Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER)

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 with you about a study you were invited to participate in by [NAME]. I work for [COLLABORATING SITE] and we are conducting a study on behalf of the U.S. Food and Drug Administration (also known as the FDA). We are holding discussions to learn more about how the FDA can improve its health communications to women aged 38 years old and older about the products that it oversees. If you agree to participate, we will schedule you for an in-person focus group with 5-7 other women. Each discussion will take about an hour and a half to two hours. You will receive a gift card as a token of appreciation.

Are you still interested in participating?

Yes. Continue with script.

No. Go to Closing Statement.

I have a few questions before I can schedule you for a group, which should take about 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: ________________________

Best phone number to call: ________________

I have a few questions to find out about you, so that I can make sure you are eligible to participate. Everything you tell me will be kept confidential and will not be shared outside the study.

1. Do you identify as a woman or female?

Yes. Continue with script.

No. Ineligible, go to Closing Statement.

2. What year were you born? __________________________ (ineligible = July 1981 - present)

Note: each collaborating site must make sure they are recruiting participants from the generation group agreed upon:

• Generation A: Born 1966 to 1981; 39 to 54 years old in 2019;

• Generation B: Born 1947 to 1965; 55 to 73 years old in 2019; and

• Generation C: Born 1929 to 1946; 74 to 91 years old in 2019.

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

African American/Black Native Hawaiian/Pacific Islander

Asian White

American Indian/Alaska native

4. Are you of Hispanic, Latino, or Spanish background?

Yes No

5. What is your highest level of education?

Less than high school High school graduate/GED

Trade or technical school Some college education

College graduate Postgraduate education

6. What is your employment status?

Employed Unemployed

Retired

7. How much was your household annual income in the previous year?

Less than $20,000 $20,000-40,000

$40,000-60,000 $60,000-80,000

$80,000-100,000 Above $100,000

8. Do you have access to any of these types of health insurance coverages (select all that apply)?

Medicaid Indian Health Service

Medicare State-sponsored or government health insurance plan

Military/Champus/Tricare Private health insurance

No health insurance coverage Other health insurance _________________________

9. Are you a caregiver of a child, spouse, or other family member or friend? (A caregiver is a person who provides direct care to people who need help taking care of themselves, including making or helping them making decisions about their health; such as children, elderly people, disabled people, or the chronically ill patients)

Yes No

If yes, describe the person for whom you provide care, such as a spouse, child, parent, friend, or someone else: __________________________

10. Have you ever been in a focus group or taken surveys for which you received compensation?

Yes No

If yes, when was the last time you did that? ____________________

11. How did you hear about this project?

Personal communication Flyer

Other: __________________________

12. What interested you in this project?

Your interest in health-related matters Your interest in research

The gift card Other: __________________________

PART 2: SCHEDULING AND CLOSING STATEMENTS

If the participant is eligible:

Great, those are all the questions I have for you today.

The focus group is scheduled for [time] on [date] at [address]. Are you willing to participate in this focus group?

Yes No

If the potential participant accepts the above mentioned schedule:

We look forward to seeing you on [day, time]. If you have any questions, please call me at [insert number]. We will email, mail, and/or call you, whichever is more convenient, two days before the focus group to give you directions and more details. Would you prefer that we email, mail, or call you as a reminder? Would you please provide your contact information (obtain contact information for their preferred mechanism):

Email address _______________________ Phone Number ____________________

Mailing address _______________________

If the participant is no longer interested or doesn’t accept the suggested schedule :

We appreciate your initial interest in the focus group and I thank you for speaking with me today. If it’s OK with you, we will keep your information on file in case we conduct another study that you may be interested in.

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 your time, and if it’s OK with you, we will keep your information on file in case we conduct another study for which you may be eligible.

Reminder E-mail/Call

Greetings Ms./Mrs. [Participant’s Name],

This is a friendly reminder that you have signed up for a focus group at [time] on [date] at [address].

• Parking directions: [XXXXXXX]

• Please feel free to call [PHONE NUMBER] if you face any issues on the day of the focus group e.g., running late, problem finding the location, etc.

Thank you so much for your willingness to participate in research in improving health communications regarding FDA regulated products. We look forward to meeting you soon!

Sincerely,

[Name]

Collaborating Site Representative

FDAOW Patient Screener