CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response

16018 CONFER TASK 1

SUBJECT ID

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LABEL COMPREHENSION STUDY
GROUPS 1 - 3 SCREENER
COHORT INFORMATION
GROUP 1

PRESCRIPTION OPIOID USERS AND ASSOCIATES

1

GROUP 2

HEROIN USERS AND ASSOCIATES

2

GROUP 3

ADOLESCENT USERS AND ASSOCIATES

3

SUBGROUP INFORMATION
SUBGROUP A:

TARGETED LOW LITERACY (N=3)

A

SUBGROUP B:

NON-LOW LITERACY (N=6)

B

USER TYPE

PRESCRIPTION OPIOID/HEROIN USER OR IN-TREATMENT
(MINIMUM N=3)

1

USER TYPE

ASSOCIATE (MINIMUM N=3)

2

VISIT INFORMATION
INTERVIEW APPT (MM/DD)

INTERVIEW APPT TIME:

RECRUITMENT INFO
RECRUIT DATE:

RECRUITER INITIALS:

QUALIFIED (YES/NO)

IF NO, DQ NO.:

SUBJECT NAME:
SUBJECT TELEPHONE:
EMAIL ADDRESS:

BEST TIME:

16018 CONFER TASK 1

SUBJECT ID

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TELEPHONE RECRUITMENT SCRIPT [Participant calls recruitment phone number]
Thank you for calling about Project CONFER. My name is _______________. RTI International
and Concentrics Research are conducting a 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
conducting an independent review of new medicines to make sure they work and are safe before
they are approved and can be prescribed by health care providers and used by patients. We are
looking for people to take part in a research study to evaluate the labeling for a healthcare
product that may be available over-the-counter, or without a prescription. We are not selling or
promoting any product.
The study involves participating in a one-time in-person interview lasting no more than 45
minutes and answering some questions about instructions for the product. As a thank you for
your time, you will be given $60.
To see if you are eligible for this study, I need to ask you a few questions that will take a few
minutes of your time. All of your responses will be kept private. May I proceed with my
questions?

1. How old were you on your last birthday?

Age 15 – 17  CONTINUE
_____

Age 18+  CONTINUE
Under Age 15 TERMINATE

QUESTIONS TO ASSESS OPIOID/HEROIN USE
2. During the past 90 days, have you used any prescription opioid? An opioid is a
prescription pain medication such as vicodin, oxycontin, opana, dilaudid, percocet,
oxycodone, or morphine?
Yes

 CONTINUE

No

 GO TO Q5

16018 CONFER TASK 1

SUBJECT ID

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3. During the past 30 days, have you used any prescription opioid? [IF NEEDED: An opioid
is a prescription pain medication such as vicodin, oxycontin, opana, dilaudid, percocet,
oxycodone, or morphine]
Yes

 CONTINUE

No

 GO TO Q5

Don’t Know

 GO TO 3a

[Note: If respondents answers “don’t know” determine if it is because he/she doesn’t know if the
medication is an opioid or if he/she doesn’t know whether it was used in the past 30 days.]
a. What is the name of the medication you are taking?
Codeine (Fioricet w/ codeine, Fiorinal
w/ codeine, Tylenol w/ codeine)

 CONTINUE

Fentanyl transdermal (Abstral, Actiq,
Duragesic, Fentora, Ionsys, Lazanda,
Sublimaze, Subsys)

 CONTINUE

Hydrocodone (Anexsia, Hysingla ER,
Lortab, Norco, Reprexain, Vicodin,
Vicoprofen, Zohydro ER)

 CONTINUE

Hydromorphone (Dilaudid, DilaudidHP, Exalgo)
Methadone (Dolophine, Methadose)

 CONTINUE

Morphine (Astramorph PF,
Duramorph PF, Embeda, Infumorph,
Kadian, Morphabond, MS Contin)

 CONTINUE

Oxycodone (Oxaydo, Oxycet,
Oxycontin, Percocet, Percodan,
Roxicet, Roxicodone, Xartemis XR)

 CONTINUE

Oxymorphone (Opana, Opana ER)

 CONTINUE

 CONTINUE

16018 CONFER TASK 1

SUBJECT ID

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NOTE: IF DRUG MENTIONED IS NOT ON THE LIST YOU CAN LOOK IT UP AT:
http://www.rxlist.com/script/main/hp.asp.
IF OPIOID CONTINUE; OTHERWISE GO TO Q5
4. During the past 30 days, on how many days did you use a prescription opioid? [IF
NEEDED: An opioid is a prescription pain medication such as vicodin, oxycontin, opana,
dilaudid, percocet, oxycodone, or morphine]
_______ Days  CONTINUE

5. During the past 30 days, have you used heroin?
Yes

 CONTINUE

No/Don’t Know

 GO TO Q7

6. During the past 30 days, on how many days did you use heroin?
_______ Days  CONTINUE

QUESTIONS TO ASSESS WHETHER OR NOT IN TREATMENT
7. Are you currently in treatment for prescription opioid or heroin use? This could be an
outpatient therapy group or medication assisted treatment such as methadone or
suboxone. [IF NEEDED: A prescription opioid is a pain medication such as vicodin,
oxycontin, opana, dilaudid, percocet, oxycodone, or morphine]
Yes

 GO TO Q10

No

 IF YES TO PRESCRIPTION OPIOID USE (Q3) OR HEROIN USE (Q5),
GO TO Q10
 IF NO PRESCRIPTION OPIOID USE (Q3) OR HEROIN USE (Q5),
CONTINUE

16018 CONFER TASK 1

SUBJECT ID

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QUESTIONS TO IDENTIFY FAMILY/FRIENDS
8. Do you have a family member or friend who took prescription opioids during the past
30 days? An opioid is a prescription pain medication such as vicodin, oxycontin, opana,
dilaudid, percocet, oxycodone, or morphine.
Yes

 CONTINUE

No

 CONTINUE

Not sure

 CONTINUE

9. Do you have a family member or friend who took heroin during the past 30 days?
Yes
 CONTINUE
No

 CONTINUE IF YES TO Q8 [friend/family in
treatment for prescription opioid use], OTHERWISE
TERMINATE

Not sure

 CONTINUE IF YES TO Q8 [friend/family in
treatment for prescription opioid use], OTHERWISE
TERMINATE

QUESTIONS TO ASSESS LOW LITERACY
[NOTE: DO NOT ASK THIS QUESTION IF RESPONDENT IS UNDER 18. GO TO Q11.]
10. How confident are you in filling out medical forms by yourself?
Extremely

 CONTINUE

Quite a bit

 CONTINUE

Somewhat

 CONTINUE

A little bit

 CONTINUE

Not at all

 CONTINUE

Not asked (Under 18
years old)

 GO TO Q11

16018 CONFER TASK 1

SUBJECT ID

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At least 30% (n=3) of the sample should answer “somewhat”,
“a little bit” or “not at all”.

OTHER
11. Can you read, speak and understand English?
Yes

 CONTINUE

No

 TERMINATE

12. Are you, or is anyone in your household, currently employed by any of the following?
A marketing or research company

 TERMINATE

An advertising agency or public relations firm

 TERMINATE

A pharmacy or pharmaceutical company

 TERMINATE

A manufacturer of medicines

 TERMINATE

A managed care or health insurance company

 TERMINATE

A healthcare practice

 TERMINATE

None of the above

 CONTINUE

13. Have you ever worked for…? [Read the options below]
Department of
Health and Human
Services

 TERMINATE

U.S. Food and Drug
Administration

 TERMINATE

RTI International

 TERMINATE

Concentrics
Research

 TERMINATE

None of the above

 CONTINUE

16018 CONFER TASK 1

SUBJECT ID

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14. Have you ever been trained or worked as a healthcare professional?
Yes

 TERMINATE

No

 CONTINUE

15. Have you participated in any market research study, product label study, or clinical
trial in the past 12 months?
Yes

 TERMINATE

No

 CONTINUE

Don’t know

 TERMINATE

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

 CONTINUE

No

 CONTINUE

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

 TERMINATE

No

 CONTINUE

DEMOGRAPHIC QUESTIONS
18. What is the highest level of education you have completed?
________________________Degree

16018 CONFER TASK 1

SUBJECT ID

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[DO NOT READ LIST – ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]
Less than high school

 CONTINUE

High school graduate (HS diploma or GED)

 CONTINUE

Some college (no degree)

 CONTINUE

College (2-year) degree (Associate degree)

 CONTINUE

College (4-year) degree (e.g., BA, BS, AB)

 CONTINUE

Some post-college

 CONTINUE

Advanced or post-graduate degree (e.g.,

 CONTINUE

Masters, MD, PhD)

19. Please answer the next two questions about your ethnicity and race.
Are you Hispanic or Latino?
Yes

 CONTINUE

No

 CONTINUE

20. What is your race? (Please select one or more from the following):
[READ LIST IF NECESSARY– ASSIGN RESPONSE TO ONE OR MORE GROUPS BELOW]
American Indian / Alaska Native

 CONTINUE

Asian

 CONTINUE

Black or African American

 CONTINUE

Native Hawaiian / other Pacific Islander

 CONTINUE

White

 CONTINUE

Some other race

DOCUMENT:
SCREEN FOR MIX

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

Male

16018 CONFER TASK 1

SUBJECT ID

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Female
Other
SCREEN FOR MIX OF MALE/FEMALE
SCREENER: COMPLETE TABLE ON LAST PAGE TO DETERMINE GROUP ASSIGNMENT.
IF INELIGIBLE  Closing for Ineligible Participants: Thank you for answering our questions. At
this time you are not eligible to be in this study. However, we appreciate your time and
willingness to help us. We will not keep any of the information that you provided during our
call. Goodbye.

IF ELIGIBLE  CONTINUE to Invitation Script…

Invitation for Eligible Participants: Thank you for answering all of my questions. We would like
to invite you to take part in the study for a one-time, individual in-person interview. The
interview will take place at the SouthLight Healthcare offices located at [ADDRESS].
The discussion will last up to 45 minutes. No one will attempt to sell you anything, and no one
will call you for other studies as a result of your participation in this study. You may be audio
recorded during the course of the study. Transcripts and audio files with all personally
identifiable information removed will be provided to the FDA after the completion of the
interviews. RTI, Concentrics, and FDA will maintain the tapes and transcripts securely until they
are destroyed at the end of the study. Any forms related to the project that have your name on
them will be kept in a locked file cabinet or on a password-protected computer. In appreciation
for your time and effort, you will receive $60 after completion of the interview. This is an
important research effort and we hope that you will be part of it.
Are you interested in participating in this study?
Yes  CONTINUE
[SCHEDULE INTERVIEW and COLLECT CONTACT INFORMATION]
No  [Thank respondent and end call]
I’m glad that you will be able to join us. We currently have interview slots available on [Day],
[Date], at [Time]. Would any of those times be convenient for you?

Yes  Document agreed upon date/time: ____________________________________

16018 CONFER TASK 1

SUBJECT ID

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Thank you for your willingness to participate in this study. I would like to collect some minimal
contact information for our reminder call and email.
Contact Information
First Name: _________________________
Phone number (for reminder call): ______________Best time: _______________
Email address (for reminder email):_______________________
You will receive a reminder call and email the day before your appointment. We have you
scheduled on [Day], [Date], at [Time]. The interview will be held at [Address].
I also want to give you some information about the interview day:
• If you said that you needed glasses or contacts to read, please remember to bring them
with you for your appointment.
• Because of the nature of the study, we will not be able to accommodate unattended
small children during your visit. If you need to bring small children to the interview, you
will need to bring another adult to supervise the child while you are in the interview.
• If you need to reschedule your appointment, please call the number you just called
[PHONE NUMBER] to let us know.
Do you have any questions about the study?
Thank you. Goodbye.

REMINDER CALL
Hello this is [NAME] calling regarding an in-person interview you recently agreed to participate
in that is being conducted by RTI International and Concentrics Research for U.S. Food and
Drug Administration (FDA).
I’m calling to remind you that you are scheduled for an interview on [Day], [Date], at [Time].
The interview will be held at [Address].
I also wanted to remind you that if need glasses or contacts to read, please remember to bring
them with you for your appointment. Because of the nature of the study, we will not be able to
accommodate unattended small children during your visit. If you need to bring small children to
the interview, you will need to bring another adult to supervise the child while you are in the
interview.

16018 CONFER TASK 1

SUBJECT ID

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Do you have any questions or concerns that I can address about the study?
If you need to be in touch with us before your interview, you can call [PHONE NUMBER].
Thank you. We appreciate your participation in this study.
REMINDER EMAIL
Dear [NAME]
Thank you for agreeing to participate in the research study to evaluate the labeling for a
healthcare product that will be available over-the-counter, or without a prescription. This study
is being conduct by RTI International and Concentrics Research for U.S. Food and Drug
Administration (FDA).
You are scheduled for an interview on [Day], [Date], at [Time]. The interview will be held at
[Address].
Please remember that if need glasses or contacts to read, you should bring them with you for
your appointment. Because of the nature of the study, we will not be able to accommodate
unattended small children during your visit. If you need to bring small children to the interview,
you will need to bring another adult to supervise the child while you are in the interview.
If you have any further questions, please let me know. If you need to be in touch with us before
your interview, you can call [PHONE NUMBER].
Thank you,
[NAME]

16018 CONFER TASK 1

SUBJECT ID

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GROUP ASSIGNMENT
Assign respondent to a group based on responses to the questions. If the person qualifies for
both Group 1 and Group 2 (e.g., uses opioids and heroin), assign them to a group based on
whichever currently has fewer people.

GROUP

Group 1: Prescription Opioid User or Associate
User
• Q1 – age 18+ AND
• Q3 – Yes [used opioids in past 30 days]

In treatment
•
•
•

Q1 – age 18+ AND
Q3 – Yes [used opioids in past 30 days] AND
Q7 – Yes [in treatment for opioid or heroin use]

Associate
•
•

Q1 – age 18+ AND
Q8 – Yes [family/friend used opioids in past 30 days]

Group 2: Heroin User or Associate
User
• Q1 – age 18+ AND
• Q5 – Yes [used heroin in past 30 days]

In treatment
•
•
•

Q1 – age 18+ AND
Q5 – Yes [used heroin in past 30 days] AND
Q7 – Yes [in treatment for opioid or heroin use]

Associate
•

Q1 – age 18+ AND

• Q9 – Yes [family/friend used heroin in past 30 days]
Group 3: Adolescent or Associate
User
• Q1 – age 15-17 AND
• Q3 – Yes OR Q5 – Yes [used opioids or heroin in past 30 days]

In treatment
•
•

Q1 – age 15-17 AND
Q3 – Yes OR Q5 – Yes [used prescription opioids or heroin in past 30 days]

YES/NO

16018 CONFER TASK 1
•

SUBJECT ID

Q7 – Yes [in treatment for opioid or heroin use]

Associate
•
•

Q1 – age 15-17 AND
Q8 – Yes OR Q9 [family/friend used [prescription opioids or heroin in past 30 days]

-