CDC-RFA-DD20-2002.pdf

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Evaluation of Health Promotion and Prevention Programs for Blood Disorders

CDC-RFA-DD20-2002

Application Due Date: 05/15/2020

Evaluation of Health Promotion and Prevention Programs for Blood Disorders

CDC-RFA-DD20-2002

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (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 "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- DD20-2002. 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:

Evaluation of Health Promotion and Prevention Programs for Blood Disorders 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)).

Amendment 1 dated 4/13/2020 ---- Application due date changed to May 15, 2020

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD20-2002

E. Assistance Listings (CFDA) Number:

93.080 F. Dates:

1. Due Date for Letter of Intent (LOI): 04/15/2020

2. Due Date for Applications: 05/15/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Amendment 1 dated 4/13/2020 ---- Application due date changed to May 15, 2020.

3. Date for Informational Conference Call:

04/01/2020 Scheduled for 1:00 - 2:00pm, Eastern Standard Time.

Skype Number: (855) 348-8390 Conference ID: 1611483

G. Executive Summary:

1. Summary Paragraph:

The purpose of this NOFO is to provide credible health information and evidence-based training as well as to support the implementation and evaluation of evidence-based health promotion and education programs aimed at reducing or preventing complications of blood disorders on a national level; specifically: hemophilia and von Willebrand Disease, or venous thromboembolism, or thalassemia. These health-related activities may include: (1) 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 implementing and evaluating public health promotion and wellness programs and initiatives, (2) improving access to health promotion programs and activities, (3) developing, disseminating, and evaluating health communication materials, and (4) developing, implementing, and evaluating training for healthcare providers. Outcomes may include increased knowledge and awareness of signs, symptoms, diagnosis, and best treatment practices by consumers and healthcare providers and increased access to/receipt of screening and specialty services.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 5 Component 1: up to 3 awards Option A: 1 award Option B: up to 2 awards Component 2: 1 award Component 3: 1 award.

The final number of recipients will be determined by the objective review scoring and available funding.

d. Total Period of Performance Funding: $8,200,000

e. Average One Year Award Amount: $328,000 Component 1:

Option A: $500,000 Option B: $320,000 Component 2: $350,000 Component 3: $150,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/01/2020

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 NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview

Blood disorders are causes of morbidity and mortality, affecting one in 76 people in the United States (US). Hemophilia, von Willebrand disease (VWD), venous thromboembolism (VTE), and thalassemia are the blood disorders addressed within three separate components in this notice of funding opportunity (NOFO). The purpose of this NOFO is to provide credible health information and evidence-based training as well as to support the implementation and evaluation of evidence-based health promotion and education programs nationally. The health promotion framework will be to improve outcomes for people with blood disorders.

Applicants must apply for only one of the three following blood disorder components: 1) Hemophilia and VWD or 2) VTE or 3)Thalassemia.

Component 1. Hemophilia and VWD are the most common inherited bleeding disorders and affect 20,000 and up to 3.2 million people in the US, respectively. People with bleeding disorders have a predisposition to spontaneous or traumatic bleeding episodes following injuries and surgery. The focus areas for this component are treatment (specific to males), inhibitor development, and women with bleeding disorders. In males with hemophilia, prophylaxis can reduce joint damage, however, treatment initiation and adherence remain as barriers. Inhibitor development is a large cause of morbidity among persons with hemophilia and type 3 VWD.

Delayed diagnosis of bleeding disorders in women and delayed treatment can increase complications and reduce quality of life. Health information, education, and evidence-based innovative health promotion programs are needed for persons with hemophilia and VWD, and healthcare providers, to increase the knowledge and awareness of: best treatment practices, inhibitor risk factors, and signs, symptoms and treatment of bleeding disorders in women.

Applicants for component 1 may select either all three focus areas (funding Option A) or two of the focus areas of their choice (funding Option B). Applicants must state which funding option (A or B) they are applying for and specify the focus areas.

Component 2. Each year in the US, it is estimated that VTE affects as many as 900,000 people, is responsible for up to 100,000 deaths, and is associated with healthcare costs of approximately $10 billion dollars. Over half of VTE events are associated with a recent hospitalization.

Hospital-associated VTE is often preventable but VTE prevention strategies are not applied uniformly or systematically across US hospitals. This funding opportunity supports sustained health promotion and awareness of VTE using credible VTE health information, among individuals at risk for VTE, via existing materials. It additionally seeks to promote VTE best practices that are inclusive of the utilization of standardized risk assessment models and appropriate prophylaxis by providers for their hospitalized adult medical patients and the awareness of technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of VTE to advance health equity and to improve quality of life through improved patient safety.

Component 3. Beta thalassemia major is the most severe form of thalassemia and affects at least 1,000 people in the US. Blood transfusions for thalassemia are the foundation of care;

however, transfusion-related complications can result in morbidity and mortality. This component builds on earlier work and previously developed strategies that can be expanded to locate people with thalassemia and disseminate evidence-based, credible health information.

b. Statutory Authorities Sections 301 [42 U.S.C. 241] and 317C [42 U.S.C 247 b-4] of the Public Health Service Act.

c. Healthy People 2030 This NOFO specifically supports Healthy People 2020 Objectives for Blood Disorders and Blood Safety: BDBS-13 (Developmental) ?Reduce the number of adults who develop venous thromboembolism (VTE) during hospitalization?; BDBS-15 ?Increase the proportion of persons with von Willebrand disease (VWD) seen in specialty care centers who were diagnosed by 21 years of age?; and BDBS-16 ?Reduce the proportion of persons with severe hemophilia who have more than 4 joint bleeds per year?.

d. Other National Public Health Priorities and Strategies N/A

e. Relevant Work CDC previously funded health promotion for blood disorders through cooperative agreement

CDC-RFA-DD-14-1405.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

The logic model is generic and meant to broadly cover activities/outcomes across the three components and that each component will focus on some, but not all, of the activities and outcomes in the model.

CDC-RFA-DD20-2002 Logic Model: Evaluation of Health Promotion and Prevention Programs for Blood Disorders Bold indicates period of performance outcome

Strategies and Activities Short-term Outcomes Intermediate Outcomes

Long-Term Outcomes

S1. Assess gaps in information and programs

S2. Establish key partnerships and collaborations

S3. Develop and disseminate evidence-based health promotion and education materials

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level

SO2. Increased knowledge and awareness of best treatment practices by consumers and

Increased number of consumers diagnosed

IO1. Increased access to/receipt of screening and specialty services on a national level

Increased proportion of consumers receiving best

Early diagnosis and entry into treatment

Reduction in or prevention of complications due to blood disorders

Reduction in morbidity and mortality due to blood disorders

S4. Provide credible health information to consumers and people at risk

S5. Provide evidence-based training to healthcare providers

S6. Promote access to and/or referral to and/or implement programs for screening and specialty services

S7. Promote adherence to treatment

S8. Provide a webinar platform to disseminate public health education for the CDC?s Public Health Webinar Series on Blood Disorders healthcare providers on a national level treatments

IO2. Increased adherence to treatment on a national level

Improved quality of life

i. Purpose Hemophilia, VWD, VTE, and thalassemia are blood disorders that contribute towards the mortality, morbidity, and significant healthcare costs in men and women living in the United States. These blood disorders represent three components in this funding announcement. The purpose of the NOFO and each component is to provide credible health information and evidence-based training as well as to support the implementation and evaluation of evidence-based health promotion and education programs on a national level.

ii. Outcomes Of the outcomes listed in the generic logic model, applicants for this component will be held accountable for the following short-term outcomes (SO) and intermediate outcomes (IO) during the period of performance:

Component (1): Hemophilia and VWD

Outcomes:

This component will focus on selected outcomes listed in the generic logic model, specifically:

Focus Area: Treatment. The treatment component option will focus on selected outcomes listed in the generic logic model, specifically:

SO2. Increased knowledge and awareness of best treatment practices by consumers and healthcare providers on a national level o Increased knowledge and awareness about the benefits of prophylactic treatment regimen by consumers or hematology providers o Increased knowledge and awareness of emerging consumer and hematology provider treatment needs related to novel treatment products

IO2. Increased adherence to treatment on a national level o Increased adherence to prescribed prophylactic treatment by consumers

Focus Area: Inhibitors. The inhibitor component option will focus on selected outcomes listed in the generic logic model, specifically:

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level o Increased knowledge and awareness about risk factors and routine screening for inhibitors by consumers and hematology providers

IO1. Increased access to/receipt of screening and specialty services on a national level o Increased proportion of consumers screened for inhibitors

Focus Area: Women. The women with bleeding disorders component will focus on selected outcomes listed in the generic logic model, specifically:

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level o Increased knowledge and awareness about the signs, symptoms, and diagnosis of bleeding disorders in women among women and hematology and/or non-hematology providers

SO2. Increased knowledge and awareness of best treatment practices by consumers and healthcare providers on a national level o Increased knowledge and awareness of best treatment practices for women with bleeding disorders among women diagnosed with a bleeding disorder and/or hematology providers

IO1. Increased access to/receipt of screening and specialty services on a national level o Increased number of non-hematology providers who refer women for diagnosis and clinical management of a bleeding disorders

Component (2): VTE Outcomes:

This component will focus on selected outcomes listed in the generic logic model, specifically:

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level o Increased knowledge and awareness of the signs, symptoms, and diagnosis of VTE by consumers and healthcare providers

SO2. Increased knowledge and awareness of best treatment practices by consumers and healthcare providers on a national level o Increased knowledge and awareness of best treatment practices by consumers and healthcare providers for VTE o Increased knowledge and awareness about the importance of the utilization of standardized VTE risk assessment models with clinical decision support for appropriate prophylaxis among hospitalized adult medical patients, targeted to healthcare providers, hospitals, and hospital systems o Increased knowledge and awareness of health system technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of VTE

Component (3): Thalassemia Outcomes:

This component will focus on selected outcomes listed in the generic logic model, specifically:

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level o Increased knowledge and awareness of signs, symptoms, and diagnosis for thalassemia by consumers and healthcare providers

SO2. Increased knowledge and awareness of best treatment practices by consumers and healthcare providers on a national level o Increased knowledge and awareness of the best treatment practices for thalassemia by consumers and healthcare providers

iii. Strategies and Activities Component (1): Hemophilia and VWD Applicants are expected to address either two (funding Option B) or three (funding option A) of the following focus areas. Applicants for this component will be held accountable for the following strategies (S) listed in the generic logic model and should focus on the following based on the focus areas selected:

Focus Area: Treatment

S1. Assess gaps in information and programs o Assess gaps in information and programs, using scientific methods such as literature reviews or needs assessments, regarding prophylactic treatment, treatment adherence, and emerging needs related to novel treatment products

S2. Establish key partnerships and collaborations o Establish and engage in key partnerships and collaborations for Hemophilia and

VWD treatment (examples could include but are not limited to community-based organizations, patient centered organizations, provider organizations, or professional hematology organizations)

S3. Develop and disseminate evidence-based health promotion and educational materials o Develop and disseminate evidence-based health promotion materials about prophylactic treatment, treatment adherence, and emerging needs related to novel treatment products

S4. Provide credible health information to consumers and people at risk o Provide credible health information about prophylactic treatment, treatment adherence, and emerging needs related to novel treatment products (examples could include but are not limited to previously developed materials, translations, or clear communication synopses of publications for the community members)

S7. Promote adherence to treatment o Promote adherence to prescribed treatment for Hemophilia and VWD through implementing programs, grounded in health promotion theory S8. Provide a webinar platform to disseminate public health education for the CDC?s

Public Health Webinar Series on Blood Disorders

Focus Area: Inhibitors

S1. Assess gaps in information and programs o Assess gaps in information and programs, using scientific methods such as literature reviews or needs assessments, regarding inhibitor risk factors, testing, diagnosis, and treatment for consumers and providers

S2. Establish key partnerships and collaborations o Establish key partnerships and collaborations regarding inhibitors (examples could include but are not limited to community-based organizations, patient centered organizations, provider organizations, or professional hematology organizations)

S3. Develop and disseminate evidence-based health promotion and educational materials o Develop and disseminate evidence-based health promotion materials about inhibitor risk factors, testing, diagnosis, and treatment for persons at risk, diagnosed, and providers

S4. Provide credible health information to consumers and people at risk o Provide credible health information about inhibitor risk factors, testing, diagnosis, and treatment for persons at risk, diagnosed, and providers (examples could include but are not limited to previously developed materials, translations, or clear communication synopses of publications for the community members)

S5. Provide evidence-based training to healthcare providers o Develop and disseminate innovative hematology provider training on inhibitor development and inhibitor treatment and/or laboratorian training on inhibitor detection methods

S6. Promote access to and/or referral to and/or implement programs for screening and specialty services o Promote access to increased inhibitor screening for those at risk through implementing programs, grounded in health promotion theory

S8. Provide a webinar platform to disseminate public health education for the CDC?s Public Health Webinar Series on Blood Disorders

Focus Area: Women

S1. Assess gaps in information and programs o Assess gaps in information and programs, using scientific methods such as literature reviews or needs assessments, regarding women and bleeding disorders S2. Establish key partnerships and collaborations o Establish key partnerships and collaborations to promote women and bleeding disorders (examples could include but are not limited to community-based organizations, patient centered organizations, provider organizations, or professional organizations)

S3. Develop and disseminate evidence-based health promotion and educational materials o Develop and disseminate evidence-based health promotion materials about signs, symptoms, risk factors, testing, diagnosis, and treatment for women with bleeding disorders targeted to women at risk, diagnosed women, and hematology and/or non-hematology providers

S4. Provide credible health information to consumers and people at risk o Provide credible health information about signs, symptoms, risk factors, testing, diagnosis, and treatment for women at risk, diagnosed women, and providers (examples could include but are not limited to previously developed materials, translations, or clear communication synopses of publications for the community members)

S5. Provide evidence-based training to healthcare providers o Develop and disseminate evidence-based trainings and resources on bleeding disorders in women for hematology and/or non-hematology providers S6. Promote access to and/or referral to and/or implement programs for screening and specialty services o Promote access to and/or referral to screening and specialty services for women with bleeding disorders S8. Provide a webinar platform to disseminate public health education for the CDC?s

Public Health Webinar Series on Blood Disorders

Component (2): VTE Applicants for this component will be held accountable for the following strategies listed in the generic logic model, and should focus on the following:

S1. Assess gaps in information and programs o Assess gaps in information and barriers to implementing the utilization of standardized VTE risk assessment models with clinical decision support for appropriate prophylaxis among hospitalized adult medical patients at admission, during hospitalization, and at discharge o Assess gaps in information and barriers to implementing novel technologies within health systems for early identification, diagnosis, and treatment of VTE.

S2. Establish key partnerships and collaborations o Establish key partnerships and collaborations that will advance best practices to promote and increase the utilization of standardized VTE risk assessment models with clinical decision support for appropriate prophylaxis among hospitalized adult medical patients o Establish key partnerships and collaborations with experts in VTE and in health system informatics/analytics to identify technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of

VTE

S3. Develop and disseminate evidence-based health promotion and educational materials o Develop, disseminate, and evaluate health promotion materials that increase the utilization of standardized VTE risk assessment models with clinical decision support for appropriate prophylaxis among hospitalized adult medical patients o Develop, disseminate, and evaluate health promotion materials that describe and educate on novel health system technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of

VTE

S4. Provide credible health information to consumers and people at risk o Provide credible health information using existing material that build upon previously funded Division of Blood Disorder health promotion work to consumers and people at risk regarding VTE

S5. Provide evidence-based training for healthcare providers o Provide and evaluate training for healthcare providers regarding VTE

S8. Provide a webinar platform to disseminate public health education for the CDC?s Public Health Webinar Series on Blood Disorders

Component (3): Thalassemia Applicants for this component will be held accountable for the following strategies listed in the generic logic model, and should focus on the following:

S2. Establish key partnerships and collaborations o Establish and engage in key partnerships and collaborations with persons with thalassemia and clinicians in thalassemia treatment centers to promote and increase awareness of best practices for thalassemia management

S3. Develop and disseminate evidence-based health promotion and educational materials o Develop and disseminate health information materials about the signs, symptoms, and treatments for thalassemia S5. Provide evidence-based training for healthcare providers o Provide innovative evidence-based provider training on thalassemia conducted through forums such as educational consortia or virtual case-study conferences

S8. Provide a webinar platform to disseminate public health education for the CDC?s Public Health Webinar Series on Blood Disorders

1. Collaborations

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

N/A

b. With organizations not funded by CDC:

Collaborations between consumer groups, community-based organizations, clinicians, and researchers are encouraged. If collaborations are proposed, it is expected that the nature of these collaborations are clearly described in the proposal and letters of support included in the appendix. If contractual agents or agencies will be used, the role of the contractor and how they will be selected should be described. Letters of support should be named ?letter of support' and uploaded as a pdf to www.grants.gov.

2. Target Populations The target populations are people with blood disorders, specifically hemophilia, VWD, VTE, and thalassemia, as well as healthcare providers and the general public, nationwide. The target population will vary based on the component:

Component 1. The target population for the treatment focus area includes men of all ages living with hemophilia or VWD and healthcare providers who treat those individuals. The target population for the inhibitor focus area includes men with hemophilia or VWD, healthcare providers, and general public. The target population for the womens' focus area includes women with symptoms of or a diagnosed with a bleeding disorders, healthcare providers, and the general public.

Component 2. The target population includes individuals who may be at risk of a VTE, healthcare providers in hospitalized settings, and the general public.

Component 3. The target population includes individuals of all ages with thalassemia, healthcare providers, and the general public.

a. Health Disparities Where appropriate, applicants are encouraged to include people with disabilities; non-English speaking populations; racial and ethnic minorities; lesbian, gay, bisexual, transgender, and questioning (LGBTQ) populations; people with limited health literacy; or populations that may otherwise be overlooked by the program. It is expected that, if applicable, applicants will identify health disparities among the target population(s) and include a plan with activities to reduce or eliminate these disparities.

iv. Funding Strategy An applicant must apply for only 1 of the 3 components. Funding listed is an annual amount.

Component 1 (Hemophilia & VWD): one award for option A (applicant selected all three focus areas) with an award ceiling of $500,000; up to two awards for option B (applicant selected only two of the focus areas) with an award ceiling of $320,000.

Component 2 (VTE): one award with an award ceiling of $350,000.

Component 3 (Thalassemia): one award with an award ceiling of $150,000.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Applicants are required to provide an evaluation and performance measurement plan that identifies the type of evaluation measure for the proposed strategies (S). The strategies below are generic and meant to broadly cover activities/outcomes across the three components and that each component will focus on some, but not all, of the activities and outcomes in the model.

Applicants should provide an evaluation and performance measurement plan for strategies that are specific to the component they are applying too. Evaluation measures may include the following:

S1. Assess gaps in information and programs o Proposed process measures to evaluate gaps in information and programs could include but are not limited to: a summary of current literature, key informant interviews, needs assessment surveys

S2. Establish key partnerships and collaborations o Proposed process measures to evaluate establishment of key partnerships or collaborations could include but are not limited to: a list of collaborators and their roles and responsibilities, types of collaboration, evidence of ongoing collaborative efforts that demonstrate engagement in collaboration

S3. Develop and disseminate evidence-based health promotion and education materials o Proposed process measures to evaluate the development and dissemination of evidence-based health promotion and education materials could include but are not limited to: the number and types of materials developed, clearly identified target populations, language and health literacy level of materials for target population, methods of dissemination, number of resources requested and distributed, or quality assessment of materials

S4. Provide credible health information to consumers and people at risk o Proposed process measures to evaluate provision of credible health information could include but are not limited to: the types and numbers of dissemination channels, numbers and types of materials distributed, populations reached, types of digital engagement on health information disseminated, or web metrics

S5. Provide evidence-based training to healthcare providers o Proposed process measures to evaluate provision of evidence-based training to healthcare providers could include but are not limited to: types of training, clearly identified healthcare provider population, number of healthcare providers who receive training, healthcare provider assessment of the quality of training, or whether providers intend to implement elements learned

S6. Promote access to and/or referral to and/or implement programs for screening and specialty services o Proposed process measures to evaluate promotion of access to/and or referral to and/or implementing programs for screening and specialty services could include but are not limited to: identification of barriers and promoters to screening, list and location of specialty services, number of referrals, number of people screened may be used to promote access to screening and specialty services

S7. Promote adherence to treatment o Proposed process measures to evaluate promotion of adherence to treatment could include but are not limited to: summary of approaches or technologies to measure adherence, evidence of reaching intended population, pre-post surveys may be used to evaluate an increase in adherence

S8. Provide public health technical assistance on the implementation of CDC?s Public Health Webinar Series o Proposed process measures to evaluate provision of public health technical assistance on the implementation of CDC?s Public Health Webinar Series could include but are not limited to: evaluation reports on numbers of people who registered, numbers of people who logged in and attended the webinar, summary of responses to select population poll questions, or summary of responses to post-event evaluation questions on quality and usefulness of information provided

Applicants are required to provide an evaluation and performance measurement plan that identifies the type of evaluation measure for the proposed short-term outcome (SO) and intermediate outcome (IO) measures, which may include the following:

SO1. Increased knowledge and awareness of signs, symptoms, and diagnosis by consumers and healthcare providers on a national level o Proposed outcome measures could include but are not limited to baseline surveys prior to the implementation of an intervention/program and a survey completed afterwards to measure a change in knowledge and awareness

SO2. Increased knowledge and awareness of best treatment practices by consumers and healthcare providers on a national level o Proposed outcome measures could include but are not limited to baseline surveys prior to the implementation of an intervention/program and a survey completed afterwards to measure a change in knowledge and awareness; or documentation of provider implementation of best treatment practices

IO1. Increased access to/receipt of screening and specialty services on a national level o Proposed outcome measures could include but are not limited to baseline surveys prior to the implementation of an intervention/program and a survey completed afterwards to measure a change in access to or receipt of screening or specialty services.

IO2. Increased adherence to treatment on a national level o Proposed outcome measures could include but are not limited to baseline surveys prior to the implementation of an intervention/program and a survey completed afterwards to measure a change in adherence to treatment; evaluation of direct measures of adherence such as treatment logs, pharmacy records, prescription refill practices; or discussion groups / key informant interviews to evaluation behavior change to increase adherence

For each process and outcome measure, the applicant should identify potential data sources and discuss the feasibility of collecting appropriate data for the measure. In addition, the applicant should describe how evaluation findings will be used for continuous program quality improvement. When applicable, the applicant should also describe how key partners and/or collaborators will participate in the evaluation and performance measurement planning processes.

Since this NOFO does not involve the generation or collection of public health data, a Data Management Plan is not required for this NOFO.

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.

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:

Each of the performance measures (process and outcome) that will be used How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement Available data sources, feasibility of collecting appropriate evaluation and performance https://www.cdc.gov/grants/additionalrequirements/ar-25.html data, and other relevant data information (e.g. performance measures proposed by the applicant) for each performance measure

Describe how evaluation and performance measures will yield findings to demonstrate an impact of cooperative agreement activities on the component specific outcomes

If applicable, how key program partners will participate in the evaluation and performance measurement planning processes

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

c. Organizational Capacity of Recipients to Implement the Approach Applicants must demonstrate the ability to execute program requirements on a national level and meet period of performance outcomes. Successful applicants will demonstrate the necessary skills, relevant experience, and capacity to successfully implement the strategies and activities listed above.

All applicants should:

Describe their organizations/institution?s experience in working with the target population and describe their understanding of the need for this program as well as their agency?s capacity in implementing and evaluating the activities with the proposed plan.

Demonstrated readiness to implement the strategies includes the ability of applicants to describe the following:

o Experience and capacity to conduct program evaluation, both process and outcome, and implement the evaluation plan on a national level o Established organizational policies and procedures to ensure sufficient fiscal and budgetary oversight and capacity to provide required reports

Provide a description of their organizations structure and proposed staffing for the project.

o A CV/Resume is required for each team member and should clearly indicate their experience and expertise. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

o If the organization intends to contract for a position outside of the organization, this should be specified as well as how the contractor will be identified.

o Proposed staffing should include the team structure for the cooperative agreement, the role of each proposed team member, and the percent time expected of each team member for each major activity proposed in the Work Plan.

o The applicant should identify appropriate team member?s responsible for each strategy listed in their Work Plan. The applicant should describe the extent to which team member?s experience and expertise align with the strategies for which they will be responsible.

Demonstrate that they have a financial management system that will allow proper funds management and segregation of funds by program, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_13 02"45 CFR 75.302 The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award.

o Demonstrate capacity of managing the required procurement efforts, include the ability to write and award contracts in accordance with 45 CFR Part 74.Applicants must file the CVs/resumes for each team member, as appropriate, name the file ?CVs/resumes?, and upload it as a PDF file at www.grants.gov.

In addition, the applicant should describe the following component-specific information:

Component 1 (Hemophilia and VWD)

Applicant is required to demonstrate how team members' experience and expertise align with the focus areas selected (treatment, inhibitor development, women with bleeding disorders) as well as the strategies for which they will be responsible for based on their Work Plan.

The applicant should identify and state which team member(s) have strong experience and expertise with the following: 1) health education, health communication, or health promotion; 2) a subject matter expert for each of the focus areas they have selected (if they have selected two focus areas, e.g. treatment and inhibitor, they should have either one team member with strong experience and expertise in both treatment and inhibitor development ? or identified a team member that is a subject matter expert in treatment and a second team member that is a subject matter expert in inhibitor development.

CV/Resumes for these team member(s) should clearly demonstrate the necessary experience for each person identified.

Component 2 (VTE)

Applicant is required to demonstrate a history of experience in national VTE-related health communication/promotion projects.

The applicant should identify and state which team member(s) have strong experience and expertise with the following: 1) health communication or health promotion; 2) VTE risk assessment models; and 3) informatics. CV/Resumes for these team members should clearly demonstrate the necessary experience for each person identified.

The applicant should describe their access to VTE clinical expertise.

Component 3 (Thalassemia)

Applicant is required to demonstrate their history in working collaboratively with other key stakeholders in thalassemia as well as expertise in developing, leading, and evaluating national thalassemia-related health communication/promotion projects.

The applicant should identify and state which team member(s) have strong experience and expertise with the following: 1) health communication or health promotion; 2) operating a webinar platform and providing post-event reporting and metrics; and 3) developing evidence-based provider training. CV/Resumes for these team members https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 http://www.grants.gov/ should clearly demonstrate the necessary experience for each person identified.

The applicant should describe their access to thalassemia clinical expertise.

d. Work Plan Applicants must submit a detailed Work Plan that covers the first year of the project period and a high level plan for subsequent years. At a minimum, the Work Plan should demonstrate how the outcomes, strategies, activities, timelines, and staffing/collaborations work together. The applicant should provide detail about how they will implement the given strategies and activities. For example, the applicant should describe the activity(s) they will perform to assess gaps or barriers; and if applicable, the applicant should identify a potential gap or barrier and specify how they will implement a strategy and activity, with the specific target population, to address that gap.

The Work Plan should describe how the applicant plans to implement all of the required strategies and activities to achieve NOFO outcomes. A sample Work Plan format is presented below to show how a traditional Work Plan aligns with the logical model and narrative. A separate table should be included in the Work Plan for each of the outcomes that will be completed during the one year period of performance. If a particular activity leads to multiple outcomes, it should described under each outcome measure. Applicants are not required to use the example Work Plan format; however, all Work Plans must contain all of the elements shown in the example (outcome(s), outcome measure(s), etc).

Example Work Plan Table Period of Performance Outcome: (from Logic Model) Outcome Measure: (from Evaluation and Performance Measurement)

Strategies and Activities

Process Measure (from Evaluation and Performance Measurement)

Responsible Team Member(s)

Target Population

Setting(s) Completion Date

1.

2.

3.

4.

5.

CDC will provide feedback and technical assistance to award recipients to finalize the Work Plan activities post-award.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient 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 recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient 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 deemed necessary to monitor the award:

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

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

Working with recipients 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.

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 recipients.

Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including Work Plans, performance, and financial reporting).

HHS expectations for post-award monitoring for grants and cooperative agreements includes:

Tracking awardee progress in achieving desired outcomes Insuring 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 objectives within stated time frames

Working with awardees on adjusting the Work Plan based on achievement of objectives and changing budgets

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

These may include monitoring and reporting activities as outlined in GPAM that assists grant management staff (e.g., grants management officers and specialists, and program officers) in the identification, notification, and management of high-risk awardees CDC will use the Work Plan to track progress towards the short-term and intermediate outcomes outlined in the logic model (outcome evaluation). Each recipient will be required to develop a Work Plan that outlines how and by when they will achieve strategies and activities and outcomes outlined in this NOFO. Recipient will update their Work Plans every 3 months and provide an accurate and detailed assessment of their progress. CDC will review the Work Plan to track implementation as outlined in the recipient strategies and activities (process evaluation) and determine progress on achieving the period performance outcomes (outcome evaluation). Work Plans will be discussed on one-on-one calls.

CDC will provide routine feedback to recipients throughout the period of performance using bimonthly calls, emails, weekly email communication, and the data quality summaries referenced above.

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

COOPERATIVE AGREEMENTS)

The CDC program supporting this NOFO will be substantially involved in the activities and beyond routine grant monitoring throughout the period of performance. To ensure the success of the cooperative agreement, CDC will provide the following:

Technical Assistance: CDC technical assistance will include access to subject matter experts in hemophilia, VWD, VTE, and thalassemia as well as experts in public health practice and evaluation; and expertise in health promotion design and methodology.

CDC staff will provide advisory technical assistance on health promotion design and methodology as well as evaluation throughout the project. CDC staff will conduct regular conference calls with the awardee and will assist, as needed with capacity building, program planning, Work Plan development, implementation, performance measurement and evaluation.

Information Dissemination: CDC staff will collaborate in the development of health promotion materials, presentations, and publications associated with the strategies and activities. CDC staff will share information, practices, lessons learned, and evaluation results among partners through meetings, conferences, listservs, webinars, and other social media.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U27

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $1,640,000

5. Approximate Period of Performance Funding: $8,200,000

This amount is subject to the availability of funds.

Estimated Total Funding: $8,200,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 5 Component 1: up to 3 awards Option A: 1 award Option B: up to 2 awards Component 2: 1 award Component 3: 1 award.

The final number of recipients will be determined by the objective review scoring and available funding.

8. Approximate Average Award: $328,000 Per Budget Period Component 1:

Option A: $500,000 Option B: $320,000 Component 2: $350,000 Component 3: $150,000

9. Award Ceiling: $500,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $150,000 Per Budget Period

11.…