Schizophrenia Clinical Trial
— EPI-SETOfficial title:
Enhancing Evidence-Based Practice for Youth and Emerging Adults With Early Psychosis: Implementation and Evaluation in Diverse Service Settings
NCT number | NCT03919760 |
Other study ID # | MY9-158586 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2020 |
Est. completion date | May 31, 2024 |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | North Bay Regional Health Centre | North Bay | Ontario |
Canada | Durham Amaze- Lakeridge Health | Oshawa | Ontario |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | Niagara Region Public Health | Thorold | Ontario |
Canada | First Place Clinic and Regional Resource Centre | Thunder Bay | Ontario |
Canada | CMHA Waterloo Wellington | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Canadian Institutes of Health Research (CIHR), Canadian Mental Health Association - Thunder Bay, Canadian Mental Health Association - Waterloo Wellington, Health Sciences North, Institute for Clinical Evaluative Sciences, Lakeridge Health Corporation, Niagara Region Public Health, North Bay Regional Health Centre |
Canada,
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* Note: There are 72 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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] | |
Primary | 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. | Month 48 | |
Primary | 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] | |
Primary | Hypothesis 1: Sustainability | Staff attendance during ECHO sessions will indicate ECHO engagement and retention. | Ongoing throughout study [years 2-4 inclusive] | |
Primary | 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] | |
Primary | Hypothesis 1: Affordability | The investigators will employ a costing algorithm developed in SASĀ®, 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | 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] | |
Primary | Hypothesis 3: Assessment of parental socio-economic status | Parental and participant education will be used as indicator of SES. | Admission to clinic [month 0] | |
Primary | 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 | |
Primary | 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] | |
Primary | 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] | |
Primary | 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 | Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts | 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. |
End of study [approx. year 4] | |
Secondary | Hypothesis 3: Demographics | 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. | Admission to clinic [month 0] |
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