This study evaluates the impact on risky drinking days and quality of life for patients with alcohol use disorder among patients who use a mobile health smart phone application. A third of the participants will receive access to the smart phone app without any monitoring; a third of the participants will receive access to the smart phone app monitored by and connected with a peer mentor; a third will receive access to the smart phone app monitored by and connected with a health coach who works within a healthcare system.
Patients in the trial will be given versions of an evidence-based mobile-health (mHealth) system (re-design based on A-CHESS) that is delivered using different implementation strategies according to study group. A-CHESS has more than 18 services designed to improve social relatedness, coping competence, and intrinsic motivation. The following describes key A-CHESS services that will be tested in the current study: * Welcome message - patients write why they are choosing to reduce their drinking. * Coping with Cravings - the system automatically notifies nearby pre-approved friends, family, and peers, who can respond to a request for support. The patient can also be linked to positive activities, such as suggested games to download and play and audio/video-based relaxation recordings. * Monitoring functionality- self-assessment measures, record of A-CHESS use, and prediction of the patient's likelihood of having a heavy drinking episode in the next week. A-CHESS sends patients with worrisome responses suggestions of coping skills, online peer support, healthy events, etc. With patient permission, a prediction of high-risk can be shared with others in a position to provide support. * Triage and feedback functionality is designed to derail a setback in goal attainment, giving the patient 'just in time,' tailored support by linking patients to relevant A-CHESS resources or individuals (depending on group assignment). * The Specialist Report, harvests clinically relevant data from A-CHESS and presents it to a peer mentor (in the peer-supported group) or a health coach (in the clinically integrated group), at which point they may intervene with patients (e.g., through texting in A-CHESS). * Facilitated discussion groups (in the clinically integrated group.) Discussions are monitored daily by an A-CHESS coach. * Library - information about healthy lifestyle choices, calendar of healthy events in the area, etc. * Drink tracker and report feature - patients to self-monitor their drinking and each week see a summary of how they did the past week. * Profiles about why patients want to reduce their drinking. 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. All patient will undergo a 72-hour run-in period. After 72 hours, patients who remain in the study will be randomized to one of the following groups and receive the appropriate access to features. One group will operate independently; one group will have help from a peer-mentor; one group will be connected to a healthcare system by a health coach.
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a research team member. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a counselor. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
UW Health at the American Center
Madison, Wisconsin, United States
Percentage of Heavy Drinking Days, PHDD
Percentage of self-reported Heavy Drinking Days (HDD: 5 or more standard drinks on any day for men under 65, 4 or more standard drinks for women and men over 65) in the last 7 days
Time frame: 12 months
Quality of Life-Physical Health
The physical health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-physical health (QoL-PH). It consists of 4 questions that assess overall physical health aspect of quality of life. Each question will ask patients to indicate their physical health on a scale of 1 (poor) to 5 (excellent). The raw scores of physical health scores (range: 0 to 20) are converted to T-scores (16.2 to 67.7). Higher scores mean better physical health aspects of quality of life.
Time frame: 12 months
Quality of Life-Mental Health
The mental health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-mental health (QoL-MH). It consists of 4 questions that assess overall mental health aspect of quality of life. Each question will ask patients to indicate their mental health on a scale of 1 (poor) to 5 (excellent). The raw scores of mental health scores (range: 0 to 20) are converted to T-scores (21.2 to 67.6). Higher scores mean better mental health aspects of quality of life.
Time frame: 12 months
Number of Patients Who Are Willing to Share Data
Patients in the clinically-integrated arm will have the option to share their data collected by A-CHESS with the health coach. Knowing how many patients are willing to share data about their drinking will allow researchers to make hypotheses about how effective A-CHESS can be in a healthcare setting. We did not collect data for this metric.
Time frame: 12 months
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
558
Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a health coach. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
Number of Hospital Nights in the Past 6 Months
Patients will be asked to indicate hospital stay (nights) in the past 6 months. Researchers will include this in the cost-effectiveness analysis.
Time frame: 12 months
Cost of Implementation of Each Intervention Arm in US Dollars
The cost (in US dollars) of the intervention will be calculated to determine cost-effectiveness of the study.
Time frame: up to 3 years
Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool
The Alcohol Use Disorders Identification Test (AUDIT) screening tool was used to assess patient alcohol severity. The screening tool consists of 10 questions with 5 possible answers (scoring 0-4). The sum scores of the 10 items are the scale scores ranging from 0 to 40. Higher scores indicate greater alcohol severity.
Time frame: 12 months
Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity
The Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria of alcohol use disorder will be used to assess the patient's alcohol use disorder severity. Each item has a score of 1 for agreement or 0 for disagreement of a statement. The sum score of all 11 items is the scale score (range of 0-11 - higher scores indicate greater severity). The severity of the AUD can also be defined as 1) mild: 2 to 3 symptoms; 2) moderate: 4 to 5 symptoms; 3) severe: 6+ symptoms.
Time frame: 12 months
Score of Relatedness as Assessed by the CHESS Bonding Scale
The study will assess how connected patients feel with others. Greater connectedness is associated with fewer risky drinking days. Patients are asked five Likert-scale questions about their relationships with others, responding on a 1-5 scale from 'Never' to 'Nearly Always.' Mean scores are calculated as scale scores, ranging from 1 to 5. Higher scores indicate greater perceived relatedness with others.
Time frame: 12 months
Score of Competence as Assessed by the Perceived Competence Scale (PCS)
The study will assess patients' perceptions of their ability to control and reduce their drinking in order to meet their alcohol use goals. Patients tend to drink less when they feel more confident in managing their alcohol use. Patients will respond to four questions from the Perceived Competence Scale (PCS) about their confidence in responsibly managing alcohol use in various situations. Responses are on a 1-7 scale, from 'Not at all' to 'Very true.' Mean scores (ranging from 1 to 7) are used as the scale scores, with higher scores indicating greater confidence in controlling or reducing drinking.
Time frame: 12 months
Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire
The study assesses how motivated patients are by their own goals. Patients typically drink less when they, themselves, want to reduce their alcohol. Patients will be asked 6 questions from the autonomous motivation subscale of the Treatment Self-Regulation Questionnaire (TSRQ) about why they will reduce their alcohol use and can indicate how much they identify with each statement on a 1-5 scale corresponding to "Not true" to "Very true", respectively. The mean scores are the scale scores, ranging from 1 to 5. Higher scores mean more autonomous motivation to control and reduce alcohol use.
Time frame: 12 months
Time of Tula Used
The time that participants spent using Tula will be assessed.
Time frame: 12 months
Number of Setback Status Triggered by A-CHESS
The patient's ability to meet their weekly goal will be assessed. When patients are not on track to meet their weekly goal a setback alert will be triggered.
Time frame: 12 months
Variables Used for Predictive Setback Status
The variables that help predict a setback will be assessed and reported. Knowing the variables for setbacks will help researchers program A-CHESS to better predict when patients are likely to have a setback.
Time frame: up to 3 years
Number of Response Statuses Addressed
Clinicians and patients will be alerted when the system predicts that they may have a setback. This allows researchers to know how useful patients and health coaches found the alerts.
Time frame: up to 3 years
Pages Viewed on A-CHESS
The number of pages viewed by patients and health coaches will be assessed know how useful patients found different content.
Time frame: 12 Months
Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor
Patients will take a revised Brief Alcohol Monitor survey weekly that asks patients to indicate whether any of the five protection factors exist (sleep, mood, social interaction, work, and urges to drink). The protective factor score is the sum of the number of protection factor items reported by patients during the study period. The scores of the protective factors were planned to be used in the lapse prediction model. Since the study plan changes and the lapse prediction was not the focus of the study, only descriptive statistics are reported. No additional statistical analysis was conducted. Scores range from 7-35. Lower scores indicate a worse outcome for each factor.
Time frame: 12 months