IRB #2020-0335

Information Sheet for Research

University of Cincinnati

Department: Communication Sciences and Disorders

Principal Investigator: Chitrali Ramakant Mamlekar, MS

Faculty advisor: Dr. Aimee Dietz, PhD, CCC-SLP

Title of Study: Improving Patient-provider communication preparedness during COVID-19 crisis.

Introduction:

You are being asked to take part in a research study. Please read this paper carefully and ask questions about anything that you do not understand.

Who is doing this research study?

The people in charge of this research study are Chitrali R. Mamlekar and Dr. Aimee Dietz of the University of Cincinnati (UC) Department of Communication Sciences and Disorders (CSD). There may be other people on the research team helping at different times during the study.

What is the purpose of this research study?

The purpose of this research study is to understand your experience of using a patient-provider communication tool.

Who will be in this research study?

About 500 healthcare providers will take part in this study. You may be in this study if you are a healthcare provider who is currently working with patients who are diagnosed with COVID-19.

What if you are an employee where the research study is done?

Taking part in this research study is not part of your job. Refusing to be in the study will not affect your job. You will not be offered any special work-related benefits if you take part in this study.

What will you be asked to do in this research study, and how long will it take?

The participation will begin immediately after the consent form is read. You will be provided a free communication tool to use with COVID-19 patients to support patient-provider communication and asked to complete a survey. It will take about 2-5 minutes. The survey will take place online.

  • Information about your experiences while interacting with the communication tool will be collected. At the time of the prototype download, you will be required to enter your email. This will be used to send a reminder to complete a 2-5 minute survey regarding the helpfulness of the communication tool after 1 week, 2 weeks, and 4 weeks after you download the communication tool. You may also receive emails inviting you to participate in the next phase of the study, which is an interview about your experiences communicating with COVID-19 patients.

Are there any risks to being in this research study?

It is not expected that you will be exposed to no more than minimal to no risk in this research study.

Are there any benefits from being in this research study?

You will probably not get any benefit from taking part in this study. But, being in this study may help research team members to understand your experiences while interacting with the patient-provider communication prototype.

What will you get because of being in this research study?

You will not be given anything to take part in the study.

Do you have choices about taking part in this research study?

If you do not want to take part in this research study, you may simply not participate.

How will your research information be kept confidential?

Emails will not be shared or sold and will be kept on a HIPAA-secure server that only study personnel will access. All the data will be stored on a HIPAA secured UC’s RedCap and will be used only to send email reminders to complete the survey. Each consented participant will receive a unique identification code for entry into the computerized database that provides for participant confidentiality. All links between participant identifier and the database will be destroyed 3 years after completion of the study. Databases are backed up daily to a remote site via UCIT. Only the research study personnel, will have access to the stored data in RedCap. Your survey responses will be destroyed by deleting computerized records of the survey three years after the study is complete, in compliance with University of Cincinnati regulations. Any printed copies of the survey or associated data will be shredded.

The researcher cannot promise that information sent by the internet or email will be private. Agents of the University of Cincinnati may inspect study records for audit or quality assurance purposes.

What are your legal rights in this research study?

Nothing in this consent form waives any legal rights you may have. This consent form also does not release the investigator, the institution, or its agents from liability for negligence.

What if you have questions about this research study?

If you have any questions or concerns about this research study, you should contact Chitrali Mamlekar at mamlekcr@mail.uc.edu

The UC Institutional Review Board reviews all research projects that involve human participants to be sure the rights and welfare of participants are protected.

If you have questions about your rights as a participant, complaints and/or suggestions about the study, you may contact the UC IRB at (513) 558-5259. Or you may call the UC Research Compliance Hotline at (800) 889-1547, or write to the IRB, 300 University Hall, ML 0567, 51 Goodman Drive, Cincinnati, OH 45221-0567, or email the IRB office at irb@ucmail.uc.edu.

Do you HAVE to take part in this research study?

No one has to be in this research study. Refusing to take part will NOT cause any penalty or loss of benefits that you would otherwise have. The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Please print and keep this information sheet for your reference. You can download the sheet at the link in this field:

Information Sheet

IMPORTANT: If you decide to volunteer for the study, please open this email on your phone to complete the survey and access the communication tool.

BY SUBMITTING THIS PAGE, YOU INDICATE YOUR CONSENT TO TRY A PATIENT-PROVIDER COMMUNICATION TOOL AND COMPLETE A SURVEY.

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