Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional)

Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Encourages pilot studies to implement and sustain evidence-based mental health services in community settings.

Expired PAR-25-278: Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) National Institute on Drug Abuse ( NIDA ) Funding Opportunity Title Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This notice of funding opportunity (NOFO) solicits exploratory/developmental research applications within the learning health care framework to support adoption, implementation, sustainability, and continuous improvement of evidence-based practices in outpatient mental health and substance use treatment systems.

These settings could include, but are not limited to, Certified Community Behavioral Health Clinics (CCBHCs) funded through the Substance Abuse and Mental Health Services Administration (SAMHSA) expansion grant program and CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or as a part of independent state programs where the CCBHCs are meeting the federal CCBHC certification criteria.

This NOFO requires active collaboration between behavioral health researchers and community behavioral health partners across all phases of the research process.

Studies that are co-designed between community clinic staff/service users and health services researchers may focus on (1) identifying subgroups within the population of individuals served by CCBHCs with unique needs, including health disparities experienced by people from racial and ethnic minority groups or underserved communities; (2) workforce development strategies, including new approaches to train providers who vary in terms of prior experience, expertise and skills; (3) developing and testing tools to promote measurement-based treatment; (4) hybrid effectiveness-implementation trials aimed at implementing and improving evidence-based prevention, treatment, or services delivery approaches in real-world settings; and (5) research to establish and/or expand 988 crisis response services within CCBHC settings.

Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description This notice of funding opportunity (NOFO) solicits exploratory/developmental research applications within the learning health care framework to support adoption, implementation, sustainability, and continuous improvement of evidence-based practices in outpatient mental health and substance use treatment systems.

These settings could include, but are not limited to, Certified Community Behavioral Health Clinics (CCBHCs) funded through the Substance Abuse and Mental Health Services Administration (SAMHSA) expansion grant program and CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or as a part of independent state programs where the CCBHCs are meeting the federal CCBHC certification criteria.

This NOFO requires active collaboration between behavioral health researchers and community behavioral health partners across all phases of the research process.

Studies that are co-designed between community clinic staff/service users and health services researchers may focus on (1) identifying subgroups within the population of individuals served by CCBHCs with unique needs, including health disparities experienced by people from racial and ethnic minority groups or underserved communities; (2) workforce development strategies, including new approaches to train providers who vary in terms of prior experience, expertise and skills; (3) developing and testing tools to promote measurement-based treatment; (4) hybrid effectiveness-implementation trials aimed at implementing and improving evidence-based prevention, treatment, or services delivery approaches in real-world settings; and (5) research to establish and/or expand 988 crisis response services within CCBHC settings.

This R34 funding opportunity extends NIMH and NIDA support for practice-oriented research that aims to advance implementation, sustainability, continuous improvement, and effectiveness of evidence-based practices, which may include adaptations of established evidence-based practices, in community-based mental or general medical health care settings.

SAMHSA encourages such studies in Certified Community Behavioral Health Clinics established though recent CCBHC expansion grant initiatives, CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or CCBHCs that are part of independent state programs where the CCBHCs are meeting the federal CCBHC certification criteria.

The purpose of the CCBHC initiative is to increase access to comprehensive, coordinated, and person-centered behavioral health care for all persons seeking mental health and/or substance uses services, including individuals with serious mental illness (SMI) or substance use disorders; children and adolescents with serious emotional disturbance (SED); and individuals with co-occurring mental and substance disorders.

Elements required in CCBHCs include 24/7 crisis intervention and stabilization services; screening, assessment, and diagnosis, including risk assessment; outpatient mental health and substance use treatment; outpatient primary care screening and monitoring of key health indicators; targeted case management; psychiatric rehabilitation; peer support and peer counselor services; and intensive community-based mental health care for military service members and veterans.

CCBHC certification criteria encourage participating clinics to (1) deliver evidence-based practices; (2) collect data on clinical encounters, quality of services, and patient outcomes; and (3) evaluate program effectiveness regarding access to care, scope and quality of services, and behavioral health care costs.

These requirements 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 NOFO encourages practice-oriented research to advance data-driven learning health care in community-based mental health and substance use treatment settings, including CCBHCs, leading to better knowledge and tools that are informed by clinical teams and patients for implementing, sustaining, and optimizing evidence-based, high quality, and effective services. NIMH Strategic Objective 4. 2.

A advocates strong science-practice partnerships in the development of research projects that produce generalizable findings that can improve care for all people with mental illness, including those with SMI, SED, substance use disorders, and other co-occurring conditions, throughout the United States.

To be responsive to this NOFO, applicants must involve clinical practice partners in the scientific development of the project and have institutional support for applying study findings to influence clinical practice within the outpatient mental health treatment setting.

To this end, applicants must have an advisory board whose membership includes clinical practice partners and/or clinical practice partners as key personnel on the project. Clinical practice partners could include, but are not limited to, community behavioral health practitioners, clinic leaders, service user advocates, and/or policymakers. .

Examples of healthcare delivery organizations include current CCBHC expansion grant awardees and Federally Qualified Health Centers that provide comprehensive mental health and substance use services. An example of an organization charged to deliver implementation support is the SAMHSA-funded Technical Assistance (TA) Center .

Examples of high priority research topics include, but are not limited to the following: Projects that seek to identify mutable patient, provider, organization, or community-level factors that impact access, initial and sustained engagement, continuity, utilization, quality, and outcomes of evidence-based services offered in outpatient mental health and substance use treatment settings and represent potential targets for intervention.

Studies that test novel strategies that can be used to reduce disparities, address social determinants of health, and advance effectiveness in availability, quality, and outcomes of mental health and substance use services for underserved groups, for example racial and ethnic minority groups, individuals impacted by language or cultural barriers and individuals living in rural areas.

Projects that seek to adapt established evidence-based practices to improve care for specific populations served by CCBHCs, including people from racial and ethnic minority groups or historically underserved communities or those who experience challenges related to underlying structural factors within communities that affect health, such as access to safe spaces, housing, healthy food, employment opportunities, transportation, and quality health care.

Projects that seek to test novel strategies or to adapt established evidence-based practices for outpatient mental health and substance use treatment settings to improve behavioral health care for vulnerable populations across the lifespan such as children, adolescents, older adults, and pregnant and postpartum people.

For example, CCBHC-supported behavioral health services including early childhood initiatives, school-based supports, disability and aging services, and perinatal/postpartum services.

Research that seeks to test novel strategies or to adapt established evidence-based practices for outpatient mental health and substance use treatment settings to improve care for justice-involved populations (e.g., CCBHC-supported behavioral health services including juvenile justice programs and re-entry services).

Research that evaluates whether intervention effectiveness, or successful implementation of evidence-based services, is mediated by individuals’ health-related social needs or other environmental conditions that affect mental health, functioning, or quality of life.

Projects are encouraged that test approaches for addressing health-related social needs such as employment, housing, transportation, food security, or other social determinants of health. For example, targeted case management, supported employment, psychiatric rehabilitation, or other social services that are integrated with behavioral health interventions.

Projects that seek to streamline evidence-based service delivery interventions for people with mental illness and other medical or behavioral health needs (e.g., opioid use disorder) to improve adoption, contextual fit, scalability, affordability, and sustainability of integrated care.

Projects that test/compare sustainable staff training and supervision approaches (e.g., technology-assisted training, expert telephone consultation, training approaches for alternate or extender staff) that can be used to train providers to initial competence in evidence-based practices, to monitor intervention quality, turnover, and to promote sustained fidelity in the delivery of research-supported services, across a range of clinical modalities, including telehealth, for people with mental illness and/or substance use disorders.

Cost-effectiveness of various approaches can also be considered. Projects that examine the mechanisms by which peer service providers may improve access, continuity, utilization, quality, and outcomes of evidence-based services in outpatient mental health and substance use treatment settings.

Projects that examine the mechanisms by which recovery support services and/or psychiatric rehabilitation services may improve engagement, continuity, utilization, quality, and outcomes of evidence-based services in outpatient mental health and substance use treatment settings.

Studies that identify barriers to implementing measurement-based care (MBC) in community-based mental health and substance use treatment settings that represent potential targets for intervention and/or studies that test targeted strategies to support implementation of MBC with fidelity and maintain MBC over time.

Projects focused on developing, refining, and/or testing the utility of screening, clinical assessment, and data reporting tools that support MBC (e.g., measures of risk, symptoms, and functioning, electronic health record documentation, paper-pencil questionnaires, mobile health technology, telephone monitoring), that can be used to assist providers and empower patients to track their progress.

Projects that implement and evaluate data-driven quality improvement approaches to suicide care in health systems, which may include adoption of zero suicide common data elements, monitoring key metrics for high quality suicide care, and using data visualization tools to track and communicate progress on effective care practices and patient outcomes.

Projects that employ Hybrid Type 2 and 3 Effectiveness-Implementation Trial designs to test the effectiveness of implementation strategies and measure clinical outcomes for prevention, treatment, or services interventions.

Type 2 designs simultaneously test the effectiveness of (a) implementation strategies and (b) promising prevention, treatment, or services interventions with some empirical support, but lacking sufficient evidence for inclusion in clinical practice guidelines.

Type 3 designs test strategies to implement prevention, treatment, or services interventions with strong extant evidence of effectiveness (e.g., recommended in a clinical practice guideline). Projects that develop and test practical shared decision-making strategies for children and adolescents with serious emotional disturbance and adults with serious mental illness.

Projects to develop and optimize care models that integrate primary care services into mental health treatment settings to reduce modifiable health risks associated with premature mortality in people with SMI, e.g., smoking, overweight and obesity, dyslipidemia, and other common cardiovascular disease risk factors.

Projects that test financing and payment strategies, including alternative payment models, that incentivize the implementation and sustainment of evidence-based practices and their effects on clinical, functional, and health services (e.g., access, continuity, and effectiveness of care) outcomes.

Projects focused on refining and testing the feasibility and utility of patient and provider facing technologies (e.g., SMS reminders, digital tracking, and action plan/workflow support) to support decision-making, evidence-based practices and interventions, treatment fidelity, and care integration .

Projects that seek to understand circumstances and test strategies to stop or reduce (i.e., “de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful in efforts to demonstrably free up resources and then implement a high-value EBP.

Projects to develop new components or unbundle or test the unique contributions of existing components (and/or combinations of components) of multi-component service delivery interventions using designs such as the following: factorial designs and their derivatives (e.g., fractional factorial); Multiphase Optimization STrategy (MOST); Sequential, Multiple Assignment, Randomized Trials (SMART); randomized encouragement; and interrupted time series designs or other quasi-experimental approaches, where randomization may not be possible.

Projects that optimize interventions and implementation approaches by testing implementation strategies and their alignment with school programs, medical facilities (e.g., primary care, emergency departments), the criminal justice system and/or employment settings for people with mental illness and other co-occurring conditions.

Studies that are designed to identify the specific components or underlying mechanisms that account for the effectiveness of best practices in the delivery of crisis services in community-based mental health and substance use care settings, where a wide range of clinical presentations, psychosocial factors, age-related (e.g., child; youth; adult; older adult), geographic (rural/remote settings), cultural considerations, and health disparities influence the types of crisis care provided.

Projects that address research topics listed in NOT-MH-23-140 , Notice of Special Interest: Priority Research Opportunities in Crisis Response Services.

This R34 NOFO supports projects designed to (1) examine the feasibility of learning health research approaches, (e.g., ability to recruit and retain participants); (2) refine and pilot test experimental protocols, including assessment protocols and experimental intervention protocols, as relevant; and (3) yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered R01-level studies.

The scope of research for such pilot research projects is generally analogous to the scope of research described in the NIMH R01 Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (PAR-25-178) or for the Innovative Pilot Mental Health Services Research Not Involving Clinical Trials ( PAR-23-105 ).

Depending on the research question, a variety of methodologically rigorous approaches may be indicated for proposed studies.

These may include randomized controlled trials, natural experiments, quasi-experimental designs with non-randomized comparison groups (including propensity score matching and instrumental variables designs), time-series designs, difference-in-difference, stepped wedge, and other designs of equivalent rigor and relevance.

Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the trade-off between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

Guidance Regarding Clinical Trials All applications that propose clinical trials testing mental health treatment or preventive interventions must follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www. nimh. nih.

gov/funding/opportunities-announcements/clinical-trials-foas/index. shtml ). That is, the scope of work should include the specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes.

The approach should involve exploring mediation and potential mechanisms, consistent with the pilot phase of research (i.e., fully powered analyses may not be possible).

In this manner, the results of the trial should advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).

Applications involving clinical trials that test mental health services interventions, policy interventions, and/or implementation strategies should employ methods that seek to understand how, why, for whom, and/or in what circumstances the intervention is effective. That is, methodology should go beyond assessing just whether an intervention is effective (or not).

Potential approaches include but are not limited to mediation analyses (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, and partial or full factorial designs.

For multi-component interventions, other methods to examine the direct effects of each of the intervention components on the ultimate intervention outcome (versus modelling such effects through target/mediator variables) could also be employed. The approach should be consistent with the pilot phase of the research (i.e., fully powered analyses may not be possible).

In this manner, the study results may be informative regardless of the primary outcomes (e.g., in the event of overall negative results, it may be informative to examine whether the intervention was effective in certain circumstances or for certain populations).

Projects seeking to adapt established evidence-based practices must provide an empirical rationale for the adaptation; a clear hypothesis and a plan to address how, why, and for whom the adapted intervention will enhance outcomes (e.g., an adaptation or augmentation might target a factor that has been previously shown to be associated with non-response, partial response, poor engagement, or relapse).

Applications Not Responsive to this NOFO. The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

Applications that do not include a clinical partner advisory board and/or involvement of clinical practice partners as key personnel (e.g., community behavioral health practitioners, clinic leaders, service user advocates, and/or policymakers).

That is, clinical practice partners must be involved in the scientific development of the project and have institutional support for applying study findings to influence clinical practice within the outpatient mental health treatment setting. Clinical trials testing mental health treatment or preventive interventions that do not follow NIMH’s experimental therapeutics approach to intervention development and testing (see https://www.

nimh. nih. gov/funding/opportunities-announcements/clinical-trials-foas/index.

shtml). That is, the scope of work for clinical trials testing treatment or preventive interventions must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes. Applications that propose adaptations of existing interventions in the absence of a justification for that adaptation.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Direct costs are limited to $450,000 over the R34 project period, with no more than $225,000 in direct costs allowed in any one year.

The total project period for an application submitted in response to this funding opportunity may not exceed three years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: The Research Strategy must include the following information: Factor 1.

Importance of the Research Describe the overall significance and potential impact of the proposed research on data-driven learning health care in community-based mental health treatment settings in relation to the state-of-the-art of the field.

Describe the likelihood that the project will generate knowledge and practices that advance implementation, sustainability, continuous improvement, and effectiveness of evidence-based practices in community-based mental health systems.

Detail how the proposed research will generate data that will lead to a conclusion about the feasibility of a regular research project grant or full-scale clinical trial and provide information about the anticipated scope and goals of intended future work. Projects should propose novel solutions to challenges in implementing and sustaining data-driven learning health care in community-based mental health treatment settings . Factor 2.

Rigor and Feasibility Describe how input from community behavioral health partners (e.g., service users, practitioners, CCBHC administrators, and/or policymakers) has contributed to the development and design of the research project.

Describe the methods by which community and research partners will collaborate, including but not limited to state-of-the-art team building methods, such as Team Science Approaches, Lean business methodology, Plan-Do-Study-Act (PDSA) cycles and interactive design teams.

Describe how the research project employs state-of-the-art methods in health services research, comparative effectiveness trials, implementation science, hybrid effectiveness-implementation designs, and/or learning health care research to study adoption, implementation, sustainability, continuous improvement, and outcomes of evidence-based practices in outpatient mental health treatment systems.

Explain how prior research informs the approach, including any preliminary data that may be available, that supports the feasibility, tolerability, acceptability and safety and preliminary effectiveness of approaches to improve mental health/functional outcomes, to modify risk factors, or to improve service delivery (e.g., improve access, continuity, quality, effectiveness, and value of care).

Discuss plans for rapid implementation of research findings to improve clinical practices in community-based mental health treatment settings . For clinical trials testing treatment or prevention interventions , specify an intervention target(s); include measures that assess the target(s) before and after exposure to an experimental intervention; and propose a data analysis plan that is consistent with the pilot phase of