Early Psychosis Intervention - Spreading Evidence-based Treatment (EPI-SET)

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ClinicalTrials.gov Identifier: NCT03919760

Recruitment Status : Not yet recruiting

First Posted : April 18, 2019

Last Update Posted : April 18, 2019

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Sponsor:

Collaborators:

Canadian Institutes of Health Research (CIHR)

Institute for Clinical Evaluative Sciences

North Bay Regional Health Centre

Health Sciences North

Niagara Region Public Health

Lakeridge Health Corporation

Information provided by (Responsible Party):

Centre for Addiction and Mental Health

Study Description

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:

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
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

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Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	1200 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
Estimated Study Start Date :	May 1, 2019
Estimated Primary Completion Date :	May 31, 2023
Estimated Study Completion Date :	May 31, 2024

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizophrenia

MedlinePlus related topics: Mental Disorders Psychotic Disorders

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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: individualized medication management using a decision support tool; a package of psychoeducation and a blend of evidence-based psychotherapies called "individual resiliency training" (IRT); supported employment and education (SEE); a family education program
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).
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).

Outcome Measures

Primary Outcome Measures :

Hypothesis 1: Fidelity/Adaptability [ Time Frame: Exploration stage of implementation [approx. year 1] ]
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 30 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: Fidelity/Adaptability [ Time Frame: Following full implementation [approx. year 2] ]
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 (EPI) in relation to 31 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: Fidelity/Adaptability [ Time Frame: 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 (EPI) in relation to 31 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 ]
Penetration assesses the extent to which eligible program patients receive the NAVIGATE treatments, and identifies any biases in delivery.

Fidelity to NAVIGATE will be calculated from the contact forms (clinician report) and the SURF (client report), and will be used to assess penetration and to identify variations in delivery across patients within sites and across sites. When assessing scalability, the unit of analysis will be the patient (n=400 patients). The outcome will be percentage of modules received for each of the four interventions and will be reported using percentages, means, medians, standard deviations, and interquartile ranges. A linear regression model will be used to identify predictors, with patient baseline characteristics such as sex, age, and illness complexity. The nesting of patients within each site will be accounted for in the analysis. All statistical tests will be two-tailed and statistical significance will be defined as p-values less than 0.05.
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] ]
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: Sustainability [ Time Frame: 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 currently universally for individuals under age 25); home care; long-term 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] ]
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.

The primary outcome is days in hospital in the year following NAVIGATE admission.
Hypothesis 2: System-Level: Time to first psychiatric hospitalization [ 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.

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 [month 0] ]
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] ]
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] ]
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 clinical psychopathology [BPRS] [ Time Frame: Month 6 ]
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: Month 6 ]
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: Month 6 ]
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 clinical psychopathology [BPRS] [ Time Frame: Month 12 ]
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: Month 12 ]
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: Month 12 ]
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 clinical psychopathology [BPRS] [ Time Frame: Month 18 ]
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: Month 18 ]
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: Month 18 ]
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 clinical psychopathology [BPRS] [ Time Frame: Month 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: Month 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: Month 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] ]
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 illness severity and improvement [ Time Frame: Month 6 ]
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 illness severity and improvement [ Time Frame: Month 12 ]
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 illness severity and improvement [ Time Frame: Month 18 ]
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 illness severity and improvement [ Time Frame: Month 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 [QLS] [ Time Frame: Admission to clinic [month 0] ]
Quality of Life Scale (QLS). Functioning will be assessed with the QLS. It is designed to evaluate the current functioning of nonhospitalized individuals with schizophrenia. It is a semi-structured interview with 4 subscales: Interpersonal Relations, Instrumental Role, Intrapsychic Foundations [which will be excluded], and Common Objects and Activities. Subscales (Range 0-6) and total score. Lower score = worse symptoms.
Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Admission to clinic [month 0] ]
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 functioning [QLS] [ Time Frame: Month 6 ]
Quality of Life Scale (QLS). Functioning will be assessed with the QLS. It is designed to evaluate the current functioning of nonhospitalized individuals with schizophrenia. It is a semi-structured interview with 4 subscales: Interpersonal Relations, Instrumental Role, Intrapsychic Foundations [which will be excluded], and Common Objects and Activities. Subscales (Range 0-6) and total score. Lower score = worse symptoms.
Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Month 6 ]
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 functioning [QLS] [ Time Frame: Month 12 ]
Quality of Life Scale (QLS). Functioning will be assessed with the QLS. It is designed to evaluate the current functioning of nonhospitalized individuals with schizophrenia. It is a semi-structured interview with 4 subscales: Interpersonal Relations, Instrumental Role, Intrapsychic Foundations [which will be excluded], and Common Objects and Activities. Subscales (Range 0-6) and total score. Lower score = worse symptoms.
Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Month 12 ]
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 functioning [QLS] [ Time Frame: Month 18 ]
Quality of Life Scale (QLS). Functioning will be assessed with the QLS. It is designed to evaluate the current functioning of nonhospitalized individuals with schizophrenia. It is a semi-structured interview with 4 subscales: Interpersonal Relations, Instrumental Role, Intrapsychic Foundations [which will be excluded], and Common Objects and Activities. Subscales (Range 0-6) and total score. Lower score = worse symptoms.
Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Month 18 ]
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 functioning [QLS] [ Time Frame: Month 24 ]
Quality of Life Scale (QLS). Functioning will be assessed with the QLS. It is designed to evaluate the current functioning of nonhospitalized individuals with schizophrenia. It is a semi-structured interview with 4 subscales: Interpersonal Relations, Instrumental Role, Intrapsychic Foundations [which will be excluded], and Common Objects and Activities. Subscales (Range 0-6) and total score. Lower score = worse symptoms.
Hypothesis 3: Assessment of functioning [WHODAS 2.0] [ Time Frame: Month 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 ]
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 3: Measurement of Service Utilization [ Time Frame: Month 12 ]
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 3: Measurement of Service Utilization [ Time Frame: Month 18 ]
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 3: Measurement of Service Utilization [ Time Frame: Month 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 the 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. Semi-structured interviews will be conducted with patients, families, and NAVIGATE staff members.
Hypothesis 4: Engagement [ Time Frame: 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] ]
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 the first engagement [approx. year 1] ]
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 4: Engagement [PPEET/PCORI] [ Time Frame: End of the 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: End of the 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 semi-structured interview will be conducted with Youth and Family Advisory Members.
Hypothesis 4: Engagement [PPEET/PCORI] [ Time Frame: 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 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: 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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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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

Locations

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Canada, Ontario
North Bay Regional Health Centre	Not yet recruiting
North Bay, Ontario, Canada, P1B 0A4
Contact: Josette Morin 705-474-8600 ext 4220 Josette.Morin@nbrhc.on.ca
Durham Amaze- Lakeridge Health	Not yet recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Sheila Gallagher, MSW 905-576-8711 ext 6233 sgallagher@lakeridgehealth.on.ca
Niagara Region Public Health	Not yet recruiting
Thorold, Ontario, Canada, L2V 4Y6
Contact: Krista Whittard, MSW 905-688-2854 ext 7356 Krista.whittard@niagararegion.ca

Sponsors and Collaborators

Centre for Addiction and Mental Health

Canadian Institutes of Health Research (CIHR)

Institute for Clinical Evaluative Sciences

North Bay Regional Health Centre

Health Sciences North

Niagara Region Public Health

Lakeridge Health Corporation

Investigators

Layout table for investigator information

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

Study Documents (Full-Text)

Documents provided by Centre for Addiction and Mental Health:

Study Protocol and Statistical Analysis Plan [PDF] September 10, 2018

More Information

Additional Information:

World Economic Forum and the Harvard School of Public Health. (2011) Methodological Appendix: The Global Economic Burden of Non-Communicable Diseases. This link exits the ClinicalTrials.gov site

Ministry of Health and Long-Term Care (2011). Early Psychosis Intervention Program Standards This link exits the ClinicalTrials.gov site

Fixsen DL, Blasé KA, Naoom SF, Wallace F. Core Implementation Components. Research on Social Work Practice. 2009 Sep;19(5):531-540. This link exits the ClinicalTrials.gov site

Implementation of Early Psychosis Intervention Program Standards in Ontario: Results from a Provincial Survey: Centre for Addiction and Mental Health and the Ontario Working Group for Early Psychosis This link exits the ClinicalTrials.gov site

Implementation research: A synthesis of the literature. Tampa, FL: University of South Florida, Louis de la Parte Florida Mental Health Institute, National Implementation Research Network; 2005. This link exits the ClinicalTrials.gov site

United States Congress. Public Law 114-270-Dec. 14, 2016. This link exits the ClinicalTrials.gov site

Youth Services System Review - Report This link exits the ClinicalTrials.gov site

Youth Service System Review: Phase 2 Report. CAMH This link exits the ClinicalTrials.gov site

National Youth Screening Project Phase Two Report. CAMH. This link exits the ClinicalTrials.gov site

Measuring health and disability: Manual for WHO Disability Assessment Schedule WHODAS 2.0. Geneva: World Health Organization. This link exits the ClinicalTrials.gov site

Structured Clinical Interview for DSM-5—Research Version (SCID-5 for DSM-5, Research Version; SCID-5-RV, Version 1.0.0). Arlington, VA, American Psychiatric Association, 2015 This link exits the ClinicalTrials.gov site

Children's Participation: From tokenism to citizenship, Innocenti Essay no. 4, International Child Development Centre, Florence (1992). This link exits the ClinicalTrials.gov site

Ready... Set... Engage! Building Effective Youth/Adult Partnerships for a Stronger Child and Youth Mental Health System This link exits the ClinicalTrials.gov site

Patient Engagement and Canada's SPOR Initiative. McMaster University (2015). This link exits the ClinicalTrials.gov site

CIHR's Citizen Engagement Handbook (2012). This link exits the ClinicalTrials.gov site

Briefing notes for researchers: involving the public in NHS, public health and social care research. This link exits the ClinicalTrials.gov site

PCORI Engagement Rubric (2014). This link exits the ClinicalTrials.gov site

Strategy for Patient-Oriented Research: Patient Engagement Framework (2014). This link exits the ClinicalTrials.gov site

Marshall MN. Sampling for Qualitative Research. Family Practice.1996 Dec;13(6):522-525. This link exits the ClinicalTrials.gov site

Patient and Public Engagement Evaluation Toolkit. Centre of Excellence on Partnership Patients and the Public. This link exits the ClinicalTrials.gov site

Publications:

McGlashan TH. Early detection and intervention of schizophrenia: rationale and research. Br J Psychiatry Suppl. 1998;172(33):3-6. Review.

Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9. Review.

Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

Schoenbaum M, Sutherland JM, Chappel A, Azrin S, Goldstein AB, Rupp A, Heinssen RK. Twelve-Month Health Care Use and Mortality in Commercially Insured Young People With Incident Psychosis in the United States. Schizophr Bull. 2017 Oct 21;43(6):1262-1272. doi: 10.1093/schbul/sbx009.

Gatov E, Rosella L, Chiu M, Kurdyak PA. Trends in standardized mortality among individuals with schizophrenia, 1993-2012: a population-based, repeated cross-sectional study. CMAJ. 2017 Sep 18;189(37):E1177-E1187. doi: 10.1503/cmaj.161351.

Correll CU, Solmi M, Veronese N, Bortolato B, Rosson S, Santonastaso P, Thapa-Chhetri N, Fornaro M, Gallicchio D, Collantoni E, Pigato G, Favaro A, Monaco F, Kohler C, Vancampfort D, Ward PB, Gaughran F, Carvalho AF, Stubbs B. Prevalence, incidence and mortality from cardiovascular disease in patients with pooled and specific severe mental illness: a large-scale meta-analysis of 3,211,768 patients and 113,383,368 controls. World Psychiatry. 2017 Jun;16(2):163-180. doi: 10.1002/wps.20420. Erratum in: World Psychiatry. 2018 Feb;17 (1):120.

Hjorthøj C, Stürup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22.

Craig TK, Garety P, Power P, Rahaman N, Colbert S, Fornells-Ambrojo M, Dunn G. The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis. BMJ. 2004 Nov 6;329(7474):1067. Epub 2004 Oct 14.

Kuipers E, Holloway F, Rabe-Hesketh S, Tennakoon L; Croydon Outreach and Assertive Support Team (COAST). An RCT of early intervention in psychosis: Croydon Outreach and Assertive Support Team (COAST). Soc Psychiatry Psychiatr Epidemiol. 2004 May;39(5):358-63.

Grawe RW, Falloon IR, Widen JH, Skogvoll E. Two years of continued early treatment for recent-onset schizophrenia: a randomised controlled study. Acta Psychiatr Scand. 2006 Nov;114(5):328-36.

Anderson KK, Norman R, MacDougall A, Edwards J, Palaniyappan L, Lau C, Kurdyak P. Effectiveness of Early Psychosis Intervention: Comparison of Service Users and Nonusers in Population-Based Health Administrative Data. Am J Psychiatry. 2018 May 1;175(5):443-452. doi: 10.1176/appi.ajp.2017.17050480. Epub 2018 Mar 2.

Petersen L, Jeppesen P, Thorup A, Abel MB, Øhlenschlaeger J, Christensen TØ, Krarup G, Jørgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep 17;331(7517):602. Epub 2005 Sep 2. Erratum in: BMJ. 2005 Nov 5;331(7524):1065.

Malla A, Schmitz N, Norman R, Archie S, Windell D, Roy P, Zipursky RB. A multisite Canadian study of outcome of first-episode psychosis treated in publicly funded early intervention services. Can J Psychiatry. 2007 Sep;52(9):563-71.

Bond GR, Drake RE, Luciano A. Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review. Epidemiol Psychiatr Sci. 2015 Oct;24(5):446-57. doi: 10.1017/S2045796014000419. Epub 2014 Jul 14.

Fusar-Poli P, McGorry PD, Kane JM. Improving outcomes of first-episode psychosis: an overview. World Psychiatry. 2017 Oct;16(3):251-265. doi: 10.1002/wps.20446.

Jääskeläinen E, Juola P, Hirvonen N, McGrath JJ, Saha S, Isohanni M, Veijola J, Miettunen J. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull. 2013 Nov;39(6):1296-306. doi: 10.1093/schbul/sbs130. Epub 2012 Nov 20. Review.

Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7. Review.

Addington D, Anderson E, Kelly M, Lesage A, Summerville C. Canadian Practice Guidelines for Comprehensive Community Treatment for Schizophrenia and Schizophrenia Spectrum Disorders. Can J Psychiatry. 2017 Sep;62(9):662-672. doi: 10.1177/0706743717719900. Review.

Kane JM, Robinson DG, Schooler NR, Mueser KT, Penn DL, Rosenheck RA, Addington J, Brunette MF, Correll CU, Estroff SE, Marcy P, Robinson J, Meyer-Kalos PS, Gottlieb JD, Glynn SM, Lynde DW, Pipes R, Kurian BT, Miller AL, Azrin ST, Goldstein AB, Severe JB, Lin H, Sint KJ, John M, Heinssen RK. Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program. Am J Psychiatry. 2016 Apr 1;173(4):362-72. doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.

Durbin J, Selick A, Hierlihy D, Moss S, Cheng C. A first step in system improvement: a survey of Early Psychosis Intervention Programmes in Ontario. Early Interv Psychiatry. 2016 Dec;10(6):485-493. doi: 10.1111/eip.12201. Epub 2014 Nov 4.

Nolin M, Malla A, Tibbo P, Norman R, Abdel-Baki A. Early Intervention for Psychosis in Canada: What Is the State of Affairs? Can J Psychiatry. 2016 Mar;61(3):186-94. doi: 10.1177/0706743716632516.

Catts SV, Evans RW, O'Toole BI, Carr VJ, Lewin T, Neil AL, Harris MG, Frost AD, Crissman BR, Eadie K. Is a national framework for implementing early psychosis services necessary? Results of a survey of Australian mental health service directors. Early Interv Psychiatry. 2010 Feb;4(1):25-30. doi: 10.1111/j.1751-7893.2009.00157.x.

Cheng C, Dewa CS, Goering P. Matryoshka Project: lessons learned about early intervention in psychosis programme development. Early Interv Psychiatry. 2011 Feb;5(1):64-9. doi: 10.1111/j.1751-7893.2010.00255.x.

Addington DE, Norman R, Bond GR, Sale T, Melton R, McKenzie E, Wang J. Development and Testing of the First-Episode Psychosis Services Fidelity Scale. Psychiatr Serv. 2016 Sep 1;67(9):1023-5. doi: 10.1176/appi.ps.201500398. Epub 2016 Apr 1.

Kane JM, Schooler NR, Marcy P, Correll CU, Brunette MF, Mueser KT, Rosenheck RA, Addington J, Estroff SE, Robinson J, Penn DL, Robinson DG. The RAISE early treatment program for first-episode psychosis: background, rationale, and study design. J Clin Psychiatry. 2015 Mar;76(3):240-6. doi: 10.4088/JCP.14m09289.

Rosenheck R, Mueser KT, Sint K, Lin H, Lynde DW, Glynn SM, Robinson DG, Schooler NR, Marcy P, Mohamed S, Kane JM. Supported employment and education in comprehensive, integrated care for first episode psychosis: Effects on work, school, and disability income. Schizophr Res. 2017 Apr;182:120-128. doi: 10.1016/j.schres.2016.09.024. Epub 2016 Sep 23.

Rosenheck R, Leslie D, Sint K, Lin H, Robinson DG, Schooler NR, Mueser KT, Penn DL, Addington J, Brunette MF, Correll CU, Estroff SE, Marcy P, Robinson J, Severe J, Rupp A, Schoenbaum M, Kane JM. Cost-Effectiveness of Comprehensive, Integrated Care for First Episode Psychosis in the NIMH RAISE Early Treatment Program. Schizophr Bull. 2016 Jul;42(4):896-906. doi: 10.1093/schbul/sbv224. Epub 2016 Jan 31.

Mueser KT, Penn DL, Addington J, Brunette MF, Gingerich S, Glynn SM, Lynde DW, Gottlieb JD, Meyer-Kalos P, McGurk SR, Cather C, Saade S, Robinson DG, Schooler NR, Rosenheck RA, Kane JM. The NAVIGATE Program for First-Episode Psychosis: Rationale, Overview, and Description of Psychosocial Components. Psychiatr Serv. 2015 Jul;66(7):680-90. doi: 10.1176/appi.ps.201400413. Epub 2015 Mar 16.

Fixsen DL, Blase KA, Van Dyke MK. Mobilizing communities for implementing evidence-based youth violence prevention programming: a commentary. Am J Community Psychol. 2011 Sep;48(1-2):133-7. doi: 10.1007/s10464-010-9410-1.

Arora S, Kalishman S, Dion D, Som D, Thornton K, Bankhurst A, Boyle J, Harkins M, Moseley K, Murata G, Komaramy M, Katzman J, Colleran K, Deming P, Yutzy S. Partnering urban academic medical centers and rural primary care clinicians to provide complex chronic disease care. Health Aff (Millwood). 2011 Jun;30(6):1176-84. doi: 10.1377/hlthaff.2011.0278. Epub 2011 May 19.

Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, Parish B, Burke T, Pak W, Dunkelberg J, Kistin M, Brown J, Jenkusky S, Komaromy M, Qualls C. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011 Jun 9;364(23):2199-207. doi: 10.1056/NEJMoa1009370. Epub 2011 Jun 1.

Sockalingam S, Arena A, Serhal E, Mohri L, Alloo J, Crawford A. Building Provincial Mental Health Capacity in Primary Care: An Evaluation of a Project ECHO Mental Health Program. Acad Psychiatry. 2018 Aug;42(4):451-457. doi: 10.1007/s40596-017-0735-z. Epub 2017 Jun 7.

Henderson J, Brownlie E, Rosenkranz S, Chaim G, Beitchman J. Integrated Knowledge Translation and Grant Development: Addressing the Research Practice Gap through Stakeholder-informed Research. J Can Acad Child Adolesc Psychiatry. 2013 Nov;22(4):268-74.

Henderson JL, Cheung A, Cleverley K, Chaim G, Moretti ME, de Oliveira C, Hawke LD, Willan AR, O'Brien D, Heffernan O, Herzog T, Courey L, McDonald H, Grant E, Szatmari P. Integrated collaborative care teams to enhance service delivery to youth with mental health and substance use challenges: protocol for a pragmatic randomised controlled trial. BMJ Open. 2017 Feb 6;7(2):e014080. doi: 10.1136/bmjopen-2016-014080.

Ferrari M, Flora N, Anderson KK, Tuck A, Archie S, Kidd S, McKenzie K; ACE Project Team. The African, Caribbean and European (ACE) Pathways to Care study: a qualitative exploration of similarities and differences between African-origin, Caribbean-origin and European-origin groups in pathways to care for psychosis. BMJ Open. 2015 Jan 14;5(1):e006562. doi: 10.1136/bmjopen-2014-006562.

Lester H, Khan N, Jones P, Marshall M, Fowler D, Amos T, Birchwood M. Service users' views of moving on from early intervention services for psychosis: a longitudinal qualitative study in primary care. Br J Gen Pract. 2012 Mar;62(596):e183-90. doi: 10.3399/bjgp12X630070.

Hui CLM, Lo MCL, Chan EHC, Chen ESM, Ko RWT, Lee EHM, Chang WC, Chan SKW, Chen EYH. Perception towards relapse and its predictors in psychosis patients: A qualitative study. Early Interv Psychiatry. 2018 Oct;12(5):856-862. doi: 10.1111/eip.12378. Epub 2016 Aug 29.

Connell M, Schweitzer R, King R. Recovery from first-episode psychosis and recovering self: A qualitative study. Psychiatr Rehabil J. 2015 Dec;38(4):359-64. doi: 10.1037/prj0000077. Epub 2014 Jun 9.

Nilsen L, Norheim I, Frich JC, Friis S, Røssberg JI. Challenges for group leaders working with families dealing with early psychosis: a qualitative study. BMC Psychiatry. 2015 Jul 2;15:141. doi: 10.1186/s12888-015-0540-8.

Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. Epub 2011 Jun 8.

de Oliveira C, Cheng J, Rehm J, Kurdyak P. The Economic Burden of Chronic Psychotic Disorders in Ontario. J Ment Health Policy Econ. 2016 Dec 1;19(4):181-192.

Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98.

Leifker FR, Patterson TL, Heaton RK, Harvey PD. Validating measures of real-world outcome: the results of the VALERO expert survey and RAND panel. Schizophr Bull. 2011 Mar;37(2):334-43. doi: 10.1093/schbul/sbp044. Epub 2009 Jun 12.

Zarate CA Jr, Weinstock L, Cukor P, Morabito C, Leahy L, Burns C, Baer L. Applicability of telemedicine for assessing patients with schizophrenia: acceptance and reliability. J Clin Psychiatry. 1997 Jan;58(1):22-5.

Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0. Review.

Meyers DC, Durlak JA, Wandersman A. The quality implementation framework: a synthesis of critical steps in the implementation process. Am J Community Psychol. 2012 Dec;50(3-4):462-80. doi: 10.1007/s10464-012-9522-x. Review.

Fortney J, Enderle M, McDougall S, Clothier J, Otero J, Altman L, Curran G. Implementation outcomes of evidence-based quality improvement for depression in VA community based outpatient clinics. Implement Sci. 2012 Apr 11;7:30. doi: 10.1186/1748-5908-7-30.

Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23.

Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

Kessler RS, Purcell EP, Glasgow RE, Klesges LM, Benkeser RM, Peek CJ. What does it mean to "employ" the RE-AIM model? Eval Health Prof. 2013 Mar;36(1):44-66. doi: 10.1177/0163278712446066. Epub 2012 May 21.

Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013 May 10;8:51. doi: 10.1186/1748-5908-8-51.

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Layout table for additonal information

Responsible Party:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT03919760 History of Changes
Other Study ID Numbers:	MY9-158586
First Posted:	April 18, 2019 Key Record Dates
Last Update Posted:	April 18, 2019
Last Verified:	April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No: There is not a plan to make IPD available. The results of this study will guide evaluation: of the extent to which programs operating in different contexts with different resources are able to implement NAVIGATE as intended; of the extent to which all eligible program patients receive NAVIGATE; that will assess contextual factors (stakeholder perceptions of acceptability, appropriateness, feasibility) that help or hinder use of NAVIGATE. that will inform wider efforts to adapt NAVIGATE and tailor implementation (adaptability and scalability).

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Centre for Addiction and Mental Health:


Implementation Science Youth and Emerging Adults First Episode Psychosis Schizophrenia	Mental Health Psychiatric Services NAVIGATE

Additional relevant MeSH terms:

Layout table for MeSH terms

Disease Schizophrenia Psychotic Disorders Mental Disorders Mood Disorders	Schizophrenia Spectrum and Other Psychotic Disorders Affective Disorders, Psychotic Schizophrenia, Childhood Pathologic Processes Neurodevelopmental Disorders

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