Key Dates
- September 29, 2023 - Notice of Intent to Publish Funding Opportunity Announcement for Early Psychosis Intervention Network (EPINET) Data Coordinating Center (U24 Clinical Trial Not Allowed). See Notice NOT-MH-23-296.
National Institute of Mental Health (NIMH)
The National Institute of Mental Health intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications from scientific hubs to support learning health care research in clinics offering evidence-based Coordinated Specialty Care (CSC) to persons in the early stages of psychotic illness. For this NOFO, “early psychosis” is defined as the period spanning the onset of an affective or non-affective psychotic disorder and up to 5 years following the first episode of psychosis (FEP). Each scientific hub will link multiple early psychosis service programs through (1) the EPINET Core Assessment Battery (CAB) of early psychosis clinical features, CSC services, and treatment outcomes; (2) informatics tools to collect de-identified, person-level data across sites; and (3) a unified approach for analyzing pooled data and disseminating promising findings rapidly across the network. The P01 mechanism supports research that has multiple distinct but synergistic projects built around a clearly defined unifying central theme or well-defined overall objective.
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 P01 mechanism. 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. These complementary activities align with the Institute of Medicine vision of learning health care in which health systems provide effective treatments, evaluate care processes and outcomes systematically, strive for continuous improvement and innovation in care delivery, and utilize data collected in clinical practice to drive the process of scientific discovery.
This initiative, along with the companion EPINET National Data Coordinating Center (ENDCC; NOT-MH-23-296), will continue NIMH support for practice-oriented 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. The NOFO will seek applications for research within the learning health care framework to promote measurement-based care in real-world settings, personalized interventions to improve engagement and outcomes, and new approaches to eliminate racial and ethnic health disparities in early psychosis diagnosis and intervention.
Research Objectives
The NOFO will support practice-oriented research in a diverse set of “hub and spoke” CSC networks across the United States. For this initiative, a “hub” is the research anchor site of CSC services delivered across multiple clinical programs and provides scientific and technical expertise to support uniform assessment and data collection, data integration, data analysis, and data presentation across connected sites. “Spokes” are clinical programs that provide evidence-based care within the CSC model and are connected to the central hub through standard clinical measures included in the CAB, information technology, and a uniform data processing system. Scientific hubs must partner with 5 or more early psychosis intervention programs that offer CSC, practice measurement-based care (i.e., standardized clinical assessment, systematic monitoring of key outcomes, and timely feedback to clinicians about patients’ progress), and are committed to practice-oriented research aimed at improving CSC services and patient outcomes. In aggregate, CSC programs within each network will enroll ?125 persons each year in CSC services. To support data-driven learning health care in CSC programs, newly enrolled participants will be subject to CAB data collection at admission and subsequent longitudinal assessments at a minimum of every 6 months as part of routine care.
Program Project Structure
Applications submitted to this NOFO must include an Overall section, an Administrative Core responsible for the overall organization and management of the research program, and a minimum of two Learning Health research projects. In addition, Program Projects are expected to form an EPINET Research Consortium with each other, with the overarching goal of advancing learning health research and practice in early psychosis treatment systems.
Administrative Core (Required)
The Administrative Core is responsible for the overall organization and management of the research program, including (1) partnering with CSC programs for FEP that are adopting learning health care practices; (2) promoting effective communication and collaboration among service users, clinicians, program administrators, and scientists to boost participation in co-designed practice research; (3) fostering scientific interaction, sharing of resources, and monitoring of progress across complementary research projects; and (4) implementing the CAB across participating CSC programs and acquiring high quality practice data to support learning health research. Each Administrative Core will lead the scientific hub’s planning for consortium-related activities. In addition, the Administrative Core will establish an efficient and effective process for sending de-identified, patient-level CAB data, and raw and analyzed data from research projects to the ENDCC for eventual submission to the NIMH Data Archive (NDA).
Learning Health Research Projects (Required)
Learning Health Research Projects should reflect self-standing scientifically meritorious research efforts and must include at least one Clinical Practice Data Research Project and at least one Prospective Practice-Oriented Research Project. The individual projects should complement one another so that the research ideas, efforts, and outcomes of the overall program demonstrate the clinical utility and scientific impact of embedded research in early psychosis learning health care systems.
- The Clinical Practice Data Research Project(s) will include at least one research project that focuses on the practice-to-knowledge component of learning health care. This research project should use standardized measures of early psychosis clinical features, interventions, and treatment outcomes to examine service delivery across CSC programs and to identify opportunities for sustaining and/or improving evidence-based care. Such research might seek to identify mutable factors that impact access, continuity, utilization, quality, value, and outcomes of CSC, including disparities in outcomes, or scalability of services. Scientific hubs must use the CAB as the principal source of longitudinal clinical practice data for all newly enrolled patients and the Program Level Core Assessment Battery to collect information about CSC program characteristics. Supplementing CAB data with additional measures is permissible but should be justified based on the program evaluation, quality improvement, and/or implementation question being addressed and the design of the proposed study. Data science, predictive analytics, and other computational methods can be applied to CAB data to study FEP populations, clinical workflows, and the quality of CSC services in real-world settings.
- The Prospective Practice-Oriented Research Project(s) will include at least one research project that addresses the knowledge-to-practice component of learning health care. This project, which may include clinical trials, should explore service innovations that address unmet needs among persons with FEP or aim to support/expand the CSC workforce. Such research might address racial and ethnic disparities in early psychosis intervention, integration of primary care and health promotion services in CSC programs, strategies to strengthen career planning and progression among CSC participants, or developing scalable methods for training, supervising, promoting and retaining CSC team members. The prospective study should include plans for rapid implementation of promising practices across the CSC network to enhance routine care. Scientific hubs are strongly encouraged to use data collected via the CAB as the foundation for prospective studies. Additional measures are permissible but should be justified based on the clinical question, research design, and scientific and public health significance of the proposed study.
Scope of Research Projects
Applications may propose learning health research projects that are informed by existing pilot data and are adequately powered, analogous to the scope of research addressed in the NIMH R01 NOFOs for Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (PAR-21-130) or for Innovative Mental Health Services Research Not Involving Clinical Trials (PAR-23-095). In other cases where preliminary data are required, projects might be designed to examine the feasibility of the research approach, (e.g., feasibility of recruiting and retaining participants); to refine and pilot test the experimental protocols, including assessment protocols and the experimental intervention protocol, as relevant; and to yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered studies. The scope of research for such pilot research projects is generally analogous to the scope of research described in the NIMH R34 Research Mechanisms for Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (PAR-21-131) or for Pilot Services Research not Involving Clinical Trials (PAR-23-105).
Applications are Expected to Include the Following Items:
Administrative Core Executive Committee. Each P01 Project will have an Administrative Core Executive Committee that consists of representatives from each affiliated CSC program and Learning Health Research Projects.The goals of the Executive Committee are to (1) promote effective communication and collaboration among CSC service users, practitioners, and Research Projects Leaders involved in the P01; (2) exchange information about the Learning Health Research Projects; (3) facilitate meaningful innovation in clinical assessment, data management, data sharing, and CSC performance reporting; and (4) enhance the participation of FEP patients, family members, clinicians, and administrators in proposed research activities.
Interaction with the EPINET National Data Coordinating Center (ENDCC). The ENDCC will develop infrastructure necessary for combining separate network datasets into a national repository of early psychosis common data elements, clinical measures, and data processing tools. In addition, it will maintain an integrated national database of de-identified person-level CAB data from many thousands of patients who receive CSC services each year, as well as raw and analyzed data from Learning Health Research Projects. Each scientific hub will establish procedures for transmitting de-identified, person-level CAB information from all newly enrolled patients receiving services in associated CSC clinics, as well as Program-Level CAB data and raw and analyzed data from Learning Health Research Projects, to the ENDCC. The ENDCC will deposit all data submitted by the scientific hubs into the NDA within 6 months of collection. De-identified CAB data submitted by scientific hubs will become part of a readily accessible early psychosis data resource that will be made available to qualified investigators through the NDA.
Research Team Experience and Responsibilities. The PD/PI of the overall project will be responsible for the scientific, operational, administrative, and budgetary leadership of the Program. This individual will lead the Administrative Core and be responsible for managing day-to-day activities and monitoring overall progress of the P01 Project, including participant enrollment, longitudinal CAB data collection, and the completeness and quality of CAB and other prospective research data. The PD/PI will also lead one of the Learning Health Research Projects. For applications involving multiple PDs/PIs, effort may be divided between administrative and scientific duties. The PD(s)/PI(s) should be an outstanding and productive researcher with the experience, ability, and sufficient time commitment to fulfill the responsibilities listed above. Leaders of the individual research projects, which could include Early-Stage Investigators as MPIs, should be independent and experienced investigators in their respective fields with records of research productivity, including successful leadership of research programs and peer-reviewed research publications. Research teams should have past productive collaborations or there should be a strong collaborative environment for the proposed research project. All investigators should contribute to and share the responsibilities of fulfilling the P01 Program Project goals and objectives.
Plan for Enhancing Diverse Perspectives (PEDP). This NOFO will require a Plan for Enhancing Diverse Perspectives 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
TBD
TBD
Application budgets are limited to no more than $1,000,000 direct costs per year.
93.242
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
and Human Services (HHS)
