Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge about How FDA Communicates Risks and Benefits of Prescription Medicines

Focus Groups to Investigate Drug Safety Communications

Respondent Screener

Recruiting Goals

• 24 focus groups to take place in four cities (Philadelphia, PA; Fresno, CA; Asheville, NC; and Appleton, WI), 6 in each city

• Up to 10 participants in each focus group

• At least 15% of respondents in Philadelphia, PA, Fresno, CA, and Asheville, NC should come from the following zip codes:

Philadelphia, PA		Fresno, CA	Ashville, NC
18974 19320 19358 19013 19061 19401 19462 19464 19102 19103 19104 19106 19107 19108 19118 19119 19121 19122 19123 19125 19129 19130 19131 19132 19133 19134 19138 19139 19140 19141 19142 19143 19144 19145 19146	19147 19150 19151 19153 19701 19702 19703 19720 19730 19801 19802 19804 19805 19806 19807 19808 19809 21903 21911 08015 08064 08068 08511 08562 08101 08102 08103 08104 08105 08109 08110 07093 08014 08094 08079	93210 93234 93608 93609 93616 93619 93622 93630 93631 93640 93648 93657 93662 93668 93701 93702 93703 93706 93721 93723 93725 93726 93727 93737 93744 93775 93844	28801 28803 28806 28709

Facility Recruitment Instructions

• The 6 focus groups in each city should be divided as follows:

  • 3 moderate health literacy groups

  • 3 low health literacy groups

• At least 15% of participants in Philadelphia, Fresno, and Asheville should come from zip codes with medically underserved areas (as defined by HRSA)

• Adults 18+, mix of education and race/ethnicity

• An attempt should be made to recruit an approximately equal number of males and females

• Participants must have taken at least 2 over-the-counter and/or prescription drugs in the past 6 months

• Participants must report having at least one chronic condition.

• Participants must use the internet at least 2 hours a month

• Participants must speak, read, and understand English, but they do not need to be native English speakers

• Participants must not work for a pharmaceutical company, an advertising agency, a market research company, a communications/PR firm

• Participants must not work as a healthcare professional, professional scientist, or researcher

• Exclude anyone who has participated in a focus group or cognitive interview in the last three months

Script

Hello Mr./Ms. __________________________________, my name is __________________ and I'm calling about a research study in your area. We are recruiting for an upcoming focus group in which participants will be asked to share their thoughts and feelings about prescription drug information. Could I ask you a few questions? It will take approximately 5 minutes.

Screening Questions

1. How old were you on your last birthday

   1. Record years _______

2. Can you speak, read and understand English?

   1. Yes (Continue)

   2. No (Terminate)

3. Are you, anyone from your immediate family, or anyone in your household trained or employed as a health care professional?

   1. Yes (Terminate)

   2. No (Continue)

4. Do you, anyone from your immediate family, or anyone in your household work for a pharmaceutical company?

   1. Yes (Terminate)

   2. No (Continue)

5. Do you, anyone from your immediate family, or anyone in your household work for an advertising agency, a market research company or a communications/public relations firm?

   1. Yes (Terminate)

   2. No (Continue)

6. Are you a professional scientist or researcher?

   1. Yes (Terminate)

   2. No (Continue)

7. Have you participated in focus groups or a personal interview for research in the last 3 months?

   1. Yes (Terminate)

   2. No (Continue)

8. How many medications have you taken in the past 6 months? Please include all over-the-counter and prescription medications, but do not include vitamins and other nutrition supplements?

   1. Less than 2 (Terminate)

   2. 2 – 3 (Continue)

   3. 4 – 5 (Continue)

   4. More than 5 (Continue)

9. Do you suffer from a chronic condition, such as diabetes, high cholesterol, asthma, high blood pressure, a mental illness, heart disease, rheumatoid arthritis, or any similar condition?

   1. Yes (Continue)

   2. No (Terminate)

10. Which of the following best describes your health insurance coverage?

    1. My health insurance is all or partially paid for by an employer or union

    2. I pay for health insurance completely out of pocket

    3. I have health insurance through an Affordable Care Act Health Exchange

    4. I receive Medicaid

    5. I receive Medicare

    6. I have no health insurance

    7. None of these

11. How many hours do you use the internet each month, including at home, at work, or anyplace else?

    1. Less than 2 (Terminate)

    2. 2 or more (Continue)

12. Do you use any of the following medications?

FDA-approved testosterone products

1. Yes

2. No

Fentanyl pain patch

1. Yes

2. No

Sodium phosphate products to treat constipation (e.g. “Fleet” enema)

1. Yes

2. No

Demographics

13. Gender

    1. Male

    2. Female

14. What is the highest level of school you have completed or the highest degree you have received?

    1. Some high school or less

    2. High school graduate—high school diploma or the equivalent (for example: GED)

    3. Some college but no degree

    4. Associate degree in college

    5. Bachelor’s degree (for example: BA, AB, BS)

    6. Advanced or graduate degree (for example: Master’s degree, MD, DDS, JD, PhD, EdD)

15. Are you Hispanic or Latino?

    1. Yes

    2. No

16. What is your race? You may select one or more races.

1. American Indian or Alaska Native

2. Asian

3. Black or African American

4. Native Hawaiian or other Pacific Islander

5. White

6. Some Other Race

Health Literacy

17. How often do you have someone help you read hospital materials?’’

    1. All of the time (1)

    2. Most of the time (2)

    3. Some of the time (3)

    4. A little of the time (4)

    5. None of the time (5)

18. ‘‘How confident are you filling out medical forms by yourself?’’

1. Extremely (5)

2. Quite a bit (4)

3. Somewhat (3)

4. A little bit (2)

5. Not at all (1)

19. ‘‘How often do you have problems learning about your medical condition because of difficulty understanding written information?’’

1. All of the time (1)

2. Most of the time (2)

3. Some of the time (3)

4. A little of the time (4)

5. None of the time (5)

Sum score in parentheses to yield a composite score (3-15)

Health Literacy Score

3-8 Low (Assign to low health literacy group, unless full, then terminate)

9-14 Moderate (Assign to moderate health literacy group, unless full, then terminate)

15 High (Terminate)

Instructions: If focus groups corresponding to the respondent’s literacy score are full (has 13 individuals in it), terminate. Otherwise, continue.

Recruitment script

Thank you! We would like to invite you to participate in a research group discussion about prescription drug communications and drug safety. The study involves one individual session. The discussion will last approximately two hours and will be audio- and video-taped. The study will take place on [dates] at our [city] facility. Your participation and everything you say during the discussion will remain confidential. You will receive a payment of $75 to thank you for your time and opinions.

Scheduling

1. Would you like to participate in this study?

1. Yes (Continue)

2. No (Terminate)

I’m glad that you will be able to join us! The group will take place at [site location] on [Day], [Date], at [time]; [Day], [Date], at [time]; etc. [list all dates].

2. What time would you like to come?

Confirmation Letter

I would like to send you a confirmation letter and directions to the facility. In order to do so, could you please tell me your mailing address (or fax number, e-mail address) and a phone number where you can be reached:

Name:______________________________________

Address:__________________________________________________________

City:_______________________ State:_________ Zip:______________

Phone:_______________________

Email:_______________________

Date of focus group:__________________ Time:________________

We are only inviting a small number of people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call [recruiter] at [telephone number] if this should happen. We look forward to seeing you on [date] at [time]. If you use reading glasses, please bring them with you to the focus group.