Form 0923-0063 Eligibility Screening Script

Attachment 4.

Multi-site Study

Eligibility Screening Script

Flesch-Kincaid Readability Score – 5.8

Form Approved

OMB No. 0923-XXXX

Exp. Date xx/xx/201x xx/xx/20xxExDaxx/xx/20xx

Exp. Date xx/xx/20xx

Multi-site Study –Eligibility Screening Script

ATSDR estimates the average public reporting burden for this collection of information as 10 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information 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 (0923-xxxx).

[SHADED TEXT DENOTES INFORMATION COLLECTION]

Inbound call:

Hello. My name is _____________. I’d like to thank you for calling about the Multi-site Study. < go to Intro;

For outbound call:

Hello. My name is _____________. I’d like to thank you for being interested in the Multi-site Study. We are calling you as you have kindly provided your contact information to us. < go to Intro.

Intro:

The Agency for Toxic Substances and Disease Registry, or ATSDR for short, is funding the study and [insert study investigators institution name] would like to recruit people for the Multi-site Study [and insert local study name].

We want to learn more about [insert site/community name(s)], and to study whether any health outcomes may be potentially associated with historical exposure to per- and poly-fluorinated chemicals, or PFAS for short, in the drinking water.

People who reside or resided at/in [insert site/community name] and/or in [insert site/community name] may be eligible for the study.

Before we ask you about your eligibility, we would you like to ask you a few questions about how you heard about the study (and decided to contact us?).

S1 (if applicable). Have you participated in the PFAS health study in the area [insert name of applicable health study conducted in a target area; i.e. PFAS- AWARE] /and have consented to be contacted for future studies/?

• YES > go to A1.

• NO > go to S2

S2 (if applicable). Have you participated in ATSDR Exposure Assessments (EA) or other PFAS exposure studies /and have consented to be contacted for future studies/?

• YES > go to A1.

• NO > go to S3

S3: How have you heard about the Multi-site Study? < Mark all that apply:

S3a. Study packet in the mail? YES;

S3b. A recruitment event/community meeting? YES, Please specify: ____________;

S3c. A posting in local newspaper, radio or tv? YES, Please specify: ____________;

S3d. A posting on social media (Facebook, Twitter etc.) YES, Please specify: ____________;

S3e. Any other way? Please note: _____________________; Thank you. < Go to A1.

[Screening Questions for ADULT – If a PARENT calls who is not going to enroll as an ADULT > go directly to Screening Questions for PARENT/CHILD]

A1. Are you 18 years or older?

• YES > go to A2.

• NO (under 18) > OK, can I speak to your parent or guardian? [becomes PARENT ONE] > go to Screening Questions for PARENT/CHILD.

A2. Have you lived in [insert study area/community name(s)] between [2005] and [insert year]?

That is prior to [insert month/year] when the PFAS in the [ insert water supply name] were mitigated.

• YES > go to A3.

• NO > If applicable (additional site/community) go to A2a. I’m sorry. People who did not live in {insert site] before [insert month/date] are not eligible for this study. > go to Screening Questions for PARENT/CHILD SCP2.

If additional site/community:

A2a. Have you lived in [insert study area/community name(s)] between [2005] and [insert month/year]?

That is prior to [insert month/year] when the PFAS ) in the [insert water supply name] were mitigated.

• YES > go to A3.

• NO > I’m sorry. People who did not live in [insert site] before [insert month/year] are not eligible for this study. > go to Screening Questions for PARENT/CHILD SCP2.

A3. Have you ever worked as a firefighter or ever participated in training exercises using firefighting, or AFFF, foam?

• YES > I’m sorry. People who ever worked as a firefighter or used firefighting foam are not eligible for this study as they may have been exposed to PFAS at work and not through drinking water. > go to Screening Questions for PARENT/CHILD SCP2.

• NO > go to A4.

A4. Have you ever worked at industrial facilities that used PFAS chemicals in the manufacturing process for example to make Teflon or Scotch Guard?

• YES > I’m sorry. People who ever worked at facilities using PFAS chemicals are not eligible for this study as they may have been exposed to PFAS at work and not through drinking water. > go to Screening Questions for PARENT/CHILD SCP2.

• DON’T KNOW > go to A5

• NO > go to A5.

A5. Are you in prison or under house arrest?

• YES > I’m sorry. The federal regulations say that people who are in prison or under house arrest cannot be in this study. > go to Screening Questions for PARENT/CHILD SCP2.

• NO > Thank you very much. You are eligible to take part in the Multi-site Study as an adult participant. > go to A6.

A6. If you want to enroll in the Multi-site Study as a participant, I will need your contact information to send you some recruitment materials and to set up an appointment.

Record ADULT Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

A6a. Is this your mailing address as well?

• YES <No action needed

• NO. <Please record the mailing address.

• STREET ADDRESS/P.O. BOX |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility <IF NOT go to A1

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

A6b. What is your preferred way to be contacted?

• Mail

• Email

• Phone

• Cell Phone A6c? May we use your cell phone number to text you study information?

  • YES

  • NO

After the call is over, enter the assigned ADULT STUDY ID number to begin tracking enrollment and biospecimen sample logistics. Be sure to link the ID numbers for an individual who has both an ADULT STUDY ID and one or more PARENT STUDY IDs.

• ADULT STUDY ID |__________________________|

A7. The study interview will take place at our central study office at [insert address]. We will obtain your consent, do body measurements, collect your blood and urine samples during the visit, and have you complete a questionnaire. If you prefer, we can do an interview over the phone, but you would still need to come to the office to do body measurements and provide a blood sample and urine sample. At the end of the appointment you will also receive a gift card for study participation. We will not provide a separate travel reimbursement.

We will keep all your information confidential and will send you results of the analyses when the study is completed.

In special circumstances if you are incapable of getting to the study office (serious illness, disability), we will try to work with you to send an interview team to your home.

A8. Please indicate the study appointment location.

Record Appointment Location

• STUDY OFFICE

• Phone interview/Office visit for blood and urine collection

• REQUESTED HOME VISIT

A8a. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

Remember to fast at least 8 hours before your appointment. During the interview, we will ask you about your medical history as well as residential and occupational history from 1993 to present, so it is good to write that information down before the study office appointment or interview call.

A9. Thank you for your interest. We will mail you a packet of information with more information about the study, consent forms for you to review and sign, and information about what to expect at your appointment.

A10. Are there any other adults in your household that may be eligible for the study? I would be happy to speak to them now, or at another more convenient time.> When additional adults are available, begin at A1.

>If not available; Is this the best number to reach them?

• YES > Thanks again.

• NO > A10a. What is the best number to contact them?

FIRST NAME |__________________________|

LAST NAME |__________________________|

PHONE NUMBER |_________________________

A11. We are also interested in speaking with adults who used to be part of your household but have moved away (for instance, your children who have grown up and moved out). Do you have their contact information?

• YES > record contact information.

FIRST NAME |__________________________|

LAST NAME |__________________________|

PHONE NUMBER |_________________________|

• NO > OK. Thank you very much for your interest.

A12. Children between the ages of 4 and 17 may also be eligible to participate in this study.

Do you have any children that you would like to enroll in the study as well?

• YES > go to Screening Questions for PARENT/CHILD. SCP3

• NO > OK. Thank you very much for your interest. We will mail your Appointment Packet shortly.

[Screening Questions for PARENT/CHILD]

SPC1: For parents/guardians who are only calling to enroll their children.

Hello. My name is _____________. I’d like to thank you for calling about the Multi-site Study. The Agency for Toxic Substances and Disease Registry, or ATSDR for short, is funding the study and [insert study investigators institution name] would like to recruit children for the Multi-site Study [and local study name if applicable].

We want to learn more about [insert site/community name(s)], and to study whether any health outcomes may be potentially associated with historical exposure to per- and poly-fluorinated chemicals, or PFAS for short, in the drinking water. We will also need to collect your child’s blood and urine and set up an appointment to evaluate your child’s attention, memory, and decision making through tests and games.

For this research study, we are looking for children between 4 and 17 years who reside or resided in [insert site/community name] and/or in [insert site/community name] that may be eligible for the study. You may enroll more than one child and you don’t have to enroll as an adult for the study. < go to P1.

SCP2: For parents and guardians who started to complete the first part of the script but weren’t eligible.

Even though you’re not eligible to take part in the study, it’s possible that your child or children will be able to participate. Now, I would like to ask you a few questions about your child or children to determine if they are eligible to participate in our study.

For this research study, ATSDR and [insert study investigators institution name] are looking for children between 4 and 17 years who reside or resided in [insert site/community name] and/or in [insert site/community name] that may be eligible for the study. A parent or guardian may also enroll with more than one child and you don’t have to enroll as an adult for the study. < go to P1.

SCP3: For parents and guardians who completed the first part of the screening script and are eligible

Now I would like to ask you a few questions about your child or children to determine if they are eligible to participate in our study. < go to P1.

P1. When we enroll children in the Multi-site Study, we ask a few questions the child’s birth mother about her work and drinking water exposure before and during pregnancy.

Is the birth mother available now or in the near future who could answer such questions about her prior exposures?

• YES < stop and wait for that person to get on the line THEN go to P2

• YES, but is not available < OK, if this isn’t a good time, they can call our office later (phone number XXX-XXX_XXXX). Thanks very much for your interest.

• NO < go to P1a.

• P1a. Is there another parent or guardian who would be able now or in the near future who could answer such questions about the child’s birth mother’s exposures before and during pregnancy?

  • YES <stop and wait for that person to get on the line, THEN go to SCP1

  • YES, but is not available < OK, if this isn’t a good time, they can call our office later (phone number XXX-XXX_XXXX). Thanks very much for your interest.

  • NO<Ok. Thanks very much for your interest.

P2. I need to find out a bit more about each child who wants to be in the Multi-site Study. If you have more than one, let’s start with the youngest. How old is [CHILD 1; CHILD 2; CHILD 3; etc.]?

• AGE |__|__| years > eligible age is 4-17 years >

  • If not age eligible, go to P2a.

  • If age eligible, go to P3.

P2a. I’m sorry. We are looking for children 4-17 years. Do you have other children who are 4-17 years?

• YES > OK, let me find out more about them. > go back to P2.

• NO > Thank you very much for calling us today. It appears that your children are not eligible to take part in the Multi-site Study. We appreciate your interest in this research.

P3. Have your [CHILD 1; CHILD 2; CHILD 3; etc.] lived in [insert study area/community name(s)] between [2005] and [insert month/year]?

That is prior to [insert month/year] when the PFAS in the [insert water supply name] were mitigated.

• YES > go to P4.

• NO > OK. Children may also be eligible if their birth mothers may have been exposed to the contaminated water prior to the child’s birth.

P3a. Did the child’s birth mother live in [insert study area/community name(s)] between [2005] and [insert month/year]?

• YES > go to P4

• NO < I’m sorry. Children who did not live in {insert site] before [insert month/year] either after birth or while their mother was pregnant are not eligible for this study.

If additional community:

P3b. Have your [CHILD 1; CHILD 2; CHILD 3; etc.] lived in [insert study area/community name(s)] between [2005] and [insert month/year]?

That is prior to [insert month/year] when the PFAS in the [insert water supply name] were mitigated.

• YES > go to P4.

• NO > OK. Children may also be eligible if their birth mothers may have been exposed to the contaminated water prior to the child’s birth.

P3c. Did the child’s birth mother live in [insert study area/community name(s)] between [2005] and [insert month/year]?

• YES > go to P4

• NO < I’m sorry. Children who did not live in {insert site] before [insert month/year] either after birth or while their mother was pregnant are not eligible for this study.

P4. Has [CHILD 1; CHILD 2; CHILD 3; etc.]’s birth mother ever worked as a firefighter or ever participated in training exercises using firefighting, or AFFF, foam?

• YES > I’m sorry. Children whose birth mother ever worked as a firefighter or used firefighting foam are not eligible for this study as they may have been exposed to PFAS at work and not through drinking water. If you have other children who are 4-17 years, let me ask these same questions about them. > go back to P2. If no more children, go to P4a

P4a. Thank you very much for calling us today. It appears that your children are not eligible to take part in the Multi-site Study. We appreciate your interest in this research.

• DON’T KNOW> go to P5

• NO > go to P5.

P5. Has [CHILD 1; CHILD 2; CHILD 3; etc.]’s birth mother ever worked at industrial facilities that used PFAS chemicals in the manufacturing process (for example to make Teflon or Scotch Guard)?

• YES > I’m sorry. Children whose birth mother ever worked at facilities using PFAS chemicals are not eligible for this study as they may have been exposed to PFAS at work and not through drinking water. If you have other children who are 4-17 years, let me ask these same questions about them. > go back to P2. If no more children, go to P5a.

P5a. Thank you very much for calling us today. It appears that your children are not eligible to take part in the Multi-site Study. We appreciate your interest in this research.

• DON’T KNOW> go to P6

• NO > Thank you. > go to P6.

P6. Is your child in juvenile detention or under house arrest?

• YES > I’m sorry. The federal regulations say that people who are in juvenile detention or under house arrest cannot be in this study.

• NO > Thank you very much. Your child is eligible to enroll in the Multi-site Study> go to P7.

P7. I will need your contact information to send you some recruitment materials and to set up an appointment.

P7a. Record PARENT 1 Contact Information only if not completed in adult screening section

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P7b. Is CHILD 1’s Contact Information different from yours? < Record if YES.

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility <IF NOT go to P2a

• PARENT 1 STUDY ID |__________________________|

• CHILD 1 STUDY ID |__________________________|

P7c. The study interview will take place at our central study office at [insert address]. We will also obtain your consent and your child’s assent (if they are older than 7), do body measurements, collect your child’s blood and urine samples during the visit, and you will complete a questionnaire about your child. If you prefer, we can do an interview over the phone, but you would still need to come to the office to do your child’s body measurements, collect blood and urine, and do the neuro-behavioral testing. We will keep all yours and your child’s information confidential and will send you results of the analyses when the study is completed.

At the end of the appointment you will also receive a gift card for study participation. We will not provide a separate travel reimbursement.

In special circumstances if you or your child are incapable of traveling (serious illness, disability), we will try to work with you to send an interview team to your home.

Record Appointment Location

• STUDY OFFICE

• Phone interview/Office visit for blood and urine collection

• REQUSTED HOME VISIT

P7d. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

Remember to fast at least 8 hours before your appointment. During the interview, we will ask you about your child’s medical history and vaccination schedule as well as your residential and occupational history from 1993 to present, so it is good to write that information down before the study office appointment or the interview call.

P7e. We also need to schedule the neurobehavioral testing appointment. It includes various tests and games that evaluate your child’s attention, memory, behaviors, and decision making. It will take about 60 to 90 min depending on your child’s age (shorter for younger children). Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P8. If you have another eligible child who would like to enroll, I will fill in their contact information, too. Let me go back through the screening questions. > go back to P2. If no more children, go to P8a.

P8a. Thank you very much for your interest. We will mail your child/ren’s Appointment Packet shortly. Thanks again.

P8b. Record PARENT 2 Contact Information

• FIRST NAME |__________________________| (enter “SAME AS PARENT 1” if applicable > go to P8c)

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P8c. Record CHILD 2 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|(enter “SAME AS PARENT 1” if applicable > go to P8d)

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• PARENT 2 STUDY ID |__________________________|

CHILD 2 STUDY ID |__________________________|.

P8d. In special circumstances if you or your child are incapable of traveling (serious illness, disability), we will try to work with you to send an interview team to your home.

Record Appointment Location

• STUDY OFFICE

• Phone interview/Office visit for blood and urine collection

• REQUSTED HOME VISIT

P8e. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

Remember to fast at least 8 hours before your appointment. During the interview, we will ask you about your medical history as well as residential and occupational history from 1993 to present, so it is good to write that information down before the study office appointment or interview call.

P8f. We also need to schedule the neurobehavioral testing appointment. It includes various tests and games that evaluate your child’s attention, memory, behaviors, and decision making. It will take about 60 to 90 min depending on your child’s age (shorter for younger children). Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P9. If you have another eligible child between the ages of 4 and 17 who would like to enroll, I will fill in their contact information, too. Let me go back through the screening questions. > go back to P2. If no more children, go to P9a.

P9a. Thank you very much for your interest. We will mail your children’s Appointment Packets shortly. Thanks again.

P9b. Record PARENT 3 Contact Information

• FIRST NAME |__________________________| (enter “SAME AS PARENT 1” if applicable > go to P9c)

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P9c. Record CHILD 3 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|(enter “SAME AS PARENT 1” if applicable > go to P9d)

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• PARENT 3 STUDY ID |__________________________|

• CHILD 3 STUDY ID |__________________________|

P9d.In special circumstances if you or your child are incapable of traveling (serious illness, disability), we will try to work with you to send an interview team to your home.

Record Appointment Location

• STUDY OFFICE

• Phone interview/Office visit for blood and urine collection

• REQUSTED HOME VISIT

P9e. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P9f. We also need to schedule the neurobehavioral testing appointment. It includes various tests and games that evaluate your child’s attention, memory, behaviors, and decision making. It will take about 60 to 90 min depending on your child’s age (shorter for younger children). Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P10. (CLOSING REMARKS) Thank you very much for your interest. We will mail your [child’s/children’s] Appointment Packet(s) shortly. Thanks again.

P11. Data Linkages

After the call is over, enter the assigned PARENT (1,2,3, etc.) STUDY ID number(s) to begin tracking enrollment and biospecimen sample logistics for each child. Be sure to link the ID numbers for an individual who has both an ADULT STUDY ID and one or more PARENT STUDY ID aliases.

• ADULT STUDY ID |__________________________| (IF APPLICABLE ALIAS)

• PARENT 1 STUDY ID |__________________________|

• PARENT 2 STUDY ID |__________________________| (IF APPLICABLE ALIAS)

• PARENT 3 STUDY ID |__________________________| (IF APPLICABLE ALIAS)