IMPROVE Study Phase 2

Data to Support Drug Product Communications as Used by the Food and Drug Administration

FDA IMPROVE SURVEY

IMPROVE Study Phase 2

OMB: 0910-0695

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Survey Design
Individual participants will be randomized to one of four blocks. Each block has one of four different
combinations of [A – WHOM] and [C – PATIENT DRUG PREFERENCE] that are held constant over two
vignettes. Two sets of identical questions per vignette will vary [B – MESSAGE]. [D – DRUG] will vary
between vignettes. The order of the vignettes and question sets will be randomized.
VIGNETTE 1
VIGNETTE 2
a0b0 c0d0
a0b1 c0d0 a0b0 c0d1 a0b1 c0d1
BLOCK 1
(A0C0)
a0b0 c1d0
a0b1 c1d0 a0b0 c1d1 a0b1 c1d1
BLOCK 2
(A0C1)
a1b0 c0d0
a1b1 c0d0 a1b0 c0d1 a1b1 c0d1
BLOCK 3
(A1C0)
a1b0 c1d0
a1b1 c1d0 a1b0 c1d1 a1b1 c1d1
BLOCK 4
(A1C1)
Variables:
[A – WHOM]
 a0 FDA – “from/by the FDA”
 a1 professional societies – “from/by your professional society”
[B – MESSAGE]
 b0 “equally as effective as”
 b1 “bioequivalent to”
[C – PATIENT DRUG PREFERENCE]
 c0 neutral – “has never expressed a preference for brand or generic drugs”
 c1 brand name preference – “expressed concern that the generic drug will not work for her”
[D – DRUG]
 d0 “antidepressants”
 d1 “oral contraceptives”

Survey
A preview of the survey is available through the following link:
https://qtrial2016q3az1.qualtrics.com/SE/?SID=SV_8iVlufkwzVUpaF7
Note: The following vignette questions demonstrate how the vignette questions are presented to a participant
within one of the four blocks. The bolded text in brackets (i.e. [D-DRUGa]) shows how the variables are
presented and change within a given block.
As mentioned above, the [A-WHOM] and [C-PATIENT DRUG PREFERENCE] variables remain constant
throughout the vignettes within each block.

Since [B – MESSAGE] and [D – DRUG] variables change between the vignettes in a given block and the order
of the vignettes would be randomized, [B – MESSAGEa] represents the first message variable option while [B –
MESSAGEb] demonstrates the second variable option. The same is true for [D – DRUGa] and [D – DRUGb].
For example, suppose a participant in Block 1 receives the following structures for vignettes 1 and 2, respectively:
Vignette 1: a0b0c0d0 a0b1c0d0
Vignette 2: a0b0c0d1 a0b1c0d1
In this situation for Block 1, [A-WHOMa] corresponds to a0= “from/by the FDA” and [C-PATIENT DRUG
PREFERENCEa] corresponds to c0= “has never expressed a preference for brand or generic drugs”. Since the
first vignette structure is a0b0c0d0, [B – MESSAGEa] corresponds to b0= “equally as effective as”, making [B –
MESSAGEb] represent b1= “bioequivalent to”. Similarly, [D – DRUGa] corresponds to d0=“antidepressants”
and [D – DRUGb] corresponds to d1=“oral contraceptives”. As a result, the questions for the first vignette in this
situation would be presented as follows:
Questions:
1. How often do you prescribe [DRUGa: antidepressants]?
The following questions pertain to the bolded text below:
One of your patients comes to your clinic for a medication refill. She is currently taking a brand name [DRUGa:
antidepressants]. She has no complaints and is doing well. In previous visits, the patient [PATIENT
PREFERENCEa: has never expressed a preference for brand or generic drugs].
Recently you received a notification from [WHOMa: the FDA]. The message highlighted the importance of
prescribing generic [DRUGa: antidepressants] since they are [MESSAGEa: equally as effective as] brand name
[DRUGa: antidepressants].
2. How likely are you to discuss switching from a brand name to generic [DRUGa: antidepressants] with
your patient?
3. How likely are you to prescribe this patient a generic [DRUGa: antidepressants]?
What if the message from [WHOMa: the FDA] highlighted the importance of prescribing generic [DRUGa:
antidepressants]since they are [MESSAGEb: bioequivalent to] brand name [DRUGa: antidepressants]?
4. How likely are you to discuss switching from a brand name to generic [DRUGa: antidepressants] with
your patient?
5. How likely are you to prescribe this patient a generic [DRUGa: antidepressants]?

SURVEY QUESTIONS
Introduction:
The aim of this survey is to gather your opinions and perspectives on generic prescribing. Please note that once
you start the survey you cannot go back to questions you already answered.
Your participation in this survey is voluntary and you can exit at any time. Submission of this survey is
considered implied consent. Any responses you provide will be confidential. If you have any questions, please
contact the ACP/AANP Research Department by email at  or phone at .
This survey will take approximately 12 minutes.
Questions:
6. How often do you prescribe [D – DRUGa]?
All the time

Quite often

Moderately often

Sometimes

Rarely or never

The following questions pertain to the bolded text below:
One of your patients comes to your clinic for a medication refill. She is currently taking a brand name [D –
DRUGa]. She has no complaints and is doing well. In previous visits, the patient [C – PATIENT DRUG
PREFERENCEa].
Recently you received a notification from [A – WHOMa]. The message highlighted the importance of
prescribing generic [D – DRUGa] since they are [B – MESSAGEa] brand name [D – DRUGa].
7. How likely are you to discuss switching from a brand name to generic [D – DRUGa] with your patient?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

8. How likely are you to prescribe this patient a generic [D – DRUGa]?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

What if the message from [A – WHOMa] highlighted the importance of prescribing generic [D – DRUGa] since
they are [B – MESSAGEb] brand name [D – DRUGa]?
9. How likely are you to discuss switching from a brand name to generic [D – DRUGa] with your patient?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

10. How likely are you to prescribe this patient a generic [D – DRUGa]?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

Now consider the same scenario but with respect to [D – DRUGb]
11. How often do you prescribe [D – DRUGb]?
All the time

Quite often

Moderately often

Sometimes

Rarely or never

The following questions pertain to the bolded text below:
One of your patients comes to your clinic for a medication refill. She is currently taking a brand name [D –
DRUGb]. She has no complaints and is doing well. In previous visits, the patient [C – PATIENT DRUG
PREFERENCEa].
Recently you received a notification from [A – WHOMa]. The message highlighted the importance of
prescribing generic [D – DRUGb] since they are [B – MESSAGEa] brand name [D – DRUGb].
12. How likely are you to discuss switching from a brand name to generic [D – DRUGb] with your patient?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

13. How likely are you to prescribe this patient a generic [D – DRUGb]?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

What if the message from [A – WHOMa] highlighted the importance of prescribing generic [D – DRUGb] since
they are [B – MESSAGEb] brand name [D – DRUGb]?
14. How likely are you to discuss switching from a brand name to generic [D – DRUGb] with your patient?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

15. How likely are you to prescribe this patient a generic [D – DRUGb]?
Extremely
likely

Somewhat
likely

Neither likely
nor unlikely

Somewhat
unlikely

Extremely
unlikely

KNOWLEDGE QUESTIONS
16. In general, generic drugs are as effective as their corresponding brand name versions.
Strongly
Somewhat
Neither agree
Somewhat
Strongly
agree
agree
nor disagree
disagree
disagree
17. In general, generic drugs are as safe as their corresponding brand name versions
Strongly
agree

Somewhat
agree

Neither agree
nor disagree

Somewhat
disagree

Strongly
disagree

18. In general, generic drugs do not cause more adverse events than their corresponding brand name
versions.
Strongly
agree

Somewhat
agree

Neither agree
nor disagree

Somewhat
disagree

Strongly
disagree

19. Generic drugs approved by the FDA are substitutable for brand name counterparts.
Strongly
agree

Somewhat
agree

Neither agree
nor disagree

Somewhat
disagree

Strongly
disagree


File Typeapplication/pdf
File TitleFDA IMPROVE 3
AuthorQualtrics
File Modified2016-10-03
File Created2016-10-03

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