Erin E. Bonar , Jason E. Goldstick , Matthew J. Rostker , Shayla E. Dailey , Alyssa N. Augustiniak , Carly Brin , Deborah A. Manderachia , Carrie Bourque , Rachel Girard , Lisa Sulkowski , Lewei Allison Lin
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Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days).</p></div><div><h3>Conclusions</h3><p>This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD.</p></div><div><h3>Trial Registration</h3><p><span>ClinicalTrials.gov</span><svg><path></path></svg> # <span>NCT05410561</span><svg><path></path></svg>. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol\",\"authors\":\"Erin E. Bonar , Jason E. Goldstick , Matthew J. Rostker , Shayla E. Dailey , Alyssa N. Augustiniak , Carly Brin , Deborah A. Manderachia , Carrie Bourque , Rachel Girard , Lisa Sulkowski , Lewei Allison Lin\",\"doi\":\"10.1016/j.cct.2024.107549\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. 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The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days).</p></div><div><h3>Conclusions</h3><p>This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. 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Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol
Background
The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD.
Methods
We aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days).
Conclusions
This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD.
Trial Registration
ClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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