Service-Ready Tools for Identification, Prevention, and Treatment of Individuals at Risk for Suicide (R43/R44 Clinical Trial Optional)

Research Strategy Applications should address the following additional issues: Rationale The rate of death by suicide in the United States has increased each year since 2005, from 11.0/100,000 to 14.8/100,000 of the population in 2018. Distinct subgroups have experienced even greater increases in the rate of suicide deaths during this period. With an estimated 20 suicide attempts per death by suicide, and millions of people seriously considering and/or making plans for death by suicide each year, the cumulative toll on public health is enormous. Simultaneously, the field of suicide prevention research has seen unprecedented growth during the past decade, with sustained investment in research and health-systems changes by both federal and non-profit organizations that provide hope for reducing the annual suicide rate if evidence-based strategies can be widely implemented and sustained. Consistent with the goals of the National Action Alliance for Suicide Prevention, NIMH seeks to support research on strategies that could be used to reduce the rate of suicide in the US. To realize this goal, it is imperative that suicide prevention strategies be brought to scale at a level not seen before. There is a chasm between what research has demonstrated are useful strategies for suicide prevention and what is often delivered in healthcare systems. To bridge this gap and aid in the systematic implementation of evidenced-based suicide prevention services, the NIMH seeks to fund small businesses to develop and test service-ready tools for identification, prevention, and treatment of individuals at risk for suicide. Research Scope and Objectives Examples of relevant research topics include but are not limited to: Delivery-oriented tools and technologies including mHealth platforms, existing passive sensing systems to enhance administration and precision of screening; Digital health based clinical decision-support tools for risk stratification that could facilitate efforts to match individuals to the appropriate intensity of services across service settings; sSystems-level strategies that incorporate predictive analytics, practice alerts, or clinical dashboards to reduce provider burden, facilitate surveillance of suicidal ideation and behaviors, and improve detection of at-risk individuals above and beyond what is possible with standard approaches; Service-ready technology-based preventive interventions and crisis management approaches that are of appropriate intensity/dose and are scalable, such that they can be delivered with fidelity by setting providers; Scalable mHealth approaches that can be used to safely and effectively promote engagement and continuity of care during high-risk transitions (e.g., following evaluation in the ED, post-discharge from inpatient treatment) within and across settings; Pragmatic technology-assisted strategies that can be used to monitor the quality of suicide prevention services in practice settings; and Technology-assisted strategies and other scalable approaches (e.g., sustainable models for expert telephone consultation) that can be used to train providers to initial competence, to monitor quality, and to promote sustained fidelity in the delivery of research-supported suicide prevention services across a range of clinical modalities, including telehealth. Applications should incorporate strategies to ensure the proposed tool is scalable and sustainable and would be expected to: Propose optimized, practice-ready technology-assisted strategies that can achieve or surpass benchmarks for screening, identification of cases, referral to evidence-based care, and suicide prevention outcomes reported in previous efficacy studies; Develop tools that can be integrated into practice with minimal reconfiguration; Incorporate design features that make the tools scalable and robust against implementation drift (e.g., using Technology as scaffolding or expert consultation via existing resources/ other sustainable means to support delivery); Utilize deployment-focused approaches with proactive attention to workforce capacity and system-level factors that influence uptake/implementation Given the focus on developing pragmatic, service-ready approaches, the scope of work should also include: plans to assess and examine consumer-, provider- and setting- level factors that might be associated with uptake, implementation fidelity, and sustained use of the approach that is being developed and tested; and plans to quantify the resources necessary to implement the tool or strategy (e.g., provider qualifications, training and supervision requirements, therapist administration/delivery time and burden). Because this FOA is intended to support the development and testing of scalable, sustainable approaches, applications that propose complex, provider-intensive approaches/interventions without incorporating features that can, by design, enhance scalability and sustained delivery with fidelity, will be considered of low priority for NIMH. For Clinical Trial Applications: Consistent with the NIMH experimental therapeutics approach, this Funding Opportunity Announcement (FOA) is intended to support studies that not only test the service tool’s effects on the outcomes of interest, but also inform understanding regarding the mechanisms of action of the service tool. As such, the scope of work must include specification of service tool targets/mechanisms and assessment of service tool-induced changes in the presumed targets/mechanisms that are hypothesized to account for the service tool outcomes (see Support for Clinical Trials at NIMH). In this manner, the results of the trial will 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 service tool was successful at engaging its targets can facilitate interpretation). NIMH encourages a deployment-focused model of intervention and services design and testing that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows), that are intended to implement optimized mental health interventions. This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure that the resultant interventions and service delivery strategies are acceptable to consumers and providers, to ensure that the approaches are feasible and scalable in the settings where individuals are served, and to ensure that the research results will have utility for end users and increase the likelihood that the end product will be commercially successful. NIMH encourages effectiveness research on potentially scalable preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between small businesses, academic researchers and clinical or community practice partners or networks are encouraged. When possible, studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), electronic medical records, administrative databases, patient registries, institutions with Clinical and Translational Science Awards) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) and to facilitate the collection of moderator data (e.g., clinical characteristics, biomarkers), longer-term follow-up data, and broader, stakeholder-relevant outcomes (e.g., mental health and general health care utilization, value and efficiency of intervention approaches). Information about the mission, strategic plan, and research interests of the NIMH can be found at the NIMH website: . Applicants are also strongly encouraged to review the information on Support for Clinical Trials at NIMH. Potential applicants are also strongly encouraged to consult with NIH staff as early as possible when developing plans for an application (see Scientific/Research Contacts, Section VII). This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and the goals of this FOA. Scale and Scope of Studies Covered Under this Announcement This FOA will utilize the R43 (Phase I) mechanism to support pilot studies that are designed: to examine the feasibility of the proposed tool/product, to provide an opportunity 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. Phase II applications (R44) should be focused on further development of the proposed tool/product and on testing hypotheses that are supported by Phase I project data. Phase II studies should be powered to definitively answer the primary research questions. All PD(s)/PI(s)s submitting clinical trials applications consistent with NIMH priorities are encouraged to visit the NIMH Clinical Trial web page and consult with Scientific/Research Staff regarding FOAs that are appropriately matched to the study scope and stage of intervention development and testing. Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. 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 and Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researcher). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in the NIMH notice and website. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII. Other Information for award authorities and regulations. See Section VIII. Other Information for award authorities and regulations.