Change Request Memo - 25 AUG2020

Non-Substantive Change Request to OMB Control Number 0920-1296

Contact

Nora Chea, MD, MSc

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: [email protected]

Submission Date: 08/19/2020

CDC requests approval for a non-substantive change to OMB Control No. 0920-1296: Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel.

Form Name: Assessment of Healthcare Personnel (HCP) Exposed to or Infected with SARS-CoV-2

Justification for changes:

1. We propose to add a field in the header section of the form to capture the matching HCP identification (ID) code when the form is completed for a HCP non-case. This information is already captured on the form in the “Comments” field; having a specific field to report the matching HCP case ID for non-cases will facilitate efficient data cleaning and analysis.

2. We propose to add “ Prefer not to answer (Not to be read by INTERVIEWER)” as a response choice for the question about ethnicity. This addition WILL NOT be read to respondents by interviewers. It simply allows interviewers to accurately report a situation in which the respondent declines to answer the question about ethnicity.

3. We propose to add “ Prefer not to answer (Not to be read by INTERVIEWER)” as a response choice for the question about race. This addition WILL NOT be read to respondents by interviewers. The additions allow interviewers to accurately report a situation in which the respondent declines to answer the question about.

4. We also proposed to change from “a few minutes” to “15 minutes” in the instructions section (page 5) to the definition of close contact for the assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2. It is a correction of a typo in the previous version.

Protocol Name: Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version July 17, 2020

Justification for changes:

Based on feedback from the EIP sites about their experiences to date contacting HCP for this project and to maximize the opportunity to include HCP who wish to participate, we propose to modify the maximum number of attempts EIP staff may make to contact HCP for an interview (currently five attempts). Each HCP case or non-case will be contacted by EIP site staff up to five times to schedule a future time for the interview or to conduct the interview, unless the HCP case or non-case requests a call back, or if the HCP case or non-case returns the call from the EIP site staff. In these instances, another call is permissible. For example, if the EIP site staff person makes contact with a HCP on the fifth call attempt, and the HCP requests a call back the next day, that will be permitted. This change will increase the number of HCP participating in the project and avoid the exclusion of HCP who indicate that they want to participate but for whom an interview could not be scheduled or initiated by the fifth contact attempt.

Burden:

Because the changes to the form and protocol are minimal, the estimates of annualized burden hours for this change request will stay the same.

The burden estimate for the form included in OMB Control No. 0920-1296 is 2,133 minutes.

	Form Name	No. of Respondents	No. of responses per respondent	Avg. burden per response (hours)	Total burden (hours)
Approved	Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2 Form	4,000	1	32/60	2,133
Requested	Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2 Form	4,000	1	32/60	2,133

Description of Changes:

The changes to the form are as follows:

1. Addition of a field “If a NON-CASE, enter the EIP HCP ID of the matching HCP COVID case here: ________________” in the header section of the form.

2. Addition of “ Prefer not to answer (Not to be read by INTERVIEWER)” to the question about ethnicity.

3. Addition of “ Prefer not to answer (Not to be read by INTERVIEWER)” to the question about race.

4. Change from “a few minutes” to “15 minutes” in the definition of close contact in the instruction section on page 5 of the form.

Form

Current Question

Requested Change

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

EIP HCP ID: ________________ COVID-NET ID: ________________ CDC/STATE CASE ID: ________________

EIP HCP ID: ________________ COVID-NET ID: ________________ CDC/STATE CASE ID: ________________

If a NON-CASE, enter the EIP HCP ID of the matching HCP COVID case here: ________________

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

How would you define your ethnicity? (Check one)

Hispanic or Latino Not Hispanic or Latino

How would you define your ethnicity? (Check one)

Hispanic or Latino Not Hispanic or Latino

Prefer not to answer (Not to be read by INTERVIEWER)

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

How would you define your race? (Check all that apply)

American Indian or Alaska Native	White
Asian
Black or African American
Native Hawaiian/other Pacific Islander

How would you define your race? (Check all that apply)

American Indian or Alaska Native	White
Asian	Prefer not to answer (Not to be read by INTERVIEWER)
Black or African American Native Hawaiian/other Pacific Islander

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

REMINDER: For this interview, close contact means: a) being within approximately 6 feet (2 meters) of a person with COVID-19 for at least a few minutes; or b) having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand).

REMINDER: For this interview, close contact means: a) being within approximately 6 feet (2 meters) of a person with COVID-19 for at least 15 minutes; or b) having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand).

The changes to the protocol are as follows:

Update “Data Collection” section to allow EIP site staff to contact HCP one more time after the 5^th attempt or take a return call from HCP to initiate the interview if requested by the HCP.

Protocol	Current wording	Requested Change
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version July 17, 2020	Each HCP case or non-case will be contacted a maximum of five times for the interview.	Each HCP case or non-case will be contacted by EIP site staff up to five times to schedule a future time for the interview or to conduct the interview, unless the HCP case or non-case requests a call back, or if the HCP case or non-case returns the call from the EIP site staff. In these instances, another call is permissible. For example, if the EIP site staff person makes contact with a HCP on the fifth call attempt, and the HCP requests a call back the next day, that will be permitted. Contact with HCP cases and non-cases may be via telephone, email or text message at the sites’ discretion. EIP sites are responsible for ensuring that site-initiated communications with HCP comply with applicable privacy and information security standards.