Telephone Script Template

TELEPHONE SCRIPT (Talking to parents/guardians and prospective participants)BEST PRACTICES:What should I be aware of when presenting study information over the phone?  People can easily multi-task and pay less attention while speaking to you on the phone There are no body language cues to give you an indication of how the conversation is goingWhat can help?  Ask the family if this is a good time to discuss the research study. IF it is not, ask when a better time to reach them would be, then follow up. Let the family know how long you expect the conversation to be and OVERESTIMATE! On average telephone conversations should not last more than 30 minutes. Set the agenda…review with the family what your plan is for the conversation. Encourage the family to interrupt with questions.  Talk slowly!  Assess understanding/your communication this is always critical but becomes even more essential when there are no physical cues to pick up on.How can I use this script?  The script is meant to guide a thoughtful and consistent conversation that a study team plans to have with a potential adult or child participant, a prospective participant’s legal guardian or both parties if appropriate.  This script is intended to be used for Study Introduction/Recruitment, Screening or as part of an IRB approved full Consent, Assent or Parental Permission Process via telephone. Please select the appropriate sections to complete for your study.  The script may contain more information than what is necessary for your study or it may not contain enough information. Page 1 of 14 Revised: 7/2/12 What should I consider when developing my consent/parental permission and assent process?  Cold calling is generally prohibited at Seattle Children’s. You will likely need to develop a letter to participants introducing the study and setting the expectation of future contact.  Providing the consent/parental permission, assent, and/or information sheets along with an introductory letter allows families to fully consider their interest in participation prior to you phoning them. This process is also more respectful of families’ time and likely a more efficient use of yours.  If you need to document parental permission and/or consent and/or assent, mail two copies of each form. One copy is for participants to keep and one copy is for participants to sign and send back. The mailed forms should NOT already be signed by the research team. Research teams will most likely want to document that the consent process took place as well as note the date for their study records.  If young people will be approached to give assent, you will need to discuss the study with the young person as well as the parent/guardian. The team should approach the parent first and ask for their permission prior to approaching their child about participating in the study.  Once the PI/research team member receives the forms the team member who led the consent conference should sign the form and date with the date received (NOT the date they spoke with the participant/parent/guardian). Research teams may want to document on the form itself that a consent conference was held via phone and record the date.  It is best practice to have appropriate forms signed by participants and/or parents/legal guardians prior to starting study procedures. If there is a need to speed up the process, please consider exchanging the forms electronically - either by email or fax. Page 2 of 14 Revised: 7/2/12 Step 1: Calling the Family/Potential Participant Hello, I am [study team member’s first and last name], from Seattle Children’s Research Institute [or appropriate clinic name]. May I please speak to ______?Hello (Mr./Ms). ______. I am [study team member’s full name] from Seattle Children’s Research Institute When desired person gets [or appropriate clinic name]. on the phone I am returning your call about our research study XX [OR I am calling you about XX study]. Explain how you received the individual’s contact message [e.g.) “You left a message on our study line with your telephone number” or “Two weeks ago we sent you a letter letting you know we planned to give you a call” or "Your child is a patient in our clinic and we are contacting all patients to see if they would like to take part in a research study.]Joining a research study is completely voluntary. If it's alright with you I'd like to take about XX minutes to explain the basic idea of the study and to see if you would be interested in your child taking part. Is now a good time?IF NO, GO TO STEP 2a IF YES, GO TO STEP 2b Is there a better day and time to reach (Mr./Ms). ______? If desired person is not Note days and times and enter into XX. available Thank you. I will try to call back then. End call Step 2: Describing the ProjectSTEP 2a Is there another time I can call you back?If interrupted or strong IF YES, Thank you. We will try to call back then. Note date and time immediate refusal IF NO/NOT INTERESTED, Okay, thank you for your time. End call. STEP 2b Before I continue, I need to ask if you are [young person’s name]’s legal guardian? If not interrupted IF YES, GO TO STEP 2c Page 3 of 14 Revised: 7/2/12 IF NO: We very much appreciate your time, but we need to discuss participation in the study with the [young person’s name]’s legal guardian. However, I would be happy to answer any questions you have about XX research study. [Add any applicable study specific procedures] End callSTEP 2c First, I’d like to tell you more about the study. As I explain the basic idea of the study, please feel free to stop me at anytime with questions. As I said the research study is called XX. All research studies ask a question. In this study we are asking… XX (e.g. “Does a new treatment for teens struggling with depression work better than treatments that are currently available.”)Give a basic explanation of what study participation would entail including the number of visits and essential procedures.Now that I've given you a basic idea of what the joining the study would look like, what questions do you have?Are you still interested in [your child]taking part?IF NO, GO TO STEP 2dIF YES and SCREENING/ Eligibility (i.e. finding out if the potential participant’s situation meets criteria to participate in the study) IS INCLUDED, GO TO STEP 2eIF YES and SCREENING IS NOT INCLUDED, GO To STEP 4STEP 2d Okay, thank you for your time. Not interested End CallSTEP 2e I have several questions I’d like to ask you that will help me figure out if the study would be an option for your child. If caller is parent or guardian The questions ask about XX. Of course you are free to skip any questions you do not wish to answer. All of your responses will be kept private and confidential. Is it OK if I ask these questions? Page 4 of 14 Revised: 7/2/12 IF NO, GO TO STEP 3a IF YES, GO TO STEP 3bStep 3: Assessing Eligibility STEP 3a Again, it is your choice to answer any of these questions, but we will need the information to determine if the study would be an option for your child. If NO to eligibility questions If parent does not want to answer questions: Okay. I appreciate your time. Thank you. End CallSTEP 3b Great, thanks. Please feel free to stop me any time if you have any questions. IF YES to eligibility [Fill in appropriate screening questions according to your study requirements] questions 1) [Question 1]? 2) [Question 2]?Condition meets criteria → GO TO QUESTION 3Condition DOES NOT meet criteria → Unfortunately, this study is not a good fit for your child. For scientific reasons we are not allowed to include children in the study who have/don’t have [insert criteria]. We appreciate your interest. Thank you for taking the time to talk with me today. End call.3) [Question 3]?Condition meets criteria → GO TO QUESTION 4Condition DOES NOT meet criteria → Unfortunately, this study is not a good fit for your child. For scientific reasons we are not allowed to include children in the study who Page 5 of 14 Revised: 7/2/12 have/don’t have [insert criteria]. We appreciate your interest. Thank you for taking the time to talk with me today. End call 4) [Question 4]?Condition meets criteria → Based on your answers, it appears that this study might be a good fit for your child. To Schedule a future consent conference on the phone or in- person GO TO STEP 4 to schedule a consent conferenceTo continue and complete presenting the study over the telephone GO TO STEP6Condition may not meet criteria → Because [criteria] might not fit with the scientific rules for this study, I’m not sure if this study will be a good fit for your child. I will need to check with Dr. XX to be sure. [If appropriate] Let’s continue with our conversation and I will call you to let you know what Dr. XX says about the this issuesStep 4. Scheduling a Consent Conference [in person or over the phone]Would you be interested in setting up a meeting with a research team member to go over what study participation would look like in detail? [Researcher should tailor response to fit his/her study design]If yes: If an assent process is required, Let’s find a time to have a detailed [phone or in-person] conversation with a research team member. Both you and [young person’s name] would need to decide that joining the study is a good idea, so we’d also like to talk with her/him about the study. What day and time works best for both of you [or, we have XX dates Page 6 of 14 Revised: 7/2/12 available]? Continue to STEP 5 if the IRB approved sending forms to families.If assent is NOT required- Let’s find a time for you to have a detailed [phone or in-person] conversation with a research team member. What day and time works best for you [or we have XX dates available]? Continue to STEP 5 if the IRB approved sending forms to families.If no: Thanks for taking the time to speak with me today. End call. Can I answer any questions that would help you make your decision? If Not Is there a time I can call back to follow-up with you? Sure: Arrange a time and thank them for their consideration. End call.Step 5. Confirming contact information and ending the call [if appropriate for you study]Before meeting with a research team member, I’d like to send you some study information to review, including a parental permission form.Could I please get/confirm [if already in the database] your mailing address? [Record address in the database]And your home phone number is…? [Record home number in the database]Do you have a cell phone or alternate number? [Record cell phone or alternate in the database]Which is the best number to reach you at? [Record phone preference in the database][Ensure that this is approved by the Institutional Review Board] Do you have an email address you would like us to use? [Record email address in the database]To whom does this email address belong to? [e.g., family, parent, work] [Record name/owner in database]Would you prefer to receive the forms and information via postal mail or email? [Record preference in database]We have also found that families like to receive a reminder call or email before their meeting. Is this something you’d like us to do?Great. So just to confirm, [review any study specific information such as directions and parking etc].Page 7 of 14 Revised: 7/2/12 Thanks again for your interest in XX study. What other questions do you have? Again, my name is ______(first name). If you have any questions or concerns before the meeting, please feel free to call me at ______. We look forward to seeing you and (young person’s name) on ______(meeting date) at (meeting time). Thanks for your time today. End call. Step 6. Presenting the Study in Full Step 6a Since you are interested in the study the next step would be for me to walk through the parental permission [consent] form with you. It’ll take me about XX minutes to do so, would that be alright?” If seeking parental permission or consent only IF No, Is there another time that would work better for you? Schedule a time and End Call.IF YES, Go through the parental permission form or consent form just as you would during an in- person process. Make sure you ASSESS YOUR COMMUNICATION using open-ended questions. See Best Practices BASICS for Consent, Assent and Parental Permission Process. GO TO STEP 7a STEP 6b Since you are interested in the study, the next step would be for me to walk through the parental permission form with you. [Young person’s name] would also need to decide that joining the study is a good idea. My If seeking parental plan would be to talk with you first. And then, if you agree to have him/her participate I would speak with permission and assent him/her and see if he/she agrees as well. It will take us about XX minutes to walk through the form with you. Would now be a good time to do that? IF NO, Is there another time that would work better for you? Schedule a time and End Call.IF YES, Continue with the script below…Go through the parental permission form or consent form just as you would during an in- person process. Making sure that you ASSESS YOUR COMMUNICATION using open-ended questions. See Best Practices BASICS for Consent, Assent and Parental Permission Process.After all questions are answered and the PI/research staff feels confident that the participant/parent/guardian understands the study: Page 8 of 14 Revised: 7/2/12 I would now like to speak to your child. It will take me about XX minutes to explain the study to him/her. No matter what he/she chooses, I will ask to speak to you after. If he/she agrees, I will then walk you through signing the form(s).If this is alright with you, would you please hand the phone to [young person’s name]?Speaking with the minor: Go through the assent information sheet/ assent form just as you would during an in-person process. Make sure you ASSESS YOUR COMMUNICATION using open-ended questions. The language below is recommended for children ages 7-13. Hi my name is [NAME] and I want to talk with you about a research study called XX. Research studies help us learn new things. We are doing this research study to find out more about [….. ][Explain why you are talking to them] I am talking with you because your [mom, dad, legal guardian’s name] said it was okay and because you[….. ]Before I tell you more about what joining the study would mean, I want to talk about a few import things.  You get to decide if you want to take part in our research study.  You can say ‘No’ or you can say ‘Yes’.  No one will be upset if you say ‘No’.  If you say ‘Yes’, you can always say ‘No’ later.  You can say ‘No’ at anytime.  We will still take good care of you no matter what you decide. If you decide to join the study that would mean we would [list basic procedures]Bad things that could happen are [explain risks]This could help you [explain]because…/ OR This won’t help[explain]. This could help other people because [explain]. What questions do you have?Page 9 of 14 Revised: 7/2/12 Is this something you want to do?NO to study participation Thank you for talking with me. Please give the phone to your [legal guardian’s name].Once on the phone with legal guardian: I explained the study to [young person’s name] and he/she told me that he/she is not interested in joining the study. Do you have any questions or concerns? Thank you for having this conversation with me. I very much appreciate your time. End Call UNSURE If the young person is unsure about their participation and does not have any questions.Why don’t you talk about whether you want to join the study or not with your mom/dad. You can work together with them and come up with any questions that you have. Please give the phone to your [legal guardian’s name].Once on the phone with legal guardian: I explained the study to [young person’s name] and he/she is unsure about joining the study. I suggested that he/she talk with you about any questions he/she may have and then I would be happy to set up a time to answer those questions. Share your contact information with the family. Please give me a call to discuss any questions [young person’s name] may have. [Explain if you will call the family again or let them know that if you don’t hear from them you’ll assume they are not interested.]If Yes AND… YES Assent Documentation is required GO TO STEP 7bAssent Documentation is NOT required 7cPage 10 of 14 Revised: 7/2/12 Step 7. Documenting Consent, Parental Permission and AssentSTEP 7a After all questions are answered and the PI/research staff feels confident that the participant/parent/guardian understand the study. Have parent or participant sign and date the Parental Permission or appropriate research forms and mail back the signed copies. Encourage them to keep the extra Consent only copy for their records.Please sign and date [list appropriate form] and mail the signed copy back to us. The second copy is for you to keep and reference.If HIPAA is required GO TO STEP 8IF HIPAA is not required [Include any follow-up information] Once all the appropriate signatures are completed: Please [mail, fax] the signed copy of the form back to us at [address]. Thank you very much for your time and for volunteering. The next step will be: XX [fill in as is study appropriate]. Thank you very much for you time. End Call.Page 11 of 14 Revised: 7/2/12 STEP 7a To young person: Thank you for talking with me. I would like you to sign the form that I mailed to your Assent Documentation house to show that you agree to take part in the study. Insert direction about which form and where Required on the form to sign. Remember you can contact XX if you have any questions and you can always change your mind. Thank you very much for talking with me. I’d like to finish speaking with your mom/dad/[guardian’s name]. Please give them the phone.GO TO STEP 7D STEP 7c To young person: Remember you can contact XX if you have any questions and you can always change Assent Documentation your mind. Thank you very much for talking with me. I’d like to finish speaking with your mom/dad/ NOT [guardian’s name]. Please give them the phone. Required GO TO STEP 7DSTEP 7d I explained the study to [young person’s name] and he/she told me that he/she is interested in taking part. You and I have walked through the consent/parental permission form. Do you have any questions? Are Once on the phone with you still comfortable with taking part/having your child take part? the legal guardian: NO: Are there concerns I can address? Address concerns and continue with signatures if guardian is comfortable or End Call. YES: After all questions are answered and the PI/research staff feels confident that the participant/parent/guardian understands the study. Have parent sign and date the appropriate research forms and mail the signed copy back to us. Encourage them to keep the extra copy for their records. We mailed you XX forms [list appropriate form]. One copy is for you to keep and one is for our research records. Please sign and date the form that is labeled “Research Team Copy”. Go through the appropriate way to sign/complete your study’s form, one blank at a time e.g.) Please write your name on page XX above the line that says “Name of Parent”. Then sign your name on the signature line. Please write today’s date XX and the current time, XX. If documentation of assent is required: I also asked [young person’s name] to sign the form. If HIPAA is required GO TO STEP 8 Page 12 of 14 Revised: 7/2/12 IF HIPAA is not required [Include any follow-up information] Once all the appropriate signatures are completed: Please [mail, fax] the signed copy of the form back to us at [address]. Thank you very much for your time and for volunteering. The next step will be: XX [fill in as is study appropriate]. Thank you very much for you time. End Call.Step 8. Documenting HIPAAReview the HIPAA Form making sure that you collect HIPAA for each participant that you are collecting Private Health Information from.This form is a HIPAA form. You may have filled one of these out before when you’ve gone to the doctor’s office. This form asks for your permission to use, create and share health information for research. It allows researchers to use your private health information for a specific research study—in this case the XX study. There are three important parts to this form 1) The kind of health information our study will be looking at2) Who we may share your information with3) What to do if your change your mind about giving permission for [you or your child]Review the form highlighting these three main points!If you decide that you want to sign this form-- We will keep a copy for our records, I will make a copy for you [ if appropriate: and I will put a copy in [ your or young person’s name] medical record.]If you are still comfortable with your decision to take part [have your child take part] please sign a HIPAA form …. Explain the number of HIPAA forms needed and who each form is for e.g.) Please sign one form listing yourself as the participant and then the a second HIPAA form listing your child as the participant. Explain how to sign the form line by line.Once all the appropriate signatures are completed: Please [mail, fax] the signed copy of the form back to us at [address]. Thank you very much for your time and for volunteering. The next step will be: XX [fill them in as is study appropriate].Page 13 of 14 Revised: 7/2/12 NOTE: It is imperative that the research team re-visit the idea of research when the parent/guardian/participant begins the research intervention. For example, if a young person has agreed to a research procedure and arrives at the clinic, a research team member should remind the young person that this portion of the visit is part of the research study the young person agreed to, explaining what the research visit will look like, and emphasizing that the young person is encouraged to ask any questions and is free to change his/her mind.Page 14 of 14 Revised: 7/2/12

Telephone Script Template

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