Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
Condition: Alcohol-Related Disorders; Alcohol Drinking; Alcoholism; Alcohol Abuse; Alcohol Use Disorders
MeSH terms: Alcoholism; Alcohol-Related Disorders; Alcohol Drinking
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Motivation Enhancement Therapy; Modified Behavioral Self-Control Therapy; Naltrexone; Brief Advice; Referral to specialty substance use disorder treatment
Intervention type(s): Behavioral; Behavioral; Drug; Behavioral; Other
Intervention description(s): Motivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan).; Motivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers.; Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day).; Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.; Participants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders.
Other intervention name(s): MET; MBSCT; NTX; BA; Referral
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drinking; Excessive drinking; Alcohol use disorders; Primary Care