PRAMS Livebirth Phone Introduction and Informed Consent (English)

Att 12e - PRAMS Livebirth Phone Introduction and Informed Consent - ENGLISH.docx

[NCCDPHP] Pregnancy Risk Assessment Monitoring System (PRAMS)

PRAMS Livebirth Phone Introduction and Informed Consent (English)

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Attachment 12e – Livebirth Phone Introduction and Informed Consent - English


PRAMS Livebirth Standardized Telephone Introduction & Informed Consent - English


The standardized telephone disposition codes and introductions are used for all PRAMS women and contain all required elements of informed consent. Each is translated into Spanish for those women who prefer to have the interview conducted in Spanish.


The disposition codes and the introductions are presented here; the main body contains the elements of informed consent. Prior to 2006 data collection, most state PRAMS projects used hard copy call worksheets, introductory scripts, and telephone questionnaires to conduct the telephone interviews. In 2006, the standard Web-CATI system became available for all PRAMS states to use. All call dispositions (shown below) along with each state’s introduction were programmed into the system. Starting in 2013, the Web-CATI system was replaced by the CATI system within PIDS. The CATI system assigns a disposition code at each call attempt based on the information the interviewer provides. Scripts for special situations are programmed into the CATI system based on information documented in state protocols. For a more detailed description of telephone interviewing procedures, refer to the PRAMS Telephone Interviewer Training Manual.



Protocol Development Task


Complete the state-specific information in the telephone introductions below (state name, telephone number, etc.). No other changes shall be made to any introductions without prior approval from the CDC IRB (see Section 10.2 (Informed Consent) for more information).


If your state must report physical abuse to minors, this should be stated when speaking to minors. Add these introductions in this appendix; these will be identical to introductions 1-4 below, with the addition of the reporting requirement. Again, send these introductions to CDC for approval.



  1. Telephone Disposition Codes (English)


<STATE> PHASE 8 TELEPHONE QUESTIONNAIRE


OFFICE USE ONLY

PRAMS--__________________ Batch # __ __

Respondent project ID#: __ __ __ __ __ __ __ __ Phone No.______________________


CALL RECORD



CALL


DATE

MM/DD


TIME

hh mm


am/pm

(a)(p)


RESULT

CODE


INTER-

VIEWER



APPOINTMENT/COMMENTS


1














2














3














4














5














6














7














8














9














10














11














12














13














14














15















START TIME : END TIME : Did Mom have a copy of the MAIL

TIME TO CONDUCT INTERVIEW:__ __ (in minutes) QUESTIONNAIRE with her? [ ]yes [ ]no

DIAL TELEPHONE NUMBER:


* NO ANSWER AFTER 5 RINGS: ENTER CODE N. TRY LATER.


* BUSY SIGNAL: ENTER CODE NB. TRY LATER.


* ANSWERING MACHINE: ENTER CODE A IF MESSAGE INDICATES THAT MOM IS AT THIS NUMBER AND NO MESSAGE IS LEFT ON MACHINE.


ENTER CODE AM IF MESSAGE INDICATES THAT

MOM IS AT THIS NUMBER AND MESSAGE IS

LEFT ON MACHINE.


ENTER CODE AW IF MESSAGE INDICATES THAT MOM IS NOT AT THIS NUMBER.


ENTER CODE AU IF MESSAGE IS UNCLEAR IF NUMBER IS CORRECT OR NOT. TRY LATER.


* PAGER: ENTER CODE P IF NO MESSAGE LEFT ON PAGER.


ENTER CODE PM IF MESSAGE LEFT ON PAGER.


* TELEPHONE COMPANY MESSAGE: ENTER CODE NDD. CALL BACK AFTER A FEW DAYS.


* TECHNICAL BLOCK ENTER CODE TB. TRY LATER.


IF ANSWERED, SAY: Hello, may I speak to (RESPONDENT NAME) ?


* YES/SPEAKING/THAT=S ME: CONTINUE WITH AINTRODUCTION@.


* IF THE PERSON ASKS WHY YOU

WANT TO SPEAK WITH THE

RESPONDENT:

SAY: I’m with the <STATE> PRAMS project. We

would like her help in a survey we are doing

about the health of women in <STATE>.


* RESPONDENT NOT AVAILABLE: ENTER CODE FB IF NO TIME SCHEDULED FOR CALL BACK.


ENTER CODE FBS IF TIME SCHEDULED FOR

CALL BACK.


ENTER CODE FM IF MESSAGE LEFT FOR MOM

TO CALL PRAMS OFFICE.

* RESPONDENT NOT AT THIS ASK HOW TO REACH RESPONDENT:

LOCATION/DOESN=T LIVE HERE: TRY TO GET TELEPHONE NUMBER

AND/OR ADDRESS—

RECORD UNDER COMMENTS. IF UNABLE TO GET ADDITIONAL CONTACT INFORMATION, ENTER CODE UW. YOU ARE DONE.


* REFUSAL/NO YOU MAY NOT: ENTER CODE FB IF NO TIME

SAY: I’m with the <STATE> PRAMS SCHEDULED FOR CALL BACK.

Project. We’re doing a survey about the

health of women in <STATE>. If this is ENTER CODE FBS IF TIME

not a good time to talk with SCHEDULED FOR CALL BACK.

(RESPONDENT=S NAME) , I can call

back later. ENTER CODE FM IF MESSAGE LEFT

FOR MOM TO CALL PRAMS OFFICE.


* 2ND REFUSAL/NO YOU MAY NOT: THANK RESPONDENT, ENTER CODE FR, NOTE REASON FOR REFUSAL.


* IF PERSON SPEAKS SPANISH: HAVE SPANISH-SPEAKING INTERVIEWER

CALL BACK, ENTER CODE FLS.


* IF RESPONDENT SPEAKS SPANISH: HAVE SPANISH-SPEAKING INTERVIEWER

CALL BACK, ENTER CODE MLS.



* IF PERSON DOESN’T SPEAK THANK PERSON, ENTER CODE FL.

ENGLISH OR SPANISH: YOU ARE DONE.


* IF RESPONDENT DOESN’T THANK RESPONDENT, ENTER CODE

SPEAK ENGLISH OR SPANISH: ML. YOU ARE DONE.


* IF PERSON OR RESPONDENT

HANGS UP ENTER CODE H. TRY LATER.


* WHEN RESPONDENT

COMES TO PHONE: CONTINUE WITH INTRODUCTION.

  1. Telephone Introduction: Baby Living (English)


Introduction, Part 1.

Hello, I’m _________________, and I’m calling from the <STATE> PRAMS project. PRAMS is a research project to learn more about the health of women in <STATE>.


Recently we mailed you a questionnaire. <Did you receive it?> Since we have not received it yet, I’d like to go ahead and do the survey with you now. <In appreciation for your help, we will send you a special gift.>


First, I’d like to make sure that I am talking with the right person. You are <mother’s name>__ and you were born in <mother’s year of birth>_. Is that correct?

à IF YES, CONTINUE WITH PART 2.


à IF NO:


What’s not correct?


à REMEMBER: DO NOT GIVE OUT ANY CONFIDENTIAL INFORMATION

FROM PRAMS UNTIL YOU KNOW YOU HAVE THE CORRECT PERSON.


à DESCRIBE SITUATION (MOM USES MAIDEN NAME, ETC.):


_______________________________________________________


_______________________________________________________



à IF THE MOM GIVES A YEAR OF BIRTH VERY DIFFERENT (+ 2 years) FROM WHAT YOU READ, ASK:

Have you recently lived at <street address>.?



à IF YOU ARE SATISFIED YOU HAVE THE CORRECT PERSON,

CONTINUE WITH PART 2.


à IF YOU DO NOT HAVE THE CORRECT PERSON:


I’m sorry. It seems we reached you by mistake. Thank you for your time.


OPTIONAL STATEMENT: < I have a brief introduction to read to you before we begin>


Introduction, Part 2.

PRAMS is short for the Pregnancy Risk Assessment Monitoring System. PRAMS is sponsored by the Centers for Disease Control and Prevention and the <NAME OF HEALTH DEPARTMENT>. Answering some questions about your recent pregnancy can help us find out why some babies are born healthy and others are not. The information you give us will be used to help us build programs to benefit mothers and babies in <STATE>.


We are asking <NUMBER> women in <YOUR STATE> to answer these same questions. Your name was picked by a computer from recent birth certificates.


Your answers are very important, whether you and your baby have been healthy or sick. If you have lost your baby because of death, we are truly sorry about your loss and offer our sympathy to you and your family. We also ask that you do the interview because your answers are important, and could help other mothers and babies in the future.


Most questions are about your health and life before, during, and after pregnancy. It takes about <NUMBER OF MINUTES> minutes to answer all questions. Some questions may be sensitive, such as questions about smoking or drinking during pregnancy.


You are free to do the survey or not. If you don’t want to participate at all, or if you don’t want to answer a particular question, that’s okay. There is no penalty or loss of benefits for not participating or answering all questions.


Your answers will be grouped with those from other women. Your name will not be on any reports from PRAMS. Your survey may be combined with information the health department has from other sources.

If you choose to do the survey, your answers will be kept private and will be used only to answer questions related to the purpose of this study. What we learn from PRAMS will be used to plan programs to help mothers and babies in <YOUR STATE>.


This study has been given a Certificate of Confidentiality. This means that we may not share information that may identify you in legal suits or proceeding, even if a court orders us to do so, unless you say it’s okay. <OPTIONAL STATE-SPECIFIC LANGUAGE BASED ON STATE REPORTING REQUIRMENTS SUCH AS child abuse, elder abuse, harm to self and others. For example: But under the law, we must report to the state suspected cases of child abuse or elder abuse or if you tell us you are planning to cause serious harm to yourself or others.>



If you have questions about PRAMS, please call <PROJECT COORDINATOR’S NAME>, <YOUR STATE> PRAMS Project Coordinator, at 1-800-<###-####>. If you have any questions about your rights in the project, please call <NAME OF A PERSON AT YOUR LOCAL IRB OFFICE> at <PHONE NUMBER>.


IF THE MOM IS IN JAIL, SAY: Your participation in the study will have no effect on parole.


Shall we begin?


IF NO, THEN SAY:

If this is not a good time to talk, I can call back later.


TRY TO SCHEDULE A CONVENIENT TIME TO INTERVIEW MOTHER.

1. THANK RESPONDENT.

2. ENTER APPROPRIATE CODE ON TELEPHONE INTERVIEW FORM:

ENTER MB IF NO TIME SCHEDULED FOR CALL BACK.

ENTER MBS IF TIME SCHEDULED FOR CALL BACK.

ENTER MWC IF MOM WILL CALL PRAMS OFFICE.

ENTER MWM IF MOM SAYS SHE WILL MAIL SURVEY.

(NOTE: TELL MOM THAT INTERVIEWER WILL CALL HER IN A FEW DAYS IF SURVEY HAS NOT BEEN RECEIVED IN THE MAIL.)

ENTER MWW IF MOM SAYS SHE WILL COMPLETE THE SURVEY ONLINE

(NOTE: TELL MOM THAT YOU WILL SEND HER AN EMAIL WITH THE

WEB SURVEY URL AND PASSCODE.)


COLLECT THE MOTHER’S EMAIL ADDRESS: ____________________.


IF MOM WON’T PROVIDE EMAIL ADDRESS, OFFER OPTION TO SEND HER A LETTER THROUGH THE MAIL WITH THE WEB LINK AND PASSCODE.

TELL MOM AN INTERVIEWER WILL CALL HER IN A <X> DAYS IF THE SURVEY HAS NOT BEEN COMPLETED ONLINE.



IF MOTHER DOES NOT WANT TO DO INTERVIEW LATER, THEN:

1. THANK THE RESPONDENT

2. ENTER THE APPROPRIATE CODE ON TELEPHONE INTERVIEW FORM:

ENTER MR IF HARD REFUSAL.

ENTER MRT IF JUDGED A ASOFT REFUSAL@ TO BE

FOLLOWED-UP.

3. NOTE THE REASON FOR REFUSAL


IF YES, THEN SIGN BELOW AND BEGIN INTERVIEW.






DO NOT READ ALOUD THE FOLLOWING:

THIS IS TO CERTIFY THAT I HAVE READ THE ENTIRE INTRODUCTION ABOVE TO THE RESPONDENT.


____________________________________________________________

(SIGNATURE OF INTERVIEWER) (DATE)




Introduction, Part 3.

Before we start, it might help for you to have a calendar to refer to. If you have the copy of the questionnaire we mailed to you, you may want to get it also and read along.


Please give me your answers as I read the questions to you.



***MOTHER OF TWINS OR MULTIPLE BIRTHS ONLY***

Some of the questions are about mothers and some are about babies. For the questions about babies, please answer only for <baby’s name> .



GO TO PAGE 1 AND BEGIN THE QUESTIONNAIRE.



  1. Telephone Introduction: Baby Deceased (English)


Introduction, Part 1.

Hello, I’m _________________, and I’m calling from the <STATE> PRAMS project. PRAMS is a research project to learn more about the health of women in <STATE>.


Recently we mailed you a questionnaire. <Did you receive it?> Since we have not received it yet, I’d like to go ahead and do the survey with you now. <In appreciation for your help, we will send you a special gift.>


First, I’d like to make sure that I am talking with the right person. You are <mother’s name>__ and you were born in <mother’s year of birth>_. Is that correct?

à IF YES, CONTINUE WITH PART 2.


à IF NO:


What’s not correct?


à REMEMBER: DO NOT GIVE OUT ANY CONFIDENTIAL INFORMATION

FROM PRAMS UNTIL YOU KNOW YOU HAVE THE CORRECT PERSON.


à DESCRIBE SITUATION (MOM USES MAIDEN NAME, ETC.):


_______________________________________________________


_______________________________________________________



à IF THE MOM GIVES A YEAR OF BIRTH VERY DIFFERENT (+ 2 years) FROM WHAT YOU READ, ASK:

Have you recently lived at <street address>.?



à IF YOU ARE SATISFIED YOU HAVE THE CORRECT PERSON,

CONTINUE WITH PART 2.


à IF YOU DO NOT HAVE THE CORRECT PERSON:


I’m sorry. It seems we reached you by mistake. Thank you for your time.


OPTIONAL STATEMENT: < I have a brief introduction to read to you before we begin.>


Introduction, Part 2.

PRAMS is short for the Pregnancy Risk Assessment Monitoring System. PRAMS is sponsored by the Centers for Disease Control and Prevention and the <NAME OF HEALTH DEPARTMENT>. After your name was selected, we learned that your baby had died. I’m very sorry to hear about your loss. We are asking you to take part in an interview. Some of the questions I’ll ask you may be painful, but your answers are very important and could help other mothers and babies in the future. Answering some questions about your pregnancy can help us find out why some babies are born healthy and others are not. The information you give us will be used to help us build programs to benefit mothers and babies in <STATE>.


We are asking <NUMBER> women in <YOUR STATE> to answer these same questions. Your name was picked by a computer from recent birth certificates.


Most questions are about your health and life before, during, and after pregnancy. It takes about <NUMBER OF MINUTES> minutes to answer all questions. Some questions may be sensitive, such as questions about smoking or drinking during pregnancy.


You are free to do the survey or not. If you don’t want to participate at all, or if you don’t want to answer a particular question, that’s okay. There is no penalty or loss of benefits for not participating or answering all questions.


Your answers will be grouped with those from other women. Your name will not be on any reports from PRAMS. Your survey may be combined with information the health department has from other sources.


If you choose to do the survey, your answers will be kept private and will be used only to answer questions related to the purpose of this study. What we learn from PRAMS will be used to plan programs to help mothers and babies in <YOUR STATE>.


This study has been given a Certificate of Confidentiality. This means that we may not share information that may identify you in legal suits or proceeding, even if a court orders us to do so, unless you say it’s okay. <OPTIONAL STATE-SPECIFIC LANGUAGE BASED ON STATE REPORTING REQUIRMENTS SUCH AS child abuse, elder abuse, harm to self and others. For example: But under the law, we must report to the state suspected cases of child abuse or elder abuse or if you tell us you are planning to cause serious harm to yourself or others.>


If you have questions about PRAMS, please call <PROJECT COORDINATOR’S NAME>, <YOUR STATE> PRAMS Project Coordinator, at 1-800-<###-####>. If you have any questions about your rights in the project, please call <NAME OF A PERSON AT YOUR LOCAL IRB OFFICE> at <PHONE NUMBER>.


IF THE MOM IS IN JAIL, SAY: Your participation in the study will have no effect on parole.


Shall we begin?


IF NO, THEN SAY:

If this is not a good time to talk, I can call back later.


TRY TO SCHEDULE A CONVENIENT TIME TO INTERVIEW MOTHER.

1. THANK RESPONDENT.

2. ENTER APPROPRIATE CODE ON TELEPHONE INTERVIEW FORM:

ENTER MB IF NO TIME SCHEDULED FOR CALL BACK.

ENTER MBS IF TIME SCHEDULED FOR CALL BACK.

ENTER MWC IF MOM WILL CALL PRAMS OFFICE.

ENTER MWM IF MOM SAYS SHE WILL MAIL SURVEY.

(NOTE: TELL MOM THAT INTERVIEWER WILL CALL HER IN A FEW DAYS IF SURVEY HAS NOT BEEN RECEIVED IN THE MAIL.)

ENTER MWW IF MOM SAYS SHE WILL COMPLETE THE SURVEY ONLINE

(NOTE: TELL MOM THAT YOU WILL SEND HER AN EMAIL WITH THE

WEB SURVEY URL AND PASSCODE).


COLLECT THE MOTHER’S EMAIL ADDRESS: ____________________.


IF MOM WON’T PROVIDE EMAIL ADDRESS, OFFER OPTION TO SEND HER A LETTER THROUGH THE MAIL WITH THE WEB LINK AND PASSCODE.

TELL MOM AN INTERVIEWER WILL CALL HER IN A <X> DAYS IF THE SURVEY HAS NOT BEEN COMPLETED ONLINE.



IF MOTHER DOES NOT WANT TO DO INTERVIEW LATER, THEN:

1. THANK THE RESPONDENT

2. ENTER THE APPROPRIATE CODE ON TELEPHONE INTERVIEW FORM:

ENTER MR IF HARD REFUSAL.

ENTER MRT IF JUDGED A ASOFT REFUSAL@ TO BE

FOLLOWED-UP.

3. NOTE THE REASON FOR REFUSAL


IF YES, THEN SIGN BELOW AND BEGIN INTERVIEW.





DO NOT READ ALOUD THE FOLLOWING:

THIS IS TO CERTIFY THAT I HAVE READ THE ENTIRE INTRODUCTION ABOVE TO THE RESPONDENT.


____________________________________________________________

(SIGNATURE OF INTERVIEWER) (DATE)




Introduction, Part 3.

Before we start, it might help for you to have a calendar to refer to. If you have the copy of the questionnaire we mailed to you, you may want to get it also and read along.


Please give me your answers as I read the questions to you.



***MOTHER OF TWINS OR MULTIPLE BIRTHS ONLY***

Some of the questions are about mothers and some are about babies. For the questions

about babies, please answer only for <baby’s name> .



GO TO PAGE 1 AND BEGIN THE QUESTIONNAIRE.


  1. Telephone Introduction for Partial Survey: Baby Living or Deceased (English)


Hello, I’m _________________, and I’m calling from the <STATE> PRAMS project. PRAMS is a research project to learn more about the health of women in <STATE>.


Recently you completed part of the PRAMS survey (online/on the phone). Since you did not answer all of the questions, I’d like to go ahead and finish the survey with you now. <In appreciation for your help, we will send you a special gift.>


First, I’d like to make sure that I am talking with the right person. You are <mother’s name>__ and you were born in <mother’s year of birth>_. Is that correct?

à IF YES, CONTINUE.


Shall we begin?


IF NO, THEN SAY:

If this is not a good time to talk, I can call back later.


TRY TO SCHEDULE A CONVENIENT TIME TO INTERVIEW MOTHER.

1. THANK RESPONDENT.

2. ENTER APPROPRIATE CODE ON TELEPHONE INTERVIEW FORM:

ENTER MB IF NO TIME SCHEDULED FOR CALL BACK.

ENTER MBS IF TIME SCHEDULED FOR CALL BACK.

ENTER MWC IF MOM WILL CALL PRAMS OFFICE.

ENTER MWM IF MOM SAYS SHE WILL MAIL SURVEY.

(NOTE: TELL MOM THAT INTERVIEWER WILL CALL HER IN A FEW DAYS IF SURVEY HAS NOT BEEN RECEIVED IN THE MAIL.)

ENTER MWW IF MOM SAYS SHE WILL COMPLETE THE SURVEY ONLINE

(NOTE: TELL MOM THAT YOU WILL SEND HER AN EMAIL WITH THE

WEB SURVEY URL AND PASSCODE.)


COLLECT THE MOTHER’S EMAIL ADDRESS: ____________________.


IF MOM WON’T PROVIDE EMAIL ADDRESS, OFFER OPTION TO SEND HER A LETTER THROUGH THE MAIL WITH THE WEB LINK AND PASSCODE.


TELL MOM AN INTERVIEWER WILL CALL HER IN A <X> DAYS IF THE SURVEY HAS NOT BEEN COMPLETED ONLINE


***MOTHER OF TWINS OR MULTIPLE BIRTHS ONLY***

Some of the questions are about mothers and some are about babies. For the questions about babies, please answer only for <baby’s name> .



GO TO PAGE WHERE RESPONDENT LEFT OFF AND CONTINUE THE QUESTIONNAIRE.





  1. Special Text at the Conclusion of the Interview


In certain situations it may be necessary to include special text at the end of the telephone interview. For states wishing to conduct toddler follow-up surveys on the PRAMS sample, the interviewer would need to inform the mother that she may be contacted in the future and obtain additional contact information. If a reward is sent to responders, the interviewer may need to verify the mother’s address or give the mother a choice of rewards from which to choose. This text is not part of the telephone survey but is incorporated into the CATI software.


Protocol Development Task


If your state includes special text at the conclusion of the telephone interview, provide the exact text here. Any additional information collected from the mother must be recorded manually by the interviewer. The text will appear on the CATI screens but the CATI system will not record any responses.





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