Introduction and Informed Consent for the Stillbirth Phone Survey (English)

Att 12g-PRAMS Stillbirth Introduction and Informed Consent_Phone_English.docx

Pregnancy Risk Assessment Monitoring System (PRAMS)

Introduction and Informed Consent for the Stillbirth Phone Survey (English)

OMB: 0920-1273

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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 STILLBIRTH PROJECT NAME> 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 STILLBIRTH SCHEDULED FOR CALL BACK

PROJECT> .

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 SSP 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.


Telephone Introduction: Stillbirth (English)


Introduction, Part 1.

Hello, I’m _________________, and I’m calling from the <STATE STILLBIRTH PROJECT NAME> project. <STATE STILLBIRTH PROJECT NAME> is a research project to learn more about why stillbirths happen to help prevent stillbirths in <STATE>.


On behalf of the <NAME OF HEALTH DEPARTMENT>, please accept our deepest sympathies to you and your family on the loss of your baby. This recent loss brings sadness and sorrow, and the death of any baby in our community affects us all.


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.


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.

<STATE STILLBIRTH PROJECT NAME> is sponsored by the Centers for Disease Control and Prevention and the <NAME OF HEALTH DEPARTMENT>. The survey asks women who have had a stillbirth about things that may have happened before, during, and after a pregnancy that ended in a loss.


I am very sorry to hear about your loss and I would like to extend my deepest sympathies to you and your family. 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 by doing so you will be helping to improve the services and care for women and babies in the future. The information you give us will be used to help us find out why stillbirths happen and how to improve the care that families like yours receive.


We are asking all women in <YOUR STATE> who have had a stillbirth to answer these same questions. Your name was identified from recent vital records files.


Most questions are about your health and life before, during, and after your pregnancy that ended in a loss. It takes about 25 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 <STATE STILLBIRTH PROJECT NAME>. 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 to the extent allowed by law and will be used only for research. What we learn from <STATE STILLBIRTH PROJECT NAME> will be used to plan programs to help prevent stillbirths in <YOUR STATE>.


If you have questions about <STATE STILLBIRTH PROJECT NAME>, please call <PROJECT COORDINATOR’S NAME>, <YOUR STATE> <STATE STILLBIRTH PROJECT NAME> 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 REFUSAL.

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.


GO TO PAGE 1 AND BEGIN THE QUESTIONNAIRE.


Stillbirth Telephone Intro and Consent

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