Paul Coverdell National Acute Stroke Program
Supporting Statement B
Program Official/Contact
Sallyann Coleman King, MD, MSc
Medical Officer
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
P: (770) 488-5892
F: (770) 488-5199
2/22/2021
TABLE OF CONTENTS
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 3
B1. Respondent Universe and Sampling Methods 3
B2. Procedures for the Collection of Information 3
B3. Methods to Maximize Response Rates and Deal with No Response 4
B4. Tests of Procedures or Methods to be Undertaken 5
B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5
1. Public Health Service Act [42 U.S.C. 247b(k)(2)]
2. PCNASP NOFO 2021-Logic Model
3. Crosswalk of strategies and measures
4a. Pre-hospital care data elements
4b. In-hospital care data elements
5a. Template of hospital inventory data elements for hospitals
5b. Template of hospital inventory data elements for awardees
6. PCNASP 60-Day Federal Register Notice (FRN)
7. Privacy Narrative
8. Human subjects document non-research determination
9. Screenshot of Secure Access Management Services (SAMS) web portal
10. Information collection and transmission flow diagram
11a. Crosswalk of pre-hospital care data element changes
11b. Crosswalk of in-hospital care data element changes
11c. Crosswalk of hospital inventory data element changes
12. Example table shells of performance measure summary reports
13. Data burden excerpt from PCNASP Reference Guide
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
The PCNASP is funded 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 through organized quality improvement activities. Awardees are expected to ensure all efforts are designed to close the gap in stroke care for high burden populations and improve state-level stroke care across the continuum of care 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. Awardees will work directly with their selected partners, which includes, but is not limited to, local/regional EMS systems and hospitals, state/regional EMS Directors, hospitals, integrated healthcare systems, and community clinical services.
The target populations for data collection include acute stroke patients (intracerebral hemorrhage, ischemic stroke, potential acute stroke patients, and patients presenting with a transient ischemic attack (TIA)). The inclusion criteria can be defined as all individuals diagnosed with an acute stroke (ischemic stroke or intracerebral hemorrhage) or transient ischemic attack (TIA) presenting to acute care hospitals or emergency departments, and all individuals presenting to EMS with a potential acute stroke or TIA. CDC encourages but does not require the inclusion of patients presenting with stroke in pregnancy (including peripartum stroke). CDC encourages the inclusion of patients with acute stroke or TIA that are in ED boarding. CDC strongly encourages the inclusion of patients presenting with subarachnoid hemorrhage.
Table B.1.a Respondent and Associated Partners for the Collection and Transmission of Information
Information |
Respondent and Associated Partners (N) |
Pre-hospital quality of care data |
Awardees (13) in coordination with hospital and EMS partners |
In-hospital quality of care data |
Awardees (13) in coordination with hospital partners |
Hospital inventory data |
Hospitals (650) |
Awardees (13) |
*Note: burden is not assessed for the hospital’s collection or transmission of in-hospital data. Burden is also not assessed for the collection or transmission of pre-hospital data when existing data systems are used. Please reference section A.12 in Supporting Statement A for further details about this.
PCNASP currently receives data from 9 awardees under the current cooperative agreement (CDC-RFA-DP15-1514). Under a new Notice of Funding Opportunity (NOFO) the number of awardees will expand to 13. Neither hospital nor direct patient identifiers are included in the data sent to CDC. Awardees are not required to develop a sampling plan for the selection of hospitals. Hospitals are not required to develop a sampling plan for the selection of patients, but are given the option to abstract all stroke cases or to use the sampling strategy developed by The Joint Commission and Centers for Medicare & Medicaid Services (CMS) for reporting of stroke quality of care data to those two entities.
Quality of care information collection includes data from 2 phases of the continuum of stroke care: pre-hospital (Attachment 4a), and in-hospital (Attachment 4b). Attachment 10 describes the flow of this information collection and transmission. The pre-hospital and in-hospital care data elements are defined with national partner organizations to align data standards and collection methods when possible. Awardees choose their own data sources/systems to collect the data. The data system chosen by awardees depends on the availability of the data and their access to it. For example, pre-hospital care data can be collected by awardees from their partner hospitals or in partnership with their state office of EMS. Awardees send compiled data to CDC through secure access management services (SAMS) web portal quarterly (Attachment 9). Information is transmitted as a SAS (Statistical Analysis System) data set. All the information is de-identified.
Additionally, hospital inventory data will be collected by hospitals on an annual basis (Attachment 5a) and transmitted to the hospitals’ awardee either electronically or on a paper form. The awardee then compiles all hospital responses into a single Excel file to submit to CDC annually (Attachment 5b). Without PCNASP, this data is not systematically or routinely collected by hospitals and sent to their respective awardee. The hospital inventory data can be linked to in-hospital data through a unique de-identified hospital ID common to both sources.
CDC will aggregate data from all awardees. The data will reside in a secured file location on CDC servers, which is only accessible by the PCNASP data analyst and statistician.
All PCNASP awardees are expected to report data in a timely manner. CDC requires data submission as a stipulation of the Notice of Funding Opportunity and the cooperative agreement notice of grant award. Awardees that have difficulty with data submission will be provided technical assistance by PCNASP data program personnel. If necessary, short extensions will be provided to give the awardees additional time to report. The schedule for data reporting will remain consistent.
The use of existing data dictionary (Attachments 4a, 4b, 5a, 5b) and data abstraction guidelines for electronic submission of data makes it easy for awardees to comply with the request. In addition, CDC’s PCNASP team will provide a detailed assessment of data quality to all awardees after each data submission.
The data uploading systems developed and maintained by CDC have been tested by PCNASP staff. SAMS is used by awardees for a variety of purposes and is a familiar process to them.
CDC staff from the PCNASP program were consulted about the substantive, methodological, and statistical aspects of the study.
All of the data analyses will be done on site at CDC in the Division for Heart Disease and Stroke Prevention. CDC investigators will collaborate with the awardees and their partners on ideas for analyses, development of analytic plans for each study, interpretation of the data and manuscript preparation. The following is a list of PCNASP staff at CDC who work on the oversight, development, methodology, and statistical design of data that is collected.
Name |
Contact Info |
Organization |
Role |
Letitia Presley-Cantrell, PhD, MEd |
[email protected] 770-488-5177 |
CDC |
Program Development and Services Branch – Branch Chief |
Rebekah Buckley, MPH, CRT, AE-C |
[email protected] 770-488-6215 |
CDC |
Program Development and Services Branch – Deputy Branch Chief |
Sallyann Coleman King, MD, MSc |
[email protected] 770-488-5892 |
CDC |
PCNASP Director & Medical Officer |
Lisa Cooper, MPA |
[email protected] 404-498-0393 |
CDC |
Project Officer |
Cindy Tong, MPH |
[email protected] 770-488-4551 |
CDC |
Statistician |
Xiaoping Yin, MS |
[email protected] 404-718-6612 |
CDC |
Data analyst |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement B template |
| Subject | Supporting Statement B template |
| Author | Centers for Disease Control and Prevention |
| File Modified | 0000-00-00 |
| File Created | 2022-01-19 |