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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885311
• Other study ID #: 15-0743
• Secondary ID: R34AA024589
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: October 2018

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorders
• Alcohol-Related Disorders
• Alcoholism

Intervention

Behavioral:
• Motivation Enhancement Therapy
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).
• Modified Behavioral Self-Control Therapy
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.

Drug:
• Naltrexone
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).

Behavioral:
• Brief Advice
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.

Other:
• Referral to specialty substance use disorder treatment
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.

Locations

Country	Name	City	State
United States	Northwell Health	Great Neck	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Change in Drinking	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.	Baseline (8 weeks prior to study enrollment) and the 12-week treatment period