Rapid Message Testing with Consumer Panel - Public Service Announcements About Safe Disposal of Opioids

Opioid “The Nephew” PSA (Spanish)

Cognitive Interview Guide

Introduction

Hello, my name is INTERVIEWER NAME. I work for Westat, a research company in Rockville, Maryland. Thank you for taking the time to be a part of this study.

Westat is working with the U.S. Food and Drug Administration, or FDA, to see what people think about a story they might make into a short video. The FDA is interested in getting opinions about the story we are about to show you.

They want to know that the story makes sense, is easy to understand, and that all people understand it the same way. If you agree to be interviewed, we will ask you about the item we sent you in the mail. After you look at the information, I will ask you some questions about your thoughts and feelings about the information. Any ideas you have are okay.

Do you have the package we mailed to you with you right now?

IF YES, CONTINUE

IF NO BUT PACKAGE IS NEARBY, ALLOW PARTICIPANT TIME TO GET IT

IF NO AND NOT NEARBY, CONTINUE USING ON-SCREEN VERSION OR ASK IF IT’S OKAY TO EMAIL THE DOCUMENT TO R

Color Key:

Purple – Section headings and titles

Black –Text for interviewer to read

Red – Interviewer instructions (not to be read aloud)

Green – Research questions (for interviewer’s information, not to be read aloud)

Informed Consent

Before we get started, there are a few things I need to tell you. This is a research project, and this interview is voluntary. That means that if you do not want to answer a specific question just tell me and I’ll go to the next one. It is okay if you want to stop after we start. Just let me know.

All of your answers and everything you say will be kept secure to the extent permitted by law. This means that we will not share your name or information. Also, we will not link any information to your answers to figure out who you are. The interview will take about 30 minutes and you will get $35 e-rewards for your time. We would like to record our conversation if you are okay with that. The recording helps us to make sure we hear everything you say correctly. Only the people who work on this research project will be able to listen to the recording and see our notes. Your name will not be linked to any of your responses, though we may include quotes that you provide in our reports. The recordings and our notes will be destroyed after we finish the project.

IF FDA STAFF ARE ON THE PHONE: I want you to know that some people from the FDA who work on this research project are listening to this interview to see if there are ways to make the story better.

Before we start, do you have any questions? Do you agree to be interviewed? Is it okay with you if I record the interview?

TURN ON RECORDER. The date and time is ____________. Now that I am recording, I want to ask again, is it okay if I record this interview?

Background Questions and Video Review

Before we talk about the story I mailed to you, I have a few questions.

Have you ever heard what you are supposed to do with unused prescription medications?

• IF YES, What have you heard? IF NEEDED: Should you keep unused prescription medications in case you need them in the future, throw them away, or do something else with them?

  • Where did you hear this? IF NEEDED: Radio, television, from your doctor directly, or from something you saw in your doctor’s office?

    • IF PRINT/MEDIA (NOT FROM DOCTOR): Can you recall who the message you heard (or saw) was from? IF NEEDED: Was it from a federal government agency, your state or local government, or someone else?

• IF NO, What do you think you are supposed to do with them? IF NEEDED: Should you keep unused prescription medications in case you need them in the future, throw them away, or do something else with them?

Do you think you have any leftover or unused prescription medications in your home?

• What, if anything, do you plan to do with them?

Have you heard about a type of pain reliever known as opioids?

• IF YES, What do you know about them? IF NEEDED, What are the benefits of opioids? What are the risks?

REVIEWING THE PSA

Now please open the package we sent you in the mail. Do you see the pages with a picture on top of two women having coffee? These pages show a series of pictures that tell a story. Please take a few minutes to read the story now. There are also a couple of envelopes in the package we sent you, but I’ll ask you to open those later. Keep in mind that the FDA may turn these pictures into a short video. When you are done, I have some questions for you about the story. CHECK IN AFTER 3 MINUTES. ALLOW 2-3 MORE MINUTES IF NEEDED.

CONCURRENT OBSERVATIONS/INSTRUCTIONS.

NOTE ANY OF THE FOLLOWING BEHAVIORS TO RECORD IN NOTES OR PROBE ON RETROSPECTIVELY:

• Any verbal reaction to images or messages in the PSA.

• Any verbal expressions of confusion, surprise, discomfort, offense. Note which images or messages evoked any of these reactions.

RETROSPECTIVE GENERAL PROBES

TO BE ADMINISTERED AFTER RESPONDENT COMPLETES HIS/HER REVIEW.

SHOW PSA SCENES ON SCREEN AS NEEDED TO AID DISCUSSION.

RESEARCH QUESTIONS

Does the PSA increase overall understanding of the importance of properly disposing of unused prescription medications?

Do the images and language in the PSA resonate with participants?

Do participants recognize the call to action of checking their homes for unused prescription medications?

Does the PSA provide useful information about how to properly dispose of unused prescription medications?

How well do specific phrases resonate with a Spanish speaking audience?

Thank you for reviewing the package. Now I’m going to ask you some questions about it.

First, just tell me your overall thoughts about the story.

What do you like about this story?

What don’t you like?

How easy or difficult is it to understand this story? Is there anything confusing or unclear?

OVERALL TONE AND BELIEVABILITY

How did this story make you feel? IF NEEDED, Concerned? Bored? Something else?

How would you describe the tone of this story? IF NEEDED, Scary? Informative? Something else?

Overall, did you find this story to be believable?

• IF YES, What about this story made it believable to you?

• IF NO, What parts were not believable?

This story takes place in a kitchen. Does the kitchen seem like a place where this type of conversation might take place?

• Would you suggest a different setting for this story? Why?

CONTENT

Now let’s talk about what this story has to say.

Who do you think this story is for? What about the story makes you say that?

• Do you feel like it’s for you? Why or why not?

In your own words, can you tell me what the story was?

What is the overall, main message that the story is trying to tell you?

• What, if anything, is it asking you to do?

• Is the most important information clear?

Do you think the characters in the story do a good job, an okay job, or a bad job of getting the main message across? What makes you say that?

Were there any words or phrases that confused you or that you weren’t sure of?

IMPACT

After seeing this story, what new information, if any, have you learned about opioids or the safe disposal of prescription pain medications?

• What did you think of the statement on page 5 that, “over 100 people die every day from opioid overdoses?” Is this statistic meaningful to you?

• Now I’d like you to open Envelope 1 that is in the package we sent you. The envelope includes a page from the story with a different statistic. Instead of it reading “over 100 Americans die every day from opioid overdoses,” this version reads, “44 Americans die every day from overdose of prescription pain medicines.” What do you think about the statistic of 44 Americans dying every day? EXPLAIN IF NEEDED, The statistic about 44 Americans dying is from overdose of prescription pain medicines alone, not including illegal opioids like heroin. The statistic about 100 Americans dying is from overdose of prescription and illegal opioids combined.

  • Which statistic do you think should be used in the story—over 100 Americans die every day from overdosing on opioids of all types, or 44 Americans die every day from overdose of prescription pain medications? Why?

Do you have any other questions about opioids or the safe disposal of prescription pain medications? IF YES, What are they?

If this story was made into a short video and you saw it on a TV in your doctor’s office or at the airport, or came across it online, what would you do? IF NEEDED, Watch it, ignore it, act on it, etc.

• What is it about the story that would make you do that?

How likely are you to visit the FDA website to learn how to properly dispose of unused prescription medications if you had them in your home? Please respond on a scale of 1 to 5 where 1 is not at all likely and 5 is extremely likely.

• What makes you say {PARTICIPANT’S SCALE NUMBER}?

• IF R SAYS 1-3, What, if anything, would encourage you to go to the website?

ASK IF IN BACKGROUND QUESTIONS R SAID THEY HAVE UNUSED PRESCRIPTION MEDICATIONS AT HOME:

Before reading this story, you said you may have unused prescription medications at home. You said you planned to {KEEP THEM, GET RID OF THEM, SOMETHING ELSE}. Now that you’ve read the story, what do you plan to do with them?

• IF STILL KEEP, It seems the story has not changed your mind about disposing of unused prescription medications. Why is that?

• IF CHANGE TO GET RID, What about the story made you change your mind?

VIDEO IMPROVEMENTS

Do you have any other suggestions for improving the story?

• Is there any information that is NOT needed or can be removed? IF YES, What information?

• Is there any information that could be added? IF YES, What information?

• Is there anything that could be stated more clearly? IF YES, What could be stated more clearly?

RELATED PHRASES

Now I’d like you to open Envelope 2 that is in the package we sent you. The envelope includes a page a few phrases on it.

• “eliminación de medicamentos no utilizados”

• “desecho de medicamentos”

• “lista de medicamentos recomendados para su eliminación en el inodoro”

• “deshacerse de medicamentos”

• Is there anything confusing or unclear about these phrases?

• How well do each of these phrases relate to the story?

• The last phrase, “deshacerse de medicamentos” might be used in the name of a website that has more information about this topic. Is this a good name for the website? Why?

PROBE ON ANY OUTSTANDING ISSUES FROM OBSERVATION (INFORMATION THAT R SEEMED CONFUSED ABOUT).

Closing and Incentive

IF OBSERVERS ARE PRESENT, CHECK TO SEE IF THEY HAVE FURTHER QUESTIONS.

Those are all the questions I have for you. Is there anything we haven't talked about that you would like to tell me?

DISCUSS ANY RESPONDENT COMMENTS.

Thank you for your time.

STOP TAPE RECORDER.

FDA RAPID: Year 1/Message 8
Opioid “The Nephew” PSA (Spanish) 9