Rapid Message Testing with Consumer Panel - Storyboards About Safe Disposal of Opioids and Other Medicines

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What It Spells Moderator's Guide - English

Rapid Message Testing with Consumer Panel - Storyboards About Safe Disposal of Opioids and Other Medicines

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What It Spells” Videos (English)

Cognitive Interview Guide

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)

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 couple stories that could be turned into a television ad or an online video. The FDA is interested in getting opinions about the stories.


You should have gotten [a packet in the mail/ an email] for this study. Do you have the [packet we mailed to you with you/email we sent you available] right now?


IF YES, CONTINUE

IF NO BUT PACKET/EMAIL IS NEARBY/ACCESSIBLE, 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 RESPONDENTS


Please wait to open the [packet/attachments] until I tell you it is time to start. After you look at the [material inside the packet/attachments], I will ask you some questions about your thoughts and feelings about the information. Any ideas you have are okay.



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 45 minutes and you will get $50 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 also want you to know that a couple other people from the FDA who work on this research project are listening to this interview to take notes as we talk.

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 Storyboard Review

To start, I have a few questions.

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

  • IF YES, What have you heard? IF NEEDED: Should you keep unused prescription medicines 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, online, 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, a non-profit organization, or someone else?

  • IF NO, What do you think you are supposed to do with them? IF NEEDED: Should you keep unused prescription medicines 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 medicines 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?


Randomly assign half of the participants to view ‘Story P’ (the 2-minute storyboard) first, and half to view ‘Story L’ (the 1-minute storyboard) first.


REVIEWING THE FIRST STORYBOARD

Now please open the [packet we sent you in the mail, and open the envelope/email we sent you and open the attachment] labeled [‘Story P’ OR ‘Story L’]. Do you see the pages with [‘Story P’ OR ‘Story L’] at the top? Please take a few minutes to read the story and look over the pictures now. There is another [envelope in the packet/attachment in the email] we sent you, but I’ll ask you to open that later. Keep in mind that the FDA may turn this story into an animated 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 public service announcement (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

Do the PSAs increase participants’ overall understanding of how to properly dispose of unused prescription medicines? Of opioids, specifically?

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

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

Do the PSAs convince participants that it is unsafe to keep unused or expired medicines?

GENERAL IMPRESSIONS

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?


CONTENT

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


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


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

  • What is it asking you to do?

  • IF NEEDED FOR STORY P, What is the best way to dispose of unused prescription medicines?

  • IF NEEDED FOR STORY L, What is the best way to dispose of unused prescription opioid pain medicines?

  • IF NEEDED, If you did not have a take-back location near you, what would you do?


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?


Do you think the pictures 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 pages where you weren’t sure what the pictures were showing? IF NEEDED, Would you suggest using any different pictures than what was used in the story?


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


OVERALL TONE

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?


IMPACT

IF STORY L, 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?


IF STORY P, After seeing this story, what new information have you learned about the safe disposal of prescription medicines?

  • IF NEEDED FOR STORY P, What do you think of the words ‘Risk,’ ‘Danger,’ and ‘Theft?’ Are these words meaningful to you?

IF STORY L, After seeing this story, what new information have you learned about the safe disposal of prescription opioid pain medicines?

  • IF NEEDED FOR STORY L, What do you think of the words ‘Risk,’ ‘Addiction,’ and ‘Overdose?’ Are these words meaningful to you?


What did you learn about FDA’s Flush List? IF NEEDED How do you think medicines on the Flush List differ from medicines not on the Flush List?


How likely are you to visit the FDA website mentioned in this story? 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 RESPONDENT SAYS 1-3, What would encourage you to go to the FDA website?

  • What information about drug disposal would you expect to find on the FDA website?

IF STORY P, How likely are you to visit the DEA website mentioned in this story? 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 RESPONDENT SAYS 1-3, What would encourage you to go to the DEA website?

  • What information about unused prescription medicines would you expect to find on the DEA website?

ASK IF IN BACKGROUND QUESTIONS RESPONDENTS SAID THEY HAVE UNUSED PRESCRIPTION MEDICINES AT HOME:

Before reading this story, you said you may have unused prescription medicines 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 medicines. Why is that?

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


SUGGESTED IMPROVEMENTS

Do you have any other suggestions for improving the story?

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

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

  • Is there any other information that could be stated more clearly? IF YES, What could be stated more clearly?


REVIEWING THE SECOND STORYBOARD

Now please open [the envelope in your packet/the attachment labeled [‘Story P’ OR ‘Story L’]]. Do you see the pages with [‘Story P’ OR ‘Story L’] at the top? Please take a few minutes to read the story and look over the pictures now. Some of what you see is the same as the last story while some of it is different. When you are done, I have some more questions for you. 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.


GENERAL IMPRESSIONS

Did you like this story any more or less than the first one? Why is that?


Was this story any easier or more difficult to understand than the first story? What makes you say that?

  • Is there anything confusing or unclear about this second story?


CONTENT

Again, let’s talk about what this second story has to say.


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

  • What is it asking you to do?


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?


Were there any pages where you weren’t sure what the pictures were showing?


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


OVERALL TONE

Did you feel differently about this story than the first story? How did this story make you feel? IF NEEDED, Concerned? Bored? Something else?


Was the tone of this story any different compared to the first story? How would you describe the tone of this story? IF NEEDED, Scary? Informative? Something else?

IF STORY L, 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?


What new information have you learned from this story that wasn’t in the first story?

  • IF NEEDED FOR STORY P, What do you think of the words ‘Risk,’ ‘Danger,’ and ‘Theft?’ Are these words meaningful to you?

  • IF NEEDED FOR STORY L, What do you think of the words ‘Risk,’ ‘Addiction,’ and ‘Overdose?’ Are these words meaningful to you?


After reading the first story, you said you were a {STORY 1 SCALE NUMBER} on a scale of 1 to 5 where 1 is not at all likely and 5 is extremely likely to visit the FDA website. Where on that scale are you after reading this story?

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

  • IF RESPONDENT SAYS 1-3, What would encourage you to go to the FDA website?

IF STORY P, How likely are you to visit the DEA website mentioned in this story? 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 RESPONDENT SAYS 1-3, What would encourage you to go to the DEA website?

  • What information about unused prescription medicines would you expect to find on the DEA website?

SUGGESTED IMPROVEMENTS

Do you have any other suggestions for improving the second story?

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

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

  • Is there any other information that could be stated more clearly? IF YES, What could be stated more clearly?


PROBE ON ANY OUTSTANDING ISSUES FROM OBSERVATION (INFORMATION THAT RESPONDENT 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: Message 20
“What It Spells” Videos (English)
11



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