Telephone script for Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barrett's Esophagus: Sedated EGD Arm

Hello Mr/Ms.

I am XXXX calling from the Mayo Clinic to talk to you about taking part in a study to find conditions increasing the risk of esophageal cancer in the community.In this study we are offering a free test to look for conditions which may increase the risk for esophageal cancer or early esophageal cancer. Would you like to hear more about this study?

No: stop: would you mind answering a few questions?

If no: Stop

If yes:

Can you give us a reason for not participating in this study:

Do you have heartburn yes/no

Do you have acid regurgitation yes/no

Do you have abdominal pain yes/no

Yes: proceed as below

The test is called endoscopy. Have you ever had an evaluation of your swallowing tube or a colonoscopy?

If yes, when ------(date)

The study involves completing a questionnaire on abdominal symptoms, followed by an endoscopy. For this test you will have to be fasting for 6 hours. You will first receive intravenous medications which will make you sleepy. We will then place a thin tube with a camera attached to its end (called an endoscope) into your swallowing tube, as we monitor your breathing and heart rate. We will check the esophagus, stomach and first part of your small intestine. We will take small tissue samples from any abnormal appearing areas and from the esophagus and stomach for research purposes. The procedure will take us 7-10 minutes to complete.

You will then be watched for another 45 minutes and discharged.

For this study, you will need to bring a person with you as you will not be able to drive for the next 24 hours.

Risks of the study include: very small (< 1 in 1000) risk of bleeding or causing a tear in the intestine or allergic reactions to the medications.

Do you have any other questions for us?

Would you be interested in taking part in this study?

If No, would you mind answering a few questions?

If no: Stop

If yes:

Can you give us a reason for not participating in this study?

Do you have heartburn yes/no

Do you have acid regurgitation yes/no

Do you have abdominal pain yes/no

If yes:

Do you take any blood thinners?

Plavix: yes/no

Coumadin/Warfarin: yes/no