Information Collection Request
Reinstatement
Paul Coverdell National Acute Stroke Program
(PCNASP) Reporting System
OMB No. 0920-1108
Supporting Statement Part B
Program Official/Contact
Sallyann Coleman King, MD, MSc
Medical Officer
Division for Heart Disease and Stroke Prevention
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
Atlanta, GA 30341
Telephone: (770) 488-5892
Fax: (770) 488-8334
Email: [email protected]v
April 23, 2019
Table of Contents
Statistical Methods
Respondent Universe and Sampling Methods
Procedures for the Collection of Information
Methods to Maximize Response Rates and Deal with Nonresponse
Test of Procedures or Methods to be Undertaken
Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
List of Attachments
1: 2015-2020 PCNASP Awardees
2: Section 317 of the Public Health Service Act [42 U.S.C. 247b(k)(2)]
3a: Crosswalk between program aims and short/intermediate/long term outcomes
3b: Crosswalk between short/intermediate/long term outcomes, performance measures, and data sources
4a: Pre-hospital care data elements
4b: In-hospital care data elements
4c: Post-hospital quality of care data elements
5a: Template of hospital inventory data elements for hospitals
5b: Template of hospital inventory data elements for awardees
6: 60-day Federal Register Notice (FRN)
7: IRB approval letter
8: Screenshot of Secure Access Management Services (SAMS) web portal
9: Information collection and transmission flow diagram
10a: Crosswalk of pre-hospital care data element changes
10b: Crosswalk of in-hospital care data element changes
10c: Crosswalk of post-hospital care data element changes
10d: Crosswalk of hospital inventory data element changes
11: Example table shells of performance measure summary reports
12: Data burden excerpt from PCNASP Reference Guide
The PCNASP is funded to improve quality of care for acute stroke patients from stroke onset through hospital discharge through organized quality improvement activities. During this cooperative agreement, PCNASP funds 9 awardees (Attachment 1), who are state departments of health. As detailed in the funding opportunity announcement (FOA), awardees establish/maintain a steering committee that serves to advise and help establish program partnerships. Awardees 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 post-hospital care providers.
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 (9) in coordination with hospital and EMS partners |
In-hospital quality of care data |
Awardees (9) in coordination with hospital partners |
Post-hospital quality of care data |
Awardees (9) in coordination with hospitals and post-hospital care providers |
Hospital inventory data |
Hospitals (378) |
Awardees (9) |
*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 or post-hospital data when existing data systems are used. Please reference section A.12 in Supporting Statement A for further details about this.
The target populations 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.
PCNASP receives data from all 9 awardees under the cooperative agreement (CDC-RFA-DP15-1514). 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. However, hospitals 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 3 different phases: pre-hospital (Attachment 4a), in-hospital (Attachment 4b), and post-hospital (Attachment 4c). Attachment 9 describes the flow of this information collection and transmission. The pre-, in-, and post-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. Post-hospital care data can be collected by awardees from their partner hospitals or other healthcare facilities (e.g., stroke rehabilitation facilities). Awardees send compiled data to CDC through secure access management services (SAMS) web portal quarterly (Attachment 8). 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 the PCNASP Health Scientist, the PCNASP Project Officers, and/or the data contractor. 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, 4c, 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 states 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.
Sallyann Coleman King, MD, MSc
PCNASP Director & Medical Officer
770-488-5892
Lisa Cooper
Project Officer
404-498-0393
Xin Tong, MPH
Statistician
770-488-4551
Xiaoping Yin, MS
Data Analyst
404-718-6612
Epidemiology and Surveillance Team
Division for Heart Disease and Stroke Prevention
Centers for Disease Control and Prevention
4770 Buford Hwy NE, MS F-77
Atlanta, GA 30341-3717
770-488-8080 / 770-488-8334 Fax
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