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

Primary Purpose

Alcohol-Related Disorders, Alcohol Drinking, Alcoholism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivation Enhancement Therapy
Modified Behavioral Self-Control Therapy
Naltrexone
Brief Advice
Referral to specialty substance use disorder treatment
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Drinking, Excessive drinking, Alcohol use disorders, Primary Care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwell Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

At-Risk Drinkers (AR)

Problem Drinkers (PD)

AD with physiological withdrawal (AD-W)

AD with complex presentation (AD-CMPLX)

Arm Description

AR will receive feedback about their drinking and brief advice along with follow up assessments.

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-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-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.

Outcomes

Primary Outcome Measures

Change in drinking from Baseline to Week 12
Change in drinking, as measured by the Timeline Follow Back (TLFB; a retrospective, self-report measure of drinking) will be assessed from baseline to end of treatment at week 12 in the study.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2016
Last Updated
November 19, 2020
Sponsor
Northwell Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02885311
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse, Alcohol Use Disorders
Keywords
Drinking, Excessive drinking, Alcohol use disorders, Primary Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
At-Risk Drinkers (AR)
Arm Type
Other
Arm Description
AR will receive feedback about their drinking and brief advice along with follow up assessments.
Arm Title
Problem Drinkers (PD)
Arm Type
Other
Arm Description
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.
Arm Title
AD with physiological withdrawal (AD-W)
Arm Type
Other
Arm Description
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.
Arm Title
AD with complex presentation (AD-CMPLX)
Arm Type
Other
Arm Description
AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
Intervention Type
Behavioral
Intervention Name(s)
Motivation Enhancement Therapy
Other Intervention Name(s)
MET
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Modified Behavioral Self-Control Therapy
Other Intervention Name(s)
MBSCT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
NTX
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Other Intervention Name(s)
BA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Referral to specialty substance use disorder treatment
Other Intervention Name(s)
Referral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in drinking from Baseline to Week 12
Description
Change in drinking, as measured by the Timeline Follow Back (TLFB; a retrospective, self-report measure of drinking) will be assessed from baseline to end of treatment at week 12 in the study.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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