Rapid Message Testing with Consumers and Healthcare Professionals - Children's Cough and Cold Consumer Update (CDER)

OMB Control No. 0910-0695

Expiration date: 3/31/2024

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0695 and the expiration date is 3/31/2024. The time required to complete this information collection is estimated to average 3 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

FDA RAPID – MESSAGE #27

Children’s Cough and Cold

Consumer Update

Introduction

The U.S. Food and Drug Administration, or FDA, hired Westat to help them get opinions about health information. [Plaza Research (parents/caregivers) OR WebMD Professional/Medscape (Pediatric primary care)] is helping Westat and FDA find people who may be interested in being interviewed about health information. To make sure you are a good fit for the interview, please take about 3 minutes to answer the questions below.

1. What is your age?

 Under 18  INELIGIBLE

 18 to 24

 25 to 34

 35 to 44

 45 to 54

 55 or older

2. Are you a healthcare professional?

 Yes, physician  GO TO Q3

 Yes, physician assistant  INELIGIBLE

 Yes, nurse practitioner  INELIGIBLE

 Yes, nurse  INELIGIBLE

 Yes, pharmacist  INELIGIBLE

 Yes, medical assistant  INELIGIBLE

 Yes, dietician  INELIGIBLE

 No  GO TO Q5

3. [Ask if Q2 = Yes, physician] Do you specialize in pediatrics?

 Yes, pediatric primary care  GO TO Q4

 Yes, pediatric specialist  INELIGIBLE

 No  INELIGIBLE

4. [Ask if Q3 = Yes, pediatric primary care] In an average year, what percentage of your work time is spent on patient care? Patient care activities include examining patients, performing diagnostic tests, prescribing or dispensing medications, reviewing patient records, and other activities directly connected to treatment. Non-patient care activities include teaching, research, and administration.

 50% or more  GO TO Q5

 Less than 50%  INELIGIBLE

5. [Ask if Q4 = 50% or more] Are you an…?

1. Employee of the U.S. Department of Health and Human Services, or any of its agencies including the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health INELIGIBLE

2. Employee of a state or local health department INELIGIBLE

3. None of the above  GO TO Q7

6. [Ask if Q2 = No] Are you an…?

1. Employee in a healthcare position or working for a health organization (for example: health consultant, health advocacy)  INELIGIBLE

2. Employee of the U.S. Department of Health and Human Services, or any of its agencies including the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health INELIGIBLE

3. Employee of a state or local health department INELIGIBLE

4. None of the above  GO TO Q7

7. Do you, or does any member of your household or immediate family work…?

1. For a market research company  INELIGIBLE

2. For an advertising agency, communications, or public relations firm  INELIGIBLE

3. In the media (TV, radio, newspapers, magazines)  INELIGIBLE

4. In the pharmaceutical industry  INELIGIBLE

5. None of the above  IF Q5C = None of the above GO TO Q14  IF Q6C = None of the above GO TO Q8

8. [Ask if Q1 = 18 to 54 AND Q2 = No] Are you a parent or guardian of any children?

 Yes, one child  GO TO Q9

 Yes, multiple children  GO TO Q9

 No  INELIGIBLE

9. [Ask if Q8 = Yes, one child OR Yes, multiple children] Are any children living in your household younger than 4 years old?

 Yes  GO TO Q12

 No  INELIGIBLE

10. [Ask if Q1 = 55 or older AND Q2 = No] Are you a grandparent who lives with or watches any grandchildren regularly in your own home?

 Yes,  GO TO Q11

 No  INELIGIBLE

11. [Ask if Q10 = Yes] Are any grandchildren that you live with or watch regularly younger than 4 years old?

 Yes  GO TO Q12

 No  INELIGIBLE

12. [Ask if Q9 = Yes OR Q11 = Yes] In the past 12 months, have you given any cough and cold medicine purchased over-the-counter without a prescription to a child younger than 4 years old?

 Yes

 No

13. [Ask if Q2 = No] What is the highest grade or level of education you have completed?

1. Less than High School

2. High School Diploma or GED

3. Some College, but no degree

4. Associate’s Degree  INELIGIBLE

5. Bachelor’s Degree (for example: BA, BS)  INELIGIBLE

6. Graduate or Professional Degree  INELIGIBLE

14. What is your sex?

 Female

 Male

15. Are you of Hispanic, Latino, or Spanish origin?

 Yes

 No

16. What is your race? Please select one or more.

□ White

□ Black or African-American

□ American Indian or Alaska Native

□ Asian

□ Native Hawaiian or other Pacific Islander

17. What state do you live in? [DROP DOWN LIST OF US STATES, INCLUDING “OUTSIDE OF THE US”] [“OUTSIDE OF THE US”  INELIGIBLE]

Request for Contact Information

C1. Thank you for answering the questions. Based on your answers, you may be selected for a 45-minute interview. If selected, you will receive [$50 (parents/caregivers) OR $100 (Pediatric primary care)] as a token of appreciation for your participation. At the start of the interview, the interviewer will ask if it’s okay to audio record it. This helps Westat to make sure they correctly hear everything you say. Are you okay with being audio recorded during the interview?

 Yes

 No  INELIGIBLE

As stated earlier, [Plaza Research (parents/caregivers) OR WebMD Professional/Medscape (Pediatric primary care)] is helping to identify people interested in providing opinions about health information. If you are chosen for an interview, you will get an email for this study. Make sure you have access to your email during the interview. Is it okay with you for [Plaza Research (parents/caregivers) OR WebMD Professional/Medscape (Pediatric primary care)] to share your contact information with Westat?

 Yes

 No  INELIGIBLE

Thank and Terminate

Thank you for taking our survey. Unfortunately, based on your responses, you are not eligible for this study. However, we appreciate you taking the time to answer our questions today.

Contact Information

C2. In the space below, please provide us with your contact information, including phone number and email address. Westat will not share your contact information with anyone else, including the FDA. Your personal information will be deleted upon completion of the research project.

Name ______________________________________________________________________

Phone Number _______________________________________________________________

Email Address ________________________________________________________________

Technology Preferences

C3. The Westat interviewer would like you to share your computer screen during the interview so that you can view the health information together. Westat will send directions for how to do this. Which app do you prefer for screen sharing? [SINGLE SELECT]

1. Skype

2. Zoom

3. WebEx

4. I am not able to use any of these, please just call me

Closing

Thank you for your answers to these questions. If you are chosen for an interview, someone will contact you within the next 1-2 days.