Attachment A

Health Message Testing System Expedited Review Form

Be Antibiotics Aware Educational Effort – Consumer Audiences

Attachment A. Study Population

(Discuss study population and explain how they will be selected/recruited.)

Study population. Based on previous formative research related to the Be Antibiotics Aware (BAA) educational effort and CDC subject matter expert guidance, CDC has developed new or revised educational effort materials and is planning to develop additional educational effort materials for four new consumer audiences described in the table below.

Consumer Audience	The Why	Criteria
Healthy adults who use urgent care	Use urgent care for their medical needs and lack knowledge about when antibiotics are and are not needed and therefore demand and expect antibiotics, so they can feel better quickly	26–64 years old “Healthy” (i.e., is not living with cancer or on dialysis) Used urgent care at least once within the last 12 months for their own care (illness, not injury). Fluent in English
Family caregivers of long-term care (LTC) patients	Make decisions for their older adult family members who are at high risk of antibiotic-related adverse drug events, complications from drug-drug interactions, and increased risk for C. difficile infection.	26 years of age or older In charge of medical decisions for an adult family member in LTC Fluent in English
Community dwelling older adults	Improving antibiotic prescribing and use, particularly quinolones and azithromycin, is important in this age group due to high risk of adverse drug events, complications from drug-drug interactions, and increased risk for C. difficile infection.	65 years of age or older  “Healthy” (i.e., is not living with cancer or on dialysis) Participants in charge of their own medical care decisions Living in the community (i.e., not in a NH or other LTC facility) Fluent in English
Spanish-speaking women	Lack knowledge about appropriate antibiotic use, and demand and expect antibiotics for themselves and those they care for. In addition, more likely to self-administer, share antibiotics among family members, and take antibiotics without a prescription	Hispanic/Latina woman 26–64 years Spanish is preferred language spoken with family/friends, and the preferred language for receiving health information

The Be Antibiotics Aware educational effort targets health consumers in the states with the highest rates of antibiotic prescriptions per 1,000 population, including:

• Alabama

• Arkansas

• Iowa

• Kentucky

• Louisiana

• Mississippi

• Nebraska

• Tennessee

• West Virginia

In addition, the BAA educational effort targets Spanish-language audiences in Florida, Georgia, and Texas.

The following table depicts the proposed locations for conducting focus groups with the above consumer audiences.

Proposed Focus Group Locations	Healthy adults, who use urgent care	Community dwelling older adults	Family caregivers of LTC patients	Spanish speaking women,
Georgia (Atlanta)				●
Missouri*	●		●
Louisiana		●	●
Tennessee	●	●
Texas (San Antonio)				●

* Because there are so few urgent care centers in Iowa, CDC identified Missouri as a proxy Midwest state.

This proposed research is being done in parallel with similar materials testing research with corresponding HCP audiences for the Be Antibiotics Aware educational effort (OMB package under preparation). The study population for the work proposed here was selected to align with the geographic sampling frame for the HCP research.

Screening and recruitment. CDC and their contractor ICF, will partner with a professional recruitment firm to contact the potential participants by phone, and with their permission, use the screener to determine eligibility, interest, and availability for each focus group. The recruitment firm will over recruit for each group (approx.10-12 eligible persons) to ensure there are a minimum of 5 participants for each focus group.​ After completing the screener and confirming that the individual agrees to participate, the recruitment firm will send a confirmation message to the email address and/or mobile phone number provided by the participant.

Two days before the interview, the recruitment firm will email the participant the informed consent form to review, sign, and return prior to the interview. The day before the focus group, the recruitment firm will contact the participant via phone call and/or text to remind them about the focus group. On the day of the focus group, the recruitment firm will prepare the facility for in-person focus groups, including providing on-site staff to greet participants, operate audio-visual equipment (for recording and live streaming for observers), and manage the distribution of participant incentives. ​

Lastly, the firm will update ICF and the CDC on the number and demographics of individuals recruited using unique identifiers to protect participant confidentiality.​ If more than the eight individuals show up for the focus groups, CDC and ICF staff will review the screeners to select individuals that offer an appropriate mix of perspectives as specified in the recruitment considerations as well as a mix across demographics (age, gender, and race/ethnicity for the non-Spanish speaking group). Other individuals will be dismissed, but offered the incentive in appreciation for their time.

Attachment A 2