Seattle-Denver Center of Innovation (COIN)

Step Away Study Consent Form

LAY TITLE: Step Away Study

Principal Investigator: Eric Hawkins, PhD (206-764-2743)
Research Staff: John Baer, PhD (206-768-5224), John Fortney, PhD (206-764-2821), Carol Malte, MSW (206-277-3780)

We are inviting you to be in a research study. The purpose of this Consent Form is to give you the information you will need to help you decide whether to be in the study. Please read this form carefully. You may ask questions about the purpose of the research, what we would ask you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this form that is not clear. Your participation in this study is entirely voluntary. Please take as much time as you need to discuss the study with your doctors, family, and friends. The decision to participate or not is yours. If you choose to participate, you have the right to withdraw from the study at any time.

Who can I contact with questions while I am in this research study?
• During business hours (8:00 a.m. – 4:30 p.m.), please call the Research Coordinator at 206-277-4835 or Principal Investigator Dr. Hawkins 206-764-2743.
• After business hours (nights and weekends), please call 206-762-1010 or 1-800-329-8387 and ask for the on-call psychiatrist.

The study researcher(s) listed above must be contacted immediately if:
• You think you may have been harmed or injured as a direct result of this research; and/or
• You have any questions regarding your medical care issues.

You may also contact the Institutional Review Board (IRB) at 206-277-1715 if you:
• Would like to speak with a neutral party who is not involved with this study;
• Have questions, concerns, or complaints about the research;
• Would like to verify the validity of the study; or
• Have questions about your rights as a research subject.

1. What is the purpose of this research study?
We will be studying a mobile application called Step Away, which is designed to help manage unhealthy drinking and alcohol-related problems. The purpose of this study is to understand Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans’ interest in using Step Away to manage unhealthy alcohol use. We would also like to better understand how Step Away can be adapted to the preferences of OEF/OIF Veterans. We are most interested in Veterans’ thoughts, feelings, and experiences with using the Step Away app. We will ask the Veterans who participate in this study to provide feedback about how Step Away can be improved. Another purpose of this study is to assess the effectiveness of our online advertising methods in recruiting study participants.This study is designed for OEF/OIF Veterans interested in managing unhealthy drinking and alcohol-related problems. We will enroll up to 75 OEF/OIF Veterans to be in this study. Participation in this study will last approximately 6 months. All study assessments will be completed by telephone. Veterans must own an iPhone to participate in this study.

2. What will I be asked to do in this research study?
If you decide to participate in this study,we will encourage you to use Step Away. We will also ask you to complete an initial baseline assessment and brief follow-up assessments at 1, 3, and 6 months. You may refuse to answer any questions that you do not wish to answer. Based on your engagement with Step Away, we may also ask you to complete an interview with someone on our study team to talk about your experiences. This interview will be audio-recorded.

Baseline Assessment

Questions.
The baseline assessment will be conducted by phone and will take about 2 hours to complete. During the baseline assessment, we will ask you to provide basic demographic information, such as race/ethnicity and marital status, and prior participation in alcohol-related treatment. We will also ask you questions about your alcohol use and mental health. Examples of the kinds of questions we will ask are: (1) Has your physical health been harmed by drinking or drug use? and (2) Have you ever experienced or witnessed or had to deal with an extremely traumatic event that included actual or threatened death or serious injury to you or someone else?

Contact person(s).
We will also ask you how to best contact you over the course of the study. This will involve you providing us with names, phone numbers, and mailing addresses of people with whom you have regular contact, such as relatives or friends. We will contact these individuals by telephone or mailed letters. Study staff will contact these individuals at the start of the study for verification as well as over the course of the study just to maintain accuracy of the contact information you provided (such as phone numbers and address). Should we lose contact with you, we will attempt to contact you through the individual(s) that you provide. The contact person(s) will be given the name and phone number of the person from our study team who is contacting them; the contact person(s) will be told that the caller is from the VA and, if you give permission, may leave a message regarding a missed or upcoming appointment. The contact person(s) will not be informed of the nature of the research or treatment activities at the VA.

Step Away instructions.
Following the baseline assessment, you will receive instructions about how to download Step Away from the Apple App Store to your smartphone.

Using Step Away
Throughout the study, we would like you to please use the Step Away app. This may include reading through the modules, participating in daily brief check-ins about your current mood, drinking behaviors, and alcohol cravings, and using In-the-Moment Tools. As you use Step Away, data will be automatically generated about your Step Away usage, such as time spent per module, use of Step Away features, and completion of daily brief check-ins. These data will be stored on a secure server operated by Here and Now Systems, LLC, the developer of the Step Away app. These data are not research data and fall under the control of Here and Now Systems, LLC. The guidelines for how these data are collected and stored are described in the End User License Agreement for the Step Away app.

Follow-Up Assessments
We will ask you to complete brief follow-up assessments at 1, 3, and 6 months. These assessments will take between 10 to 45 minutes, and will be completed by telephone. The purpose of these follow-up assessments is to learn about your experience using Step Away. Examples of the kinds of questions we will ask are: (1) Did you find the Step Away app easy to use? and (2) Did you find this app very cumbersome/ awkward to use?

SMS Text Messages
To remind you of upcoming follow-up assessments, we will send you secure text messages 4 days before and 1 day before your phone follow-up assessment. For example, a text message may read, "This is a reminder that you have a follow-up assessment scheduled for Monday, March 1, 2016 at 2 p.m. Thank you!"

You will also have the choice to receive a text message with a link to study materials.

Interview
Based on your engagement with Step Away, you may be asked to complete a telephone interview about your experiences. Please note that only a subset of participants will be invited to participate. We will ask permission to audio-record this interview. Examples of the kinds of questions we will ask are:(1) How would you describe Step Away to a friend? and (2) How does Step Away compare to prior treatment experiences?

3. What are some risks of joining this research study?
The procedures in this study mayinvolve risks that are currently unknown. We may need to contact you if we learn of a new study risk, even if you have completed the study. You may be asked to sign a new (updated) Consent Form to document that this new information has been explained to you.

Below are study-related risks that are known at this time:

• Discomfort or inconvenience. You may feel embarrassed, distressed, or inconvenienced answering questions about your alcohol use and mental health symptoms. If you experience any discomfort at any time, a person from our study team who you are speaking with will work with you to make you feel more comfortable. If you continue to feel distressed, the session may be Department of Veterans Affairs terminated or rescheduled for another time. Breaks will be provided as need, and you may choose not to answer any question that makes you feel uncomfortable.

• Confidentiality. Although we will make every effort to keep your information confidential, no system for protecting your confidentiality can be completely secure. It is possible that someone could find out that you are in this study and could find out information about you. As described in Section 7, the researchers have taken a number of steps to prevent this from happening.

• Audio-recording. Some participants will be asked to complete an interview about their experiences using Step Away. This interview will be audio-recorded and transcribed (written down word for word) in order to review your responses as part of the data collected for this study. If you are asked to do so and you agree to this audio-recorded interview, it is possible that your confidentiality could be at risk if someone outside the research team were to hear the recording. Our methods for securing your privacy and confidentiality are described in Section 7. You will also have the right to review and mark for erasure any portions of the audio-recordings.

If any of the risks included in this Consent Form change enough during this study that may change your decision to be in this research study, we will let you know.

4. What are some benefits of joining this research study?
No direct benefits from this study are guaranteed. Taking part in this study may not personally help you, but your participation in research addressing safety concerns in Veterans may lead to knowledge that will help others.

5. Are there other ways I could receive these benefits?
This study is voluntary and forresearch purposes only. The alternative to the study is to not take part in it. If you wish to download and use the Step Away app but do not wish to participate in the study, it is available for download from the Apple App Store.

6. Who will see my information and where will it be stored?
Your research information will be kept confidential. However, some data will be shared, communicated, or stored during or after this research study.

If we learn you intend to harm yourself or others, we must report this information to appropriate authorities.

The following list of people or groups may know that you are in this study. They will have access to your research records:
• Research team members
• Federal agencies including, the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP), the VA Office of Research Oversight (ORO), the VA Office of the Inspector General (OIG), and the Government Accountability Office (GAO)
• The VA committees that oversee research
• The VA Puget Sound Fiscal Department and U.S. Department of the Treasury will be provided with your full name, address, phone number, and social security number in order to authorize payment for your participation in this study.

The access to your records could be either for study-related purposes or to make sure your study record meets all legal, compliance, and administrative requirements. The reviewers will protect your privacy.

Certificate of Confidentiality
Clinical research relies on truthful data collected from you without the fear of disclosure of your sensitive information. Congress authorized the Secretary of Health and Human Services to issue Certificates of Confidentiality (CoCs) which allows research investigators to refuse to disclose identifiable information about you even under a subpoena.  This study has been issued a CoC from the National Institute on Alcohol Abuse and Alcoholism (NIAAA).  As a subject, you must also do your part in protecting your identity and your sensitive information linked specifically to this study:  The CoC remains protective if you do not disclose your participation in this study to others.  Once disclosure is in the public domain, it’s possible that the CoC can be challenged.  

The Certificate of Confidentiality does not protect us from:
• Disclosing information to state or federal public health authorities to whom certain contagious diseases (tuberculosis, HIV, anthrax, syphilis) are reported (if we observe such diseases in any subjects).
• Disclosing information to appropriate authorities if we get any information that suggests the occurrence of child abuse, elder abuse, or your intent to immediately and substantially harm yourself or others.
• Giving the VA Puget Sound office that manages payment to subjects your name, social security number, address, and the name of this study.
• Disclosing information during programmatic and auditing review.

Safekeeping and Storage of Study Data
Privacy and confidentiality will be maintained throughout the study. We will not place your name, social security number, or any other personal identifiers on any research data. Instead, we will assign a code number to your information. We will keep a master list that links study participants’ names to code numbers separate from the research data in a secure VA database with restricted access.

Data Generated by Step Away
As you use the Step Away app, data will be automatically generated. These data will include time you spent reading Step Away modules, use of Step Away features, and completion of daily brief check-ins. These data are encrypted and are stored on a secure server operated by Here and Now Systems, LLC, the developer of the Step Away app. The study will request these data from Here and Now Systems to understand which modules and features of Step Away were used and for how long. After obtaining this information from Here and Now Systems, the data will be stored in a secure VA database with restricted access and the same procedures described under Safekeeping and Storage of Study Data will be applied.

Telephone Interview
If you are asked to complete an interview about your experiences with the Step Away app and you agree, we will ask permission to audio-record the interview. Your name or any identifying information
will not be included on the recording. However, please note that your voiceprint is considered a personal identifier according to the patient privacy rules, so the research will ensure the security of these recordings.

The original audio-recording will be erased from the recorder after it has been uploaded and stored electronically on a secure VA server. The recording will then be transcribed (written down word for word) in order to review your responses as part of the data collected for this study. If the recorder contains any audio-recordings which have not yet been transcribed, it will be stored in a locked file cabinet in an office which will be locked when unoccupied.

After Study Completion
Once this study is completed, we will not use the study code linking you to your data for any additional research. We will store the code linking you to your data in a secure database or in a locked filing cabinet until the VA receives authorization to destroy it in accordance with federal records regulations. The coded data will be kept indefinitely.

In the future, researchers may write about the information collected from this research study. Any future publications or articles will not include any identifying information about you without your approval in writing.

Your study information will be used for research purposes only and will not be sold. Information gained from this research may be used to develop new ways to manage unhealthy drinking and alcohol-related problems. However, neither you nor your family will gain financially from discoveries made using the information you provide.

7. What are some other things to think about before I decide to join this research study?
The VA requires some Veterans to pay co-payments for medical care and services. You will still have to pay these co-payments as long as they are not related to this research study.

You will not be charged for research assessments that take place during the study. All research-related services, including the Step Away app, will be provided to you free of charge.

If you participate in this study, you will be compensated for your time. Payments will be made through the U.S. Treasury in the form of a check as follows:

You will be paid for the assessments you complete. If you complete all of the assessments, you will receive $130. Those who agree to complete the Telephone Interview will receive an additional $20.

Please note that it may take up to 2 months to receive payment in the mail after you complete the study.

To receive payment for your participation in the study, we must collect your social security number (SSN) to comply with Internal Revenue Service (IRS) guidelines.

You may receive an IRS Form 1099. Current VA regulations do not allow us to collect SSNs over the phone. We have included a space on the first page of this Consent Form for you to write down your SSN if you would like to receive payment for your participation in the study.

However, you do not have to provide your SSN in order to participate in this study. The decision to provide your SSN or not is yours. If you do not provide your SSN, you will not receive payment for your participation.

8. What will happen if I decide I don’t want to be in this research study later?
You do nothave to take part in this study. If you are in this study, you can withdraw at any time. If you decide not to participate or to withdraw, no action will be taken against you; for instance, you will not lose your VA benefits. If you decide to withdraw from the study, no new information will be collected from you. Information already collected up to that point will continue to be used for the study.

Your participation may be terminated without your consent if the Principal Investigator feels that it is in your best interest. If you decide to withdraw, or if you are terminated from the study, a person from the study team may need to meet with you to discuss the steps that are necessary to end your participation in the study. You will be compensated for the activities you participated in up to the time that you withdrew or were terminated from the study.

9. What will happen if I am hurt in this research study?
If you are injured as a result ofparticipation in a VA-approved research study, the VA will provide you with the necessary medical treatment. You will not be charged for this treatment. Veterans who are injured because of being in this study may receive payment under Title 38, United States Code, Section 1151. Veterans or non-Veterans who are injured may receive payment under the Federal Tort Claims Act.

You do not waive any legal rights by signing this Consent Form.

10.What am I agreeing to by signing this form?
I have read or have had read to me all of theabove. The study has been explained to me, including a description of what the study is about and how and why it is being done. All of my questions have been answered. I have been told of the risks and/or discomforts I may encounter in the study, of the possible benefits of the study, and of the other choices of treatment that are available to me.

My rights as a research subject have been explained to me and I voluntarily consent to participate in this study. I will receive a copy of this Consent Form.

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