Appendix A - Questionnaire FINAL

Perceptions of Prescription Drug Products with Medication Tracking Capabilities

Appendix A - Questionnaire FINAL

OMB: 0910-0916

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Perceptions of Prescription Drug Products with Medication Tracking Capabilities

Questionnaire

OMB Control No. 0910-xxxx

Expiration date: xx/xx/xxxx


According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-xxxx and the expiration date is xx/xx/xxxxv. The time required to complete this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.


Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to [email protected].



INTRODUCTION

Thank you for participating in this survey. The survey questions will ask about your opinions and experiences with pharmaceutical marketing materials about prescription drugs. Please answer honestly and give us your best guess on answers you do not know.

[-----------------------------------------------------------NEXT SCREEN-----------------------------------------------------------]

On the next screen, you will be shown a webpage for a new prescription drug. The researchers are looking at how [people / providers} think about drug information. Take your time looking at the webpage. Carefully read the information presented to see what you think and feel about it. After you finish viewing the webpage, we will ask you some questions about what you saw.


[Utilize randomization procedures provided by Westat]

[-----------------------------------------------------------NEXT SCREEN-----------------------------------------------------------]

[VIEWWEBPAGE] Were you able to view the webpage for the prescription drug?

  1. Yes

  2. No [TERMINATE]


[-----------------------------------------------------------NEXT SCREEN-----------------------------------------------------------]



Please answer the following questions based on the information you have just seen.

[Programmer Notes:

1. do not display question headings,

2. IF A RESPONDENT SKIPS A QUESTION, PROGRAM A REMINDER IMMEDIATELY FOLLOWING THE QUESTION SKIPPED, SUCH AS “You did not answer this question. Your answers are important. If you meant to skip this question, you can click “next” to go to the next question.]

Adherence

  1. [Q1_HELPPATIENTS] Based on the webpage information that you saw, how likely is it that Sustadia would help patients take their medication as directed?

  • Very unlikely

  • Unlikely

  • Neither likely nor unlikely

  • Likely

  • Very likely



  1. [PCPs only] [Q2_DOCTORSTRACK_PCP] Based on the webpage information you saw, how effective is Sustadia at helping doctors keep track of when patients take their medication?

  • Extremely effective

  • Very effective

  • Somewhat effective

  • Slightly effective

  • Not at all effective



  1. [Consumers only] [Q3_YOUTRACK_CON] Based on the webpage information you saw, how effective would Sustadia be at helping you keep track of when to take your medication?

  • Extremely effective

  • Very effective

  • Somewhat effective

  • Slightly effective

  • Not at all effective



  1. To what extent do you agree or disagree with the following statements about Sustadia, the medicine that tracks medication use:


Completely agree

Agree

Neither agree nor disagree

Disagree

Completely Disagree

[Q4A_EVIDENCE_EFFECTIVE] There is evidence that Sustadia, the medicine that tracks medication use, is effective in helping people manage their diabetes.

[Q4B_EVIDENCE_HELPS] There is evidence that Sustadia, the medicine that tracks medication use, helps people take their medication as directed.

[Q4C_BENEFITS_WORTH] The benefits of Sustadia, the medicine that tracks medication use, are worth the possible side effects.



Efficacy – Managing Diabetes

  1. [Consumers only] [Q5_HOWEFFECTIVE_CON] Based on the webpage information you saw, how effective would Sustadia be at managing your diabetes?



  • Extremely effective

  • Very effective

  • Somewhat effective

  • Slightly effective

  • Not at all effective



  1. [PCPs only] [Q6_HOWEFFECTIVE_PCP] Based on the webpage information you saw, how effective would Sustadia be at managing diabetes?



  • Extremely effective

  • Very effective

  • Somewhat effective

  • Slightly effective

  • Not at all effective



Manipulation Check  

  1. [Q7_EVIDENCE_MORELIKELY] Based on the information that you saw, is there evidence that people who use Sustadia are more likely to take their medicine as directed?

  • Yes

  • No

  • Do not know


Risks - Side Effects

  1. Based on the webpage information you saw, what are the most serious side effects of Sustadia? Check all that apply.

[RANDOMIZE ORDER]

  • [Q8_SIDEEF_NAUSEA] Nausea

  • [Q8_SIDEEF_VOMIT] Vomiting

  • [Q8_SIDEEf_HEADACHE] Headache

  • [Q8_SIDEEF_ITCH] Itching or pain where you injected the medicine

  • [Q8_SIDEEF_WEIGHT] Weight gain

  • [Q8_SIDEEF_BLOODSUGAR] Low blood sugar

  • [Q8_SIDEEF_POTASS] Low blood potassium levels

  • [Q8_SIDEEF_HEART] Heart failure

  • [Q8_SIDEEF_ALLERGIC] Serious allergic reactions. 

  1. [Q9_HOWSERIOUS] In your opinion, how serious are the Sustadia side effects that you selected in the question above?



  • Extremely serious

  • Very serious

  • Somewhat serious

  • Slightly serious

  • Not at all serious



Perceived Risk – Data Privacy

  1. [Q10_PRIVACYRISK] Based on the webpage information that you saw, how likely is it that the privacy of a person’s information would be at risk if they use Sustadia? (ASK to Conditions 1-4 only)



  • Very unlikely

  • Unlikely

  • Neither likely nor unlikely

  • Likely

  • Very likely



Intention – [PCPs Only]

  1. Based on the webpage information that you saw, how likely would you be to:


Very unlikely

Unlikely

Neither likely nor unlikely

Likely

Very likely

[Q11A_TALKTOPATIENTS_PCP] Talk to your patients about Sustadia?

[Q11B_PRESCRIBE_PCP] Prescribe Sutadia to a patient with diabetes?

[Q11C_LOOKINFO_PCP] Look for more information about Sustadia?



  1. [Q12_COMFORTPRESCRIBING_PCP] How comfortable would you be prescribing Sustadia to your patients?



  • Very comfortable

  • Comfortable

  • Neither comfortable nor uncomfortable

  • Uncomfortable

  • Very uncomfortable



Intention – [Consumers Only]

  1. Based on the webpage information that you saw, how likely would you be to:


Very unlikely

Unlikely

Neither likely nor unlikely

Likely

Very likely

[Q13A_TALKTODOCTOR_CON] Talk to your doctor about Sustadia?

[Q13B_ASKPRESCRIBE_CON]Ask your doctor to prescribe Sustadia for you?

[Q13C_LOOKINFO_CON] Look for more information about Sustadia?



  1. [Q14_SWITCH_CON] I would consider switching from my current prescription to Sustadia.



  • Completely agree

  • Agree

  • Neither agree nor disagree

  • Disagree

  • Completely disagree



Disclosure Recall

  1. The following statements may or may not have been in the webpage you viewed. Please indicate whether you recall seeing the following statements.

[RANDOMIZE ORDER]


Yes – Recall seeing

No- Do not recall seeing

Don’t know

[Q15A_DISCLOSURE_MORELIKELY] In studies, people who used Sustadia SmartPen were more likely to take their medication as directed than people who used similar medicines without this technology. (Show Conditions 1-4)




[Q15B_DISCLOSURE_NOMORELIKELY] In studies, people who used Sustadia SmartPen were no more likely to take their medication as directed than people who used similar medicines without this technology. (Show Conditions 1-4)




[Q15C_DISCLOSURE_NOTKNOWN] It is not known whether people who use Sustadia SmartPen are more likely to take their medicine as directed. (Show Conditions 1-4)






  1. The following statements may or may not have been in the webpage you viewed. Please indicate whether you recall seeing the following statements.


Yes – Recall seeing

No- Do not recall seeing

Don’t know

[Q16A_DISCLOSURE_BUILTIN] The Sustadia SmartPen has built-in digital technology that helps you and your doctor keep track of when you take your medicine and how much you take. (Show Conditions 1-4)




[Q16B_DISCLOSURE_APPVIEW] The information goes to an app that you and your doctor can view on a smartphone or tablet. (Show Conditions 1-4)




[Q16C_DISCLOSURE_REMINDERS] The Sustadia SmartPen provides helpful reminders and alerts (Show Conditions 1-4)




[Q16D_DISCLOSURE_DATETIME] Sustadia captures the date and time the medication was taken. (Show Conditions 1-5)




[Q16E_DISCLOSURE_FINDBALANCE] Get closer to finding your balance with Sustadia. (Show Conditions 1-5)




[Q16F_DISCLOSURE_BLOODSUGARCONTROL] When you have type 2 diabetes, you know that keeping your blood sugar under control is a balancing act. (Show Conditions 1-5)







Credibility

  1. [Q17_CONFIDENTACCURACY] How confident are you in the accuracy of the information presented on the website?



  • Very confident

  • Confident

  • Neither confident nor unconfident

  • Unconfident

  • Very unconfident



  1. [Q18_TRUEFALSE]To what extent do you believe this statement is true?


The Sustadia SmartPen built-in digital technology can help people, and their doctors, keep track of when they take their medicine. (Conditions 1-4)



  • Definitely false

  • Probably false

  • Neither true nor false

  • Probably true

  • Definitely true



  1. [Q19_MISLEADEFFECTIVENESS] Would this webpage mislead people about the effectiveness of Sustadia?



  • Definitely not

  • Probably not

  • Neither yes nor no

  • Probably yes

  • Definitely yes



  1. [Q20_MISLEADRISKS] Would this webpage mislead people about the risks of Sustadia?



  • Definitely not

  • Probably not

  • Neither yes nor no

  • Probably yes

  • Definitely yes



Other: Open-ended

  1. [Q21_OPENEND_WHATBENEFITS] Based on the webpage information that you saw, what are the benefits of Sustadia?





  1. [Q22_OPENEND_ADHERENCE] When thinking about prescription drugs, what does “adherence” mean to you?





  1. [Q23_OPENEND_OTHERINFO] What other information would you like to know about Sustadia?



Attitudes and Beliefs

We are now done asking you about the webpage that you looked at today. We would like to ask you about your personal experience and views on technology and prescription drugs.



  1. [Q24_FAMILIARITY] How familiar are you with medications with built-in technology that help patients and their doctors keep track of when they take their medication and how much they take?

  • Extremely familiar

  • Very familiar

  • Somewhat familiar

  • Slightly familiar

  • Not at all familiar



  1. [Consumers Only] [Q25_EVERUSED] Have you ever used a medication with built-in technology that helps you and your doctor keep track of when you take your medication and how much you take?

o Yes

o No



  1. [PCPs Only] [Q26_EVERPRESCRIBED] Have you ever prescribed a medication with built-in technology that helps you keep track of when patients take their medication and how much they take?

o Yes

o No





  1. To what extent do you agree or disagree with each of the following statements?


Completely agree

Agree

Neither agree nor disagree

Disagree

Completely Disagree

[Q27A_EASYTOUSE] Technology that helps people take their medication as prescribed would be easy to use.

[Q27B_APPREHENSIVE] (I/Most of my patients) would be apprehensive about using technology to track (my/their) medication use.

[Q27C_IMPROVECOMMUNICATIONS] Technology that helps (me/patients) take medication as directed would improve communication with my [healthcare provider/patients]

[Q27D_INFOSECURE_CON] Information collected with technology, about my medication use, would be kept secure and private. (Consumers only)

[Q27E_TIMECONSMING_PCP] Using technology to monitor my patients’ medication use would be too time consuming. (PCPs only)

[Q27F_NEEDHELP] (I/My patients) need help taking medication as directed.





Consumer Demographics

Finally, we would like to ask you a few questions about yourself. This section will help us determine how representative the participants are who complete this questionnaire.

  1. [Q28_HEALTH_CON] In general, would you say your health these days is:

    • Excellent

    • Very good

    • Good

    • Fair

    • Poor



  1. [Q29_YEARSPRESCRIPTION_CON] For how many years have you taken prescription drug(s) for diabetes?


Choose an item [DROP DOWN MENU WITH YEARS, STARTING WITH ‘Less than 1 year.’]

-Less than 1 year

- 1

- 2

- 3

- 4

- 5

- 6

- 7

- 8

- 9

- 10

- 11 to 19

- 20 or more


  1. [Q30_EDUCATION_CON] What is the highest level of education that you have completed? Please select one.

    • Less than high school

    • High school graduate or equivalent (for example: GED)

    • Some college, but no degree

    • Associate or two-year college degree

    • Bachelor’s degree (for example: BA, AB, BS)

    • Advanced or post-graduate degree (for example: Master’s degree, MD, DDS, JD, PhD, EdD)





  1. [Q31_STATE_CON] In which state do you currently live? [DROP DOWN MENU OF STATES BELOW ]



Provider Demographics

Finally, we would like to ask you a few questions about yourself. This section will help us determine how representative the participants are who complete this questionnaire.

32. [Q32_NUMBERPATIENTS_PCP] During your last normal week of practice, how many patient visits did you have at all office locations?

  • Number of patient visits.





33. [Q33_NUMBERPRESCRIPTIONS_PCP] Approximately, how many prescriptions do you write in a typical week?

  • Number of prescriptions per week.



34. [Q34_STATEPRACTICE_PCP] In which state is your practice based? [SEE DROP DOWN MENU OF STATES BELOW]



35. [Q35_URBANRURAL_PCP] Is your practice located in an urban, suburban, or rural area?

  • Urban

  • Suburban

  • Rural



36. [Q36_TYPEOFPRACTICE_PCP] Which of the following best describes the practice location you work in most often (i.e., where you spend the most hours per week)? Please select one.

  • Private solo or group practice

  • Freestanding clinic/urgent care (not part of a hospital outpatient department)

  • Non-Federal Government clinic (e.g., state, county, city, maternal and child health, etc.)

  • Federal Government operated clinic (e.g., Veterans Affairs, military, etc.)

  • Health maintenance organization or other prepaid practice (e.g., Kaiser Permanente)

  • Community Health Center (e.g., Federally Qualified Health Center (FQHC), federally funded clinics or “look alike” clinics)

  • Other, please specify __________________



Consumer Debriefing

Thank you for completing the questionnaire. Sustadia is not a real product and it is not available for sale.  The purpose of this research is to understand how people think about information in prescription drug advertisements. In order to get an unbiased reaction to this information, we created a brand for this study. Please see your healthcare professional for questions about diabetes.  This study was sponsored by the U.S. Food & Drug Administration (FDA).


Please click the submit button to complete the survey.


PCP Debriefing

Thank you for completing the questionnaire. Sustadia is not a real product and it is not available for sale.  The purpose of this research is to understand how healthcare professionals think about information in prescription drug advertisements. In order to get an unbiased reaction to this information, we created a brand for this study. This study was sponsored by the U.S. Food & Drug Administration (FDA).



Please click the submit button to complete the survey.





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