Study Population

Health Message Testing System Expedited Review Form

Get Ahead of Sepsis 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 Get Ahead of Sepsis (GAOS) 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 six new consumer audiences described in the table below.

Consumer Audience	The Why	Criteria
Women who care for a child 12 years or younger	Makes medical decisions for their children who are at risk for sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Female Currently a day-to-day caregiver for and helping make healthcare decisions for a child 12 years old or younger 18-64 years old Speaks and reads in English at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator
Women who care for an aging parent aged 65 years or older	Makes medical decisions for their aging parents who are at risk for sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Female Currently a day-to-day caregiver for and helping make healthcare decisions for an aging parent 65 years or older 18-64 years old Speaks and reads in English at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator
Women who primarily speak Spanish	Makes medical decisions for their children and/or aging parents who are at risk for sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Female Hispanic/Latina Currently a day-to-day caregiver for and helping make healthcare decisions for a child 12 years old or younger OR an aging parent 65 years or older 18-64 years old Spanish is preferred language spoken with family/friends Speaks and reads in Spanish at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator
Men aged 65 years or older, with one or more chronic conditions	Person at high risk of sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Male 65+ years old Diagnosed by a healthcare professional with one or more chronic medical conditions or diseases Speaks and reads in English at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator
Cancer patients and their caregivers	Person with cancer/making medical decisions for cancer patient who is at high risk of sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Diagnosed with Stage I-III cancer by a healthcare professional and received chemotherapy and/or radiation treatment within the past 3 years OR currently a day-to-day caregiver for cancer patient described above 18-64 years old Has access to a phone, computer, and reliable Internet to participate in the discussion Has access to a webcam or a computer where they can establish a secure video connection (caregivers only) Speaks and reads in English at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator
Patients who have survived sepsis and their caregivers	Sepsis survivor/making medical decisions for sepsis survivor who is at high risk of sepsis, and infections that can lead to sepsis	Currently lives in one of the GAOS target states Diagnosed with sepsis within past 5 years OR currently a day-to-day caregiver for patient who survived sepsis within past 5 years 18-64 years old Has access to a phone, computer, and reliable Internet to participate in the discussion Has access to a webcam or a computer where they can establish a secure video connection (caregivers only) Speaks and reads in English at a level necessary for participation Does NOT work in the healthcare field as a healthcare professional, paramedical professional, or health educator

The Get Ahead of Sepsis educational effort targets consumers in the following states: Illinois, Louisiana, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and West Virginia.

In addition, the GAOS 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	Women who care for a child 12 years or younger	Women who care for an aging parent aged 65 years or older	Women who primarily speak Spanish	Men aged 65 years or older, with one or more chronic conditions	Cancer patients and their caregivers	Patients who have survived sepsis and their caregivers
Georgia (Atlanta)			●
Illinois		●
New York/New Jersey	●		●
Pennsylvania/Ohio/West Virginia (Pittsburgh)		●		●
Tennessee	●			●
Online Only*					●●	●●

*Because the individuals in two of the target audiences are likely to be immunocompromised and/or not well enough to travel to a focus group facility, these focus groups will be conducted online. Participants in these focus groups will be recruited from across all GAOS target states.

This proposed research is being done in parallel with similar materials testing research with corresponding HCP audiences for the Get Ahead of Sepsis 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. ​

For the online consumer focus groups, the recruitment firm will perform similar tasks with the exception that the firm will provide the web conferencing platform for the online focus group and provide staff to troubleshoot any technical issues participants may have on the conferencing platform.

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