Non-English Speaking Patients

The catch-22 here is that we want to make research participation accessible to all patients, so that research results are drawn from a sample of patients that represent real-world demographics as far as possible. However, we also need to be able to communicate clearly with patients, to make sure they understand the study fully and have all their questions answered.

I found a potentially eligible patient whose primary language is not English, what do I do?

1. Check with investigator. Tell them it is possible to enroll a patient whose primary language is not English but it takes a few extra steps. You might want to ask them to review the patient's recent imaging to get a better gauge of how well they meet the angiographic criteria.

   • If they can predict a patient will likely angiographically screen-fail, it may not be worth pursuing the whole translation process

   • Some physicians speak Spanish and have a higher chance of having a study-eligible Spanish-speaking patient, such as (but not limited to): Dr Mendes, Dr Nanez, Dr Kass-Hout

   • WAVE and NECC already have Spanish ICFs translated. If you find a Spanish-speaking patient for those studies, you can just go ahead and plan to consent them. Checking with the investigator to confirm eligibility is always a good idea, but for these 2 studies you do not need to wait for translations, etc. --> Skip directly to "How to use interpreter services at Rex?"

2. If you and the investigator decide to go ahead and consider consenting this patient for research, inform Cathy and the sponsor as soon as possible. Cathy will work with the sponsor and IRB to get the IRB translated.

3. Translation time can take 10-14 business days. So, it is a good idea to start the translation process as soon as you find even a slightly possibly eligible patient whose has a non-English primary language. There is no harm in having the translation even if you & the investigator decide not to enroll the patient.

4. However, do not be thrown off by the 10-14 business day wait. There is a way to use a WCG Short Consent Form to consent the patient right away.

   • This only applies to studies who are underWCG IRB, which is most of our studies, but check with Cathy to be sure.

How to use Short Forms?

https://www.wcgclinical.com/irb-resources/additional-irb-resources/

Short Forms are short 'templates' of ICFs available in various languages. They do not contain information about any sites or studies. The gist of them goes like,

• You are being invited to participate in the study

• Make sure the research team tells you about the purpose, duration, investigational elements, risks, benefits, alternatives, confidentiality rights, etc. before you consent

Since the patient cannot read a full ICF about the study, it becomes even more imperative for you & the investigator to explain clearly to them verbally.

Steps to using a Short Form:

1. Speak with Cathy. She can help download a copy of the Short Form in the language of interest and fill out some basic information in the Short Form "template".

2. Consent the patient using a Short Form, with the help of an interpreter.

3. Within 60 days, the patient needs to be reconsented with a full-length translated ICF. This is usually not difficult as many studies ask patients to come in at around 1 month for follow-up, and the translation should be ready by then.

   • If they do not have a follow-up visit within the 60 day time frame, you might need to ask them to come in to meet with you to sign.

   • It is also possible to reconsent via mail - speak with Cathy/Allie/Kyle for more information. I personally never had to do that.

How to use the interpreter services at Rex?

If you need to speak with a patient via an interpreter in pre/post-op, let one of the nurses know and the fastest way to do it is usually via one of their iPads (virtual interpreter).

Follow these steps if you need to independently request an interpreter to speak with a patient. If you know when you will need to speak with the patient, you can book the appointment ahead of time. If not, you can put in an immediate request (see below for how to do that).

1. Go to the Rex Intranet: https://rex.intranet.unchealthcare.org/

2. On the sidebar on the left, go to "Teammate Resources" then "Patient Care Resources", then "Language Interpreter Services"

3. Click the link under "Rex"

4. In the page you are redirected to, click "New Request" at the top left corner

5. Fill out the information. I strongly recommend using the "ETA alert" function.

   • Red blanks - mandatory

   • Black blanks - optional

6. Under "Priority", you can choose "immediate" or "future appointment" accordingly

7. Under "Interaction Type", I have always chosen "Face to Face". If there is not a face-to-face interpreter available, I assume they will reach out to coordinate a virtual interpreter or something - I personally have never run into that.

8. When the time of the appointment is approaching, the interpreter will reach out to you to confirm the request.

9. Interpreter will show up and help translate as you speak with the patient. They are very patient and helpful. I have had a 100% positive experience with the Spanish interpreters that helped me with my patients.

10. Remember to get the full name of the interpreter so you can include that in your documentation on Epic. Something like: I communicated with the patient via interpreter FirstName LastName, who is part of the interpreter team at UNC REX Hospital.

Please refer to the following document regarding UNC's policies for interpreters:

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Effective Communication For Limited English Proficiency Patients and Patients with Disabilities-History.pdf

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Hugo Ocampo is the manager of Interpreter Services if you need to reach out for any questions: [e-mail]