Rapid Message Testing with Consumer Panel - Vaccines and Seniors Brochure

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Informed Consent Form

Rapid Message Testing with Consumer Panel - Vaccines and Seniors Brochure

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Vaccines for Seniors Brochure

Cognitive Interview Guide

Introduction

Hello, my name is INTERVIEWER NAME. We 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 brochure they created. The FDA is interested in getting opinions about the information we are about to show you.


They want to know that the information 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 BROCHURE 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 remain private 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 information 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 Brochure Review

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

Have you gotten any vaccines in the last 5 years? (IF NEEDED: This could include a flu shot, the td/tdap vaccine to prevent tetanus, diphtheria and whooping cough, the zoster vaccine to prevent against shingles, and the pneumococcal vaccine to prevent pneumonia infections).

  • IF YES, What did you get vaccinated for?

  • IF NO, Skip to next question

Do you plan to get any vaccines soon?

  • IF YES, What do you plan to get vaccinated for?

  • IF NO TO FIRST 2 QUESTIONS (HAVE NOT GOTTEN VACCINES IN PAST 5 YEARS AND DO NOT PLAN TO), What are some of the reasons why you wouldn’t get a vaccine?

Now please open the envelope we sent you in the mail. Do you see a brochure that says “Vaccines and Seniors”? Please take a few minutes to look at it now. When you are done, I have some questions for you about the brochure.

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 statements in the brochure.

  • 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 BROCHURE PANELS ON SCREEN AS NEEDED TO AID DISCUSSION.

RESEARCH QUESTIONS

Do participants see themselves as at risk for diseases that they could be vaccinated against and what would they do about that risk?

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

What would motivate participants to get vaccinated?

Does the brochure change people’s minds about getting vaccinated?

Does the brochure provide useful information for deciding whether to get vaccinated?

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

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

What do you like about this brochure?


What don’t you like?


DESIGN AND LAYOUT

What do you think about the colors? How about the graphics, like the circles and lines?


What do you think about the size of the text? Is there enough space between text?


What do you think about the picture of the people?

  • Do you think they go with what’s written in the brochure?


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

  • Is it easy to read?

  • Does the order from one page to the next make sense?


Where would you expect to see a brochure like this?


If you saw this at your doctor’s office, your place of worship, or your grocery store, what would you do? IF NEEDED, Read it, ignore it, act on it, etc. What is it about the brochure that would make you do that?

CONTENT

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


Who do you think this brochure is for?

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

  • IF NEEDED: What do you think of the word “seniors”? Do you identify with that word? Is there a word or phrase that you think should be used instead of “seniors?”


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

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

  • What is the most important message of the brochure?

  • Is the most important information easy to find?

  • Is the most important information in the place where it should be?

  • Of all the things you read in this brochure, what are the most important things that people should see first? Where should that information be placed?


Based on what you’ve read, why do you think it’s important for seniors to prevent against getting these conditions?


Did you notice the Glossary section? How helpful or unhelpful is that section?


Do you have any other questions about vaccines? IF YES, What are they?


Now that you’ve read what the brochure has to say, what do you think of the title? Would you change it in any way?


ASK IF IN BACKGROUND QUESTIONS R SAID THEY PLAN TO GET VACCINATED SOON:

Before reading the brochure, you said that you PLAN TO GET vaccinated soon. Now that you’ve read the brochure, how likely are you to get vaccinated for all of the conditions listed here? 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}?

  • Are you more likely to get vaccinated for some conditions than others? IF YES, Why is that?

  • IF R IS 4 or 5 ON THE SCALE, If you were interested in getting vaccinated right now, how would you do that? Can you name places in your community that offer vaccines?


ASK IF IN BACKGROUND QUESTIONS R SAID THEY DO NOT PLAN TO GET VACCINATED SOON:

Before reading the brochure you said you DO NOT PLAN TO GET vaccinated soon. Now that you’ve read the brochure, how likely are you to get vaccinated? 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 IS 4 or 5 ON THE SCALE, What did you see in the brochure that made you think that?

  • Are you more likely to get vaccinated for some conditions than others? IF YES, Why is that?

  • If you were interested in getting vaccinated right now, how would you do that? Can you name places in your community that offer vaccines?

  • IF R IS 1-3 ON THE SCALE, It seems like the brochure did not change your mind. Is there anything the brochure should have said that could have changed your mind? Are you concerned about the cost of getting vaccinated?

FINAL QUESTIONS

Do you have any other suggestions for improving the brochure?

  • 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 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/Message7, Vaccines for Seniors Brochure 9



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorWeinberg, Jessica
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File Created2021-01-21

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