Early Psychosis Intervention - Spreading Evidence-based Treatment

NCT03919760 | Completed

• 1 other identifier: MY9-158586
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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. 1.Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve.
2. 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. 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. 4.The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.

Conditions

First Episode Psychosis; Psychosis; Schizophrenia, Childhood; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Bipolar I Disorder; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic; Psychotic Disorder Due to Unspecified Substance

Keywords

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

Outcome Measures

Primary Outcomes (19)

• Hypothesis 1: Fidelity/Adaptability

  First Episode Psychosis Service-Fidelity Scale (FEPS-FS) will be used to assess fidelity of service delivery to the current standard of early psychosis intervention in relation to 32 program-specific items (individual and team practices) on a 5-point scale from "1=not implemented" to "5=fully implemented". Ratings for each site will be made through a remote assessment process that includes a review of site administrative data, data abstracted from client health records, and phone interviews with site staff. Site will be the unit of analysis. Descriptive statistics (percentages, means, medians, range) will be reported for the total scale score and for subscale scores that align with NAVIGATE components. Fidelity scores will be calculated per site in relation to the four core NAVIGATE interventions using measurements of service utilization. Total and subscale scores will be an average of item scores, reported out of 5.

  Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and end of study [approx. year 4]

• Hypothesis 1: Penetration/Scalability

  To determine whether implementation of NAVIGATE is associated with improvement in fidelity to the EPI standard, program staff will document delivery of core modules for each of the four interventions. We will calculate the percentage of core modules completed per intervention per patient to assess penetration and to identify variations in delivery both within sites and across sites. Additionally, we will calculate frequency of team activities (e.g., weekly meetings, direct supervision) and assess staff perceived competence in delivery of NAVIGATE using the Readiness Monitoring Tool and the competency assessment questionnaires completed at the conclusion of each ECHO cycle.

  End of study [approx. year 4]

• Hypothesis 1: Contextual Factors

  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.

  End of study [approx. year 4]

• Hypothesis 1: Sustainability

  Staff attendance during ECHO sessions will indicate ECHO engagement and retention.

  Ongoing throughout study [years 2-4 inclusive]

• Hypothesis 1: Sustainability

  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.

  Prior to ECHO participation [approx. year 2] and end of study [approx. year 4]

• Hypothesis 1: Affordability

  The investigators will employ a costing algorithm developed in SAS®, and available at ICES, to estimate all direct patient-level health care costs incurred by the public third-party payer (Ontario Ministry of Health and Long-Term Care) across the three comparison groups. Included will be costs of hospitalizations (both non-psychiatric and psychiatric); ED visits; physician services (i.e. primary care, psychiatry and other care) and diagnostics tests; outpatient prescription drugs for individuals covered under the provincial public drug insurance plan only (for individuals under 65 who receive social assistance and for individuals under age 25 who lack private insurance coverage); home care; and other care (this includes other ambulatory care, such as same-day surgery/procedures, cancer and dialysis clinic visits, and other hospital-based care, such as rehabilitation and complex continuing care).

  End of study [approx. year 4]

• Hypothesis 2: System-Level: Number of psychiatric hospitalization days in the year following NAVIGATE admission

  Propensity scores will be used to compare NAVIGATE participants with 2 groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment. The primary outcome is days in hospital (psychiatric hospitalizations) in the year following NAVIGATE admission.

  End of study [approx. year 4]

• Hypothesis 2: System-Level: Time to first psychiatric hospitalization

  Propensity scores will be used to compare NAVIGATE participants with 2 comparison groups: 1) FEP patients attached to EPI programs who are not participating in the NAVIGATE trial; and 2) FEP patients with no EPI program attachment. Hospitalization-based outcomes assessed include time to first psychiatric hospitalization.

  End of study [approx. year 4]

• Hypothesis 3: Assessment for diagnosis

  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.

  Admission to clinic [month 0, 12, 24]

• Hypothesis 3: Assessment of clinical psychopathology [BPRS]

  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.

  Admission to clinic [months 0, 6, 12, 18, 24]

• Hypothesis 3: Assessment of clinical psychopathology [PHQ-9]

  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).

  Admission to clinic [month 0, 6, 12, 18, 24]

• Hypothesis 3: Assessment of clinical psychopathology [QLS]

  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).

  Admission to clinic [month 0, 6, 12, 18, 24]

• Hypothesis 3: Assessment of illness severity and improvement

  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).

  Admission to clinic [month 0, 6, 12, 18, 24]

• Hypothesis 3: Assessment of functioning [WHODAS 2.0]

  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).

  Admission to clinic [month 0, 6, 12, 18, 24]

• Hypothesis 3: Assessment of parental socio-economic status

  Parental and participant education will be used as indicator of SES.

  Admission to clinic [month 0]

• Hypothesis 3: Measurement of Service Utilization

  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.

  Month 6, 12, 18, 24

• Hypothesis 4: Engagement

  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.

  End of implementation [approx. year 2], Study end [approx. year 4]

• Hypothesis 4: Engagement [PPEET/PCORI]

  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.

  After the first engagement [approx. year 1]. end of implementation [approx. year 2]

• Hypothesis 4: Engagement [Interview]

  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.

  After first engagement [approx. year 1], End of the implementation [approx. year 2], study end [approx. year 4]

Secondary Outcomes (2)

• Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts

  End of study [approx. year 4]

• Hypothesis 3: Demographics

  Admission to clinic [month 0]

Study Arms (3)

NAVIGATE EPI

EXPERIMENTAL

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

Non-NAVIGATE EPI

ACTIVE COMPARATOR

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).

Behavioral: Treatment as Usual

Non-EPI

NO INTERVENTION

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).

Interventions

NAVIGATE BEHAVIORAL

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

NAVIGATE EPI

Treatment as Usual BEHAVIORAL

Received standard Ontario EPI clinical services.

Non-NAVIGATE EPI

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• Absence of psychosis
• Inability to provide informed consent to participate in the research study

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Institute for Clinical Evaluative Sciences: collaborator
• North Bay Regional Health Centre: collaborator
• Health Sciences North: collaborator
• Niagara Region Public Health: collaborator
• Lakeridge Health Corporation: collaborator
• Canadian Mental Health Association - Waterloo Wellington: collaborator
• Canadian Mental Health Association - Thunder Bay: collaborator

Study Sites (6)

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

North Bay Regional Health Centre

North Bay, Ontario, P1B 0A4, Canada

Location

Durham Amaze- Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

Location

Niagara Region Public Health

Thorold, Ontario, L2V 4Y6, Canada

Location

First Place Clinic and Regional Resource Centre

Thunder Bay, Ontario, P7A4K9, Canada

Location

CMHA Waterloo Wellington

Waterloo, Ontario, N2J 4M1, Canada

Location

Related Publications (73)

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

  PMID: 9764119 BACKGROUND

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

  PMID: 9764127 BACKGROUND

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

  PMID: 10842426 BACKGROUND

• 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.

  PMID: 28398566 BACKGROUND

• 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.

  PMID: 28923795 BACKGROUND

• 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.

  PMID: 28498599 BACKGROUND

• Hjorthoj C, Sturup 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.

  PMID: 28237639 BACKGROUND

• 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. doi: 10.1136/bmj.38246.594873.7C. Epub 2004 Oct 14.

  PMID: 15485934 BACKGROUND

• 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. doi: 10.1007/s00127-004-0754-4.

  PMID: 15133591 BACKGROUND

• 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. doi: 10.1111/j.1600-0447.2006.00799.x.

  PMID: 17022792 BACKGROUND

• 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.

  PMID: 29495897 BACKGROUND

• Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen 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. doi: 10.1136/bmj.38565.415000.E01. Epub 2005 Sep 2.

  PMID: 16141449 BACKGROUND

• 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. doi: 10.1177/070674370705200904.

  PMID: 17953160 BACKGROUND

• 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.

  PMID: 25016950 BACKGROUND

• 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.

  PMID: 28941089 BACKGROUND

• Jaaskelainen 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.

  PMID: 23172003 BACKGROUND

• 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.

  PMID: 26063472 BACKGROUND

• 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.

  PMID: 28886669 BACKGROUND

• 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.

  PMID: 26481174 BACKGROUND

• 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.

  PMID: 25366518 BACKGROUND

• 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.

  PMID: 27254094 BACKGROUND

• 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.

  PMID: 20199477 BACKGROUND

• 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.

  PMID: 21272277 BACKGROUND

• 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.

  PMID: 27032665 BACKGROUND

• 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.

  PMID: 25830446 BACKGROUND

• 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.

  PMID: 27667369 BACKGROUND

• 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.

  PMID: 26834024 BACKGROUND

• 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.

  PMID: 25772766 BACKGROUND

• 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.

  PMID: 21203828 BACKGROUND

• 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.

  PMID: 21596757 BACKGROUND

• 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.

  PMID: 21631316 BACKGROUND

• 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.

  PMID: 28593537 BACKGROUND

• 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.

  PMID: 24223045 BACKGROUND

• 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.

  PMID: 28167747 BACKGROUND

• 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.

  PMID: 25588783 BACKGROUND

• 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.

  PMID: 22429435 BACKGROUND

• 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.

  PMID: 27573207 BACKGROUND

• 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.

  PMID: 24912055 BACKGROUND

• Nilsen L, Norheim I, Frich JC, Friis S, Rossberg 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.

  PMID: 26134829 BACKGROUND

• 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. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.

  PMID: 21818162 BACKGROUND

• 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.

  PMID: 27991417 BACKGROUND

• 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. doi: 10.1093/schbul/10.3.388.

  PMID: 6474101 BACKGROUND

• 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.

  PMID: 19525354 BACKGROUND

• 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. doi: 10.4088/jcp.v58n0104.

  PMID: 9055833 BACKGROUND

• 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.

  PMID: 18322790 BACKGROUND

• 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.

  PMID: 22644083 BACKGROUND

• 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.

  PMID: 22494428 BACKGROUND

• 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.

  PMID: 19104929 BACKGROUND

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 22615498 BACKGROUND

• 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.

  PMID: 23663819 BACKGROUND

• Damschroder LJ, Moin T, Datta SK, Reardon CM, Steinle N, Weinreb J, Billington CJ, Maciejewski ML, Yancy WS Jr, Hughes M, Makki F, Richardson CR. Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial. Implement Sci. 2015 May 12;10:68. doi: 10.1186/s13012-015-0250-0.

  PMID: 25962598 BACKGROUND

• Zhou C, Crawford A, Serhal E, Kurdyak P, Sockalingam S. The Impact of Project ECHO on Participant and Patient Outcomes: A Systematic Review. Acad Med. 2016 Oct;91(10):1439-1461. doi: 10.1097/ACM.0000000000001328.

  PMID: 27489018 BACKGROUND

• Moore DE Jr, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. J Contin Educ Health Prof. 2009 Winter;29(1):1-15. doi: 10.1002/chp.20001.

  PMID: 19288562 BACKGROUND

• Scott VC, Kenworthy T, Godly-Reynolds E, Bastien G, Scaccia J, McMickens C, Rachel S, Cooper S, Wrenn G, Wandersman A. The Readiness for Integrated Care Questionnaire (RICQ): An instrument to assess readiness to integrate behavioral health and primary care. Am J Orthopsychiatry. 2017;87(5):520-530. doi: 10.1037/ort0000270. Epub 2017 Apr 10.

  PMID: 28394156 BACKGROUND

• Kurdyak P, Lin E, Green D, Vigod S. Validation of a Population-Based Algorithm to Detect Chronic Psychotic Illness. Can J Psychiatry. 2015 Aug;60(8):362-8. doi: 10.1177/070674371506000805.

  PMID: 26454558 BACKGROUND

• Gatov E, Kurdyak P, Sinyor M, Holder L, Schaffer A. Comparison of Vital Statistics Definitions of Suicide against a Coroner Reference Standard: A Population-Based Linkage Study. Can J Psychiatry. 2018 Mar;63(3):152-160. doi: 10.1177/0706743717737033. Epub 2017 Oct 23.

  PMID: 29056088 BACKGROUND

• Saunders NR, Lebenbaum M, Stukel TA, Lu H, Urquia ML, Kurdyak P, Guttmann A. Suicide and self-harm trends in recent immigrant youth in Ontario, 1996-2012: a population-based longitudinal cohort study. BMJ Open. 2017 Sep 1;7(9):e014863. doi: 10.1136/bmjopen-2016-014863.

  PMID: 28864687 BACKGROUND

• Steele LS, Glazier RH, Lin E, Evans M. Using administrative data to measure ambulatory mental health service provision in primary care. Med Care. 2004 Oct;42(10):960-5. doi: 10.1097/00005650-200410000-00004.

  PMID: 15377928 BACKGROUND

• Wodchis WP, Austin PC, Henry DA. A 3-year study of high-cost users of health care. CMAJ. 2016 Feb 16;188(3):182-188. doi: 10.1503/cmaj.150064. Epub 2016 Jan 11.

  PMID: 26755672 BACKGROUND

• Doyle R, Turner N, Fanning F, Brennan D, Renwick L, Lawlor E, Clarke M. First-episode psychosis and disengagement from treatment: a systematic review. Psychiatr Serv. 2014 May 1;65(5):603-11. doi: 10.1176/appi.ps.201200570.

  PMID: 24535333 BACKGROUND

• Herman DB, Susser ES, Jandorf L, Lavelle J, Bromet EJ. Homelessness among individuals with psychotic disorders hospitalized for the first time: findings from the Suffolk County Mental Health Project. Am J Psychiatry. 1998 Jan;155(1):109-13. doi: 10.1176/ajp.155.1.109.

  PMID: 9433347 BACKGROUND

• Anderson KK, Flora N, Ferrari M, Tuck A, Archie S, Kidd S, Tang T, Kirmayer LJ, McKenzie K; ACE Project Team. Pathways to First-Episode Care for Psychosis in African-, Caribbean-, and European-Origin Groups in Ontario. Can J Psychiatry. 2015 May;60(5):223-31. doi: 10.1177/070674371506000504.

  PMID: 26174526 BACKGROUND

• Anderson KK, McKenzie KJ, Kurdyak P. Examining the impact of migrant status on ethnic differences in mental health service use preceding a first diagnosis of schizophrenia. Soc Psychiatry Psychiatr Epidemiol. 2017 Aug;52(8):949-961. doi: 10.1007/s00127-017-1403-z. Epub 2017 Jun 10.

  PMID: 28601943 BACKGROUND

• Nagendra A, Schooler NR, Kane JM, Robinson DG, Mueser KT, Estroff SE, Addington J, Marcy P, Penn DL. Demographic, psychosocial, clinical, and neurocognitive baseline characteristics of Black Americans in the RAISE-ETP study. Schizophr Res. 2018 Mar;193:64-68. doi: 10.1016/j.schres.2017.06.038. Epub 2017 Jul 11.

  PMID: 28709773 BACKGROUND

• Whitbeck LB, Sittner Hartshorn KJ, Crawford DM, Walls ML, Gentzler KC, Hoyt DR. Mental and substance use disorders from early adolescence to young adulthood among indigenous young people: final diagnostic results from an 8-year panel study. Soc Psychiatry Psychiatr Epidemiol. 2014 Jun;49(6):961-73. doi: 10.1007/s00127-014-0825-0. Epub 2014 Feb 2.

  PMID: 24488151 BACKGROUND

• Soleimani A, Rosychuk RJ, Newton AS. Predicting time to emergency department re-visits and inpatient hospitalization among adolescents who visited an emergency department for psychotic symptoms: a retrospective cohort study. BMC Psychiatry. 2016 Nov 9;16(1):385. doi: 10.1186/s12888-016-1106-0.

  PMID: 27825324 BACKGROUND

• Bolton SL, Sareen J. Sexual orientation and its relation to mental disorders and suicide attempts: findings from a nationally representative sample. Can J Psychiatry. 2011 Jan;56(1):35-43. doi: 10.1177/070674371105600107.

  PMID: 21324241 BACKGROUND

• Zeldin S, Christens BD, Powers JL. The psychology and practice of youth-adult partnership: bridging generations for youth development and community change. Am J Community Psychol. 2013 Jun;51(3-4):385-97. doi: 10.1007/s10464-012-9558-y.

  PMID: 23054170 BACKGROUND

• Tambuyzer E, Pieters G, Van Audenhove C. Patient involvement in mental health care: one size does not fit all. Health Expect. 2014 Feb;17(1):138-50. doi: 10.1111/j.1369-7625.2011.00743.x. Epub 2011 Nov 10.

  PMID: 22070468 BACKGROUND

• Abelson J, Li K, Wilson G, Shields K, Schneider C, Boesveld S. Supporting quality public and patient engagement in health system organizations: development and usability testing of the Public and Patient Engagement Evaluation Tool. Health Expect. 2016 Aug;19(4):817-27. doi: 10.1111/hex.12378. Epub 2015 Jun 25.

  PMID: 26113295 BACKGROUND

• Forsythe LP, Ellis LE, Edmundson L, Sabharwal R, Rein A, Konopka K, Frank L. Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned. J Gen Intern Med. 2016 Jan;31(1):13-21. doi: 10.1007/s11606-015-3450-z. Epub 2015 Jul 10.

  PMID: 26160480 BACKGROUND

• Kozloff N, Foussias G, Durbin J, Sockalingam S, Addington J, Addington D, Ampofo A, Anderson KK, Barwick M, Bromley S, Cunningham JEA, Dahrouge S, Duda L, Ford C, Gallagher S, Haltigan JD, Henderson J, Jaouich A, Miranda D, Mitchell P, Morin J, de Oliveira C, Primeau V, Serhal E, Soklaridis S, Urajnik D, Whittard K, Zaheer J, Kurdyak P, Voineskos AN. Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults. BMJ Open. 2020 Jun 3;10(6):e034280. doi: 10.1136/bmjopen-2019-034280.

  PMID: 32499262 DERIVED

Related Links

• World Economic Forum and the Harvard School of Public Health. (2011) Methodological Appendix: The Global Economic Burden of Non-Communicable Diseases.
• Ministry of Health and Long-Term Care (2011). Early Psychosis Intervention Program Standards
• Fixsen DL, Blasé KA, Naoom SF, Wallace F. Core Implementation Components. Research on Social Work Practice. 2009 Sep;19(5):531-540.
• 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
• 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.
• United States Congress. Public Law 114-270-Dec. 14, 2016.
• Youth Services System Review - Report
• Youth Service System Review: Phase 2 Report. CAMH
• Measuring health and disability: Manual for WHO Disability Assessment Schedule WHODAS 2.0. Geneva: World Health Organization.
• 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
• Children's Participation: From tokenism to citizenship, Innocenti Essay no. 4, International Child Development Centre, Florence (1992).
• Patient Engagement and Canada's SPOR Initiative. McMaster University (2015).
• CIHR's Citizen Engagement Handbook (2012).
• Briefing notes for researchers: involving the public in NHS, public health and social care research.
• PCORI Engagement Rubric (2014).
• Strategy for Patient-Oriented Research: Patient Engagement Framework (2014).
• Marshall MN. Sampling for Qualitative Research. Family Practice.1996 Dec;13(6):522-525.
• Patient and Public Engagement Evaluation Toolkit. Centre of Excellence on Partnership Patients and the Public.

MeSH Terms

Conditions

Schizophrenia, Childhood; Psychotic Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will recruit participants from 6 EPI programs across various geographic regions in Ontario. Recruitment will be gradually phased in, after which time sites will proceed with full recruitment.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 18, 2019
• Study Start: January 3, 2020
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: March 18, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final data that has not yet been published will be shared after acceptance of publication of the relevant paper.
• Access Criteria: The requesting investigator requires appropriate approval (see above).

Locations

CA (6)