CDC-RFA-DP18-1816.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion

WELL-INTEGRATED SCREENING AND EVALUATION FOR WOMEN ACROSS THE

NATION (WISEWOMAN)

CDC-RFA-DP18-1816

Application Due Date: 08/03/2018

WELL-INTEGRATED SCREENING AND EVALUATION FOR WOMEN ACROSS THE

NATION (WISEWOMAN)

CDC-RFA-DP18-1816

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DP18-1816. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

WELL-INTEGRATED SCREENING AND EVALUATION FOR WOMEN ACROSS THE

NATION (WISEWOMAN)

C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DP18-1816

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.436 F. Dates:

1. Due Date for Letter of Intent (LOI): 05/25/2018

2. Due Date for Applications: 08/03/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

“ Entities who successfully submitted an application for consideration during the original open submission period may not re-submit duplicate or new applications for consideration.”

Additional information about this NOFO may be found at:https://www.cdc.gov/wisew oman/1816-nofo.htm Questions may be submitted to WW1816Comms@cdc.gov through July 31, 11:59 p.m.

ET. Responses will be posted by August 1, 2018.

3. Date for Informational Conference Call:

No additional Informational Calls will be held.

G. Executive Summary:

1. Summary Paragraph:

This funding opportunity is comprised of two components – Core and Innovation.

https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://www.cdc.gov/wisewoman/1816-nofo.htm https://www.cdc.gov/wisewoman/1816-nofo.htm https://foa.grantsolutions.gov/WW1816Comms@cdc.gov

Final funding amounts will depend upon the quality of the application, regardless of whether an applicant intends to support implementation of innovative strategies.

Core Component: This competitive component will support the implementation and evaluation of a core set of evidence-based strategies designed to reduce risks, complications, and barriers to the prevention and control of heart disease and stroke among the target population.

Applicants must propose a comprehensive work plan that addresses hypertension in alignment with the broad Strategies indicated in the NOFO. Applicants for the Core Component must propose criteria for selection of health systems and communities in which to work, based on a robust analysis of overall health burden and across population subgroups.

Innovation Component: This competitive component will support the implementation and evaluation of a small set of innovative strategies designed to reduce risks, complications, and barriers to the prevention and control of heart disease and stroke. All applicants must apply for the Core Component in order to be considered for the Innovation Component via a single application that clearly identifies the Core and Innovation Components. Only those successful applicants under the Core Component will be eligible for Innovation Component funding.

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 21 Final number of funded award recipients will be determined by the objective review scoring and available funding.

d. Total Period of Performance Funding: $80,000,000 Estimated total funding reflects Core + Innovation

e. Average One Year Award Amount: $750,000 Approximate average award reflects Core + Innovation

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/29/2018

h. Cost Sharing and / or Matching Requirements: Y In preparing budgets, applicants must include financial participation described below.

Recipient financial participation is required for this program in accordance with the authorizing legislation. Section 1502(a) and (b)(1), (2), and (3) of the PHS Act, as amended, requires matching funds from non-Federal sources in an amount not less than one dollar for every three dollars of Federal funds, a ratio of 3:1, awarded under this program. However, Title 48 of the US Code 1469a (d) requires DHHS to waive matching fund requirements for Guam, U.S.

Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands up to $200,000.

The match requirement may include third-party in-kind contributions, as well as expenditures from the grantee. The matching funds may be cash, in-kind or donated services or equipment.

Public Law 93-638 authorizes tribal organizations contracting under the authority of Title I to use funds received under the Indian Self-Determination Act as matching funds.

Matching funds may not include: 1) payment for treatment services or the donation of treatment services; 2) services assisted or subsidized by the Federal government; or 3) the indirect or overhead costs of an organization. All costs designated as meeting the match requirement must be documented by the applicant and will be subject to audit. Documentation of appropriate matching is to be provided in the detailed budget and narrative justification.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Heart disease is the leading cause of death and stroke is the 5th leading cause of death in the United States. Cardiovascular Disease (CVD) , including heart disease, stroke and other vascular diseases accounts for >800 000, or about 1 in 3 deaths/year, and around 1 in 5 who die from CVD are younger than 65 years. CVD is costly, with an estimated 1 in every 7 health care dollars is spent on CVD (about 15%). Considerable improvements in CVD mortality have been recognized in the preceding decades, with advancements in the treatment of CVD and in public health interventions significantly contributing to the gains. Some areas of CVD mortality have seen a slowing in progress, as evidenced by the recent report on stroke mortality, and increased efforts to target risk factors are urgently needed. Primary modifiable risk factors for CVD are well-known and can be largely prevented and controlled from evidence-based interventions.

Public health interventions and health systems advancements targeting primary risk factors for CVD are complementary to interventions targeting other CVD outcomes. For example, nearly

6.5 million Americans age ≥20 have heart failure, and hypertension is the predominant risk factor for heart failure in African Americans. Health system interventions can lead to improvements with multiple CVD risk factors and outcomes, and should be maximized. These may include interventions utilizing team-based care, community-health workers, electronic health record alignment with national guidelines and recommendations, technological advances improving medication adherence, interventions supporting better continuity of care across health care settings, and other related interventions supporting community and clinical linkages and partnerships.

These public health interventions are important because over the last decade only 54% of women recognize that heart disease is the leading cause of death for women. More women die from CVD than from Alzheimer’s disease, accidents, chronic lower respiratory diseases, diabetes, influenza, and pneumonia combined. While heart disease is the leading cause of death for both men and women, stroke is the fourth leading cause of death for women compared to the fifth leading cause of death for men. Some risk factors for CVD are high blood pressure, overweight obesity, diabetes, smoking and high cholesterol.

CDC's Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program is now at the forefront of the nation’s efforts to improve cardiovascular health for low-income, uninsured, and underinsured women by offering screenings, referrals for treatment, and support for lifestyle change among participants. The WISEWOMAN Program was authorized by Congress in 1993 to extend the preventive health services offered to participants of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). The intent was to expand services of an existing federal program to address cardiovascular health concerns in this vulnerable, high-risk population. The program gradually expanded to fund 21 programs and has moved to a public health practice approach that focuses on delivery of clinical cardiovascular preventive screening and lifestyle interventions. The current cooperative agreement (2013-2018), is focused on engaging women in becoming informed, activated patients for cardiovascular disease self-management such as self-monitoring blood pressure, healthy diet, physical activity, and smoking cessation.

b. Statutory Authorities This program is authorized under 42 U.S.C. § 300l-1 (2012), sections 1501-1510 [42 U.S.C.

300k, 42 U.S.C. 300l, 42 U.S.C. 300m, 42 U.S.C. 300n, 42 U.S.C. 300 n-1, 42 U.S.C. 300 n-2, 42 U.S.C. 300 n-3, 42 U.S.C. 300 n-4, 42 U.S.C. 300 n-4a, 42 U.S.C. 300 n-5] of the Public Health Service Act, as amended. WISEWOMAN must follow the legislative requirements detailed in these sections.

c. Healthy People 2020 The NOFO directly addresses these Healthy People 2020 objectives related to Heart Disease and Stroke available at: https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disea se-and-stroke) HDS–1: (Developmental) Increase overall cardiovascular health in the U.S. population.

HDS–2: Reduce coronary heart disease deaths.

HDS–3: Reduce stroke deaths.

HDS–10: Increase the proportion of adults with hypertension who meet the recommended guidelines.

HDS–11: Increase the proportion of adults with hypertension who are taking the prescribed medications to lower their blood pressure.

HDS–12: Increase the proportion of adults with hypertension whose blood pressure is under control.

d. Other National Public Health Priorities and Strategies This NOFO supports efforts in improving the quality of care in health care systems and building community-clinical linkages, which are strategic priorities of the National Center for Chronic Disease Prevention and Health Promotion. Additionally, this NOFO supports work on the following priority areas identified by the Division for Heart Disease and Stroke Prevention.

Hypertension prevention, detection, and control through:

o a systems change model for public health that engages relevant stakeholders https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke across state and local communities—including public health agencies, healthcare, quality improvement organizations, health information technology experts, payers, and community-based organizations—to develop, expand, and sustain efforts to improve hypertension prevention, detection, and control.

Million Hearts® 2022, whose focus remains on:

o Optimizing Care by using teams, health information technology, and evidence-based processes to improve the ABCS (Aspirin when appropriate, Blood pressure control, Cholesterol management, and Smoking cessation), increase use of cardiac rehab, and enhance heart-healthy behaviors o Keeping People Healthy with public health efforts that promote healthier levels of sodium consumption, increased physical activity, and decreased tobacco use.

o Improving Outcomes for Priority Populations selected based on data showing a significant CV health disparity, evidence of effective interventions, and partners ready to act. (https://millionhearts.hhs.gov/ )

National Prevention Strategy (NPS) whose vision emphasizes:

o Working together to improve the health and quality of life for individuals, families, and communities by moving the nation from a focus on sickness and disease to one based on prevention and wellness. WISEWOMAN specifically targets three of the areas that the NPS has established as national priorities to address: (1) Healthy Eating, (2) Active Living, and (3) Tobacco Free Living.

(https://www.surgeongeneral.gov/priorities/prevention/index.html )

e. Relevant Work The WISEWOMAN Program began by funding three research programs in 1995. These three programs were funded to compare the effectiveness of enhanced lifestyle interventions (LSI’s) and minimal, or usual care in reducing cardiovascular risk among low-income, under, or uninsured 40-64 year old women. From 1999-2007 Congress authorized an expansion of the Program that allowed CDC to fund up to 15 organizations for either research or public health practice. The non-research or public health practice programs focused on service delivery and evaluated the feasibility of implementing evidence-informed LSI’s in local settings. From 2000–2008, 15 programs served approximately 80,000 women.

Under a new cooperative agreement in 2008, the program expanded to fund 21 programs and moved completely to a public health practice approach that focused on delivery of cardiovascular preventive screening and lifestyle interventions. From 2008-2013, 149,767 women aged 40–64 received 217,415 total screenings for cardiovascular and other chronic disease risk factors, and 100,697 lifestyle intervention sessions were delivered.

The current cooperative agreement (2013-2018), is focused on engaging women in becoming informed activated patients for cardiovascular disease self-management such as self-monitoring blood pressure, healthy diet, physical activity, and smoking cessation. From January 2014 through December 2016, 19 state health departments and 2 tribal organizations have provided WISEWOMAN services to 51,266 women aged 40–64 who received 63,825 total screenings for https://millionhearts.hhs.gov/ https://www.surgeongeneral.gov/priorities/prevention/index.html cardiovascular and other chronic disease risk factors, and a total of 95,115 healthy behavior support services. Currently in the target population 38% have hypertension while 79% are obese or overweight. Currently 61% percent of WISEWOMAN participants belong to minority racial/ ethnic groups.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-DP18-1816

Logic Model: WELL-INTEGRATED SCREENING AND EVALUATION FOR WOMEN

ACROSS THE NATION (WISEWOMAN)

Bold indicates period of performance outcome

Strategies and Activities

Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Track and Monitor Clinical Measures shown to improve healthcare quality and identify patients with hypertension

Implement Team-Based Care to reduce CVD risk with a focus on HTN control and management

Link Community Resources and Clinical Services that support bi-directional referrals, self-management, and lifestyle change for women at risk for CVD

Increased reporting, monitoring, and tracking of clinical data for improved identification, management, and treatment of women with high blood pressure

Increased use of and adherence to evidence-based guidelines and policies related to team-based care

Increased use of data systems to identify and refer at risk women to appropriate

HBSS

Increased data sharing and utilization (e.g., through a bi-directional feedback mechanism)

Increased engagement in self-management among women at-risk for and with CVD

Increased participation in Healthy Behavior Support Services

(HBSS)

Increased blood pressure control

Improved detection, prevention and control of CVD

Improved and maintained healthy behaviors and lifestyle changes

i. Purpose The purpose of the WISEWOMAN program is to extend preventive health services to women who are participants of the CDC-funded National Breast and Cervical Cancer Early Detection Program (NBCCEDP). These extended preventive health services include assessment of cardiovascular risk factors and provision of services to reduce those risks through improved diet, physical activity, tobacco cessation, and medication adherence support. A focus on the health systems and community-clinical links that are supportive of these preventive health services is required.

ii. Outcomes This NOFO has two components:

1. A competitive Core Component that is mandatory for all applicants.

2. A competitive Innovation Component that is optional.

Both components are designed to reduce cardiovascular disease risk factors among high-risk women. Addressing risk factors such as high blood pressure, elevated cholesterol, obesity, poor nutrition, inactivity, diabetes, and smoking greatly reduces a woman’s risk of CVD-related illness and death.

Outcomes (Core Component):

WISEWOMAN Program Long Term Outcomes:

Increased blood pressure control Improved detection, prevention, and control of CVD

WISEWOMAN Program Short Term Outcomes:

Increased reporting, monitoring, and tracking of clinical data for improved identification, management, and treatment of women with high blood pressure

Increased use of and adherence to evidence-based guidelines and policies related to team-based care

Increased use of data systems to identify and refer at risk women to appropriate HBSS

WISEWOMAN Intermediate Outcomes:

Increased data sharing and utilization (e.g., through a bi-directional feedback mechanism)

Increased engagement in self-management among women at-risk for and with CVD Increased participation in HBSS Improved and maintained healthy behaviors and lifestyle changes

Outcomes (Innovation Component):

Those also applying under the Innovation Component should include a logic model and program outcomes developed by the applicant. Additionally, applicants should include plans for publication and how lessons learned or innovation can be translated for use by others to increase scale and spread of successful program outcomes.

During the period of performance, recipients are expected to achieve all proposed Innovation Component activities and make progress toward outcomes in the logic model submitted with the Innovation Component section of application.

iii. Strategies and Activities This NOFO has two components:

1. A competitive Core Component that is mandatory for all applicants.

2. A competitive Innovation Component that is optional.

Both components are designed to reduce cardiovascular disease risk factors among high-risk women. Addressing risk factors such as high blood pressure, elevated cholesterol, obesity, poor nutrition, inactivity, diabetes, and smoking greatly reduces a woman’s risk of CVD-related illness and death.

1) Core Component: This competitive component will support the implementation and evaluation of a core set of evidence-based strategies designed to reduce risks, complications, and barriers to the prevention and control of heart disease and stroke among the target population.

Recipients funded under the Core Component must implement the following strategies and activities:

Track and Monitor Clinical Measures shown to improve healthcare quality and identify patients at risk for and with hypertension

Provide cardiovascular risk screening to under- or uninsured women in the priority age range of 40-64 years during the clinic office visit.

Provide reports to monitor, and track clinical data for improve identification, management, treatment, and outcomes of women with high blood pressure.

Develop metrics to evaluate the effectiveness of interventions using collected data and deploy improvement strategies as needed.

Implement Team-Based Care to reduce CVD risk with a focus on HTN control and

Engage health professionals and community health workers, social workers, patient navigators, pharmacists and others to expand follow-up and support expanded health team members engaged in community settings outside of health care facilities.

Communicate and coordinate care among team members (including coordination of community resource referrals and HBSS and clinical services).

Support provider assessment, planning, training, implementation, and sustainability of care teams to support CVD improvements.

Link Community Resources and Clinical Services that support bi-directional referrals, self-management, and lifestyle change for women at risk for CVD

Partner or contract with community groups that provide evidence-informed HBSS.

Identify, enhance, or build systems that facilitate provider and community bi-directional referrals to support medical follow-up, healthy behavior support services, tracking of the nature, type, and scope of referrals, and other critical support services.

Use evidence-based and evidence-informed strategies (EBS/EIS) to ensure participants are engaged in HBSS.

WISEWOMAN Flow Chart: The following flow chart describes the process of providing WISEWOMAN screening and lifestyle program services to women enrolled in the program.

Health care providers screen women for cardiovascular risk. Based on risk factors, women receive referrals to healthy behavior support services (evidence-based lifestyle programs, health coaching and community resources) that support bi-directional referrals, self-management, and lifestyle change.

Recipients must ensure the delivery of services in the flow diagram including risk reduction counseling, health risk assessment, addressing medication adherence, and follow-up of abnormal values as outlined below:

Health Risk Assessment: Cardiovascular health risk assessment is completed at baseline and rescreening visits. Results must be reported in participant data files. Completion of the health assessment will facilitate immediate risk reduction counseling which is particularly valuable when lab work is not available.

Risk reduction counseling: Every program participant must receive a baseline screening and rescreening results, interpretation of the results, and appropriate recommendations in accordance with national clinical care guidelines. In a team-based care design it is critical to have patients understand their screening and health assessment findings. In the WISEWOMAN model, the patient is a critical member of the health team. This also facilitates increased self-management behavior. Screening information must be delivered both verbally and in writing using health literacy and plain language standards. If complete screening results are not available, programs should use participant’s results of the health risk assessment to provide initial risk reduction counseling. Risk reduction counseling should include motivational interviewing that will encourage the participant to change behaviors and lifestyle. Aspects of effective motivational interviewing including skill building, self-monitoring, social support, and strategies for maintenance of change.

Medication Adherence: Reduce barriers to understanding the treatment regimen and to accessing medication, particularly for high blood pressure.

Clinical/Medical Follow-up: Ensure women with alert values for blood pressure and blood glucose are provided with follow-up within 7 days and documentation is provided in minimum data elements (MDEs).

Recipients must develop, implement, and use minimum data elements (MDEs) collection system and other data collection activities for program monitoring and reporting. Recipients must also enter into effective partnerships with state and community based organizations and governmental entities to support the program.

2) Innovation Component: This competitive component will support the implementation and evaluation of a small set of innovative strategies designed to reduce risks, complications, and barriers to the prevention and control of heart disease and stroke. All applicants must apply for the Core Component in order to be considered for the Innovation Component via a single application that clearly identifies the Core and Innovation Components. Only those successful applicants under the Core Component will be eligible for the Innovation Component.

Recipients awarded under the Innovation Component must focus on one or more strategies related to:

Identifying and targeting hard to reach and underserved women, Working with health care systems and other stakeholders to expand use of telehealth technology to promote management of hypertension and high blood cholesterol, Implementing novel strategies to enhance referral, participation, and adherence in cardiac rehabilitation programs in traditional and community settings, including home-base settings, Implementing novel approaches to facilitate bi-directional referral between community programs/resources and health care systems (e.g. using electronic health records (EHR), digital blood pressure (BP) monitoring, 800 numbers, 211 referral systems, etc.), and

Developing a statewide infrastructure to promote long-term sustainability/coverage for community health workers (CHW).

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

The following sections apply to both Core and Innovation Components:

Recipients should establish collaborative, strategic partnerships with other CDC funded programs within and outside the state health departments, tribes and tribal organizations to allow for more efficient use of existing resources. This also allows for exchange of information among experts working in various areas of public health and other sectors. At a minimum, partnerships must be established with heart disease and stroke, tobacco, cancer (especially the NBCCEDP), diabetes, and nutrition and physical activity programs. Partnerships should move the goals and objectives for relevant and engaged programs forward and contribute significantly to the WISEWOMAN program. The Million Hearts® initiative provides multiple collaborative partnerships, resources, and supportive opportunities. (http://millionhearts.hhs.gov).

http://millionhearts.hhs.gov/

Recipients are encouraged to identify and leverage opportunities, which will also enhance the recipient’s work with other State health department programs that address related chronic diseases or their underlying risk factors. This may include cost sharing to support a shared position such as Chronic Disease epidemiologist, health communication specialist, data manager, program evaluator, or policy analyst to work on risk factors or other activities across units/departments within the State health department. This may include, but is not limited to, joint planning and leadership activities (including updating of chronic disease state plans);

coalition alliances and joint health education and communication activities; data acquisition, analysis and communication; combined development and implementation of environmental, policy, systems, or community interventions; and other cost sharing activities that cut across Chronic Disease Programs and relate to recipient program activities.

b. With organizations not funded by CDC:

The following sections apply to both Core and Innovation Components:

Recipients are expected to collaborate with a variety of public and private partners to leverage resources and maximize reach and impact. Collaborative partners can include entities from many sectors. Recipients are required to collaborate with partners and agencies that serve the priority population of interest or work with the identified communities of interest. For example, partner with health systems to improve heart disease screening, management, medical follow-up and HBSS referrals to improve cardiovascular health.

Applicants should consider strategic partnerships with community health centers including Federally Qualified Health Centers, Health Center Controlled Networks, Regional Extension Centers, state Rural and Primary Care Associations, health plans, health systems, clinics and hospitals, managed care organizations, Medicaid/HRSA, Indian Health Service clinics, American Indian/Alaska Native tribal governments and/or tribally designated organizations.

Recipients are expected to collaborate with organizations to that support heart disease prevention, physical activity, healthy food choices, chronic disease self-management, and smoking cessation. Recipients are also expected to collaborate with organizations to provide resources appropriate for underserved sub-populations that address participant barriers to accessing care and changing behavior (e.g., transportation, mental health, housing resources).

Recipients are also strongly recommended to collaborate with non-traditional partner agencies and organizations (e.g., Federal Office of Rural Health Policy, Department of Transportation, and Department of Housing and Urban Development) to reach more underserved women. Recipients should establish or continue strategic partnerships that support the Division for Heart Disease and Stroke Prevention (DHDSP) goals with professional organizations;

businesses; not-for-profit organizations, such as the American Heart Association; community-based organizations; for-profit organizations; non-governmental organizations; state and local governments; community advocates and members; and other stakeholders that may have a vested interest in improving cardiovascular health.

Recipients are expected to work with Quality Improvement Organizations/Quality Improvement Networks (QIO/QIN) or other health care quality improvement entities to enhance patient care and improve health systems.

Letters of support with a firm commitment from providers and partners should be included in the application.

Applicants should submit letters of support from organizations and clinics that will have a role in helping to achieve specific NOFO activities and outcomes. Letters must be dated within 45 days of the application. These letters must state the role of organizations and clinics and specify how they will help the applicant achieve the goals and outcomes of the NOFO and by component, as appropriate. If awarded, MOUs or MOAs with these partner organizations or contracts must be submitted within 90 days of award.

Applicants must file the letter of support, as appropriate, name the file “Letter of Support”, and upload it as a PDF file at www.grants.gov

2. Target Populations The target population is low income women ages 40-64 who are uninsured or under-insured and who participate in the NBCCEDP. Applicants must target locations where the population experiences disparities in CVD risk factors, morbidity, and/or mortality. Applicants should ensure that data, including burden data, are used to identify strategies and/or communities within their populations to support program initiatives. Emphasis should be placed on achieving maximum reach and impact across these populations. Organizations serving the population as well as representatives of the target population should be engaged in planning processes and selecting lifestyle programs.

a. Health Disparities Disparities exist within cardiovascular health outcomes for women. These disparities are compounded by variations in disease rates and access to preventive and treatment services among the low-income, uninsured and/or racial and ethnic minority populations.

Among the populations that will benefit from this funding are low-income women, rural and frontier populations, and those experiencing health disparities within the following population subgroups: the uninsured or under-insured, geographically or culturally isolated, medically under-served, racial, ethnic, and/or cultural minorities, including African Americans, Alaska Natives, American Indians, Asian Americans, Hispanics, Pacific Islanders, and women with disabilities. Recipients should seek to implement priority population approaches to prevent heart disease and stroke and reduce health disparities among women in the target population.

iv. Funding Strategy This funding opportunity is comprised of two components – Core and Innovation.

Final funding amounts will depend upon the quality of the application, regardless of whether an applicant intends to support implementation of innovative strategies.

All applicants must apply for the Core Component in order to be considered for the Innovation Component via a single application that clearly identifies the Core and Innovation Components.

Only those successful applicants under the Core Component will be eligible for Innovation Component funding.

http://www.grants.gov/

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and performance measurement help to demonstrate program accomplishments and strengthen the evidence for strategy implementation. It can also determine whether the identified strategies and associated activities can be implemented at various levels (i.e., state, sub-population, etc.) within a state.

Throughout the five year period, CDC will work individually and collectively with recipients to track the implementation of recipient strategies and activities and assess progress on achieving the five year NOFO outcomes. Both the process and outcome evaluation will seek to answer the following overarching evaluation questions:

1. Approach: To what extent did the recipients’ implementation approach result in achieving the desired outcomes?

2. Effectiveness:

o To what extent has the program increased the reach of the strategies to prevent and control cardiovascular disease?

o To what extent has implementation of the strategies led to improved health outcomes among WISEWOMAN participants?

o What factors were associated with effective implementation of the strategies?

3. Efficiency: To what extent has the NOFO affected efficiencies within infrastructure, management, partners, and financial resources?

4. Sustainability: To what extent can the strategies implemented be sustained after the

NOFO?

5. Impact: To what extent have the strategies implemented contributed to a measureable change in health, behavioral, or environment in a defined community, population, organization, or system?

6. Innovation: What innovative strategies have been identified that can be replicated and scaled?

CDC will use an evaluation approach that consists of (1) ongoing monitoring and evaluation through the collection and reporting of performance measures, (2) a CDC-led national evaluation and (3) recipient-led evaluations. Innovation recipients will also be required to conduct rigorous evaluations of their innovative strategies.

Performance measures developed for this program correspond to the strategies and outcomes described in the logic model. Performance measures that recipients will be responsible for collecting and reporting are noted in Table 1. CDC will work with recipients on operationalizing and further defining each performance measure and guidance will be provided prior to the first year of reporting. Performance measures will be reported annually to CDC and CDC will manage and analyze the data to identify recipient program improvements, respond to broader technical assistance needs, and to report to stakeholders. CDC will analyze performance measure data annually and develop annual, aggregate performance measure reports to be disseminated to recipients and other key stakeholders, including federal partners, non-funded partners, and policy makers as appropriate. These aggregate findings may also be presented during site visits and recipient meetings. In addition to performance measures reported by recipients, CDC will track all outcome measures (not listed in required recipient table for reporting) that are relevant to the program through national data sets or the national evaluation activities.

For the CDC-led national evaluation activities, CDC will lead the design, data collection, analysis, and reporting. Recipients will be expected to participate in evaluation activities such as surveys, interviews, case studies, and other data collection efforts. An appropriate level of guidance and support will be provided to the recipients to ensure effective participation of recipients in the national evaluation. CDC will use findings from these evaluation efforts to refine its technical assistance and, in turn, maximize and sustain program outcomes.

For recipient-led evaluations, CDC will assist recipients’ development and implementation of evaluation plans that are useful for recipient program improvement and provide valuable information for the overall evaluation of the program. Recipients with innovation funding will be expected to conduct rigorous evaluations of their innovative strategies and activities as noted in the Applicant Evaluation and Performance Measurement Plan. CDC and recipients will only collect data that will be analyzed and used.

CDC will provide recipients with performance measure reporting templates, and potentially evaluation plan and reporting templates. CDC will provide evaluation technical assistance and ongoing evaluation guidance on recipient-level evaluation and performance measures.

Evaluation technical assistance will be provided using a customized approach to ensure that the tools and services provided best meet the needs of the recipients. All information will be collected via a secure system and according to a Data Management Plan (DMP) to be developed. All evaluation findings produced by CDC and recipients will contribute to: (1) continuous program and quality improvement of program efforts; (2) the evidence base; (3) documentation and sharing of lessons learned to support replication and scaling up of these program strategies and/or (4) future funding opportunities at CDC.

The data collected by CDC for performance measurement and evaluation are directly related to the implementation of the strategy and/or the desired outcome indicated in the logic model. The data collected for this NOFO for performance measurement and national evaluation does not include any personal identifiable information. Data being collected are strictly related to the implementation of the NOFO strategies, and shall be used for assessing and reporting progress and for other pertinent implementation improvement actions. All performance measure data will be collected via a secure data system that will be developed. Recipients will report their performance measure data annually via the data system and will only have access to their data.

Over the 5-year performance period, data will be secured with limited access to authorized CDC program and evaluation staff. CDC will aggregate data across all recipients to publish annual and summative reports.

Plans for updating or creating the Data Management Plan (DMP), must be described throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations;

and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49.

http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49

A Data Management Plan (DMP) must be included as part of the evaluation and performance measurement plan. The DMP is the applicant’s assurance of the quality of the public health data through the data’s lifecycle and plans to deposit data in a repository to preserve and to make the data accessible in a timely manner. See web link for additional information: http://www.cdc.gov /grants/additionalrequirements/index.html#ui-id-49.

This Data Management Plan will also include identification of the awardee’s planned data platform and data collection system. The awardee data management system must be implemented in a timely manner, no later than January 2019. The system identified as part of the Data Management Plan should be easily adaptable to data requirements and be user-friendly for data entry and extraction. The data management system should also produce reports that allow awardees to monitor overall performance and deliver feedback to providers. It is essential grantees have a user-friendly, reliable method to track clinical data and referrals at the individual patient level that assures communication with providers. This communication with providers is important. It allows for timely reporting on the provider capabilities to meet award objectives, and monitors the provider’s reporting accuracy. Additional preference will be given to applicants whose systems interact with provider EMRs.

Table 1. WISEWOMAN Strategies, Outcomes, and Performance Measures

WISEWOMAN Strategies, Outcomes, and Performance Measures

Strategies (recipients will implement all 3 strategies

Short term outcomes and measures (recipients are required to report the short term measure for each strategy)

Intermediate outcomes and measures

Long term outcomes and measures

Track and Monitor Clinical Measures shown to improve healthcare quality and identify patients with

Outcome: Increased reporting, monitoring, and tracking of clinical data for improved identification, management, and treatment of women with hypertension

Outcome: Increased data sharing and utilization (e.g., through a bi-directional feedback mechanism)

Outcome: Increased blood pressure control

Improved detection, prevention, and control of cardiovascular disease

Measure: 1. # and % of WISEWOMAN participants within

WISEWOMAN

providers with a

Measure: 4. # and % of WISEWOMAN providers with an implemented community referral

Measure: 6. # and % of women in WISEWOMAN with protocol for identifying patients with undiagnosed system (through bi-directional referrals) for healthy behavior support services for people with high risk for cardiovascular disease

Implement Team- Based Care to reduce CVD risk with a focus on hypertension control and management

Outcome: Increased use of and adherence to evidence-based guidelines and policies related to team-based care

Outcome: Increased engagement in self-management among women at-risk for and with cardiovascular disease

Measure: 2. # and % of WISEWOMAN participants within

WISEWOMAN

providers that have policies or systems to implement a multi-disciplinary team approach to blood pressure control.

Link Community Resources and Clinical Services that support bi-directional referrals, self-management, and lifestyle change for women at risk for cardiovascular disease

Outcome: Increased use of data systems to identify and refer at risk women to appropriate healthy behavior support services

Outcomes:

Increased participation in healthy behavior support services

Improved and maintained healthy behavior and lifestyle changes

Measure 3. # and % of at risk women in

WISEWOMAN

referred to an appropriate healthy behavior support service

Measure 5. # and % of women in

WISEWOMAN

referred to a healthy behavior support service who attend at least one session known high blood pressure who have achieved or are currently maintaining blood pressure control.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

All applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, evaluation and performance plans must describe 1) how the applicant will collect the performance measures, 2) how key program partners will participate in the evaluation and performance measurement planning process; 3) available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant); and 4) plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project.

The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https https://www.cdc.gov/grants/additionalrequirements/ar-25.html

://www.cdc.gov/grants/additionalrequirements/ar-25.html.

In addition, evaluation plans should:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions (including strategy-specific questions) to be addressed in addition to those provided by CDC.

Data collection approaches, measures, and data sources.

Align each evaluation question with the approach, instruments/data sources, and timeline.

Propose analyses for at least two time points (baseline and follow-up) and assess program impact on any intended health disparate populations.

Describe dissemination and publication plans

Applicants applying for the Innovation Component evaluation plans should also identify relevant measures and previously untapped data sources (e.g., health systems and electronic health record systems; surveys, etc). Enhanced measurement and monitoring will be encouraged for health behaviors, preventive care practices, behavioral uptake of recommended, evidence-based interventions, quality of primary care, and longitudinal changes in risk factors and costs.

All applicants are encouraged to work with professional evaluators (either internal or external) to meet the evaluation and performance reporting requirements of this NOFO. Therefore, CDC encourages allocating at least 10% of the total funding award to evaluation and performance monitoring and consider both development and implementation costs. For information on developing an evaluation plan, please refer to the CDC Framework for Program Evaluation in Public Health (Centers for Disease Control and Prevention. Framework for Program Evaluation in Public Health. MMWR 1999; 48, No RR-11).

https://www.cdc.gov/eval/framework/index.htm With support from CDC, recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Report Section of this NOFO. CDC will work closely with recipients to develop the detailed plan to ensure that it is appropriate for the activities to be undertaken as part of the agreement, for compliance with the monitoring and evaluation guidance established by CDC, or other guidance otherwise applicable to this cooperative agreement. CDC will provide additional templates and guidance for developing the Evaluation and Performance Measurement plan. Applicants should review the published Performance Measure Guidance Document in-depth before finalizing this plan, to gain an understanding of the purpose of each measure, the values to be reported, as well as the supporting qualitative information to be reported, and attachments to be submitted with the report. Any anticipated issue with data collection should be highlighted the plan, along with options to remedy it.