Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

Study Overview
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Brief Summary
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The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting. This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Official Title
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Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

Conditions
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Substance Use Disorders, Substance Use, Substance Dependence

Intervention / Treatment
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* Behavioral: Enhanced Usual Care (EUC)
* Behavioral: TeleTx intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist An average of 3 or more drinking days per week for the past 30 days Have regular access to a device with video capabilities or a phone to use for study related calls Exclusion Criteria: Inability to speak or understand English Conditions that preclude informed consent or understanding of assessment or intervention content Past 90-day AUD psychotherapy treatment, At elevated risk for complicated alcohol withdrawal Past-year drug injection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TeleTx intervention<br>The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing. | Behavioral: TeleTx intervention<br>* TeleTx will consist of an initial session and then 8  counseling sessions.<br>|
| Active Comparator: Enhanced Usual Care (EUC)<br>EUC will include brief psychoeducation about AUD and resources for treatment. | Behavioral: Enhanced Usual Care (EUC)<br>* EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use Disorder Treatment Initiation | Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment | 3 months | 
| Alcohol Use Disorder Treatment Engagement | Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions | 3 months | 
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 3-months | 
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 6-months | 
| Alcohol consumption days | Percent days of alcohol use on the Timeline Follow Back interview | 12-months | 
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 3-months | 
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 6-months | 
| Heavy drinking days | Percent days heavy drinking on the Timeline Follow Back interview | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions | 6-months | 
| Total Alcohol Use Disorder Psychotherapy Treatment Attendance | Total number of psychotherapy sessions | 12-months | 
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 3-months | 
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 6-months | 
| Drinking Risk Levels (Based on World Health Organization Cut-Offs) | Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes) | Baseline to 12-months | 
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 3-months | 
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 6-months | 
| World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF) | Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life. | Baseline to 12-months | 
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 3-months | 
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 6-months | 
| Alcohol consequences | Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R | Baseline to 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption