Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (CDER)

Participant Screener—Phone/Online

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	10	10	18	16	54
Suburban	10	10	8	10	38
Rural	10	10	4	4	28
Total	30	30	30	30	120

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

3. Must not have participated in research-related focus groups or interviews in past month

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.”

[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 eye tracking to understand what readers look at. 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 will include looking at a computer screen and answering questions. We will also be using audio 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 includes eye tracking to understand what readers look at. You will be paid for your participation. The tasks you will be asked to perform will take place in a simulated environment and will include looking at a computer screen and answering questions. We will also be using audio equipment to record the session for the purposes of data collection.

[READ FOR ALL PARTICIPANTS]

In this study, we will be keeping any information you provide us private and confidential to the extent allowable by law. We will be keeping your personal information, such as your name and contact information, separate from all collected data during both the eligibility screening and study session. Screening information will be retained even if you decide not to participate. There are no direct benefits for participating and anticipated risks are minimal. Your decision to participate or not participate will have no effect on your employment with MedStar. Your participation is voluntary and you may withdraw from participating at any point of the study process.

[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, Single prescription reading glasses

Yes, bifocals, trifocals, or progressives (Go to Glasses2])

No (Go to MedConcerns)

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

Yes

No (Go to Glasses 2a)

Glasses 2a: Are you able to read on a computer screen without your glasses and avoiding distress to your eyes?

Yes

No [Hold participant]

MedConcerns. The eye-tracking equipment uses an infrared light that carries a risk of affecting people with photosensitive epilepsy or who use medical equipment that is sensitive to infrared light. Do you have any conditions like these that would cause concern?

Yes -> THANK AND TERMINATE

No

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

Within the last month-> THANK AND TERMINATE

More than a month ago

Never

Location. What is your current care center of employment? [RECORD ANSWER]

StudySession. What is your preferred location to have your study session? [RECORD ANSWER]

(Specific site location options may be provided as a multiple choice option)

We would like to track some demographic information for this study.

Hispanic/Latino. Are you Hispanic or Latino?

Hispanic or Latino

Not Hispanic or Latino

Refused

Race. What is your race? You may select one or more races. [READ LIST OF OPTIONS]

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or other Pacific Islander

White

Prefer not to answer

[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].

At this time, may I collect your email address and verify your phone number? [Record contact information separate from rest of screener data]

Email Address: __________________________________

Phone Number: __________________________________

In the chance that we are unable to conduct your study session at the confirmed date/time, could you please provide at least two additional dates/times that also work for your schedule (i.e., Thursday, 9/19 morning/afternoon)? [Record additional availability in screening tracker]

A confirmation email from Acuity Scheduling will be sent to your email shortly including details about your study location. If it has not been received within the next 5 minutes, please check your spam inbox. You will also receive an email two days before the study date to remind you of the upcoming session.

During the session and before participating, we will ask you to read and sign an informed consent form that has detailed information about the study, including what to expect, benefits and risks, privacy and confidentiality information, and details about the eye tracking. Please feel free to review this beforehand – a link to the document will be included in your confirmation email.

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.