CDC-RFA-DP21-2102.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Paul Coverdell National Acute Stroke Program

CDC-RFA-DP21-2102

Application Due Date: 03/18/2021

Paul Coverdell National Acute Stroke Program

CDC-RFA-DP21-2102

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- DP21-2102. 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:

Paul Coverdell National Acute Stroke Program 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.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52. 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)).

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DP21-2102

E. Assistance Listings (CFDA) Number:

93.810 F. Dates:

1. Due Date for Letter of Intent (LOI): 02/11/2021

2. Due Date for Applications: 03/18/2021, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

CDC-RFA-DP21-2102: Paul Coverdell National Acute Stroke Program Applicant Information Call:

Date: January 14, 2021 Time: 3:00p.m.- 4:00p.m. U.S. Eastern Standard Time Conference line: 1-888-989-9773 Conference ID: 2568038# Join via Computer: https://adobeconnect.cdc.gov/rvu1et3m3oy1/ Potential applicants may also submit questions via email at: Coverdell2102Comms@cdc.gov Questions and responses will be posted to the Coverdell NOFO Information webpage within 72 hours of receipt so that all applicants have access to any information shared. https://www.cdc .gov/dhdsp/programs/pcnasr_foa.htm https://www.grants.gov https://www.grants.gov https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://adobeconnect.cdc.gov/rvu1et3m3oy1/ mailto:Coverdell2102Comms@cdc.gov https://www.cdc.gov/dhdsp/programs/pcnasr_foa.htm https://www.cdc.gov/dhdsp/programs/pcnasr_foa.htm

G. Executive Summary:

1. Summary Paragraph:

The aim of this NOFO is to support the implementation of comprehensive stroke systems for individuals, both at highest risk for stroke events and for stroke patients, across the continuum of care. This will be achieved via enhancing and improving the quality of stroke care across the continuum of care in states with high burden populations. For this NOFO, high burden populations are those that state-level data indicate are disproportionately impacted by stroke outcomes, including stroke hospitalizations and stroke mortality, and have disproportionately high prevalence for those at highest risk for stroke events, including individuals with high blood pressure and/or high blood cholesterol, which may be a result of socioeconomic factors, such as living in underfunded urban and rural communities, being uninsured/underinsured, having limited access to routine medical care, or other related factors. Successful applicants are expected to ensure all efforts are designed to close the gap in stroke care for high burden populations as described above and improve state-level stroke care across the continuum of care. This is expected to be achieved by implementing a state-wide registry, along with evidence-based strategies to measure, track, and improve access to and quality of care for those individuals at highest risk for stroke events and for stroke patients from onset of stroke symptoms through rehabilitation and recovery.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 13

d. Total Period of Performance Funding: $23,100,000

e. Average One Year Award Amount: $575,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 05/30/2021

h. Cost Sharing and / or Matching Requirements: N Although no statutory matching requirement for this NOFO exists, applicants are encouraged to leverage other resources and related ongoing efforts to promote sustainability.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Heart disease is the leading cause of death in the United States. Cardiovascular Disease (CVD), including heart disease, stroke, and other vascular diseases, accounts for >800,000, or about 1 in 3, deaths/year, and around 1 in 5 who die from CVD are younger than 65 years. CVD is costly, with an estimated 15%, or 1 in 7 health care dollars spent on CVD. Stroke is the 5th leading cause of death and is a major cause of disability. After decades of decline, progress has slowed in preventing stroke deaths. About 795,000 people have a stroke each year. About 610,000 of these are first or new stroke events and nearly 1 in 4, are in people who have had a previous stroke. Stroke costs the United States an estimated $34 billion each year, with this figure representing the cost of health care services, medicines to treat stroke, and missed days of work.

The risk of having a stroke varies with race and ethnicity, but it is clear the risk of having a first stroke is nearly twice as high for Black individuals as for White individuals. Black persons have the highest rate of death due to stroke among all races/ethnicities. Stroke death rates among Hispanic adults increased by 6% each year from 2013 to 2015. Stroke deaths also increased in southern states, where high burden populations, specifically communities of color, exist. High blood pressure (hypertension) is the most important risk factor for stroke and less than half of those with hypertension are controlled. High blood pressure is more common in non-Hispanic Black adults (54%) than in non-Hispanic White adults (46%), non-Hispanic Asian adults (39%), or Hispanic adults (36%). High blood cholesterol, smoking, obesity, and diabetes also significantly contribute to stroke risk and have a huge impact on high burden populations. These data are disturbing because about 80% of strokes are preventable. These data also highlight the critical need to improve access to and quality of care for those at highest risk for stroke events and stroke patients along the continuum of care, particularly among high burden populations.

People of color experience disparities in access to health care, the quality of care received, and health outcomes. Analyses of data collected under previous cycles of this cooperative agreement found that women and African Americans were less likely to be treated with alteplase within 60 minutes. Other analyses determined that ischemic stroke patients who were women and Medicaid or Medicare recipients had lower odds of receiving defect-free care. A robust body of research supports the assertion that biases, both implicit and explicit, by clinical providers, can significantly impact health care delivery, clinical decision-making, patient-provider interactions, treatment decisions, treatment adherence, and the resulting patient health outcomes.

This NOFO will build upon accomplishments, outcomes achieved, and lessons learned through CDC-RFA-DP15-1514 by focusing efforts on implementing a state-wide registry, along with evidence-based strategies to measure, track, and improve access to and quality of care for those individuals at highest risk for stroke events and for stroke patients from onset of stroke symptoms through rehabilitation and recovery. These efforts must accurately identify disparities and effectively address the relevant inequities, including identification, assessment, and treatment across the continuum of care for those at highest risk for stroke events and for stroke patients.

b. Statutory Authorities This program is authorized under Section 317(k)(2) of the Public Health Services Act (PHS Act), 42 U.S.C. 247b(k)(2) as amended.

c. Healthy People 2030 This NOFO addresses the Healthy People 2030 focus area of Heart Disease and Stroke: ;https ://health.gov/healthypeople/objectives-and-data/browse-objectives/heart-disease-and-stroke ;

HDS-03: Reduce stroke deaths HDS-05: Increase control of high blood pressure in adults https://health.gov/healthypeople/objectives-and-data/browse-objectives/heart-disease-and-stroke https://health.gov/healthypeople/objectives-and-data/browse-objectives/heart-disease-and-stroke

HDS-D04: Increase the proportion of stroke patients who get IV reperfusion therapy within 3 hours of symptom onset

HDS-D05: Increase the proportion of adult stroke survivors who participate in rehabilitation services

HDS-D06: Increase the proportion of people with strokes who get mechanical thrombectomy within 16 hours of symptom onset

d. Other National Public Health Priorities and Strategies This NOFO supports efforts in facilitating community-clinical links and improving access to and quality of comprehensive stroke systems across the care continuum. Priority areas identified by the Division for Heart Disease and Stroke Prevention include:

Hypertension prevention, detection, and control: https://www.cdc.gov/chronicdisease /about/foa/1815/index.htm, https://www.cdc.gov/wisewoman/1816-nofo.htm and https ://www.cdc.gov/chronicdisease/about/foa/1817/index.htm

Million Hearts® 2022: https://millionhearts.hhs.gov/ Recommended strategies for Cardiovascular Disease Prevention and Control: https

://www.thecommunityguide.org/topic/cardiovascular-disease

e. Relevant Work This NOFO builds on the accomplishments and outcomes achieved in the NOFO CDC-RFA- DP15-1514 (https://www.cdc.gov/dhdsp/programs/stroke_registry.htm) including development of comprehensive stroke systems of care to improve the quality of care for acute stroke patients, improve recovery, and reduce early mortality for acute stroke patients. This NOFO also builds on efforts to "Link Community Resources and Clinical Services" under CDC-RFA-DP18-1815, CDC-RFA-DP18-1816, and CDC-RFA-DP18-1817, which identifies, enhances, or builds systems that facilitate provider and community bi-directional referrals to support identification of and referrals for those with risk factors for CVD and those with CVD.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

https://www.cdc.gov/chronicdisease/about/foa/1815/index.htm https://www.cdc.gov/chronicdisease/about/foa/1815/index.htm https://www.cdc.gov/wisewoman/1816-nofo.htm https://www.cdc.gov/chronicdisease/about/foa/1817/index.htm https://www.cdc.gov/chronicdisease/about/foa/1817/index.htm https://millionhearts.hhs.gov/ https://www.thecommunityguide.org/topic/cardiovascular-disease https://www.thecommunityguide.org/topic/cardiovascular-disease https://www.cdc.gov/dhdsp/programs/stroke_registry.htm

i. Purpose The aim of this NOFO is to support the implementation of comprehensive stroke systems for individuals, both at highest risk for stroke events and for stroke patients, across the continuum of care in states with high burden populations. For this NOFO, high burden populations are those that state-level data indicate are disproportionately impacted by stroke outcomes, including stroke hospitalizations and stroke mortality, and have high prevalence for those at highest risk for stroke events, including high blood pressure and/or high blood cholesterol, and other relevant socioeconomic factors.

ii. Outcomes Applicants will only be required to focus and report on those outcomes that align with the strategies selected. Within each of the three broad strategy categories, applicants are required to select the identified required strategy and at least one additional strategy, for a minimum of 6 strategies selected. Refer to the Strategy Table in Section 2.b.i. CDC Evaluation and Performance Measurement Strategy for more information.

Short term outcomes:

Increased measurement, tracking, and assessment of data across stroke systems of care for those at highest risk for stroke events and stroke patients

Increased implementation of data-driven Quality Improvement activities across stroke systems of care for those at highest risk for stroke events and stroke patients

Increased establishment of community resources and clinical services for those at highest risk for stroke events and stroke patients across stroke systems of care

Intermediate Outcomes:

Increased linkage and usage of data across stroke systems of care for those at highest risk for stroke events and stroke patients

Increased linkage and usage of data across stroke systems of care for those at highest risk for stroke events and stroke patients

Increased provision of community resources and clinical services to those at highest risk for stroke events and stroke patients across stroke systems of care

Long term Outcomes:

Increased access to care and improved quality of care for stroke patients

Decreased disparities in access to and quality of care for populations at highest risk for stroke events

iii. Strategies and Activities Recipients are expected to engage in efforts supporting the development and implementation of a state wide stroke registry, and also the implementation of evidence-based strategies and activities to measure, track, and improve access to and quality of care for those individuals at highest risk for stroke events and for stroke patients from onset of stroke symptoms through rehabilitation and recovery, thereby improving stroke care across the care continuum. (https ://www.cdc.gov/dhdsp/programs/about_pcnasp.htm). Recipients are expected to utilize data expertise to successfully develop, implement, and use data collection systems and other data collection activities for program monitoring and reporting, including data elements and hospital metrics. (https://www.cdc.gov/dhdsp/programs/pcnasr_metrics.htm). Recipients are expected to submit to CDC through CDC's secure data systems on a recurring basis, aggregated and de-identified data, via an integrated data management system that links pre-hospital and in-hospital data.

Recipients are expected to implement activities designed to achieve the short, intermediate, and long term outcomes specified in this NOFO that are in alignment with the following broad strategy categories:

I. Track and Monitor Clinical Measures to Improve Data Infrastructure Across Stroke Systems of Care

II. Implement a Team-Based Approach to Enhance Quality of Care for Those at Highest https://www.cdc.gov/dhdsp/programs/about_pcnasp.htm https://www.cdc.gov/dhdsp/programs/about_pcnasp.htm https://www.cdc.gov/dhdsp/programs/pcnasr_metrics.htm

Risk for Stroke Events and Stroke Patients Across Systems of Care III. Link Community Resources and Clinical Services That Support Those at Highest Risk for Stroke Events and Stroke Patients Across Systems of Care

Applicants must select the bold strategy plus at least 1 additional strategy from each of the three broad strategy categories. (Item numbers begin with C for Coverdell):

I. Track and Monitor Clinical Measures to Improve Data Infrastructure Across Stroke Systems of Care

C1. Leverage electronic health records (EHRs) and health information technology (HIT) to identify patients with stroke risk factors (e.g. undiagnosed hypertension) and monitor health care disparities for those at highest risk for stroke events.

C2. (Required) Establish and expand state-wide data infrastructure through an integrated data management system that links pre-hospital, hospital, and post-hospital follow up data for measurement, tracking, and assessment of quality of stroke care data.

C3. Coordinate the development and implementation of a referral tracking system to support transitions of care for stroke patients post-discharge.

II. Implement a Team-Based Approach to Enhance Quality of Care for Those at Highest Risk for Stroke Events and Stroke Patients Across Systems of Care

C4. (Required) Analyze data and identify areas to improve the efficiency and quality of care within EMS and hospital settings and to improve transitions of care between settings through systematic Quality Improvement (QI) methods and interventions (e.g. PDSA, Lean, Six Sigma).

C5. Coordinate, develop, and implement professional and workforce development opportunities (e.g. training, technical assistance, peer to peer learning, continuing education, workshops, etc.) to improve evidence-based clinical knowledge for stroke care, recognition of disparities in stroke care, and implementation of activities to address them (e.g. unconscious bias training, clinical decision-making tools, cultural competence).

C6. Develop and implement patient care practices/patient care protocols within EMS and hospital systems to coordinate patient hand-off and transitions in care throughout the stroke systems of care.

III. Link Community Resources and Clinical Services That Support Those at Highest Risk for Stroke Events and Stroke Patients Across Systems of Care:

C7. Establish and strengthen partnerships with relevant state or local stroke coalitions, initiatives, professional organizations, providers, and health systems that provide resource support for stroke patients, as well as those at highest risk for stroke events.

C8. (Required) Facilitate engagement of patient navigators/community health workers in the management of those at highest risk for stroke events and post-event discharge support and follow-up of stroke patients across clinical and community settings.

C9. Coordinate and/or promote stroke messaging/education within communities and clinical settings around the importance of addressing the needs of those at highest risk for stroke events and the appropriate response during a stroke event, including utilizing EMS for stroke transport.

1. Collaborations

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

Recipients will be expected to collaborate with other related CDC-funded programs that have a role in achieving the NOFO outcomes for the strategies selected. Collaborations may center on shared data; partner organizations; coalitions; intervention settings/locations; marketing approaches/messages; and Electronic Health Records/Health Information Technology-focused entities. Recipients are expected to engage with applicable subject matter experts within the CDC's Division for Heart Disease and Stroke Prevention (DHDSP) and engage in network collaborations with other recipients under this NOFO. Recipients are expected to work with other applicable units that could include local, regional, or state health entities to advance program outcomes. Depending on the Health Department organizational structure, this may include Heart Disease and Stroke Prevention programs, Emergency Medical Services (EMS) units, or health care Quality Improvement (QI) entities and resources.

Recipients should establish collaborative, strategic partnerships with other CDC funded programs within and outside the state health departments, tribes and tribal organizations to allow for more efficient use of existing resources. This also allows for exchange of information among experts working in various areas of public health and other sectors. Related CDC-funded programs include but are not limited to CDC-RFA-DP18-1815 (https://www.cdc.gov/chronicdis ease/about/foa/1815/index.htm), CDC-RFA-DP18-1816 (https://www.cdc.gov/wisewoman /1816-nofo.htm), CDC-RFA-DP18-1817 (https://www.cdc.gov/chronicdisease/about/foa/1817 /index.htm), and other CDC-funded chronic disease prevention and management programs.

Applicants should also link to strategies and collaborations described in the State Chronic Disease Plan, as appropriate.

Letters of support and MOAs/MOUs are not required, but strongly encouraged. These should be considered for submission as a part of the full application, and include a firm commitment from partner organizations, along with the role it will play in helping achieve the NOFO outcomes.

Applications will be evaluated based on strength and quality of collaborations.

If Applicants choose to submit a Letter of Support, the Letter of Support should be saved as a .pdf file with a name beginning "Letter of Support", and uploaded as a PDF file at www.grants.gov.

If Applicants choose to submit a MOA/MOU, the document should be saved as a .pdf file with https://www.cdc.gov/chronicdisease/about/foa/1815/index.htm https://www.cdc.gov/chronicdisease/about/foa/1815/index.htm https://www.cdc.gov/wisewoman/1816-nofo.htm https://www.cdc.gov/wisewoman/1816-nofo.htm https://www.cdc.gov/chronicdisease/about/foa/1817/index.htm https://www.cdc.gov/chronicdisease/about/foa/1817/index.htm a name beginning with "MOA" or "MOU", and uploaded as a PDF file at www.grants.gov.

b. With organizations not funded by CDC:

Recipients are required to collaborate with partners and agencies that serve the priority population of interest or work with the identified communities of interest. Recipients are expected to collaborate with a variety of public and private partners to leverage resources and maximize state-wide reach and impact. Collaborative partners can include entities from many sectors. Collaborations with a variety of public and private organizations are encouraged to leverage resources and maximize reach and impact for the strategies selected. These organizations may include employers; commercial health plans; hospitals; Federally Qualified Health Centers(FQHC)/Rural Health Clinics and Centers (RHC)/Community Health Centers;

non-profit agencies; other federal, state, or local government agencies (e.g., State Medicaid Agency, State Employee Benefit Agency, etc.); Tribes or Tribal organizations; professional associations (state medical society, other medical specialty associations, etc.); Quality Improvement (QI) organizations; and others that have a stake in supporting the evidence-based strategies described in this NOFO.

Letters of support and MOAs/MOUs are not required, but strongly encouraged. These should be considered for submission as a part of the full application, and include a firm commitment from partner organizations, along with the role it will play in helping achieve the NOFO outcomes.

Applications will be evaluated based on strength and quality of collaborations.

If Applicants choose to submit a Letter of Support, the Letter of Support should be saved as a .pdf file with a name beginning "Letter of Support", and uploaded as a PDF file at www.grants.gov.

If Applicants choose to submit a MOA/MOU, the document should be saved as a .pdf file with a name beginning with "MOA" or "MOU", and uploaded as a PDF file at www.grants.gov.

2. Target Populations The aim of this NOFO is to support the implementation of comprehensive stroke systems for individuals, at highest risk for stroke events and stroke patients, across the continuum of care.

This will be achieved via enhancing and improving the quality of stroke care across the continuum of care in states with high burden populations. For this NOFO, high burden populations are those that state-level data indicate are disproportionately impacted by stroke outcomes, including stroke hospitalizations and stroke mortality, and have disproportionately high prevalence for those at highest risk for stroke events, including individuals with high blood pressure and/or high blood cholesterol, which may be a result of socioeconomic factors, such as living in underfunded urban and rural communities, being uninsured/underinsured, having limited access to routine medical care, or other related factors.

Applicant must demonstrate that they are located in a state with either stroke hospitalizations rate higher than the 2017 national average (283 stroke hospitalizations per 100,000 people), or stroke mortality rate higher than the 2018 national average (55.4 per 100,000 people).

Additionally, applicant must include data that demonstrates high burden populations within the state at highest risk for stroke events, as evidenced by significant prevalence of high blood pressure and/or high blood cholesterol. Applicant must use data to describe the priority population identified in this NOFO. The state-level, county-level, or local hospital level data on mortality/hospitalizations can be used to identify priority populations. High burden populations should include those affected disproportionately by high blood pressure, high blood cholesterol, or diabetes due to socioeconomic or other characteristics, including inadequate access to care, poor quality of care, or low income. Emphasis should be placed on achieving maximum reach and impact across the state with a focus on these populations.

a. Health Disparities The aim of this NOFO is to enhance and improve the quality of stroke care in states with a high burden of stroke with a special focus on identifying health inequities and reducing stroke disparities within high burden populations, who may be at risk of stroke disparity due to lower socioeconomic status, race/ethnicity, urban/rural communities, uninsured/underinsured health care coverage, or other social determinants negatively affecting stroke outcomes. Recipients will use data-driven methods to identify high burden populations and to implement quality improvement efforts, with the aim of closing the gap in stroke disparities.

This NOFO will address the challenges and health inequities in chronic disease risk factors and conditions that high-burden populations experience, specifically those related to stroke outcomes. These efforts will help determine the public health impact of programs intended to improve specific risks, conditions, and/or barriers experienced by populations living with high levels of disease burden for stroke outcomes, high blood pressure, high blood cholesterol, diabetes, or pre-diabetes. Additionally, the program will include populations who can benefit from the strategies included in this NOFO (e.g., people with disabilities; non-English speaking populations; lesbian, gay, bisexual, and transgender (LGBT) populations; people with limited health literacy); or other targeted populations. These efforts must accurately identify disparities and then effectively address the relevant inequities, including identification, assessment, and treatment across the continuum of care for those at highest risk for stroke events and stroke patients along the care continuum.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and performance measurement help demonstrate program accomplishments and strengthen the evidence for strategy implementation. They can also determine whether the identified strategies and associated activities can be implemented at various levels (i.e., public health systems, health care systems, and in communities with populations at highest risk for stroke event).

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

1. (Approach) How has the Coverdell Program implemented activities to improve stroke systems of care and reach those at highest risk for stroke events?

2. (Effectiveness) To what extent has the Coverdell Program improved system-level processes for stroke care, such as linking and using data, using team-based approaches to coordinate stroke care, and providing community resources across stroke systems of care?

3. (Impact) To what extent has the Coverdell Program reduced disparities in access to quality care for those at highest risk for stroke events compared to overall populations?

CDC will use an evaluation approach that consists of (1) ongoing monitoring and evaluation through the collection and reporting of performance measures, (2) a CDC-led comprehensive evaluation and (3) recipient-led evaluations.

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

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

For recipient-led evaluations, CDC will help recipients develop and implement evaluation plans that they can use to make program improvements and demonstrate the outcomes and impact of their programs. Recipients will be expected to conduct in-depth evaluation of at least three of their selected strategies as noted in the Applicant Evaluation and Performance Measurement Plan.

CDC and recipients will only collect data that will be analyzed and used. CDC will provide recipients with performance measure reporting templates, and potentially evaluation plan and reporting templates. CDC will provide ongoing technical assistance on recipient-level evaluation and performance measure reporting. Evaluation technical assistance will be provided using a customized approach to ensure that the tools and services provided best meet the needs of the recipients. All evaluation findings produced by CDC and recipients will contribute to: (1) program and quality improvement of program efforts; (2) practice-based evidence; (3) documentation and sharing of lessons learned to support replication and scaling up of these program strategies and/or (4) future funding opportunities at CDC.

The data CDC collects for performance measurement and evaluation are directly related to the implementation of the strategy and/or the desired outcome indicated in the logic model. Data being collected are strictly related to the implementation of the NOFO strategies and shall be used for assessing and reporting progress and for other pertinent implementation improvement actions. All performance measure data will be collected via a secure data system. Recipients will report their performance measure data annually via the data system and will only have access to their data. Over the 3-year performance period, data will be secured with limited access to authorized CDC program and evaluation staff. CDC will publish annual and summative reports on individual and aggregate performance measure data.

Short-term measures and intermediate measures reported by recipients are described in the table below. Recipients will report two levels of measures:

short-term outcomes measures for each required strategy and for each additional strategy selected intermediate outcomes measures

The table aligns with the logic model and shows the alignment between the overarching focus areas, specific strategies, outcomes and performance measures.

Paul Coverdell National Acute Stroke Program: Strategies, Outcomes, and Performance Measures

Strategies (Applicants must select the bold strategy plus at least 1 additional strategy from each of the three broad strategy categories)

Short-term Outcomes and Measures (Recipients will report short-term measures aligned with each required strategy and the additional strategies they select). Note:

All measures are broadly stated and will be refined with recipients and CDC based on activities proposed.

Intermediate Outcomes and Measures (Recipients will report all intermediate measures) Note: All measures are broadly stated and will be refined with recipients and CDC based on activities proposed.

Long-Term Outcomes and Measures (CDC will track/ evaluate all long-term measures)

Track and Monitor Clinical Outcome: Increased Outcome:

Measures to Improve Data Infrastructure Across Stroke Systems of Care linkage and usage of data across stroke systems of care for those at highest risk for stroke events and stroke patients

C1. Leverage electronic health records (EHRs) and health information technology (HIT) to identify patients with stroke risk factors (e.g. undiagnosed hypertension) and monitor health care disparities for those at highest risk for stroke events.

C2. (Required) Establish and expand statewide data infrastructure through an integrated data management system that links pre-hospital, hospital, and post-hospital follow up data for measurement, tracking, and assessment of quality of stroke care data.

Measure (Required): # and % of stroke patient records submitted to a statewide integrated management system by hospitals and EMS agencies

Measure (Optional): # and % of hospitals and EMS agencies submitting data to a statewide integrated data management system

C3. Coordinate the development and implementation of a referral tracking system to support transitions of care for stroke patients post-discharge.

Measure: # and % of hospitals with an implemented referral tracking system to support transitions of care for stroke patients post-discharge

Measure (required): # and % of entities across stroke systems of care monitoring disparities in identification of stroke risk factors, stroke care, and referrals for populations at highest risk for stroke events compared to all stroke patients

Increased access to care and improved quality of care for stroke patients

Outcome:

Decreased disparities in access to care and quality of care for populations at highest risk for stroke events

Implement a Team-Based Approach to Enhance Quality of Care for Those at Highest Risk for Stroke Events and Stroke Patients Across Systems of Care

Outcome: Increased implementation of data-driven QI activities across stroke systems of care for those at highest risk for stroke events and stroke patients

Outcome: Increased coordination of care across stroke systems of care for those at highest risk for stroke events and stroke patients

C4. (Required) Analyze data and identify areas to improve the efficiency and quality of care within EMS and hospital settings and to improve transitions of care between settings through systematic quality improvement methods and interventions (e.g. PDSA, Lean, Six Sigma).

Measure (Required): # and % of EMS agencies and hospitals implementing improvements in stroke care practices or patient care protocols as a result of quality improvement activities

C5. Coordinate, develop, and implement professional and workforce development opportunities (e.g. training, technical assistance, peer to peer learning, continuing education, workshops, etc.)

to improve evidence-based clinical knowledge for stroke care, recognition of disparities in stroke care, and implementation of activities to address them (e.g.

unconscious bias training, clinical decision-making tools, cultural competence)

Measure: # and % of hospitals and EMS agencies with system-wide workforce development efforts in place to improve clinical knowledge for stroke care and recognition of disparities in stroke care

C6. Develop and implement patient care practices/patient care protocols within EMS

Measure: # and % of EMS agencies and hospitals with established processes (e.g.

Measure (Required): # and % of EMS agencies and/or hospitals reporting an improvement in a selected performance measure of care based on identified performance gaps and quality improvement activities and hospital systems to coordinate patient handoff and transitions in care throughout the stroke systems of care.

patient care protocols, feedback loops) for coordination of transitions of care for those at highest risk for stroke events and stroke patients across systems of care

Link Community Resources and Clinical Services That Support Those at Highest Risk for Stroke Events and Stroke Patients Across Systems of Care

Outcome: Increased establishment of community resources and clinical services for those at highest risk for stroke events and stroke patients across stroke systems of care

Outcome: Increased provision of community resources and clinical services to those at highest risk for stroke events and stroke patients across stroke systems of care

C7. Establish and strengthen partnerships with relevant state or local stroke coalitions, initiatives, professional organizations, providers, and health systems that provide resource support for stroke patients, as well as those at highest risk for stroke events.

Measure: # of partnerships established with community organizations and resources for the purposes of providing resource support for stroke patients and those at highest risk for stroke events

C8. (Required) Facilitate engagement of patient navigators/community health workers in the management of those at highest risk for stroke events and post-event discharge support and follow-up of stroke patients across clinical and community settings.

Measure (Required): # of patients at high risk for stroke events or post-acute stroke within clinical and/or community settings that engage with patient navigators or community health workers for follow up and support

Measure (Required): # and % of patients linked to community resources and clinical services appropriate to their medical, social and functional determinants of health

C9. Coordinate and/or promote stroke messaging/education within communities and clinical settings around the importance of addressing the needs of those at highest risk for stroke events and the appropriate response during a stroke event, including utilizing EMS for stroke transport.

Measure: # of individuals within communities and/or clinical settings reached through stroke messaging and education, including populations at high risk for stroke events

The long-term outcomes performance measures will be calculated on behalf of the recipient using the data submitted to CDC through the stroke registry requirement and the CDC-led comprehensive evaluation. All measures are broadly stated and will be refined based on activities proposed, but they will be tracked and/or evaluated by CDC. Measures of access to and quality of care may include, but are not limited to the following:

· % of acute ischemic stroke patients who arrive at the hospital within 210 minutes (3.5 hours) of time last known well and for whom IV alteplase was initiated at this hospital within 270 minutes (4.5 hours) of time last known well.

· % patients with door-to-needle time ? 60 minutes and ?45 minutes

· Median door-to-needle time

· % of stroke patients arriving to hospital by EMS

· % of stroke transports where EMS called in a stroke alert pre-notification Measures of disparities in access to and quality of care may include, but are not limited to the following:

· % change over time in the performance measures (above) for priority populations compared to overall populations

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) as new pertinent information becomes available, if applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual reports. 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/additional-requirements/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.

In addition to the minimum requirements listed above, the evaluation and performance measurement plan should:

Include strategy-specific evaluation questions to be addressed that align with the overarching evaluation questions provided by CDC.

Describe the monitoring and evaluation or quality improvement framework that will guide the evaluation.

Describe data collection approaches, measures, and data sources.

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

Propose analyses for at least two time points (baseline and follow-up) and assess program impact on those at highest risk for a stroke event and stroke patients across stroke systems of care.

https://www.cdc.gov/grants/additional-requirements/ar-25.html

Describe dissemination and publication plans.

CDC will work closely with recipients to develop the detailed Evaluation and Performance Measurement plan within the first 6 months of award to ensure that it is appropriate for the activities to be undertaken as part of the agreement, for compliance with the monitoring and evaluation guidance established by CDC, or other guidance otherwise applicable to this cooperative agreement. CDC will provide additional guidance for developing the Evaluation and Performance Measurement plan, and recipients should review all CDC guidance before finalizing this plan.

Recipients must work with professional evaluators (either internal or external) to meet the evaluation and performance reporting requirements of this NOFO. Therefore, CDC recommends allocating at least 10% of the total funding award to evaluation and performance monitoring and consider both development and implementation costs. For information on developing an evaluation plan, please refer to the CDC Framework for Program Evaluation in Public Health (Centers for Disease Control and Prevention. Framework for Program Evaluation in Public Health MMWR 1999; 48, No RR-11) (https://www.cdc.gov/eval /framework/index.htm)

c. Organizational Capacity of Recipients to Implement the Approach Applicants must describe their organizational capacity to carry out the selected strategies within the explicit context of addressing health equity within the state/jurisdiction; minimizing duplication of effort; and coordinating efforts with other federally and privately funded programs within the state in an effort to leverage resources and maximize reach and impact.

Applicants must describe the following:

Established partnerships with groups/organizations relevant to the strategies selected.

Prior experience in identifying their state as high burden based on high burden of stroke mortality, incidence, stroke hospitalizations, and other metrics and prior experience identifying priority populations within their high burden state.

Established collaborations with or demonstrated in-house stroke clinical experts, experience successfully coordinating with state EMS entities, and quality improvement expertise.

Experience with collecting data at a population level and using data to demonstrate impact.

Experience with planning and implementing programs at a state level and/or state-wide or at a systems level and successfully executing proposed strategies and activities to meet NOFO requirements.

Sufficient leadership and/or partnership within the state health department for program planning and development including the identification, hiring, or reassignment and supervision of staff, contractors, and/or consultants sufficient in number and subject matter expertise to plan and implement strategies.

Proven ability or sufficient capacity to collect, report and use data elements, hospital https://www.cdc.gov/eval/framework/index.htm https://www.cdc.gov/eval/framework/index.htm metrics, and information from other sources for the purposes of quality improvement, program evaluation, and monitoring.

Proven ability or sufficient capacity to meet reporting requirements, as well as programmatic, financial, and management benchmarks.

Proven ability or sufficient capacity to convene and support relevant partnerships, including those with clinicians (e.g.stroke physicians, stroke coordinators, stroke nurses, and other clinical providers), state and/or regional EMS Directors, state stroke and/or cardiovascular disease coalitions, and stroke and/or cardiovascular disease professional organizations.

Proven ability or sufficient capacity to access, collect, and link state-wide stroke data between the pre-hospital/EMS and hospital settings.

Proven ability or sufficient capacity to establish systems to connect those at highest risk for stroke events and stroke patients to community organizations and resources.

Experience conducting professional and workforce development needs assessments, developing technical assistance and training tools and materials, and implementing continuous quality improvement processes.

d. Work Plan The applicant must submit a detailed work plan for Year 1 of the 3-year period of performance and a general summary of work plan activities for Years 2-3 in narrative form. The work plan should describe how the applicant plans to implement all of the required and selected strategies and activities to achieve NOFO outcomes.

Recipients will be expected to submit linked pre-hospital and in-hospital as de-identified data to CDC through CDC's secure data systems on a recurring basis. Additionally, recipients will be required to engage in data collection and periodic reporting of performance measures that are aligned with specific selected strategies included in this NOFO. Recipients are expected to enter into effective partnerships with state, local and community- based organizations, governmental entities, public health agencies, health care, quality improvement organizations, health information technology experts, payers, and health care systems and providers to support the program.Therefore, applicants must reflect comprehensive descriptions of the aforementioned requirements, where appropriate, throughout the required application sections, specifically throughout the work plan.

Work plan must include objectives, activities, and timelines for developing or modifying a data collection and reporting system and meeting evaluation requirements. Work plan must include the specific community and clinical entities to support those at highest risk for stroke events and stroke patients post-discharge. Key staffing roles and functions to support implementation of the award should be described and include timelines, strategies for hiring program staff if applicable and interim staffing plans should hiring be delayed. Partnerships that are in place or will be developed for the purposes of supporting the program should be described.

A sample work plan template is available below. Applicants are not required to use the work plan template but are required to include all of the elements listed within the template. CDC will provide feedback and technical assistance to recipients to finalize the work plan activities post-award.

Applicants must select the BOLD (Required) strategy plus at least 1 additional strategy from each of the three broad strategy categories.