U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office on Women’s Health, Office of the Assistant Secretary for Health
Office of the Secretary

Announcement Type: New, Open Competition

Funding Opportunity Number: Not Applicable.

Funding Opportunity Title: Sustainable Comprehensive Tobacco Cessation and Prevention Clinical Program for Low Socio-economic Status Women of Childbearing Age

Action: Notice.

Matching: No matching required.

OMB Catalog of Federal Domestic Assistance: 93.088

Dates: Applications must be received by the Office of the Assistant Secretary for Health (OASH), Office of Grants Operations, 1400 Key Boulevard, Suite 910, Arlington, VA 22209 no later than 5 p.m. Eastern Time on July 15, 2011. Applications that are electronically submitted through Grants.gov or GrantSolutions.gov will be accepted until 9:00 p.m. on this date. Applications will not be accepted by fax, nor will the submission deadline be extended. Applications that do not meet the deadline will be returned to the applicant unread. See heading “APPLICATION and SUBMISSION INFORMATION” for information on application submission mechanisms.

Table of Contents

SUMMARY 1

BACKGROUND 3

I. FUNDING OPPORTUNITY DESCRIPTION 5

1. Awardees and Partnerships 6

2. Project Goals and Objectives 6

3. Federal Clinical Partners 10

4. Non-Federal Partners 11

II. AWARD INFORMATION 12

III. ELIGIBILITY INFORMATION 16

1. Eligible Applicants 16

2. Program Requirements 16

3. Cost Sharing or Matching 17

IV. APPLICATION AND SUBMISSION INFORMATION 17

1. Address to Request Application Information 17

2. Content and Form of Application Submission 17

3. Program Abstract and Program Narrative 18

4. Submission Date and Time 22

V. APPLICATION REVIEW INFORMATION 30

1. Criteria 30

2. Review and Selection Process 34

VI. AWARD ADMINISTRATION INFORMATION 34

1. Award Notices 34

2. Administrative and National Policy Requirements 34

3. Reporting 35

4. Agency Contact 36

VII. OTHER INFORMATION 36

1. Resources 36

2. Definitions 40

APPENDIX I: OWH Tobacco Clinical Collaborative Project Description 43

APPENDIX II: Implementation Process Steps 45

APPENDIX III: List of Phase 1 Tobacco Clinical Collaborative Sites 52

iii

SUMMARY

The mission of the Office on Women’s Health (OWH) of the Department of Health and Human Services (HHS) is to provide leadership to promote health equity for women and girls through sex/gender-specific approaches. The Tobacco and Young, Low-Socio Economic Status (LSES) Women: Federal Collaboration to Make a Difference interagency working group (the Collaboration) was launched by HHS/OWH, the National Cancer Institute (NCI) and other agencies of HHS in 2008. Because LSES women and girls of childbearing age have special burdens related to tobacco use, OWH and the Collaboration implemented a three-phase initiative, outlined below, to reduce tobacco use in this population. (See Appendix I for more information).

·  Phase 1 – Tobacco Clinical Collaborative Programs (TCCP) involves implementing the Treating Tobacco Use and Dependence, Clinical Practice Guideline 2008 Update (hereafter referred to as the Public Health Service Guideline), or similar tobacco cessation programs, in selected Health Resources and Services Agency (HRSA) and Indian Health Service (IHS) funded clinics.

·  Phase 2 – Expansion Planning involves using lessons learned from the TCCP to develop a “toolkit” of resources and to plan expansion from the TCCP to other populations of LSES women of childbearing age served through Federal healthcare dollars.

·  Phase 3 – Comprehensive and Sustainable Funded Projects involves providing Cooperative Agreements to projects that (1) implement the Public Health Service Guideline to provide comprehensive culturally and linguistically appropriate tobacco prevention and cessation services for the targeted population, (2) show organization and structural changes that will ensure long term sustainability and ability to implement and to replicate the Public Health Service Guideline implementation, and (3) evaluate the impact of the Public Health Service Guideline implementation and structural changes on tobacco cessation in LSES women of childbearing age.

Through this Cooperative Agreement, which is Phase 3 of the Collaboration initiative, OWH intends to foster its mission and support the Collaboration by providing OWH FY2011 appropriated funds to entities to:

1.  Partner with Federally-funded healthcare organizations and/or Medicaid-reimbursed providers (hereafter referred to as “Federal Clinical Partners”) that serve LSES women of childbearing age;

2.  Provide training, materials, and technical assistance to implement a comprehensive and sustainable tobacco cessation and prevention program in the Federal Clinical Partners’ organizations for LSES women of childbearing age, based on the Public Health Service Guideline;

3.  Assist the Federal Clinical Partners to implement a process model to create an organizational culture of tobacco awareness and action that results in increased quit attempts, abstinence, and/or cessation for LSES women of childbearing age; and

4.  Contribute new information and resources that will assist other Federally-funded clinics to replicate this program.

BACKGROUND

In its recently published action plan, Ending The Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the U.S. Department of Health and Human Services (the HHS Tobacco Strategic Action Plan), HHS reports that tobacco use is the leading cause of preventable death in the United States. Tobacco use is responsible for more than 440,000 premature deaths in the United States each year. Although tobacco use is reduced from historic levels, prevalence remains unacceptably high and progress in reducing smoking has recently stalled. In 2009, 20.6% of adults and 19.5 percent of high school students smoked cigarettes. The summary numbers do not tell the entire story, however, as reported in the HHS Tobacco Strategic Action Plan:

Members of certain racial/ethnic minority groups, individuals of low socioeconomic status (SES), pregnant women, and other groups carry a disproportionate burden of risk for tobacco use and tobacco-related illness and death. Smoking rates are highest among American Indians/Alaska Natives (32.4%). Subpopulations such as Korean, Vietnamese, and Puerto Rican men also have very high smoking rates compared with the overall population. Although African Americans have lower smoking rates compared with American Indians/Alaska Natives and whites (21.3%, 32.4%, and 22% respectively), they bear the greatest burden of tobacco-caused cancer. Thirty-one percent of persons living in poverty smoke and the challenges continue to be greatest among adults with low educational attainment.

Significant tobacco-related disparities also exist by geographic area, with higher smoking rates typically in states with few smoke-free protections, lower tobacco taxes, and limited tobacco control program funding. Enormous disparities exist by race/ethnicity, age, and socio economic status in secondhand smoke exposure. Among the highest exposed are:

71% of African Americans

63% of low-income individuals

61% of children aged 4-11 years.[1]

Expert panelists, at a meeting supported by OWH and the Collaboration in December 2008, presented research about the special burdens of tobacco use for LSES women of childbearing age:

·  Tobacco may be used as self-medication for stress and depression due to poverty and other factors.

·  Low income is a risk factor for prenatal smoking and two-thirds of women who quit during pregnancy relapse within six months.

·  Healthcare services for tobacco use may not be covered by insurance. Even if insurance is available, there are obstacles to clinic visits, such a childcare concerns and lack of trust in healthcare systems.

·  Living with others who smoke creates greater risks for starting or resuming tobacco use.

·  Body weight concerns and/or mental health issues such as mood and stress contribute to tobacco use.

·  Lack of social support contributes to difficulties in quitting tobacco.

·  The tobacco industry targets LSES women when marketing tobacco products.

I. FUNDING OPPORTUNITY DESCRIPTION

Authority: 42 U.S.C. 300u-2(a)

The purpose of this project is to implement and to evaluate the success of tobacco cessation and prevention programs in selected Federal Clinical Partners to address tobacco use among LSES women of childbearing age. The Federal Clinical Partners are: the Health Resources and Services Administration (HRSA) and/or Indian Health Service (IHS) federally-funded healthcare clinics, and/or Medicaid-reimbursed providers. Successful applicants will design tobacco cessation and prevention programs to be implemented in the Federal Clinical Partners’ organizations that:

1.  Are based on “Treating Tobacco Use and Dependence, Clinical Practice Guideline, 2008 Update” (Public Health Service Guideline);

2.  Employ implementation process steps that will ensure project sustainability after the grant period ends for the Federal Clinical Partners;

3.  Ensure that a certified tobacco specialist uses the 5As (Ask, Advise, Assess, Assist, Arrange; see the Public Health Service Guideline for detailed information) with every patient;

4.  Ensure LSES women of childbearing age identified as tobacco users are offered brief intervention, counseling, follow-up, and other cessation services listed in the Public Health Service Guideline; and,

5.  Demonstrate increased quit attempts, abstinence, and/or cessation for LSES women of childbearing age using the services of the Federal Clinical Partners.

1. Awardees and Partnerships

Any public or private entity, including an Indian tribe or tribal organization (as those terms are defined at 25 U.S.C. 450b) is eligible to apply for this Federal funding. Faith-based and community-based organizations are also eligible to apply.

Federal government entities cannot be a direct recipient of this Cooperative Agreement. Awardees must implement the tobacco cessation and prevention program through partnerships with Federal Clinical Partners (including, at a minimum, Federally-funded HRSA or IHS health clinics and/or Medicaid-reimbursed providers).

2. Project Goals and Objectives

The goals of this project are:

1.  Implementation of as many aspects of the Public Health Service Guideline as possible given funding levels.

2.  Establishment of implementation process steps that ensure sustainability of the project after the grant funding ceases; and,

3.  Demonstration of increased quit attempts, abstinence, and/or cessation for LSES women of childbearing age using the services of the Federal Clinical Partners.

The objectives of the OWH program, organized by goals, are listed below:

Goal 1. Implementation of as many aspects of the Guideline as possible given funding levels

Specific details about each of the items listed below are included in the Public Health Service Guideline, which can be found at http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf, with additional information at http://www.surgeongeneral.gov/tobacco/.

Implementing the Public Health Service Guideline includes achieving the following objectives for each patient that is an LSES woman of childbearing age. Applicants should strive to implement as many aspects of the Public Health Service Guideline as funding will allow. All interventions must be documented. Clinical interventions should include as many as possible of the following:

·  Determining and documenting in medical charts tobacco use, and, for tobacco users, readiness to change and cessation intervention.

·  Providing tobacco-related health education materials to patients.

·  Referring tobacco using patients to quitlines or other cessation resources promoting and sustaining change.

·  Ensuring that a certified tobacco specialist uses the 5As (Ask, Advise, Assess, Assist, Arrange) with every patient, and that LSES women of childbearing age identified as tobacco users are offered brief intervention, counseling, follow-up, and other cessation behavioral services during clinical visits.

·  Providing culturally and linguistically appropriate interventions. OMH culturally and linguistically appropriate standards (CLAS) can be found at http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=15.

·  Providing nicotine replacement therapy (NRT) or other Food and Drug Administration (FDA) approved medications to treat tobacco dependence, as appropriate. It is not necessary that Awardees provide all FDA-approved tobacco medications, but they must provide a selection of them, and they are encouraged to provide NRT.

·  Providing incentives for tobacco cessation compliance for tobacco users.

·  It should be noted that these interventions are, in general, appropriate for all clinical patients. LSES women of childbearing age do not necessarily need a separate clinical program to receive the services. However, OWH expects that successful applicants will collect data to determine participation and tobacco use outcomes for this specific population.

·  Goal 2. Establishment of implementation process steps that ensure sustainability of the project after the grant funding ceases.

The Public Health Service Guideline recommends implementing a systems strategy for addressing tobacco use. Steps and objectives for a systems strategy at the clinical level were identified in the initial stages of the Collaboration initiative. The steps and objectives are listed below and should serve as guidance for developing programs under this Cooperative Agreement. Additional information about the OWH tobacco project is available in Appendix I. More details about each implementation process step are available in Appendix II.

·  Assess Current Status - Objective: Determine baseline data to collect and how to collect it.

·  Identify Champion/Leader(s) - Objective: Identify a person or persons able to lead in creating a culture of tobacco awareness and cessation in the clinic environment.

·  Plan Data Collection and Evaluation - Objective: Have the ability to collect and retrieve pertinent data from the medical records system.

·  Determine Funding/Reimbursement - Objective: Fund tobacco cessation and prevention activities.

·  Formulate Policies and Internal Links - Objective: Create and support a culture of tobacco awareness and cessation in the clinic environment.

·  Establish Linkages (external) - Objective: Leverage resources, information, and knowledge to gain efficiency and effectiveness in program implementation, evaluation and success.

·  Provide Training - Objective: Establish a culture of tobacco awareness and cessation within the clinic by training all staff and ensuring that each person knows his/her role in the program, policies, and procedures related to tobacco use, cessation, and prevention.

·  Deliver Interventions - Objective: Provide smoking cessation interventions to the clinic’s patient population of LSES women of childbearing age, including those who are pregnant or post-partum.

·  Assess/Evaluate Program - Objective: Determine what works and what does not work for implementing the Public Health Service Guideline and employing implementation process steps in Federally-funded healthcare settings.

Goal 3. Decrease tobacco use among LSES women of childbearing age.

Objectives for this goal include the following:

·  Demonstration of increased quit attempts, abstinence, and/or cessation for LSES women of childbearing age using the services of the Federal Clinical Partners.

3. Federal Clinical Partners

The Awardees must partner with one or more of the Federal entities listed below to implement the tobacco cessation and prevention program. Proposals should identify all partners and must include a Memorandum of Agreement (MOA) from each partner organization that delineates its specific roles and responsibilities for the program. The MOA must be on the partner’s letterhead and signed by an official with the authority to commit organizational resources to the project.