Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adolescents)

Data to Support Drug Product Communications

Attachment C3 Structured Interview Guide

Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adolescents)

OMB: 0910-0695

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According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.  The valid OMB control number for this information collection is 0910-0695 and the expiration date is 2/28/2021.  The time required to complete this information collection is estimated to average 30 minutes per response, including the time for reviewing instructions, and completing and reviewing the collection of information.



ATTACHMENT C3


LABEL COMPREHENSION STUDY

TASK 3: GROUP 3 (ADOLESCENT ALL-COMERS) – STRUCTURED INTERVIEW GUIDE



GROUP NUMBER: _____

PARTICIPANT ID: _____

INTERVIEWER INITIALS: _____

INTERVIEW DATE/TIME: _______



Group 3 Screening Questions (Note: for age, grade, grades in school, ethnicity, race, gender, the interviewer enters data from the participant grid provided by the recruitment firm) The interviewer’s tablet will have entries for each of these screening questions with answer categories that the interviewer will select from- e.g. for “Ethnicity—Hispanic” the interviewer will select “yes” or “no”. For literacy level, this data will be entered not from the participant grid, but from the REALM-Teen test that will be administered immediately after administration of the assent form.



  • Age

  • Grade

  • Grades in school

  • Ethnicity—Hispanic: Yes/No

  • Race

  • Gender

  • Literacy Level: NL/LL









INFORMED ASSENT


INTERVIEWER TO BRING PARTICIPANT TO ROOM.


VERIFY THAT THE PARTICIPANT STILL AGREES TO BE AUDIO RECORDED. [IF THEY OBJECT, DISMISS AND DO NOT PROVIDE REIMBURSEMENT.]


PARTICIPANTS MUST SIGN ASSENT FORM AT THE TIME OF THEIR INTERVIEW IN FRONT OF THE INTERVIEWER.


Before we get started I’m going to give you an assent form that describes the research study and what you’ll be asked to do in more detail. I’m going to give you two copies—one for you to sign for us and one for you to take home. Please take a few minutes to read the form. Once you are finished reading, we will talk through any questions you might have. Please do not sign anything until yet.


HAND THE PARTICIPANT THE ASSENT FORM AND ASK THEM TO LET YOU KNOW WHEN THEY ARE DONE READING IT.

ONCE THE PARTICIPANT IS FINISHED, REVIEW EACH SECTION OF THE ASSENT FORM WITH THE PARTICIPANT AND EMPHASIZE THAT THEY SHOULD NOT REVEAL PII DURING THE INTERVIEW.

THEN ASK THE FOLLOWING:

A. Do you have any questions about the assent form that you just read?

DISCUSS QUESTIONS

YES

1

CONTINUE

NO

2


B. Do you wish to participate in the study?

CONTINUE

YES

1

THANK AND TERMINATE

NO

2


ONCE ALL QUESTIONS ARE ADDRESSED AND PARTICIPANT AGREES TO PARTICIPATE, ASK PARTICIPANT TO SIGN THEIR NAME, AND DATE THE LAST PAGE.


THE INTERVIEWER IS TO…

  1. SIGN AND DATE THE LAST PAGE AS A WITNESS.

  2. GIVE THE PARTICIPANT A COPY OF THE ASSENT FORM FOR THEIR RECORDS.


REALM TEST

ADMINISTER REALM TEST AND PLACE SCORE IN THE BLANK BELOW.

Hello, my name is [NAME] and I’m going to be conducting today’s interview.

First, I would like to show you a word list of medical-related terms. These words are sometimes found on packages of medicines.

Please look at this list of words, beginning here [POINT TO FIRST WORD]. Say all of the words you know. If you come to a word you don’t know, you can sound it out or just skip it and go on.


ENTER REALM-TEEN SCORE:


RECORD LITERACY SUBGROUP ON PAGE 1











INTRODUCTION


Once again, thank you for agreeing to participate in our study today. Your opinions are very important and we appreciate your time.


Today I will be showing you a label for a medicine that is currently available only by prescription, but may become available over-the-counter without a prescription. I would like for you to read the entire label and then I will ask you to answer some questions about what you have just read. We want to make sure that the label is clear and understandable even if this is something that you may or may not personally use.


Please read the label and take as much time as you need. When you are through, we will begin with the questions. During my questions, you will be able to refer back to the label as often as you like. I’m going to step out of the room now - please come to the door and let me know when you are finished.


HAND THE PARTICIPANT THE LABEL (Interviewer to alternate labels for each interview).


LEAVE INTERVIEWING AREA AND WAIT FOR THE PARTICIPANT TO LET YOU KNOW WHEN THEY HAVE FINISHED WITH THE LABEL.


RETURN TO THE INTERVIEWING AREA.


IF PARTICIPANT ASKS ANY QUESTIONS, RESPOND WITH: To make sure that each person is interviewed the same, I cannot give you any information other than what is on my script. Please keep in mind that I am testing the label and I am not testing you.









Part 1: cognitive walkthrough


Now, I would like for you to answer some questions about what you have just read. My questions will be about what you have read on the label, not your personal experience or thoughts on what you would do. We are testing the words on the label.


I want to stress that I am testing the label and not testing you.


  1. Imagine you were in a situation where you had to use this product on a friend. Talk out loud and explain to me what you would do based on the label.”


INTERVIEWER: DOCUMENT RESPONSES, SEQUENCE, AREAS OF STATED/APPARENT CONFUSION ON OBSERVER’S CHECKLIST







TASKS

ORDER

ADDITIONAL COMMENTS

Steps 1-5

(Radio Buttons to select)

(Drop-down #s)

Additional Participant Comments

Cognitive Walkthrough

Mentioned

Order

Step 1: CHECK




Check



Yell “Wake up”


Shake the person gently


Try to wake the person up


If person is not awake, go to step 2


Other (Specify):


Step 2: GIVE 1st dose




Give 1st dose



Give the medicine


Other (Specify):


Step 3: CALL




Call 911 immediately after giving the 1st dose



Call 911


Other (Specify):


Step 4: WATCH & GIVE




Wait 2-3 minutes after 1st dose



If the person wakes up, go to Step 5



If person does not wake up – continue to give doses every

2-3 minutes


It is safe to keep giving doses


Other (Specify):


Step 5: STAY




Stay until ambulance arrives



Stay with the person


Give another dose if person gets sleepy again


Other (Specify):


Comments




Note: Calling 911 must be mentioned within steps 1-3 to be considered “correct” or within steps 1-5 to be “acceptable”.


Part 2: Label Comprehension


Once again, I would like for you to answer some questions about what you read on the label. My questions will be about what you have read on the label, not your personal experience or thoughts on what you would do. We are testing the words on the label.


I want to stress that I am testing the label and not testing you.


Here is a booklet of the questions I am going to ask so you can follow along as I read them aloud. Please do not skip ahead, but wait for me to tell you when to go to the next page. Keep in mind this is not a memory test, so you can refer back to the label as often as you would like during the interview.


HAND PARTICIPANT THE BOOKLET OF SHOWCARDS.


FOR ALL QUESTIONS: INTERVIEWER SELECT THE RESPONSE THAT CORRESPONDS TO THE PARTICIPANT’S ANSWER TO EACH QUESTION UNLESS OTHERWISE SPECIFIED.

Please turn to Card A. READ CARD ALOUD TO THE PARTICIPANT.



1a) According to the label, what is this product used for?



DO NOT READ LIST. MULTIPLE RESPONSES ALLOWED.


Correct

Emergency treatment OF OPIOID OVERDOSE

1

Correct

emergency treatmEnt of overdose

2

Correct

to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin

3

Correct

Opioid overdose

4

Correct

heroin overdose

5

Correct

Overdose of prescription pain medications

6

Acceptable

drug overdose

7

Acceptable

overdose

8

Incorrect

Don’t Know

9


Other (Specify)

10








1b) Why do you say that?





1c) Can you tell me more about that?










Please turn to Card B. READ CARD ALOUD TO THE PARTICIPANT.



2a) According to the label, if you suspect an overdose, what will the person look like or be doing?



DO NOT READ LIST.


Correct

Will not wake up, is very sleepy or not breathing well

1

Correct

Will not wake up

2

Correct

Very Sleepy

3

Acceptable

Not breathing well (e.g. breathing slowly, shallow, etc.)

4

Correct

Can’t arouse the person (or other similar responses)

5

Incorrect

Don’t know

6

Incorrect

nothing

7


Other (Specify)

8













2b) Why do you say that?







The next few questions describe possible situations or scenarios that could occur to someone in real life. Also, please assume that each question has all the information you need in order to make a decision. Please do not try to guess the answers to the questions – either refer back to the labeling for this product or simply say you don’t know.

Please turn to Card C. READ CARD ALOUD TO THE PARTICIPANT.


IF PARTICIPANT DID NOT MENTION “CALL 911” DURING COGNITIVE WALKTHROUGH, READ:


  • Dre’s cousin is overdosing on a prescription pain medicine.

  • Dre just gave him a second dose of this medicine [POINT TO DFL] and he still is not waking up.


OR


IF PARTICIPANT MENTIONED “CALL 911” DURING COGNITIVE WALKTHROUGH, READ:


  • Dre’s cousin is overdosing on a prescription pain medicine.

  • Dre called 911 and just gave him a second dose of this medicine (POINT TO DFL).

  • He still is not waking up.


3a) What, if anything, does the label say Dre should do now?



ROTATE ORDER OF THIS QUESTION AND Q.5A/B.


DO NOT READ LIST.


Correct

give another dose every 2-3 miNutes until the person wakes up

1

Correct

Continue to give doses until the person wakes up

2

Acceptable

Give another dose

3

Acceptable

Call 911

4

Incorrect

stay with the person until the ambulance arrives

5

Incorrect

Don’t know

6

Incorrect

nothing

7


Other (Specify)

8












3b) Why do you say that?






Please turn to Card D. READ CARD ALOUD TO THE PARTICIPANT.




  • Rodney’s friend is overdosing on a prescription pain medicine.

  • Rodney gave his friend a dose of this medicine [POINT TO DFL], and his friend woke up but is sweating and feeling angry.


4a) What, if anything, does the label say about this?




DO NOT READ LIST.


Correct

Some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry

1

Correct

Some People may experience Symptoms when they wake up

2

Correct

  • Responses similar to: The drug is making them feel this way and it says so on the labeL OR

  • THIS IS TO BE EXPECTED OR

  • It sounds like it is a normal reaction – it says so on the label OR

  • It’s a reaction to the drug that is stated on the label

3

Acceptable

i took away their high, of course they’re going to be mad

4

Incorrect

Don’t know

5

Incorrect

nothing

6


Other (Specify)

7












4b) Why do you say that?





Please turn to Card E. READ CARD ALOUD TO THE PARTICIPANT.



IF PARTICIPANT DID NOT MENTION “CALL 911” DURING COGNITIVE WALKTHROUGH, READ:


  • Macy’s friend is overdosing on heroin

  • Macy gave her friend 2 doses of this medicine (POINT TO DFL), and he is starting to wake-up.


OR


IF PARTICIPANT MENTIONED “CALL 911” DURING COGNITIVE WALKTHROUGH, READ:


  • Macy’s friend is overdosing on heroin

  • Macy called 911 and gave her friend 2 doses of this medicine (POINT TO DFL).

  • He is now starting to wake-up.


5a) What, if anything, does the label say Macy should do now?



ROTATE ORDER OF THIS QUESTION AND Q.3A/B.


DO NOT READ LIST.


Correct

Stay with the person until the ambulance arrives

1

Acceptable

Stay with the person

2

Incorrect

Don’t know

3

Incorrect

nothing

4


Other (Specify)

5













5b) Why do you say that?






Please turn to Card F. READ CARD ALOUD TO THE PARTICIPANT.





6a) According to the label, is it safe to keep giving doses of this medicine?




DO NOT READ LIST.


Correct

Yes

1

Incorrect

No

2

Incorrect

Don’t know

3


Other (Specify)

4













6b) Why do you say that?







Please turn to Card G. READ CARD ALOUD TO THE PARTICIPANT.



  • Tiana’s friend is overdosing on heroin.

  • Tiana gave her friend one dose of this medicine and called 911.

  • Her friend woke up, but is now very sleepy again.


7a) What, if anything, does the label say Tiana should do now?




DO NOT READ LIST.


Correct

Give another dose if the person becomes very sleepy again

1

Correct

give another dose

2

Incorrect

Don’t know

3

Incorrect

nothing

4


Other (Specify)

5













7b) Why do you say that?










8a) What do you think the word “opioid” means?




DO NOT READ LIST.


Correct

prescription pain medications or street drugs such as heroin

1

Acceptable

prescription pain medications

2

Acceptable

street drugs such as heroin

3

Acceptable

heroin

4

Incorrect

OPIUM

5

Incorrect

Don’t know

6

Incorrect

nothing

7


Other (Specify)

8




























  1. Overall, would you say you had any trouble finding information on the label or following what to do or any confusion with the words or pictures?


     Identification issue (locating information)  

Navigation Issues (flow of words/concepts)





Confusion with words

Confusion with pictures





None of the above

Other







  1. Had you heard of naloxone before today?


Yes

1


No

2


Don’t know

3


  1. Have you or someone you know ever used naloxone on someone?


Yes

1


No

2


Don’t know

3




Those are all of my questions. Thank you so much for your time.
































TO THE BEST OF MY ABILITY AND KNOWLEDGE, THE INFORMATION ENTERED INTO THE SURVEY IS COMPLETE AND CORRECT, AND THE SURVEY WAS CONDUCTED ACCORDING TO THE METHODOLOGY I WAS INSTRUCTED TO FOLLOW, ACCORDING TO THE STUDY PROTOCOL.

INTERVIEWER print name:


INTERVIEWER sign name:



ADULT REALM WORD LIST


CONFER – Task 3

#16020




Showcards







Card A



According to the label, what is this product used for?












Card B




According to the label, if you suspect an overdose, what will the person look like or be doing?




Card C-1



  • Dre’s cousin is overdosing on a prescription pain medication.

  • Dre just gave him a second dose of this medicine and he still is not waking up.



What, if anything, does the label say Dre should do now?





Card C-2



  • Dre’s cousin is overdosing on a prescription pain medication.

  • Dre called 911 and just gave him a second dose of this medicine.

  • He still is not waking up.



What, if anything, does the label say Dre should do now?






Card D



  • Rodney’s friend is overdosing on a prescription pain medication.

  • Rodney gave his friend a dose of this medicine, and his friend woke up but is sweating and feeling angry.



What, if anything, does the label say about this?





Card E-1



  • Macy’s friend is overdosing on heroin.

  • Macy gave her friend 2 doses of this medicine, and he is starting to wake-up.



What, if anything, does the label say Macy should do now?





Card E-2



  • Macy’s friend is overdosing on heroin.

  • Macy called 911 and gave her friend 2 doses of this medicine.

  • He is starting to wake-up.



What, if anything, does the label say Macy should do now?




Card F





According to the label, is it safe to keep giving doses of this medicine?








Card G



  • Tiana’s friend is overdosing on heroin.

  • Tiana gave her friend one dose of this medicine and called 911.

  • Her friend woke up, but is now very sleepy again.



What, if anything, does the label say Tiana should do now?




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