0920-20PT Moderator Guide-IDI_Physician

ATTACHMENT 3c: MODERATOR’S GUIDE

OMB No. 0920-0572

Exp. Date 08/31/2021

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INTERVIEW GUIDE (PHYSICIANS)

February 5, 2020 FINAL

60-Minute Interviews With

Board Certified Practicing MDs and DOs (Physicians)

About Tuberculosis*

Interview Composition:

Audience	Los Angeles, CA	Houston, TX	New York, NY
Interviews Per Location	4	4	4
Total Interviews	12 interviews

DIRECTIONS TO MODERATOR:

• Sections of the guide are marked by gray boxes. Each section is given a time estimate and additional details on rationale or goal of each section.

• Instructions for the Moderator are noted with ALL-CAPS and marked in bold.

• Questions are numbered. Some questions include sub-questions. These are marked by letters.

• Probes are listed as “probes” under the questions. They are listed as additional points to bring up if participant gets off track or does not provide a detailed response.

• TOTAL INTERVIEW TIME IS APPROXIMATELY 60 MINUTES

DISCUSSION OVERVIEW:

60 minutes

1. Background & Introductions (5 minutes)

2. Patient Population & Cultural Considerations (5 minutes)

3. General Knowledge & Awareness of TB/latent Tb infection (5-7 minutes)

4. Guidelines & Testing of TB/latent TB infection (10 minutes)

5. Treatment of TB/latent TB infection (15 minutes)

6. Material Review (15 minutes)

7. Wrap-up (3 minutes)

1. BACKGROUND & INTRODUCTIONS (5 MINUTES)

Moderator Introduction (2 min.)

1. Thank you for taking the time to speak with me today. I appreciate your time and feedback.

2. My name is [INSERT]. I’m an independent interviewer with GC Global Research.

3. The sole sponsor of this interview is The Centers for Disease Control and Prevention—CDC. Our conversation today will focus on a health topic.

4. I’m a professional researcher, but not a CDC employee or a subject matter expert on health topics. I’ll be leading our conversation today, which will last up to 1 hour.

5. During this time, I will be sharing information with you to look at.

6. There are no wrong answers, I am simply interested in your full and honest opinion. However, if you feel uncomfortable answering a particular question, you do not have to respond.

7. Because privacy is important, I’m going to read our Privacy Policy to you. READ:

   1. We will protect your privacy for today’s discussion, and nothing you say will be reported in association with your name.

      1. Your name will not be included in any reports. We are talking to multiple physicians. Comments from everyone will be compiled into a single report for the project sponsor and is for internal use only.

      2. So that I don’t have to take notes, I’d like to record our conversation so we have an accurate record for reporting.

      3. We ask that you not share any information from today’s discussion with others.

Participant Introduction (3 min.)

8. Ok, thanks again for joining me today. We are having discussions with physicians in a few different cities. I’ve already told you a bit about me; to start, could you please introduce yourself. Tell me:

   1. Where you practice medicine (state, city)

   2. About your medical practice (size, specialty, health issues you see most often, and any emerging challenges)

   3. In thinking about how you stay updated on new clinical developments and guidelines, what digital or online resources do you use most frequently?

2. PATIENT POPULATION & CULTURAL CONSIDERATIONS (5 MINUTES)

The goal of this section is to warm-up and understand the physician’s patient population and how he or she communicates with them, specific to the at-risk populations included in this project.

Let’s start off by talking about your patient population.

1. What does your patient population look like demographically?

   1. PROBE: What are the ranges of ages you typically see?

   2. PROBE: Do you see patients of all income levels? What about the education levels of your patients?

2. What are the largest racial and ethnic populations that you see and treat?

   1. Are there any specific health concerns that affect this population at higher rates than other populations? LISTEN FOR MENTIONS OF TB/latent TB infection

3. What language do you use to communicate with your [Chinese/Filipino/Indian/Vietnamese] patients?

   1. PROBE: Do you have some patients that speak their native language only?

   2. Do you ever experience language barriers when communicating with your patients?

      1. IF YES, PROBE: What types of barriers do you encounter?

   3. How have you overcome or avoided cultural and/or language barriers that might arise when delivering health care to this population?

      1. PROBE: Do you have tools or resources that help you navigate cultural barriers?

      2. PROBE: Do you rely on any specific educational materials? IF YES: What are they and how do you utilize them?

3. GENERAL KNOWLEDGE & AWARENESS OF TB/LATENT TB INFECTION

(5-7 MINUTES)

The goal of this section is to understand the physician’s knowledge about TB and latent TB infection, including its seriousness, prevalence and risk factors.

Next, I’d like to discuss topics related to specific diseases and infections that you see and treat in your practice.

1. Thinking specifically about your [Chinese/Filipino/Indian/Vietnamese] patient populations, are there certain diseases that you regularly test for? LISTEN FOR MENTIONS OF TB/LATENT TB INFECTION AND DIABETES.

   1. IF NO MENTION OF INFECTIOUS DISEASE: What about infectious diseases?

2. For the remainder of our discussion today, we are going to talk specifically about tuberculosis disease, or TB, and latent tuberculosis infection, or latent TB infection. What first comes to mind when you hear TB?

   1. PROBE: How familiar are you with TB?

   2. PROBE: How familiar are you with latent TB infection?

   3. PROBE: Where do you hear about it currently, and in what context? Who is talking about it? What are they saying?

3. Let’s talk about each of these conditions individually. First, let’s discuss TB disease.

   1. In your opinion, how serious of a problem is tuberculosis disease in the United States? What about in your state? What about in your city?

      1. PROBE: What about among your patient population?

   2. In your opinion, how common is tuberculosis disease in the U.S.? What about in your state? What about in your city?

      1. PROBE: What about among your patient population?

   3. What are some of the risk factors for contracting and developing TB?

4. Now let’s talk about latent TB infection.

   1. How serious of a problem is latent TB infection in the U.S.? What about in your state? What about in your city?

      1. PROBE: What about among your patient population?

   2. How prevalent is latent TB infection in the U.S.?

      1. PROBE: What about among your patient population?

   3. What are some of the risk factors for latent TB infection?

      1. PROBE: What are the risk factors that lead to an increased likelihood of latent TB infection developing into TB disease?

   4. How do you diagnose latent TB infection in your practice setting?

   5. How do you treat latent TB infection?

      1. PROBE: If you need to look up information about treatment regimens for latent TB infection, what would be your first go-to resource?

         1. PROBE: What about resources like colleagues and infectious disease specialists? What about websites? Which websites do you frequent? What about medical apps like UptoDate, Epocrates, or Medscape?

      2. PROBE: Are you familiar with the shorter treatment regimens, specifically the 3-month regimen of Isoniazid (INH) and Rifapentine (RPT) and the 4-month regimen of Rifampin?

5. HAND OUT LEVEL-SETTING MATERIAL AND READ ALOUD: Here is some brief information about tuberculosis. I will give you a few minutes to review it. Once you’ve finished, we will discuss it.

   1. What is your reaction to this information?

   2. Is any of this new information to you? IF SO: What is new?

   3. What is your reaction to these recommendations?

      1. PROBE: How familiar are you with the recommendations?

4. GUIDELINES & TESTING OF TB/LATENT TB INFECTION (10 MINUTES)

The goal of this section is to explore the prevalence of TB/LTBI in the physician’s practice, their testing and treatment protocols within their practice, and their level of knowledge of the TB/latent TB infection guidelines.

1. Let’s now discuss how much TB and latent TB infection you see in your practice.

   1. Can you estimate the proportion of your patients that you test for TB, both TB disease and latent TB infection? Your best guess if fine.

   2. And of that proportion, how many cases of TB disease have you identified in the last year? What about the last five years? MODERATOR NOTE NUMBER OF CASES AND REFER TO IT IN SECTION V.

   3. And how many of the cases of latent TB infection have you seen in the last year? What about the last five years? Your best guess is fine.

   4. And how many cases of latent TB infection in your patients were identified outside of your own testing?

2. Let’s discuss reasons for testing patients for TB. Typically, when would you test a patient for TB?

   1. PROBE: What protocols does your practice have in place for testing for TB?

   1. If you can, please walk me through the protocols and procedures.

LISTEN FOR KNOWLEDGE OF TESTING OPTIONS, INCLUDING THE TB BLOOD TEST, AND BCG. PROBE TO DETERMINE IF EHR PROMPTS FOR TESTING AND THE TRIGGERS.

1. IF NO PROTOCOL/EXPERIENCE: If you did have a patient you suspected might be at risk for TB or latent TB infection, what steps would you take then?

1. I have a list of factors here and I am going to read them to you. For each, please tell me whether you would generally test for TB if the factor is present.

   1. MODERATOR READ LIST OF FACTORS AND RECORD ANSWERS

      1. Patient was born in a country where TB disease is common

      2. Patient has spent time with someone who has TB disease

      3. Patient has a history of incarceration or has worked in a correctional facility

      4. Patient has lived or worked in a long-term care facility, nursing home, or homeless shelter

      5. Patient is HIV positive

      6. Patient has a history of injection drug use

      7. Patient has another illness that weakens their immune system, or is taking medications that suppress the immune system such as corticosteriods

      8. Patient has been diagnosed previously with latent TB infection

1. What are some other considerations you take into account when deciding to test a patient?

   1. PROBE: What about considerations like benefits/potential complications, insurance, billing, reimbursement, CDC guidelines, EMR, and priorities/policies of your practice?

2. Which TB test do you typically use—the TB blood test or the skin test? For what reasons?

   1. PROBE: What are some reasons or scenarios where you wouldn’t recommend the TB blood test? What if the patient has had the BCG vaccine?

3. Where do you go for information and guidelines related to TB and latent TB infection?

   1. LISTEN FOR CDC AND PROBE FOR OTHER CREDIBLE SOURCES

4. I want you to imagine that it’s your responsibility to increase latent TB infection testing in your practice setting. Your goal is to test 100% of your high-risk patients.

   1. What would you need to do to accomplish this goal?

   2. What would you worry about getting in the way of accomplishing that goal?

      1. PROBE: What about clinic-related barriers like time, training, supplies, costs, insurance, or EMR? What about patient-related barriers like communication, culture, or stigma?

c) What are some solutions you think might resolve these issues?

5. TREATMENT OF TB/LATENT TB INFECTION (15 MINUTES)

The goal of this is to understand how physicians determine how to treat their patients with TB and/or latent TB infection and the challenges they (and their patients) may face.

1. Now I’d like to turn our attention to your process for treatment of TB and latent TB infection. Which treatment regimens are you aware of for TB and latent TB infection?

   1. PROBE: What about shorter treatment regimens for latent TB infection, specifically the 3-month regimen of Isoniazid (INH) and Rifapentine (RPT)?

   2. What considerations do you think about when making a treatment recommendation?

      1. PROBE: What about the patient’s clinical situation, including issues like HIV positive, liver function, etc.? What about the benefits/potential complications like insurance, billing, reimbursement, CDC guidelines, EMR, or priorities/policies of your practice?

IF TIME PERMITS AND PROVIDER HAS SEEN TB/latent TB infection IN THEIR PRACTICE, ASK:

2. Earlier you said you have seen [INSERT NUMBER] of TB cases and/or [INSERT NUMBER] of latent TB infection cases over the last year. IF NO, MODERATOR TO SKIP AND MOVE ON TO QUESTION 3

   1. IF YES: Can you pick one case and walk me through it, from start to finish—what prompted testing, what you did? [NOTE TO MODERATOR: PRIORITIZE THE latent TB infection CASE(S)]

      1. PROBE: What prompted testing?

      2. PROBE: What tests were ordered, including follow-up tests?

      3. PROBE: What discussions occurred with patients? How did you explain TB/latent TB infection to them? What were their reactions and concerns?

         1. PROBE: What are some of the things you said or did to help them understand the test result?

         2. PROBE: Stigma or embarrassment?

      4. PROBE: What was the ultimate treatment recommendation? How did you arrive at that decision?

      5. PROBE: What interaction, if any, did you have with the public health department and other experts?

      6. Did you consult any other references such as medical reference apps, CDC website, others?

3. Now, imagine again that you are doing more testing for TB and you have more patients with positive diagnoses for latent TB infection.

1. What, if anything, would you need to do in order to make it viable for your practice setting to treat these patients?

1. PROBE: What about clinic-related barriers like time, training, supplies, role of support staff for managing side effects, monitoring treatment, costs, insurance, or EMR? What about patient-related barriers like communication, culture, or stigma?

2. What are some solutions you think might resolve these issues?

6. MATERIAL REVIEW (15 MINUTES)

The goal of this section is to test messages to motivate (a) testing for TB/latent TB infection and (b) to get treated for latent TB infection.

1. Now let’s look at some information about TB. The last item on our agenda tonight is to review some information and get your feedback. This is information that would be included in materials specifically for healthcare providers about tuberculosis. This information was created specifically for you and it is not final. It is important to remember that we want your full and honest feedback. I did not create these messages and won’t feel offended by your opinions. Again, we only want your full and honest opinion.

[MESSAGE CATEGORIES WILL BE SHOWN IN ORDER, EACH MESSAGE TYPED ON A SINGLE SHEET OF PAPER, AND MESSAGES RANDOMIZED WITHIN EACH CATEGORY. RESPONDENT WILL NOT SEE THE MESSAGE CATEGORIES. EACH MESSAGE WILL BE HANDED OUT SEPARATELY]

Here is the first statement [MODERATOR TO HAND OUT FIRST MESSAGE]. I will read the statement aloud. Please also take a moment to read this silently to yourself. As you review, please circle things you like about this statement and cross out things you don’t like or find confusing.

Additionally, please rate the statement using a 1-5 scale, where 1 means not at all compelling and 5 means very compelling [RESPONDENT WILL SEE THE RATING ON THE HANDOUT AND ONLY NEED TO CIRCLE THE RATING]. Once you are finished, we will discuss the statement.

FOR EACH MESSAGE, ASK:

1. What is your overall reaction to this statement?

   1. How clear is this information? What is the information telling you?

2. What did you like about this information—what did you circle? For what reasons? What caught your attention in a good way?

3. Is there anything you didn’t like about this information—what did you cross out? For what reasons?

4. What, if anything, would you change in this statement?

5. What rating did you give this statement? For what reasons?

AFTER RESPONDENT HAS SEEN ALL MESSAGES IN A SPECIFIC CATEGORY, ASK: Now, let’s put the statements we just looked at side-by-side and I’d like you to choose the one statement that is most motivating to test at-risk patients for TB and latent TB infection. Stack the statements and place the one you feel is most motivating on top and draw a star on it.

Why did you choose that statement as most motivating? What about it is motivating?

Wonderful. Now, let’s place this group of statements to the side, so we can look at some others.

CONTINUE FOR ALL CATEGORIES/MESSAGES. SEE PROBES FOR EACH CATEGORY/MESSAGE BELOW.

7. WRAP UP (3 MINUTES)

1. Thank you for spending this last hour with me.

2. If there were a communication campaign with information for healthcare providers like yourself, what would get your attention and encourage you to think more about TB among your patient population?

   1. What information would you need that would motivate you to test at-risk patients for TB and latent TB?

   2. What information would you need to motivate you to recommend treatment to patients diagnosed with latent TB infection?

3. I am going to the back room to see if my colleagues have any additional questions for you.

4. While I do that, on the pad of paper in front of you, please write down any advice you have for CDC about how to best communicate the value of testing for TB and latent TB to your patients.

5. THANK AND DISMISS ONCE ALL QUESTIONS ARE ANSWERED.

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