Title: PHONE (Phone Health Outreach and Education) Study
Principal Investigator: Gail L. Rose, Ph.D.
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
This study is being conducted by UVM at The University of Vermont Medical Center, the health care organization affiliated with UVM College of Medicine.
We are conducting this study to see how well an automated Telephone Health Survey system works to screen for health-related behaviors among patients visiting their primary care providers. Approximately 8000 patients will participate.
You may contact Dr. Gail Rose, the Principal Investigator in charge of this study, at (802) 847-2255 for more information about this study, or explore the information provided below. If you have any questions about your rights as a participant in a research project or for more information on how to proceed should you believe that you have been injured as a result of your participation in this study you should contact Nancy Stalnaker, the Institutional Review Board Administrator at the University of Vermont at (802) 656-5040.
What is involved in the research study?
- The purpose of the study is to determine if we can enhance your provider visit by identifying patients ahead of time who might want information, evaluation, referral or treatment for various health-related concerns.
- The study involves answering 6 questions about your current health. Based on your responses to the questions, you may be offered information, resources, and/or opportunities to participate in other research. A small number of patients who complete the survey will then be invited to use the automated telephone system to hear specific information based on their survey responses. If you are asked to participate in that study, the UVM researchers will provide you with information to help you decide whether to take part. For this second project, you would be compensated financially for your time.
- The questions will be asked by automated telephone. You will answer the questions by pressing numbers on the keypad. It takes about two minutes. You do not need to be tech-savvy to complete the screening.
- Your answers to the questions will be completely confidential and will be saved in a secure research database. This database is linked to your personal information only by a specific ID code.
- You will have the option at the end of the screen to indicate whether you would like to share your responses with your doctor or not. If you choose to, your answers will go directly to your electronic medical record. However, your provider will not necessarily be reviewing this at the time of your visit.
- Participation in the study is voluntary, and you may withdraw at any time. Your choice to participate or not will in no way impact the quality of care you receive at The University of Vermont Medical Center.
- The telephone screen must be completed before your appointment with your doctor.
What are the possible risks/discomforts associated with participating in the research study?
- While there are no physical risks to participating in this study, there is some risk involved in handling medical information and confidential documents. Any mishandled information may have social or employment consequences. However we will make every effort to maintain your privacy and keep your information confidential.
- Responding to questions about sensitive health information could cause you some anxiety.
What are the benefits of participating in the research study?
- You may benefit personally from having the opportunity to reflect on the 6 areas of health covered by the questions. You also may benefit from having this information available to your doctor at the time of your visit.
- You may benefit from the information provided about local treatment resources.
- The medical community may benefit from the added knowledge this study will generate and if successful, a program like this one may become a standard part of primary medical care.
- You may receive satisfaction from contributing to new medical knowledge.
What other options are there?
- If you do not consent to participate, you will continue on with your medical appointment as you normally would. No decision you make regarding the study will affect the regular medical care you will receive from your physician.
Can you withdraw from this study?
- Yes. Once enrolled, you may discontinue your participation at any time. Your choice to participate or not will in no way impact the quality of care you receive at The University of Vermont Medical Center.
- After completing the six health questions, you will have the option to save or not save your answers. If you choose not to save your answers your provider would not see them and you would not receive further contact from research staff.
- If you prefer not to be contacted at all about this study you may call (802) 847-0729 to remove your name from the project list. There will be no change in your care.
Is there any cost or compensation associated with the research study?
- There will be no costs to you, nor will you be compensated for participating.
- If you pay for minutes receiving a call, your phone carrier will charge you for this call. We will not be able to reimburse for these charges.
What is a Confidentiality Certificate?
The Confidentiality Certificate will protect the investigators from being forced, even under a court order or subpoena, to release information that could identify you. However, we do maintain the right to report medical information (if you need medical help), communicable diseases, probable harm to yourself or others, or probable child abuse or neglect. We will discuss these issues with you first, when possible. Also, staff from the government agency sponsoring this research (NIAAA) as well as the UVM Institutional Review Board may see your information if it audits us. They can't report anything that would harm you, and also will protect your privacy to the fullest extent possible. This Certificate, however, does not imply that the Secretary, DHHS, approves or disapproves of the project. You should understand that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. Note, however, that if an insurer or employer learns about your participation and obtains your consent to receive research information, then the investigator may not use the Confidentiality Certificate to withhold this information. This means that you and your family must also actively protect your own privacy.