Consumer Fact Sheet and Website Outreach Card on Medication Use during Pregnancy

DRAFT: 12.1.14

OMB: 0910-0497

Exp. Date: TBD

FDA OFFICE OF WOMEN’S HEALTH

Medication & Pregnancy

F

Introduction: Hello, I am {INTERVIEWER NAME}, and I am calling to invite women in your area to participate in a small group discussion about medication use during pregnancy. This discussion will be confidential and anonymous. Your name or other identifying information will not be shared with anyone outside this research project. You do not need to prepare to participate. We are interested in your opinions and comments on health education materials. You will receive $75 for your participation and light refreshments will be provided during the discussion. May I ask you a few questions to determine if you are eligible to participate?

Voicemail Message: Hi, my name is {INTERVIEWER NAME} I am calling about participating in a women’s health project about medication use during pregnancy. We will try to call you back over the next few days to see if you may be interested in participating.

ocus Group Screener Guide

01 CONTINUE

02 TERMINATE (RECORD REASON AND THANK) _____________________

03 CONTINUE IN SPANISH (for Miami and one DC group)

Questions

1. [INTERVIEWER: INDICATE LOCATION OF FOCUS GROUP AREA]

1. Washington DC area: English

2. Washington DC area: Spanish

3. Chicago

4. Miami: Spanish

2. Is participant female? [INTERVIEWER: ASK ONLY IF NECESSARY]

01 Male (TERMINATE)

02 Female (CONTINUE)

3. Are you currently pregnant, have given birth within the last year or are currently trying to get pregnant?

01 Yes, currently pregnant (CONTINUE)

02 Yes, given birth within the last 5 years (CONTINUE)

03 Yes, currently trying to get pregnant (CONTINUE)

04 No (TERMINATE)

4. What is the highest grade or year of school you completed? [INTERVIEWER: DO NOT READ LIST]

01 6^th grade or less (TERMINATE)

02 7^th grade-11^th grade (CONTINUE)

03 12^th grade/GED (CONTINUE)

04 Some college/Associate (CONTINUE)

05 College graduate or higher (TERMINATE)

99 Refused (TERMINATE)

5. Are you currently employed in the health care field?

01 Yes (TERMINATE)

02 No (CONTINUE)

6. Have you participated in a focus group in the past 6 months?

01 Yes (TERMINATE)

2. No (CONTINUE)

7. Are you currently taking any prescription medication or have you ever taken prescription medicine during pregnancy?

01 Yes (CONTINUE)

02 No (TERMINATE)

8. Was the medicine for an ongoing chronic condition (like diabetes or asthma) or was it for an acute condition (like an infection)?

1. On-going/ chronic condition (i.e., diabetes, seizure, etc.)

2. Acute condition (i.e., antibiotics for an infection)

9. Have you been diagnosed with any of the following conditions? (MAY SELECT MORE THAN ONE CONDITION)

1. High blood pressure

2. Autoimmune Disease (e.g. Lupus, MS, Rheumatoid Arthritis)

3. Type I Diabetes

4. Type II Diabetes

5. Gestational Diabetes (diabetes that is first diagnosed during pregnancy)

6. Asthma

7. Seizures/Epilepsy

8. Depression/Anxiety/ Other Mental Health Condition

9. Other: _______________________________________

10. NONE

10. Have you ever taken over-the-counter medicine during pregnancy? (over-the-counter refers to medicine that you can buy without a prescription)

01 Yes

02 No

11. Have you ever received a vaccine during pregnancy (includes flu shot or mist)?

01 Yes

02 No

12. Would you take medication during pregnancy, if necessary?

1. Yes, (CONTINUE)

2. Maybe, it depends (CONTINUE)

3. No, I would not take any medication during pregnancy (TERMINATE)

13. How old are you? _________

[INTERVIEWER: RECORD AGE AND SELECT AGE CATEGORY. IF RESPONDENT PREFERS NOT TO PROVIDE AGE, READ THE LIST OF CATEGORIES]

01 18 to 20

02 21 to 30

03 31 to 40

04 41 or over

99 Refused

15. How would you best describe yourself? [INTERVIEWER: READ LIST]

01 White, non-Hispanic

02 Black, non-Hispanic

03 Hispanic/Latino

04 Asian, describe: __________________

05 American Indian/Native American

06 Other, describe: ________________________________

99 Refused

16. Thank you for answering the questions. We would like to invite you to participate in a discussion about medication use in pregnancy with a small group of 6-8 other women from the {Washington DC/Chicago/Miami} area on {March/April XX at Xpm?}. Again, you will receive $75 for your participation and it should take 60-90 minutes of your time, if you choose to participate. Light refreshments will also be provided. During the discussion we will ask your opinion and comments and everything discussed will be confidential and anonymous. No identifying information will be used. Participation is voluntary and you may leave at any time. Would you like to participate in this group?

1. Yes (CONTINUE TO COLLECTING CONTACT INFORMATION)

2. No (THANK FOR TIME AND TERMINATE)

INTERVIEWER: Recruit a mix of women who are:

• currently pregnant, given birth within the last 5 years, or are currently trying to get pregnant

• AND currently taking prescription medication or had exposure to prescription medication, over-the-counter medication or vaccine during pregnancy

• with a 7^th grade up to some college education level

• with a variety of chronic conditions,

• with a variety of ages and ethnicities

PARTICIPANT CONTACT INFORMATION

Thank you very much for your interest in participating. The last thing I need to ask is for contact information to send you a letter with details about participating including location/directions to the focus group on March/April XX at XXam/pm. We will also call you before the discussion to confirm. Again, this information will be used only to confirm participation and will not be used for any other purposes.

Lastly, we will make every effort to accommodate persons with physical disabilities or special needs. Do you require special accommodations due to a disability?

1. Yes. Describe: _______________________________________________

2. 
   

   Respondent name____________________________________________________

   
   

   Telephone __________________________ Alternate ___________________________

   
   

   Address _____________________________________________________________

   
   

   _____________________________________________________________________

   
   

   E-mail __________________________________________________________

   
   

   Best time and way to be reached __________________________________________

   
   

   Preference for focus group time?

   01 Morning `

   02 Afternoon

   03 Evening

   04 No preference

   No

Participant # _______ Group # __________

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