semi-structured interviews will be conducted with patients, families, and NAVIGATE staff members.
- Hypothesis 4: Engagement [PPEET/PCORI] [ Time Frame: After the first engagement [approx. year 1]. end of implementation [approx. year 2] ]The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. A modified (simplified/combined) PPEET (Public and Patient Engagement Evaluation Tool) & PCORI engagement activity inventory will be administered to Youth and Family Advisory Members.
- Hypothesis 4: Engagement [Interview] [ Time Frame: After first engagement [approx. year 1], End of the implementation [approx. year 2], study end [approx. year 4] ]The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. A semi-structured interview will be conducted with Youth and Family Advisory Members.
- Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts [ Time Frame: End of study [approx. year 4] ]
Each NAVIGATE subject will be matched to two types of subjects: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment.
Investigators will measure psychiatric emergency department visits with a year of admission as well as ED visits for suicide attempts. Visits to psychiatrists and primary care physicians will also be counted. Visits to primary care physicians will be stratified as mental health related versus non-mental health related based on a previously validated algorithm.
- Hypothesis 3: Demographics [ Time Frame: Admission to clinic [month 0] ]A demographic questionnaire will be administered. Example items include participant sex, gender, education, employment, financial support, ethnicity, race, language, legal system involvement, housing situation, and sibling and parent information.

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Ages Eligible for Study: | 14 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919760
Contact: Aristotle Voineskos, MD, PhD | 416-535-8501 ext 34378 | aristotle.voineskos@camh.ca | |
Contact: Dielle Miranda, MA | 416-535-8501 ext 33120 | dielle.miranda@camh.ca |
Canada, Ontario | |
North Bay Regional Health Centre | Recruiting |
North Bay, Ontario, Canada, P1B 0A4 | |
Contact: Josette Morin 705-474-8600 ext 4220 Josette.Morin@nbrhc.on.ca | |
Durham Amaze- Lakeridge Health | Recruiting |
Oshawa, Ontario, Canada, L1G 2B9 | |
Contact: Sheeba Narikuzhy, MA 905-576-8711 ext 36233 snarikuzhy@lh.ca | |
Health Sciences North | Recruiting |
Sudbury, Ontario, Canada, P3E 5J1 | |
Contact: Anne-Marie Baker-Devost, RN 705-523-7100 ext 4238 amdevost@hsnsudbury.ca | |
Niagara Region Public Health | Recruiting |
Thorold, Ontario, Canada, L2V 4Y6 | |
Contact: Kerri Nagy, RN 905-688-2854 ext 7190 kerri.nagy@niagararegion.ca | |
First Place Clinic and Regional Resource Centre | Recruiting |
Thunder Bay, Ontario, Canada, P7A4K9 | |
Contact: Joy Kolic, NP (807)345-5564 ext 203 jkolic@cmha-tb.on.ca | |
CMHA Waterloo Wellington | Recruiting |
Waterloo, Ontario, Canada, N2J 4M1 | |
Contact: Kim Hewitt-McVicker, OT 1-844-264-2993 ext 4510 khewitt@cmhaww.ca |
Principal Investigator: | Aristotle Voineskos, MD, PhD | Centre for Addiction & Mental Health | |
Principal Investigator: | George Foussias, MD, PhD | Centre for Addiction & Mental Health | |
Principal Investigator: | Paul Kurdyak, MD, PhD | Centre for Addiction & Mental Health | |
Principal Investigator: | Janet Durbin, PhD, MSc | Centre for Addiction & Mental Health | |
Principal Investigator: | Sanjeev Sockalingam, MD | Centre for Addiction & Mental Health |
Documents provided by Centre for Addiction and Mental Health:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT03919760 |
Other Study ID Numbers: |
MY9-158586 |
First Posted: | April 18, 2019 Key Record Dates |
Last Update Posted: | July 29, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Deidentified individual data (other than that held by ICES, which is not permitted to be shared) will be available by request to the lead principal investigator and managed by a publications committee, provided the project has Research Ethics Board approval. Investigators who are not project collaborators may require a data sharing agreement with CAMH based on institutional policies. |
Time Frame: | Final data that has not yet been published will be shared after acceptance of publication of the relevant paper. |
Access Criteria: | The requesting investigator requires appropriate approval (see above). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Implementation Science Youth and Emerging Adults First Episode Psychosis Schizophrenia |
Mental Health Psychiatric Services NAVIGATE |
Disease Schizophrenia Psychotic Disorders Mental Disorders Mood Disorders |
Schizophrenia Spectrum and Other Psychotic Disorders Affective Disorders, Psychotic Schizophrenia, Childhood Pathologic Processes Neurodevelopmental Disorders |