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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
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

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.

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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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.

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


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:

  1. individualized medication management using a decision support tool;
  2. a package of psychoeducation and a blend of evidence-based psychotherapies called "individual resiliency training" (IRT);
  3. supported employment and education (SEE);
  4. 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).




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.

  6. Hypothesis 1: Sustainability [ Time Frame: Ongoing throughout study [years 2-4 inclusive] ]
    Staff attendance during ECHO sessions will indicate ECHO engagement and retention.

  7. 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.


  8. 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.


  9. 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).

  10. 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.


  11. 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.


  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. 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.

  17. 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).

  18. 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).

  19. 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.

  20. 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).

  21. 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).

  22. 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.

  23. 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).

  24. 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).

  25. 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.

  26. 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).

  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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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.

  34. 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).

  35. 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.

  36. 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).

  37. 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.

  38. 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).

  39. 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.

  40. 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).

  41. 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.

  42. 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).

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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 :
  1. 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.


  2. 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.



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


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
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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:

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:

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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).

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