Assessing Barriers to Clinical Trial Participation

Assessing Barriers to Clinical Trial Participation

Assessing Barriers to Clinical Trial Participation

Sample Assessment Questions

General Questions

1. What may make it difficult for you to participate or stay enrolled in the clinical trial? ______

2. What worries or concerns do you have about this clinical trial? ______

3. What have you heard about clinical trials from family or friends? ______

4. What have you heard in the media (TV, radio, newspaper) about clinical trials? ______

5. What has been explained to you by your doctor or health provider about clinical trials? ______

Practical Barriers

Housing:

1. Where do you usually stay/live? ______

2. Do you have a permanent address? Yes no

3. What housing programs have you already applied for? ______

4. What housing assistance would you like help getting? ______

Telephone:

1. Where do you typically receive your calls? ______

2. How often is that cell phone disconnected? ______

3. How reliable is that person in giving you messages? ______

4. How much medical information can be left on the voice mail/with the person for you? ______

Health Insurance:

1. What type of health insurance coverage do you have? ______

2. How do you usually pay for medical visits? ______

3. How do you usually pay for prescription medicines? ______

4. What programs such as Medicaid or Medicare have you already applied for? ______

5. What options do you think you have to pay for your medical care? ______

Transportation

1. How do you typically get to medical appointments? ______

2. What friends/family members can you go to for help getting to a medical appointment? ______

3. How comfortable are you using public transportation? ______

Day care/eldercare

1. Are you responsible for caring for another person? Yes No

2. What options do you have for having someone else care for the person when you are at a medical visit? ______

3. How have you handled this in the past when you have to go to an appointment? ______

US Citizenship/Legal Resident Status

Ask ONLY if it is required by the clinical trial!

  1. The study requires that I ask this, do you have US citizenship, permanent or temporary legal residence?

Treatment for a Co-morbidity

1. What other medical conditions do you have? ______

2. Are you under the care of a specialist of a health care provider for a condition? Yes No

3. What health concerns do you have right now in addition to your [condition under study]? ______

Limited English Proficiency

1. In what language do you feel most comfortable speaking? ______

2. In what language do you feel most comfortable reading written materials? ______

3. Would you prefer translated materials to read? Yes No

4. Would you feel more comfortable if I bring in an interpreter? Yes No

5. What is the easiest way for you to learn new information- reading, listening, computer, video, etc?

Low Literacy Level

  1. Please tell me what you understood of my explanation about the clinical trial.
  2. Which medical or confusing terms can I explain? ______
  3. What is the easiest way for you to learn new information- reading, listening, computer, video, etc?
  4. What did you find most interesting or just learned (the person will have to explain)? ______

Lack of Understanding of the Healthcare System

1. Please tell me about past experiences when you had to get specialty medical care? ______

2. What do you find most confusing about where you get your health care? ______

3. What do you think would be most helpful for you to figure out where to go and who to call when you have a question? ______

4. What do you typically do when you need something from your health care provider? ______

Cultural Differences

1. How comfortable do you feel with your health care team? ______

2. How welcome do you feel at the places where you get your medical care? ______

3. What do you think is needed for you to feel more comfortable with your healthcare team? ______

4. How comfortable do you feel asking questions? ______

5. What can we do so you feel more comfortable asking questions and getting answers to your questions? ______

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