SSB_Tracking of HCP with COVID-19 omb_20200422

SSB_Tracking of HCP with COVID-19 omb_20200422.docx

Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel

OMB: 0920-1296

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Emerging Infections Program

Tracking of SARS-CoV-2 Infections among Healthcare Personnel


Request for OMB approval of a New Information Collection

April 22, 2020









Supporting Statement B

















Contact:

Nora Chea

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404)-639-0025

Email: xdc7@cdc.gov

The information collection does not involve statistical methods. The purpose is not to make statistical generalizations beyond the particular respondents.

  1. Respondent Universe and Sampling Methods

This project will be conducted with the Emerging Infections Program (EIP), a network of 10 state health departments and their local public health and academic partners. The 10 EIP sites are: California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon and Tennessee. Up to 10 sites may participate in this project, depending on available resources. There are two project options; sites may participate in one or both options. Option 1 is tracking of SARS-CoV-2 infections among HCP in selected healthcare facilities. Option 2 is an assessment of risk factors for SARS-CoV-2 infection among HCP exposed to COVID-19 patients in the healthcare facility. EIP sites that participate in the project will recruit a convenience sample of at least three healthcare facilities each within their catchment areas. Due to the burden of responding to the novel coronavirus SARS-CoV-2, and COVID-19, the disease it causes, it will not be possible for EIP sites to engage all healthcare facilities within their catchment areas. In healthcare facilities that participate in option 1 of the project, EIP site staff will aim to identify and contact all HCP with COVID-19 (cases) for the duration of the surveillance. In healthcare facilities that participate in option 2, EIP site staff will identify and contact a subset of HCP exposed to COVID-19 patients who become cases and HCP exposed to COVID-19 patients who do not become cases (HCP non-cases).

The expected response rate is 80%. This is a conservative estimate based on experience during a COVID-19 field investigation in Solano County, California in March 2020; of 43 HCP who were contacted for interviews, responses were obtained for 37 (86%).

  1. Procedures for the Collection of Information

EIP sites that participate in this project may choose to implement one or both project options:

  • Option 1: Tracking of SARS-CoV-2 infections among HCP

  • Option 2: Assessing risk factors for infection among HCP exposed to COVID-19 patients in healthcare facilities (HCFs)

EIP site staff will identify a convenience sample of healthcare facilities within the EIP catchment areas. Hospitals and nursing homes are prioritized for inclusion, but other types of facilities may participate. Each EIP site will seek to identify three or more facilities to participate.

For option 1, EIP staff will obtain lists of HCP cases and contact information from local or state health department partners (preferred option) or in some cases from a healthcare facility’s occupational health department (e.g., from occupational health nurses) or infection control program. To minimize burden on healthcare facilities, EIP staff will attempt to obtain HCP lists and contact information from health departments whenever possible.

For option 2, EIP staff may need to work directly with a healthcare facility’s occupational health department or infection control program to obtain HCP names and contact information because this option requires identification and data collection from HCP non-cases (HCP who are exposed to COVID-19 patients but who do not become cases).

For both options, EIP staff will collect data from HCP via telephone interviews using an introductory script and Exposure Assessment Form (see Attachment 4a and Appendix 3 of Attachment 3) or a self-administered electronic case report form (see Attachment 4b).

  1. Methods to Maximize Response Rates and Deal with No Response

Each HCP case or non-case will be contacted via telephone or email a maximum of five times (and no more than once per day) for the interview. After 5 attempts the HCP will be categorized as “No Response” and not contacted further. For sites that opt to collect data electronically, EIP staff will contact the HCP case or non-case if the electronic case report form has not been submitted within 3 days after the initial email was sent. It is expected that most interviews will be completed in one 30-minute phone call once the HCP agrees to participate.

This data collection has limitations. Despite efforts to contact HCP multiple times, we may not achieve a high response rate. For HCP who are too ill to participate at the time of initial contact, a future contact attempt will be offered, but it is possible that we will not be successful in reaching those HCP who are hospitalized and seriously ill. In addition, we will not have data from HCP who have died. Furthermore, we recognize that this data collection is limited to a maximum of 10 EIP sites and a limited number of healthcare facilities. Further, due to the voluntary nature of this collection and choice to pursue option 1 or option 2 at each EIP site, the participating hospitals within the 10 catchment areas will be a convenience sample. Thus, the results of the project will not be representative of all HCP in the U.S.

  1. Tests of Procedures or Methods to be Undertaken

No tests of procedures or methods will be undertaken. A version of the HCP case report form has already been used in a limited number of COVID-19 field investigations in selected jurisdictions, such as in Santa Clara and Solano Counties, California (OMB Control No. 0920-1011, expiration date: 04/23/2020).


  1. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

CDC statistician consulted for project design and data analysis:

Jonathan R. Edwards, MStat

Leader, Statistics Team

Surveillance Branch, Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

1600 Clifton Rd, NE

Atlanta, GA 30333

(404) 639-4177

Email: JREdwards@cdc.gov



Data will be collected by staff in the EIP sites. Data will be analyzed by EIP site and CDC staff. CDC staff involved in this data collection include:



Nora Chea, MD, MSc

Medical Epidemiologist

Epidemiology Research and Innovations Branch

Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

Atlanta, Georgia

(404) 639-0025

xdc7@cdc.gov



Austin Penna, MPH

Health Research Analyst

Northrop Grumman Corporation

Health Protection Solutions

Contractor for Division of Healthcare Quality Promotion (DHQP)

Centers for Disease Control and Prevention

404-718-6560

apenna@cdc.gov

Shelley S. Magill, MD, PhD

Director of Healthcare-Associated Infections/Community Interface (HAIC) Program

Epidemiology Research and Innovations Branch

Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

Atlanta, Georgia

(404) 639-0291

smagill@cdc.gov

Attachments

Attachment 1 – Authorizing Legislation

Attachment 2 – 60-Day Federal Register Notice

Attachment 3 – Protocol

Attachment 4 – Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2

Attachment 5 – Research Determination Form


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSamuel, Lee (CDC/OID/NCEZID)
File Modified0000-00-00
File Created2021-01-14

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