Rapid Message Testing with Consumer Panel - Safe Drug Disposal Notecard

OMB Control No. 0910-0695

Expiration date: 2/28/2021

Safe Drug Disposal

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 information related to prescription medications. The FDA is interested in getting opinions about the information I am about to discuss with you. You should have gotten a package in the mail for this study.

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

IF YES, CONTINUE

IF NO BUT FORM 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

Please wait to open the packet until I tell you it is time to start. After you look at the material inside, 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 30 minutes and you will receive $35 as a token of appreciation. We would like to record this conversation if you are okay with that. The recording helps us 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 Information Review

Before we talk about the information 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?

[IF CAREGIVER] You told us when you volunteered for this interview that you help manage medications for another adult. Do you think this person has any leftover or unused prescription medications in your home or his/her home?

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

Now please open the envelop we sent you in the mail. Do you see a piece of paper that says “3 Options for Safe Drug Disposal”? This content is for a notecard that you might find at a community health fair, and it might also be posted to the FDA website. Please take a few minutes to look at it now. When you are done, I have some questions for you about the information.

CHECK IN AFTER 2 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 statements in the information.

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

RETROSPECTIVE GENERAL PROBES

TO BE ADMINISTERED AFTER RESPONDENT COMPLETES HIS/HER REVIEW.

SHOW NOTECARD ON SCREEN AS NEEDED TO AID DISCUSSION.

RESEARCH QUESTIONS

Is the notecard clear and understandable?

What is the main message that participants get from the notecard?

Do participants recognize the call to action to choose an appropriate disposal option?

Does the notecard provide participants with useful information about safe drug disposal, including the risks and benefits?

Do participants indicate that any of the notecard’s information is new to them?

Do participants recognize the pictures and understand how they relate to the text?

Is the general layout appealing?

Do participants want the information presented in other formats (e.g., fact sheet, magnet, foldable card)?

INTRODUCTORY TEXT

Thank you for reading the notecard. Now I’m going to ask you some questions about it. I want you to know that I did not develop this material, so please give me your honest opinion about it—you will not hurt my feelings.

First, just tell me your overall thoughts about what you’ve just read.

What do you like about it?

What don’t you like?

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

DESIGN AND LAYOUT

What do you think of the way the information is set up?

• Is it easy to read? What are your thoughts about the font used on this notecard?

• Does the order of the information make sense?

Would you say the amount of information on this page is too little, just right, or too much? What makes you say that?

Take a look at the blue symbols used on this notecard – do each of these make sense to you? Do you think they go with the text?

Are you familiar with the black and white patterned square? What is that for? IF UNFAMILIAR, That square is called a QR code. If you use a smartphone to scan the code, it will lead you to a website with more information.

• What information do you think you might find if you scanned the code with a smartphone? IF NEEDED, Whose website do you think it leads to? For example, FDA’s, local law enforcement, a drug company’s, or something else?

• How likely are you to scan this QR code? 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}?

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

CONTENT

Now let’s talk about what the fact sheet has to say.

In your own words, what is the overall, main message that this material is trying to tell you?

• What, if anything, is it asking you to do? IF SAFELY DISPOSE, Should you use any of these options to safely dispose of prescription medications? How would you know which option to choose?

  • Are you less likely to use any of these options than the others? Why is that?

• What is the most important message?

• Is the most important information easy to find?

• How well does the title describe the information this notecard provides?

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

Does this material clearly explain the importance of safe drug disposal?

• IF YES, Can you tell me what about this materials makes you say it is important?

• IF NO, Can you say more about what wasn’t clear?

After reading this material, do you have any questions about safe drug disposal? IF YES, What are they?

Do you have any questions about how this information relates to minority health? IF YES, What are they?

IMPACT

If you saw this notecard at your doctor’s office or a health fair, what would you do? IF NEEDED, Pick it up, read it, ignore it, act on it, etc. What is it about this notecard that would make you do that?

• IF IGNORE, What would make this material more worth reading?

How helpful is this material to you? Please respond on a scale of 1 to 5 where 1 is not at all helpful and 5 is extremely helpful.

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

• Which parts of the material are of most interest to you?

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

Before seeing this material, you said you may have unused prescription medications at your home [IF CAREGIVER, or at the home of the person you are helping manage medications]. You said you planned to {KEEP THEM, GET RID OF THEM, SOMETHING ELSE}. Now that you’ve seen this notecard, what do you plan to do with them?

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

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

Would you prefer to see this information presented in other formats? IF NEEDED, For example, as fact sheet, a magnet, a brochure, or something else? Why would you like the information in that format?

WRAP-UP

Do you have any other suggestions for improving this material?

• 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?

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

Closing

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.