Thomas J. “Chip” Daymude
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, NE
Atlanta, Georgia 30333
Email: [email protected]
Assessment of the Get Ahead of Sepsis Consumer and Healthcare Professional Media Campaign 1
Request for OMB approval of a New Information Collection 1
1. Respondent Universe and Sampling Methods 3
2. Procedures for the Collection of Information 3
3. Methods to maximize Response Rates and Deal with No Response 5
4. Tests of Procedures or Methods to be undertaken 6
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 6
The priority populations for this new information collection (study) are consumers and healthcare professionals (HCPs) in select markets (New York, Illinois, and Louisiana) who have and have not been exposed to the Get Ahead of Sepsis (GAOS) pilot campaign messaging and partner outreach. The target subpopulations include six consumer audiences who have a higher risk for developing infections that can lead to sepsis and seven HCP audiences who play a role in diagnosing and treating sepsis (See Supporting Statement A. Tables 1 and 2). Non-probability sampling, specifically quota sampling, will be used during the recruitment of participants. A quota for the consumer group as well as for the HCP group was set to sample participants based on an equal ratio across all priority locations, and a 50/50 ratio in pre-exposed and post-exposed groups. The total pre-and post-campaign target sample size recommended for this study is n= 4,096 (n=1,890 for consumers and n=2,206 for HCPs). The expected response rate is approximately 33 percent.
We will use a repeated cross-sectional design carried out using online surveys. Data will be collected from consumers and HCPs respondents at two different points in time– pre-campaign and post-campaign –using different participants in each time point while measuring campaign exposure and outcomes simultaneously.
Because these will be cross-sectional surveys, any differences in outcomes cannot be directly attributed to the campaign. We can, however, examine correlations between campaign exposure and the identified study outcomes which will enable us to determine whether a relationship exists between campaign exposure and the outcomes of interest (e.g., awareness, knowledge, attitudes, beliefs, and behaviors). The effects of moderating variables such as the COVID-19 pandemic will also be explored. The findings will be useful in determining whether to incorporate messages about COVID-19 prevention practices, resources for educational purposes, and ways to reduce COVID-19 fatigue into future GAOS campaign materials.
Although the sample is not meant to be generalized to the entire target populations, this information collection will enable CDC to gather information critical to ensuring the efficacy of the GAOS initiative.
Recruitment
CATMEDIA (CDC’s contractor) along with their online survey panel subcontractor (hereafter called vendor) will recruit the sample, program the online surveys, and conduct the data collection for both pre-and post-campaign phases. Panelists registered with the vendor who have provided their consent to receive invitations to participate in online surveys, and who meet the preliminary eligibility criteria (e.g., geographic location and age) will receive an email invitation to participate (Attachments H). Individuals interested in participating in the survey will click the link provided and be directed to the vendor’s secure website.
Informed Consent
When individuals enter the study’s secure website, they will be presented with a consent form (Attachment I). The consent addresses the following:
Study purpose and procedures.
Estimated time required to participate
Statement that participation is voluntary.
Measures taken to protect privacy.
Potential risks and benefits.
Disclosure of incentive.
Contact information of a person they may contact for further questions.
Individuals who agree to participate will be required to enter their full name and date in the corresponding signature and date lines and check the ‘Yes’ box to the accompanying question, “Do you agree to participate in this survey?” thereby providing their consent. Only participants who electronically sign and agree to participate in the survey will be able to proceed to the online survey instrument. Participants will be able to download a PDF copy of the consent form for their records. Those who do not consent will be thanked for their time and provided with exit instructions.
The vendor will provide CATMEDIA with electronic (soft) copies of signed consent forms and destroy their copies after data analysis and reporting is complete and CATMEDIA has confirmed that the data can be deleted. CATMEDIA will store the signed consent forms on a password-secured network with encryption to which only approved personnel will have access. All signed consent forms will be destroyed by permanent deletion three years after the completion of the project.
Screener and Survey
The survey will begin with a brief screener to determine participant eligibility. Ineligible participants will be immediately disqualified when they choose a response that does not fall within the inclusion criteria. Participants who meet the inclusion criteria after responding to all the screening questions will receive a follow-up email with the online cross-sectional survey link to take takethe survey. Those who are deemed ineligible will be thanked for their time and provided with exit instructions.
Participants eligible and consenting to participate will become survey respondents and will have up to three weeks to complete the survey on a computer, tablet, or smartphone from a location where they feel most comfortable. The vendor will send one email reminder (Attachment J) about the survey to non-responders requesting their participation. Respondents can complete the survey only once. Completing the survey will take approximately 20 minutes.
Participants who complete either the pre-or post-campaign survey will receive a token of appreciation for their participation within seven days of taking the survey. Respondents will receive $25 (consumers) or $75 (HCPs) in the form of Venmo or PayPal (electronic delivery) or a pre-paid gift card. At the end of the survey, respondents will be asked to choose their preferred method to receive their incentive. The information needed to send incentives such as full name, mailing address, Venmo or PayPal account information will be collected by the vendor from respondents who opt-in to receive incentives. There will be no association between the PII collected because of the delivery of incentives to respondents and their responses in the survey.
The vendor will obtain a dataset of all eligible respondents, including those who did and did not complete the full survey. The vendor will provide CATMEDIA with weekly aggregate reports on the number of individuals who opened and started the screener, stopped taking the screener, completed the screener, and were eligible for the full survey. For those deemed ineligible, the vendor will provide an aggregate report of the eligibility criteria not met. The vendor will not provide the individual screener responses for those who are ineligible. CATMEDIA will use these data to describe the sampling and data collection process.
Data Security and Management
Data in the form of raw data will be collected by the vendor. The raw data, which are survey responses and demographic information associated with responses, will be collected. No personal identifying information (PII), such as names, addresses, or phone numbers, will be collected during the data collection or maintained in any data files held by CDC or CATMEDIA. The online survey panel vendor maintains PII, such as name, address, phone, and email addresses in their database of registered panelist to contact individuals for participation and for following up with incentive payments. The vendor’s database is maintained according to privacy regulations. The PII is stored with the vendor and will never be shared with CDC or CATMEDIA.
Demographic information (e.g., age, gender, race/ethnicity, etc.) will be collected as part of the screening to determine participant eligibility, however no direct personal identifiers (e.g., date of birth, full name, phone number, social security number, etc.) will be collected or maintained. All PII will be kept separate from participants responses to the surveys. The GAOS questionnaires do not collect additional PII.
The vendor will provide a secure link containing the de-identified survey data to CATMEDIA. CATMEDIA will share a secure link containing the de-identified survey data with CDC DHQP for further discussion and analysis. CATMEDIA will decrypt and download the data from the vendor into an SPSS data file and then analyze these data and summarize the findings in a report for CDC.
CATMEDIA will securely store and manage all signed consent forms and de-identified data received from the vendor. CATMEDIA uses the Microsoft Enterprise Suite cloud platform to store data securely. Cloud data is stored in an encrypted format, to prevent sensitive data from being exfiltrated and readable if ever there was a data breach. Permissions to access the stored data will be managed by CATMEDIA’s IT Administrator. Only approved personnel will be granted restricted access to the stored data on a need-to-know basis. Anyone accessing the data will be easily identified with a timestamped history of when data was accessed or edited. CATMEDIA engages in regular cloud-based back-ups in the event of a data breach or loss. If for any reason, data collected needs to be printed, the printed data will be handled appropriately by shredding the data when done or storing it in physical folders inside secured file cabinets and locked away
The following procedures will be used to maximize cooperation and to achieve the desired response rates:
A token of appreciation will be provided to respondents upon completion of the survey.
Online survey panel vendor will send one email reminder to non-responders.
Online survey panel vendor will provide a phone number and email address to all respondents so that they can call with any questions or concerns about any aspect of the study.
Respondents will have the option to complete the survey in one or multiple sittings which will allow them to take it at their own pace.
CDC’s contractor, CATMEDIA, will work closely with the online survey panel vendor to monitor progress and troubleshoot issues related to sample recruitment and data collection.
A formal pilot test of the survey instruments with the target audiences has not yet been conducted. Therefore, to estimate the time burden for screening and the survey, CATMEDIA survey specialists tested the time burden by providing affirmative responses to all of the survey questions. By testing the screener and survey in this manner, the burden estimate approximates the maximum average burden because almost all survey questions will be asked of participants during the actual data collection.
Formal pilot testing will precede data collection once OMB PRA approval is received. Approximately 15-25 participants per target group will be recruited as testers. Lessons from the pilot test will be identified, and changes, if necessary, will be incorporated into the survey instrument and method. We will verify with NCEZID’s PRA contact that a change request will be accepted as minor or non-substantive changes versus revisions.
CDC |
CATMEDIA |
Catherine Capers (Katy) Health Communication Specialist CDC/DDID/NCEZID/DHQP
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Emmase Adams, PhD CATMEDIA Research Scientist 404-315-9700 |
Jennifer Mullen, MPH Health Communication Specialist CDC/DDID/NCEZID/DHQP
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Penny McMillan-Hughes, MPH CATMEDIA Public Health Scientist penny [email protected] 404-315-9700 |
Vanessa Iheanachor, PhD, MSPH Health Communication Specialist CDC/DDID/NCEZID/DHQP
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Deborah W. Gould, PhD CATMEDIA Consultant Health Scientist 404-315-9700 |
Nicole Gladden Health Communication Specialist CDC/DDID/NCEZID/DHQP |
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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Samuel, Lee (CDC/OID/NCEZID) |
File Modified | 0000-00-00 |
File Created | 2023-07-29 |