Alcohol Drinking, Telemedicine
Conditions
Keywords
implementation, alcohol drinking, mHealth, wellness
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALA-CHESS self-monitored
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.
BEHAVIORALA-CHESS peer-supported
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.
BEHAVIORALA-CHESS clinically-integrated
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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will have rolling enrollment over two years. Patients will be enrolled and randomized to one of three interventions for 12 months.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* are 21+ years old, * interested in learning about ways to reduce drinking, * willing to download and use A-CHESS, * lives in within the geographical boundaries of the UW Health system * be able to understand and sign an electronic consent form in English, * own an Apple or android smart phone, * meets the criteria for at risk drinking on the AUDIT screening, * responds yes to at least one question on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5 survey, and * indicates in the past week they have had at least 7 drinks and 3 on a single day (women), or had at least 14 drinks and 4 on a single day (men).
Exclusion criteria
* has a severe alcohol use disorder (yes to 6+ items on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5) * have a current psychotic disorder * have an acute medical problem requiring immediate hospitalization * have a known terminal illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Heavy Drinking Days, PHDD | 12 months | 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 |
| Quality of Life-Physical Health | 12 months | 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. |
| Quality of Life-Mental Health | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool | 12 months | 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. |
| Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity | 12 months | 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. |
| Score of Relatedness as Assessed by the CHESS Bonding Scale | 12 months | 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. |
| Score of Competence as Assessed by the Perceived Competence Scale (PCS) | 12 months | 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. |
| Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire | 12 months | 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. |
| Number of Patients Who Are Willing to Share Data | 12 months | 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. |
| Number of Setback Status Triggered by A-CHESS | 12 months | 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. |
| Variables Used for Predictive Setback Status | up to 3 years | 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. |
| Number of Response Statuses Addressed | up to 3 years | 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. |
| Pages Viewed on A-CHESS | 12 Months | The number of pages viewed by patients and health coaches will be assessed know how useful patients found different content. |
| Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor | 12 months | 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 of Tula Used | 12 months | The time that participants spent using Tula will be assessed. |
| Number of Hospital Nights in the Past 6 Months | 12 months | Patients will be asked to indicate hospital stay (nights) in the past 6 months. Researchers will include this in the cost-effectiveness analysis. |
| Cost of Implementation of Each Intervention Arm in US Dollars | up to 3 years | The cost (in US dollars) of the intervention will be calculated to determine cost-effectiveness of the study. |
Countries
United States
Participant flow
Recruitment details
A three-pronged recruitment strategy encompassing clinical settings, community-based organizations, and public media was used. Clinical study champions, including primary care providers, behavioral health specialists, etc., provided information to potentially eligible patients. Leaders from underrepresented communities promoted the study to their respective diverse populations. Lastly, targeted digital, television, and print media promoted the study broadly.
Pre-assignment details
The site staff were not enrolled in the clinical trial that is represented in the overall study flow diagram above and as such are not included in it. They were engaged in a post hoc interview to understand the study results for an exploratory analysis.
Participants by arm
| Arm | Count |
|---|---|
| Self Monitored Patients of this group will continue receiving regular care from their physician with no interference from the two experimental groups. Patient subjects will download the app on their Android or Apple smart phone that will direct them to external information hosted on the internet that may help reduce their drinking (e.g., NIAAA resources). For the first 12 weeks, once a week patients can set a weekly goal related to their alcohol use or other health related behaviors (e.g., I will only drink on Friday this week.). At the end of the week subjects will be prompted to take a weekly survey, which will include questions such as a variation of the brief alcohol monitor (BAM) and timeline followback. Patients will then receive feedback on the amount of drinks they had compared to their goal. Then the patient will set a new goal for the following week. Patients will complete quarterly surveys on the A-CHESS app to assess study outcomes.
A-CHESS self-monitored: 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. | 185 |
| Peer Supported Patients will be asked to take the same surveys and have the access to the same information as the self-monitoring group. Patient subjects in this group will have access to discussion boards where they can talk to one another and have the ability to share and see stories of other patients. The only involvement of someone other than patients themselves in the peer-supported group will be by a sponsor (i.e., a dedicated user from the area with a sustained history of successful alcohol reduction). The sponsor will participate in discussion groups and encourage use of the system. Patient-reported feedback will be presented directly to the patient.
A-CHESS peer-supported: 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. | 186 |
| Clinically Integrated Patients in the clinically integrated group will receive the same intervention as the peer-supported group aside from three differences: 1) patients have the option to share selected elements of their app data with the University of Wisconsin (UW) Health health coach, 2) the health coach will replace the role of the sponsor in the peer-support group, and 3) patients will have the option to attend an initial 60- to 90-minute and two 30-minute follow-up consultations with the health coach in-person, via phone, or via video chat.
A-CHESS clinically-integrated: 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. | 187 |
| Total | 558 |
Baseline characteristics
| Characteristic | Clinically Integrated | Total | Peer Supported | Self Monitored |
|---|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 12.9 | 42.8 years STANDARD_DEVIATION 12.9 | 42.8 years STANDARD_DEVIATION 12.9 | 42.80 years STANDARD_DEVIATION 12.9 |
| AUDIT Category Alcohol dependence | 62 Participants | 184 Participants | 61 Participants | 61 Participants |
| AUDIT Category Harmful drinking | 84 Participants | 241 Participants | 72 Participants | 85 Participants |
| AUDIT Category Low risk | 41 Participants | 133 Participants | 53 Participants | 39 Participants |
| Education Bachelors | 76 Participants | 235 Participants | 83 Participants | 76 Participants |
| Education Doctorate | 14 Participants | 47 Participants | 19 Participants | 14 Participants |
| Education < High school | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Education HS or GED | 32 Participants | 67 Participants | 19 Participants | 16 Participants |
| Education Masters | 48 Participants | 121 Participants | 29 Participants | 44 Participants |
| Education Vocation or associate | 16 Participants | 85 Participants | 34 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 14 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 544 Participants | 180 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Percentage of heavy drinking days (PHDD) | 41.9 percentage STANDARD_DEVIATION 31.4 | 38.4 percentage STANDARD_DEVIATION 31.1 | 36.2 percentage STANDARD_DEVIATION 31.2 | 37.1 percentage STANDARD_DEVIATION 30.6 |
| Quality of life-mental health, QOL-MH | 45.4 T-scores STANDARD_DEVIATION 6.9 | 45.4 T-scores STANDARD_DEVIATION 7.1 | 45.5 T-scores STANDARD_DEVIATION 7.5 | 45.5 T-scores STANDARD_DEVIATION 6.9 |
| Quality of life-physical health, QOL-PH | 48.3 T-score STANDARD_DEVIATION 6.5 | 48.3 T-score STANDARD_DEVIATION 6.5 | 48.1 T-score STANDARD_DEVIATION 6.7 | 48.4 T-score STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 11 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 25 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 170 Participants | 507 Participants | 167 Participants | 170 Participants |
| Sex: Female, Male Female | 123 Participants | 365 Participants | 122 Participants | 120 Participants |
| Sex: Female, Male Male | 64 Participants | 193 Participants | 64 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 186 | 0 / 187 |
| other Total, other adverse events | 0 / 185 | 0 / 186 | 0 / 187 |
| serious Total, serious adverse events | 0 / 185 | 0 / 186 | 0 / 187 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Percentage of Heavy Drinking Days, PHDD | 24.4 percentage of heavy drinking days | Standard Deviation 28.2 |
| Peer Supported | Percentage of Heavy Drinking Days, PHDD | 21.4 percentage of heavy drinking days | Standard Deviation 28.9 |
| Clinically Integrated | Percentage of Heavy Drinking Days, PHDD | 21.3 percentage of heavy drinking days | Standard Deviation 30.4 |
p-value: 0.688Mixed Models Analysis
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Quality of Life-Mental Health | 46.7439 T-Scores | Standard Deviation 8.25969 |
| Peer Supported | Quality of Life-Mental Health | 47.6715 T-Scores | Standard Deviation 8.30113 |
| Clinically Integrated | Quality of Life-Mental Health | 48.1160 T-Scores | Standard Deviation 7.03693 |
p-value: 0.014Mixed Models Analysis
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Quality of Life-Physical Health | 48.5806 T-Scores | Standard Deviation 6.81051 |
| Peer Supported | Quality of Life-Physical Health | 49.2869 T-Scores | Standard Deviation 6.44004 |
| Clinically Integrated | Quality of Life-Physical Health | 48.1010 T-Scores | Standard Deviation 7.45609 |
p-value: 0.261Mixed Models Analysis
Secondary
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
Population: Cost reflects total number enrolled, not number completed, to account for program being at full capacity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self Monitored | Cost of Implementation of Each Intervention Arm in US Dollars | 0 dollars |
| Peer Supported | Cost of Implementation of Each Intervention Arm in US Dollars | 71750 dollars |
| Clinically Integrated | Cost of Implementation of Each Intervention Arm in US Dollars | 124250 dollars |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Number of Hospital Nights in the Past 6 Months | 0.0534 Hospital nights | Standard Deviation 0.35762 |
| Peer Supported | Number of Hospital Nights in the Past 6 Months | 0.0469 Hospital nights | Standard Deviation 0.39404 |
| Clinically Integrated | Number of Hospital Nights in the Past 6 Months | 0.2178 Hospital nights | Standard Deviation 1.34613 |
Comparison: A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).p-value: 0.908ANCOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor | 21.96 Score on a scale | Standard Deviation 5.45 |
| Peer Supported | Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor | 23.02 Score on a scale | Standard Deviation 5.25 |
| Clinically Integrated | Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor | 23.48 Score on a scale | Standard Deviation 5.63 |
Secondary
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
Population: We did not collect data for this metric.
Secondary
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
Population: We did not implement this setback alert so no data are collected for this measure.
Secondary
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
Population: We did not implement this setback alert so no data are collected for this measure.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Pages Viewed on A-CHESS | 753.12 Page view counts | Standard Deviation 517.05 |
| Peer Supported | Pages Viewed on A-CHESS | 891.84 Page view counts | Standard Deviation 544.44 |
| Clinically Integrated | Pages Viewed on A-CHESS | 773.1 Page view counts | Standard Deviation 458.18 |
p-value: 0.02Kruskal-Wallis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool | 9.0303 Scores on a scale | Standard Deviation 4.91289 |
| Peer Supported | Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool | 9.3386 Scores on a scale | Standard Deviation 5.9271 |
| Clinically Integrated | Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool | 8.8283 Scores on a scale | Standard Deviation 5.54948 |
Comparison: A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).p-value: 0.206ANCOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire | 3.8913 Scores | Standard Deviation 0.67081 |
| Peer Supported | Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire | 3.9244 Scores | Standard Deviation 0.7311 |
| Clinically Integrated | Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire | 4.0283 Scores | Standard Deviation 0.811 |
p-value: 0.555Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Score of Competence as Assessed by the Perceived Competence Scale (PCS) | 5.1377 Scores | Standard Deviation 1.26652 |
| Peer Supported | Score of Competence as Assessed by the Perceived Competence Scale (PCS) | 5.0788 Scores | Standard Deviation 1.34071 |
| Clinically Integrated | Score of Competence as Assessed by the Perceived Competence Scale (PCS) | 5.39 Scores | Standard Deviation 1.50013 |
p-value: 0.025Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Score of Relatedness as Assessed by the CHESS Bonding Scale | 2.3022 Scores | Standard Deviation 0.85985 |
| Peer Supported | Score of Relatedness as Assessed by the CHESS Bonding Scale | 2.7538 Scores | Standard Deviation 0.87037 |
| Clinically Integrated | Score of Relatedness as Assessed by the CHESS Bonding Scale | 2.668 Scores | Standard Deviation 0.95525 |
p-value: <0.001Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity | 2.5364 Scores on a scale | Standard Deviation 1.76447 |
| Peer Supported | Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity | 2.5229 Scores on a scale | Standard Deviation 1.65326 |
| Clinically Integrated | Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity | 2.9178 Scores on a scale | Standard Deviation 2.17763 |
Comparison: A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).p-value: 0.104ANCOVA
Secondary
Time of Tula Used
The time that participants spent using Tula will be assessed.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Monitored | Time of Tula Used | 17142.98 Seconds | Standard Deviation 15043.75 |
| Peer Supported | Time of Tula Used | 19851.64 Seconds | Standard Deviation 16160.12 |
| Clinically Integrated | Time of Tula Used | 17000.83 Seconds | Standard Deviation 12961.23 |
p-value: 0.131Kruskal-Wallis
Secondary
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
Population: We did not implement this setback alert so no data are collected for this measure.