Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

SCREENER & SCHEDULING SCRIPT FOR PARTICIPANTS

RECRUITMENT ID: ___________

DATE: ____________________

My name is [NAME] and I’m following up about a research project you were invited to participate in by [NAME]. I work for University of Maryland and we are conducting this study on behalf of the U.S. Food and Drug Administration (also known as the FDA). We are holding discussions to learn from you how the FDA can improve health communications to women aged 38 and older about the products that it regulates. We will schedule focus groups made up of 8-10 women each. The discussion will take about an hour and a half to two hours, and you will receive token of appreciation for your time. Are you still interested in participating?

Yes. Continue with script.

No. Go to Closing Statement.

I have a few questions to ask you to confirm your eligibility. Everything you tell me will be kept confidential. This conversation should take less than 10 minutes. Do you have time now to talk?

Yes. Continue with script.

No. Is there a better day and time when I can call you back?

Date: _________________________

Time: ________________________

1. How did you find out about the project?

Personal communication Flyer

Other: __________________________

2. What interested you in this project?

Interest in matters of health Interest in research

The compensation Other: __________________________

PART 1: DEMOGRAPHICS

Now, I’d like to get some basic information about who you are.

3. What year were you born? __________________________ (ineligible = July 1980 - present)

4. Which racial or ethnic group(s) do you identify with (select all that apply)?

Black or African American Native Hawaiian or Other Pacific Islander

Asian Hispanic, Latino, or Spanish background

American Indian or Alaska Native White

5. What is your highest level of education?

Less than high school High school

Some college education College graduate

Postgraduate education

6. Are you a caregiver? (for example, a caregiver is a person who provides direct care (as for children, elderly people, or the chronically ill))

Yes No

If yes, for whom: __________________________

7. How much, if any, experience do you have in research?

None - I have never participated in or worked on a research project.

Some - I have been a participant in research a few times (e.g., focus group participant, complete survey)

Moderate – I have worked on a research project in the past 6 months and/or participate in research on occasion.

Extensive – I have run my own research project and/or participated in research for more than 5 years.

PART 2: SCHEDULING

We will schedule the focus groups throughout June and July 2018 at locations [X and Y] on days and times that are convenient to the participants, so I have a few questions about your availability.

8. The focus groups will likely be held in the Baltimore area. Are you willing to travel to Baltimore to participate?

Yes No (ineligible)

If yes, where: __________________________ (research staff will read a list of potential locations)

9. What days of the week are you most available?

Mon Tues Wed Thurs Fri Sat Sun

10. Are there any blocks of time in June and July 2018 that are not good for you?

_____________________________________

11. What time of day is best for you? [read all options]

Morning Mid-day Afternoon Evening

Closing Statements

If the participant is eligible:

Great, those are all the questions I have for you today. The following days and times are available to participate in a focus group [select the applicable location, target audience, day and time]. Which of these groups would you like me to sign you up for? ____________________________________________

We will call to remind you about the group a day or two in advance and to provide directions and details about the location. Would you prefer that I email this reminder to you or give you a call?

Email address _____________________________________

Phone Number _____________________________________

Thanks for the information you’ve given me today. We look forward to seeing you on [day, time]. If you have any questions, please do not hesitate to call me at [insert number].

If the participant is ineligible:

Thank you for your interest in the focus group. Unfortunately, based on your responses, we will not be able to enroll you as a participant in a focus group at this time. I appreciate the time that you have taken with me today, and we will keep your information on file, should we conduct another study for which you may be eligible.

If the participant is no longer interested:

I appreciate your initial interest in the focus group and the time you took to talk with me today. We will keep your information on file, should we conduct another study for which you may be eligible and interested in.

FDAOW Patient Screener