Educating Groups Influencing Generic Drug Use

Data to Support Drug Product Communications

Appendix I - Protocol for Patients and Caregivers

Educating Groups Influencing Generic Drug Use

OMB: 0910-0695

Document [pdf]
Download: pdf | pdf
Appendix ,: Face-to-face survey Instrument – patients/caregivers

OMB No. 0910-0695
Expiration Date: 02-28-2021

Paperwork Reduction Act Statement
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 0910-0695 and the expiration date is 2/28/2021.
The time required to complete this information collection is estimated to average 30 minutes per response,
including the time for reviewing instructions and completing and reviewing the collection of information.

Patient/Caregiver Survey
(NOTE: DO NOT SIGN THIS DOCUMENT UNLESS AN IRB APPROVAL STAMP
WITH CURRENT DATES HAS BEEN APPLIED TO THIS DOCUMENT.)
Informed Consent for a research study entitled: “Educating Groups
Influencing Generic Drug Use”
You are invited to participate in a research study to better educate groups influencing
generic drug use, based on their unique educational needs, sponsored by the US Food
and Drug Administration (FDA). The study is being conducted by Dr. Jingjing Qian,
Assistant Professor in the Auburn University Department of Health Outcomes Research
and Policy and Dr. Ilene Harris, Principal Research Scientist at IMPAQ International.
You were selected as a possible participant because you have been identified as a
patient or caregiver and are age 19 or older.
As part of your participation in this research study, you will speak to one of our
student pharmacists in person to answer a survey about your review of the developed
educational materials. Your total time commitment will be approximately 30 minutes.
The risks associated with participating in this study are minimal. Your protected
health information will not be used or disclosed to a third party. If you participate in this
study, what the research team learns from your survey may better inform whether the
developed educational materials are successful in educating various groups on
generic drugs. You will receive $25 as a token of our appreciation for your
participation after completion of the survey.
If you change your mind about participating, you can withdraw at any time during
the study. Your participation is completely voluntary. If you choose to withdraw, your
data can be withdrawn as long as it is identifiable. Your decision about whether or not
to participate or to stop participating will not jeopardize your future relations with Auburn
University, the Department of Health Outcomes Research and Policy, or IMPAQ
International.
If you agree, any data obtained in connection with this study will be anonymous. Notes
and completed surveys will be saved in password protected folders on a password and
firewall protected server at Auburn University.
Information collected through your participation may be published in governmental
reports, professional journals, and/or presented at a professional meeting. As described
above, surveys will have no identifying information attached to them, and if information
learned from this study is published, you will not be identified by name or other personal
information. Also, survey answers will be used for analytical purposes only.
1

Appendix I: Face-to-face survey Instrument – patients/caregivers

If required, personal information collected in connection to your honorarium will be
saved in password protected folders on a password and firewall protected server at
Auburn University. This information is being collected in order to withhold necessary
tax payments on your behalf and will remain private to the extent permitted by law.
If you have questions about this study, please ask them now or contact Jingjing Qian
at (334) 844-5818 or [email protected] or Ilene Harris at (443) 259-5250 or
[email protected].
If you have questions about your rights as a research participant, you may contact the
Auburn University Office of Research Compliance or the Institutional Review Board by
phone at (334) 844-5966 or e-mail at [email protected] or [email protected].
HAVING READ THE INFORMATION PROVIDED, YOU MUST DECIDE WHETHER OR NOT
YOU WISH TO PARTICIPATE IN THIS RESEARCH STUDY. IF YOU DECIDE TO
PARTICIPATE, YOUR SIGNATURE WILL SERVE AS YOUR AGREEMENT TO DO SO. A
COPY OF THIS LETTER IS YOURS TO KEEP.

Do you agree to participate in this survey?
 Yes
 No

If ‘Yes’ then the participant will sign the informed consent document. Continue to the
next page.
1. Are you at least 19 years of age?
 Yes
 No
If ‘No’ then END THE SURVEY.

2

Appendix I: Face-to-face survey Instrument – patients/caregivers

2. Are you a healthcare professional, like a physician, pharmacist, or nurse?
 Yes
 No
If ‘Yes’ then END THE SURVEY.

3. During the past 6 months, have you taken at least 1 prescription medication?
 Yes
 No

4. During the past 6 months, have you helped a friend or family member manage
his or her prescription medications?
 Yes
 No
If ‘No’ to both 3 AND 4, then END THE SURVEY. If ‘Yes’ to either 3 OR 4, then
continue to the next page.

3

Appendix I: Face-to-face survey Instrument – patients/caregivers

Thank you for agreeing to participate in this survey! Your thoughtful responses
are important to us.

These questions ask about your thoughts on generic drug safety and
effectiveness.
5. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement.

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5











Generic drugs
are just as safe
as brand drugs











Generic drugs
are the same
quality as brand
drugs































Strongly
Disagree
1
Generic drugs
are just as
effective as
brand drugs

I believe a
cheaper
medication is of
lower quality
Generic drug
companies are
not as good as
brand drug
companies

4

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about your thoughts on generic drug cost.
6. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement.

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5































Many brand
drugs have
generic drug
alternatives











I have
resources to
help me get
information on
generic drug
availability and
cost











Generic drugs
cost less than
brand drugs
I prefer to use
generic drugs
because they
cost less
Brand drugs are
too expensive
for most people

Strongly
Disagree
1

5

Appendix I: Face-to-face survey Instrument – patients/caregivers

Now we will show you an example of an educational material about generic drugs
that we designed for patients and caregivers. Please take a few minutes to look
over the handout. After you look it over, we will ask you a few questions about its
content, format, and delivery.
Give about 3 minutes to look over the handout, then continue to the next page.

6

Appendix I: Face-to-face survey Instrument – patients/caregivers

Now that you've looked over the handout, please answer a few questions. There
are no right or wrong answers. We value your opinions.

These questions ask about your thoughts on generic drug safety and
effectiveness after seeing the handout.
7. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement.

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5



















































Strongly
Disagree
1
Generic drugs
are just as
effective as
brand drugs
Generic drugs
are just as safe
as brand drugs
Generic drugs
are the same
quality as
brand drugs
I believe a
cheaper
medication is
of lower quality
Generic drug
companies are
not as good as
brand drug
companies

7

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about your thoughts on generic drug cost after seeing the
handout.
8. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement.

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5



















































Strongly
Disagree
1
Generic drugs
cost less than
brand drugs
I prefer to use
generic drugs
because they
cost less
Brand drugs
are too
expensive for
most people
Many brand
drugs have
generic drug
alternatives
I have
resources to
help me get
information on
generic drug
availability and
cost

8

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about how you intend to get information on generic drugs
next time you need it.
9. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement.

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5









































Strongly
Disagree
1
I will ask my
pharmacist for
information
about generic
drugs
I will ask my
doctor for
information
about generic
drugs
I will ask my
prescription
insurance for
information
about generic
drugs
I will look for
information
myself about
generic drugs

9

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about how SURE you feel about choosing between a brand
and generic drug.
10. Please indicate YES or NO to each statement. When choosing between brand
and generic drugs...
Yes

No

Do you feel SURE about the
best choice for you?





Do you know the benefits and
risks of each option?













Are you clear about which
benefits and risks matter most
to you?
Do you have enough support
and advice to make a choice?

The questions on the next two pages ask about your thoughts on the handout's
CONTENT.

10

Appendix I: Face-to-face survey Instrument – patients/caregivers

11. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement. The handout...
Strongly
Disagree
1

Disagree
2

Neither Agree
nor Disagree
3

Agree
4

Strongly
Agree
5

Gave good
information about
generic drug
safety and
effectiveness











Gave good
information about
how generic drugs
are approved by
the FDA











Gave good
information about
generic drug cost











Gave useful
information on
resources for
generic drugs











Gave just the right
amount of
information about
generic drugs











Gave unbiased
information











Gave information
that was
interesting to me











Gave information
that was new to
me











Gave information
that will help me
manage
medications











Gave information
that I agree with











11

Appendix I: Face-to-face survey Instrument – patients/caregivers

12. On a scale of 1 to 5, where 1=Not at all Satisfied and 5=Very Satisfied, how
satisfied were you with the handout's content?






Not at all Satisfied=1
Slightly Satisfied=2
Fairly Satisfied=3
Satisfied=4
Very Satisfied=5

13. Please provide any comments about the handout's CONTENT.

12

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about your thoughts on the handout's FORMAT.

14. On a scale of 1 to 5, where 1=Strongly Disagree and 5=Strongly Agree, please
indicate how much you agree or disagree with each statement. The handout...

Disagree
2

Neither
Agree nor
Disagree
3

Agree
4

Strongly
Agree
5









































Was visually
appealing











Was well
organized











Was just the
right length











Was easy to
see































Strongly
Disagree
1
Was easy to
read
Was easy to
understand
Had a layout
that made
sense
Had just the
right amount of
writing

Loaded easily
on my
computer or
phone
Had a format
that was easy
for me to use

13

Appendix I: Face-to-face survey Instrument – patients/caregivers

15. On a scale of 1 to 5, where 1=Not at all Satisfied and 5=Very Satisfied, how
satisfied were you with the handout's format?






Not at all Satisfied=1
Slightly Satisfied=2
Fairly Satisfied=3
Satisfied=4
Very Satisfied=5

16. Please provide any comments about the handout's FORMAT.

14

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about your thoughts on the handout's DELIVERY.

17. From whom would you most prefer to receive a handout with information
about generic drugs?








Food and Drug Administration (FDA)
Your doctor's office
Your pharmacy
The hospital
Prescription insurance company
Pharmaceutical company
Other, please specify ____________________

18. How would you most prefer to receive a handout about generic drugs?









Email
Online website
Mobile app on your smartphone
Mail
At the doctor's office
At the pharmacy
At the hospital
Other, please specify ____________________

19. Please provide any comments about the handout's DELIVERY.

15

Appendix I: Face-to-face survey Instrument – patients/caregivers

These questions ask about your OVERALL SATISFACTION with the handout.

20. On a scale of 1 to 5, where 1=Not at all and 5=Completely, please indicate your
opinion for each statement.
Not at all
1

Slightly
2

Somewhat
3

A lot
4

Completely
5

How satisfied are
you with the
quality of the
handout?











How interesting
was the handout?









































How necessary
does this type of
handout seem?
How likely are you
to use this
handout to help
make decisions
between brand
and generic
drugs?
How confident
would you be in
recommending
this handout to
other patients or
caregivers?

16

Appendix I: Face-to-face survey Instrument – patients/caregivers

21. What did you LIKE MOST about the handout?

22. What did you LIKE LEAST about the handout?

23. Please provide any comments about HOW TO IMPROVE the handout for
patients and caregivers.

17

Appendix I: Face-to-face survey Instrument – patients/caregivers

Next, please tell us a bit about yourself.

24. What is your age?

25. What is your gender?
 Male
 Female

26. What is your race?







Caucasian/White
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
Native American or Alaska Native
Two or more races

27. What is your ethnicity?
 Hispanic or Latino(a)
 Not Hispanic or Latino(a)

28. What is your marital status?
 Single, never married
 Married or with partner
 Divorced, separated, or widowed

18

Appendix I: Face-to-face survey Instrument – patients/caregivers

29. What is your highest level of education completed?









Less than high school
High school graduate or GED
Trade/technical/vocational school
Some college
Associates degree
Bachelors degree
Masters degree
Doctoral degree

30. What is your annual household income?








Under $25,000
$25,000 to $34,999
$35,000 to $49,999
$50,000 to $74,999
$75,000 to $99,999
$100,000 to $149,999
$150,000 or more

31. What type of prescription insurance do you currently have for your primary
insurance?












None
From a current or former employer
COBRA
Purchased directly from an insurance company
Marketplace (Obamacare)
Medicare
Medicaid
Tricare or other military insurance
VA
Indian Health Service
Other, please specify ____________________

19

Appendix I: Face-to-face survey Instrument – patients/caregivers

32. How would you describe the area/community that you currently live in?
 Rural
 Suburban
 Urban

33. How many years have you been managing prescription medications for
yourself, family, or friends?

34. Have you ever been told by a doctor or other healthcare professional that you
have any of the following conditions? Please mark all that apply.











Heart disease
High blood pressure
High cholesterol
Diabetes
Asthma or COPD
Osteoporosis (low bone density)
Arthritis
Depression
Cancer
Other, please specify ____________________

Thank you for taking the time to fill out this survey!

20

Appendix I: Survey Collection Form – Honorarium
Contact Information for Survey Honorarium
If you provide your contact information, you will have the opportunity to receive a $25 as
a token of our appreciation for your participation. Would you like to provide your
contact information?

What is your first name?

What is your last name (family name)?

What is your Auburn University Banner ID (for faculty or staff)?

What is your mailing address?

What is your daytime telephone number?

What is your email address?


File Typeapplication/pdf
AuthorJennifer Howard
File Modified2018-02-22
File Created2018-02-21

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