Appendix A - Recruitment Script Screener

Data to Support Drug Product Communications

Appendix A - Recruitment Script Screener

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Appendix A:
One-on-One Interview Recruitment and Screener Scripts

Any text in curly brackets “{ }” indicates part of the script that will change based on the participant, or situation. The intended content (or content options) is indicated in the brackets.

Diagnosed Consumers

Email Screener

Subject: Interview for FDA Study on Selecting Medical Treatments

Hello, we are currently recruiting consumers for an upcoming research study sponsored by the Food and Drug Administration. The purpose of the study is to understand how people make decisions about medical treatment.

RTI International, an independent, non-profit research institute, will be conducting one-on-one online video interviews on this topic with consumers nationwide. The interview will take up to 60 minutes. Interviews will be scheduled between {DATE and DATE}. You will receive a {$50 | $75} gift card from your choice of a variety of top brands as a token of appreciation. To see if you are eligible, please complete the brief survey linked below. If you have any questions about the study, or prefer to complete the screening by phone, I can be reached at {EMAIL/PHONE}.

{Link to Screener: Subset of the Screener Questions Below}

Thank you for your time. Someone from L&E Research may contact you in a couple of days to finish the screening process if it looks like you will qualify for the study.

{Recruiter’s name}

{Signature line with phone number and email}



Email Follow-up to Non-Respondents

Subject: Participants Needed for Research Study

{Forward previous email}

Dear {NAME}:

I am from L&E Research and I recently sent an email inviting you to participate in an interview. As a reminder, we are conducting online video interviews about how people select medical treatments.

Your input is important, and your participation is greatly appreciated. If you are interested in participating, please click the link below to complete a brief screener by {DATE}. If you have any questions about the study, or prefer to complete the screening by phone, I can be reached at {EMAIL/PHONE}.

{Link to Screener: Subset of the Screener Questions Below}

Kind regards,

{RECRUITER’S NAME}

{Signature line with phone number and email}



Introduction: Telephone Screener

Hello, my name is _______________, and I’m calling from L&E Research on behalf of RTI International, a non-profit research organization working with the U.S. Food and Drug Administration on a research study. We are conducting online video interviews to learn more about the factors people consider when selecting medical treatments.

L&E Research is currently recruiting participants nationwide for this research study. The interview will last about one hour and will take place on {DATES}. As a token of appreciation for taking part in this study, you will receive your choice of a variety of rewards from top brands, either a prepaid e-gift card or a physical gift card equivalent to {$50 | $75}.

Before we continue, I want to let you know that the interviews will be conducted through online video conferencing and other members of the study team may observe. The interview will be audio recorded and transcribed. All recordings and transcript files will be kept on password protected computers at RTI and FDA and will only be accessible to study staff.

To protect your privacy, we ask that you only use your first name during the interview, and that you do not disclose personal information about yourself. Your name will not be associated with the recordings or transcript of your interview, and no one at FDA will have your full name or contact information. RTI project staff will have your phone number so that they can contact you if needed about your appointment. They will delete the records containing this information after your interview has been completed.

To see if you are eligible, I’d like to ask you some questions.

May I continue?

Yes CONTINUE

No [Thank respondent and end call.]



CONSENT TO RECORDING AND LIVESTREAM

  1. If you are eligible and agree to participate, do you consent to having your interview audio recorded?

Yes


CONTINUE

No


TERMINATE



  1. Do you consent to having your interview livestreamed?

Yes


CONTINUE

No


TERMINATE



CORE ELIGIBILITY CRITERIA

  1. What is your current age?

_____

IF Q1 < 18, TERMINATE



  1. Do you read and speak English fluently?

Yes


CONTINUE

No


TERMINATE



  1. Do you currently work in any of the following occupations?

Medical Doctor


TERMINATE

Any Other Type of Health Care Provider (Nurse, Physician Assistant)


TERMINATE

None of the above


CONTINUE



  1. Have you ever been diagnosed by a health care provider with any of the following conditions? (Select all that apply).

Allergies


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Asthma


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Chronic Pain


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

High Blood Pressure


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Psoriasis


CONTINUE

Type 2 Diabetes


CONTINUE

IF NEITHER DIABETES NOR PSORIASIS SELECTED TERMINATE

SCREEN FOR 50:50 MIX



  1. Are you currently receiving treatment for {TYPE 2 DIABETES/PSORIASIS}?

FOR TYPE 2 DIABETES: Treatment may include insulin or another medication.

FOR PSORIASIS: Treatment may include a medication or a cream or ointment.

Yes


CONTINUE

No


CONTINUE



  1. Do you currently work for any of the following organizations? (Occasional consulting is acceptable)

    US Department of Health and Human Services


    TERMINATE

    Pharmaceutical Company


    TERMINATE

    Market Research Firm


    TERMINATE

    RTI International


    TERMINATE

    None of the above


    CONTINUE

  2. Have you participated in an interview or focus group during the past three months?

Yes


TERMINATE

No


CONTINUE



TECHNOLOGY QUESTIONS

These interviews will take place via web-based video conferencing. The next few questions will involve technology – please answer these questions considering the location and computer you will be joining the interview from

  1. Do you have access to a reliable, high-speed Internet connection (i.e., DSL or broadband) at the location you will be joining the interview from?

Yes


CONTINUE

No


TERMINATE



  1. What type of computer will you be using to join the interview?

PC laptop or desktop


CONTINUE

Mac laptop or desktop


CONTINUE

Tablet or mobile device


TERMINATE



  1. Do you have a webcam installed or connected to your PC/MAC laptop or desktop?

Yes


CONTINUE

No


TERMINATE





DEMOGRAPHIC QUESTIONS

  1. What is your gender?

Male


CONTINUE

Female


CONTINUE

Prefer not to answer


CONTINUE

SCREEN FOR A MIX



  1. What is your race? Please select all that apply. [Read options below]

American Indian or Alaska Native


CONTINUE

Asian


CONTINUE

Black or African-American


CONTINUE

Native Hawaiian or other Pacific Islander


CONTINUE

White


CONTINUE

Prefer not to answer


CONTINUE

SCREEN FOR A MIX



  1. Are you Hispanic/Latino?

Yes


CONTINUE

No


CONTINUE

SCREEN FOR A MIX





  1. In what state do you currently live?

____________


CONTINUE

SCREEN FOR A MIX BASED ON THE FOLLOWING REGIONS:

Northeast: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, and Pennsylvania

South: Delaware, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, Washington D.C., West Virginia, Alabama, Kentucky, Mississippi, and Tennessee, Arkansas, Louisiana, Oklahoma, and Texas

Midwest: Illinois, Indiana, Michigan, Ohio, Wisconsin, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota

West: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming, Alaska, California, Hawaii, Oregon, and Washington



HEALTH LITERACY QUESTION

  1. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?



  1. Never


CONTINUE

  1. Rarely


CONTINUE

  1. Sometimes


CONTINUE

  1. Often


CONTINUE

  1. Always


CONTINUE

20% LOW HEALTH LITERACY QUOTA:

Include at least 7 participants with psoriasis and at least 7 participants with type 2 diabetes who have a score of 3 or higher








INTERVIEW INVITATION FOR ELIGIBLE PARTIIPANTS

Thank you for answering all my questions. Based on your responses, we would like to invite you to take part in the study.

If you agree to participate, we can schedule your online video interview now. Each interview will last about one hour, and we will audio record the discussion. You will receive a {$50 | $75} gift card from your choice of a variety of top brands after completing the discussion as a token of appreciation for your participation. May I schedule you?

Yes CONTINUE to scheduling.

No [Thank you for your interest.]

The interviews will take place on {DATES AND TIMES}. Which date and time would work best for you?

Great, we have you scheduled for an interview on {DATE/TIME}. I will be sending you a confirmation email with this date and time that will include instructions for accessing the interview. I will also be sending you an email with the informed consent form for the study. Please read the form carefully and reply indicating whether you agree or decline to participate. You won’t be able to participate unless we get your response. I will also call you a day or two before your scheduled appointment to remind you. If you need to reschedule or cancel your appointment, please contact me at {PHONE/EMAIL}.

CLOSING FOR INELIGIBLE PARTICIPANTS

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.



PHYSICIANS

Email Screener

Subject: Interview for FDA Study on Selecting Medical Treatments

Hello, we are currently recruiting physicians for an upcoming research study sponsored by the Food and Drug Administration. The purpose of the study is to understand how physicians make treatment decisions.

RTI International, an independent, non-profit research institute, will be conducting one-on-one online video interviews on this topic with physicians nationwide. The interview will take up to 60 minutes. Interviews will be scheduled between {DATE and DATE}. You will receive a $200 gift card from your choice of a variety of top brands as a token of appreciation. To see if you are eligible, please complete the brief survey linked below. If you have any questions about the study, or prefer to complete the screening by phone, I can be reached at {EMAIL/PHONE}.

{Survey Link: Survey will include a subset of the screener questions below}

Thank you for your time. Someone from L&E Research may contact you in a couple of days to finish the screening process if it looks like you will qualify for the study.

{Recruiter’s name}

{Signature line with phone number and email}



Email Follow-up to Non-Respondents

Subject: Participants Needed for Research Study

{Forward previous email}

Dear {NAME}:

I am from L&E Research and I recently sent an email inviting you to participate in an interview. As a reminder, we are conducting online video interviews about how physicians make treatment decisions.

Your input is important, and your participation is greatly appreciated. If you are interested in participating, please click the link below to complete a brief screener by {DATE}. If you have any questions about the study, or prefer to complete the screening by phone, I can be reached at {EMAIL/PHONE}.

{Link to Screener: Subset of the Screener Questions Below}

Kind regards,

{RECRUITER’S NAME}

{Signature line with phone number and email}



Introduction: Telephone Screener

Hello, my name is _______________, and I’m calling from L&E Research on behalf of RTI International. We are conducting online video interviews to learn more about how physicians make treatment decisions.

L&E Research is currently recruiting participants nationwide for this research study. The interview will last about one hour and will take place on {DATES}. As a token of appreciation for taking part in this study, you will receive your choice of a variety of rewards from top brands, either a prepaid e-gift card or a physical gift card equivalent to $200.

Before we continue, I want to let you know that the interviews will be conducted through online video conferencing and other members of the study team may observe. The interview will be audio recorded and transcribed. All recordings and transcript files will be kept on password protected computers at RTI and FDA and will only be accessible to study staff.

To protect your privacy, we ask that you only use your first name during the interview, and that you do not disclose personal information about yourself. Your name will not be associated with the recordings or transcript of your interview, and no one at FDA will have your full name or contact information. RTI project staff will have your phone number so that they can contact you if needed about your appointment. They will delete the records containing this information after your interview has been completed.

To see if you are eligible, I’d like to ask you some questions.

May I continue?

Yes CONTINUE

No [Thank respondent and end call.]

CONSENT TO RECORDING AND LIVESTREAMING

  1. If you are eligible and agree to participate, do you consent to having your interview audio recorded?

Yes


CONTINUE

No


TERMINATE



  1. Do you consent to having your interview livestreamed?

Yes


CONTINUE

No


TERMINATE



CORE ELIGIBILITY CRITERIA AND MEDICAL PRACTICE BACKGROUND

  1. Are you a…?

Primary Care Physician (Family Practice, Internal Medicine, General Practitioner)


CONTINUE (GO TO Q5)

Specialist Physician


CONTINUE (GO TO Q4)

Any Other Type of Health Care Provider (Nurse, Physician Assistant)


TERMINATE

None of the above


TERMINATE



  1. {IF SPECIALIST PHYSICIAN SELECTED FOR Q3} What is your primary area of specialization (e.g., Internal Medicine, Gastroenterology, etc.)?

{OPEN ENDED}

  1. Are you currently practicing medicine?

    Yes


    CONTINUE

    No


    TERMINATE

  2. What percentage of your time do you spend providing direct patient care? Your best estimate is fine.

50% or higher


CONTINUE

Less than 50%


TERMINATE



  1. Which of the following conditions do you treat? (Select all that apply).

Allergies


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Asthma


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Chronic Pain


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Hypertension


TERMINATE (if Type 2 Diabetes or Psoriasis not selected)

Psoriasis


CONTINUE

Type 2 Diabetes


CONTINUE

IF NEITHER DIABETES NOR PSORIASIS SELECTED TERMINATE

IF BOTH DIABETES AND PSORIASIS SELECTED CONTINUE TO Q7

IF ONLY ONE OF DIABETES OR PSORIASIS SELECTED CONTINUE TO Q8 OR Q9



  1. {IF BOTH DIABETES AND PSORIASIS SELECTED FOR Q7} You mentioned you treat both type 2 diabetes and psoriasis. Between these two conditions, which would you say you treat more often?

Type 2 Diabetes


CONTINUE

Psoriasis


CONTINUE

SCREEN FOR 50:50 SPLIT of Diabetes or Psoriasis as condition treated most frequently



  1. {IF DIABETES SELECTED FOR Q7} In a typical week, how many prescriptions do you write for type 2 diabetes treatments? Your best estimate is fine.

_____

CONTINUE



  1. {IF PSORIASIS SELECTED FOR Q7} In a typical week, how many prescriptions do you write for psoriasis treatments? Your best estimate is fine.

_____

CONTINUE



  1. Do you currently work for any of the following organizations? (Occasional consulting is acceptable).

US Department of Health and Human Services


TERMINATE

Pharmaceutical Company


TERMINATE

Market Research Firm


TERMINATE

RTI International


TERMINATE

None of the above


CONTINUE



  1. Have you participated in an interview or focus group during the past three months?

Yes


TERMINATE

No


CONTINUE



TECHNOLOGY QUESTIONS

These interviews will take place via web-based video conferencing. The next few questions will involve technology – please answer these questions considering the location and computer you will be joining the interview from

  1. Do you have access to a reliable, high-speed Internet connection (i.e., DSL or broadband) at the location you will be joining the interview from?

Yes


CONTINUE

No


TERMINATE



  1. What type of computer will you be using to join the interview?

PC laptop or desktop


CONTINUE

Mac laptop or desktop


CONTINUE

Tablet or mobile device


TERMINATE



  1. Do you have a webcam installed or connected to your PC/MAC laptop or desktop?

Yes


CONTINUE

No


TERMINATE



DEMOGRAPHIC QUESTIONS

  1. What is your gender?

Male


CONTINUE

Female


CONTINUE

Prefer not to answer


CONTINUE

GENDER IDENTITY SOFT QUOTA (~60% MALE/~40% FEMALE):

Aim to include about 20 male participants and about 15 female participants; screen for a mix by gender who treat psoriasis and type 2 diabetes.





  1. What is your race? Please select all that apply. [Read options below]

American Indian or Alaska Native


CONTINUE

Asian


CONTINUE

Black or African-American


CONTINUE

Native Hawaiian or other Pacific Islander


CONTINUE

White


CONTINUE

Prefer not to answer


CONTINUE

SCREEN FOR A MIX





  1. Are you Hispanic/Latino?

Yes


CONTINUE

No


CONTINUE

SCREEN FOR A MIX





  1. In what state(s) are you currently practicing?

____________


CONTINUE

SCREEN FOR A MIX BASED ON THE FOLLOWING REGIONS:

Northeast: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, and Pennsylvania

South: Delaware, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, Washington D.C., West Virginia, Alabama, Kentucky, Mississippi, and Tennessee, Arkansas, Louisiana, Oklahoma, and Texas

Midwest: Illinois, Indiana, Michigan, Ohio, Wisconsin, Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota

West: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming, Alaska, California, Hawaii, Oregon, and Washington



  1. How long have you been practicing medicine?

Less than 5 years


CONTINUE

6-10 years


CONTINUE

11-20 years


CONTINUE

21-30 years


CONTINUE

31 or more years


CONTINUE

SCREEN FOR A MIX





  1. How would you classify your practice?

Solo


CONTINUE

Small group practice (2-10 HCPs)


CONTINUE

Large group practice (>10 HCPs)


CONTINUE

SCREEN FOR A MIX



  1. Do you practice at an academic or teaching hospital?

Yes


CONTINUE

No


CONTINUE



INTERVIEW INVITATION FOR ELIGIBLE PARTICIPANT

Thank you for answering all my questions. Based on your responses, we would like to invite you to take part in the study.

If you agree to participate, we can schedule your online video interview now. Each interview will last about one hour, and we will audio record the discussion. You will receive a $200 gift card from your choice of a variety of top brands after completing the discussion as a token of appreciation for your participation. May I schedule you?

Yes CONTINUE to scheduling.

No [Thank you for your interest.]

The interviews will take place on {DATES AND TIMES}. Which date and time would work best for you?

Great, we have you scheduled for an interview on {DATE/TIME}. I will be sending you a confirmation email with this date and time that will include instructions for accessing the interview. I will also be sending you an email with the informed consent form for the study. Please read the form carefully and reply indicating whether you agree or decline to participate. You won’t be able to participate unless we get your response. I will also call you a day or two before your scheduled appointment to remind you. If you need to reschedule or cancel your appointment, please contact me at {PHONE/EMAIL}.

CLOSING FOR INELIGIBLE PARTICIPANTS

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

F-16


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