Integrating mHealth for Alcohol Use Disorders Into Clinical Practice
Phase: NA
Conditions: Alcohol Drinking, Telemedicine
Sponsor: University of Wisconsin, Madison

 
 
 
 
 NCT04011644  
Integrating mHealth for alcohol use disorders into clinical practice  
07.13.2023  
 
 

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Integrating mHealth for alcohol use disorders into clinical practice 
 
PRINCIPAL INVESTIGATOR: 
Andrew R. Quanbeck, PhD. 
University of WI – Madison 
Department: Family Medicine 
800 University Bay Drive 
Madison, WI 53705 
Phone 608.262.7385 
Email: ARQUANBE@WISC.EDU 
 
COORDINATING CENTER: 
Implementation Science and Engineering Lab 
 
CO-INVESTIGATORS:  
 
Randall Brown, M.D., PhD. 
Department: Family Medicine and Community Health 
1100 Delaplaine Ct Room 3832 
Madison, WI 53715 
Phone: 608.263.6558, 608.263.3111 
E-mail: randy.brown@fammed.wisc.edu 
 
David H. Gustafson, PhD. 
University of WI - Madison  
 
 
 
 
Department: Industrial and Systems Engineering 
1513 University Avenue, ME Bldg. Suite 4109 
Madison, WI 53706 
Phone 608.263.4882 
Fax:608.265.3281 or 608.890.1438 
Email: Dhgustaf@wisc.edu 
 
Bruce Barrett, MD, PhD. 
Department: Family Medicine and Community Health 
1100 Delaplaine Ct Room 3832 
Madison, WI 53715 
Phone 608.263-2220 
Email: bruce.barrett@fammed.wisc.edu  
 
Ming-Yuan Chih, PhD. 
University of Kentucky 
Department: Human Health Sciences 
900 South Limestone St Room 209 
Lexington, Kentucky 40536 
Phone: 859.257.2454 

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Email: m.chih@uky.edu 
 
STUDY COORDINATOR: 
Christine Stephenson, Ph.D. 
 
FUNDING SPONSOR:  
National Institute of Health: National Institute on Alcohol 
Abuse and Alcoholism 
PARTICIPATING 
INSTITUTIONS:  
The Center for Health Enhancement System Studies (CHESS) 
The University of Wisconsin Department of Family Medicine and 
Community Health (DFMCH) 
 The University of Wisconsin School of Medicine and Public Health 
 The University of Kentucky 
 
 

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TABLE OF CONTENTS 
 
Study Summary 
1. Background & Significance  
2. Study Objectives  
3. Selection of Subjects 
4. Registration Procedures   
5. Treatment Plan  
6. Measurement of Effect   
7. Study Parameters  
8. Statistical Considerations  
9. Bibliography  
 

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STUDY SUMMARY 
The purpose of this study is twofold: (1) to assess the impact a mobile health tool may have on 
reducing alcohol use and improving quality of life for patients with moderate to high risk drinking 
patterns and/or mild to moderate alcohol use disorder; and (2) describe how mobile health technology 
designed to support alcohol use reduction may be effectively integrated into primary care.   
The primary aim of this study is to assess the impact on risky drinking patterns and quality of life for 
patients with risky drinking patterns or mild to moderate alcohol use disorder among patients who 
self-refer to our study from a primary healthcare system. Patients in the trial will be given versions of 
an evidence-based mobile-health (mHealth) system (A-CHESS) that is delivered using different 
implementation strategies according to study group. The original A-CHESS is an evidence-based, 
smartphone-delivered system characterized by the essential elements of relapse prevention: long 
duration,1,2 assertive outreach,3 monitoring,4-6 prompts,7-9 case management,10-12 and peer13-15 and 
family16-18 support that was tested among patients exiting 90-day residential treatment for severe 
alcohol use disorder. A-CHESS has more than 18 services designed to improve social relatedness 
(e.g., online peer discussions), coping competence (e.g., guided relaxation and other interventions), 
and intrinsic motivation (e.g., reminders of why a patient wants and needs to control his or her 
drinking).  
The version of A-CHESS to be tested in this trial maintains its core components but is modified to be 
appropriate for a self-referred study population in a primary healthcare system who are likely to 
represent a broad spectrum of patients who use alcohol. We have named this modified version of A-
CHESS “Tula,” from the Sanskrit word for balance. We propose to randomly assign 546 patients who 
self-report moderate- to high-risk drinking patterns from UW Health clinics to one of 3 groups: 1). A 
self-monitoring group that receives information on alcohol, 2). A peer-supported group that uses the 
Tula system independently of the health system, or 3). A version of the Tula system that is clinically 
integrated in the health system.       
Secondarily, we want to detect differences between groups in health system use, whether patients’ 
sex (male/female) moderates outcomes, whether effects are mediated by measures of competence, 
relatedness, and autonomous motivation, and whether levels of use of Tula correlate to changes 
observed in health outcomes (i.e., dose/response relationship). The study is designed to isolate and 
examine the role of the clinician in delivering an mHealth system. The cost-effectiveness of each 
approach will be assessed. This research examines a unique and promising mHealth system with 
potential clinical, economic, and societal importance and aims to determine the most cost-effective 
strategy for implementing mHealth into primary healthcare systems.  
 
 

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1.0 BACKGROUND & SIGNIFICANCE 
Importance of improving outcomes for alcohol use disorders (AUD). According to the Pew 
Research Center’s 2018 Internet Project Survey, 77% of adults in the U.S. owned a smartphone in 
2018. The proliferation of smartphone use holds great potential for monitoring patients’ chronic 
conditions outside the clinic setting. An increasing number of smartphone applications are designed 
to help patients manage their chronic conditions, such as diabetes and cardiovascular disease.19,20 
Studies in which clinicians monitor patient-reported data about chronic illnesses have shown better 
results with monitoring than without it.21-29 Wisconsin ranks among the worst in the nation for heavy 
drinking and binge drinking among adults. According to the Wisconsin Department of Health 
Services, 22% of Wisconsin adults engage in binge drinking and 7% of Wisconsin adults engage in 
heavy drinking; nationwide30, Wisconsin ranks 49th for binge drinking and 45th for chronic drinking.31  
 
Barriers to effective treatment. Access and referral to necessary treatment represents an enormous 
barrier to treatment. Improving access to effective treatment is critical for a disease as pervasive as 
AUD and for which so few get treatment. In the U.S. in 2015, 26.9% of adults reported they engaged 
in binge drinking in the past month. By definition binge drinking is having 5 or more alcoholic drinks 
for males or 4 or more alcoholic drinks for females on the same occasion. About one in three adults 
18 and older in the USA reported they drank excessively in the past month.32 Given the prevalence of 
problematic drinking, it is evident that a large gap exists in the extent to which AUD is treated in 
primary care settings. Currently, the most popular and comprehensive primary care program for AUD 
treatment is SBIRT (Screen, Brief Intervention, Referral to Treatment). Patients who screen to have 
an AUD will receive a short talk about how to reduce their drinking, then will be referred to an 
addiction specialist. In a patient reported assessment, referral to treatment after screening only 
happens about 40% of the time.33  
 
Advances in treatment and scientific knowledge. While mHealth is beginning to take hold in the 
clinical management of chronic conditions, the literature contains few examples in which patients and 
clinicians use patient generated data by mobile technology to manage AUD, even though AUD is a 
chronic, relapsing condition.34-41 Patient self-management is fundamental to effectively treating 
AUD,42 just as it is with other chronic diseases.43 One mobile technology, A-CHESS, proved effective 
in a randomized clinical trial of recovering AUD patients.44 We propose to use a modified platform of 
A-CHESS (as Tula) to find out whether mHealth can significantly improve AUD treatment in primary 
care settings. The proposed study also seeks to understand in what ways an mHealth system works 
and does not work, for whom, and under what circumstances. This new knowledge could have wide 
and lasting benefits in integrating mHealth systems for alcohol use disorders in primary care.  
 
The Center for Health Enhancement Systems Studies (CHESS). CHESS focuses on two 
important areas of healthcare innovation: the use of technology by patients and family and 
implementation research. CHESS is home to the Network for the Improvement of Addiction 
Treatment (NIATx), the AHRQ-funded Center of Excellence in Active Aging Research, the 

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coordinating office for the Addiction Technology Transfer Centers, and research projects in family 
care, primary care, cancer, and dissemination and sustainability. 
 
CHESS’s current technology work focuses on smartphone applications. These apps are the latest 
evolutions in computer systems we have designed and tested for over 30 years with patients and 
family caregivers to improve health behaviors, quality of life, and access to care (chess.wisc.edu).45, 46 
The systems have been based on extensive needs assessments.47-49  
 
Pilot tests (reported below) suggest that A-CHESS (Addiction – CHESS) will have positive effects on 
subjects who want to reduce their alcohol consumption: 
 
1. In the first large randomized trial50 studying the effects of mHealth on alcohol use disorders 
(AUDs), patients (n=349; 39% women) leaving residential treatment were randomly assigned 
to A-CHESS or usual care for 8 months and followed for 12 months. Over this period, those 
with A-CHESS had 57% fewer risky drinking days than those without it as well as longer 
abstinence. Participants used A-CHESS heavily, with nearly 60% still using it at 8 months.  
2. In the most recent implementation research trial51 which studied the effects of mHealth patients 
with a range of substance use disorders (n=268; 48% women) in federally qualified health 
centers (primary care clinics that serve patients regardless of their ability to pay) were provided 
access to an iteration of A-CHESS, called Seva, for 12 months. Over this period, patients had 
a 44% reduction in risky drinking days and improvements in self-reported quality of life.      
Patients sustained heavy use of the system over the 12 months across the three clinics. This 
suggests that Tula (the version of A-CHESS central to this study; see description, below) may 
prove to be an effective tool to reduce alcohol consumption in primary care patients. 
Tula is a mobile health system based on A-CHESS but modified for self-referred patients in primary 
care who want to reduce their drinking. Participants are likely to represent a wide spectrum of 
patients, from those concerned about their drinking to those whose lives are seriously affected by 
their drinking. Patients randomized to all three groups in the study will download Tula on their 
smartphones and receive the same static content. This static content will appear in the following 
sections: 
Thought of the Day—an inspirational quote intended to motivate participants. 
Motivation—Participants can record, in words and photos, their reasons for wanting to work 
on their drinking and wellness; respond to a prompt to write a daily reflection; complete or 
revise What Matters to Me, about why they want to work on their drinking and wellness; and 
save favorites in Tula. 
Tracker—Participants can set goals for 90 days—how many total drinks they’ll have in a week 
and the number of days per week they’ll drinking as well as goals related to other aspects of 

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wellness, such as exercise and sleep; keep track of their progress week by week; and take the 
weekly survey about factors related to drinking and wellness (mood, sleep, social pressure, 
etc.) 
Information—Participants will see a library of information related to wellness, such as building 
healthy habits, reducing drinking, food and nutrition, physical activity, etc. 
Relaxation—Information on relaxation techniques and audio recordings for meditation and 
binaural beats. 
Strategies—Tips for reducing drinking and meeting other health goals, including “Rethinking 
Drinking” from National Institute for Alcohol and Alcohol Abuse, cognitive behavioral therapy, 
and quick tips for building skills related to making changes. 
The content of Tula will vary by randomization group in two ways: the in-app communication services 
participants can access, and whether they work with a health coach, as follows: 
● In the self-monitoring group, participants will not have access to a discussion group with others 
using the app. They will be able to send private messages only to the research coordinator (a 
member of the research team).  
● In the peer-supported group, participants will have access to a discussion group available to all 
members of the group and moderated by a trained peer specialist. Participants will identify 
themselves in the discussion group by usernames they create, not by their real names. 
Participants in this group will be able to send private messages to others in the peer-supposed 
group as well as to the peer moderator. If participants have a question that the peer moderator 
cannot answer, he or she will refer the question to the research team. 
● In the clinically integrated group, participants will have access to a discussion group available 
to all members of the group and moderated by a health coach. Participants will identify 
themselves in the discussion group by usernames they create, not by their real names. In 
addition, patients can send private messages to other members of the clinically integrated 
group and to the health coach. If participants have a question that the health coach cannot 
answer, he or she will refer the question to the research team. Participants in this group will be 
encouraged to have up to three sessions in person or by phone with the health coach at the 
beginning, middle, and end of the active 90-day implementation period. 
 
We believe this RCT will have the following effects. (1) It will be the first RCT to test the impact on 
alcohol-related patient outcomes of mHealth in primary care. (2) Moderation and mediation analyses 
will help us understand how the elements have their effects on primary care patients. (3) We will 
better understand how sex relates to mHealth use and benefit. (4) We will test an mHealth system 
that offers essential elements of alcohol use reduction in a cost-effective and accessible way.  

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2.0 STUDY OBJECTIVES 
This project proposes a hybrid type II effectiveness/implementation trial that will test the effect on risky drinking 
patterns and quality of life associated with patient use of an mHealth system under a variety of implementation  
Primary Aim: 
Detect the effectiveness of interventions by assessing the difference in self-reported risky drinking 
patterns and quality of life between subjects in the three study groups (self-monitoring, peer-
supported, and clinically integrated groups). 
Secondary Aims: 
Because the study is designed to investigate both the effectiveness of Tula in primary care and the 
comparative effectiveness of different implementation strategies, the following secondary goals 
complement study’s primary aims: 
● Understand the significance clinician monitoring has on alcohol use interventions and patient 
outcomes. 
● Calculate the costs of health system use for each group. 
● Develop an mHealth reimbursement strategy prototype using CMS billing codes in the clinically 
integrated group.  
● Understand the degree to which sex moderates the intervention outcomes among Tula users. 
● Understand the degree to which patient competence, relatedness, and autonomous motivation 
(three tenets of self-determination theory) mediate the intervention effect in the Tula groups. 
● Assess the dose/response relationship between Tula use and degrees of outcomes 
● Understand the impact clinician monitoring has on AUD treatment. 
● Qualitatively assesses clinician engagement and clinic needs to further refine Tula and its 
associated integration for future implementation and dissemination. 
 
Sub-aim: 
• 
Understand the relationship between pain and alcohol consumption after the 3-month active 
intervention. 
 
Study Coordination 
The Implementation Science and Engineering Lab is the coordinating site for this study. The UW 
study coordinator will oversee all activities at participating UW Health recruitment sites. Activities 
include: 
● developing site-specific recruitment and data collection processes that meet study objectives; 
● training the health coaches on protocol procedures prior to the start of recruitment and continuous 
monitoring to assure compliance with the protocol and human subjects regulation; 
● communicating with site staff via regular conference calls to monitor progress, inform of protocol 

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changes/distribute new version of protocol, and address unanticipated issues or challenges; 
● overseeing and managing recruitment of patients; 
● following up with subjects who have completed the electronic recruitment and consent process; 
● conducting voluntary qualitative interviews with clinic staff subjects (audio-recorded with permission); 
and managing all study data. 
 
3.0 SELECTION OF SUBJECTS 
Patients: A total of 546 men and women will be recruited from the UW Health academic medical 
center (e.g., primary care clinics, emergency medicine, and other entities of the University of 
Wisconsin-Madison for which the HS IRB is the IRB of record). Inclusion criteria: 
1. Meet the criteria for at-risk drinking on the AUDIT screening (scoring 8+);  
OR respond yes to at least two questions on the AUD DSM-5;  
OR report moderate- to high-risk drinking patterns as defined by the NIAAA (i.e. more than 7 
drinks per week and 3 on a single day for women; more than 14 drinks per week and 4 on a 
single day for men) 
2. Are interested in learning about ways to reduce drinking and want to reduce or modulate their 
alcohol use 
3. Are 21+ years old 
4. Own an iPhone or android smartphone and are willing to download the Tula app 
5. Are able to understand and sign an electronic consent form in English 
Patients will undergo a 72-hour run-in period. Those who return to the app to submit a baseline and 
weekly survey during the run-in period will qualify to continue with the study and will be randomized to 
a study group. 
Abuse or dependence on other substances will not exclude patients from participation. Patients 
whose eligibility screen results suggest the possibility of severe alcohol use disorder (at least 6 of 11 
symptoms according to DSM-5 criteria) will be excluded. Patients who report having a current 
psychotic disorder that would prevent participation, have an acute medical problem requiring 
immediate hospitalization, or have a known terminal illness will likewise be excluded from the study. 
When the study team notifies patients about their eligibility status, the team will encourage all 
ineligible patients to talk with their primary care provider to address any concerns they have about 
their alcohol use.  
If the following scenarios occur during a patient’s study period, the patient will remain enrolled in the 
study and their circumstances will be documented by the UW study coordinator: (1) is unreachable for 
follow-up surveys; or (2) becomes incarcerated. In the case of incarceration, no study data will be 
collected from incarcerated individuals during the time they are in prison or jail. 

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Site Staff: Up to 20 staff from participating UW Health clinics will be recruited to participate in 
interviews to provide feedback on the implementation of Tula. Interviews will take place with two 
distinct groups of staff: 
1. Primary care clinicians are from a clinic that had at least 10 patients enroll in the clinically integrated 
group; and 
2. Clinicians who participated in interviews during the development year. 
 
4.0 REGISTRATION PROCEDURES 
Patients 
Recruitment. Study subjects who are patients at UW Health clinics will be recruited in many ways. 
The research team will implement one or two methods, assess effectiveness, and implement more if 
necessary: 
 
1. Recommendation. Clinicians of UW Health Collaborative Care, such as primary care providers 
and behavioral health specialists, will recommend the study to potentially eligible patients who 
initiate a conversation about their alcohol use by giving them the flyer informing patients about the 
study and how to enroll. Potential subjects will be given the flyer at their appointments only once. 
As primary care providers and behavioral health specialists turn to telehealth to deliver care, 
providers may also provide information regarding the study via the additional channels described below. In 
each situation, recruitment materials supplied to clinicians will be shared with potential participants at the 
discretion of the clinic and/or clinician and are informational in scope: subjects will ultimately self-refer to 
the study.  
 
2. Emergency Department Research Coordinator: An Emergency Department Research 
Coordinator, who is a staff person employed by the Department of Emergency Medicine, will 
monitor the HealthLink trackboard for eligible patients. The trackboard will notify them of 
individuals who may be eligible. Patients they visit will have a positive AUDIT-C screen (score of 
4+ for men; 3+ for women). EDRC study staff with UW Health electronic health record (Health 
Link) access may also use tools made available to them as part of their research access to Health 
Link, including searching patient list templates or receiving automated alerts (use of a silent BPA-
best practices alert), to help identify potential subjects for study enrollment evaluation. This pre-
screening eligibility review of medical records will be used to identify the subjects to be 
approached. These staff members have a broader role in the ED. They complete duties as 
assigned by the Department Chair as it relates to the overall mission of the Department of 
Emergency Medicine (e.g., research, clinical operations such as quality improvement, 
communication, & process monitoring, etc.). These RAs, under the direction of the ED clinical 
providers, will approach subjects and inform them about the study by offering the flyer and 
answering any questions.  
 

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3. Flyers. Recruitment flyers will be placed in UW Health clinics and other relevant facilities (UW 
Hospital, community centers, etc.) with permission from the hosting organization. Flyers will 
specify the inclusion criteria and requirements for patients to self-refer into the study; provide 
contact information for study staff, a means for interested individuals to request more information 
or ask questions; and direct potential participants to the online screening survey. 
 
As a recruitment strategy, thoughtful placement of recruitment flyers aims to promote the study by 
increasing its visibility. Effective March 2020, the necessary and widespread constraints, 
restrictions, and closures occasioned by the COVID-19 pandemic response significantly 
undermines this strategy. As an extension of flyer placement in strategic locations, the study team 
will pursue alternate spaces, both traditional and internet-mediated, for hosting the information 
represented in the flyer. In some cases, the information will be adapted only insofar it is necessary 
to fit the space and will preserve the content and language, if not necessarily the design, of the 
existing IRB-approved flyer. These alternatives include: 
a. Health newsletters and digital communications. As a component of our recruitment strategy, we 
will seek opportunities to promote the study through health newsletters, including e-newsletters. 
Such newsletters typically operate as a service to patients as an extension of a health system, 
health care organization, or other relevant professional body and provide wellness tips and 
resources from health experts to help its constituents maintain a healthy lifestyle. We will adapt 
the information from the IRB-approved study flyer for these media, including contact details for 
the study team should interested individuals wish to learn more or ask questions about the 
study.  
 
b. Websites. With permission from the hosting organization, and in compliance with each site’s 
terms of use, we will seek to promote the study on websites appropriate for an eligible 
participant population, including but not limited to the Department of Family Medicine and 
Community Health, the Implementation Science and Engineering lab (home website for the 
study), and other relevant professional bodies and interest groups. Information provided to each 
hosting website will rely on the language and information included in the existing IRB-approved 
flyer and/or use a digital file format of the same.    
 
c. Traditional media outlets: television, radio, and newspapers. In consultation with UW 
Communications’ News & Media Relations, we will explore and, where appropriate, pursue 
opportunities to promote the study through traditional media channels using the information 
contained in the existing flyer. We will limit our activity in these traditional media channels to 
communication tactics that serve only to offer public notice. These may include purchasing 
advertising space or issuing an informative press release,  
d. Social media. The study team proposes limited use of social media to increase the visibility of 
the study under these strict conditions and in compliance with HIPAA standards: 1) information 
from the flyer will be posted only under conditions that neither allow nor support public 
comment; 2) eligibility criteria, as presented in the flyer, is clear and explicit; 3) the study team 
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means (phone or email) presented in the flyer. 
4. Community outreach. Historic distrust of medical research has resulted in lower participation rates from 
underrepresented populations. Recruiting from communities of color requires building relationships 
within those communities via direct personal contacts. With their permission, flyers will be sent to 
community centers and other community organizations that serve in those neighborhoods where 
information can be provided to their residents. Directors of those community organizations will be 
instructed to refer any interested participants to the study team for more details.  
Screening and Enrolling in the Study. No subjects will be coerced to enroll in the study. Interested 
subjects will be directed to a website (isel.wisc.edu/screen) to complete an initial screening survey via 
Qualtrics. Potentially eligible participants will consent that they are submitting data for a screening 
which will assess eligibility. During the eligibility screening, patients will be asked to provide their e-
mail address (to be notified of their eligibility and to receive the $10 Amazon.com Gift Card (digital 
code) and their zip code to verify their residency within the UW Health service area). Individuals will 
be informed that email is not guaranteed as a secure means of communication. Scripts for 
communicating screening participants’ eligibility status have been uploaded to ARROW.  
 
All screening survey results will be reviewed by study staff, who will notify all who complete the 
screening survey of their eligibility or ineligibility. The screening survey is not intended to diagnose 
AUD, but if an individual is found to be ineligible based on DSM-5 scores that are consistent with 
severe AUD, the individual will be notified that they are not eligible. These individuals, as well as all 
others who screen ineligible, will be encouraged to talk about their drinking with their primary care 
provider, who is qualified to provide resources and/or refer them for evaluation and treatment (see 
Post-Screen Script – Not Eligible in ARROW). Data (except age, biological sex, and reason for 
exclusion) from ineligible participants will be destroyed. 
 
Individuals who screen eligible for the study will be notified via email and invited to enroll in the study. 
Instructions for downloading the app and enrolling in the study are optimized for digital methods of 
communication and include links to download the app, available in the Apple App Store and on 
Google Play (see attached “Post-Screen Script -- Eligible” in ARROW). Participants will be asked to 
download the Tula app within 48 hours of receiving the invitation to join the study. If a participant has 
not downloaded the app after 48 hours, the study team will send up to 2 reminders over a 2 week 
period, provided the participant granted the study team permission to send them reminder emails at 
the time of screening. Screening data from eligible participants will be recorded in Qualtrics. Once 
screening data has been reviewed, the data will be removed of identifiers, coded, and stored on a 
secure server at HIP. 
 
Consent. The following two-step consent process will occur within the Tula app on the patient 
subject’s smartphone. After the individual has downloaded the app, they will be presented with 
Informed Consent #1, which requests their broad consent for the study. This consent includes 
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assignment, and a step-by-step process overview of their activities—including their immediate next 
steps for completing their enrollment (comprised of the 72-hour run-in and Consent #2). Upon 
completing Consent #1, participants will be asked to create a Tula account. Once created, they will be 
asked to complete the items on the Quick Start Checklist. Patients who do not complete the checklist 
tasks will not be randomized and all collected data (except age, biological sex, and reason for 
ineligibility) will be destroyed. Age, biological sex, and reason for ineligibility will be kept for 
generalizability and reporting reasons. Randomization (see below) occurs after patients complete the 
checklist tasks during the 72-hour run-in period.  
The research team will use the private messaging feature in Tula to schedule a phone call with 
individuals who remain in the study. During that call, a member of the research team will confirm the 
participant’s consent, answer any additional questions about the study that the patient has, and will 
randomize the individual to one of three groups of Tula users. Once randomized, patients will be 
prompted to complete Informed Consent #2 via the app, the next time they login. Informed consent #2 
serves as an addendum to Consent #1 and provides detailed information specific to the patient’s 
assigned group.   
Patients are advised to take their time reading the consent forms; they may leave and return to them 
and reread sections if they’d like to. To mitigate any potential difficulties related to readability (i.e. 
length of the document, screen size, small text) and to ensure participants understand the most 
critical aspects of their participation  in the study, we will preface the full text of the consent form with 
a bulleted list, highlighting in plain language the following sections: what the study is about, how we 
will protect their confidentiality, benefits and risks involved, remuneration, voluntary nature of 
participation, their participation and their healthcare, and contact information for questions. Subjects 
will also be able to listen to a verbatim recording of each consent form using a screen reader. If the 
subject has not agreed to the informed consent after two weeks, he or she will no longer be able to 
join the study and all data collected during the screening process will be destroyed (except age, 
biological sex, and reason for exclusion, per CONSORT standards), A copy of the consent form will 
be accessible to the study coordinator via the Tula server. Subjects can refer to the consent forms 
electronically by navigating to the Study Information sections of Tula. They will also be able to email 
the consent form to themselves. If a subject declines to participate at any time during the consent 
process, he or she may select a “I choose to not participate” button that will ask them why and return 
them to the launch screen. Reasons for refusal will be noted, in line with CONSORT standards.57 
Subjects who choose not to disclose why they are ending their participation in the study will also be 
able to say “I choose not to respond” or “none.” All subjects will be reminded that they are under no 
obligation to participate in this study and can withdraw from the study at any time. They are also told 
that their health care will not be affected by their participation in this study. Once subjects opt out of 
the study, they will no longer have access to Tula. 
Randomization. Randomization will be done by the study coordinator using the urn randomization 
program and happen prior to informed consent #2. Study staff will access the admin tool within Tula 
to assign patients to the self-monitoring, peer-supported, or clinically integrated groups. 
Randomization will be done in block randomization by clinic, sex, and severity of alcohol use. 

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Following randomization, study staff will call the individual to notify them which group they are in and 
explain what is required of them. 
Patients will need to install just one version of Tula because the features patients have access to will 
be modified according to the randomization group.  
Patients in all groups will be asked during the consent process to allow monitoring of their Tula usage 
by the research team to determine which parts of Tula are most helpful; patients randomized to the 
clinically integrated group will have the option to share information from Tula with the health coach at 
UW Health. All data shared from patients to the UW Health health-coach will be initiated by the 
patient.  
Remuneration. Participants who complete the screening survey will receive a $10 digital 
Amazon.com Gift Card in the email sent to communicate their eligibility status, regardless of their 
eligibility.     . 
In all recruitment scenarios, subjects will be told the study incentives ($10 for completing the eligibility 
screen; up to $250 for enrollment and participation in the study) and how to earn them in the study: 
● complete baseline measures in the Tula app, for which subjects will be paid $30; 
● complete weekly surveys for the first 12 weeks of the study, for which subjects will be paid $10 
per completed week (all groups); 
● complete 4 quarterly surveys (between months 3-12), for which participants will be paid $20 
each; 
● earn a bonus of $20 for completing all surveys  
Incentives will be distributed monthly to subjects by digital gift code. If subjects prefer to receive 
incentives via e-mail, they must grant the study team permission to use their email address for this 
purpose; otherwise, monthly incentives will be delivered securely through the in-app communication 
tool (private message). Subjects will be notified of this information when they formally consent to 
participate in the study     . 
 
For the participant interviews, each participant will receive a $50 gift card in remuneration for their 
time. 
 
 
Clinic Staff  
Recruitment and Consent. Site staff (up to 20) eligible for interviews will be 1) primary care 
clinicians who the study team interviewed in the development year and 2) providers from clinics that 
had at least 10 patients in clinically integrated group. Primary care clinicians, whom the study team 
interviewed in the development year (IRB ID 2018-0885), will be recruited by emailing them to ask if 
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month 36). Interviews will be used to assess the implementation process (what worked well, what did 
not work well, and whether and how clinicians valued Tula). 
At baseline, participants will be asked what their home clinic is. Clinicians of clinics that had at least 
10 or more patients in the clinically integrated group will be contacted by email. The email will ask the 
clinicians at the end of the study if they want to participate in an interview to share information about 
his or her experience and feedback related to Tula. Details of the study and their participation will be 
explained and if they agree to participate in the study, signed informed consent will be collected in 
person.  
 
Participant interviews 
We will recruit 9-18 participants total across the three study arms (self-monitoring, peer-supported, 
and clinically integrated). Participants will be currently active participants as well as participants who 
already completed their 12 months of the study. Based on data assessed by use engagement data 
and engagement in discussion group forums, we will recruit participants who are/were heavy users of 
the Tula app and those who are/were light users of the app. For participants in the peer-supported 
and clinically integrated groups, we will also recruit participants who are/were or were not engaged 
with either the peer support specialists or health coaches. Lastly, we will recruit participants who were 
active in the discussion group forums. A waiver of signed consent will be sent to participants to 
review. We will review and ask for verbal consent prior to the interview. Interview questions will use 
the domains of the CFIR framework to explore participants’ experiences with the app and, for those 
randomized to these study groups, the health coaching and the peer mentoring. Sample interview 
questions for each domain are shown below. Members of the research team who have received 
training in qualitative interviewing will conduct the interviews. Interviews will be conducted via a 
secure video conference call (Zoom) and will be audio recorded. Each participant will receive a $50 
gift card in remuneration for their time. 
 
CFIR Domain 
Sample Interview Questions 
Inner context 
Overall, did Tula help you to reduce your 
drinking? 
• 
If yes, probe for how it helped 
• 
If no, probe for why it didn’t help and 
how it might be changed to be more 
helpful 
Are there people for whom Tula is going to be 
a better fit than others?  
• 
Probe for explanation of answer. 

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Outer context 
We know that the pandemic was a hard time 
for a lot of people. How did you do during the 
pandemic? 
• 
Probe for how pandemic affected their 
drinking 
• 
Probe for whether pandemic affected the 
ways they used Tula 
Innovation 
I’m so glad to have the opportunity to talk to 
you so I can understand more about your 
experience using Tula. To begin, please tell 
me why you decided to join the Tula study? 
How did you use the app? 
• 
Probe for components used [have list of 
components and prompt if the 
participant does not mention using them] 
For PM group, tell me about your experience 
with [the PM]. 
What suggestions would you have for them to 
improve the experiences of people using 
Tula? 
For the HC group, tell me about your 
experience with [the HC]. 
What suggestions would you have for them? 
What was most valuable to you about using 
Tula? 
What was most frustrating? 
How could Tula be improved? 
If you had a friend who wanted to reduce their 
drinking, would you recommend Tula?  
• 
Probe why or why not 
• 
If yes, probe what they would tell friend 
about how to get the most out of the 
app. 
 
 
Bridging 
What technical support did you need to help 
you use Tula? 

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Did you get that support? 
What suggestions do you have for how that 
support could be improved? 
 
 
 
5.0  INTERVENTION PLAN 
All patients enrolled in the study will participate in a 3-month intervention period followed by a 9-
month follow-up period, for a total of 12 months. Patients are allowed to continue using Tula after the 
12-month period, but will not be asked survey questions after 12 months. Please note that Tula is not 
a treatment—it is a resource used to help patients reduce their drinking. 
All patient subjects will undergo a 72-hour run-in period when they will have access to the basic 
version of Tula. During this period, potential subjects will be asked to complete the Quick Start 
checklist items within the 72 hours. The checklist tasks are completing the baseline survey; setting 
goals for the 90-day active intervention period related to drinking and, optionally, to other aspects of 
health (e.g., sleep, exercise); completing the first weekly survey; and completing a survey called What 
Matters to Me, which helps patients think about their current health status and what they would like to 
change. After 72 hours, patient subjects who complete these tasks will be randomized to one of three 
groups and receive the appropriate access to Tula features. 
Patients in all three groups—regardless of randomization group—will have access to the same static 
content on Tula, which is described in Section 1, Background and Significance. In addition, patients in 
all three groups will be asked to complete (1) a weekly survey during the active intervention period 
and, optionally, to revise the goals they set during the run-in period and (2) quarterly surveys at 
month 3, 6, 9, and 12. Subjects are free not to answer any survey questions. 
 
Self-monitoring (control) group. Patients of this group will continue receiving regular care from their 
physician with no interference from the two experimental groups. No data will be shared with other 
participants. Only the research team will have access to subject data for evaluation purposes.  
 
Peer-supported group. In addition to the static content available to patient subjects in all three 
groups, patient subjects in this group will have access to a discussion group where they can message 
one another and have the ability to share and see posts of other patients. The only involvement of 
someone other than patients themselves in the peer-supported Tula group will be by a trained peer 
mentor (i.e., a dedicated Tula user from the area with a sustained history of successful alcohol 
reduction). The peer mentor will participate in Tula discussion groups, moderate the discussions, and 
encourage use of the system (e.g., by posting topics in the discussion group, pointing Tula users to a 
potentially helpful tip). The peer mentor will not have access to individual Tula use data. Patient-
reported feedback will be presented directly to the patient only. The peer mentor will be introduced to 

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the study by the study coordinator and receive access to Tula for 36 months.  
 
     Two Certified Peer Specialists from Safe Communities of Madison-Dane County will provide 
participant mentoring and discussion forum moderation for the peer-supported group. These peer 
specialists, who will serve as peer mentors for the study intervention, completed the CITI Human 
Subjects Research Training: UW Biomedical Course using the materials and attestation form 
provided by UW’s Human Research Protection Program (HRPP) and have been added to the IRB 
study record as external personnel. 
 
Clinically integrated group. In addition to receiving the same static content available to all patients, 
patients in the clinically integrated group will also have access to a discussion group with others in the 
group (like the peer-supported group described above) and access to a health coach from the UW 
Health Wellness Center. Health Coaching at UW Health’s Center for Wellness at the American 
Center is provided by a Certified Wellcoach, either in-person at the American Center or over the 
phone.  Health Coaching sessions are not scheduled via Health Link: Health Coaches directly and 
independently manage their own client calendars. Patients schedule a session directly with the Health 
Coach via phone or email. When the Health Coach sees a client for more than one session, they 
schedule the first session via phone or email, then set up subsequent sessions during the first 
session. Standard clinical Health Coach appointments are not documented in any way in in Health 
Link, nor will they be for this study; as an out-of-pocket, open-to-the-public service, The Center for 
Wellness uses an independent third-party system, ActiveNet, for any billing needs.  
 
Patients will be encouraged to participate in up to three in-person or phone visits with the health 
coach at the beginning, middle, and end of the active 90-day implementation period, with the first visit 
lasting between 60 and 90 minutes and the other two lasting between 20 and 45 minutes. The health 
coach will also function as the moderator of the discussion group, as the peer mentor does in the 
peer-supported group.   
 
Patients will have the option to share selected Tula data with the health coach through a dashboard. 
When a patient in this group completes a survey, they will be presented with a question: “Do you want 
to share your responses with the health coach? Yes/No.” If the subject responds “yes,” their survey 
responses will populate a dashboard that contains data on drinking days / drinks per day and other 
data reported via the weekly survey. The health coach will have the option to view the data in the 
dashboard. Data in the dashboard will not be placed in the patient subject’s electronic medical record. 
However, if the health coach sees any data that is concerning that would normally prompt follow-up 
within the scope of their clinical role, the health coach will contact and follow-up with the patient 
subject if such a situation were to arise.  
 
The UW Health Coach at the American Center is not professionally obligated to communicate with a 
patient’s PCP; in most coaching circumstances, the Health Coach would not know the identity of a 
patient’s PCP, and having an established relationship with a PCP is not a prerequisite for inclusion in 

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the study or health coaching in general. That said, there may be circumstances where 
action/communication may be warranted if a subject discloses information that has a direct bearing 
on his or her health. The Wellness Center has several primary care providers on site at the American 
Center that the health coaches involved in this study routinely consult in such circumstances. 
 
This sensitive health information being collected and shared through the Tula dashboard allows the 
coaches to be better informed and provide more responsive treatment. Information shared via the 
dashboard serves only to support the intervention and will not be used as study data; no response is 
expected of the health coach relative to her research role. Health coach communication with a patient 
in the course of the intervention will be dependent on the individual health coaching plan the patient 
creates with the support of the health coach in accordance with the Whole Health model used by the 
health coach. If a patient declines to share data to the dashboard, no data will be transmitted to the 
dashboard.  
 
To schedule the first of three coaching visits, which may take place on-site at the UW Health Center 
for Wellness or via phone conversation, the health coach will use the private messaging feature in 
Tula. Subsequent visits may be scheduled during that first 60-90 minute visit or via the app’s private 
messaging feature, depending on the patient’s preference. During the consult, the health coach will 
review “What Matters to Me,” the Wellness Center survey patients complete during the run-in period. 
The health coach will work with the patient to form a vision of what their health could be by asking the 
patient “What do you want your health for?”, helping the patient develop a short-term goal, and 
formulate an action plan. Following the initial coaching session, the patient may use Tula to journal 
about their experiences so they can refer to this information during brief weekly or bi-weekly follow-up 
encounters with the health coach, which will take place via private message over Tula, and/or during 
their two subsequent health coaching visits. The health coach will ask patients how they are doing, 
how they are progressing toward their goals, where they want to go from here, and how they want to 
get there. The health coach will provide structure for the patient to achieve their self-identified goals. 
 
Clinic staff. Clinic staff will be asked to participate in interviews in a private room at their clinic. The 
study team will interview two groups of clinicians: 1) the primary care clinicians who the team 
interviewed in the developmental year and 2) clinicians at clinics that have had at least 10 patients (in 
the clinically integrated group) using Tula. Interviews will take place once the intervention phase of 
the study is complete. Clinic staff subjects will be informed of the study and sign an informed consent. 
Subjects will be reminded that their participation is voluntary, that they do not need to answer any 
questions they do not want to answer, and that they may leave the interview at any time. The study 
team will ask open-ended questions about the implementation process of Tula such as what barriers 
to implementation the clinic experienced, what worked well, and what can be improved upon for next 
time. Clinicians will also be asked the “Iowa A-CHESS value for clinic managers” survey. The 
interview will be recorded and transcribed by a member of the study team. During transcription all 
names will be coded and any identifying information will be removed. 
 

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External Research Site and Personnel 
     Safe Communities of Madison–Dane County is a local non-profit [501(c)(3)] coalition that brings 
together public and private sector partners to save lives, prevent injuries, and make the community a 
safer place. The organization focuses on projects and programs with a track record of positive impact 
and success and has been involved with research projects and initiatives at UW–Madison and UW 
Health since its inception in 1999. As a community partner for this study, Certified Peer Specialists 
employed by Safe Communities will provide in-app peer mentoring and discussion forum 
monitoring/moderation for the study arm receiving the peer-supported intervention. Certified Peer 
Specialists recognized in the State of Wisconsin complete peer support training, examination, and 
continuing education requirements specific to both mental health and substance use-oriented lived 
experiences. Safe Communities of Madison–Dane County is accredited under guidelines established 
by the World Health Organization Collaborating Center on Community Safety Promotion, National 
Safety Council’s Safe Communities America Network and Pan Pacific Network of Safe Communities.         
Data collection. 
 
Table 1 shows the data collection for the study, including source, burden, and timing.  
 
Table 1: Quantitative Outcomes 
Dimension  
Measure  
Source  
Burden  
Timing (after rand.)  
Patient Outcomes  
 
 
 
 
Risky drinking 
patterns        
Timeline followback58,59  
Patient survey  
5  
0, 3, 6, 9, 12 mo. 
Quality of life   
PROMIS Global Health60  
Patient survey  
10  
0, 3, 6, 9 ,12 mo. 
Willingness to share data  Number of participants opting to share Tula 
data with clinicians  
Tula  
NA  
Continuous  
Cost   
 
 
 
 
Healthcare utilization  
Medical services utilization form61  
Patient survey  
4  
0, 6, 12 mo.  
Implementation costs  
    Clinician experience with 
implementation of Tula.      
Staff interview  
60 min.  
    Once, after the intervention is 
complete. 
Other Outcomes  
 
 
 
 
Risk/protection factors  
Brief Alcohol Monitor 63 
Patient survey  
10  
0, 3, 6, 9, 12 mo. 
Specialist report use 
(clinicians)  
Number of days used  
Server log files  
NA  
Continuous   
Alcohol use severity 
AUDIT 
Patient survey 
10 
Pretest, 12 months 
AUD severity 
DSM-564 
Patient survey 
11 
Patient and clinician 
decision making 
Value and decision framing survey 
Patient/ clinician 
survey 
9 
Patient: Pretest, 12 months 
Clinician: during interview at month 36 
Mediators   
 
 
 
 
Relatedness  
CHESS Bonding Scale48,65  
Patient survey  
5  
0, 3, 6, 9, 12 mo.  
Competence  
Perceived Competence Scale  
Patient survey  
4  
Autonomous motivation  
TSRQ66  
Patient survey  
6 
Tula use (patients)  
Number of days used, number of pages 
viewed  
Server log files  
NA  
Continuous  
Moderators   
 
 
 
 
Patient characteristics  
Race, ethnicity, gender, age  
Patient survey  
NA  
Pretest  
 

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All survey data collected through Tula is housed on CHESS servers then exported to the UW 
sponsored Google Drive folder for statistical analyses. 
 
Screening survey: People interested in participating in the study will be directed to take a Qualtrics 
screening survey hosted on the Web      to determine if they are eligible to participate in the study. 
 
Baseline survey. After patient subjects are enrolled in the study, they will be asked to take a baseline 
survey consisting of demographic questions, medical service utilization, quality of life, a modified 
version of the Brief Alcohol Monitor, the CHESS bonding scale, the alcohol competence scale, the 
TSRQ, and the value of Tula. Data from the screening survey will be used as baseline data for the 
AUDIT, AUD DSM-5, and timeline follow-back. Two additional questions related to the impact of 
COVID-19 on participants’ physical and mental health will be added to the quality of life measures. 
These questions will operate on a 5-point Likert scale and will be included across all CHESS studies. 
(See supporting document “4.6.20 Global Health Scale v1.3_COVID.docx”). 
  
Quarterly follow-up surveys. Starting at month 3, patient subjects will be asked to take surveys once 
every 3 months. The study team will ask patient subjects to take the following surveys: 1) quality of 
life, 2) a modified version of the brief alcohol monitor, 3) timeline follow-back, 4) CHESS bonding 
scale, 5) alcohol competence scale, 6) TSRQ, 7) medical services utilization (6 months and 12 
months only), 8) AUD severity (12 months only), 9) value of Tula (12 months only), 10) quality of life 
and 11) AUDIT. Two additional questions related to the impact of COVID-19 on participants’ physical 
and mental health will be added to the quality of life measures. These questions will operate on a 5-
point Likert scale and will be included across all CHESS studies. (See supporting document “4.6.20 
Global Health Scale v1.3_COVID.docx”). 
 
Use data. The app automatically collects use data by placing “cookies” on subjects’ smartphones 
(with patients’ consent) when randomization takes place. Data are stored on a secure central server 
at CHESS. 
 
Qualitative interviews. In order to better understanding the implementation of Tula in the health 
coaching and peer mentoring organizations, the study team will use the CFIR framework to interview 
the two health coaches and four peer mentors, as well decision makers in these organizations. In 
order to better understand the conditions under which Tula can be sustained, the team will conduct 
interviews with organizational decision makers and health system decision makers. Sample questions 
for each of these interviews are shown below. Interviews will take place at month 36 and last 30-60 
minutes. Members of the research team who have received training in qualitative interviewing will 
conduct the interviews. Interviews will be conducted via a secure video conference call (Zoom) and 
will be audio recorded. Participant identities  will be protected. Any identifiers will be coded in the 
transcripts so that there will be no way to link clinicians to their interview responses. Data collected 
will be used to refine the system for future dissemination.  
 

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For health coaches and peer 
recovery workers 
 
CFIR Domain 
Sample Implementation 
Questions 
Inner Context 
How would you describe 
your role in Tula? 
Please walk me through 
everything you did related to 
Tula.  
Probe for both interpersonal 
(inc. discussion facilitation) 
and logistical work. 
Probe for what worked well 
and what didn’t relative to the 
interpersonal and logistical 
tasks. 
Probe for what was gained ad 
what was lost by doing 
everything virtually. 
In what ways did your work 
on Tula fit well with your 
broader role here at 
[organization]? 
In what ways was it a poor 
fit? 
Is Tula’s harm reduction 
philosophy consistent with 
the philosophy at 
[organization]? If yes, tell me 
more about how it is 
consistent? If no, tell me 
more about how that affected 
your work with Tula? 
Thinking about [your 
organization], what do you 
have in place here that made 
it possible for you to do your 
Tula work? 
What were the barriers? 
Outer Context 
Other than [things mentioned 
within organization that 

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supported Tula], what helped 
Tula to be successful? 
And what got in the way of 
that success? 
How did the pandemic shape 
your experience? 
How did the pandemic affect 
the experience of people 
using Tula? 
Which users seem to benefit 
from Tula? What tells you 
this? 
What about users for whom it 
didn’t seem to work? 
 
Innovation 
I’m interested in learning 
about how you think about 
how people change. 
Specifically, please tell me 
what you understand about 
how people reduce their 
alcohol consumption? 
In what ways does Tula help 
people in reducing their 
alcohol consumption? 
In what ways does it fall 
short? 
How should Tula be changed 
to work better for folks in 
making this change? 
 
 
Bridging 
Thinking about the Tula team 
[name individuals], what did 
they do that was most 
important to supporting you 
in working with Tula? 
What could be improved? 
 
 

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For HC/PM decision-
makers 
 
CFIR Domain 
Sample Implementation 
Questions 
Sample Sustainment 
Questions 
Inner Context 
What is your role at 
[organization]? 
What role did you play in 
implementing Tula at 
[organization]? 
Thinking about [your 
organization], what do you 
have in place here that made 
it possible for you to 
implement Tula? 
What were the barriers to 
implementation? 
Is Tula’s harm reduction 
philosophy consistent with 
the philosophy at 
[organization]?  
If yes, tell me more about 
how it is consistent?  
If no, tell me more about how 
that affected [organization’s] 
implementation of Tula? 
 
Who at [organization] would 
make the decision about 
making Tula part of your 
regular service offerings? 
What would matter when 
making this decision? 
What steps would need to 
taken in order to make Tula 
part of your regular service 
offerings? 
What would need to be in 
place at [organization] in 
order for you to make Tula 
part of your regular service 
offerings? 
Outer Context 
Other than [things mentioned 
within organization that 
supported Tula], what helped 
[organization] to implement 
Tula? 
And what made 
implementation difficult? 
What would need to be in 
place external to 
[organization] in order for 
Tula to be made part of your 
regular service offerings? 
Innovation 
What’s your overall 
assessment of Tula? 
What’s the value of Tula?  
• 
For users 
• 
For the work that you 
do here at 
[organization] 
How could Tula be improved 
to enhance [the value of Tula 
they have described]? 

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Bridging 
Thinking about the Tula team 
[name individuals], what did 
they do that was most 
important to supporting you 
in working with Tula? 
What could be improved? 
What can the Tula team do 
now that would make it more 
likely that [organization] 
would make Tula part of its 
regular service offerings? 
 
For health system decision makers 
 
CFIR Domain 
Sample Sustainment Questions 
Inner Context 
Who at [organization] would make the 
decision about making Tula part of your 
regular service offerings? 
What would matter when making this 
decision? 
What steps would need to taken in order to 
make Tula part of your regular service 
offerings? 
What would need to be in place at 
[organization] in order for you to make Tula 
part of your regular service offerings? 
Outer Context 
What would need to be in place external to 
[organization] in order for Tula to be made  
part of your regular service offerings? 
Innovation 
Knowing what you know about Tula, which 
needs at [organization] might it fill? 
What changes could be made to Tula that 
would improve its ability to meet those 
needs? 
Bridging 
What can the Tula team do now that would 
make it more likely that [organization] would 
make Tula part of its regular service 
offerings? 
 
Remuneration. No remuneration will be provided to these participant groups. 
 
Unanticipated Events 
Should any unanticipated problems arise, the research team will work with the HS IRB to address the 
problems according to posted IRB guidance. The following is intended to further clarify some possible 
scenarios.  

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If a patient (1) stops receiving treatment at one of the participating clinics or (2) becomes 
incarcerated, the patient will remain enrolled in the study and their circumstances will be documented 
by the UW study coordinator. 
 
In the first case, the patient would continue to complete surveys and use Tula if applicable per the 
study protocol. 
 
In the second case, no research activities would occur during the time of incarceration. If the patient 
is released during the study period, s/he can contact the study coordinator to continue in the study, if 
s/he would like. The reason for any missed data will be documented. 
 
Subjects may sometimes use Tula inappropriately. Discussion group moderators will review and 
delete any discussion board messages deemed inappropriate (i.e., those containing nudity, threats, 
racism, and bigotry). A research staff member will then follow up with the author of the inappropriate 
content. 
 
Cases in which a subject has ongoing borderline behavior will be evaluated individually and the 
subject may be removed from study if the research team feels it is in the best interest of the subject 
as well as the others in the study.  
 
Privacy and Confidentiality 
To mitigate the risk of patient breaches of confidentiality, all patient subjects will choose a username 
when they create an account. A list of patient subject usernames will be kept by the research team PI 
and stored in a secure, limited access, password-protected file service on HIP servers, which are 
located in the University Bay Office Building. Any hard copy identifying information will be stored in a 
locked cabinet. Other identifiable data entered into Tula by the patient subject will be removed by 
Adam Maus, the CHESS data security officer, before it can be accessed by the research team. Adam 
Maus acts as an honest broker at CHESS for the patient data collected through Tula; the study team 
will also request that Tom Callaci, SMPH honest broker, confirm that the dataset s de-identified 
before it is uploaded to Google Drive. During account creation, the Tula system will assist patients in 
choosing a username and password to log in to the Tula system. Patients will be instructed not to use 
their real names or other identifying information as a username and will be made aware of the 
potential dangers of divulging confidential information (e.g. real names or telephone numbers). 
 
Subjects in the clinically integrated group who decide to share their Tula data with health providers 
may choose to stop sharing at any time. Subjects will be asked whether or not they want to share 
data with the health coach each time they enter data in Tula, and have the option to stop sharing their 
data permanently and retrospectively by going to the app privacy settings and selecting the option “do 
not allow others to see my data.” In this case, the health coach would not see anything about the 
patient’s participation and only the research team would have access to the subject’s data.  

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No data collected by Tula will be entered into patients’ electronic medical record or affect the legal 
medical record. 
 
Clinician interview data will be recorded using secure encrypted, password-protected recording 
devices. The recording will be transferred to the Health Innovation Program password-protected 
servers as soon as possible and deleted from the recording device. Recordings will be transcribed, 
coded, and removed of all identifying information. Once the recording is transcribed, the recording will 
be deleted from the server. 
 
Participant interviews will audio recorded and transcribed by a HIPAA approved service from the 
Wisconsin Surgical Outcomes Research program. All data will be coded, de-identified, and assigned 
a study ID. Any identifying information will be stored separately in a password-protected server as 
soon as possible. Once the recording is transcribed and the transcript is spot checked for accuracy, 
the recording will be deleted from the server.  
 
Potential Risks 
The main risks are the potential for subjects to receive and act on bad information or misinterpret 
accurate information, and the potential that confidentiality of the subjects’ records will be breached. 
More specifically: 
● Depending on the method of recruitment and how a participant learns about the study, it is 
possible some participants may feel compelled or obliged to participate because the 
recommendation comes from a person deemed by the participant to be in an authority position. 
Participants may be concerned about maintaining their standard of care. Every effort will be 
made to clarify to participants that their care will not be affected whether they participate or not.  
● Through screening processes, which derives its questions from AUDIT and DSM-5 
questionnaires, individuals’ responses may suggest symptoms of an undiagnosed severe case 
of alcohol use disorder. This may be upsetting to them, especially in the context of not being 
able to take advantage of the resources/support provided in Tula. Like all participants who 
screen ineligible, these individuals will receive either an email or a phone call, per the 
communication preference they selected during the screening survey, informing them that they 
are not eligible for this study. They will be encouraged to talk with their primary care provider 
about their alcohol use. Patients do not have to follow through on the recommendation to 
receive treatment. 
● Patient subjects in the clinically integrated group could be disclosing possibly stigmatizing 
alcohol use data to the health coach that may affect treatment at UW Health. We will mitigate 
this risk by giving the patient subject the option of choosing which data, if any, to share with the 
health coach. Consent forms will make it clear that any data that the patient does not want to 
share will be not be available to the health coach and by extension any providers within the 
UW Health system. Furthermore, Tula data will not be entered into the patient’s electronic 
medical record. 

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● Tula could provide inaccurate or harmful information. The information will carefully vetted      by 
experts from the clinics (Dr. Brown), the study team, and UW CHESS’s Steering Committee. 
Network communications between subjects will be monitored. Inaccurate or harmful 
statements will be addressed by the Tula moderator. Additionally, messages exchanged within 
the Tula support groups will be monitored to make sure the information is accurate and that 
study participants are using the system for its intended purpose. 
● There could be a breach of confidentiality that could result in disclosure of research data 
outside of the study team. This could carry economic or legal risks for subjects. To prevent 
this, all subjects will be assigned a de-identified code number (separate from the username). 
These lists will be kept in a locked spreadsheet on the HIP servers, and will not be shown to 
anyone except study staff. Data collected from smartphone use files will have the name 
removed and the code number attached by the research team study coordinator. Interviews 
will be conducted by research staff trained in human subjects training. 
● There is risk that information provided in Tula will be used to the detriment of the subjects. 
Particular sources of risk include email and newsgroups, as well as Tula communications 
written within the discussion groups or personal profiles. Patients will create an account with a 
username and password to use on Tula. They will be instructed to not use their real name as a 
username and will be warned of the potential dangers of divulging confidential information (e.g. 
real names or telephone numbers). Patients will also be asked in the informed consent and 
given directions to set up a passcode on the phone to protect their information in the event 
someone else finds the phone. 
● There may be a stigma attached to using Tula. There are times and contexts when 
notifications of weekly or monthly surveys draws unwanted attention. In these instances, study 
participants can set their smartphones to vibrate so they are subtly prompted           to complete 
their weekly check-in survey     , and they can also have the option to prompt the system to 
remind them later for a check-in at a more appropriate time. 
● Participants may send messages when moderators cannot respond quickly. Offering features 
could produce over reliance on Tula to provide support during periods of      distress. Study 
participants will be told that the moderator of their discussion group will make every effort to 
follow-up on their messages for support. If the moderator is not immediately available, the app 
will let the participant know that a moderator is unavailable and if they need immediate assistance they 
should contact their UW health clinic. To maintain a separation between research and clinical activities, 
members of the study team will not forward patient messages to the central desk of their UW health 
clinic.      
 
Additional risks may include: 
● Learning about sensitive issues, such as excessive alcohol use, while using the Tula app may 
cause anxiety, distress, embarrassment, or feelings of sadness. However, patient subjects do 
not have to answer any questions that they don’t want to answer. 
● The research team will be collecting information on how the smartphone is used and may 
discover behavior that raises concern about harm to self or others. If we see anything that 

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suggests that patient subjects or others face imminent risk of harm, we will contact appropriate 
others to intervene (e.g. the police). Individuals will be told this during informed consent. 
● All clinicians who are interviewed will be told that they do not have to answer any questions 
they do not wish to answer. The study team will have any identifying information coded and 
removed from transcripts. The code key will be kept separate from the transcripts in a locked 
cabinet. After transcripts are made from recordings of the interviews, the recordings will be 
destroyed. 
 
To further protect subject confidentiality, all studies funded by the National Institute of Health are 
issued a Certificate of Confidentiality which prevents investigators and institutions from being required 
to release identifiable subject information. 
 
Data Storage and Protection 
 
CHESS and HIP servers are separate servers. All data collected through the Tula app will be stored 
on CHESS password-protected servers. CHESS programmers will create de-identified data exports 
and uploaded to a UW-sponsored Secure Box where it can be accessed for statistical analyses by 
UW study members and Ming-Yuan Chih of the University of Kentucky. All data collected outside of 
Tula (interview transcripts, code keys, etc.) will be stored on HIP password-protected servers.  
 
When all study activities are complete, audio recordings, participant IDs, and other identifiable 
information will be destroyed; only the de-identified code will remain. The study team does not intend 
to retain data collected for this study for purposes not described in this application.       
 
Table 2. Data and location of storage. 
Data 
Location 
Subject intake 
CHESS servers, Google Drive 
Subject demographics 
CHESS servers, Google Drive 
Subject electronic consent  
CHESS servers, Google Drive 
De-identified Tula surveys 
CHESS servers, Google Drive 
De-identified Tula use data 
CHESS servers, Google Drive 
Interview data 
HIP servers 
Initial screening data 
Qualtrics 
Any other hardcopy records 
Locked file cabinet 
 
6.0  MEASUREMENT OF EFFECT 
All scales have good psychometric properties with similar populations. Listed below are the factors to 
be measured and measurement instruments. 
 
Intake only. Study staff will confirm patient eligibility via patients’ UW Qualtrics screening surveys     . 
Patients report demographics (biological sex, race, ethnicity, age, education).  

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Drinking and quality of life. Patients will be asked to take surveys administered via the Tula app (see 
Table 1 for frequencies). Patients will be asked to report on their drinking using the 7-day timeline 
follow-back58,59 survey. Patients will also take the PROMIS Global Health60 survey (10 items) to 
assess patient self-reported quality of life and a modified version of the Brief Alcohol Monitor63 survey 
(10 items) to assess their risk and protection factors for problematic alcohol use. Alcohol use disorder 
severity (AUD scale,64 11 items; AUDIT, 10 items; 7-day timeline followback, 5 items) will be 
assessed at baseline and once every 3 months. 
 
Mediators. Self-determination theory constructs will be assessed (see Table 1 for frequencies) via the 
Tula app as follows: 
● Competence – Perceived Competence Scale  (4 items) 
● Relatedness – CHESS Bonding Scale65,66 (5 items) 
● Autonomous motivation – revised Treatment Self Regulations Questionnaire67 (6 items) 
 
Tula use. Tula use is collected in time-stamped log files and includes when a patient accessed Tula, 
the services used, duration of service use, pages viewed, messages posted and received, and 
content of messages. Tula use will be used to measure dose of intervention received for 
dose/response analyses. Patients will be asked to take a survey about their value of Tula at baseline 
and 12 months. 
 
Healthcare utilization. Healthcare utilization will be collected from the self-reported medical services 
utilization form61 (6 items; see Table 1 for frequency).  
 
Intervention and implementation costs. Intervention costs will be determined using Tula time-stamped 
log files and billing codes logged by the health coach. Implementation costs will be determined 
through clinic staff interviews at the end of the intervention period.      Cost per patient will be 
determined for each study group (self-monitored, peer-supported, and clinically integrated) with 
intervention and implementation costs separated within each group.  
 
7.0   STUDY PARAMETERS 
 
Patients will be block randomized by clinic, sex, and alcohol use severity to control for demographics 
at a 1:1:1 ratio to be in the self-monitoring, peer-supported Tula, or clinically integrated Tula groups. 
It’s anticipated that 3-7 clinics (defined as having at least 10 patients in the study) with 3-7 clinicians 
each and 546 patient subjects will be recruited from the participating UW Health clinics. Patients will 
have access to Tula for up to 48 months, depending on time of enrollment, although the active period 
of participation is defined as 3 months with follow up through 12 months post enrollment (9 month 
follow-up). Health coaches will have access to patient-shared Tula data from patients of the clinically 
integrated Tula group for the duration of the study. The peer mentor will have access to discussion 
boards and private messages on Tula for the duration of the study for patients in the peer-supported 

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group. The research team will have access to all Tula data for all subjects in all groups for the 
duration of the study.  
 
8.0  STATISTICAL CONSIDERATIONS  
 
Analyses will assess the effectiveness between the three groups longitudinally on the primary and 
secondary outcomes. 
 
Descriptive analyses. The research team will use descriptive statistics for all demographic and clinical 
variables across all three arms. To assess the impact of chance baseline imbalances between arms 
on intervention effect estimates, variables with noticeable differences will be included as covariates in 
a sensitivity analysis. 
 
Intervention analyses. The analysis assesses direct treatment effects on patient outcomes over time 
over the 12-month study period. The research team will construct a longitudinal model of our outcome 
measures at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months after randomization. The stratification 
variables will be by clinic, biological sex, and alcohol severity. They will be included as factors in the 
model and the baseline values of patient outcomes will be included as covariates, with a separate 
model for each primary outcome (risky drinking patterns     , quality of life, and cost). This longitudinal 
analysis is complicated by the dependence among successive observations made on the same 
individual. Since complete control of measurement is not possible, there may be incomplete data from 
individual subjects. Therefore we will conduct a mixed-model analysis of repeated measures based 
on the general linear model with assessment of various covariance structures (compound symmetric, 
autoregressive order one, and unstructured). Covariance structure selection will be based on Akaike’s 
information criterion and Schwarz’s Bayesian criterion.46, 47 Pairwise comparisons between treatment 
groups and specific treatment time contrasts in the mixed model will be conducted to respond to 
between-group effects and time-based effects. To address issues of incomplete data we plan to 
estimate treatment effects according to 4 approaches: intention-to-treat, as-treated, per-protocol, and 
complier-average causal effect. Missing data patters will be established from the longitudinal data and 
will be used to adjust the longitudinal intervention analysis according to pattern-mixture modeling.69 
 
Mediation analysis. To augment the intervention analysis, we will estimate the effects that mediating 
variables have on the outcomes. Services in Tula were developed to meet three psychological needs 
(competence, relatedness, and autonomous motivation) and accordingly the research team will use a 
mediational model in which patients in the clinically integrated Tula group will improve these 
psychological needs, relative to the peer-supported Tula group and the self-monitoring group. In turn, 
the research team will analyze whether improvements in the psychological needs correlates to 
improved patient outcomes. Analyses will control for baseline scores on outcome variables and the 
design variables that are used to stratify our sample during randomization (site). The research team 
will use structural equation models to assess both direct and indirect influences of our intervention on 
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will be constructed to test the mediation effects between randomization variable and 12-month patient 
outcomes.  
 
Operational cost analysis. Costs will be calculated based on tenets of engineering economics. This 
study will use incremental cost effectiveness ratios (ICERs) to quantify the tradeoff between the 
additional effectiveness achieved through clinical integration of the clinically integrated group 
compared to the peer-supported group. The main ICER will be the incremental cost per reduced 
drinking days over the 12-month period. We will train the health coach in the clinically integrated 
group to simulate use of CMS billing codes for mHealth to estimate potential reimbursement potential 
of the system that may be used to offset the costs of implementation.  
 
Power. Power calculations are based on the previous randomized clinical trial of the platform.71 The 
study is powered to detect a difference between groups in risky drinking episodes across the 12-
month intervention period. Based on the attrition rate in the previous randomized clinical trial of Tula, 
we assume an attrition rate of 23% over the course of the study. To detect an effect size of Cohen’s 
d=0.23 the research team will recruit 182 patients per group (546 patients total) to have sufficient 
power (1-β=0.8, multiple comparison adjusted α=0.0167, two-tailed). This would be a difference of 
1.37 risky drinking episodes per month.  
 
Quantitative data collection. The data collected in will come from multiple sources (see Table 1). 
Data collected from patient surveys will be collected by the Tula system and securely stored on 
CHESS servers. All log files will be stored on the CHESS server to be used to assess Tula use. 
 
Qualitative data collection. This project will make use of clinician interviews to better understand the 
effect of Tula in the primary care setting. The interview will occur at intervention month 36 and take 
place at the clinicians’ primary care clinic. Qualitative researchers will ask clinicians to talk about their 
experiences with Tula to refine the system for future use in primary care. 
 
Qualitative data analysis. Content analysis will describe how Tula use can improve patient 
outcomes; identify potential improvements in Tula; and identify how qualitative data can supplement 
the quantitative analysis. A qualitative researcher will construct a coding scheme to assess the ideas 
of the study in order to capture references to a concept. The analyses will help the research team 
refine Tula for future dissemination by determining the individual and organizational conditions 
necessary to promote effectiveness. 
 
 

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