Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

Attachment D-2

LABEL COMPREHENSION STUDY

GROUP 4 Closing Script and Contact Information Sheet

COHORT INFORMATION
GROUP 4	All comers	4

LITERACY SUBGROUP INFORMATION
SUBGROUP A:	TARGETED lOW lITERACY (n=7-9)				A
SUBGROUP B:	PREGNANT (n=1-2)				B
VISIT INFORMATION
INTERVIEW APPT (MM/DD)			INTERVIEW APPT TIME:
RECRUITMENT INFO
RECRUIT DATE:
QUALIFIED (YES/NO)
RECRUITER INITIALS: ______
SUBJECT NAME:
SUBJECT TELEPHONE:		BEST TIME:
EMAIL ADDRESS:

*This form should be stored in a locked filing cabinet in a separate location from screener*

Closing Script

IF INELIGIBLE  Closing for Ineligible Participants: Thank you for answering our questions. At this time you do not qualify to be in this study. However, we appreciate your time and willingness to help us. We will not keep any of the information that you provided during our call. Goodbye.

IF ELIGIBLE BUT HOLDING  Hold Script

Thank you for answering all my questions. At this time, the section of the study you qualify for is full but we’d like to add you to a waitlist in case a spot opens up. Depending on the group of the study you fit best for you may get called sooner or later than others on the waitlist. Would you like to be added to the waitlist? (If participant answers yes, take them to Contact Information questions.)

IF ELIGIBLE  CONTINUE to Invitation Script…

The session will last no more than 45 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, and project team members may observe the interview either in-person or by live streaming. Written records of the sessions and audio files will have any information that could identify you removed before sending to the FDA. RTI, Concentrics, and FDA will maintain the tapes and written records of sessions securely until they are destroyed at the end of the study. 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 $50 [FORM TBD BY RECRUITMENT FIRM; CASH/CHECK ARE TYPICAL] at the end of the interview to reimburse you 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 and COLLECT CONTACT INFORMATION]

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. I would like to collect some simple contact information for our reminder call and email.

Collect contact information for reminder call [RECORD ON PAGE 1 WHICH IS TO BE STORED SEPARATELY FROM THE SCREENER]

First Name: _________________________

Phone number (for reminder call): ______________Best time: _______________

Email address (for reminder email):_______________________

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.

Thank you. Goodbye.

REMINDER CALL

Hello this is [NAME] with a reminder call about an individual, in-person interview you recently agreed to be in that is being conducted by RTI International and Concentrics Research for U.S. Food and Drug Administration (FDA).

I’m calling to remind you that you are scheduled for an interview on [Day], [Date], at [Time]. The interview will be held at [Address]. Please arrive 10 minutes prior to your interview time. If you are more than 10 minutes late, we may need to give your interview slot to another person. If this happens, we won’t be able to give you the $50 [FORM TBD BY RECRUITMENT FIRM; CASH/CHECK ARE TYPICAL].

I also wanted to remind you that if need glasses or contacts to read, please remember to bring them with you for your appointment. 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.

Do you have any questions or concerns that I can help you with about the study?

If you need to be in touch with us before your interview, you can call [PHONE NUMBER].

Thank you. We greatly appreciate you being in this study.

*This form should be stored in a locked filing cabinet in a separate location from screener*

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