Expedited Review Form

HMTS Expedited Review Form_Sepsis Consumer final.pdf

CDC and ATSDR Health Message Testing System

Expedited Review Form

OMB: 0920-0572

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Health Message Testing System Expedited Review Form
1. Title of Study: (Please append screener and questionnaire)

Message and material testing for the Get Ahead of Sepsis (GAOS) campaign for consumer audiences. The
other GAOS package is distinctly aimed at testing material for healthcare professionals (HCPs).
2. Study Population: (Discuss study population and explain how they will be selected/recruited.)

1) Cancer patients and caregivers, 2) men aged 65+ with 1 or more chronic conditions, 3) sepsis survivors
and caregivers, 4) women who care for an aging parent 65+, 5) women who care for a child 12 years or
younger, and 6) women who primarily speak Spanish. See attachment A for more detail.
Respondent characteristics:
Number of subject: 60-96

Number of males:

20-32

Age range: 18 years or older

Number of females: 40-64

Racial/ethnic composition: 100% Hispanic/Latina for Spanish-speaking women, ages 18-64 years; N/A for
Special group status: (e.g., risk group, health care providers)
Type of group(s): Cancer patients and caregivers, men aged 65+ with 1 or more
chronic conditions, sepsis survivors and caregivers
Geographic location(s): Illinois; Louisiana; Mississippi; New Jersey; New York; Ohio;
Pennsylvania; Tennessee; West Virginia
3. Incentives: (State what incentive will be offered and justify proposed incentives to be used in study.)

Participants will receive a $50 gift card (or cash) in appreciation for their time. The incentive is based on
their participation in a 75-minute, in-person focus group discussion or a 60-minute online discussion (for
cancer patients and caregivers and sepsis survivors and caregivers). In person participants will be asked to
arrive 15 minutes earlier to check-in and review/sign the informed consent form. Online participants will
complete the informed consent at home. See Attachment B for justification of the proposed incentive.

4. Study method: (Please check one below)
Central location intercept interview:
Online Interview:
Telephone interview:
Other (describe):

Focus group:
Individual in-depth interview (cognitive interview):

(CATI used: yes or no):

5. Purpose of the overall communication effort into which this health message(s) will fit:
(Please provide 2-3 sentences below.)

The GAOS educational effort seeks to prevent and reduce infections that lead to sepsis and optimize
healthcare quality and patient safety by raising awareness, knowledge, and motivating behavior change
related to sepsis prevention, early recognition, and appropriate treatment among consumer target
audiences.

6. Category of time sensitivity: (Please check one below)
Health emergency:
Time-limited audience access:
Press coverage correction:
Time-limited congressional/administrative mandate:
Trend Tracking
Ineffective existing materials due to historical event/social trends:
7. Describe nature of time sensitivity: (Please provide 2-3 sentences below.)
Sepsis is the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis
happens when an infection you already have —in your skin, lungs, urinary tract, or somewhere else—
triggers a chain reaction throughout your body. At least 1.7 million adults in America develop sepsis, and
nearly 270,000 Americans die as a result of sepsis each year. Public education is needed to increase
awareness and knowledge related to sepi prevention, early recognition, and appropriate treatment.

8. Number of burden hours requested: 186 hours

BURDEN HOURS
No. of
Participation
Respondents Time

Category of Respondent

Burden

Potential respondents (estimate)

600

5 min

3000 min

Focus group participants (includes sign-in and discussion)

96

85 min

8160 min

Totals

696

9. Are you using questions from the approved question bank?

11,160 min

Yes

If yes, please list the item number(s) for questions used from the question bank separated by a comma.
(e.g., 1a, 3c, 130d)
4d, 6d, 12d, 29d, 43e

*** Items below to be completed by Office of Associate Director for Communication (OADC)***
1. Number of burden hours remaining in current year's allocation: 6433
2. OADC confirmation of time-sensitivity:
Yes:
No:

Dawn B. Griffin
Project Officer
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