Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home

Phase 1

Completed

• Conditions: Alcohol-Related Disorders; Alcohol Drinking; Alcohol Abuse; Alcoholism; Alcohol Use Disorders
• Interventions: Behavioral: Motivation Enhancement Therapy; Behavioral: Modified Behavioral Self-Control Therapy; Other: Referral to specialty substance use disorder treatment; Drug: Naltrexone; Behavioral: Brief Advice

• Registration Number: NCT02885311
• Lead Sponsor: Northwell Health

Brief Summary

The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.

Detailed Description

Excessive drinking (ED) and alcohol use disorders (AUD) remain one of the nation's leading public health problems, yet this problem is largely under-recognized and undertreated. Although many people with ED/AUD see a primary care physician annually, there has been limited research and implementation of models to treat ED/AUD in primary care. Important changes in the healthcare system and advances in alcohol research offer new and potentially transformative opportunities to integrate ED/AUD treatment into primary care practices. In particular, these changes have led to the development of new patient-centered, integrated care models that facilitate the treatment behavioral health issues in primary care. Experts have repeatedly called for the development of a chronic care model to treat alcohol problems in primary care, similar to models now used to treat other chronic illnesses, including depression. Yet, research to develop and test such models has been surprisingly limited. The primary aim of this study is to develop and test a chronic care model to treat ED/AUD in the patient-centered model home (PCMH) using the NIH stage model of intervention development. Specifically, using a mixed methods approach, this study proposes to adapt and test the collaborative care (CC) model for depression to treat ED/AUD in a high volume PCMH. Importantly, we will build the CC model onto a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program that is already in place in the PCMH. Notably, this SBIRT model currently refers those with ED/AUD out to specialty treatment providers. The proposed study will be conducted in two phases. Phase I will involve initial adaptation of the CC model for depression. During this phase, relevant depression CC protocols and measures will be adapted for ED/AUD and piloted tested on participants (n = 25) recruited in a PCMH. Phase II will involve model refinement based on iterative cycles of patient and PCMH staff feedback and examination of drinking outcome data. During this phase, participants (n = 60) will be assessed and followed for three months. Iterative development will focus on: 1) utilizing a stepped-care model of treatment which will include outpatient detoxification, behavioral interventions, and medication intervention and management, 2) maximizing patient engagement, and 3) balancing the resource and expertise constraints of treating ED/AUD in a PCMH. Participants in Phases 1 and 2 will be followed at 1 and 3 months and primary outcome data on drinking outcomes will be examined.

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Study Start: 2017-01
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2022-11-11
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Results First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Exceed NIAAA weekly or daily guidelines
• receive care at the 865 clinic
• are fluent in English
• are willing to provide signed, informed consent to participate
• available to complete research follow-ups
• are able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment

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Exclusion Criteria

• Meet DSM-V criteria for drug dependence other than for marijuana or nicotine
• on probation or parole
• have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, severe major depression, etc.) that is likely to require pharmacologic treatment or that is currently treated with psychotropic medication; organic mood or mental disorders, or substantial suicide or violence risk

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Problem Drinkers (PD)	Brief Advice	PD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments.
Problem Drinkers (PD)	Motivation Enhancement Therapy	PD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments.
AD with complex presentation (AD-CMPLX)	Brief Advice	AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
At-Risk Drinkers (AR)	Brief Advice	AR will receive feedback about their drinking and brief advice along with follow up assessments.
AD with physiological withdrawal (AD-W)	Brief Advice	AD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy \[MBSCT\]) adapted from our two prior protocols. These participants will also receive follow up assessments.
AD with physiological withdrawal (AD-W)	Modified Behavioral Self-Control Therapy	AD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy \[MBSCT\]) adapted from our two prior protocols. These participants will also receive follow up assessments.
AD with complex presentation (AD-CMPLX)	Referral to specialty substance use disorder treatment	AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
Problem Drinkers (PD)	Naltrexone	PD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments.
AD with physiological withdrawal (AD-W)	Naltrexone	AD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy \[MBSCT\]) adapted from our two prior protocols. These participants will also receive follow up assessments.

Primary Outcome Measures

Name	Time	Method
Weekly Change in Drinking	Baseline (8 weeks prior to study enrollment) and the 12-week treatment period	We used to the Timeline Followback Interview to collect the average weekly number of standard drinks of alcohol (about 9 grams) consumed at baseline (8 weeks prior to study enrollment) and during the 12-week treatment period. The minimum score is zero. There is no maximum score. Higher negative scores reflect a greater reduction in drinking and better outcomes.

Trial Locations

Locations (1)

Northwell Health; 🇺🇸 Great Neck, New York, United States