Enhancing Evidence-Based Practice for Youth and Emerging Adults With Early Psychosis: Implementation and Evaluation in Diverse Service Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Hypothesis 1: Contextual Factors
研究概览
简要总结
Implementation of 'NAVIGATE' in Ontario aims to help youth and emerging adults suffering from a first episode of psychosis. Although Ontario already has early psychosis intervention programs, the team's recent work has identified major challenges of delivering coordinated care, particularly those elements of care that enhance recovery. These challenges also exist nationally and internationally. By building on the already existing early psychosis intervention community of practice through the Early Psychosis Intervention Ontario Network, the investigators will implement NAVIGATE with the help of CAMH's Provincial System Support Program facilitators. The use of tele-videoconferencing through ECHO Mental Health Ontario and ECHO processes and protocols provide us with an opportunity to ensure sustainability. Using health administrative data held at the Institute for Clinical Evaluative Sciences (ICES), the investigators can examine system-level outcomes, including hospitalizations, emergency department visits, and outpatient physician visits of youth and emerging adults suffering from a first episode psychosis who are treated with NAVIGATE compared with those treated in early psychosis intervention programs without NAVIGATE and those who are not treated in early psychosis intervention programs. In addition, the investigators can also evaluate health care costs. Prior to initiating this project, the investigators obtained the input of youth and emerging adults with a first episode psychosis and family members. The investigators will also continue to measure engagement across the study.
Hypotheses:
- Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve.
- Compared to patients not receiving NAVIGATE, those who receive NAVIGATE through this implementation study will have fewer days in hospital, fewer emergency department visits, fewer suicide attempts, lower mortality, and lower healthcare costs.
- Improvements in functioning and symptoms will be comparable to the RAISE study (an earlier study assessing NAVIGATE); improvement may be influenced by demographic, socio-economic, geographic, and clinical factors.
- The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •Absence of psychosis
- •Inability to provide informed consent to participate in the research study
研究组 & 干预措施
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).
干预措施: NAVIGATE (Behavioral)
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).
干预措施: Treatment as Usual (Behavioral)
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).
结局指标
主要结局
Hypothesis 1: Contextual Factors
时间窗: End of study [approx. year 4]
The Consolidated Framework for Implementation Research (CFIR) will be used to systematically assess contextual factors that are associated with effective implementation. The CFIR constructs are organized within five major domains: intervention characteristics (e.g., complexity, relative advantage); outer setting (e.g., external policy, patient needs); inner setting (e.g., resources, fit, leadership); staff characteristics (e.g., knowledge, beliefs); and implementation process (e.g., facilitation, planning, coaching). The CFIR will be used to develop a semi-structured interview to guide data collection. Interviews will be conducted with stakeholders at each site (EPI staff, organization leaders) at the end of the study, recorded, and transcribed.
Hypothesis 1: Affordability
时间窗: 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 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).
Hypothesis 2: System-Level: Number of psychiatric hospitalization days in the year following NAVIGATE admission
时间窗: End of study [approx. year 4]
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.
Hypothesis 3: Assessment of illness severity and improvement
时间窗: Admission to clinic [month 0, 6, 12, 18, 24]
The Clinical Global Impressions Scale (CGI) will be administered to characterize overall illness severity. It rates both illness severity and improvement. It takes into account all available information, including knowledge of the patient's history, psychological circumstances, symptoms, behaviour, and the impact of the symptoms on the patient's ability to function. Structured interview, illness and improvement score range 0-7 (higher = worse severity/least improvement).
Hypothesis 3: Assessment of functioning [WHODAS 2.0]
时间窗: Admission to clinic [month 0, 6, 12, 18, 24]
WHO Disability Assessment Schedule 2.0: assessment of functioning to provide an assessment of health and disability. Scoring will be done using item-response theory. It takes the coding for each item response as "none", "mild", "moderate", "severe" and "extreme" separately, and then uses an algorithm to determine the summary score by differentially weighting the items and the levels of severity. Domain and total scores will be produced (total score range 0 to 100, where 0 = no disability; 100 = full disability).
Hypothesis 3: Assessment of parental socio-economic status
时间窗: Admission to clinic [month 0]
Parental and participant education will be used as indicator of SES.
Hypothesis 2: System-Level: Time to first psychiatric hospitalization
时间窗: End of study [approx. year 4]
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.
Hypothesis 3: Measurement of Service Utilization
时间窗: Month 6, 12, 18, 24
The Service Use and Resource Form (SURF) will be used to measure utilization of mental health and other medical services across residential, inpatient, and outpatient treatment settings. This will be administered by research staff either over the phone or via email survey, based on participant preference.
Hypothesis 4: Engagement
时间窗: End of implementation [approx. year 2], Study end [approx. year 4]
The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. Semi-structured interviews will be conducted with patients, families, and NAVIGATE staff members.
Hypothesis 4: Engagement [Interview]
时间窗: After first engagement [approx. year 1], End of the implementation [approx. year 2], 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.
Hypothesis 1: Sustainability
时间窗: Prior to ECHO participation [approx. year 2] and end of study [approx. year 4]
A competency assessment questionnaire will be administered to staff to assess changes in attitudes, knowledge and self-efficacy (self-reported competence) in delivering NAVIGATE components. Question domains will include Likert scales assessing self-reported knowledge and skill domains specific to the NAVIGATE model. Self-efficacy questions will focus on key competency domains of NAVIGATE and assess confidence in delivering these components in their local settings.
Hypothesis 3: Assessment of clinical psychopathology [PHQ-9]
时间窗: Admission to clinic [month 0, 6, 12, 18, 24]
The self-report Patient Health Questionnaire - 9 (PHQ-9) will be used to characterize the presence and severity of depressive symptoms. Higher score = worse symptoms (range 0-27).
Hypothesis 4: Engagement [PPEET/PCORI]
时间窗: After the first engagement [approx. year 1]. end of implementation [approx. year 2]
The investigators will build on experiential knowledge to further evaluate NAVIGATE from the patient and family perspective. This particular approach will engage patients and family members to build on qualitative work regarding acceptability, feasibility, and preference for NAVIGATE, i.e. coordinated, manualized EPI care. A modified (simplified/combined) PPEET (Public and Patient Engagement Evaluation Tool) \& PCORI engagement activity inventory will be administered to Youth and Family Advisory Members.
Hypothesis 3: Assessment of clinical psychopathology [BPRS]
时间窗: Admission to clinic [months 0, 6, 12, 18, 24]
The Brief Psychiatric Rating Scale (BPRS) (24 item) will be used to assess the severity of positive symptoms, psychosis, negative symptoms, and general psychopathology. Scores range from 2-7 for each item (7 indicates worse symptoms). Total score is a sum ranging from 48-168.
Hypothesis 1: Fidelity/Adaptability
时间窗: Exploration stage of implementation [approx. year 1], following implementation [approx. year 2] and 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 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.
Hypothesis 3: Assessment of clinical psychopathology [QLS]
时间窗: Admission to clinic [month 0, 6, 12, 18, 24]
The Intrinsic Motivation Factor of the Quality of Life Scale (QLS) will serve as a specific measure of motivation to augment the above psychopathology measures. Semi-structured interview (subscale item) score range 0-6 (higher score = higher intrinsic motivation).
Hypothesis 1: Penetration/Scalability
时间窗: End of study [approx. year 4]
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.
Hypothesis 1: Sustainability
时间窗: Ongoing throughout study [years 2-4 inclusive]
Staff attendance during ECHO sessions will indicate ECHO engagement and retention.
Hypothesis 3: Assessment for diagnosis
时间窗: Admission to clinic [month 0, 12, 24]
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.
次要结局
- Hypothesis 2: System-Level: Emergency Department Visits and Suicide Attempts(End of study [approx. year 4])
- Hypothesis 3: Demographics(Admission to clinic [month 0])