Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
Phase: NA
Conditions: Alcohol Use Disorder, Couples, Behavior, Addictive
Sponsor: University of Wisconsin, Madison

 
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol 
Use Disorder 
NCT04059549 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PI: David H. Gustafson, Ph.D. 
8/20/2020 
 
 

PartnerCHESS Protocol_8.20.2020_dhg 
 
 
 
 
 Building and pilot testing a couples-based smartphone system to address alcohol 
use disorder 
Principal Investigator: 
 
 
David H. Gustafson, Ph.D. 
 
 
 
 
 
 
 
University of WI - Madison  
 
 
 
 
 
 
 
 
Industrial Engineering 
 
 
 
 
 
 
 
1513 University Avenue, ME Bldg. Suite 4109 
 
 
 
 
 
 
 
Madison, WI 53706 
 
 
 
 
 
 
 
608-263-4882 
 
 
 
 
 
 
 
dhgustaf@wisc.edu 
 
Co-Investigators:    
 
 
Elizabeth Epstein, Ph.D. 
 
University of Massachusetts Medical School 
 
Department of Psychiatry 
 
55 Lake Ave North 
 
Worcester, MA 01655 
 
608-262-7568 
 
elizabeth.epstein@umassmed.edu 
 
 
 
 
 
 
 
Genie Bailey, M.D., DABAM 
 
Stanley Street Treatment and Resources 
 
386 Stanley St 
 
Fall River, MA 02720 
 
508-235-7006 
 
genie_bailey@brown.edu 
  
 
 
 
Study Coordinator: 
 
 
David Gustafson, Jr, M.S. 
 
Department: Industrial Engineering 
1513 University Avenue, ME Bldg. Office 4115 
Madison, WI 53706 
 
608-262-1746 
dgustafson@wisc.edu 
 
 
Sponsor:  
 
 
 
 
National Institutes of Health: NIAAA 
 
 
Participating Institution:  
Stanley Street Treatment and Resources 
(SSTAR) 
 
 
 
 
 
 
386 Stanley Street 
 
 
 
 
 
 
Fall River, MA 02720 
 
 
 
 
 
 
 
 
 

PartnerCHESS Protocol_8.20.2020_dhg 
 
 
TABLE OF CONTENTS       
 
 
Study Summary ............................................................................................................... 3 
 
1.0   Background & Significance   ................................................................................... 4 
 
2.0    Study Objectives .................................................................................................... 5 
 
3.0    Selection of Subjects .............................................................................................. 6 
 
4.0   Registration Procedures ......................................................................................... 6 
 
5.0    Treatment Plan ....................................................................................................... 7 
 
6.0    Measurement of Effect ......................................................................................... 12 
 
7.0    Study Parameters ................................................................................................. 13 
 
8.0    Statistical Considerations ..................................................................................... 14 
 
9.0  
COI Management Plan……………………………………………………………..... 14 
 
100    Records to be Kept .............................................................................................. 16 
 
11.0  References ........................................................................................................... 17 
 
 
 
 

 
 
 
 
 
 
4
STUDY SUMMARY 
 
Alcohol use disorder (AUD) is one of the most common substance use disorders. Yet 
only a small fraction of people who need treatment receive it, and most of them get only 
short-term support even though continuing care has been shown to be much more 
effective. Partner support can be critical to recovery, but many partners do not know 
how to support their partners’ recovery or manage their own responses to it. Clinicians 
also lack evidence of the efforts patients are making toward recovery. Treating couples 
in which one member is recovering from AUD has been shown to be efficacious; in 
particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. 
Still, ABCT has not been widely adopted, in part because of practical problems such as 
the stigma that goes with the partner needing to go to an addiction treatment agency to 
participate. A-CHESS is a smartphone-based system proven to substantially reduce 
relapse rates, but A-CHESS serves only the patient. 
 
This project will develop and pilot test a new smartphone-based system for AUD 
patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will 
integrate key features of ABCT and A-CHESS. The project has three specific aims: 
 
1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve 
patients, partners, and clinicians. 
2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate 
effect size and refine the protocol, procedures, recruitment strategy, measurements, 
and operations we would use in a large RCT. 
3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01. 
 
The project would engage 6 couples to help design PartnerCHESS, test its usability and 
give feedback on its utility. Once ready, the system would be tested by 34 other couples 
randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + 
TAU for a 6-month trial. We will collect survey data at baseline, 2, 4, and 6 months and 
analyze it to see if a large clinical trial holds promise and, if so, produce an application 
to support a full-scale trial based on the technology developed and the research 
procedures employed in the pilot test. 
 
The study is important to public health because of the scope of the alcohol abuse and 
the potential of technology to improve the lives of both patients and partners. If 
successful, such technology could greatly broaden the reach and impact of AUD 
treatment in general and couples therapy in particular. 
 
 
1.0 
BACKGROUND & SIGNIFICANCE 
 
Alcohol Use Disorder (AUD) has a lifetime prevalence of 29.1% in adults 18 and older.2  
In 2014, 1.5 million adults sought treatment in an addiction specialty treatment program 
for AUD.3 While treatment can be effective, its short term leads to high relapse rates; as 
many as 50% of treated patients return to problem use within a year.4 Continuing care 

 
 
 
 
 
 
5
can be effective5 but is rare.6 It is characterized by assertive outreach,7 monitoring,8-10 
action planning,11 symptom reinterpretation,12-14 peer15,16 and family support,17 
prompts,18,19 and professional support and guidance.9,20 But the cost of providing such 
care is high, and even the best research-based programs cannot address in real time 
the cravings, conflicts, and emotional states that often lead to relapse.9 At best, they 
identify relapse early and reconnect the patient with treatment rapidly.21 More 
consistent, available continuing care could considerably improve outcomes. 
 
A-CHESS is a smartphone app designed to prevent relapse after treatment for AUD by 
offering emotional and instrumental support at almost any time and place. At set-up, 
patient-specific information is entered into the app, such as the patient’s triggers, 
therapeutic goals, and healthy activities of interest. The system includes emergency 
contacts (to use when the patient is at immediate risk of relapse) and nonemergency 
resources (e.g., social support through discussion groups, weekly check-ins that lead to 
information on coping skills). If a patient nears a high-risk location (a bar she used to 
frequent), the GPS initiates asking the patient if she wants to be there. A-CHESS also 
includes—with patient permission—a report to the patient’s counselor if weekly check-in 
responses signal a need for intervention. A-CHESS was tested in a large NIAAA-funded 
randomized trial.1  
 
Partner support can help prevent relapse because alcohol problems and intimate 
relationships are reciprocally related. Distress in the relationship, along with partner 
attempts to control patient substance use, may prompt craving and trigger relapse; 
alcohol use is associated with greater relationship conflict.22 Recovery destabilizes 
relationships. New patterns of interacting need to be negotiated to support each 
partner’s needs.23 Yet many partners do not know how to support recovery or manage 
their own responses to their partner’s changed behavior and symptoms of post-acute 
withdrawal, such as irritability.17 While partners can help prevent patient relapse,24-29 
doing so may increase their own stress and negative affect. They may need help too.30-
32 Couples treatment has shown efficacy for AUD outcomes; in particular, Alcohol 
Behavioral Couples Therapy (ABCT) has demonstrated positive outcomes for men and 
women with AUD.22 Recognizing the reciprocity between intimate relationships and 
alcohol problems, ABCT tries to build abstinence support and strengthen the couple 
relationship. ABCT uses the relationship to reward abstinence and teaches tools for 
better communication22 and more positive activities. Despite its outcomes, ABCT has 
not been widely adopted because of complexity, stigma, and cost.22   
 
The proposed system, PartnerCHESS, will support the patient and partner. 
PartnerCHESS would integrate key features of ABCT and A-CHESS.  
 
Recent research indicates that mobile technology can support patient recovery from 
chronic conditions such as AUD.1,33,34 But PartnerCHESS will aim higher. It will have 2 
complementary, interconnected versions – one each for patient and partner. 
PartnerCHESS will be designed to help prevent patient relapse and help both the 
patient and partner use coping, monitoring, and social support interventions in real time 
as they face triggers, cravings, and conflict. Compared with existing counseling 

 
 
 
 
 
 
6
programs, mobile applications have the potential to provide services to more people, 
more often, for a longer period of time, with greater reach to a patient’s social support 
systems. Furthermore, being able to receive help without attending 12-step meetings 
and sessions at the clinic can reduce stigma. 
 
 
2.0 
STUDY OBJECTIVES 
 
Specific Aim 1: 
Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve 
patients and partners. 
 
Specific Aim 2: 
Conduct a pilot test (a small RCT) of PartnerCHESS to examine feasibility and refine 
the protocol, procedures, recruitment strategy, measurements, and operations we would 
use in a large RCT. 
 
This R34 will help us prepare a subsequent R01 by testing our design and our ability to 
recruit subjects, estimate effect sizes, collect data, finalize our analytical protocol, and 
create an operational manual.  
 
Study Coordination 
The UW-Madison Center for Health Enhancement Systems Studies (CHESS) is the 
coordinating site for this study. The UW study coordinator will oversee all activities at 
the recruitment site which includes:  
• developing site specific recruitment and data collection processes that meet 
study objectives; 
• training site staff on protocol procedures prior to start of recruitment and 
continuous monitoring to assure compliance with the protocol and human 
subjects regulation; 
• communicating with site staff via weekly conference calls to monitor progress, 
inform of protocol changes/distribute new version of protocol, and address 
unanticipated issues or challenges; 
• and manage all study data. 
 
 
3.0 
ELIGIBILITY 
 
Patients and Partners: A total of 40 dyads will be recruited from the community and 
outpatient treatment programs in Fall River, MA (Stanley Street Treatment and 
Resources – SSTAR) and Madison, WI (UW Behavioral Health & Recovery). 
 
Patients and partners must: 
• Must be 18 or older 
• Not have a mental or physical condition that limits smartphone use 

 
 
 
 
 
 
7
• Not report fear of being involved in PartnerCHESS or fear that their partner would 
hurt them physically or emotionally for being involved in PartnerCHESS 
• Not have a history of schizophrenia 
 
Patients: 
• Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines 
for risky drinking. 
• Have had at least one alcoholic drink in the last 3 months  
 
Partners:  
• Must be a spouse, or in a 6-month or longer committed romantic relationship 
• Willing to participate in the study 
 
4.0 
REGISTRATION PROCEDURES 
 
Patient Recruitment and Consent 
Patient recruitment will be the same for both groups of participants, the 6 dyads for the 
initial development phase and the 34 dyads for the 6-month pilot test. The consent 
process will be the same although the consent form itself will be different between the 
two groups. 
 
Community Recruitment: Recruitment targeting the general community in Fall River, MA 
and Madison, WI will be done by newspaper/Craiglist ads, flyers, and internal 
staff/faculty emails. 
 
Outpatient Treatment Recruitment: SSTAR and UW Behavioral Health & Recovery staff 
will use medical records and client intake forms to identify and prescreen patients based 
on the eligibility criteria outlined in section 3.0. 
 
After potentially eligible subjects are identified (via a phone call from the patient/partner 
regarding one of the community recruitment strategies or outpatient treatment staff), the 
research staff will explain the study and its benefits and risks via the phone. If the 
patient/partner is interested and believes their partner would be willing to learn more, 
research staff will screen the patient/partner for eligibility and discuss the options for 
talking with their partner - 1) if available, talk to the patient/partner on the phone directly 
following screening of the first member of the dyad, 2) provide research staff phone 
number for patient/partner to call when convenient, or 3) mail/email/text the Opt-in 
Letter (Partner Letter) which they can review and return if interested giving research 
staff permission to call and convenient times. Once the research staff has talked with 
both the patient and partner and they are eligible and interested, the consent forms and 
study information sheets will be mailed, emailed, or texted, whichever method the 
participants prefer. Staff will also mail the baseline surveys and a set of calendars as 
part of the survey instrument that will be administered on their first study call. At the first 
study call staff will go over the consent forms in detail, verbal informed consent will be 
documented, baseline surveys will be conducted, participants will be randomized, and 

 
 
 
 
 
 
8
an app training call will be scheduled. Staff will then mail the study phones so they 
arrive prior to the training call, at which time they will go over the different services the 
app offers. 
 
We believe that recruitment will accrue faster than normal for couples therapy because 
costs for internet coverage will be paid and partners will not have to visit the clinic at all 
(even phone delivery can be provided at a more convenient location). Hence the 
incentive is high and the stigma in participating is low. If either the patient or the partner 
declines, the dyad will be excluded. To help us prepare for an R01, we will measure the 
number and percent of patients who are eligible and accept, the number and percent of 
partners who accept, and the number of dyads that join. We will document reasons for 
any refusal and monitor whether refusal rates differ by patient and partner sex, race, 
and age. Based on the results, the recruitment process for the R01 may need to 
change. We will note whether partners are of the opposite or same sex. To avoid 
coercion, SSTAR will be paid on a fixed-price contract rather than a per-couple-
recruited basis.  
 
Patient Randomization: The 6 dyads recruited to take part in the initial development 
phase will not be randomized.  For the 34 dyads taking part in the pilot study, we will 
use www.randomization.com to stratify on patient gender so the A-CHESS and 
PartnerCHESS groups have the same proportions of men and women patients, 
balancing on same-sex couples, age, and race. When the baseline survey is complete, 
the UW Study Coordinator will enter participant numbers and randomization data 
through a secure internet line to the www.randomization.com website. 
 
5.0 
TREATMENT PLAN    
 
This project includes a 15-month initial development phase that will involve 6 dyads and 
a small 6-month randomized trial that will involve 34 dyads. During the 6-month 
randomized trial half the dyads will use A-CHESS and half will use PartnerCHESS. 
During that time, the smartphone will continuously collect data on how patients, 
partners, and clinicians are using the technologies, along with responses to a weekly 
survey about their satisfaction with services and suggestions for improvement. We will 
also conduct surveys with participants at baseline and at 2, 4 and 6 months. Based on 
past CHESS research, we expect a dropout rate of about 10%, leaving about 15 dyads 
per arm to complete the pilot RCT. 
 
Initial development phase.  After recruitment and consent, 6 dyads will take part in 3 
2-hour focus groups to help develop and test the PartnerCHESS app. Topics for the 3 
focus groups include:  
• 
Initial design feedback 
• 
Mock-ups feedback 
• 
Content feedback 
• 
Usability testing 
• 
Pilot testing  
• 
Review and give feedback on surveys to be used during the pilot 

 
 
 
 
 
 
9
 
During the development phase the PartnerCHESS software design team will develop a 
series of interface prototypes and use rapid-cycle testing to gather user feedback about 
them. We will ask questions such as how intuitive the system is (Can people find what 
they are looking for? Do the graphics and naming conventions make sense?), how 
visually appealing it is, and whether the services seem useful. We will use tools such as 
wireframes, mockups, and paper and html prototypes to test prototypes, use feedback 
to quickly make changes, and test again. The information gathered from the 6 dyads will 
help us gauge ease of use, perceived value and reveal other changes to make before 
the pilot test begins. Our baseline and follow-up surveys will also be tested with the 6 
dyads. Study participants will receive $35 for each focus group they attend for a 
maximum of $105. 
 
Approximately 2 months after the 2nd focus group we will ask study participants to 
download the app and use all the features of the app, which includes completing the 
weekly check-in, in their regular daily life.  This 1-month pilot test is an invaluable 
process that will identify programming bugs and user experience issues that we would 
not be able to get from one to two hour in-person usability testing.  If study participants 
do not have a smartphone we will provide one for the month long pilot test. If study 
participants have a smartphone we will pay them $50 toward their phone service. 
 
We will improve our predictive analytic service in A-CHESS based on our research 
indicating that real-time linguistic analysis (LIWC)57 can detect weakened defenses 
against relapse. Our analyses of A-CHESS data found that some patterns of 
participants’ word use in the discussion group (i.e., an increase in swear words) 
signaled impending relapse (R2=.40). For A-CHESS and PartnerCHESS, we propose 
modifying the analysis program so that it immediately identifies such patterns, allowing 
us to push tailored interventions right away. (This analysis currently occurs off line. The 
innovation is to make it work in real time.) Once the predictive analytic has been 
improved, the 6 dyads who user-test the technologies will test it and revisions will be 
made based on their feedback during the focus groups.  
 
6-month pilot A-CHESS services. Patients randomized to the A-CHESS group will 
receive the A-CHESS app on a smartphone.  A-CHESS services are: 
 
Instant Library. FAQs and brief information on addiction and couples-related issues, 
e.g., taking care of yourself, financial matters, alcohol abuse overview, crisis 
intervention, referral, medications. 
Discussion groups. Forums connect patients or partners with others. Posts are analyzed 
to predict relapse. 
Personal stories. Audio of both patients and partners talking about experiences dealing 
with addiction. 
Location monitor (optional). Geo-fencing of areas identified as triggers (e.g., a bar that 
was frequented), which prompts a warning followed by rescue services. If the patient 
stays in the area, a recorded message encourages him or her to leave. If the patient 
doesn’t leave, a support person is automatically notified. 

 
 
 
 
 
 
10 
Surveys/EMAs. Questions assess immediate needs and trends over time. Partners will 
be asked about their own status and their perspectives on the patient’s status. Advice or 
referrals to other A-CHESS or PartnerCHESS services will arise from responses to 
questions as well as from the Bayesian prediction of relapse risk using data from 
discussion groups and surveys.41  
Guided relaxation. Audio to guide mindfulness, relaxation exercises, games, and other 
help for cravings. 
Meeting locator. Patients and partners can use GPS to find AA/Al Anon meetings. 
Smartphone GPS data enable clinicians to estimate treatment adherence, e.g., 
attending 12-step meetings or other appointments. 
Healthy activities. Database of ideas (e.g., taking a walk) and local recovery-friendly 
activities. Couples can add them to their recovery calendar.  
Crisis button. Relaxation exercises, optional calls to supporters, games for distraction, 
and other resources. 
Skills reminders. Tips and reminders of CBT-based skills (e.g., effective communication, 
refusal skills, etc.)  
 
6-month pilot PartnerCHESS services from ABCT.  Patients randomized to the 
PartnerCHESS group will receive all A-CHESS services listed above, plus the following 
services from ABCT: 
 
Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge 
reduction options on PartnerCHESS, and encourage discussions between partners on 
the causes of and ways to reduce urges.  
Homework checklist. Tracks which interventions the couple is using/practicing, along 
with resources to help. 
Relapse plan. Monitoring and reminders of steps planned for relapse prevention.  
Reminders. Reminders to notice something positive in partner, of reasons to stay sober, 
to take meds, etc. 
Trigger identification and removal. During set-up, patient and partner enter triggers. 
PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways 
to address each.  
 
Conceptual model of study. Figure 1 shows the conceptual model we propose to 
study. It 
suggests that 
PartnerCHESS 
and A-CHESS 
will improve the 
secondary 
outcomes both 
directly and 
through 
multiple meditational paths. Changes in secondary outcomes (e.g., sleep58) will improve 
the primary outcomes. We anticipate that PartnerCHESS will (more than A-CHESS 
alone) affect the patient’s intrinsic motivation to abstain as well as his or her relatedness 

 
 
 
 
 
 
11 
and competence. Importantly, the patient effects of Partner- and A-CHESS will affect 
outcomes both directly (by affecting the patient’s secondary outcomes) and by affecting 
the partner (and vice versa). For example, if PartnerCHESS boosts the partner’s 
feelings of relatedness, the patient’s feelings of relatedness may increase as a result.59 
PartnerCHESS effects on intrinsic motivation, competence, and relatedness will 
mediate its effects on secondary outcomes such as negative affect.60 Because couple 
interventions can vary by gender,61,62 we anticipate that the sex of the patient and 
partner will moderate the indirect effects of PartnerCHESS on both mediators and 
secondary outcomes (i.e., women – partners or patients – will use discussion groups 
more and will benefit more). Similar expectations hold for patients assigned to A-
CHESS, except that the partner will not be directly affected by A-CHESS since the 
partner does not have access to it. However, partners may be indirectly affected by the 
changes A-CHESS makes in patients. Finally, we anticipate that the extent to which 
partners PartnerCHESS will affect mediation and secondary outcomes.   
 
Inclusion of sex as a moderator variable. We will examine how men and women use 
the interventions differently and how the interventions affect them differently.  
 
Comparison group and TAU. Appropriate comparison groups are a hotly debated 
topic.63-69 We considered using TAU for this pilot test and a possible RCT, but our 
concerns about the lack of equipoise and the need for the comparison arm to offer 
some proven benefit (as A-CHESS does) led us to propose comparing 
PartnerCHESS+TAU to A-CHESS+TAU rather than comparing PartnerCHESS+TAU to 
TAU alone. 
 
Treatment as Usual (TAU). At our recruitment site (SSTAR), TAU involves all patients 
learning core CBT skills. Patients receive training in anger and depression 
management, communication skills, distress tolerance, enjoying recovery, maintaining 
sobriety, parenting, problem solving, relapse prevention, seeking safety, and setting 
weekly objectives. A-CHESS and PartnerCHESS will prompt patients to use – and how 
to use – the skills that SSTAR teaches. SSTAR uses a fidelity scale to ensure that 
trainers teach the required skills, and we will use it to ensure that our services remind 
participants of the same skills. 
 
Data collection. The 34 dyads will use the technologies for 6 months. Daily, 
PartnerCHESS will track triggers, relationship satisfaction, substance use, and cravings. 
Weekly, it will track the homework couples are doing; every 2 months, surveys will track 
the skills couples are using. UW staff will conduct surveys over the phone. While 
partners of A-CHESS patients will not receive software, they will be surveyed. Each 
patient and partner in the PartnerCHESS group and patients in the A-CHESS group will 
receive $20 for each completed survey. Partners in the A-CHESS group will receive $50 
for each completed survey. In addition, if patients and partners in the PartnerCHESS 
group and patients only in the A-CHESS group have a smartphone, they will be paid 
$50 per month towards their phone service in addition to the payments for completing 
surveys. If patients and partners in the PartnerCHESS group and patients in the A-
CHESS group do not have a smartphone, they will be given one with paid service for 6 

 
 
 
 
 
 
12 
months. As appropriate, participants will provide feedback about what is helpful in the 
system and changes they would make. SSTAR will provide retention data.  
 
App use data will be automatically collected by the technologies by placing “cookies” on 
smartphones (with participants’ consent) when randomization takes place. Data are 
stored on a central server, maintained by UW-Madison Division of Information 
Technology (DoIT), for protection in case of phone loss. Remaining data will come from 
patient surveys and be entered into REDCap, a secure, web-based application 
designed to support data management for research. After baseline data collection, 
surveys will omit stable data. UW staff will periodically call participants to promote 
system use and response to assessments. The timing of surveys will be based on 
enrollment date. The payment we selected is consistent with what we have used 
successfully in earlier studies.  
 
Qualitative data and analysis. The baseline, 2, 4, and 6-month surveys will also 
collect qualitative data to help us further refine our interventions, the study design, and 
protocol. Seven issues will be addressed, tailored to whether the interviewee is a 
partner or patient and their study arm. Assuming the questions were asked of a patient 
assigned to PartnerCHESS: (1) What impact do you think PartnerCHESS has on your 
risky drinking and why? (2) What impact has it had on your relationship with your 
partner? (3) How easy was it to use the technology? What would make it easier? (4) 
How can we make the technology better? (5) Looking back on the study, what should 
have gone more smoothly (introduction, training, data collection, phone performance, 
etc.)? Be as specific as possible. (6) Suppose we could make only one change to the 
study, what should it be? (7) What do you like best/least about the technology? Non-
duplicated lists of answers will be created and we will track the number of times each 
response is noted. Survey data will be double coded with deviations, if found, resolved. 
Importance will be estimated by the number of times each issue is identified. Using that 
and our own judgments to set priorities, we will improve the technologies and the study 
design. 
 
Continuing development. Once the pilot test begins, we will analyze use data every 2 
weeks to note trends in use, which services are most accessed, and differences in 
patterns of use between patients and partners. One of the tools for patients within A-
CHESS and PartnerCHESS will be a weekly survey adapted from the Brief Alcohol 
Monitor (BAM).74 The survey asks about 5 factors that put patients at risk of relapse 
and 5 factors that protect against relapse; responses help CHESS systems tailor 
services to patients. During the pilot test, we will add 2 questions to the weekly survey 
that ask participants what they like and don’t like about their system and its services. 
We will also add questions to the 2, 4, and 6 month surveys. These questions will 
change over time as we explore specific issues and services. If a service is not used for 
a month, we will add a question on the PartnerCHESS survey about why it isn’t used. If 
certain services are used a great deal, we will ask users to describe what they are 
getting from the service. In this way, we can continue to learn about and act on what is 
helpful and not helpful in a more immediate way than just from the surveys. 
Keeping patients and partners engaged. Other CHESS studies have done 4 things to 

 
 
 
 
 
 
13 
increase engagement. We will use all 4: (1) Monitor and respond to changes in amount 
of CHESS use. (2) Examine discussion group posts using tools such as the Linguistic 
Inquiry and Word Count (LIWC)57 to automatically detect worrisome language. (3) Use 
EMAs and weekly check-in data to identify disconcerting trends. These indicators lead 
to gentle interventions from our research staff (e.g., a call to ask how the person is 
doing) and referrals to relevant CHESS services, such as games and customized tips to 
address concerns, e.g., poor sleep. In this R34, we will enhance our inventory of 
games, especially ones that can be played by couples. (4) Regularly refresh the 
interventions with new information and resources so people keep coming back.  
Dissolution of the relationship. If a partner and patient separate, we will encourage 
both to continue using the technology and completing surveys. At the request of patient 
or partner, we will disengage the portions of PartnerCHESS that connect the two of 
them. If the partner is willing to continue in the study and act as a support for the patient 
via technology, we will keep the partner in the study.  If the separated partner prefers to 
not stay involved, we will honor that request. These experiences (if they occur) will help 
us better understand relationships during recovery and plan PartnerCHESS 
modifications that account for the level of relationship dissolution or the possibility of 
repeated break-ups and reconciliations that may occur. 
Privacy and Confidentiality: 
To mitigate the risk of patient breaches of confidentiality, all subjects will be assigned a 
code number. A list of subject code numbers will be maintained by the UW project 
director and stored in a password protected spreadsheet. Participant surveys will be 
identified by code number only. The UW and SSTAR study coordinators will assist 
patient subjects in choosing codenames and passwords to use to login to the A-CHESS 
or Partner-CHESS system. Patients will be instructed not to use their real names as a 
codename and will be made aware of the potential dangers of divulging confidential 
information (e.g. real names or telephone numbers). 
Prior to gaining access to our data, all students, faculty and staff must provide our Data 
Security Officer a copy of their certificates of completion of the UW Madison Human 
Subjects online training and the online HIPAA Privacy Rule training. Furthermore, they 
are required to complete training on Center security procedures and policies and sign a 
Center Data Security Policy Certification upon completion of this training. 
Hard copy data, such as surveys, will not contain identifying information. They will be 
stored in a locked file cabinet in the study coordinators private office. Electronic data, 
such as A-CHESS or PartnerCHESS use data, will be stored on a secure UW-Madison 
DoIt serverl. Access to this data will be limited by granting individuals access via their 
UW user log-in. Paper study data, such as surveys and contact information, will be 
entered into a REDCap system managed by ICTR. 
Hard copy data at SSTAR and UW, intake and consent forms, will be stored in a locked 
file cabinet within the private office of the site coordinator. UMass will not house any 
data, electronic or paper. 
Any data stored on a participant's device are stored in an encrypted file and only 
accessible by that participant, i.e. participants won't have any other participant data on 

 
 
 
 
 
 
14 
their phone. These data are only collected after the participant has signed into their 
account and are removed when the participant signs out of the A-
CHESS/PartnerCHESS application. Any data transferred to and from CHESS servers 
are done through an encrypted connection. 
A list of subject code numbers will be maintained by the UW study coordinator and 
stored in an electronic spreadsheet. This data will be kept in a secure, limited access, 
password-protected file on CHESS servers which are located in the department of 
Systems and Industrial Engineering in the Mechanical Engineering building on the 4th 
floor. 
The study coordinator will be the only person with access to both the coded study data 
and the subject identifiers.  
When all study activities are complete identifiable information will be destroyed. De-
identified study data will be stored on the secure CHESS servers for potential future 
unspecified research for which new IRB submissions will be initiated.    
 
Potential Risks:  
Regarding risk of misinterpretation of information: Information and resources on the A-
CHESS/PartnerCHESS app will be screened by experts from our recruitment site as 
well as from our Steering Committee (Dr. Gustafson, Dr. Epstein and Dr. Bailey) for 
accuracy.  Additionally, messages exchanged within A-CHESS/PartnerCHESS will be 
monitored to make sure the information is accurate and that study participants are using 
the system for its intended purpose. Inaccurate or harmful statements will be addressed 
by the CHESS moderator. 
Possible breach of confidentiality: All subjects will be assigned a blind code number that 
will be kept in a locked file in the CHESS office. Data collected from clinic records and 
smartphone use files will have the name removed and the code number attached by the 
study coordinator.   
Possible break of confidentiality in surveys: Surveys will be conducted by UW staff 
trained in protecting patient confidentiality. Project staff who have access to the data will 
not have access to subject names.  
Possible breach of confidentiality in smartphone use: There is a risk that information 
provided on A-CHESS or PartnerCHESS will be used to the detriment of the subjects. 
Particular sources of risk include A-CHESS or PartnerCHESS messages written within 
the discussion groups or personal profiles. Patients will select code names and 
passwords to use on A-CHESS/PartnerCHESS. They will be instructed to not use their 
real name as a code name and will be warned of the potential dangers of divulging 
confidential information (e.g. real names or telephone numbers). The smartphone will 
automatically collect data on how often and for how long a subject uses each of the A-
CHESS-PartnerCHESS services. 
A-CHESS/PartnerCHESS data will be collected by subjects' codename only and will not 
be attached to real names or identities. Patients will also be asked to set up a pass 
code on the phone to protect their information in the event someone else finds the 
phone.  

 
 
 
 
 
 
15 
For the potential psychological stress regarding sensitive issues: Participants do not 
have to answer any questions that make them uncomfortable. In addition, study 
participants can change their minds and choose not to participate at any time. 
Findings of Depression/Self-harm/Harm to Others: If a patient subject is determined to 
be in danger of self-harm, suicide or harm to others when on the phone with a 
participant during a survey or by reviewing a discussion group post on the smartphone, 
a crisis intervention plan will be implemented. The UW researchers will contact 
appropriate others to intervene (e.g., the subject's health care team, and/or police). The 
study team is mandated to report child abuse and will do so if the issue arises during 
the course of this research. 
If they post a message on A-CHESS, we send a message through A-CHESS and will 
try to call the participant. We will ask them if they feel like they are in danger.  And 
provide them a set of resources in their local community. 
The research site will have at least one contact person serve as a contact for reported 
medical emergencies or for mental health referrals. Mental health referrals will be made 
when symptoms of major depression, acute anxiety, etc. are indicated in discussion 
group messages, expert mail, or in the daily or weekly A-CHESS survey. Subjects will 
be encouraged to call the site contact for further evaluation and referral.  If evidence 
arises that a participant is contemplating suicide, a 4-step protocol will be initiated that 
includes the following steps: (1) a CHESS staff person will break the code to make 
identification and emergency intervention possible (e.g., by calling the subject and 
appropriate authorities); (2) notify the site contact person; (3) initiate crisis intervention 
to disengage the writer from a suicide method, engage in stabilizing techniques, and 
connect the subject with appropriate support; (4) document and follow-up as 
appropriate.  
If there is evidence of abuse or of a smartphone user being engaged in criminal activity 
(e.g., a discussion group being used to sell an illegal drug), we may need to inform an 
appropriate authority. Hence our consent form will include the following statement: “I 
understand that subject anonymity and data confidentiality cannot be maintained if A-
CHESS or Partner-CHESS finds evidence of abuse, suicidality, or criminal activity.”  
Regarding imminent harm to self or others, a specific safety protocol will be in place at 
the treatment site. If participants experience any crises during the study period, they will 
be instructed to contact their clinician if currently in treatment or the site researcher if is 
no clinician is available during working hours. If the risk to self or another is imminent, 
we will collaborate with staff to ensure that clinical staff evaluate the need for 
emergency services and triage the participant to receive appropriate services. If 
participants have crises after hours, they will be instructed to call 911 for imminent risk 
or go to a local emergency room crisis center. All participants will be provided with a 
listing of crisis hotline numbers and community resources that participants may access 
24/7, such as the National Drug Abuse Hotline (800-662-4357), the National Domestic 
Violence Hotline (1-800-799-7233), or a Crisis Hotline for any crisis (800-233-4357). For 
patients in the A-CHESS condition and patients and partners in the Partner-CHESS 
condition, these numbers will be set up in their safety plan and stored for use with the 
“panic button” service, which the participant will be trained to use as part of the 

 
 
 
 
 
 
16 
intervention. 
 
Lost or Stolen Smartphone:  Participants will be informed that if the phone is in the 
hands of another person there is the potential that someone might see the information 
they stored on the phone (personal contacts, text messages).  Participants are advised 
to make their phone password protected to reduce the risk of someone being able to 
see their information if the phone is lost or stolen.   
Phone service for the study phone is terminated at the end of the 6 month study period: 
The study coordinator will explain this prior to informed consent and will inform the 
participants well in advance of the service ending so they have time to get their own 
service if they wish. 
To help us further protect participant privacy, we will obtain a Certificate of 
Confidentiality from the National Institutes of Health.    
 
6.0 
MEASUREMENT OF EFFECT  
Because this R34 is a planning grant to prepare for an RCT, we will conduct surveys 
that collect the same information we would collect in an RCT. Questions reflect the 
information needed to test the primary and secondary outcomes as well as mediation 
and moderation models. We will measure the time it takes to conduct each survey and 
assess participant comfort with responding. Table 2 lists items we will ask about in the 
survey. 
 
Table 2:  Measures and scales used in PartnerCHESS study 
Measure 
Who 
Source 
Reference 
# Questions 
Time (month) 
Primary outcomes 
Risky drinking days 
Patient  
TLFB every 60 days (PhenX) 
Collins et al.75     
1 
0, 2,4, 6 
Days of abstinence 
Patient 
TLFB every 60 days (PhenX) 
Collins et al.75   
1 
0, 2, 4, 6 
Secondary outcomes 
Treatment retention 
Patient 
Clinic records 
  
0 
0, 2, 4, 6 
Negative affect 
Patient & partner 
PANAS 
Crawford60     
10 
0, 2, 4, 6 
Depression 
Patient & partner 
PHQ-8 
 
8 
0, 2, 4, 6 
Sleep quality 
Patient & partner 
Smartphone data 
Sleep Cycle76     
0 
0, 2, 4, 6 
Exploratory outcomes 
Days of other drug use 
Patient & partner 
TLFB every 60 days (PhenX) 
Collins et al.75  
2 
0, 2, 4, 6 
Health service use 
Patient & partner 
TLFB every 60 days (PhenX) 
McCollister, et al.77   
8 
0, 2, 4, 6 
  Risky drinking days 
Patient & partner 
  TLFB every 60 days (PhenX) 
Collins et al.75  
2 
0, 2, 4, 6 
  Physical/psychological abuse 
Patient & partner 
  Rev. Conflict Tactics Scale 
Straus et al.78     
8 
0, 2, 4, 6 
Satisfaction with technology  
Patient & partner 
Technology Acceptance Model79 
Szajna80 
10 
0, 2, 4, 6 
Mediators 
Intrinsic motivation 
Partner 
Brief Self Control Scale. 
 Tangey81  
12 
0, 2, 4, 6 
Intrinsic motivation 
Patient 
Commitment to sobriety scale 
Kelly82 
5 
0, 2, 4, 6 
Competence 
Patient & partner 
CCQ and # of skills used. 
Schroder83     
9 
0, 2, 4, 6 
Relatedness 
Patient & partner 
Bonding 
Kim84     
5 
0, 2, 4, 6 
Moderators 
Gender/Sex 
Patient & partner 
Question (PhenX tier 1) 
Collins et al.75  
1 
0 
PartnerCHESS use 
Patient & partner 
Smartphone data 
McTavish85     
0 
0, 2, 4, 6 
A-CHESS use 
Patient 
Smartphone data 
McTavish85     
0 
0, 2, 4, 6 
Covariates 
Age 
Patient & partner 
 
1 
0 
Education 
Patient & partner 
 
1 
0 

 
 
 
 
 
 
17 
Race/ethnicity 
Patient & partner 
 
2 
0 
Relationship status 
Patient & partner 
 
 
1 
0, 2, 4, 6 
Psychiatric treatment history 
Patient & partner 
Question (PhenX tier 1) 
Collins et al.75   
1 
0 
Baseline of outcomes 
Patient & partner 
See rows above 
Collins et al.75   
11 
0 
Concurrent Tx services received 
Patient 
TSR 
McLellan et al.86    
6 
0, 2, 4, 6 
Addiction severity 
Patient  
DSM-5 
APA87      
11 
0, 2, 4, 6 
Addiction treatment level (e.g. IOP) 
Patient  
Administrative records 
Collins et al.75   
11 
0, 2, 4, 6 
Items were selected based on the conceptual model (Figure 1). When possible, we will 
use questions from PhenX toolkit on SUD so that results are comparable to those in 
other studies.88 The survey will have 134 questions for partners and 130 for patients. 
Using the survey in this pilot will help us determine which items can be eliminated or 
altered to reduce participant burden while obtaining the data necessary to analyze our 
conceptual model. All measures have been validated in the empirical studies referenced 
above. 
 
7.0  
STUDY PARAMETERS 
 
40 dyads will be recruited, 6 of whom will participate in development and initial testing of 
PartnerCHESS and the survey instruments. The remaining 34 dyads will be randomized 
on a 1:1 ratio to either A-CHESS + TAU or PartnerCHESS + TAU. Subjects will be 
stratified by gender and have access to A-CHESS or PartnerCHESS for 6 months. 
 
Patients will have access to ACHESS and Patients/Partners will have access to Partner 
CHESS for the 6 months of the study. They will be allowed to keep the phone, so that 
they could continue to use those interventions if they had other ways to access the two 
systems. Partners in the A-CHESS group will not have access to either app.   
 
 
8.0 
STATISTICAL CONSIDERATIONS 
 
Outcomes. Primary outcomes will be measured by the Time Line Follow Back over the 
last 60 days.75 Risky drinking will be >4 drinks for men and >3 drinks for women in 2 
hours, the same cutoffs used in our A-CHESS RCT.  These questions are also 
contained in the PhenX tool kit.88 Secondary outcomes are treatment retention (number 
of weeks from first to last treatment session) using SSTAR data; negative affect 
(measured by PANAS60); and sleep quality.  Exploratory outcomes are days of other 
drug use and health service use per McCollister and French77; partner risky drinking 
days; abuse; and satisfaction with technology, assessed with Technology Acceptance 
Model80 data on ease of use, safety, acceptability, attitude toward, behavioral intention, 
and perceived usage. 
Mediators and moderators. Mediators come from prior A-CHESS studies so we have 
comparable measures of them. Including partner mediators is new. Moderators are 
gender and use of the technologies. 
Demographics and other covariates. Addiction severity will be identified by the DSM-
5 categories moderate or severe based on number of symptoms present.87 We will use 
an adaptation of the Treatment Services Review to track concurrent treatments that 
patients and/or partners are receiving. 

 
 
 
 
 
 
18 
Data analysis plan. The analysis will: (1) determine if there is a significant difference 
between study arms over the 6-month pilot test, and (2) explore the conceptual model 
(Figure 1)—i.e., the relationships between the primary and secondary outcomes and 
patient and partner mediators, moderators, the 2 study arms, and covariates. We will 
report descriptive statistics for all demographic and clinical variables in both arms to 
ensure that randomization produced demographically and clinically comparable groups; 
if not, variables with significant differences will be included as covariates in a sensitivity 
analysis. Analysis of the impact of PartnerCHESS+TAU vs. A-CHESS+TAU will focus 
on outcomes over time computed from data at pretest, 2, 4, and 6 months, with 
separate models for the primary outcomes and each secondary outcome. Linear mixed 
effects models—which account for dependence among successive observations on the 
same patient and incomplete data—will analyze outcomes longitudinally and at each 
time point. Initial intercepts will be modeled as random variables to provide variance and 
covariance estimates of intervention effects at each time point and across and between 
patients. A generalized linear mixed effects model, based on a multiple regression, will 
be used for the continuous outcome of risky drinking days.89 We will conduct specific 
treatment time contrasts both between and within groups to test time-based effects. 
Sensitivity analyses (with and without covariate adjustment) will determine the 
robustness of covariate-related error control.  
Modeling mediation and moderation. For both patients and partners, we will test the 
effect of the interventions on potential mediators (competence, intrinsic motivation, and 
relatedness) on primary and secondary outcomes, using Barron and Kenny’s90 steps: 
Step 1, the outcomes (e.g., risky drinking days) will be regressed on the interventions 
(arm 1 vs. arm 2); Step 2, mediators will be regressed on the interventions; Step 3, the 
intervention variable and mediator variables will be regressed on the outcomes. 
Mediator effects are statistically significant if: (a) the beta-weight coefficients in Steps 1 
and 2 differ significantly from zero, (b) the Step 3 beta-weight coefficient of the 
mediators is statistically significant, and, (c) the difference between the beta-weight 
coefficients of the intervention variable in Steps 1 and 3 is statistically greater than zero. 
We will test whether patient and partner gender moderates the effect of intervention on 
outcomes. We will derive interaction terms for the predictor variables, incorporating 
them into the regression model, and determine whether those terms significantly 
contribute to the outcome predictions that exist independent of other significant 
contributors. We will examine moderated mediation because the process may be more 
complex than can be rendered by treating the factors independently (e.g., a mediator 
may be stronger for women than men or vice versa). We will develop a moderated 
mediation structure to determine whether the results are best described by meaningful 
higher-order interaction terms based on mediator-moderator combinations. 
Power. We understand that estimating effect size from pilots can lead to bad 
estimates. A paper by Leon, Davis, and Kraemer2 points out that a pilot study can 
evaluate the. It informs feasibility and identifies modifications needed before a larger 
hypothesis-testing study. But (they argue) a pilot study does not provide meaningful 
effect size estimates for planning subsequent studies because of the imprecision 
inherent small samples. Rather, a hypothesis-testing study should be designed to 
detect the smallest difference that is generally agreed to be clinically 
meaningful. Several studies (e.g. Walters et al.)3 suggest that an effect size of d=.35 

 
 
 
 
 
 
19 
is considered clinically meaningful. So we will use d=.35 at a power of .85 to 
determine sample size needed for the large study. 
This particular pilot is not powered to detect any effect on outcomes. Once the R34 
analyses are complete, we will develop the R01 proposal based on the previous work 
mentioned above but also considering what we learn about the feasibility of recruitment, 
randomization, retention, assessment procedures, and new methods mentioned above. 
Missing data. In previous RCTs, we completed about 85% of surveys through 12 
months and kept missing data on core survey items to about 2%. We expect these rates 
in this study. In addiction treatment, data are not likely to be missing at random (i.e., the 
probability that data are missing relates to what the data would have been had they 
been observed). For example, a patient may not want to disclose some information in 
surveys. Because this may lead to biased parameter estimates, we will identify missing 
data patterns and use pattern-mixture modeling to test the sensitivity of our analysis to 
missing data assumptions91-94 and conduct other sensitivity analyses after imputing 
missing data with a range of plausible values based on assumptions for the missing 
data (e.g., best-case, worst-case; with and without multiple imputation).95-97    
Intention-to-treat and subject noncompliance. Standard intention-to-treat (ITT) 
estimates the average treatment effect by comparing outcomes based on assignment of 
the treatment, but ignoring use of the treatment. Because ITT effect estimates do not 
represent treatment efficacy under noncompliance (e.g., a patient is randomized to 
PartnerCHESS but does not use the system), we will estimate noncompliance by also 
estimating treatment effects only for compliers using As-treated, Per-Protocol98 and 
CACE.99  
 
9.0 
COI MANAGEMENT PLAN REQUIREMENTS 
 
In accordance with Dr. Gustafson’s Conflict of Interest Management Plan Louise Mares, 
Ph.D will be responsible for acting as an independent reviewer of the analysis.  Dr. 
Mares is a professor in the Department of Communication Arts at the University of 
Wisconsin and has 30 years of experience working as a PI performing data analysis. 
10.0 RECORDS TO BE KEPT 
 
The following records will be kept during the course of the study.   
 
• Subject Intake  
• Subject Demographics 
• Subject Consent Forms 
• HIPAA Authorization Form 
• Baseline and follow up survey data 
• De-identified A-CHESS and PartnerCHESS use data collected during this study   
 
 
 
11.0 DATA SECURITY AND PRIVACY MONITORING PLAN 
 

 
 
 
 
 
 
20 
In accordance with the Health Insurance Portability and Accountability Act (HIPAA) the following 
Data Security and Privacy Monitoring Plan has been established at the Center.   
 
I. Appointment of Center Data Security Officers. 
A. Matthew Wright, Adam Maus and Gina Landucci are the security officers for the 
Center. 
B. Responsibilities of the security officers include: 
• 
Developing information technology (IT) security policies 
• 
Increasing security awareness and providing training for all Center faculty and 
Team Members 
• 
Providing virus protection for IT resources 
• 
Maintaining security patches on computing equipment 
• 
Developing and implementing back up procedures 
• 
Performing periodic vulnerability scanning on computers 
• 
Reviewing and updating firewall strategies and policies 
• 
Enhancing the physical security of IT resources 
• 
Annual review of staff policies and procedures contained in this document. 
• 
Conduct formal HIPAA Risk Assessment Inventory per requirements of the UW 
HIPAA Office; last review completed summer 2012. 
 
II. Policy for Orientation and Training 
A. All Center students, faculty and staff are required to complete the UW-Madison 
Human Subjects training on-line at https://my.gradsch.wisc.edu/citi/index.php. You 
register with your NetID. Select the training for the UW Social & Behavioral 
Course. Please print out your certificate of completion when you have finished, and 
give it to Judy Ganch. You will need to take a refresher course every three years.   
B. Successful completion of the CITI training is required before any Team Member is 
allowed access to Center data.  
C. All Center Team Members are also required to complete an on-line training course 
on the HIPAA Privacy Rule which is offered through Learn@UW at 
https://learnuw.wisc.edu/. You will only need to complete the HIPAA Privacy and 
Research at UW course. Contact Judy Ganch if you do not have the HIPAA training 
on your Learn@UW dashboard. Please print out your certificate of completion when 
you have finished, and give it to Judy. You will need to retake this course annually. 
D. Successful completion of the HIPAA training is required before any Team Member is 
allowed access to Center data.  
E. All Center Team Members are required to complete training with Judy Ganch on 
Center security procedures and policies.  
F. Sign (on the last page) the “Center Data Security Policy and Privacy Monitoring Plan” 
upon completion of this training and return to Judy Ganch.  
 
III. Workstation Policy 
A. All workstations will require login with a unique user name and password. 
B. All workstations are required to be joined to the ENGR domain under the control of 
the College of Engineering. Access to specific folders on the Center network will be 
approved by the Center Management team or the study Project Director. 
C. All workstations are required to use anti-virus software that can be remotely 
administered from the College of Engineering domain. 
D. Users will log-out from or lock workstations when leaving them unattended.   

 
 
 
 
 
 
21 
E. Screen savers will be configured to require a password and to activate after ten 
minutes of workstation inactivity. 
F. Users requiring remote access to the Center network will only do so with computers 
specifically certified by a Center Data Security Officer.  
G. Study coordinators or support personnel using desktops in private or public areas 
must have screens adjusted so that visitors cannot read the screen upon entering 
the space in case PHI or other confidential information is displayed.   
H. Access to the network or center work stations along with any on-line systems will be 
terminated immediately following an employee’s last day of work at the Center. 
 
IV. Password Policy 
A. Users will require a password to access any computer connecting to the Center 
network.   
B. Passwords must meet the requirements of the Computer Aided Engineering 
department (CAE). CAE password construction help can be found here: 
https://kb.wisc.edu/cae/page.php?id=8143. 
C. Ideally the best practice is to re-set your password on a semi-annual basis. 
D. Passwords may not be stored in proximity to the workstation and may not be shared 
by others. 
 
V. Policy for the Use of Email 
A. Patient Identifiable, Confidential, or Personnel Data may only be included in an 
encrypted attachment and should never be sent in the body or subject line of an 
email message. 
B. Team Members who need to send encrypted attachments should contact a Center 
Data Security Officer to schedule a training session.  
  
VI. Policy for Storage, Retrieval, and Disposal of Protected Information 
A. Effective 1/1/14 any new studies must use the REDCap environment for study 
participant information. Contact Matt for start-up and access information. 
B. Any Patient Identifiable, Confidential, or Personnel Data in electronic form will be 
stored on secure servers only and may not be stored on individual workstations, 
laptops, or any other endpoint devices. Currently, the only place such information 
can be stored is the R: Drive for studies prior to 1/1/14 or REDCap. 
C. Study coordinators will have printers in their office for printing any materials that 
include PHI and/or names of study participants. 
D. All paper-based files will be stored in locked rooms inside locked file cabinets with 
limited access. 
E. Any offices that contain PHI must be locked when leaving a room. 
F. Servers containing Patient Identifiable, Confidential or Personnel Data must be 
located within physically secured server rooms which can only be accessed by 
authorized personnel. 
G. The Center Data Security Officers will be responsible for assigning and restricting 
access to shared resources on Center servers.   
H. Patient Identifiable, Confidential, and Personnel Data as a general rule may not be 
copied to or stored on the Center’s publicly accessible servers at any time. However, 
in some studies, patient’s name, disease state, and physician are stored within 
Center applications only accessible via a secure connection using a 
codename/password. 

 
 
 
 
 
 
22 
I. 
Remote access to files on secure Center servers will be provided in a very limited 
case only through a connection from a certified Center Workstation (see Center 
Workstation policy above for details). 
J. Storage media containing Patient Identifiable, Confidential or Personnel Data will be 
rendered unusable before disposal. 
K. All back up media will be stored in locked rooms with limited access. 
 
VII. Policy for the use of endpoints (e.g. workstation smartphone, laptop, thumb 
drive, external hard drive, etc.) accessing Patient Identifiable, Confidential, and 
Personnel Data 
A. Staff are not allowed to access or store any PHI data on  any endpoint unless the 
endpoint is provided by a Center Data Security Officer ensuring that the endpoint is 
protected and secured. In addition, any PHI data residing on an endpoint must also 
be encrypted with the oversight of a Center Data Security Officer. 
B. All endpoints accessing PHI must be owned and provisioned by the Center. 
C. Patient Identifiable, Confidential, and Personnel Data files may not be transported 
from the Center unless the device/medium is monitored for physical security at all 
times and the data is encrypted on the mobile device. 
D. Remote access to any PHI data must be conducted using a secure and encrypted 
end-to-end connection implementing modern security best practices either over 
HTTPS or using the WiscVPN connection. 
 
VIII. Policy governing the storage and use of audiovisual materials 
A. Audiovisual media containing Patient Identifiable, Confidential, and Personnel Data 
are governed by the same policies and procedures that apply to handling and use of 
computerized data, including disposal, storage and access to media. 
B. Such audiovisual media may not be transported from the Center unless the material 
is monitored for physical security at all times. 
 
IX. Policy governing the transmission of information via fax 
A. All outgoing correspondence via fax must be stripped of confidential information. 
B. Before confidential information is transmitted to the Center via fax, the sender must 
notify the appropriate Center Team Member to ensure that the recipient is available 
to pick up the fax document. 
 
X. Field hardware policy 
A. Device provided for study participants will require log-in information to access the 
device. 
B. Upon their return, all Center study computers, smartphones, or other devices that 
have been used in the field will have all data wiped from the hard drive in compliance 
with DOD standards. 
C. Field computers will be stored at the Center in a wiped state. 
 

 
 
 
 
 
 
23 
XI. Study participant information. 
A.  Center Team Members will not share or talk about confidential information regarding 
the CHESS study participant with anyone who is not directly involved in the 
management of the CHESS Project.   
B. Confidential or other sensitive information regarding the study participant cannot be 
left in an unsecured place where others may see it.   
C. Copies of written correspondence about the study participants with anyone other 
than CHESS management cannot be provided, unless specifically authorized to do 
so by the Project Director.  
D. Access to study participant’s PHI will be approved by the Project Director in 
coordination with the PI for the project. As noted in Section VI, studies beginning 
after 1/1/14 must use REDCap to enter participant information electronically. 
 
XII. User Responsibilities 
A. All Center Team Members are responsible for adhering to the Center Data Security 
and Privacy Monitoring Plan Policies at all times. In addition, all Center Team 
Members are responsible for adhering to the UW-Madison IT policies detailed at 
https://it.wisc.edu/about/office-of-the-cio/it-policies/ at all times as well. 
B. All Center Team Members will be given a comprehensive briefing session upon hire. 
C. Usernames and passwords are not to be shared with others. 
D. No equipment may be connected to the Center network without specific prior 
certification by a Center Security Officer. 
E. Specifically, no wireless access points may be deployed or connected to the network 
under any circumstances. 
F. The Center Data Security Officers will maintain records to insure that all Center 
Team Members have been briefed. 
G. The Center Data Security Officers will provide periodic refresher sessions to all 
Center Team Members. 
 
XIII. Sanctions for non-compliance with Center data security and privacy policies 
DEFINITION OF OFFENSE: 
Class I offenses: 
(1) Accessing information that you do not need to know to do your job; 
(2) Sharing your computer access codes (user name & password); 
(3) Leaving your computer unattended while you are logged into a PHI program; 
(4) Sharing PHI with another employee without authorization; 
(5) Copying PHI without authorization; 
(6) Changing PHI without authorization; 
(7) Discussing confidential information in a public area or in an area where the public 
could overhear the conversation; 
(8) Discussing confidential information with an unauthorized person; or 
(9) Failure to cooperate with privacy officer. 
Class II offenses: 
(1) Second offense of any class I offense (does not have to be the same offense); 
(2) Unauthorized use or disclosure of PHI; 
(3) Using another person’s computer access codes (user name & password); or 
(4) Failure to comply with a resolution team resolution or recommendation. 

 
 
 
 
 
 
24 
Class III offenses: 
(1) Third offense of any class I offense (does not have to be the same offense); 
(2) Second offense of any class II offense (does not have to be the same offense); 
(3) Obtaining PHI under false pretenses; or 
(4) Using and/or disclosing PHI for commercial advantage, personal gain or malicious 
harm. 
SANCTIONS: 
Class I offenses shall include, but are not limited to: 
(a) Verbal reprimand; 
(b) Written reprimand in employee’s personnel file; 
(c) Retraining on HIPAA Awareness; 
(d) Retraining on Center’s Privacy and Security Policy and how it impacts the said 
employee and said employee’s department; or 
(e) Retraining on the proper use of internal forms and HIPAA required forms. 
Class II offenses shall include, but are not limited to: 
(a) Written reprimand in employee’s personnel file; 
(b) Retraining on HIPAA Awareness; 
(c) Retraining on Center’s Privacy and Security Policy and how it impacts the said 
employee and said employee’s department; 
(d) Retraining on the proper use of internal forms and HIPAA required forms; or 
(e) Suspension of employee (In reference to suspension period: minimum of one (1) day/ 
maximum of three (3) days). 
Class III offenses shall include, but are not limited to: 
(a) Termination of employment; 
(b) Civil penalties as provided under HIPAA or other applicable Federal/State/Local law; 
or 
(c) Criminal penalties as provided under HIPAA or other applicable Federal/State/Local 
law. 
XIV. In case of a PHI breach, Center Security Officer and/or PI reports incident to UW 
HIPAA Security Office who is responsible for adhering to breach notification 
standards.   
 
Definition of Terms 
 
Protected Health Information (“PHI”): Health information or health care payment information, 
including demographic information collected from an individual, which identifies the individual or 
can be used to identify the individual.  
 
Confidential Information:  Propriety information such as algorithms built into CHESS 
technology tools, information about a study participant (e.g. name, address, diagnosis) and 
similar topics. 
 
Personnel Information:  Salary rates, disciplinary actions, layoff notices and similar topics 
about individuals working at the Center or the university. 
 
 

 
 
 
 
 
 
25 
REFERENCES  
 
1. 
McKay JR, Van Horn DH, Oslin DW, Lynch KG, Ivey M, Ward K, Drapkin ML, 
Becher JR, Coviello DM. A randomized trial of extended telephone-based 
continuing care for alcohol dependence: within-treatment substance use outcomes. 
Journal of Consulting and Clinical Psychology. 2010;78(6):912-23. PMCID: 
PMC3082847 
2. 
Maisto SA, Zywiak WH, Connors GJ. Course of functioning 1 year following 
admission for treatment of alcohol use disorders. Addictive Behaviors. 
2006;31(1):69-79.  
3. 
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