Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

Study Overview
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Brief Summary
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The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.

Official Title
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Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Telephone Engagement
* Behavioral: Portal Engagement
* Behavioral: MI-CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AUD past month heavy alcohol use internet access phone access able to provide informed consent Exclusion Criteria: inability to speak or understand English conditions precluding informed consent or understanding of intervention or assessment content recent AUD treatment history of or at risk for complex alcohol withdrawal involvement in another ongoing study for alcohol/mental health/substance use treatment PI discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Sequential Assignment
Interventional Model Description: Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program) | Behavioral: Telephone Engagement<br>* Brief phone session with a study counselor.<br>Behavioral: MI-CBT<br>* 8 one-on-one sessions done over the phone or video chat with a study counselor<br>|
| Active Comparator: Arm B<br>First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement | Behavioral: Telephone Engagement<br>* Brief phone session with a study counselor.<br>|
| Active Comparator: Arm C<br>First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up | Behavioral: Telephone Engagement<br>* Brief phone session with a study counselor.<br>|
| Active Comparator: Arm D<br>First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up | Behavioral: Portal Engagement<br>* Access to a virtual portal where participant messages with study counselors.<br>|
| Active Comparator: Arm E<br>First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement | Behavioral: Portal Engagement<br>* Access to a virtual portal where participant messages with study counselors.<br>|
| Active Comparator: Arm F<br>First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program | Behavioral: Portal Engagement<br>* Access to a virtual portal where participant messages with study counselors.<br>Behavioral: MI-CBT<br>* 8 one-on-one sessions done over the phone or video chat with a study counselor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUD Treatment Initiation | % of patients who initiate psychotherapy treatment | 4-months post-enrollment | 
| AUD Treatment Engagement | % of patients who attend at least 2 psychotherapy treatment sessions | 4-months post-enrollment | 
| Alcohol consumption days | % of days of alcohol consumption as measured by the Timeline Follow Back Interview | 4-months post-enrollment | 
| Alcohol consumption days | % of days of alcohol consumption as measured by the Timeline Follow Back Interview | 8-months post-enrollment | 
| Alcohol consumption days | % of days of alcohol consumption as measured by the Timeline Follow Back Interview | 12-months post-enrollment | 
| Heavy drinking days | % of days of heavy drinking as measured by the Timeline Follow Back Interview | 4-months post-enrollment | 
| Heavy drinking days | % of days of heavy drinking as measured by the Timeline Follow Back Interview | 8-months post-enrollment | 
| Heavy drinking days | % of days of heavy drinking as measured by the Timeline Follow Back Interview | 12-months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth