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

Data to Support Drug Product Communications as Used by the FDA

Attachment A Group 1-2 Screener

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

OMB: 0910-0695

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CONFER TASK 2

subject id




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Attachment A

LABEL COMPREHENSION STUDY

GROUP 1 & 2 SCREENER



TELEPHONE RECRUITMENT SCRIPT [Participant calls recruitment phone number]


Thank you for calling about the product label study. My name is _______________. RTI International and Concentrics Research are doing a study that is being sponsored by the U.S. Food and Drug Administration (FDA). FDA is the government agency that protects the public health by reviewing new medicines. In these reviews, the FDA helps to make sure the medicines work and are safe before they are approved to be prescribed by health care providers and used by patients.  We are looking for people to take part in a research study to review a label for a medicine that may be available over-the-counter soon, meaning without a prescription. We are not selling or promoting any medicine.


The study involves being in a one-time individual, in-person interview lasting no more than 45 minutes. The interview will include looking at a list of medical terms and answering some questions about instructions for a medicine. The interview will be audio recorded, and project team members may listen to the interview over the telephone. You will be given a $50 Visa gift card at the end of the interview to reimburse you for your time and travel expenses.



To see if you qualify for this study, I need to ask you some questions that will take a few minutes of your time. Some of the questions are about whether you use certain prescription pain medicines or heroin, or have a family member or friend who does. If you qualify for the study you can then decide if you want to be a part of the study. If so, I will need your email address and/or phone number in order to contact you to remind you about your appointment.

The risk of others knowing your answers to the questions is minimal. To keep your information private, we will store your answers and contact information in separate, locked filing cabinets. This information will be destroyed at the end of the study. If you feel uncomfortable at all, you can choose not to answer a question or end the call at any time. Do you have any questions about the process? May I ask you my questions now?



PRESCREENING

  1. How old are you?

_____

Over Age 18 CONTINUE

Between Ages 15-17 SWITCH TO ADOLESCENT SCREENER TO PROVIDE PHONE NUMBER FOR SCREENING [NOTE TO RIHSC: Adolescents are not the subject of this review and will be reviewed separately.]

Under Age 15 TERMINATE (Ineligible for the study)

Don’t know/refused TERMINATE




  1. Are you currently employed by [INSERT OPTIONS 1-6 BELOW]? (Check all that apply.)


    1. A marketing or research company


TERMINATE (Closing Script and Contact Information Sheet)

    1. An advertising agency or public relations firm


TERMINATE (Closing Script and Contact Information Sheet)

    1. A pharmacy or pharmaceutical company


TERMINATE (Closing Script and Contact Information Sheet)

    1. A manufacturer of medicines


TERMINATE (Closing Script and Contact Information Sheet)

    1. A managed care or health insurance company


TERMINATE (Closing Script and Contact Information Sheet)

    1. A healthcare practice


TERMINATE (Closing Script and Contact Information Sheet)

    1. A hospital emergency room


TERMINATE (Closing Script and Contact Information Sheet)

    1. None of the above


CONTINUE

    1. Refuse


TERMINATE (Closing Script and Contact Information Sheet)



  1. Have you ever worked for [INSERT OPTIONS 1-4 BELOW]? (Check all that apply.)

  1. Department of Health and Human Services


TERMINATE (Closing Script and Contact Information Sheet)

  1. U.S. Food and Drug Administration


TERMINATE (Closing Script and Contact Information Sheet)

  1. RTI International


TERMINATE (Closing Script and Contact Information Sheet)

  1. Concentrics Research


TERMINATE (Closing Script and Contact Information Sheet)

  1. None of the above


CONTINUE

  1. Refuse


TERMINATE (Closing Script and Contact Information Sheet)


  1. Have you ever been trained or worked as a healthcare professional? [IF NEEDED: a health care professional (HCP) is defined as a trained person who deliver medical care to humans. Examples of HCP: nursing assistant, nurse, doctor, dentist, pharmacist, physician assistant. It is NOT a veterinarian, peer counselor, mental health counselor, or someone who is a caregiver for a family member or friend.]


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)



  1. Have you been in any research study in the past 12 months?


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Don’t Know


TERMINATE (Closing Script and Contact Information Sheet)

Refused


TERMINATE (Closing Script and Contact Information Sheet)





SECTION 1: QUESTIONS TO ASSESS ELIGIBILITY AS USER (ADULT)



READ: Now I’m going to ask you some questions about drug use. Remember that your answers will be kept private.

  1. Are you currently in treatment for [prescription opioids and/or heroin USE]? This could be individual therapy, an outpatient therapy group, or medication assisted treatment such as methadone or Suboxone. [IF NEEDED: A prescription opioid is a pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine]



Yes

No

DK

REF

1a. Prescription opioid






1b. Heroin






IF YES to either: CONTINUE TO Q3; IF NO to Both or DK or REF: GO TO Section 1a



  1. Do you take methadone or Suboxone as part of your treatment program?

Yes


CONTINUE

No


CONTINUE

Don’t know


CONTINUE

Refused


CONTINUE


  1. Have you been ordered by a judge to participate in treatment?

Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Don’t know


TERMINATE (Closing Script and Contact Information Sheet)

Refused


TERMINATE (Closing Script and Contact Information Sheet)



SECTION 1a: PRESCRIPTION OPIOID USE

  1. During the past 90 days, have you used any prescription opioid? An opioid is a prescription pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine.


Yes


CONTINUE

No


GO TO SECTION 1b: HEROIN USE

Don’t know


GO TO DK FOLLOW-UP

Refused


GO TO SECTION 1b: HEROIN USE



DON’T KNOW FOLLOW-UP: determine if it is because he/she doesn’t know if the medicine is an opioid.


IF UNSURE WHETHER MEDICINE IS AN OPIOID, ASK: What is the name of the medicine you are taking?


Codeine (Fioricet w/ codeine, Fiorinal w/ codeine, Tylenol w/ codeine)


CONTINUE

Fentanyl transdermal (Abstral, Actiq, Duragesic, Fentora, Ionsys, Lazanda, Sublimaze, Subsys)


CONTINUE

Hydrocodone (Anexsia, Hysingla ER, Lortab, Norco, Reprexain, Vicodin, Vicoprofen, Zohydro ER)


CONTINUE

Hydromorphone (Dilaudid, Dilaudid-HP, Exalgo)


CONTINUE

Morphine (Astramorph PF, Duramorph PF, Embeda, Infumorph, Kadian, Morphabond, MS Contin)


CONTINUE

Oxycodone (Oxaydo, Oxycet, Oxycontin, Percocet, Percodan, Roxicet, Roxicodone, Xartemis XR)


CONTINUE

Oxymorphone (Opana, Opana ER)


CONTINUE

Other (specify_____________________)


CONTINUE IF DRUG NAME IS FOUND HERE: http://www.rxlist.com/script/main/hp.asp; ELSE, GO TO SECTION 1b: HEROIN USE

Don’t know


GO TO SECTION 1b: HEROIN USE

Refused


GO TO SECTION 1b: HEROIN USE


  1. During the past 30 days, have you used any prescription opioid? [IF NEEDED: An opioid is a prescription pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine.]


Yes


CONTINUE

No


GO TO SECTION 1b: HEROIN USE

Don’t know


GO TO SECTION 1b: HEROIN USE

Refused


GO TO SECTION 1b: HEROIN USE



  1. During the past 30 days, on how many days did you use a prescription opioid? [IF NEEDED: An opioid is a prescription pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine]


_______ Days CONTINUE



SECTION 1b: HEROIN USE

  1. During the past 90 days, have you used heroin?


Yes


CONTINUE

No


GO TO SUMMARY OF SKIPS FOR NEXT STEP

Don’t know


GO TO SUMMARY OF SKIPS FOR NEXT STEP

Refused


GO TO SUMMARY OF SKIPS FOR NEXT STEP


  1. During the past 30 days, have you used heroin?


Yes


CONTINUE

No


GO TO SUMMARY OF SKIPS FOR NEXT STEP

Don’t know


IF USED Rx OPIOIDS IN THE PAST 30 DAYS (SECTION 1a, Q6), GO TO SUMMARY OF SKIPS, OTHERWISE TERMINATE (Closing Script and Contact Information Sheet)

Refused


IF USED Rx OPIOIDS IN THE PAST 30 DAYS (SECTION 1a, Q6), GO TO SUMMARY OF SKIPS FOR NEXT STEP OTHERWISE TERMINATE (Closing Script and Contact Information Sheet)



  1. During the past 30 days, on how many days did you use heroin?


_______ Days SEE SUMMARY OF SKIPS FOR NEXT STEP



Summary of Skips

  • If YES to either prescription opioid or heroin Treatment (Q2), Yes to Q6 (30-day opioid use), AND/OR Yes to Q9 (30-day heroin use), respondent is eligible as a USER GO TO section 3: final eligibility & DEMOGRAPHIC questions

  • If NO to Q2, Q6, AND Q9, GO TO SECTION 2 to screen for eligibility as an Associate.

  • If not a user and participant REF/DK to either Q6 and/or Q9, TERMINATE (Closing Script and Contact Information Sheet) as does not qualify for associate

Section 2: Questions to assess eligibility as an associate


  1. Do you have a family member or friend who is currently in treatment for [prescription opioids and/or heroin USE]? This could be individual therapy, an outpatient therapy group, or medication assisted treatment such as methadone or Suboxone. [IF NEEDED: A prescription opioid is a pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine]



Yes

No

DK

REF

1a. Prescription opioid





1b. Heroin






Note: If yes to either, go to section 3: final eligibility & demographic quesTIons.; Otherwise, continue.


  1. Do you have a family member or friend who uses [prescription opioids and/or heroin]? [IF NEEDED: A prescription opioid is a pain medicine such as Vicodin, OxyContin, Opana, dilaudid, Percocet, oxycodone, or morphine]



Yes

No

DK

REF

2a. Prescription opioid





2b. Heroin






Note: If yes to either go to section 3: final eligibility & demographic quesitons). If no, don’t know, or refused for both drugs, TERMINATE (Closing Script and Contact Information Sheet)




SECTION 3: FINAL ELIGIBILITY & DEMOGRAPHIC QUESTIONS


  1. How confident are you in filling out medical forms by yourself? Would you say…



Extremely


CONTINUE

Quite a bit


CONTINUE

Somewhat


CONTINUE

A little bit


CONTINUE

Not at all


CONTINUE

Don’t know


CONTINUE IF LOW LITERACY REQUIREMENT IS MET

Refuse


CONTINUE IF LOW LITERACY REQUIREMENT IS MET

At least 50% of the sample should answer “somewhat”, “a little bit” or “not at all”.


  1. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?



Never


CONTINUE

Rarely


CONTINUE

Sometimes


CONTINUE

Often


CONTINUE

Always


CONTINUE

Don’t know


CONTINUE

Refuse


CONTINUE


  1. Can you read, speak, and understand English?



Yes


CONTINUE

No


TERMINATE (Closing Script and Contact Information Sheet)

Refuse


TERMINATE (Closing Script and Contact Information Sheet)




  1. Do you normally wear corrective lenses, contacts, or glasses to read?



Yes


CONTINUE

No


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)


  1. Do you have any other problems with your eyes that would prevent you from being able to read?


Yes


TERMINATE (Closing Script and Contact Information Sheet)

No


CONTINUE

Refused


TERMINATE (Closing Script and Contact Information Sheet)



  1. What is the highest level of education you have completed? [DO NOT READ LIST – ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]

Less than high school


CONTINUE

High school graduate (HS diploma or GED)


CONTINUE

Some college (no degree)


CONTINUE

College (2-year) degree (Associate degree)


CONTINUE

College (4-year) degree (e.g., BA, BS, AB)


CONTINUE

Some post-college


CONTINUE

Advanced or post-graduate degree (e.g., Masters, MD, PhD)


CONTINUE

Refused


CONTINUE



  1. Are you Hispanic or Latino?

Yes


CONTINUE

No


CONTINUE

Refused


CONTINUE



  1. What is your race? (Check all that apply) [READ LIST IF NECESSARY]

American Indian / Alaska Native


CONTINUE

Asian


CONTINUE

Black or African American


CONTINUE

Native Hawaiian / other Pacific Islander


CONTINUE

White


CONTINUE

Other


SPECIFY_____________________

Refused


CONTINUE

AIM FOR MIX



  1. Was your total household income in 2016…?

Less than $20,000


CONTINUE

$20,000 - $34,999


CONTINUE

$35,000 - $49,999


CONTINUE

$50,000 - $74,999


CONTINUE

$75,000 - $99,999


CONTINUE

$100,000 - $149,999


CONTINUE

$150,000 or more


CONTINUE

Don’t know


CONTINUE

Refused


  • CONTINUE



  1. What is your gender? [Do not read response categories]



Male


GO TO Closing Script and Contact Information Sheet

Female


CONTINUE

Other


SPECIFY_____________________ AND CONTINUE

Refused


CONTINUE

AIM FOR MIX



  1. How did you hear about this study?

From the Hazelden Betty Ford Foundation


CONTINUE

Posted flyers in the community


CONTINUE

Posting on the internet


CONTINUE

From a friend or family member


CONTINUE

Other


CONTINUE

Don’t know


CONTINUE

Refused


  • CONTINUE



  1. For study purposes, if you participate, the interview will be audio recorded. Are you okay with us audio recording the interview?

Yes


CONTINUE

No


TERMINATE (Closing Script and Contact Information Sheet)



Note: Use the Closing Script and Contact Information sheet to schedule an interview.

SECTION 4: TERMINATION DEMOGRAPHIC QUESTIONS


Note: The goal of this section is to conceal the reason for termination.


  1. What is the highest level of education you have completed? [DO NOT READ LIST – ASSIGN RESPONSE TO EDUCATION LEVEL BELOW]

Less than high school


CONTINUE

High school graduate (HS diploma or GED)


CONTINUE

Some college (no degree)


CONTINUE

College (2-year) degree (Associate degree)


CONTINUE

College (4-year) degree (e.g., BA, BS, AB)


CONTINUE

Some post-college


CONTINUE

Advanced or post-graduate degree (e.g., Masters, MD, PhD)


CONTINUE

Refused


CONTINUE



  1. Are you Hispanic or Latino?

Yes


CONTINUE

No


CONTINUE

Refused


CONTINUE



  1. What is your race? (Check all that apply) [READ LIST IF NECESSARY]

American Indian / Alaska Native


CONTINUE

Asian


CONTINUE

Black or African American


CONTINUE

Native Hawaiian / other Pacific Islander


CONTINUE

White


CONTINUE

Other


SPECIFY_____________________

Refused


CONTINUE

SCREEN FOR MIX







  1. Was your total household income in 2016…?

Less than $20,000


CONTINUE

$20,000 - $34,999


CONTINUE

$35,000 - $49,999


CONTINUE

$50,000 - $74,999


CONTINUE

$75,000 - $99,999


CONTINUE

$100,000 - $149,999


CONTINUE

$150,000 or more


CONTINUE

Refused


  • CONTINUE



Note: After these questions, go to ineligible script (Closing Script and Contact Information Sheet).





APPENDIX 1: POTENTIAL ADDITIONAL QUESTIONS FOR CBOs WITH SPECIFIC REQUIREMENTS

  1. Do you receive services or treatment at [NAME OF ORGANIZATION]?



Yes


GO TO SECTION 1A

No


CONTINUE

Don’t know


TERMINATE

Refused


TERMINATE



  1. Do you have a family member or spouse/partner who receives services or treatment at [NAME OF ORGANIZATION]?



Yes


CONTINUE

No


TERMINATE

Don’t know


TERMINATE

Refused


TERMINATE


  1. Are you involved in their treatment at [NAME OF ORGANIZATION)]? This may mean that you went to a meeting with your family member or spouse/partner along with [NAME OF ORGANIZATION] staff to help plan their treatment, or that you come to counseling sessions with them, or provide support in some other way.


Yes


CONTINUE TO SECTION 2: QUESTIONS TO ASSESS ELIGIBILITY AS AN ASSOCIATE

No


TERMINATE IF REQUIRED BY CBO

Don’t know


HOLD [Probe to determine involvement; discuss with team to determine eligibility]

Refused


TERMINATE



19

Revised 5/19/17



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