First Episode PsychosisNCT04021719
OnTrackNY's Learning Healthcare System
An observational study of First Episode Psychosis, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Stakeholder feedback and Data infrastructure
- How many people
- 2,100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 30 Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: OnTrackNY participants at an OnTrackNY site (currently 28 sites statewide) or other stakeholders.
Who may be able to join
- OnTrackNY participants are individuals age 16-30 who have experienced non-affective psychoses for less than two years and have enrolled at an OnTrackNY site. Other stakeholders include past OnTrackNY participants, family members, clinicians, administrators, payors and agency leadership.
Who cannot join
- Not meeting inclusion criteria specified above
Trial locations and contacts
1 site in 1 country.
About this study
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. OnTrackNY has grown into a 22-site network, under the leadership of Lisa Dixon, MD, MPH.
Created and supported by the New York State's Office of Mental Health (OMH), OnTrackNY is a nationally recognized model providing coordinated specialty care (CSC) for adolescents and young adults within two years of the onset of non-affective psychosis. OMH regulates and licenses all mental health programs in New York and is a direct-services provider via state-operated programs statewide. This makes OMH an ideal partner for establishing a statewide learning health care system for early psychosis care. Further, OnTrackNY's administration, OnTrackCentral, operates within the OMH-supported Center for Practice Innovations at Columbia Psychiatry. In this model, OnTrackCentral serves as the hub and the 22 OnTrackNY programs serve as the spokes. Since 2014, the still-growing OnTrackNY network has served over 1,600 individuals. From its inception, OnTrackNY has aimed to deliver high-quality, data-driven, accountable and culturally competent care consistent with an LHS. As a condition of funding, all OnTrackNY providers follow established protocols that require submission of patient- and site-level standard measures of early psychosis clinical features, services, and treatment outcomes.
The proposed EPINET regional hub, the OnTrackNY LHS, will emphasize and enhance two critical foundational components - Aim 1: proactively engage stakeholders to optimize understanding of key problems and their solutions at every LHS phase; and Aim 2: develop data systems with enhanced standardized data collection, including post-discharge data and linkages to external data systems, and enhancing data analytics that will allow for client-level treatment planning and prospective analytics, delivering real time, dynamic and actionable information to stakeholders. These LHS components do not follow in a stepwise sequence but instead operate in parallel and interact to facilitate and enhance quality improvement processes. This backbone will support the development of practice-based research.
Read the detailed description
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of NIMH's creation of a national learning health care system (LHS) for early psychosis care. As a continuation of the NIMH-supported RAISE-Implementation and Evaluation Study, OnTrackNY has grown into the 22-site (and still expanding) network under the leadership of Lisa Dixon, MD, MPH. OnTrackNY is a nationally recognized model for providing CSC for adolescents and young adults within two years of the onset of non-affective psychosis. OnTrackNY sites are located in licensed outpatient clinics at community agencies, state-operated facilities, and community and academic hospitals in urban, suburban, and rural areas throughout New York. This network has served over 1,600 individuals to date, with 451 new enrollees in calendar year 2017. Thanks to its sponsorship by the New York State Office of Mental Health (OMH), OnTrackNY has progressed to meet its goal of providing CSC to any young person with early psychosis in New York State, regardless of ability to pay. OnTrackNY includes OnTrackCentral-the "hub"-a team of nine staff, who provide training and technical assistance to sites and manage data collection, and the 22 teams which are its "spokes." From its inception, OnTrackNY has sought to deliver high-quality, data-driven, accountable care consistent with an LHS. (See Facilities for details on sites.)
The Foundations of a LHS in OnTrackNY: Several factors facilitated OnTrackNY's LHS foundations: 1) OnTrackNY evolved from the data-oriented RAISE-Implementation and Evaluation Study; 2) its location within the Center for Practice Innovations, an OMH-funded and empirically driven technical assistance center for scaling up evidence-based practices housed within Columbia Psychiatry; and 3) a strong commitment by OMH to high quality, accountable care. OnTrackCentral obtains stakeholder input from clinicians, program directors and state administrators. All OnTrackNY teams are contractually obligated to follow established protocols requiring specific service components and standardized client- and site-level measures for treating first episode psychosis (FEP). OnTrackCentral provides ongoing technical assistance to support the model, identify programmatic gaps and problems, and facilitate practice-based learning and research.
The Opportunity for OnTrackNY to Build a Better LHS: EPINET provides the opportunity to leverage the nascent LHS foundations of OnTrackNY and build a large, state-of-the-art LHS for early psychosis care. The investigators propose to expand and restructure the continuous quality improvement (CQI) process to: (Aim 1) include key stakeholders at every phase of the LHS and (Aim 2) provide accurate and appropriate delivery of real-time data to clients and providers to facilitate measurement-based care.
LHS Frameworks and Conceptual Model: This LHS is based on the principles of the Institute of Medicine's (IOM) (now National Academy of Medicine) model for a continuously learning healthcare system which brings together stakeholders to review data and technologies to develop and apply strategies to improve quality and increase efficiency. The investigators will use the IOM's LHS model, operationalizing the components according to the six LHS phases described by the Group Health Cooperative. While this LHS model provides an aspirational roadmap for a cyclic improvement approach, significant knowledge gaps limit translation and implementation of knowledge into evidence-based communications, campaigns, guidelines and other tools, products, and interventions. The investigators will draw on the Knowledge to Action (KTA) framework, which guides knowledge translation and implementation activities within each phase of the LHS model. The KTA planning tool directs knowledge creation and action cycles through questions for stakeholders to consider during each LHS phase. Through an iterative process, knowledge creation begins with stakeholders, data and mixed methods practice- based research during the LHS Scanning and Surveillance phase. The Action Cycle outlines a process, representing the activities needed for knowledge to be implemented in practice. Knowledge is adapted to the local context, and barriers and facilitators to its use are explicitly assessed. Stakeholders are centrally involved in tailoring knowledge and interventions to those who will use it.
This proposal will thus build a stakeholder-driven LHS that will establish the data infrastructure needed to promote measurement-based treatment within a structure supporting continuous quality improvement which, in turn, supports practice-based research-with the overall goal of improving care and outcomes for individuals with early psychosis. This EPINET-supported LHS will create an engine to optimize the potential of CSC to improve the lives of people with schizophrenia.
- Conditions
- First Episode Psychosis
- Being tested
- Stakeholder feedback, Data infrastructure
- Keywords
- First Episode Psychosis, Learning Healthcare system, Stakeholders, Data infrastructure, Psychotic disorders, Mental disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stakeholder feedbackOther
Stakeholders, including OnTrackNY participants, past participants, family members, clinicians, administrators, payors and state leadership, will participate in a variety of activities to provide continuous quality improvement to the OnTrackNY program, including a Stakeholder Workgroup, interviews and focus groups
Data infrastructureOther
Data will be systematically collected as part of CQI activities, within a state-of-the-art data infrastructure that allows for client-level feedback to clients, providers and sites to improve quality of care.
| Study group | Role | What they receive |
|---|---|---|
| OnTrackNY LHS Participants and Stakeholders | OnTrackNY participants and stakeholders, including past participants, family members, clinicians, administrators, payors, and state leadership Receives: Other: Stakeholder feedback; Other: Data infrastructure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in work and school
Participation in competitive employment and/or degree-based education program, as assessed in OnTrackNY assessment instruments
Measured: Up to 5 years
MIRECC GAF occupational, social and symptom functioning
Improvements in occupational, symptom and social functioning, as measured by the MIRECC Global Assessment of Functioning (GAF) scores
Measured: Up to 5 years
Hospitalization rates
Decreases in rates of psychiatric hospitalization per quarter, as assessed in OnTrackNY assessment instruments
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Aug 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, New York University, Washington University School of Medicine, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Dixon, New York State Psychiatric Institute
- Investigators
- Lisa B Dixon, MD, MPH, Principal investigator, New York State Psychiatric InstituteIruma Bello, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021719
- Sponsor's protocol ID
- 7840
- Other IDs
- 5R01MH120597
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel SR, Bello I, Cabassa LJ, Nossel IR, Wall MM, Montague E, Rahim R, Mathai CM, Dixon LB. Adapting coordinated specialty care in the post-COVID-19 era: study protocol for an integrative mixed-methods study. Implement Sci Commun. 2021 Jul 5;2(1):72. doi: 10.1186/s43058-021-00178-x.
PubMed 34225817Patel S, Bello I, Cabassa LJ, Nossel IR, Wall MM, Montague E, Rahim R, Mathai CM, Dixon LB. Adapting Coordinated Specialty Care in the Post-COVID-19 Era: Study Protocol for an Integrative Mixed-methods Study. Res Sq [Preprint]. 2021 Apr 26:rs.3.rs-452200. doi: 10.21203/rs.3.rs-452200/v1.
PubMed 34013257
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnTrackNY's Learning Healthcare System
- ClinicalTrials.gov ID
- NCT04021719
- Acronym / sponsor ID
- 7840
- Conditions
- First Episode Psychosis
- Keywords
- First Episode Psychosis, Learning Healthcare system, Stakeholders, Data infrastructure, Psychotic disorders, Mental disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, New York University, Washington University School of Medicine, National Institute of Mental Health (NIMH)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. OnTrackNY has grown into a 22-site network, under the leadership of Lisa Dixon, MD, MPH.
Created and supported by the New York State's Office of Mental Health (OMH), OnTrackNY is a nationally recognized model providing coordinated specialty care (CSC) for adolescents and young adults within two years of the onset of non-affective psychosis. OMH regulates and licenses all mental health programs in New York and is a direct-services provider via state-operated programs statewide. This makes OMH an ideal partner for establishing a statewide learning health care system for early psychosis care. Further, OnTrackNY's administration, OnTrackCentral, operates within the OMH-supported Center for Practice Innovations at Columbia Psychiatry. In this model, OnTrackCentral serves as the hub and the 22 OnTrackNY programs serve as the spokes. Since 2014, the still-growing OnTrackNY network has served over 1,600 individuals. From its inception, OnTrackNY has aimed to deliver high-quality, data-driven, accountable and culturally competent care consistent with an LHS. As a condition of funding, all OnTrackNY providers follow established protocols that require submission of patient- and site-level standard measures of early psychosis clinical features, services, and treatment outcomes.
The proposed EPINET regional hub, the OnTrackNY LHS, will emphasize and enhance two critical foundational components - Aim 1: proactively engage stakeholders to optimize understanding of key problems and their solutions at every LHS phase; and Aim 2: develop data systems with enhanced standardized data collection, including post-discharge data and linkages to external data systems, and enhancing data analytics that will allow for client-level treatment planning and prospective analytics, delivering real time, dynamic and actionable information to stakeholders. These LHS components do not follow in a stepwise sequence but instead operate in parallel and interact to facilitate and enhance quality improvement processes. This backbone will support the development of practice-based research.
Detailed description
This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of NIMH's creation of a national learning health care system (LHS) for early psychosis care. As a continuation of the NIMH-supported RAISE-Implementation and Evaluation Study, OnTrackNY has grown into the 22-site (and still expanding) network under the leadership of Lisa Dixon, MD, MPH. OnTrackNY is a nationally recognized model for providing CSC for adolescents and young adults within two years of the onset of non-affective psychosis. OnTrackNY sites are located in licensed outpatient clinics at community agencies, state-operated facilities, and community and academic hospitals in urban, suburban, and rural areas throughout New York. This network has served over 1,600 individuals to date, with 451 new enrollees in calendar year 2017. Thanks to its sponsorship by the New York State Office of Mental Health (OMH), OnTrackNY has progressed to meet its goal of providing CSC to any young person with early psychosis in New York State, regardless of ability to pay. OnTrackNY includes OnTrackCentral-the "hub"-a team of nine staff, who provide training and technical assistance to sites and manage data collection, and the 22 teams which are its "spokes." From its inception, OnTrackNY has sought to deliver high-quality, data-driven, accountable care consistent with an LHS. (See Facilities for details on sites.)
The Foundations of a LHS in OnTrackNY: Several factors facilitated OnTrackNY's LHS foundations: 1) OnTrackNY evolved from the data-oriented RAISE-Implementation and Evaluation Study; 2) its location within the Center for Practice Innovations, an OMH-funded and empirically driven technical assistance center for scaling up evidence-based practices housed within Columbia Psychiatry; and 3) a strong commitment by OMH to high quality, accountable care. OnTrackCentral obtains stakeholder input from clinicians, program directors and state administrators. All OnTrackNY teams are contractually obligated to follow established protocols requiring specific service components and standardized client- and site-level measures for treating first episode psychosis (FEP). OnTrackCentral provides ongoing technical assistance to support the model, identify programmatic gaps and problems, and facilitate practice-based learning and research.
The Opportunity for OnTrackNY to Build a Better LHS: EPINET provides the opportunity to leverage the nascent LHS foundations of OnTrackNY and build a large, state-of-the-art LHS for early psychosis care. The investigators propose to expand and restructure the continuous quality improvement (CQI) process to: (Aim 1) include key stakeholders at every phase of the LHS and (Aim 2) provide accurate and appropriate delivery of real-time data to clients and providers to facilitate measurement-based care.
LHS Frameworks and Conceptual Model: This LHS is based on the principles of the Institute of Medicine's (IOM) (now National Academy of Medicine) model for a continuously learning healthcare system which brings together stakeholders to review data and technologies to develop and apply strategies to improve quality and increase efficiency. The investigators will use the IOM's LHS model, operationalizing the components according to the six LHS phases described by the Group Health Cooperative. While this LHS model provides an aspirational roadmap for a cyclic improvement approach, significant knowledge gaps limit translation and implementation of knowledge into evidence-based communications, campaigns, guidelines and other tools, products, and interventions. The investigators will draw on the Knowledge to Action (KTA) framework, which guides knowledge translation and implementation activities within each phase of the LHS model. The KTA planning tool directs knowledge creation and action cycles through questions for stakeholders to consider during each LHS phase. Through an iterative process, knowledge creation begins with stakeholders, data and mixed methods practice- based research during the LHS Scanning and Surveillance phase. The Action Cycle outlines a process, representing the activities needed for knowledge to be implemented in practice. Knowledge is adapted to the local context, and barriers and facilitators to its use are explicitly assessed. Stakeholders are centrally involved in tailoring knowledge and interventions to those who will use it.
This proposal will thus build a stakeholder-driven LHS that will establish the data infrastructure needed to promote measurement-based treatment within a structure supporting continuous quality improvement which, in turn, supports practice-based research-with the overall goal of improving care and outcomes for individuals with early psychosis. This EPINET-supported LHS will create an engine to optimize the potential of CSC to improve the lives of people with schizophrenia.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OnTrackNY LHS Participants and Stakeholders | – | Other: Stakeholder feedback, Other: Data infrastructureOnTrackNY participants and stakeholders, including past participants, family members, clinicians, administrators, payors, and state leadership |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OnTrackNY participants at an OnTrackNY site (currently 28 sites statewide) or other stakeholders.
Key inclusion criteria (1 listed)
- OnTrackNY participants are individuals age 16-30 who have experienced non-affective psychoses for less than two years and have enrolled at an OnTrackNY site. Other stakeholders include past OnTrackNY participants, family members, clinicians, administrators, payors and agency leadership.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria specified above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stakeholder feedbackStakeholders, including OnTrackNY participants, past participants, family members, clinicians, administrators, payors and state leadership, will participate in a variety of activities to provide continuous quality improvement to the OnTrackNY program, including a Stakeholder Workgroup, interviews and focus groups | Other | OnTrackNY LHS Participants and Stakeholders |
| Data infrastructureData will be systematically collected as part of CQI activities, within a state-of-the-art data infrastructure that allows for client-level feedback to clients, providers and sites to improve quality of care. | Other | OnTrackNY LHS Participants and Stakeholders |
Primary outcome
Participation in work and school
Time frame: Up to 5 years
Participation in competitive employment and/or degree-based education program, as assessed in OnTrackNY assessment instruments
MIRECC GAF occupational, social and symptom functioning
Time frame: Up to 5 years
Improvements in occupational, symptom and social functioning, as measured by the MIRECC Global Assessment of Functioning (GAF) scores
Hospitalization rates
Time frame: Up to 5 years
Decreases in rates of psychiatric hospitalization per quarter, as assessed in OnTrackNY assessment instruments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 34225817Patel SR, Bello I, Cabassa LJ, Nossel IR, Wall MM, Montague E, Rahim R, Mathai CM, Dixon LB. Adapting coordinated specialty care in the post-COVID-19 era: study protocol for an integrative mixed-methods study. Implement Sci Commun. 2021 Jul 5;2(1):72. doi: 10.1186/s43058-021-00178-x.
- Derived from this study: PubMed 34013257Patel S, Bello I, Cabassa LJ, Nossel IR, Wall MM, Montague E, Rahim R, Mathai CM, Dixon LB. Adapting Coordinated Specialty Care in the Post-COVID-19 Era: Study Protocol for an Integrative Mixed-methods Study. Res Sq [Preprint]. 2021 Apr 26:rs.3.rs-452200. doi: 10.21203/rs.3.rs-452200/v1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa B Dixon, MD, MPH principal investigator
New York State Psychiatric Institute
Iruma Bello, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Episode Psychosis, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in work and school (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.