Notice of Intent to Publish a Notice of Funding Opportunity for Early Psychosis Intervention Network (EPINET) Data Coordinating Center (U24 Clinical Trial Not Allowed)

Key Dates

• September 29, 2023 - Notice of Intent to Publish a Funding Opportunity Announcement for Early Psychosis Intervention Network (EPINET): Learning Health Care Research to Improve Mental Health Services and Outcomes (P01 Clinical Trial Optional) See Notice NOT-MH-23-295.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC). The ENDCC will develop infrastructure to facilitate large-scale, practice-oriented research across clinics offering evidence-based Coordinated Specialty Care (CSC) to persons experiencing a first episode of psychosis. This NOFO focuses on research tools and resources directed at (1) optimizing the EPINET Core Assessment Battery (CAB) to support learning health care studies within and across CSC research networks; (2) adapting and implementing the CAB for use in publicly funded CSC programs that aspire to measurement-based care; (3) optimizing the informatics infrastructure and pipelines necessary to gather, store, and upload de-identified, person-level data collected across participating EPINET research networks to the NIMH Data Archive (NDA); and (4) assembling individual network datasets into a national repository of early psychosis clinical features, interventions, and treatment outcomes to be shared with qualified investigators via the NDA. In addition, the ENDCC will provide operational and technical support to the EPINET Research Consortium to promote sharing of methods among research networks. 

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The NOFO is expected to be published in Fall 2023 with an expected application due date in Spring 2024

This NOFO will utilize the U24 activity code. Details of the planned NOFO are provided below.

Background

In 2019, the National Institute of Mental Health (NIMH) established the Early Psychosis Intervention Network (EPINET) to advance learning health methods in treatment programs that offer evidence-based Coordinated Specialty Care (CSC) to persons in the early stages of psychotic illness. EPINET scientific hubs and a national data coordinating center have established infrastructure to support data sharing and program evaluation and quality improvement activities across connected CSC programs, along with embedded research projects aimed at advancing knowledge about first episode psychosis populations, interventions, and recovery outcomes. 

This initiative, along with the companion Notice, NOT-MH-23-295, will continue NIMH support for practice-oriented, learning health care research that aims to improve early identification, clinical assessment, intervention effectiveness, service delivery, and long-term outcomes for youth and young adults experiencing an initial episode of psychosis. 

Research Objectives

The EPINET National Data Coordinating Center (ENDCC) is intended to conduct the following activities in support of projects funded under the companion Notice, NOT-MH-23-295:

• CSC clinical assessment, informatics, and data management infrastructure. The ENDCC will be responsible for building and maintaining informatics infrastructure and pipelines to gather and store de-identified person-level Core Assessment Battery (CAB) data submitted by EPINET scientific hubs, including CAB data dictionaries, validation tools, and quality metrics to ensure data completeness and integrity. The ENDCC will establish a reliable, efficient, and secure process for collecting CAB data on a quarterly basis, combining these data into an integrated longitudinal dataset, and submitting aggregated data to the NDA every six months. The ENDCC will propose a strategy for making aggregated CAB data Findable, Accessible, Interoperable, and Reusable (FAIR). 
• Developing data analysis, presentation and reporting tools. The ENDCC is responsible for developing data processing and visualization tools that leverage CAB information collected from large numbers of patients treated across CSC networks; support measurement-based care; and advance generalizable approaches for CSC fidelity monitoring and program evaluation/quality improvement activities that will benefit multiple CSC networks.
• Supporting the EPINET Research Consortium. The ENDCC is expected to provide operational and technical support to the EPINET Research Consortium to promote sharing of expertise, tools, and methods across the scientific hubs, and to facilitate cross-network communication and sharing about learning health care common best practices for addressing challenges in data collection, optimization, and analysis. The ENDCC is also expected to support the organization of annual research investigators meetings and recurring conference calls to allow consortium investigators to discuss new or emerging methods and techniques for data capture and analysis based on aggregated CAB data.
• Disseminating CSC clinical assessment, data management, and performance monitoring tools. The ENDCC is responsible for developing a web-based version of the CAB, including data visualization tools, CSC fidelity/quality readouts, and performance reports that meet the requirements of state and local mental health authorities. The ENDCC should propose plans for disseminating web-based clinical assessment infrastructure broadly, including technical assistance to support adoption of measurement-based care in publicly funded CSC programs. 

Research Team Expertise

It is expected that a PD/PI (or multiple PD/PIs) of the data coordinating center will have a strong track record, including peer-reviewed research publications and independent funding support, as well as a strong record of successful leadership of multi-site clinical research studies, including success in meeting project milestones and timelines. ENDCC team members are expected to have expertise and experience in bioinformatics and data processing appropriate for establishing and carrying out proposed methods for collecting, processing, and analyzing clinical practice data of various types. 

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310.

Potential applicants are strongly encouraged to consult with NIMH program staff when developing plans for an application. 

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Robert K. Heinssen, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0371
Email:  rheinsse@mail.nih.gov