Co-Occurring Mental Illness, Alcohol and/or Drug Abuse & Medical Conditions

PA Number: PA-05-007

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)

Announcement Type
This PA is replaces PA-95-055.

Update: The following update relating to this announcement has been issued:

• December 4, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-104, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.
• March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements.

1. Research Objectives

The National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute of Mental Health (NIMH) invite research grant applications to conduct services research on co-occurring mental illness, alcohol and/or drug abuse, and commonly co-occurring medical conditions

A significant number of individuals simultaneously suffer from mental illness, problem alcohol and/or drug use, and other medical or physical disorders, such as mood disorders compounded with substance abuse, chronic pain with depression and/or alcohol abuse, schizophrenia with heroin use and hepatitis C. This program announcement (PA) encourages innovative and theory-driven empirical research to examine the organization, management, integration, dissemination and implementation, and financing of services for co-occurring mental illness, alcohol and/or drug abuse, and commonly co-occurring medical conditions, as well as the impact of these factors on the quality, cost, access, utilization, outcomes, and cost and cost effectiveness of care.

Co-occurring conditions occur across the lifespan and result in levels of individual suffering, disability, and societal costs that are magnified well beyond those associated with each disorder in isolation. For example, it is estimated that up to 50% of individuals with severe mental disorders abuse substances, and this particular type of comorbidity is associated with a variety of negative outcomes, including high rates of relapse, hospitalization, violence, incarceration, homelessness, and significant infections such as HIV and hepatitis. Additional concern arises from the fact that co-occurring disorders are often chronic and/or episodic, fluctuating in a cycle of heightened risk, onset, intervention, recovery, and relapse, and, in the case of some medical conditions, a deteriorating course. Such trajectories render the traditional "acute care" model of service delivery inadequate to achieving optimal outcomes and functioning for persons suffering from co-occurring conditions. Finding ways to better serve this population is, therefore, a significant public health need.

Co-occurring disorders represent a challenge in terms of understanding the combined (and not necessarily simply additive) treatment and service needs resulting from various combinations of disorders and differences in type and severity of impairment contributed by each. In particular, there is a need for more refined assessment of symptomatic and functional needs, and for understanding how pharmacological, psychosocial, behavioral and environmental approaches can be brought to bear on achieving treatment and rehabilitation goals. Of importance are not only persons currently suffering from co-occurring disorders, but also those at risk for developing co-occurring illness. Prevention and treatment services must be optimally configured and designed to address co-occurring conditions including mental illness, alcohol and/or drug use disorders, and related medical conditions. Furthermore, new research is needed to develop effective strategies to ensure the timely adoption and implementation of evidence-based practices for the prevention and treatment of co-occurring disorders.

Listed below are examples of some research areas relevant to the purposes of this PA. This list is neither exhaustive nor prioritized; rather, it is expected that investigators who respond to this PA will identify additional critical research gaps.

Access to services. Research is needed to enable providers to best identify and prioritize the prevention, treatment, and service needs of individuals with co-occurring conditions in order to facilitate access to and utilization of an array of services. Studies must not only identify factors that impede access (including those that create health disparities for certain sub-populations) but also begin to develop interventions that surmount access barriers. Given the chronic and/or episodic nature of co-occurring conditions, the type of care for which access is needed at a given point in time will vary with the fluctuations in illness, and from first intervention through treatment of relapse to sustained recovery management.

Tailoring services to individual needs. Of interest are studies that more specifically delineate optimal services and service settings, and effective and dynamic mechanisms of service delivery for a target population that is heterogeneous with varying or fluctuating levels of severity of disorders in multiple and sometimes changing combinations. Outcomes should target optimizing functioning and community integration. In addition, there is a need to understand how non-specialty settings (primary care, schools, shelters or supported housing settings, jails or prisons) can effectively contribute to meeting complex needs and facilitating recovery. When examining the applicability or adaptation of interventions, individual factors such as age, developmental stage, stage in treatment career, socio-cultural factors, criminal involvement, and multiplicity of service needs should be addressed.

Integrated, coordinated, or collaborative care services. Of interest are studies that examine how and why various factors facilitate or impede the development or maintenance of integrated, coordinated, or collaborative care under various systemic and community circumstances. These studies should be formulated so as to inform the development of effective strategies for designing and implementing such programs in communities or systems of various sizes and compositions. Research should identify dynamic and effective ways to combine, target, and deliver linked services for defined co-morbid populations and examine the comparative contributions of the components of these models for various types of co-occurring conditions.

Treatment process. Treatment process describes the events, interventions, and interactions that occur during treatment for an individual, spanning multiple episodes of illness. While the attributes and problems patients bring to treatment are a given, it is the treatment process - how individual patient needs are assessed and how treatment services are delivered - that is subject to modification and improvement. Of interest in this area are studies that seek to understand the relationship between treatment process factors, treatment performance indicators, and patient behavioral change for specific populations. Specific domains of inquiry might include:

• Provider factors, including treatment orientation, experience, training, decision-making;
• Client factors, including degree of engagement, motivation for treatment, length and severity of illnesses, health care coverage, etc.; and
• Organizational factors, including agency organizational structure, culture and climate, availability of supportive services, relevant community factors, etc.

Commonly used interventions and practices. Developing an understanding of real-world treatment has important implications for improving the treatment of co-occurring conditions. Studies designed to develop an evidence-based perspective of existing practices currently being used to treat co-occurring conditions are needed. Applicants are encouraged to examine existing service delivery programs and initiatives developed with grant monies provided by SAMHSA and other federal agencies.

Rehabilitation and Community Integration. Research is needed to understand and implement rehabilitative and support services that enable persons with co-morbid disorders to manage their treatment in the community, maximize their overall functioning and enable and sustain community integration. Areas of particular interest include understanding how best to tailor support services to individual needs, how programs proven efficacious for persons with one disorder must be adapted to the demands of multiple disorders, and how programs can be implemented within the resource limitations of systems, organizations and agencies without reducing effectiveness.

Dissemination and Implementation Research. Research has shown that information about treatments proven efficacious in a given illness domain, such as mental disorders, is not easily transmitted to the directly relevant providers in the field. There is reason to expect that transmission across illness domains (e.g., enabling mental health providers to understand addiction treatment needs) will be an equal or greater challenge. Research on dissemination is needed to understand how information about symptoms, disability, treatment needs, and efficacious interventions in one illness domain is transmitted and interpreted into other involved illness domains. Research on implementation is needed to determine how interventions in one illness domain can fit in across a variety of real-world health service systems.

Culture and gender. Limited research has examined the culturally and/or gender-related components or conditions that contribute to the effective engagement, retention, and participation of individuals with co-occurring disorders in care. In addition, not enough is known about the gender, cultural, ethnic, and linguistic specificity necessary to effective prevention and treatment services. Still unknown is whether culturally congruent and gender-specific services improve long-term public health outcomes.

Financing and cost. Research is needed on comparative impact of different financing mechanisms, including managed care, on service utilization and the cost-effectiveness and cost-benefits of integrated service delivery models.

Section II. Award Information

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Domestic Institutions/organizations
• Foreign institutions/organizations
• Faith-based or community-based organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing
Cost Sharing is not required.

3. Other-Special Eligibility Criteria
None

Section IV. Application and Submission Information

3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm .

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the appropriate national advisory council or board

3. Merit Review Criteria

The goals of NIH'supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach . Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators . Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment . Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

Redonna Chandler, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4215, MSC 9565
Bethesda, MD 20892
Telephone: (301) 443-4060
FAX: (301) 443-2636
Email: [email protected]

Harold I. Perl, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0788
FAX: (301) 443-8774
Email: [email protected]

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Joy Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Email: [email protected]

Gary Fleming, J.D., M.A.
Office of Planning and Resource Management
National Institute on Drug Abuse
6101 Executive Boulevard, Room 3119, MSC 8001
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: [email protected]

Judy S. Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]

Section VIII. Other Information

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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