PREVENTION OF SUICIDAL BEHAVIOR IN OLDER PRIMARY CARE PATIENTS NIH Guide, Volume 26, Number 38, November 21, 1997 RFA: MH-98-002 P.T. National Institute of Mental Health Letter of Intent Receipt Date: February 2, 1998 Application Receipt Date: March 11, 1998 PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications to test models of depression recognition and treatment to prevent and reduce suicidal behavior in older patients in primary care settings. The purpose of this RFA is to encourage implementation of research studies with sufficient sample size and heterogeneity to be generalizable to various primary care settings. Research grant funds may not be used to operate a treatment, rehabilitation or other service program. Applications should represent innovations and improvements in treatments, rather than requesting support for existing or usual patient care costs. Suicidal behavior is broadly defined to include ideation and attempts, as well as completion. The results are expected to lead to treatment recommendations for primary care. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Prevention of Suicidal Behavior in Older Primary Care Patients, is related to the priority area of reduction in suicides by way of primary care recognition and treatment of mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for these awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the Investigator-Initiated Interactive Research Project Grant (R01), which is described in PA-96-001, NIH Guide, Vol. 24, No. 35, October 6, 1995. The Investigator-Initiated Interactive Research Project Grant (IRPG) group must include a minimum of two independent applications. Applications for both new (Type 1) and competing renewal (Type 2) awards may be submitted as part of an IRPG group. Responsibility for the planning, direction, coordination and execution of the proposed projects will be solely that of the applicants. It is expected that each application include a minimum of two study sites. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The estimated total costs available for the first year of support for this program is $2 million. RESEARCH OBJECTIVES Background The importance of recognizing and treating late life suicidal behavior and depression within the primary care context stems from the findings that late life suicide victims typically have contacted their primary care physician prior to their death. The majority of older suicide victims have had late onset depressions, and these depressions are not typically detected or treated by the primary care physician. This evidence, along with an uncontrolled Swedish study indicating that treatment of depression by primary care physicians led to lower suicide rates, has resulted in recommendations that late life suicide prevention efforts be focused on more adequate recognition and treatment of depression in primary care. Recognition of late life depression and suicidal behavior by primary care providers can be enhanced by several methods. These include, but are not limited to, training primary care providers to be more knowledgeable about depression and its relevant affective, cognitive, and somatic symptoms, as well as employing screening measures with proven sensitivity and specificity. Rates of major depression in older primary care patients range from 5 to 10%, while rates of minor depression have been estimated to range from 20 to 30%. Although suicide attempts and completions are relatively rare events, rates of suicidal ideation among older patients in primary care range from 5% among unselected groups, about 9% among older males, and up to 40% in depressed male patients. There are gender differences in rates of late life depression and suicidal behavior. Older women are more likely to admit to depressive symptoms, and are more likely to make non-lethal suicide attempts than older men. Older males are less likely to report depressive symptoms, but are more likely to complete suicide. In addition to reducing the risk of suicidal behavior, adequate recognition and treatment of late life depression can also prevent non-suicide mortality, and reduce unnecessary suffering in patients and their family members. Moreover, appropriate diagnosis and treatment can reduce medical morbidity, functional impairment, and excess medical costs. Research Objectives There are at least two models of treatment of late life depression and suicidal behavior in primary care that have been tested in single site studies. One model involves improving the abilities of the primary care physician to detect and treat depression without additional services of mental health professionals, using either or both pharmacologic and psychosocial or problem-solving approaches. A second general model has used a collaboration between primary care physicians and mental health professionals, where expertise in psychopharmacology in treating depression is provided by a psychiatrist, and psychosocial interventions are provided by trained mental health professionals (e.g., social workers, psychologists, nurse practitioners). With regard to treatment approaches, pharmacologic advances have indicated that the newer serotonin reuptake inhibitors (SSRIs) may be as efficacious in older adults as the proven tricylics (e.g., nortriptyline). SSRIs are of particular interest for the present research objectives for two reasons: A possibly higher treatment compliance due to a lower side effect profile, and a specific effect for decreasing suicidal ideation early in treatment in younger adults. Hormone replacement therapy as an ongoing medication for female patients, or as an adjunct treatment for depression, may be considered when designing test of pharmacologic treatment effects. With regard to psychosocial treatments, standardized (i.e., manualized) approaches must be considered and can include cognitive- behavioral, problem-solving, and interpersonal therapy approaches which have all been proven efficacious with older adults. These treatment models, as well as other approaches, deserve further consideration with regard to short- and long-term efficacy. The applicability of these approaches to primary care sites and their affordability need to be assessed. Investigators are encouraged to consider the acceptability of treatment approaches, including side effect profiles of pharmacologic approaches, and older patients? preferences for psychosocial treatments. The primary patient outcome measures of interest include, but are not limited to: suicidal behavior, including ideation (passive, active), attempts, intent, and self- destructive behavior. Secondary patient outcomes of interest include depression (minor, major), anxiety, cognitive impairment, substance use, sleep problems, hopelessness, and personality traits. Additional outcomes of interest include mortality, functional status, medical burden (including pain), service use (e.g., medication use, emergency room visits, visits not related to depression), and satisfaction with care. Provider variables of interest include, but are not limited to: knowledge of and skills for diagnosing and treating late life suicidal behavior and depression, time spent with patient, and specialty (e.g., internist, family practitioner, nurse practitioner, geriatrician). Although suicidal behavior can be a transient phenomenon, late life depression is frequently a chronic condition. Treatment designs should consider how to define both acute and maintenance phases, rationales for selection of pharmacologic and psychosocial treatments (including acceptability and side effect profiles), and protocols for suicidal behavior. Treatment studies typically have significant attrition rates, and methodological approaches to tracking and statistically modeling non-deceased attritors (e.g. effects of partial treatments) should be considered. Primary care treatment settings can include those in academic environments. However, the generalizability of study findings would be enhanced by their combination with more typical primary care sites, such as nonacademic outpatient clinic sites, including those under managed care health plans. SPECIAL REQUIREMENTS Applicants are required to include in their budgets travel costs for 3 investigators from each site to travel to Bethesda, MD, for 2 annual meetings, in addition to other scientific meetings that are justified. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 2, 1998, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Jane L. Pearson, Ph.D. Division of Services and Intervention Research National Institute of Mental Health Parklawn Building, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-3598 FAX: (301) 443-4045 E-mail: jp36u@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research or from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 710-0267; fax (301) 480-0525; E-mail: ASKNIH@OD.NIH.GOV. Each application must have its own descriptive title and a principal investigator. The contributions of all shared resources must be summarized in item (I) CONSULTANTS of the Research Plan, describing the collaborative interactions of the IRPG group. However, the detailed description and budget for each shared resource may be requested by only one application in each IRPG group, in the project most suited to oversee that resource activity. Item (I) must be complete, with enough detail for NIH staff and reviewers to understand the full scope of interactive collaborations within the IRPG group. Other component projects must NOT be included as appendix material. Shared Resources --- A description of the shared resources that will be supported with a research project must be inserted separately in the application, after item (I) of the Research Plan. This must include an explicit description of the methods and procedures to be used, the services, tests, animals, or facilities to be provided, and a description of the involvement and protection of human subjects or vertebrate animals, if appropriate. Extensive shared resources or those with large budgets may be more appropriate as "cores" in program projects. Applicants are urged to contact an NIH staff member to discuss the nature and extent of proposed shared resources in an IRPG group. The detailed description and budget request for a shared resource must be included in the application of the principal investigator who will serve as the leader of that resource. If the proposed shared resource will be managed by an individual who is not the principal investigator of any of the components of the IRPG group, the shared resource component should be included in one of the IRPG applications according to the following instructions. Support for a shared resource must not be requested by a separate application. o If the shared resource will be managed by a member of the research team of a component IRPG, the budget for the shared resource must be presented in that application. o If the shared resource will be managed by someone (but not the principal investigator) employed by an applicant institution, the budget for the shared resource component must be presented in the component IRPG application from that institution. If there is more than one component IRPG application from that institution, the request for support of the shared resource must be included in the application of the principal investigator who will use that resource the most. o If the shared resource is not located within an applicant institution, it may be supported by a contract from a component IRPG awardee. As above, support of the shared resource must be requested in the application of the principal investigator who will use the facility or resource the most. o If all projects will share a remote resource equally, or if the request is to provide only fee-for-service testing or procedures, the costs may be included within each research project. Staff in the appropriate NIH institute or center should be contacted for further guidance in preparing these requests. Instructions for Preparing Applications on the PHS 398 (rev. 5/95) The following instructions address ONLY the parts of the PHS 398 research grant application form for which information about the proposed interactive research is requested. All other parts of the grant application should be prepared according to the instructions in the PHS 398 booklet (rev. 5/95). Cover Letter: A cover letter that identifies the total number of applications in the IRPG group and the principal investigator for each must be enclosed in the package of applications. FACE PAGE - AA: Item 2. Mark "Yes" and enter the RFA number and title, ?Prevention of Suicidal Behavior in Older Primary Care Patients.? Items 7-8. Enter the direct costs and total costs - includes the costs of the specific research project AND the costs of all "shared resources" to be supported through THIS application (see below for details concerning budget presentation). Form BB: Description. Provide a brief description (abstract) of the research proposed according to the instructions provided on page 10 of booklet for the PHS 398 (rev. 5/95). The description of the proposed IRPG interactions and/or any shared resources requested through this application may be included. Performance Site(s). The performance site(s) of THIS project AND of any shared resource(s) in the IRPG group that will be used in this project (any involved institution should be named only once). Key Personnel. List first the principal investigator and key personnel engaged on THIS project, followed by all key personnel engaged on any shared resource(s) to be supported by this project. Then list, as collaborators, all principal investigators and professional personnel engaged in all component projects and shared resources in the IRPG group. Form CC: TABLE OF CONTENTS. Add the page locations for Part 2 IRPG Interactions of item (I) of the Research Plan and for each of the shared resources proposed to be supported through this application. Forms DD and EE: Project Budget. Complete these pages as directed with the budget requests for this research project only. Do not include any shared resources here, since they will have separate budget pages. Provide clear justification for all items requested in the first year and for any significant increases or decreases in any category in future years. Shared Resource Budgets(s). Complete a separate form DD and form EE for each shared resource facility or activity that will be supported through THIS project, do not include budgets for shared resources that will be supported through other projects in the IRPG group. CLEARLY LABEL these form pages as "shared resource budgets" by typing the name of the shared resource in the upper left portion of the page. Composite Budget. If any shared resources are requested as part of this application, form DD should be used to prepare a composite budget showing the requested total direct costs for the project and the shared resource(s). The dollar totals listed must match the amounts entered on Item 7 on the application face page (form AA). This composite budget will help reviewers and staff reconcile the figures on the face page with those in the body of the application. Form FF: The biographical sketch for each key investigator involved in the project AND any shared resource(s) to be supported by this project must be included. Form GG: Other support information for all professional staff involved in the project AND any shared resource(s) to be supported by this project must be included. Form HH: Besides completing form HH for the project, a separate form HH for each shared resource to be supported by the project, itemizing the facilities and major equipment that will be available to the IRPG group, must be completed. RESEARCH PLAN: The instructions in section C-9 (pages 15-19) of the PHS 398 must be followed to complete a. through d. (Page 16) of the Research Plan in detail. Attention may be given to the integration of the individual project into the overall IRPG group effort. The overall research plan (a.-d.) for the project may not exceed 25 pages. The following points may be addressed in the appropriate sections. a. SPECIFIC AIMS. Besides listing the specific objectives of the individual research project for the total period of requested support, briefly summarize how the overall objective or long-term goal of the research relates to the goals of the IRPG group. b. BACKGROUND AND SIGNIFICANCE. Besides discussing the overall scientific significance of the proposed research, this section may briefly summarize the relevance of the project to the scientific goals of the IRPG group. (I) CONSULTANTS. Particular attention must be given in completing this section of the Research Plan. It must have subsections as follows: Part 1 of (I) must address the collaborations that are unique to the research proposed in the application as an independent project. Part 2 must describe in detail the proposed interactions and collaborations within the IRPG group, and MUST BE IDENTICAL IN ALL COMPONENT APPLICATIONS OF THE IRPG GROUP. PART 1. PROJECT SPECIFIC CONSULTANTS/COLLABORATORS. Section III.A.DEFINITIONS on page 24 of the PHS 398 Instructions should be consulted for help in determining what information to provide about consultants and collaborators who are proposed for the individual research project. PART 2. IRPG INTERACTIONS. The collaborative efforts among components of the IRPG group must be described in this section. The description should be concise, although the number of pages is not restricted. However, this section must not be used to avoid the page limitations of the Research Plan in Sections a.-d. Each component application of the IRPG group must contain IDENTICAL GROUP STATEMENTS describing the collaborative efforts and the use of any requested shared resources. Preparing this section should be a joint effort among the participating principal investigators under the leadership of the Program Coordinator, who is responsible for coordinating the collaborative efforts among all of the IRPG principal investigators. The following three items must be included in Part 2 IRPG INTERACTIONS: 1. IRPG COMPONENTS AND PARTICIPATING INVESTIGATORS. A list of every application that is part of the IRPG group, giving each an IRPG project number, and showing the type of application Project Title, and principal investigator must be provided. The Program Coordinator should also be identified here. The Program Coordinator must be the first investigator named on the list, with the title "Program Coordinator" following his/her name. For example: IRPG one, R01, (project title), Jessica W. Smith, (Program Coordinator) IRPG two, R01, (project title), (PI) IRPG three, R01, (project title), (PI) 2. DESCRIPTION OF INTERACTIVE RESEARCH ACTIVITIES. This important item provides an opportunity for the IRPG group to give conceptual wholeness to the overall program. It must include discussion of the intended interactions among the IRPG component projects and describe how each shared resource will contribute to those interactions. The general IRPG group objectives and the strategy for achieving those objectives must be described. As the strategy develops, each project and shared resource should be cited for its role in the overall scheme. Include a brief overview of the goals, objectives, rationale, and key methods and approaches for the research proposed in each project and shared resource. Describe how each relates to the scientific goals of the IRPG group and/or the anticipated approach to achieve the IRPG group goals. A diagram of the interrelationships of the projects and the enhancement of the collaborative efforts of the research projects by each shared resource may be helpful. 3. SUMMARY OF SHARED RESOURCES. If any shared resources are requested by the IRPG group, identical information about their use must be included in all applications of the IRPG group to aid in review of the application. The application should specify the anticipated percent of use of each shared resource in the entire IRPG group by each project in the IRPG group. This information will provide reviewers, advisory council members, and NIH staff with a complete picture of the overall shared resource contribution to the IRPG group. DESCRIPTION OF SHARED RESOURCES TO BE SUPPORTED BY THIS APPLICATION: A new section must be added to the Research Plan, after (I) Consultants, for each shared resource to be supported by this application. The first page of this section should clearly show the descriptive title of the shared resource; the name, title and affiliation of the individual who will manage the shared resource; and the specific location (department, institution, city) of the shared resource. A concise, but explicit and complete, description and justification for the shared resource requested. This section must present a clear picture of the approaches, methods, techniques, animals, and/or special populations that will be used to support each project in the IRPG group. Specifically address how the available resources and environment will be sufficient to address the needs of all of the projects in the IRPG group. If appropriate, address the involvement and protection of human subjects and/or vertebrate animals if that has not been addressed under (e) and (f) of the Research Plan of the project. For each component of an IRPG group, a signed, typewritten original application, five exact single-sided copies, and five sets of appendix material must be submitted. Each application must be complete, with all approvals, budgets, and signatures from the appropriate officials of the applicant institution. All of the applications constituting the proposed IRPG group must be submitted in a single package, whether or not the applications are from the same institution. A cover letter must list the total number of applications submitted for the IRPG group, clearly identifying each application and the principal investigator of each. For each component application in the IRPG group, the original, five copies, and the appendix material must be bundled together and clearly identified. Failure to follow the instructions regarding application receipt dates and packaging may lead to a delay in review. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Jane L. Pearson, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Applications must be received by March 11, 1998. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and for responsiveness by NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In their written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA In the decision to fund applications, the following will be considered: The scientific and technical merit reflected in the priority score, the balance among treatment approaches, and balance among geographic areas. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jane L. Pearson, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-3598 FAX: (301) 443-4045 Email: jp36u@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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