Early Psychosis Intervention - Spreading Evidence-based Treatment

NCT03919760 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-07-29

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Institute for Clinical Evaluative Sciences

    collaborator OTHER
  • North Bay Regional Health Centre

    collaborator UNKNOWN
  • Health Sciences North

    collaborator OTHER
  • Niagara Region Public Health

    collaborator OTHER
  • Lakeridge Health Corporation

    collaborator OTHER
  • Canadian Mental Health Association - Waterloo Wellington

    collaborator UNKNOWN
  • Canadian Mental Health Association - Thunder Bay

    collaborator UNKNOWN
  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Aristotle Voineskos, MD, PhD · Centre for Addiction & Mental Health

  • George Foussias, MD, PhD · Centre for Addiction & Mental Health

  • Paul Kurdyak, MD, PhD · Centre for Addiction & Mental Health

  • Janet Durbin, PhD, MSc · Centre for Addiction & Mental Health

  • Sanjeev Sockalingam, MD · Centre for Addiction & Mental Health

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2023-05-31
Completion
2024-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919760 on ClinicalTrials.gov