Request for Approval

Request for genIC Approval

CDC/ATSDR Formative Research and Tool Development

0920-1154

CIO: National Center for Emerging and Zoonotic Infectious Diseases, Division of Foodborne, Waterborne and Environmental Diseases

PROJECT TITLE: Focus Group Study of U.S. Adults’ Knowledge, Attitudes, and Practices of Foodborne Disease Outbreaks and Illness Prevention

PURPOSE AND USE OF COLLECTION:

Each year, fourteen foodborne pathogens cost the American public 61,000 quality-adjusted life years and $14 billion dollars in economic loss (Hoffmann, Batz, and Morris, 2012). Once a foodborne outbreak of enteric bacteria has occurred, consumers need the ability to find and understand reliable information to avoid joining one of the 48 million Americans that become sick from a foodborne illness each year (CDC, 2018).

The Outbreak Response and Prevention Branch (ORPB) reduces additional incidences of foodborne illnesses by educating the public via web announcements with current and accurate information on the outbreak so that consumers, retailers, media, and medical professionals can act accordingly. Though the webpage metrics indicate high viewership of these messages since their inception in 2006, the format and content of these webpages has not undergone rigorous message testing to determine the level of understanding and behavioral responses from the general public.

A contracting company, EurekaFacts, will employ a mixed-mode approach that combines one-on-one cognitive interviewing with focus groups to derive qualitative data at the individual and group level that will help direct ORPB’s communication efforts.

Information collection activities are limited to formative work that will result in the development of improved communication materials and efforts to inform the public about emerging foodborne illness outbreaks and recalls.

DESCRIPTION OF RESPONDENTS:

General U.S. adult population reflecting a mix of age, race, ethnicity, gender, and other demographics.

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. Information gathered will not be used to substantially inform influential policy decisions.

5. The study is not intended to produce results that can be generalized beyond its scope.

Name: _Michael Jhung_______________________________________________

To assist review, please answer the following questions:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ X ] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ X] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ X ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ X ] Yes [ ] No

This study involves four 100-minute focus groups as well as four groups using a 100-minute hybrid of cognitive interviewing and focus groups. Participants will receive a $75 incentive at the end of the groups. Numerous empirical studies have shown that incentives can significantly increase response rates (e.g., Abreu & Winters, 1999; Shettle & Mooney, 1999). The token of appreciation amount was determined through discussions with contract staff with expertise in conducting interviews with the study population. Removing the incentive could negatively affect recruitment, which could threaten the development of a messaging strategy resulting from this testing.

BURDEN HOURS

Category of Respondent	Form Name	No. of Respondents	Participation Time (minutes)	Burden in Hours
General population	Screener	500	3/60	25
	Follow-up contact	250*	10/60	42
General population focus group	Moderator guide for focus group	36	100/60	60
General population - Hybrid group	Moderator guide for focus group and cognitive interview	18	100/60	30
Totals				157

* Subset of initial contact group, not double counted in the total number of respondents.

FEDERAL COST: The estimated annual cost to the Federal government is $40,197.48

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ X ] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

The EurekaFacts participant database includes tens of thousands of individuals in the DC Metro area. EurekaFacts will employ a recruitment strategy that integrates multiple outreach/contact methods and resources such as Internet ads, individual emails, telephone recruiting, and on-site location-based recruiting. Furthermore, EurekaFacts will implement snowball referrals from personal and community networks during general recruitment efforts and after completing focus groups.

For this effort, EurekaFacts will recruit an array of diverse adults of all ages, including a mix of:

• Socioeconomic status (Low, Medium, High SES)

• Educational attainment levels

• Gender

• Ages (18-75 years old)

• Urbanicity (urban, rural, suburban residency)

• Adults with and without children

EurekaFacts will inform CDC when recruitment commences and will provide updates on screening and recruitment numbers on a weekly basis throughout the recruitment period.

Screen Participants for Eligibility to Participate in Focus Groups

Respondents will be screened using the approved screener script to be programmed into a computer-assisted telephone interview (CATI) to ensure that the screening procedure is uniformly conducted, instantly quantifiable, and may be checked and monitored throughout the recruitment effort. If the respondents meet the recruitment criteria, potential participants will be provided with a study description. The screening interviewers will inform respondents about the study objectives, purpose, and participation requirements of the data collection effort, the activities that it entails, and, if applicable, any potential risks associated with participation. If respondents agree to participate in the study, EurekaFacts will collect all contact information, including telephone numbers, email, and postal contact information.

During the recruitment process, the project manager will oversee both quality control and timeline management. Disposition reports will be created and provided to CDC on a weekly basis, to describe recruitment activity and outcomes so that any potential recruitment issues/barriers can be identified early in the screening process and allow for any needed adjustments to ensure the quality of the recruitment effort. Recruiters will also be monitored for uniform administration of the screener.

A maximum of 500 individuals will be screened for eligibility. Within two days of screening completion, EurekaFacts will send de-identified screening data to CDC. The method of data transmittal will be password protected and encrypted.

Select Participants for Focus Groups

After providing the participant screening data to CDC, EurekaFacts will collaborate with CDC to select a sample of a maximum of 54 eligible participants representing a range of demographic profiles. Once the sample has been approved by CDC, EurekaFacts will begin inviting participants to participate in the focus groups and providing them with a date, time, location, and directions. Confirmation e-mails will be sent the same day the participant is scheduled for a focus group and the confirmation information will also be sent via postal mail. In addition, reminder phone calls will be made at least 24 hours prior to the scheduled appointment. If a participant declines to participate, EurekaFacts will collaborate with CDC to select a replacement from the pool of eligible participants.

For more information, please refer to Attachment A for the Sampling Plan.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ X ] Web-based or other forms of Social Media

[ X ] Telephone

[ X ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [ X ] Yes [ ] No

Please make sure all instruments, instructions, and scripts are submitted with the request.

Documentation (Supporting Statements A and B) and Attachments:

1. Sampling Plan

2. Recruitment Materials

3. Screener

4. Consent forms

5. CDC Foodborne Outbreak Knowledge and Practices FG Moderator Guide

6. CDC Foodborne Message Test FG Guide & Cognitive Interview

7. Messages to Test

8. CDC non-research determination

References

Abreu, D. A., & Winters, F. (1999). Using monetary incentives to reduce attrition in the survey of income and program participation. Proceedings of the Survey Research Methods Section of the American Statistical Association.

Centers for Disease Control and Prevention (2018, February 16). Foodborne Illnesses and Germs. Retrieved from https://www.cdc.gov/foodsafety/foodborne-germs.html

Hoffmann, Sandra, Michael B. Batz, and J. G. Morris. (2012). Annual cost of illness and quality-adjusted life year losses in the united states due to 14 foodborne pathogens. Journal of food protection 75(7) (07), 1292-302. Retrieved from http://proxygw.wrlc.org/login?url=https://search-proquest-com.proxygw.wrlc.org/docview/1024158105?accountid=11243 (accessed August 14, 2018).

Shettle, C., & Mooney, G. (1999). Monetary incentives in U.S. government surveys. Journal of Official Statistics, 15, 231–250.

Instructions for completing genIC Request for Approval for

CDC/ATSDR Formative Research and Tool Development

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is requested.

PURPOSE and USE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Briefly describe the targeted group/groups for this collection.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected.

Form: Provide the title of the information collection form.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group).

Burden in Minutes: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

6