Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers)

ATTACHMENT B2

LABEL COMPREHENSION STUDY

TASK 3: GROUP 4 (ADULT ALL-COMERS) – TELEPHONE SCREENER FOR RECRUITMENT FIRM

TELEPHONE RECRUITMENT SCRIPT

Hello, my name is _________ and I’m from [NAME OF RECRUITMENT FIRM]. I’m calling on behalf of RTI International and Concentrics Research about a research study that is being sponsored by the U.S. Food and Drug Administration (FDA). FDA is the government agency that protects the public health by reviewing new medicines. In these reviews, the FDA helps to make sure the medicines work and are safe before they are approved to be prescribed by health care providers and used by patients.  We are looking for people to take part in a research study to review a label for a medicine that may be available over-the-counter soon, meaning without a prescription. What we learn from this study will help to make sure that people understand from the label how to use the medicine so it is safe and effective. We are not selling or promoting any medicine.

The study involves being in a one-time individual, in-person interview lasting no more than 30 minutes. During the first part of the interview, we will ask you to read aloud some medical terms to get an idea of what medical words you are familiar with. Then we will ask you some questions about instructions for a medicine. The interview will be audio recorded. You will be given $40 at the end of the interview as a token of appreciation for your time and travel expenses.

To see if you qualify for this study, I need to ask you some questions that will take a few minutes of your time. If you qualify for the study and are invited to participate, you can then decide if you want to be a part of the study.

The risk of others knowing your answers to the questions is minimal. To keep your information secure, your contact information will be kept apart from your answers to these questions. Do you have any questions about the process? May I ask you my questions now?

1. How old are you?

_____	Over Age 18  CONTINUE Between Ages 15-17 SWITCH TO ADOLESCENT SCREENER TO PROVIDE PHONE NUMBER FOR SCREENING Under Age 15  TERMINATE (Ineligible for the study) Don’t know/refused  TERMINATE

2. Can you read, speak, and understand English?

Yes		 CONTINUE
No		 TERMINATE (Closing Script and Contact Information Sheet)
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

3. Are you currently employed by [INSERT OPTIONS 1-6 BELOW]? (Check all that apply.)

A marketing or research company		 TERMINATE (Closing Script and Contact Information Sheet)
An advertising agency or public relations firm		 TERMINATE (Closing Script and Contact Information Sheet)
A pharmacy or pharmaceutical company		 TERMINATE (Closing Script and Contact Information Sheet)
A manufacturer of medicines		 TERMINATE (Closing Script and Contact Information Sheet)
A managed care or health insurance company		 TERMINATE (Closing Script and Contact Information Sheet)
A healthcare practice		 TERMINATE (Closing Script and Contact Information Sheet)
A hospital emergency room		 TERMINATE (Closing Script and Contact Information Sheet)
None of the above		 CONTINUE
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

4. Have you ever worked for [INSERT OPTIONS 1-4 BELOW]? (Check all that apply.)

Department of Health and Human Services		 TERMINATE (Closing Script and Contact Information Sheet)
U.S. Food and Drug Administration		 TERMINATE (Closing Script and Contact Information Sheet)
RTI International		 TERMINATE (Closing Script and Contact Information Sheet)
Concentrics Research		 TERMINATE (Closing Script and Contact Information Sheet)
None of the above		 CONTINUE
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

5. Have you ever been trained or worked as a healthcare professional? [IF NEEDED: a health care professional (HCP) is defined as a trained person who deliver medical care to humans. Examples of HCP: nursing assistant, nurse, doctor, dentist, pharmacist, physician assistant. It is NOT a veterinarian, peer counselor, mental health counselor, or someone who is a caregiver for a family member or friend.]

Yes		 TERMINATE (Closing Script and Contact Information Sheet)
No		 CONTINUE
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

6. Have you been in any research study in the past 12 months?

Yes		 TERMINATE (Closing Script and Contact Information Sheet)
No		 CONTINUE
Don’t Know		 TERMINATE (Closing Script and Contact Information Sheet)
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

7. Do you normally wear corrective lenses, contacts, or glasses to read?

Yes		 CONTINUE
No		 CONTINUE
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

8. Do you have any other problems with your eyes that would prevent you from being able to read?

Yes		 TERMINATE (Closing Script and Contact Information Sheet)
No		 CONTINUE
Refused		 TERMINATE (Closing Script and Contact Information Sheet)

9. For study purposes, if you participate, the interview will be audio recorded. Are you okay with us audio recording the interview?

Yes		 CONTINUE
No		 TERMINATE (Closing Script and Contact Information Sheet)

10. How confident are you in filling out medical forms by yourself? Would you say…

Extremely		 CONTINUE
Quite a bit		 CONTINUE
Somewhat		 CONTINUE
A little bit		 CONTINUE
Not at all		 CONTINUE
Don’t know		 CONTINUE IF LOW LITERACY REQUIREMENT IS MET
Refused		 CONTINUE IF LOW LITERACY REQUIREMENT IS MET

LL Indicator = somewhat, a little bit, or not at all

11. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?

Never		 CONTINUE
Rarely		 CONTINUE
Sometimes		 CONTINUE
Often		 CONTINUE
Always		 CONTINUE
Don’t know		 CONTINUE
Refused		 CONTINUE

LL Indicator = often or always

12. What is the highest level of education you have completed? [DO NOT READ LIST – ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]

Less than high school graduate/GED		 CONTINUE
High school graduate or GED		 CONTINUE
Some college (no degree)		 CONTINUE
Postsecondary nondegree award (e.g., trade school diploma or certificate)		 CONTINUE
College (2 year) degree (Associate’s degree)		 CONTINUE
College (4-year) degree (Bachelor’s degree)		 CONTINUE
Master’s or doctoral/professional degree		 CONTINUE
Refused		 CONTINUE

13. Are you Hispanic or Latino?

Yes		 CONTINUE
No		 CONTINUE
Refused		 CONTINUE

14. What is your race? (Check all that apply) [READ LIST IF NECESSARY]

American Indian or Alaska Native		 CONTINUE
Asian		 CONTINUE
Black or African American		 CONTINUE
Native Hawaiian or other Pacific Islander		 CONTINUE
White		 CONTINUE
Refused		 CONTINUE
AIM FOR MIX

15. Was your total household income in 2017…?

Less than $20,000		 CONTINUE
$20,000 - $34,999		 CONTINUE
$35,000 - $49,999		 CONTINUE
$50,000 - $74,999		 CONTINUE
$75,000 - $99,999		 CONTINUE
$100,000 - $149,999		 CONTINUE
$150,000 or more		 CONTINUE
Don’t know		 CONTINUE
Refused		CONTINUE

16. What is your gender? [Do not read response categories]

Male		 GO TO Closing Script and Contact Information Sheet
Female		 CONTINUE

Note: Use the Closing Script and Contact Information sheet to schedule an interview.

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