Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers)

ATTACHMENT I

LABEL COMPREHENSION STUDY

TASK 3: Group 1-2 (USERS AND ASSOCIATES) – TELEPHONE & EMAIL SCRIPTS

VOICEMAIL MESSAGE SCRIPT TO BE RECORDED ON STUDY PHONE LINE

Thank you for your interest in the Product Label study. Please clearly state your first name, phone number and a good time to reach you, and if we still have space in the study, someone will get back to you soon.

RETURNING PHONE MESSAGES

Hello, I’m calling for [NAME]. This is [NAME] from RTI International. I’m returning your call about the Product Labels study. Please call us back at 866-354-1076. Thank you.

IF RTI CALLS TO SCHEDULE APPOINTMENT

Hello, this is [NAME] from RTI International. You recently completed an online screener for the Product Label study. We would like to invite you to take part in the study for a one-time, individual in-person interview. The interview will take place at [ADDRESS].

The session will last no more than 30 minutes. No one will attempt to sell you anything, and no one will call you for other studies as a result of being a part of this study. The interview will be audio recorded. RTI and Concentrics will maintain copies of the audio files of sessions securely until they are destroyed within 2 years of the study end date. RTI, Concentrics, and FDA will maintain the written records of sessions securely until they are destroyed within 2 years of the study end date. If the audio file has any information that can identify you, that information will not be transcribed. The audio files will not be sent to FDA. Any forms related to the project that have your name on them will be kept in a locked file cabinet or on a password-protected computer. You will be given a $40 Visa gift card at the end of the interview as a token of appreciation for your time and travel expenses. This is an important research effort and we hope that you will be part of it.

Are you interested in being in this study?

Yes  CONTINUE [SCHEDULE INTERVIEW]

No  [Thank respondent and end call]

I’m glad that you will be able to join us. Right now, we have interview slots open on [Day], [Date], at [Time]. Would any of those times work well for you?

Yes  Document agreed upon date/time: ____________________________________

Thank you for your willingness to be in this study.

You will get a reminder call and email the day before your appointment. We have you scheduled on [Day], [Date], at [Time]. The interview will be held at [Address].

I also want to point out some details about the interview day:

• If you said that you needed glasses or contacts to read, please remember to bring them with you for your session.

• Because of the nature of the study, children will not be allowed in the room during your visit. If you need to bring children with you on the day of your interview, you will need to bring another adult to supervise the children while you are in the interview.

• If you need to reschedule your appointment, please call the number you just called [PHONE NUMBER] to let us know.

Do you have any questions about the study?

If you know someone else who may be interested in this study you can share the study phone line [STUDY PHONE NUMBER] or our website [WEB ADDRESS] if they want to see if they are eligible. You do not need to do this to be part of the study.

Thank you. Goodbye.

MESSAGE TO LEAVE IF PERSON SCREENS ELIGIBLE ONLINE BUT HASN’T SCHEDULED THE INTERVIEW WITHIN 48 HOURS

Hello, I’m calling for [NAME]. This is [NAME] from RTI International. You recently completed an online screener for the Product Label study. I’m calling to schedule the interview. Please call us back at 866-354-1076. Thank you.

EMAIL SCRIPT IF THE WINDOW FOR SIGNING UP FOR AN APPOINTMENT HAS EXPIRED

Thank you for your interest in the Product Label study. Unfortunately, we are only able to hold space in the study for 48 hours. We no longer have open slots at this time, but will contact you if a space opens up.

EMAIL SCRIPT IF SOMEONE SIGNS UP FOR AN APPOINTMENT, BUT HASN’T BEEN APPROVED

Thank you for your interest in the Product Label Study. We don’t currently have you in our system. Please contact us at 866-354-1076 or go to www.PRODUCTLABLESTUDY.com to see if you qualify for the study.

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