Clinical trial NCT02885311: Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
Official title: Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol-Related Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse
Alcohol Use Disorders
Keywords: Drinking
Excessive drinking
Alcohol use disorders
Primary Care
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-08-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weekly Change in Drinking
timeFrame: Baseline (8 weeks prior to study enrollment) and the 12-week treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Northwell Health
state: New York
Study officials:
References: