Drexel-cyshcn

Appendix H
Version Date: 03.26.20

Drexel University

Phone Screen Script Template

Hello, my name is [Reginald Combs-Harris OR Iris Cruz] from the department of Pediatrics at Drexel University.

The reason I am calling is to conduct a screening interview to see if you meet the criteria for taking part in our research study looking at disaster preparedness for children and youth with special health care needs. I am going to go through a list of questions. The questions I ask will determine your eligibility to participate in the study. You may choose not to answer these questions. You also may choose to stop participating in this interview at any time; if you want to stop, please tell me.

This interview will take approximately 5 minutes.

Do I have your permission to continue? Circle one: YES NO

If you qualify and agree to participation in this research project we would like to keep the information we talk about in our files until you consent for participation in the study, which we can do over the phone today or at another time. If you qualify and choose to be part of the study, this information will become part of your study file.

If you don't come in or if you don't qualify for the study, we may ask your permission to keep this information until the study is over and then we will destroy it.

We are required by law to keep this information confidential and we will not use it for any purpose other than to see if you qualify for this study. It is possible that Drexel University and other federal and state authorities may inspect this record.

You can choose if you want or do not want to take part in this research screening procedure, it is up to you. If you refuse to answer the questions or stop answering them at any time, there will be no penalty to you, and you will not lose any benefits to which you would otherwise be entitled.

The risk to taking part in this interview is very small. The screening interview is designed to ask you for the least amount of sensitive personal information, but it is possible that some people may feel uncomfortable answering these questions with a person they do not know

The benefit to you of taking part in this interview is that you will find out whether you can take part in the study of looking at disaster and emergency preparedness for children and youth with special health care needs. This study involves using a disaster preparedness checklist created as part of this study, and going through the checklist with you in your home or virtually with a secure phone/video application. We would ask to conduct two home visits, an initial visit and a follow up visit in 3-6 months. As part of this visit we would connect to you to state and local community resources, as needs are identified.

You will not be paid for answering questions in this interview since it is only to see whether you qualify to take part in the study.

If you have any questions, concerns, or complaints about this interview, contact Dr. Renee Turchi at 215-427-5331. If you want to talk to someone separate from the research team about a concern or complaint or your rights as a possible research subject, please contact Human Research Protection at 215-762-3944 or at [email protected]

Now I would like to ask you some questions:

Criteria	Yes	No	Additional comments
Are you the primary caregiver for a child or youth with special health care needs?
What is primary medical diagnosis of your child? (Included would be any complex medical dx (epilepsy, congenital heart condition, hemophilia, etc.) or developmental/behavioral (autism, down syndrome, etc.) or visions impairment, deaf and hard-of-hearing. Also included would be any child non-ambulatory or needs assistance to ambulance.
Is your child/youth 26 years of age, or under?
[Only applicable if virtual visit is required] Do you have a smart phone, or computer with a video and microphone to do a virtual visit? This process would be similar to a FaceTime call. Otherwise, we can do this visit via a regular telephone/cell phone.			[Note what method will be used here- phone only, or virtual via phone/ Zoom]

Closing –

Eligible Participant

Based on the information you gave me, it looks like you may be eligible for this study. At this point, you have three choices. (1) if you have time today, and I can start the process of enrolling you in the study (administer consent form); (2) I can take down your contact information and myself or another staff member can contact you to set up an appointment at a later time; or (3) I can give you the number to call when you are ready; (4) if you confirm you are not interested in learning more about the study I will not keep the information collected in this interview.

___________ OK TO CONSENT NOW (continue with script below)

___________ OK TO CONTACT LATER (collect contact info)

___________ SUBJECT TO CONTACT (give contact info)

___________ NOT INTERESTED  (destroy all information collected)

___________ CALL BACK  (Phone #: )

___________ MAIL ADDRESS  )

Thank you for agreeing to review the consent process over the phone with me.

Scenario # 1 (virtual home visit): Ask the participant how they would prefer to receive the electronic consent form (a hyperlink via text or email). Review the consent summary with the participant over the phone (script below- modify as applicable for virtual visit). Allow the participant time to review and sign the electronic consent. Prior to signing, allow the participant to ask any questions they may have. If obtaining verbal consent, complete documentation of verbal consent below (page 4).

Scenario # 2 (in-person home visit): We have a written consent form which I will ask you to sign when we meet in person. For now, I’d like to review with you the purpose of this project, activities that will take place if you agree to participate, and what you need to know as someone who is a participant in this research project. Do you have any questions before I get started?

1. We want to understand what caregivers of children and youth with special health care needs (CYSHCN) need, to be prepared in an emergency or natural disaster. We would like to test an emergency preparedness checklist and resources we developed to see if it meets your needs. To do this, we would set up two different times to come to your house for an initial visit and then a follow up visit in 3-6 months. The project team members (who would come to your home) are a social worker, a community health worker, and a medical equipment provider and a first responder (like an emergency medical technician or firefighter). The home assessment team would use a checklist developed for this project and ask you some questions to see the things you have done to prepare for an emergency, try to understand your ideas about emergencies and disasters, and help you look at things you could do in the future to prepare for an emergency with your child. The team would walk through your entire house using the checklist. You (or another family member) would be with the project team the entire time but it will be important for them to see your whole house before they leave to best help you be prepared with your child with special health care needs. Before the home assessment team leaves, they will talk with you about an emergency plan that would be specific to your family, give you some resources, discuss your child’s medical needs and recommendations for you to be prepared in your house. They team may also refer you to some community resources if certain things are identified in the visit that they can help with such as help with food or utilities.

2. We expect the first visit to be about 2.5 to 3 hours long and the follow up visit to be shorter- up to 1.5 hours.

3. It is important for you to know that this project is voluntary. If you decide not to take part in the research and it will not be held against you. Your child’s healthcare will not be affected in any way if you decide not to participate.

4. If you decide later that you no longer want to participate, it will not be held against you however, already collected data may not be removed from the study database.

5. Risks of participation is discomfort from having the home assessment team in your home. In rare cases, the project team may see something in your home that they need to report to another agency such as the Department of Human Services (DHS) to help you if you or your child is in imminent danger. This would only be in the case that your child is in immediate danger or at risk of serious harm. The project team would tell you if they were planning to make such a report.

6. Efforts will be made to limit your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this organization. The Centers for Disease Control and Prevention (CDC) has hired us to conduct this study. The CDC will also be reviewing summary data from the project, but your name and your child’s name will be anonymous.

7. Lastly, if you agree to take part in this research study, you will receive a $50 gift card at the completion of each home visit (for a total of $100) for the time you spend completing the home assessments and answering our questions related to your knowledge, experience and sharing your expertise with us.

Name of person providing consent: _____________________________

Relationship to patient: ___________________________

Name of person obtaining consent: ________________________

Date: _______________

Time: ______________

Thank you for your time.

Closing : Ineligible Participant

Based on the information you gave me, you are not eligible for this study.

Thank you for your time.

Drexel University HRP 712 Phone Screen Template: Version 06-25-2015 Page 3 of 3