AzTrials
AzTrials

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.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

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.

United States1 site
  • OnTrackNY Central

    New York, New York, 10032

Other trials in United States

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.

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 groups in NCT04021719
Study groupRoleWhat they receive
OnTrackNY LHS Participants and StakeholdersOnTrackNY 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.

  1. 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

  2. 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

  3. 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.

  1. First posted16 Jul 2019
  2. Study start15 Aug 2019
  3. Primary completion30 Dec 2026 (estimated)
  4. 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

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)
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 34225817
  • Patel 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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in