Form New form New form Attachment E Screening Questions for CDI

Form Approved

OMB No. 0920-xxxx

Exp. Date xx/xx/xxxx

Screening Questions for Clostridium difficile Telephone Interview

Not transferred to CDC

q1 To the person who answers the phone, if adult, otherwise ask to speak to an adult: Hello, my name is _________. I’m calling from the [EIP SITE Name]. May I please speak to [Potential enrollee]?

___Yes: person who answered is potential enrollee; go to Q4.

___Yes: coming to the phone; go to Q3.

___No: person is not at this number; go to Q1.1.

___No: but person is deceased: I’m sorry. I was not aware of your loss. I would like to offer my condolences to you and your family. Would this be a good time to talk to you about their recent Clostridium difficile infection or should I call back another time? go to Q8.

___No: but person is incapacitated; go to Q8

___Does not speak English; Record language in Comment section of Phone Log. We will try to call back with someone who speaks Spanish. If case speaks a language other than English or Spanish, he/she is not eligible. =STOP=

Q1.1 Do you know at what phone number I could reach him/her?

___Yes, alternate number; Record alternate phone number on Phone Log. Thank you very much for your help. Good-bye. =STOP=

___Yes, this number; go to Q2; However if respondent states that the person does not live here but could best be reached at this number, Go to Q1.2.

___No; or don't know: verify that you have dialed the number noted on Phone Log. Sorry, I must have the wrong number. =STOP=

Q1.2 Do you know the phone number for [Potential enrollee]’s home?

___Yes; Record number on Phone Log as the phone number of primary residence, in case it is needed. Thank you very much for your time. Good bye. =STOP=

___No; go to Q1.3.

Public reporting burden of this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).

Q1.3 Along with the Centers for Disease Control and Prevention and health departments in other states, we are investigating cases of Clostridium difficile infection that occur in the community. His/her participation in this investigation is very important. When would be a good time to reach him/her? Record person’s name to ask for, and day/time to call on Phone Log. Thank you very much for your time. Good-bye. =STOP=

Q2 May I speak with him/her?

___Yes; but not home; go to Q2.1.

___Yes; coming to the phone; go to Q3.

___No; go to Q1.3.

Q2.1 Is there another phone number at which I could reach him/her?

___Yes; Record alternate phone number on Phone Log. Thank you very much for your time. =STOP=

___No; When would be a good time to call back to reach him/her? [Record day/ time on Phone Log]. Thank you very much for your time. =STOP=

Q3 Hello, my name is _________. I’m calling from the Monroe County Department of Public Health. We are conducting surveillance on all cases of Clostridium difficile, which is an infection that causes diarrhea. Are you [potential enrollee]?

___Yes; go to Q4. ___No; go to Q2.

Q4 Because Clostridium difficile has been designated a disease of public health importance, the Monroe County Department of Public Health is notified whenever a person has been diagnosed with this infection. We recently learned that you had a positive test for Clostridium difficile, which is why we are calling you.

We are doing surveillance with the Centers for Disease Control and Prevention to learn why some people get Clostridium difficile infection in the community.

Participation is voluntary and involves completing a 30-minute interview over the phone. It will include questions about your visits to hospitals, illnesses, and recent medications. You may choose not to answer any question. May I tell you more about this surveillance study?

___Yes; go to Q5. ___No; go to Q4.1.

Q4.1 Your participation in this investigation is very important. We are trying to determine why people get Clostridium difficile infection in the community. May I schedule a time to talk that would be better for you?

___Yes; Record day/time on Phone Log. Thank you very much for your time. =STOP=

___No; Sorry to have disturbed you. Good-bye. =STOP=

Q5 Before we proceed, I would like to ask few questions to make sure you are eligible for this investigation; go to Q5.1.

Q5.1 Criterion #1: Exposure to Healthcare – Did [you/your child] stay overnight in a hospital, long term care facility, or nursing home in the 12 weeks before the collection of [your/your child’s] stool on [specimen collection date _______________]?

___No, go to Q5.2.

___Yes, Thank you very much for taking the time to answer these questions. However, we are only interviewing people who did not stay overnight in a healthcare facility in the 12 weeks before their positive test. We appreciate your time and willingness to participate in this surveillance. Do you have any questions for me? =STOP=

Q5.2 Criterion #2: Recurrent Case Exclusion – Had [you/your child] been diagnosed with C. difficile in the 8 weeks before the collection of [your/your child’s] stool specimen on [specimen collection date _______________]?

___Yes, Thank you very much for taking the time to answer these questions. However, we are only interviewing people who did not have a previous C. difficile diagnosis. We appreciate your time and willingness to participate in this research study. Do you have any questions for me? =STOP=

___No, Okay, thank you. You are eligible to participate in the interview; I will now read the consent form; go to Q6.

Q6 Read Consent Form; Did case give consent to participate?

___Yes; go to Q6.1;

___No; ask if you can call back at more convenient time; if Yes, Record day/time on Phone Log. Thank you very much for your time. =STOP=

Q6.1 I will send you a copy of the Consent Form within the next 1-2 weeks for your records. go to Section 3 of Enrollee Interview.

If person wants to participate but this is a bad time, ask if you can call back at more convenient time; Record day/time on Phone Log.