PRAMS Livebirth Introduction and Informed Consent for Phone Survey (English)

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?

 IF YES, CONTINUE WITH PART 2.

 IF NO:

What’s not correct?

 REMEMBER: DO NOT GIVE OUT ANY CONFIDENTIAL INFORMATION

FROM PRAMS UNTIL YOU KNOW YOU HAVE THE CORRECT PERSON.

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

_______________________________________________________

_______________________________________________________

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

Have you recently lived at <street address>.?

 IF YOU ARE SATISFIED YOU HAVE THE CORRECT PERSON,

CONTINUE WITH PART 2.

 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 25-35 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.

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?

 IF YES, CONTINUE WITH PART 2.

 IF NO:

What’s not correct?

 REMEMBER: DO NOT GIVE OUT ANY CONFIDENTIAL INFORMATION

FROM PRAMS UNTIL YOU KNOW YOU HAVE THE CORRECT PERSON.

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

_______________________________________________________

_______________________________________________________

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

Have you recently lived at <street address>.?

 IF YOU ARE SATISFIED YOU HAVE THE CORRECT PERSON,

CONTINUE WITH PART 2.

 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 25-35 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.