36 Risk2 Consent Onboarding
36.1 Overview of Running Consent/Onboarding
The Study Staff running the session calls the potential participant at the appointment time. If they answer the call, study staff greets them, then ascertain they are in a safe and private place to complete the phone-visit before proceeding. Reschedule if needed.
Using the Consent/Onboarding Session Script (See below), study staff will then provide a brief overview of the study and reconfirm eligibility.
If the potential participant is still eligible, study staff will proceed with the session script and enroll the participant, then help them install the STAR app.
After participants give Consent using the Consent/Onboarding Qualtrics Form, they will be automatically redirected to the Onboarding Qualtrics, which will serve as our enrollment database. It is used to collect the consent signature, participant contact/mailing information, cell phone payment information, MAT start date, participant demographics, and DOB.
Once participants complete this form, they are enrolled in the study, and the STAR app download will begin automatically.
36.2 Steps To Complete BEFORE Successful Onboarding Session
Verify participant’s name and phone number from Google calendar. When you dial out using a desk phone, you need to hit 1+1 prior to entering their 10 digit number. (Sometimes it will take 1+10 digit, but other times it fails, so 1+1 is safest)
Find the reminder text in google voice. Prepare the link to the consent form as a text ready to send (but don’t send until the script tells you to do so). Copy & paste both the text and qualtrics link below (everything on the next line):
STAR Study Consent Form: https://uwmadison.co1.qualtrics.com/jfe/form/SV_6zzSu1ddmyfH46G
Make sure you have the script & FAQ open
Sometimes a participant might tell you something that will make it necessary to end the call without enrolling them. Examples of this are if they say they have been abstinent from opioids or have been on MAT for years (they are supposed to be within 1 month of quitting), or that they own more than one phone. In this case you might say:
Thank you for that information. Unfortunately, _______ means you won’t be able to participate in the study, so we won’t be able to proceed with this call, as the study requires that you _______ . But thank you very much for your interest and have a good rest of your day. [Insert the reasons they gave and the requirement of the study]
36.3 Consent and Onboarding Script
Italics are script you read to the participant
[Items in brackets are instructions to you]
36.3.1 Connection
[Once the participant is connected (via phone), greet them, then ascertain they are in a safe and private place to complete the phone-visit before proceeding. Reschedule if needed.]
36.3.2 Introduction
Hi my name is [name] and I’m calling from the University of Wisconsin-Madison about the STAR study. Is now still a good time for you to talk?
Great! First, I’m going to tell you more about today’s session. I’ll be talking about our research study and then, if you are eligible and interested, we can enroll you today. The entire process should take about 30 minutes, and if you have any questions at any point, feel free to interrupt me.
36.3.3 Description of the study
This is a 12-month study for people who are in recovery from opioids. It will involve using an Android smartphone app that was designed to help people in recovery, but it is not a treatment study, which means we will not be providing any treatment.
People in the study will do tasks using the app. These will include filling out short daily surveys, a longer survey once a month, and sharing smartphone data.
People who are part of this study need to keep their phone bill paid, and need to be consistent about keeping their phone charged.
This study will ask people about their experiences with drugs, so it is important that those who take part feel comfortable honestly answering questions about their use of opioids and other drugs.
All the information the study collects will be kept entirely anonymous and stored on the University’s secure servers, accessible ONLY to members of the study team.
A lot of participants ask us, “if I report a lapse, how do I know law enforcement, CPS, or my treatment provider won’t find out?” Well, to prevent that, we’ve obtained a Certificate of Confidentiality, which means we are protected by the National Institute of Health from being forced to share study information with anyone outside the study team”.
People who participate will be paid for completing daily and monthly study tasks. People who complete all the study tasks will receive about $70 a month, and we will also pay $50 a month to help people cover their monthly phone bill if they have shared their phone data with us.
Participants will also get paid for the phone calls they have with STAR study staff a total of three times during the study. This session counts as the first phone call.
So based on what I have shared, are you interested in hearing more about participating in the study?
[If yes, continue] [If no, thank and disconnect. No payment]
36.3.4 Confirm phone OS- UW only
Wonderful! So before we continue further, I’d just like to just verify that you do have an Android phone and that you have that phone available to you now?
Unfortunately, our app only works on Android phones, which means I will not be able to enroll you at this time. I apologize for the inconvenience but greatly appreciate your interest in our study and hope you have a wonderful day.
[no payment given]
Mark Visit on google calendar as “ineligible - iPhone”
[If yes]
Ok great! In that case you are able to sign up for the study if you wish and we can go ahead and continue.
36.3.5 Consent
In this part of the visit, I am going to tell you a little bit more about the study and then give you the chance to formally agree to join it.
I am going to tell you about the study goals and about the risks, benefits, and protections associated with being a participant in the study.
So - In this study, we will be collecting data from people who are in recovery from opioids because we want to identify the feelings, events, and behavior patterns that can lead to using opioids and other drugs.
A lot of people in recovery have “slips,” where they use opioids but are still committed to recovery. These slips are sometimes called “relapses,” “episodes,” or “lapses.” And while slips may seem to come out of nowhere and take people by surprise, research has found evidence of warning signs like really stressful events, big changes to life circumstances, changes in moods, or being around friends or places that remind people of their past use.
So- the goal of the STAR study is to try to find new warning signs. We are looking for warning signs in two different kinds of information.
First, we are looking for warning signs in information that people provide about their own experiences – so these are things like people’s moods, experiences of stress, urges to use, and how much people want to avoid using. This type of information will come from daily and monthly surveys that participants fill out.
Second, we are looking for warning signs in information that people do not need to tell us about, and that people might not even know about themselves. For example, people’s recent messages or where they go could contain a warning sign. People’s routines and patterns or changes to their routines and patterns could also contain warning signs. We gather this type of information from smartphone data including phone call logs, texts, and location. I’ll explain more about data sharing in a moment.
So far, I have given examples of times when people are at greater risk of using opioids, but in this study, we are also looking for positive signs. People tend to do better in recovery when they are happy, have meaningful contact with other people, and when they have healthy habits and routines.
For this study to predict future opioid slips, we will need information about when slips have happened. This means that participants in this study will be asked every day if they have used opioids; and when they used the opioids.
So that is the main purpose of the study. Do you have any questions?
[Answer questions until they have none]
Now I’m going to describe what people are asked to do as participants in our study.
- Participants download the STAR app onto their phone and have to keep that phone paid for and charged.
- Every day they fill out a short survey that asks how they are doing.
- Once a month, they fill out a longer survey that asks about their thoughts and experiences in the last month.
36.3.6 App Data
I’d like to tell you more about what we’ll be doing with the smartphone data that people share with us. After I tell you about each item I’ll pause and ask if you have any questions.
People will be asked to give the app permission to access their phone data, text messages, and their location data.
For phone data, our computer will be able to see the numbers of people you call or message frequently, and the name you have given them in your Contacts, if any. For example, we might see “this participant texted or spoke with 608-555-1234 four times over the last month. This person is saved in their contacts as Joe Smith”. We will use this information only to ask you generic questions about whether talking to this person is harmful or helpful to your recovery.
Do you have any questions about how we access your phone data? [Pause and answer questions]
For text messages, our computer is able to read ONLY the text of SMS messages you have sent or received. The computer CAN NOT see any images you might send in texts, or ANY messages sent using other apps like Snapchat or Facebook. The study team CAN NOT see your actual texts in real time; and we CAN NOT “read your messages”. Near the end of the study, our computer will sort through all the words in all of everyone’s messages to tell us general things about people’s messages. For example, the computer might tell us: “people in this study used the word ‘stressed’ in their texts much more often before they had a slip”… or… “people used the word ‘happy’ more often when talking to a person they told us was helpful to their recovery”
Do you have any questions about how we access your text messages? [Pause and answer questions]
For location data, our computer will be able to look through the GPS points recorded by your phone and use those to identify places you have spent a lot of time at over the past month. For example, the computer might tell us: “this person has visited 101 Main Street two times in the last month”. We will use this information ONLY to ask you generic questions about whether visiting this location is helpful or harmful to your recovery. We CAN NOT “see where you are” in real-time and won’t know ANYTHING about these places other than what you choose to tell us.
Do you have any questions about how we access your location data? [Pause and answer questions]
We know this is sensitive data and we want to be sure people understand and are comfortable with how we use it. Do you have ANY other questions on any of this data we’ll ask you to share? [Pause and answer questions]
I also want to reassure you that you will be able to delete any phone logs or SMS messages that you don’t want us to see, and you will be able to turn off your location sharing if you don’t want us to see where you go for a period of time.
Again, I’d like to remind you that participation in the STAR study is totally voluntary. The study lasts up to one year, but you can stop being part of the study at any time. To remain enrolled, people have to complete most tasks, meaning all monthly updates and at least 6 daily updates per week, and share their phone, text message, and location data. If someone is not able to keep up with tasks or does not want to share their data anymore, we will talk with them and may decide to stop their participation early.
It is also important that you know that any use of opioids or other drugs has NO effect on your participation. You can continue to participate regardless of when or how many times you might use opioids or other drugs. It is ONLY important that you HONESTLY report any opioid or drug use when asked about it in the surveys.
36.3.7 Risks/Benefits
Next we’ll go over study risks and benefits. There are no major risks related to participation in this study, and if you decide to participate, the main risk is that someone might see your information who should not.
For this reason, we are VERY careful and have created safeguards regarding how your data is stored and accessed. Protecting your data and privacy is our top priority, and we are overseen by a group at the University of Wisconsin-Madison that exists to protect and help research subjects. With their guidance, we follow careful protocols for storing, using, and sharing any information that could be used to find out who participants are.
Here are some examples of how we will protect your information and reduce the risk that someone might see it:
- We store your contact information like your name and address in a locked location that is separate from the study data.
- We label study data with an anonymous study id number.
- When we share results and data with other researchers, we will not share information that could be used to find out who participants are, like their location data.
- We will only ever give grouped summaries of demographic information, like average ages, or percent of the people in each gender, race or ethnicity category.
There are no direct benefits of taking part in this study. The STAR app that participants use was designed to help people in recovery and might help you, but we are not treatment providers, and this study is not a treatment. Of course, our team does hope that in the future, what we learn in this study will be used to improve treatments for other people in recovery.
We will compensate people who participate in the study for as long as they choose to do so. If you decide to enroll, you will earn:
+ $20 for this first phone visit
+ $10 for a phone call in a week to check in about the study
+ $10 for a phone call at the very end of the study
There will be only 3 calls total over the entire 12-month course of the study. This call counts as one of those three calls. To be clear, we will NOT be calling or checking-in on you regularly aside from the surveys you complete in-app.
For every task you complete in the app you will earn payments, and you can also earn bonuses for meeting target goals, with payments up to about $70 per month.
Again, we will also pay you an additional $50 a month to help cover the cost of your monthly phone bill, for every month that you have shared phone data with us.
Compensation will be provided via a payment debit card that we will mail to you after successful download of the STAR app. Once compensated for the completion of your initial calls and training, you will receive payment on your designated date once a month, either on the 15th or the 30th. We will be able to tell you which date you will be paid during the one-week check-in call.
All of that said, this study was not designed to make money for the research team or anyone else. If you participate in the study and if the research team develops products from this study, you will not receive any profits. It is also important to let you know that one member of the STAR research team partially owns the company that makes the study app, and as such they may financially benefit from this research study.
Based on what I have shared, what questions do you have for me? [Pause and answer questions]
The information I just gave you about the study goals and the risks, benefits, and protections are things that we make sure everyone who is thinking about joining the study hears and understands.
The next step of the process is to make a formal decision about whether you want to be part of the study. In a minute, I’ll send you a link to a Consent Form with all the information I just reviewed stated in more technical language. Then you’ll be asked if you are ready to decide if you want to participate. If you do, you’ll be asked a few questions, and these will take information that we need to pay you and help make sure our study includes different types of people.
Then, finally, you’ll download the app and set up an account.
36.3.8 Participant opens consent link & gives consent
[Switch to google voice and send the text message]
I’ve just sent you the link, can you let me know when you receive it and are able to open it?
Great, you should see a document that says “Consent Form” at the top. Now, you can either read it right now before we continue the call, or we can continue our call and you can read it later, or we can schedule another call to finish up after you’ve taken time to read it and think about it
[IF THEY WANT TO READ IT RIGHT NOW]
Great, you can take as much time as you like to read it over right now, and let me know when you are done. I will sit quietly here in case you have any questions.
[After they are done]
Do you have any questions or anything you want me to know before we continue the call?
[Answer their questions or move on if not]
[IF THEY WANT TO CONTINUE THE CALL] Great, you’ll also be able to download a copy of the consent form, or you can read it in the study app after we finish our call.
[IF THEY WANT TO THINK ABOUT IT] Great, we encourage people to take some time to think about things, so let’s schedule a call for me to follow up after you’ve read it.
You now have three options. You can decide to participate, decide not to participate, or you can take more time to make this decision.
If I have answered your questions, and you feel you understand the information in the consent form please tap “Continue” and then select “Yes, I am ready to say”yes” or “no” to participating in this study”.
That’s understandable and I’m glad you’re going to take more time. You should feel free to discuss the consent with anyone if you feel it will benefit you. It’s very important for you to be fully informed and not feel pressured before you consent.
You can go ahead and download the consent form by tapping the link on the screen that reads “Click here”. After you have read and considered them, please don’t hesitate to reach out if you have more questions or have made a decision. We can schedule a time window in the next few days for someone from our team to call back and discuss if you still want to participate after you have had time to review the consent form. Does that work for you?
[Pick a time window to call, Answer any remaining questions and complete the telephone visit. Then put the follow up call on the star_psych@wisc.edu google calendar. No payment given]
That’s okay, we very much appreciate your time and interest in this study. Have a great day!
[Answer any remaining questions and complete the telephone visit. No payment given]
[If ready to consent “Yes”]
Okay, great. Please type your full legal name into the space provided. This will function as your electronic signature. Once you are done, please pause and let me know.
[Pause]
In the next form, you’ll be asked to provide some contact information and information about your background. On the first page you’ll provide your phone number and phone plan provider. Then, you will be asked to provide an email you would like to use for the STAR app. Next, you’ll be asked to provide a mailing address that we will use to send you your payment debit card.
Following the completion of this call, we are going to send you a link to electronically sign a W-9 form. We will not be able to render any payment until the form is returned to us, so it is crucial you submit it as soon as possible.
We will mostly communicate with you through the study app, but we occasionally use your email address to get in touch with you. Then the final screen page of questions will ask you to select when you started your medication assisted treatment, as well as your race/ethnicity and date of birth.
When you are ready, please tap continue to be taken to the next survey form and let me know when you have entered your date of birth.
Great! Now we will get the app downloaded on your phone and set up your study account. If you are not currently on WIFI, this app download will use your cellular data. Will that be okay?
36.3.9 App Download
Great! Please tap continue, and the download should start automatically. The app will guide you through set up. You should agree to the permissions the app or your phone asks of you as it is setting up.
That’s ok, sometimes participants have trouble loading the download. [Ask questions to determine what/where the issue is]*
[You can also send this link via text: https://star.achess.wisc.edu/apps/android/latest.apk ]
[If participant does not see STAR homepage, troubleshoot]
[If it worked, they should see STAR homepage (“Welcome to STAR”, “Create your Account”)]
Great! Once the app is downloaded, please let me know what you see on the screen.
[Wait for confirmation]
And you can see the text that reads “Create your account”?
[pause]
Once you type in the site id (1202), you’ll see a brief introduction. On the next page, you will see a form to Create an Account. This form asks for you to provide your First and Last name, your email and to create a unique screen name. You are going to want to pick a username that does not contain your name, as this is the name that others using the app will see when interacting with you on discussion boards or through direct messages. It can be a nickname or something random that comes to mind. You’ll also need to create a password at least 8 characters long.
Once you’ve created your account, you should receive several access requests. Please tap allow for all the permission access requests you receive. This access will allow the STAR app to collect the data we are asking of you as part of your participation. If you want, I can walk you through how each permission will be used by the STAR app to collect data.
Allow STAR to access your location
- This permission will allow STAR to collect your GPS information and collect data for the visited locations survey
Allow STAR to access your contacts
- This permission allows us to create the social contacts survey and allow you to add contacts to the friends and family section of the star app
Allow STAR to make or manage phone calls
- This permission will allow you to dial study staff from the app and dial contacts you add to the friends and family section of the app
Allow STAR to send and view SMS
- This permission will allow us to gather data on you text message logs. Like I said earlier we will never be able to the content of any pictures you send or receive, and we will remove any personal identifiers from your text logs while we do our data analysis
- Stop Optimizing Battery usage – Please tap Allow
Do you have any other questions about the access STAR will have to your device? [Pause and answer questions]
Today, the STAR app will ask you to complete your first DAILY update. Please try to take the daily update soon after this call. You will be asked to complete another daily update every day of your participation.
On the THIRD day of your participation, and then once a month when you are on study, you’ll be prompted to complete the MONTHLY update.
Do you have any questions on that?
36.3.10 App Guidelines
Now I want to take some time to tell you a bit about the STAR user guidelines. These guidelines were designed to make sure our participants and staff are protected and are treated professionally and with respect.
Briefly, our guidelines are…
To always use respectful language on app discussion boards or in communication with study staff,
To communicate with staff and other STAR participants as you would in a professional work setting,
And to avoid sharing personal or private information on the public discussion boards.
Any questions about these guidelines?
All in-app messages, posts, and phone calls with staff are subject to review by the STAR team, and staff will remove any discussion post, comment, or individual member who does not follow these guidelines. You can find more information about the app guidelines and the review process for violating app guidelines in the Study Information tab in the STAR App.
36.3.11 Final Steps
The final step of enrolling in the study will be to watch tutorial videos that describe the app’s recovery resources and explain how to complete the different study tasks. You can find these video tutorials in a text message I will send to you shortly after we complete this phone call.
Completing these video tutorials will take about 35 minutes for four videos and you will be compensated $20 for your time.
If you experience any issues either with the video tutorials or completing any of the study tasks, please do not hesitate to email or call us.
We’ll want to call you in one week to see how everything is going with your participation. This will be a very brief call, only about 5 minutes, and you’ll receive $10 compensation for its completion.
So, one week from now will put us at {insert date/time that is one-week from onboarding session}. Does that sound like it will work for you?
And would you like to keep the same time or select a new one?
[Allow participant to pick a time]
Great! The day before the one-week check-in, we’ll send you a quick text to remind you of the call.
So that is all I have for you today. Do you have any final questions or concerns? [Answer any questions]
Wonderful! Well I want to thank you for your cooperation and patience in completing today’s consent and onboarding visit. It’s because of the commitment of people like you that we are able to do what we do and hopefully help others, and we appreciate you signing on to participate in our study. As a quick reminder, I’m going to give you a call [describe next session date/ time] but you can message us if you have any questions before then. I hope you have a wonderful day!
Thank you!
36.4 Steps To Complete AFTER an Onboarding Session
Click here for the next steps you need to take after a visit