cdc-rfa-dp15-1502 03 30 15 final.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Organized Approaches to Increase Colorectal Cancer Screening

CDC-RFA-DP15-1502

Application Due Date: 04/14/2015

Organized Approaches to Increase Colorectal Cancer Screening ***AMENDMENT TO FAQs- Changes to Question and Answer 14***

CDC-RFA-DP15-1502

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

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-DP15-1502. 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) B. Funding Opportunity Title:

Organized Approaches to Increase Colorectal Cancer Screening ***AMENDMENT TO FAQs- Changes to Question and Answer 14*** C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science /integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-DP15-1502

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

93.800 F. Dates:

1. Due Date for Letter of Intent (LOI): 03/06/2015

2. Due Date for Applications: 04/14/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 03/03/2015 Informational Conference Calls for Potential Applicants: CDC will conduct two (2) informational conference calls for interested applicants on March 3, 2015 at 11:00 AM and 3:00 PM U.S. Eastern Standard Time. The calls will last no longer than an hour and a half.

Conference call lines are limited, so we encourage those who can to call in from one location.

Call-in information:

Toll Number: 1-517-968-2548

Toll-free Number: 1-866-510-1407

Participant Passcode: 80681704

G. Executive Summary:

1. Summary Paragraph:

This five-year funding opportunity offers support to implement DP15-1502, Organized Approaches to Increase Colorectal Cancer Screening for a five-year period. The program’s purpose is to increase colorectal cancer (CRC) screening rates among an applicant-defined target population of persons 50-75 years of age within a partner health system, defined geographical areas, or disparate populations. This program has two components: 1) implement evidence-based interventions (EBIs) and other strategies in partnership with health systems to institute organized screening programs and 2) provide direct screening and follow-up services for a limited number of individuals aged 50-64 in the Program’s Priority Population (PPP) who are asymptomatic, at average risk for CRC, have inadequate or no health insurance for CRC screening, and are low-income.

http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov low-income.

Component 1: Health Systems Change to Increase and Improve Colorectal Cancer Screening (Required). To increase capacity and support organized CRC screening, awardees must partner with health systems, such as federally qualified health centers (FQHCs), academic health care systems, health plan clinic networks, Medicaid, Medicare, and insurance plans that serve the applicant-defined target population to: a) implement EBIs (e.g., reminder systems) identified in The Community Guide to increase CRC screening and

b) measure outcomes for evaluation. Supporting strategies such as small media, patient navigation, clinical-community linkages, and health information technology are secondary. The applicant-defined target population should have CRC screening rates lower than the state or national overall screening rates.

Component 2: CRC Screening Delivery to Improve Access to the Underserved (Optional):

Awardees must use an active, existing organized screening provision program to provide CRC screening and diagnostic follow-up services for the Program’s Priority Population. CDC funding may only be used to pay for services for individuals with inadequate or no health insurance. Only funded Component 1 applications will be considered for Component 2 funding.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 35 Approximately thirty (30) Component 1 awards will be made.

Approximately five (5) Component 2 awards will be made.

d. Total Project Period Funding: $114,000,000

e. Average One Year Award Amount: $0 The approximate average award for Component 1 will be $500,000 per budget period.

The approximate average award for Component 2 will be $750,000 per budget period.

f. Number of Years of Award: 5

g. Estimated Award Date: 06/30/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

Colorectal cancer (CRC) is the second leading cause of death from cancer in the United States. There is substantial evidence that screening for CRC reduces incidence of and death from the disease. Screening for CRC can both detect disease early when treatment is more effective and prevent cancer by finding and removing precancerous polyps. Of individuals diagnosed with early stage CRC, more than 90% live five or more years.

The U.S. Preventive Services Task Force recommends screening average risk adults aged 50-75 years for colorectal cancer with either: 1) fecal occult blood test (FOBT) or fecal immunochemical test (FIT) annually,

2) colonoscopy every 10 years, or 3) flexible sigmoidoscopy every 5 years with FOBT or FIT every 3 years.

Despite strong evidence to support CRC screening, currently, only 65% of adults report being up-to-date with CRC screening, with more than 22 million age eligible adults estimated to be untested. Individuals who don’t live in a city, Hispanics, adults aged 50-64, men, American Indians/Alaska Natives, and people with lower education and income are less likely to be screened. Lower rates of screening directly contribute to disparities in CRC morbidity and mortality. To reduce CRC morbidity, mortality, and associated costs, use of CRC screening tests must be increased among age-eligible adults with the lowest CRC screening rates.

Traditionally, lack of insurance has been a key barrier to cancer screening for adults. Implementation of the Affordable Care Act provides opportunities to increase participation in CRC screening and instituting the National Prevention Strategy framework can ensure that screening is more widespread and equitable.

However, many people who currently have health insurance and regular access to medical care are not screened. Barriers, such as lack of knowledge, not receiving a provider’s recommendation to be screened, and, transportation can hinder participation in screening.

To reach ambitious national CRC screening goals proposed by Healthy People 2020, the National Prevention Strategy, and other initiatives such as “80% by 2018,” systematic approaches are needed. The Guide to Community Preventive Services (The Community Guide) has identified effective evidence-based interventions (EBIs) that address many barriers to CRC screening. These interventions include patient and provider reminder systems, reducing structural barriers, and provider assessment and feedback. Other promising strategies include patient navigation to assist people with completing the screening process. Public health can play an important role in increasing CRC screening rates by partnering with health systems to implement these interventions to maximize impact.

Further increases in CRC screening rates could also be achieved with more organized approaches to screening. Currently, individuals who visit a provider regularly are more likely to be screened, as screening is often offered during visits to the provider for other reasons; this is opportunistic screening. In contrast, organized screening is an explicit policy with defined age categories, method, and interval for screening in a defined target population with a defined implementation and quality assurance structure, and tracking of cancer in the population. Organized screening programs have the potential to systematically reach an entire population eligible and due for CRC screening.

To address barriers to CRC screening, this program will support public health and health systems partnerships to implement EBIs recommended by The Community Guide and additional strategies to increase and improve the quality of CRC screening and to support the adoption of organized screening systems. Using combinations of these rigorously tested, cost-effective, and scalable EBIs along with reliable sources of data to target populations and health systems with the greatest need, this FOA’s comprehensive approach is intended to increase high-quality CRC screening. The proposed strategies and activities should complement not supplant private or public insurance.

b. Statutory Authorities

This program is authorized under section 301(a) of the Public Health Service Act, [42 U.S.C section 241(a)], as amended and 317(k)(2) of the Public Health Service Act, [42 U.S.C. section 247b(k)(2)], as amended .

c. Healthy People 2020

Activities in the proposed FOA are directly related to the Healthy People 2020 Cancer (HP-C) Focus Area:

a) Reduce the age-adjusted annual rate of cancer mortality per 100,000 population; b) Reduce the colorectal cancer death rate (HP-C5); c) Increase the proportion of adults who receive a colorectal cancer screening based on current guidelines (HP-C16); and d) Increase the proportion of adults who were counseled by their providers about colorectal cancer screening (HP-C18.3).

d. Other National Public Health Priorities and Strategies

This program supports strategies to increase and improve the quality of colorectal cancer screening, community-clinical linkages, and preventive services in the following national plans and guidelines:

The Guide to Community Preventive Services: http://www.thecommunityguide.org

The National Partnership for Action to End Health Disparities: http://minorityhealth.hhs.gov/npa/

The National Prevention Strategy: http://www.healthcare.gov/prevention/nphpphc/strategy/report.pdf

The National Quality Strategy: http://www.ahrq.gov/workingforquality/

e. Relevant Work

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Domains This FOA primarily relates to two (bolded below) of the four NCCDPHP domains of action to transform the nation’s health and support Americans to take charge of their own health: 1) epidemiology and surveillance,

2) environmental approaches that promote health and support and reinforce healthful behaviors, 3) health system interventions to improve the effective delivery and use of clinical and other preventive services, and 4) strategies to improve community-clinical linkages.

The Colorectal Cancer Control Program (CRCCP): In 2009 CDC began implementing the CRCCP across 29 grantees. The program’s primary goal is to increase CRC screening rates in the funded states and tribes. Grantees focused on using evidence-based strategies from The Guide to Community Preventive Services (The Community Guide) to increase population-level CRC screening. Grantees also used a portion of their funding to provide direct screening services to average risk, low-income, uninsured, and underinsured individuals.

80% by 2018 Initiative: A significant new effort to support increasing CRC screening is the 80% by 2018 Initiative started by the National Colorectal Cancer Round Table in partnership with CDC. The initiative leverages resources across a wide variety of organizations and agencies to increase the proportion of the population screened for CRC, with the goal of reaching an 80% screening rate by 2018:

http://nccrt.org/about/80-percent-by-2018/.

2. CDC Project Description

a. Approach

The two CRCCP logic models illustrate how the two components of the FOA will accomplish outcomes.

i. Purpose

To increase CRC screening and follow-up rates, awardee activities that may be funded include, but are not limited to: formally partnering with an FQHC to implement a provider-oriented intervention such as provider reminders, formally partnering with a state primary care association to create or modify FQHC operational models, or formally partnering with an insurer to implement client-oriented EBIs such as client reminders.

ii. Outcomes

Note: Only the five-year project period outcomes are listed below. Their accomplishment will contribute to achievement of the intermediate and long-term outcomes beyond the five-year project period.

Component 1 Outcomes

Short-term outcomes of this program are:

Outcome 1: Increased formal partnerships that support increased screening.

Outcome 2: Improved adoption of multiple evidence-based interventions within health care systems, insurers, and others.

Outcome 3: New organizational policies and systems change in partner health systems as well as community-clinical linkages that support improved access to CRC screening.

Outcome 4: Increased appropriate provider recommendations for patients to be screened for CRC.

Outcome 5: Increased knowledge about the need for CRC screening among priority populations.

Outcome 6: Reduced barriers to CRC screening.

Outcome 7: Increased provider adherence to USPSTF and USMSTF guidelines for CRC screening and surveillance.

Outcome 8: Increased provider knowledge of CRC screening quality standards.

Outcome 9: Improved measurement and use of health systems data.

Outcome 10: Increased rates of high-quality screening among defined patient population (e.g., annual fecal test rescreening rate, adequate test prep for colonoscopy).

Outcome 11: Increased adherence to timely diagnostic colonoscopy.

Outcome 12. Increased rescreening among defined patient populations.

Component 2 Outcomes

Short-term outcomes of this program are:

Outcome 1: Increased high-quality screening among defined patient population (i.e., fecal return rate, annual fecal test rescreening rate, and adequate test prep for colonoscopy).

Outcome 2: Increased adherence to timely, diagnostic colonoscopy.

Outcome 3. Increased rescreening among CRCCP clients.

iii. Strategies and Activities

Component 1

Applicants must propose activities for Partnerships and Program Coordination and Priority Evidence-based Interventions, respectively, as outlined in the logic model for Component 1:

1) Partnerships and Program Coordination

Health systems partners can include, but are not limited to: FQHCs, other publicly funded entities that provide primary care services, health care plans, health care networks, hospitals, non-profit organizations, primary care associations, insurers, regional medical associations, and professional organizations. Applicants are required to collaborate with a health systems partner to implement the applicant's proposed strategies and activities.

Identify health systems partners that serve the applicant-defined target population.1.

Strengthen existing or establish new formal strategic partnerships and collaborations with health systems partners that serve the applicant-defined target population to help facilitate implementation of EBIs to increase CRC screening and ensure quality screening. Secure a written agreement to work collaboratively to implement two or more priority EBI(s) and one or more supporting strategies described in the attached logic model.

2.

Identify and describe a defined target population(s) based on data presenting need; populations with an age range of 50-75 years with CRC screening rates lower than the state or national overall screening rate or known screening rates for that population.

3.

Assess the health system partners’ organizational data, current infrastructure, processes, procedures, and other relevant data to inform the intervention plan (e.g., a patient reminder system exists but is not used by all staff.) This assessment and the interventions selected should be done in partnership with

4.

used by all staff.) This assessment and the interventions selected should be done in partnership with health systems partner(s); the intent is to increase and improve CRC screening within the partners’ health system.

Determine a final, accurate baseline for CRC screening within the defined target population if preliminary data are used in the application for funding).

5.

Develop an implementation plan that includes evaluation measures and data sources.6.

Monitor and evaluate project progress.7.

Provide a plan to formally evaluate the process and outcomes of partnerships and partnership activities.8.

2) Priority Evidence-based Interventions

Applicants must propose at least two of the four Priority Evidence-Based Interventions described below to conduct collaboratively with partner health systems. In selecting and implementing EBIs to increase CRC screening, applicants should strive to develop a comprehensive strategy, which may include multiple interventions to address the needs of the applicant-defined target population. Applicants should choose EBIs that are well matched to the culture, needs, and capabilities target population(s). In setting priorities for EBIs to meet work plan objectives, recommendations, research-tested intervention program(s) (RTIPs) and other evidence provided in the Community Guide should be considered along with such local information as resource availability, administrative structures, and the cultural, economic, social, and regulatory environments of organizations and practitioners.

To conduct activities for the four Priority Evidence-Based Interventions, applicants will:

Determine a final, accurate baseline CRC screening rate within the selected applicant-defined target population if preliminary data are used in the application for funding

1.

Implement two or more of the following four Community Guide-recommended interventions within partner health systems:

2.

Provider Assessment and Feedback - Provider assessment and feedback interventions evaluate provider performance in delivering or offering screening to clients (assessment) and present providers with information about their performance in providing screening services (feedback).

Provider Reminders - Reminders inform health care providers it is time for a client’s cancer screening test (called a “reminder”) or that a client is overdue for screening (called a “recall”).

Client Reminders - Client reminders are written (letter, postcard, e-mail) or telephone messages (including automated messages) advising people that they are due for screening. These interventions can be untailored to reach the overall target population or tailored with the intent to reach one specific person, based on characteristics unique to that person, related to the outcome of interest, and derived from an individual assessment.

Reducing Structural Barriers - Structural barriers are non-economic burdens or obstacles that make it difficult for people to access cancer screening (e.g., inconvenient clinic hours).

Pair small media, considered a secondary EBI for purposes of this FOA, with any of the four priority EBIs above. Small media may not be used as a stand-alone activity. Applicants should propose to use existing high-quality materials, such as Screen for Life and Make It Your Own (MIYO) tested CRC messages. If adequate small media do not exist for the applicant-defined target population, awardees must obtain CDC approval to develop new materials.

1.

Patient navigation may be used to help clients overcome barriers and support adherence to screening, diagnostics, and initiation of cancer treatment.

2.

Describe the rationale for selection of the proposed EBIs and describe any adaptations made to RTIPs.3.

Describe a comprehensive plan for how each selected EBI will be implemented, including how data will be used to evaluate intervention impact.

4.

Conduct evaluation to measure progress toward meeting short-term, intermediate, and long-term outcomes.

5.

3) Community-Clinical Linkages

Facilitate collaboration between health systems and community-based organizations that serve the target population (e.g., utilize Community Health Workers for targeted outreach to reach priority populations and provide education and support to link them to primary health care/medical home).

1.

Facilitate a formal partnership with a worksite that employs members of the target population to influence adoption of a corporate policy that encourages CRC screening among employees by removing structural barriers that may prevent screening.

2.

Implement a community-based program such as, but not limited to, a Flu-FIT/Flu-FOBT program.3.

4) Professional Development Training

Promote adherence to USPSTF guidelines for CRC screening.1.

Promote USMSTF surveillance guidelines.2.

Promote CRC screening quality assurance/quality improvement practices.3.

5) Health Information Technology

Awardees may consider assisting partner health systems and stakeholders to develop new or expanded tools and procedures that facilitate the regular and ongoing use of data, including state cancer registry data, health system electronic health record data, other relevant data to:

Collect and report relevant data (e.g., baseline and post-intervention CRC screening numbers).1.

Implement EBIs to ensure patients receive CRC screening.2.

Monitor quality (e.g., timeliness) and clinical outcomes.3.

Enhance current clinical decision support, electronic health record/information technology and financial management systems to identify, screen, and follow up on persons due for CRC screening.

4.

Use data to routinely conduct quality improvement activities.5.

Provide ongoing feedback regarding progress toward meeting project goals.6.

Assist in adopting strategies to improve the exchange of electronic data across organizational and jurisdictional boundaries.

7.

Address legal, ethical, and security and confidentiality issues related to data sharing (only de-identified data will be shared with CDC).

8.

6) Program Monitoring and Evaluation

Program monitoring and evaluation allows the awardee and CDC to track progress and measure outcomes of awardees’ efforts. Awardees must:

Propose work plan objectives and activities that clearly relate to the relevant short and intermediate-term outcomes specified in the logic model.

1.

Conduct process evaluation to monitor implementation of all program activities. Monitoring implementation can serve as an early detection system to identify implementation problems allowing for mid-course corrections.

2.

Demonstrate achievement of work plan outcomes noted in the logic model as short-term outcomes (e.g., increased high quality screening among defined patient populations, increased adherence to timely, diagnostic colonoscopy, increased re-screening among defined patient populations).

3.

Provide baseline data for these outcomes prior to implementation of activities specified in the work plan followed by annual reporting of data for these outcomes.

4.

Organized Approaches to Colorectal Cancer Screening

Required and Supporting Logic Model Strategies

REQUIRED Strategies

Applicants MUST:

SUPPORTING Strategies

Applicants Can Also CHOOSE to:

1. Partner with at least one health system to select an appropriate intervention and describe preliminary data

1. Conduct the Secondary Evidence-based Intervention, small media (not a standalone intervention)

2.

Conduct at least two or more Priority Evidence-based Interventions

Patient reminder systems Provider reminder systems Provider feedback and assessment Reducing structural barriers

2. Facilitate Professional Development Training

3. Patient Navigation

4. Enhance Community-Clinical Linkages

5. Utilize Health Informatics s

Component 2: CRC Screening Delivery (Optional)

Applicants must propose activities from the following strategies as outlined in the Logic Model for Component 2:

1) Program Management

Convene medical advisor(s). Convene a medical advisory board (MAB) to provide oversight of the quality of screening services delivered throughout the five year funding period. MAB membership should reflect relevant expertise to CRC screening (e.g., primary care physicians, endoscopists, oncologists, pathologists, radiologists, nurses, patient navigators).

1.

Establish any necessary contract(s), grants, or memoranda of agreements with program partners (e.g., health care providers) in a timely manner to assure service delivery. Ensure non-CDC resources (e.g., private funds or other public funding) are in place to support treatment for persons diagnosed with cancer through the program and those experiencing medical complications from screening and diagnostic procedures.

2.

Maintain data management and billing systems to track costs and ensure proper billing and payment for services delivered.

3.

2) CRC Screening, Diagnostics, Patient Navigation, and other Support Services

Provide CRC screening and diagnostic follow-up services for the program priority population. The Program Priority Population is defined as persons ages 50-64, asymptomatic and at average risk for CRC, with inadequate or no health insurance for CRC screening, and are low-income, at or below 250% of the FPG. Awardees may define a demographic sub-population(s) of the program priority population for emphasized screening efforts. Awardees must assure appropriate medical referral for clinically ineligible patients.

1.

Collaborate with health systems that serve the priority population to assure that patients are currently enrolled with a primary care provider prior to receiving services through this program.

2.

Select CRC screening tests with two important caveats: 1) awardees can only offer screening tests for which test availability has been assessed (e.g., there is adequate endoscopic capacity and workforce to implement a large-scale intervention to increase colonoscopy), and capacity and effectiveness has been demonstrated; and 2) awardees can only offer screening tests recommended by the U.S. Preventive Services Task Force (http://www.ahrq.gov/clinic/uspstf08/colocancer/colors.htm) and approved by CDC for reimbursement.

3.

Establish and document a process to assess each participant's eligibility, including determining if the participant has other forms of insurance to pay for CRC screening.

4.

Establish realistic, annual screening projections for the five-year program period taking into consideration the size of the eligible population and previous experience providing CRC screening services.

5.

Ensure patients scheduled for endoscopy (e.g., colonoscopy, flexible sigmoidoscopy) are clinically evaluated prior to the procedure.

6.

Utilize a patient tracking and reminder system to support screening adherence, the provision of appropriate and timely follow-up of all abnormal screening results, and rescreening.

7.

Establish patient support or patient navigation services to assist patients through the screening and diagnostic testing process and facilitate access to medical care for persons identified with cancer.

Develop a plan and identify resources (e.g., financial, in-kind) to provide treatment for patients who incur an unanticipated medical complication from services provided by the program or are diagnosed with cancer through the program. CDC funds cannot be used for the treatment of complications resulting from screening or for diagnosed cancer.

8.

Integrate screening and diagnostic follow-up services, when and where appropriate, with existing CRC screening programs, the National Breast and Cervical Cancer Early Detection Program, other appropriate chronic disease programs that deliver clinical preventive services, and with health systems partners to improve the effectiveness and efficiency of public health programs and services.

9.

Deliver screening services within 60 days of award, upon approval by CDC.10.

3) Data Management and Utilization for Recruitment and Quality Assurance/Quality Improvement

Use or adapt a pre-existing data collection system to collect and report patient-level clinical data to CDC. These data will include information on patient demographics, screening and diagnostic services provided, and clinical outcomes related to this program. Awardees will be required to submit these clinical data to CDC semi-annually. A standardized clinical data set developed by CDC will be used to monitor program quality and progress. The list of current data elements can be found at http://www.cdc.gov/cancer/colorectal/pdf/CCDE_Data_DefinitiontableOMB_T.pdf.

1.

Use clinical data to support on-going monitoring of the quality, timeliness, and appropriateness of services provided by the program and adhere to current standards related to data-sharing, data security, and patient confidentiality. All data submitted to CDC must be de-identified. Awardees are required to submit these data on all persons who are screened through this program supported by CDC funds.

2.

Demonstrate achievement of work plan outcomes noted in the logic model as short-term outcomes (e.g., high quality screening among defined patient population, adherence to timely diagnostic colonoscopy, re-screening among defined patient funded externally to populations).

3.

In collaboration with the state or territorial central cancer registry, collect and report information regarding the first course of treatment for any persons diagnosed with colorectal cancer (i.e., treatment above and beyond polypectomy performed during colonoscopy such as chemotherapy).

4.

Use standards, systems, policies, and procedures to maintain high-quality services, including tracking and follow-up systems to assure appropriate and timely follow-up of all abnormal screening results and diagnoses of cancer.

5.

1.Collaborations

Collaborations with CDC-funded programs and other organizations external to CDC are strongly encouraged but are not required. If the applicant plans to collaborate with any CDC-funded program or other organizations external to CDC, applicants are strongly encouraged to provide an MOA/MOU or letter of intent (LOI) describing the proposed collaboration. Applicants should describe how they will collaborate with CDC-funded programs as well as programs CDC to implement the program strategies outlined in this FOA, if applicable. These types of collaborations allow for more efficient use of existing resources.

Awardees may establish, build, and/or maintain collaborative relationships that will support the implementation of the proposed program. Name the file "Collaborations" and upload it as a PDF at www.grants.gov.

a. With CDC-funded programs:

Component 1 and Component 2: Awardees are encouraged to collaborate with CDC-funded programs if any are currently funded in the applicant’s state, county, city, Tribe, or territory to enhance cancer prevention and control efforts and support the delivery of clinical preventive services. State- and local-level CDC-funded chronic disease programs may include the National Breast and Cervical Cancer Early Detection Program, National Comprehensive Cancer Control Program, National Program of Cancer Registries, Heart Disease and Stroke Prevention Program, Diabetes Program, and WISEWOMAN Program.

b. With organizations external to CDC:

Component 1 and Component 2: Applicants are encouraged to establish or strengthen existing partnerships and to maintain strategic partnerships and collaborations with organizations that have a role in helping to achieve the FOA outcomes and proposed activities. Applicants should consider strategic partnerships with the following types of organizations: Federal agencies (e.g., Health Resources Services Administration, specifically, FQHCs; Centers for Medicaid and Medicare Services, CMS; Indian Health Service, IHS;

American Indian/Alaska Native tribal governments and/or tribally designated organizations; primary care associations; professional organizations; businesses; not-for-profit organizations, such as the American Cancer Society; the National Association of Community Health Centers; community-based organizations;

for-profit organizations; community health centers; clinics and hospitals; non-governmental organizations;

State and local governments; community advocates, community members; and other stakeholders that may have a vested interest in increasing colorectal cancer screening.

2. Target Populations

As described in the Overview, only 65% of adults report being up-to-date with CRC screening, with more than 22 million age eligible adults estimated to be untested. Moreover, considerable and persistent gaps between the healthiest people and the least healthy continue to exist. With its focus on gathering data on disparities and the application of EBIs to achieve health equity, this program can help to eliminate health disparities within targeted populations. Applicants are expected to target disparate populations known to have lower screening rates (e.g., individuals with low income, persons who do not live in a city, Hispanics).

Component 1:

Applicants have the flexibility to define their target population (applicant-defined target population).

However, applicant-defined target populations should be within the age range of 50-75 years and special effort should be taken to focus on populations that are asymptomatic, low-income, uninsured, underinsured, racial and ethnic groups disproportionately affected, and/or geographically challenged. Applicants should use the most relevant, accurate data available to identify and address target populations that are disproportionately affected by CRC and have low screening rates. In addition to identifying populations at greatest risk, applicants should also strive to achieve the greatest health impact. For example, given the opportunity to target two similar disproportionately affected target populations with 1,000 and 10,000 eligible individuals, respectively, strong consideration should be given to focus on the larger population where the potential to reduce health disparities is greater.

Component 2:

The Program Priority Population for CRC screening delivery is persons aged 50-64, asymptomatic and at average risk for CRC, with inadequate or no health insurance for CRC screening, and who are low-income, at or below 250% of the FPG. Awardees may define a demographic sub-population(s) of the program priority population for emphasized screening efforts.

a. Inclusion

N/A

iv. Funding Strategy (for multi-component FOAs only)

Funding for Component 1 annual awards will range from $350,000 to $800,000.

Funding for Component 2 annual awards will range from $500,000 to $1,000,000.

Only Component 1 awardees are eligible to receive Component 2 awards.

Component 1 applications will be funded in order by score and rank as determined by an objective review panel process.

Component 2 funding will be determined by the score and ranking from both the Component 1 and Component 2 objective review panels. Therefore, funding decisions may be made out of rank order for Component 2.

In addition, the following factors may affect funding decisions: geographic diversity, priority populations or strategies and activities not proposed by higher ranking applicants, proposals that maximize the population served or the impact of federal funding.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Awardee evaluation and performance measurement will demonstrate achievement of the work plan outcomes and show effective implementation of the strategies within a partner health system. Evaluation findings will be used by awardees and CDC to ensure continuous program and system improvement and assess the extent to which the strategies impact screening and diagnostic services among the target and priority populations identified by the awardee.

The CDC strategy for monitoring and evaluating program and awardee performance will include several activities, spanning both process and outcome evaluation and will be consistent with the logic model and approach described previously. The CDC strategy will include monitoring and evaluation for the overall project as well as for individual awardees.

CDC will monitor intermediate outcomes noted in the logic model, including state-level CRC screening rates bi-annually using data from the Behavioral Risk Factor Surveillance Survey (BRFSS) and detection of early stage CRC using state-and national-level surveillance data from cancer registries.

CDC will monitor long-term outcomes noted in the logic model, including CRC incidence and mortality, using state- and national-level surveillance data.

CDC will provide guidance and technical assistance to awardees on required data collection and reporting, including measurement of required outcomes.

ii. Applicant Evaluation and Performance Measurement Plan

Component 1

Evaluation and performance measurement results will be used by awardees and CDC to ensure continuous program and system improvement and to assess the extent to which implemented strategies impact CRC screening, diagnostic, and rescreening services among applicant-defined target population(s) identified by awardees.

Component 2

Evaluation and performance measurement results will be used by awardees and CDC to ensure continuous program and system improvement and to assess the extent to which implemented strategies impact CRC screening, diagnostic, and rescreening services among Program Priority Population(s) identified by awardees.

Awardee evaluation and performance measurement will demonstrate achievement of the work plan outcomes and show effective implementation of the strategies within a health system. An awardee evaluation and performance measurement plan will be comprised of two parts: monitoring program implementation and measurement of short-term outcomes.

Monitoring program implementation – Awardees will track progress in implementing program activities specified in work plans. Awardees may use process evaluation methods (e.g., ongoing performance monitoring) to track implementation efforts. For example, implementation of patient navigation could be monitored by tracking the number of patients navigated per navigator, the average of number of contacts between a navigator and a patient, and the percentage of navigated patients who complete screening. Similarly, implementation of a provider reminder system could be monitored by tracking the percentage of patients due for screening that actually receive a FOBT kit or colonoscopy referral. Process evaluation data should be used to document implementation efforts, including identification of implementation challenges and successes, and inform program improvement.

1.

Measurement of short-term outcomes – Awardees will measure short-term outcomes specified in the logic models and related to increasing screening rates among defined populations, increased adherence to timely, diagnostic colonoscopy, and increased rescreening among defined patient populations within specified health system(s). Awardees must provide aggregate baseline data for these outcomes for each health system where implementation is planned followed by annual reporting of aggregate data for these outcomes for each health system.

2.

Awardee Evaluation and Performance Measurement plans should:

Describe how key health system partners or other partners will be engaged in the evaluation and performance measurement planning processes.

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

Describe key evaluation questions to be answered.

Describe potentially available data sources.

Describe how data will be analyzed and reported.

Describe how an increase in CRC screening rates in the target population will be measured (include how the denominator, or target population, and numerator, or the number of the target population that has been screened, will be determined).

Describe how data quality will be ensured.

Describe how evaluation findings will be used for continuous program and quality improvement.

Describe how evaluation and performance measurement will contribute to our understanding of the advantages and challenges of working collaboratively with health system partners to achieve stated outcomes.

c. Organizational Capacity of Awardees to Execute the Approach

Component 1 and Component 2

Applicants must describe their organizational capacity to carry out the strategies outlined in each of the components an applicant applies for. Applicants should address infrastructure, workforce capacity and competence, expertise and experience related to all program focus areas, and information and data systems to implement the award. Applicants must provide evidence of program management/staffing plans, performance measurement, evaluation, financial reporting, management of travel requirements, and workforce development and training.

Applicants should include a detailed description of their experience, with particular focus on any collaborative work with health systems partners; program management components; readiness to establish working agreements; and a plan for long-term sustainability of the project. If available, letters of commitment, MOAs, and MOUs with health partner system(s) should be included.

Flexibility will be allowed to enable applicants to implement FOA requirements based on their own organizational design and approach, unless otherwise required by statute.

Component 1

Applicants for Component 1 must also demonstrate capacity to implement relevant strategies and activities by providing a detailed description of:

Established or newly built partnerships with health systems and other relevant organizations.

Experience implementing or facilitating systems level change within health systems or other organizations.

Proven ability to collect data at a population level and health systems level and use data to demonstrate impact.

Experience implementing coordinated interventions across 2 or more categorical programs.

Experience with planning and implementing programs at a systems level.

Subject matter expertise to plan and implement strategies.

Access to health systems data, including, for example, Medicaid data or health plan performance data.

Component 2

Applicants must demonstrate their existing and future capacity to successfully deliver colorectal screening and diagnostic services to meet the following program requirements:

Identify and maintain staff to manage the program. Applicants should submit an Organizational Chart showing the core staff and their assigned duties. As appropriate,integrate program management functions with existing CRC screening programs and/or other cancer screening or chronic disease programs. Core staff must include persons to:

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Manage the program, no more than a 0.5 FTE paid with CDC funds Fulfill data management functions, no more than a 0.5 FTE paid with CDC funds Provide clinical consultation Secure at least one medical advisor with relevant expertise to CRC screening to provide oversight of the quality of screening services delivered throughout the five-year funding period.

Establish any necessary contract(s), grants, or memoranda of agreements with program partners (e.g., health care providers) in a timely manner to assure service delivery.

Use a fiscal system that tracks and monitors program expenditures and ensures the accurate and timely reimbursement for services provided by the program.

d. Work Plan

The CRCCP logic models illustrate how the two components of the FOA will accomplish outcomes.

Applicants must provide a detailed work plan for the first year of the project period and a high level plan in narrative form for subsequent years in support of FOA outcomes. Activities must be in alignment with the proposed outcomes and the chosen program strategies and must include those activities the applicant selects as priority, based on the cited evidence, for the first year of the project. CDC will provide feedback and technical assistance to awardees to finalize the work plan post-award.

The work plan must, at a minimum, include:

Activities directly related to implementation of evidence-based strategies to reach segments of the target and priority populations.

A description of intended outcomes for the five-year project period.

A description of strategies to be used in the first year of the project period.

Objectives (including measures of effectiveness to assess progress and accomplishment) Activities for the first year of the project period.

A description of how the applicant will monitor and report progress on the short-term performance

A description of how the applicant will monitor and report progress on the short-term performance measures and as many of the intermediate and long-term measures as feasible for the EBIs and/or strategies selected.

Applicants should use the template provided to document their detailed work plan for Year 1 of the award and provide a general summary of work plan activities for Years 2-5 in narrative form.

Component 1

The Component 1 work plan must also include:

A logic model or equivalent that graphically displays the specific conditions, inputs, strategies, outputs, and intended outcomes for the five-year period that have been selected from the Component 1 logic model in the Approach section of this FOA. The applicant's logic model should only include the strategies, interventions, and short-term, intermediate, and long-term outcomes the applicant proposes to implement and achieve during the five year-year period. The applicant should not propose additional activities and outcomes not included in the Component 1 logic model in the Approach section of this

FOA.

Component 2

The Component 2 work plan must also include:

Specific strategies, interventions, and short-term, intermediate, and long-term outcomes from the applicant’s CRC Screening Delivery to Improve Access to the Underserved Logic Model.

Activities directly related to implementation of strategies to the Program Priority Population. Include an estimate of the number of people in the priority population that will be screened for CRC through the program.

A complete narrative description of the process proposed to identify, locate, screen, follow-up, and re-screen the Program Priority Population.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

All of the activities above may occur during the five-year project period.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

In a cooperative agreement, CDC staff will be substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:

Collaborate to ensure coordination and implementation of strategies to increase and improve the quality of CRC screening.

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Provide guidance and coordination to awardees to improve the quality and effectiveness of work plans, monitoring and evaluation plans, products and services, and collaborative activities with other organizations.

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Collaborate to compile and publish accomplishments, performance criteria, and lessons learned during the project period.

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Collaborate, as appropriate, in assessing progress toward meeting strategic and operational goals and objectives and in establishing measurement and accountability systems for documenting outcomes.

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Convene an in-person or teleconference meeting of all new grantees at program initiation.5.

Provide priority population estimates for geographic units that are available. Estimates are currently available at the state level. Provide program policies and guidelines.

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Interpret current scientific literature and national colorectal cancer screening guidelines.7.

Develop regular data monitoring feed-back reports based on clinical data submissions to support data use for quality assurance, program improvement, and…