Notice of Intent to Publish a Funding Opportunity Announcement for A Practice-Based Research Network to Transform Mental Health Care: Science, Service Delivery & Sustainability (U19 Clinical Trial Required)NOT-MH-18-014 24 2018N/AN/A Notice Intent Publish Funding Opportunity Announcement A Practice-Based Research Network Transform Mental Health Care: Science, Service Delivery & Sustainability U19 Clinical Trial Required) Notice Number: NOT-MH-18-014 Key Dates Release Date:January 24, 2018 Estimated Publication Date Funding Opportunity Announcement: 03/01/2018  First Estimated Application Due Date: 06/01/2018 Earliest Estimated Award Date: 03/01/2019 Earliest Estimated Start Date: 03/01/2019 Related Announcements None Issued National Institute Mental Health NIMH) Purpose NIMH intends publish Funding Opportunity Announcement FOA) Cooperative Agreement U19) solicit applications a practice-based research network transform mental health care.   planned FOA support practice-based research network the United States transform development, delivery, sustainability evidence-based mental health practices services. Through research consortium embedded within large integrated healthcare delivery systems, Network result a continuously learning healthcare system defined the Institute Medicine, create ldquo;a continuous cycle feedback loop which scientific evidence informs clinical practice while data gathered clinical practice administrative sources inform scientific investigation.” Network support wide range practice-based research, including pragmatic comparative effectiveness trials focused optimizing testing scalable preventive therapeutic interventions services research focused identifying intervening mutable factors increase access, engagement, continuity, equity, efficiency/value, quality mental health care. Leveraging practice-based networks platforms launching large-scale studies offers efficient alternative those conducted de novo trials.   Demonstrable capacities efficiencies needed accomplish following: Rapidly identify, recruit enroll large representative patient populations effectiveness pragmatic trials align NIMH priorities; Harmonize electronic health record EHR) data across multiple integrated systems research use, include EHR phenotyping; Collect biologic material future analyses; Provide rapid responses address urgent questions federal, state, other key stakeholders e.g., questions related the clinical epidemiology mental disorders and/or questions related the uptake and outcomes associated mental health interventions best practices); Study low base-rate events e.g., suicide, autism spectrum disorders, first episode psychosis, other mental health conditions are difficult identify, predict, treat, manage) using advancing innovative methodologies e.g., predictive analytics) resources capitalize the network’s unique sophistication health information technology, overall size, research efficiencies; Test strategies reduce disparities mental health status, service utilization, quality care, treatment outcomes the health people mental illness, including disparities medical comorbidities among adults serious mental illness youth serious emotional disturbance; Develop strategies using implementation science secure stakeholder commitment adopt, implement, scale-up, sustain best practices the patient, provider, health system levels.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects.  FOA expected be published March 2018 an expected application due date June 2018.   FOA utilize U19 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area begin consider applying this new FOA. NETWORK GOALS   Network expected function a resource the broad mental health research community, its impact be assessed through achievement the following activities: Maintaining accessibility relevant patient, provider, health system data; Facilitating coordinating access these data research conducted Network-affiliated non-affiliated investigators using approaches solutions optimize use the Network are conducive collaborative efforts; Maintaining high levels expertise competency scientific areas relevant the Network, US healthcare system stakeholders, federal, state, other key stakeholders; Facilitating interactions research collaborations among non-network affiliated) mental health researchers might benefit these data; Increasing participation Network-affiliated non-affiliated investigators independently funded research, including efforts increase number, scope, scientific impact research projects conducted external investigators collaboration the Network; Ensuring study samples include adequate representation disparity populations examine disparity reductions mental health status, service utilization, treatment outcomes the health people mental illness, including disparities medical comorbidities among adults serious mental illness youth serious emotional disturbance; Building established relationships relevant constituent groups e.g., patients, providers, administrators, payors, relevant federal state agencies) inform research questions, attending front-end infrastructure secure stakeholder commitment adopt, implement sustain successful practices products developed within Network;  Developing testing strategies using implementation science) encourage adoption, quality, scale-up, sustainability new innovations existing best practices; Developing maintaining capacity rapidly respond and address urgent questions Network-affiliated healthcare system partners, well federal, state, other key stakeholders; Advancing expertise research methodology ldquo;big data” science, attention implementing findings these advances routine practice; Conducting well-powered studies, include least large-scale pragmatic trial described below) definitively answer research question high importance impact whose findings, whether positive negative, be used the Network’s healthcare system(s) improve practice an identifiable measurable way; Conducting pilot projects described below directly funded the Network) will allow Network external investigators develop competitive applications funding large-scale research projects; Including mid-career investigators positions leadership fostering careers junior investigators;  Developing utilizing simulation approaches model potential public health impact implementing research informed approaches to guide decision making; Harnessing perspectives new emerging fields e.g., health information communications technology, health systems engineering, decision science, behavioral economics) transform clinical research practice. practice-based research network mental health capitalize the successes and lessons learned other such networks mental health other disease areas.     OVERALL STRUCTURE THE NETWORK   effectively conduct large pilot projects to achieve aforementioned network goals, proposed practice-based research network structure be encompassed within Administrative Methods Core.    Administrative Core (three functional units): 1) Organizational Unit coordinate Network’s administrative functions, provide organizational administrative support activities, coordinate evaluation the Network's research, efficiencies created the Network, public health impact its activities.    2) Outreach External Collaboration Unit work increase usage the Network Network non-Network investigators, manage requests data resources, coordinate opportunities junior mid-career investigators, disseminate approaches research findings products.   3) Emerging Issues Unit develop rapid systematic capability response real-time inquiries policy practice relevant requests Network federal, state, other stakeholders leaders.  rapid responses capitalize Network data thus must include data pulls data analysis network healthcare systems.  will also require synthesis available literature.  capacity include transparent process clarify key question(s) being asked, level detail the response, the format timeline a response.     Methods Core (two functional units):    1) Informatics Unit the key component the Network resource function. Unit should organized support Network informatics infrastructure, notably including data warehouse, to continue improvements data development, informatics tools, etc. Informatics Unit should coordinate informatics-related efforts individual Network member sites well interact other Units Projects below) support functions.   2) Scientific Analysis Unit organized generate new methodology apply state the art analytic approaches the fields big data science, health services research, implementation science.  unit should provide consultation analytic support network affiliated projects develop, identify, engage putative change mechanisms health system research.   Large Pragmatic Trial (clinical trial required):   least large pragmatic trial should proposed part the application. trial should address significant problem the prevention, treatment, management, and/or delivery services people mental disorders served the health systems affiliated the Network. topic should align closely NIMH strategic research priorities, the topic should demonstrated be such value the affiliated healthcare system(s) a priori, is well-developed plan how definitive findings whether are positive negative) affect practice. trial should similar scope an R01 terms the research question(s), because Network infrastructure be leveraged, should significant demonstrative efficiencies created if study conducted de novo.       be responsive, trial design must follow NIMH experimental therapeutics approach; applicants strongly encouraged model RCT the NIMH R01 funding announcement clinical trials test effectiveness treatment, preventive, services interventions and   trial should a pragmatic clinical trial which, depending upon level evidence implementation readiness, should designed a hybrid effectiveness-implementation clinical trial Type I, II, III.    Pilot Projects:   Applications pilot projects should include innovative approaches consistent the goals this current announcement. pilots should seek optimize improve care a diverse population patients within defined healthcare systems the network; develop and/or test new platforms, risk algorithms, decision support systems, preventive, therapeutic, services interventions; reduce health disparities engaging intervention targets; improve methodologies systems research, and/or seek strategies continuously improve accessibility, quality, continuity, equity value services delivered within network.   pilots should modeled the NIMH R34 funding announcement clinical trials non-trial services research  Pilots or not clinical trials. any pilot is clinical trial, NIMH experimental therapeutics paradigm must followed research questions should similar type scope those supported the NIMH R34 mechanism.   is expected by leveraging infrastructure the network the healthcare systems, efficiencies be created an order magnitude compared similar studies conducted de novo. Pilot projects should involve network-affiliated well non-affiliated investigators wherever possible.   Markers Successful Practice Based Research Network   successful network accomplish following tasks within period the award: Build extend capacity the network conduct prospective trials via successful completion multiple pilot studies types interventions yet studied such networks.  Successfully complete least large pragmatic trial high impact the mental health functioning a large representative population, where positive negative findings lead measurable improvements practice across Network sites. Benchmark costs conducting range studies the network compared historical norms progress toward network-involved trials be completed costs an order magnitude below prior norms relative similar studies conducted de novo. Expand tools create efficiency the rapid conduct effectiveness, services, implementation research studies the network. business models foster data sharing, create efficiencies collaborating network-affiliated non-network-affiliated healthcare systems, strengthen self-sustainability the Network. Successfully disseminate trial results health system Network partners resulting significant change policy and/or practice a direct result study findings. Rapidly disseminate research findings high quality journals consistent NOT-OD-16-149 NOT-OD-18-011. Dissemination Network generated research products, including methodological/analytic approaches, assessment intervention approaches materials, sharable programing e.g., technology based applications), de-identified data. NIMH invest 2 million per year this 5-year project i.e., 10 million total costs over project period).   Foreign institutions NOT eligible apply.   is planned foreign components U.S. institutions be eligible apply.    Funding Information Estimated Total Funding TBD Expected Number AwardsTBD Estimated Award CeilingTBD Primary CFDA NumbersTBD Anticipated Eligible Organizations Non-domestic non-U.S.) Entity Foreign Organization) Applications not being solicited this time. Inquiries Please direct inquiries to: Michael C. Freed, Ph.D., EMT-B  National Institute Mental Health  301-443-3747