This Program Announcement expires on December 2004, unless reissued. RESEARCH ON QUALITY OF CARE FOR MENTAL DISORDERS Release Date: October 1, 2001 PA NUMBER: PA 01-145 National Institute of Mental Health (http://www.nimh.nih.gov/) THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS FOR ALL APPLICATIONS SUBMITTED IN RESPONSE TO THIS PA. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Mental Health (NIMH) invites research grant applications for multidisciplinary research, especially mixed-methods, that will characterize, examine, and assess the quality of mental health services provided to people with mental disorders. The goals of this program announcement (PA) are to encourage mental health researchers to question current conceptualizations and assessments of quality, work collaboratively with social and behavioral scientists, including those who study organizations and marketing, to develop conceptualizations that can be measured and are reliable and valid within or across populations, and design studies of quality that can lead to real improvements in how mental health services are delivered. This program announcement supercedes PA-95-066, issued May 26, 1995. It addresses priorities laid out in Bridging Science and Service: A Report by the National Advisory Mental Health Council"s Clinical Treatment and Services Research Workgroup (http://www.nimh.nih.gov/research/bridge.htm) and in the NIMH Strategic Plan for Reducing Health Disparities (http://www.nimh.nih.gov/strategic/strategicdisparity.cfm). It is also in line with a recently published report from the Institute of Medicine, which contains recommendations for improving the quality of health care and reducing the burden of disease in the United States (http://www.nap.edu/books/0309072808/html/). HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This PA, Research on Quality of Care for Mental Disorders, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. Faith-based organizations are eligible to apply for these grants. Foreign institutions, while eligible for R01 grants, are not eligible for R03 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), and small grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this PA may not exceed 5 years. For R21 applications, the project period cannot exceed 2 years and $100,000 in direct costs in each of those years. For R03 applications, the project period cannot exceed 2 years and $50,000 in direct costs in each of those years. Applicants are strongly encouraged to read the R21 and R03 announcements, which specify the goals and guidelines for each program (http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html) and (http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html). For all competing R03 and R21 applications, and those R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. R01s greater than $250,000 per year require detailed budgets and do not follow Modular Grant format. RESEARCH OBJECTIVES Quality of care research typically compares actual care provided in everyday practice to clinically- or scientifically-derived standards of care. Variance in practice patterns across clinicians or geopolitical areas has been interpreted as a warning sign, signaling a need to examine the cause of the discrepancy. Ultimately, however, quality of care studies seek to compare the degree of clinician adherence to these standards with outcomes experienced by patients or clients. Studies in this area often separate out the elements of care into structure (e.g., community, service system), process (the intervention), and outcomes (e.g., clinical status, cost, satisfaction). This general approach to understanding quality, comparing actual practice to a standard of care and to other practices, has been a staple of health services research. However, this approach to understanding quality can lead investigators to make a simplifying assumption that a single standard of or approach to providing care is optimal for all populations receiving care for a single disorder. While this is a useful way to begin to think about quality, the cultural, educational, and socioeconomic diversity of the population of the United States makes it necessary to move the field beyond comparing clinician behavior to uniform standards and to focus on client outcomes. This announcement is designed to encourage mental health investigators to think beyond standards of care and treatment guidelines when defining quality. It is designed to provide the resources necessary for multidisciplinary collaborative teams to experiment with new perspectives and methods to understand and assess quality for diverse population groups. Research Issues Listed below are examples of questions that suggest different ways of thinking about and designing research to investigate quality of care in mental health. The list of examples is illustrative, not exhaustive. It is expected that additional important research questions will be identified by investigators who work collaboratively in multidisciplinary teams to respond to this announcement. o Is patient or client satisfaction related to quality, as defined by treatment guidelines or standards of care, or to client outcomes? Do these relationships hold constant across cultural groups, disorders, and age groups? o How do typically measured aspects of quality (e.g., fidelity to the model) relate to client or parent satisfaction, clinician motivation and involvement, and clinical and functional outcomes for clients? o What factors associated with the relationship between the client and the clinician could be measured in studies of quality that would improve our understanding of quality, e.g., participatory decision making or goal setting? Do different cultural or age groups have different needs or requirements from this relationship? Do those differences have an impact on clinical and functional outcomes? o Do personality and cultural differences between clients and clinicians affect the client’s expectations from treatment, perception of quality, and his/her clinical and functional outcomes? o How do staff and organizational factors impact the delivery of care? Which are the most critical factors for producing quality or improved outcomes for clients: clinician training, clinician experience, clinician satisfaction, organizational culture, fit between clinician and client, financial incentives, family buy-in ? Is the power of these factors invariant across settings? How do factors outside the clinical setting have an impact on client outcomes that organizational quality standards cannot affect? o Particularly for children and adolescents, how can families be involved in improving the quality of care and outcomes? o How can quality be evaluated in psychotherapeutic Internet interventions? Are standards of care, credentialing, and ethical guidelines associated with increased quality? Can client satisfaction and clinical and functional outcomes be assessed on-line? Do certain clinical, cultural, or age groups respond better to on-line therapy than to face-to-face therapy? 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds, and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and 5 signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. 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, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Mental Health Council. 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 the 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. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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 adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data. o The adequacy of a multidisciplinary collaborative research perspective and team. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is available. Direct inquiries regarding programmatic issues to: Karen Anderson Oliver, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7138, MSC-9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: koliver1@mail.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC-9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3065 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 sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use 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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