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

Focus Groups About Drug Products As Used by The Food and Drug Administration

DSC Focus Group Screener Final

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

OMB: 0910-0677

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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 _______



  1. Can you speak, read and understand English?

    1. Yes (Continue)

    2. No (Terminate)



  1. 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)


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

    1. Yes (Terminate)

    2. No (Continue)


  1. 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)


  1. Are you a professional scientist or researcher?

    1. Yes (Terminate)

    2. No (Continue)


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

    1. Yes (Terminate)

    2. No (Continue)


  1. 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)


  1. 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)


  1. 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


  1. 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)


  1. 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

  1. Gender

    1. Male

    2. Female


  1. 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)


  1. Are you Hispanic or Latino?

    1. Yes

    2. No


  1. 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


  1. 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)


  1. ‘‘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)


  1. ‘‘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].


  1. 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.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleScreener
AuthorAlec Ulasevich ([email protected])
File Modified0000-00-00
File Created2021-01-28

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