OnTrackNY's Learning Healthcare System

NCT04021719 | Suspended

• 2 other identifiers: 78405R01MH120597
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

First Episode Psychosis

Keywords

First Episode Psychosis; Learning Healthcare system; Stakeholders; Data infrastructure; Psychotic disorders; Mental disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Outcome Measures

Primary Outcomes (3)

• Participation in work and school

  Participation in competitive employment and/or degree-based education program, as assessed in OnTrackNY assessment instruments

  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

  Up to 5 years

• Hospitalization rates

  Decreases in rates of psychiatric hospitalization per quarter, as assessed in OnTrackNY assessment instruments

  Up to 5 years

Study Arms (1)

OnTrackNY LHS Participants and Stakeholders

OnTrackNY participants and stakeholders, including past participants, family members, clinicians, administrators, payors, and state leadership

Other: Stakeholder feedback; Other: Data infrastructure

Interventions

Data infrastructure OTHER

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.

OnTrackNY LHS Participants and Stakeholders

Stakeholder feedback OTHER

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

OnTrackNY LHS Participants and Stakeholders

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OnTrackNY participants at an OnTrackNY site (currently 28 sites statewide) or other stakeholders.

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: collaborator
• New York University: collaborator
• Washington University School of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator
• New York State Psychiatric Institute: lead

Study Sites (1)

OnTrackNY Central

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 34225817 DERIVED

• 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.

  PMID: 34013257 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Lisa B Dixon, MD, MPH

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Iruma Bello, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: August 15, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)