Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs

Data to Support Drug Product Communications

Screener for HCP Risk Processing Interviews

Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs

OMB: 0910-0695

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Participant ScreenerPhone


FDA Healthcare Professional Interviews:

Risk Processing for Newly Promoted Prescription Drugs


RECRUITMENT CRITERIA

  1. Recruit n = 120

    1. Prescribers

  2. Inclusion Criteria:

    1. Healthcare professionals:

      1. Primary care physician (PCP)

      2. Specialists: endocrinologist or neurologist

      3. Nurse practitioner (NP)

      4. Physician assistant (PA)

      5. Soft quotas:


Location/Description

Sample Size

Total

PCP

Specialist

NP

PA

Urban

MedStar Washington Hospital Center located in Washington, DC

10

10

18



16


54

Suburban

MedStar Southern Maryland’s Hospital

Clinton, MD

10

10

8

10

38

Rural

MedStar St. Mary’s Hospital

Leonardtown, MD

10

10

4

4

28

Total

30

30

30

30

120


    1. Spends substantial time on direct patient care (≥ 50% for PCPs, NPs, and PAs; ≥ 20% for specialists)

    2. Must not have participated in research-related focus groups or interviews in past three months


THANK AND TERMINATE MESSAGE

  • If ineligible, please say:

“Thank you for your time. You do not qualify to participate in the current study. Please continue to check for opportunities to participate in research through the MedStar Health System.”


[INTRO TEXT FOR COLD CALL]

Hello, I am [NAME] with [ORGANIZATION]. I’m calling for [PARTICIPANT NAME] regarding an opportunity to participate in a new research study.


This project is aimed toward understanding how prescribers process prescription drug information. This is not a clinical study; it will involve looking at prescription drug information and includes an eye-tracking component. If you choose to participate, your session will be scheduled for one hour during [TIME FRAME] at [LOCATION]. You will be paid for your participation. The tasks you will be asked to perform will take place in a simulated environment and you will not be asked to perform any tasks on yourself or a patient. We will also be using audio and video equipment to record the session for the purposes of data collection.


Are you interested in participating?

Yes

No -> THANK AND TERMINATE


[INTRO TEXT FOR FOLLOW-UP CALL AFTER PARTICIPANT HAS EXPRESSED INTEREST VIA RESPONSE TO EMAIL/FLYER]

Hello, I am [NAME] with [ORGANIZATION]. I’m calling for [PARTICIPANT NAME] regarding their interest in participating in a new research study.


Thank you for your interest. This study will involve looking at prescription drug information and involves an eye-tracking component. You will be paid for your participation. The tasks you will be asked to perform will take place in a simulated environment and you will not be asked to perform any tasks on yourself or a patient. We will also be using audio and video equipment to record the session for the purposes of data collection.


[Please record answers for all questions]


First, I need to ask a few questions to see if you qualify for the study.


Prescriber. Are you currently a primary care physician, specialist, nurse practitioner, or physician assistant with prescribing authority?


Yes, primary care physician. (Go to TimePtCare)

Yes, specialist. (Go to Specialist)

Yes, nurse practitioner. (Go to TimePtCare)

Yes, physician assistant. (Go to TimePtCare)

No -> THANK AND TERMINATE



Specialist. What is your medical specialty? [DO NOT READ OPTIONS ALOUD]


Endocrinology

Neurology

Other-> THANK AND TERMINATE

TimePtCare. About how much time do you spend on direct patient care? [DO NOT READ OPTIONS ALOUD]

Less than 20%

20–50%

50–70%

More than 70%


If the participant is a PCP, NP, and PA, he or she must spend at least 50% of time on direct patient care to qualify.


If participant is a specialist, he or she must spend at least 20% of time on direct patient care to qualify.


OTHERWISE, THANK AND TERMINATE.


Glasses1. Do you require glasses for reading?


Yes (Go to Glasses2)

No (Go to PriorResearch)



Glasses2. Can you wear contacts to the session rather than reading glasses? For the eye-tracking portion, we have more successful calibration when participants do not wear glasses.

Yes

No


[NEW SCREEN]

PriorResearch. When, if ever, was the last time you participated in an interview or focus group? [DO NOT READ OPTIONS]


Within the past three months -> THANK AND TERMINATE

More than three months ago

Never



[IF INELIGIBLE: THANK AND TERMINATE]

Thank you for your time. You do not qualify to participate in the current study. Please continue to check for opportunities to participate in research through the MedStar Health System.


[IF ELIGIBLE: SCHEDULE (see calendars)]

You are eligible to participate in the current study.

[For PCPs:] You will be paid $150 for your participation.

[For specialists:] You will be paid $175 for your participation.

[For NPs/PAs:] You will be paid $100 for your participation.


This one-hour section will be conducted at [LOCATION] on [DATE] at [TIME].

You will also receive a call or email two days before the study date to remind you of the upcoming session. At this time, may I collect your email address and verify your phone number?

Email Address: __________________________________

Phone Number: __________________________________

Please feel free to call me if you have any questions. My phone number is [PHONE NUMBER] and again my name is [NAME].

Thank you very much! We appreciate your time and look forward to seeing you soon.



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AuthorBetts, Kevin
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File Created2021-01-21

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