K Concent form

IRB Office Use Only

IRB Approval Date: IRB Consent Version No.:

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH

ADULT ORAL CONSENT SCRIPT FOR HOSPITAL AIM PROGRAM TEAM LEADS

Study Title: Safety Program in Perinatal Care (SPPC)-II/Demonstration Project

Principal Investigator: Dr. Andreea Creanga

IRB No.: IRB00009378

PI Version Date: 1

Greetings. I am <<Data Collector Name>> from Johns Hopkins University and would like to talk to you about your experience with the teamwork and communication training workshop offered by your state in conjunction with the Alliance for Innovation on Maternal Health (AIM) program.

• We are interested in learning your opinion on the quality and utility of this training workshop.

• We are asking you to participate in this telephone interview because you are involved in the implementation of the AIM patient safety bundles at your hospital and received this training. You do not have to participate, it is your choice. There will be no penalty if you decide not to join.

• If you agree to participate, I will ask you to answer questions over the phone. You may refuse to answer any of the questions during the interview or skip any questions that you do not wish to answer. The interview will take about 60 minutes.

• With your approval, this interview will be tape recorded for note taking purposes and to ensure that we capture all your feedback. You should know that:

  • You may request that the audio recording be stopped at any time;

  • If you agree to allow the audio recording and you change your mind at a later time, you may request that the recording be destroyed;

  • The audio recordings will be transcribed for the purposes of this research, but the full transcription will not be published. We may use specific sentences from the transcript when we present the results of this research, but your name will never be identified.

• You may get tired or bored when we are asking you questions. You do not have to answer any question you do not want to answer, and you may stop the interview at any time.

• Your responses will be kept confidential to the extent permitted by law, including federal government confidentiality statute, 42 USC 299c-3(c). That law requires that information collected for research conducted or supported by the federal government that identifies individuals or establishments be used only for the purpose for which it was supplied unless you consent to the use of the information for another purpose.

• There is the risk that information about your opinions may become known to people outside this study. Standard precautions will be taken to protect your data once it is collected. Confidentiality will be maintained utilizing computer systems that require passwords for access. Collected information will be stored in a password protected computer not available to anyone not directly involved in this study. All names or other personal information will be deleted from the transcribed interview in order to protect your confidentiality. Three years after completion of the study and data analysis, all audio recordings and transcribed interviews will be destroyed.

• You will not receive any payment or other direct benefits from participating in this study. However, we will use your answers to our questions to understand experiences with the roll-out of the teamwork and communication training workshop for future participants. We hope this knowledge will improve implementation of the AIM program and its impact on teamwork and communication in clinical practice, patient safety culture, and key maternal health outcomes.

• Do you have any questions? [Probe to assess the participant’s understanding.]

• You may contact Dr. Andreea Creanga, the Principal Investigator of this study, about your questions or problems with this work.

• Her contact information is:

Telephone: 443-287-1864

Email: [email protected]

• Call or contact the Johns Hopkins Bloomberg School of Public Health IRB Office if you have questions about your rights as a study participant. Contact the IRB if you feel you have not been treated fairly or if you have other concerns. If you change your mind and do not want your information used for the study anymore, you can also call the IRB. Just remember, if we have already used your information for the study, the use of that information cannot be cancelled.

• The IRB contact information is:

Telephone: 410-955-3193; Toll Free: 1-888-262-3242

E-mail: [email protected]

• Would you like to participate in the interview?

• [If yes] May I begin?

• I will turn on the recorder now. Please say your first and last name and that you give me permission to record the interview.

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