Addiction Health Evaluation And Disease Management (AHEAD) Study

October 1, 2014 updated by: Boston Medical Center

Linkage of Alcohol Abusers to Primary Care

The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic disease management (CDM) is a collaborative, longitudinal, proven effective approach to the treatment of chronic medical illnesses that addresses individual patient and health systems barriers to receipt of needed treatment. The objective of this Addiction Health Evaluation And Disease management (AHEAD) Study is to test the effectiveness of CDM for substance dependence in primary care. The study will enroll and randomize subjects to attend a substance dependence CDM program (the AHEAD Unit) integrated into a real-world primary care clinic or to referral to usual primary care. All subjects will be assessed regarding alcohol and/or drug diagnosis, consumption and problems, readiness to change, health-related quality of life, and medical and substance abuse treatment utilization. Primary outcomes are alcohol and drug use, alcohol and drug-related problems, emergency department visits, and hospitalizations. Additional outcomes are health-related quality of life, readiness to change, medical and psychiatric comorbidity, HIV risk behaviors, and treatment utilization and costs. The hypothesis is that compared with standard care, a health services intervention -- chronic disease management for alcohol and drug dependence integrated in primary care -- will decrease alcohol and drug use and related problems, and improve health care utilization patterns.

This study contains two studies (and study populations):

  • 1. 320 alcohol dependent subjects with current risky drinking, and
  • 2. 320 drug dependent subjects with current drug use.

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center / Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Fluent in English or Spanish
  • Alcohol or drug dependent
  • Heavy drinking in the past 30 days or recent drug use
  • Provide 2 contacts to assist with follow-up
  • Have no plans to move from the local area within a year of screening
  • Score >21 on Mini-Mental State Examination (no serious cognitive impairment)

Exclusion Criteria:

  • Pregnant (self-report)
  • Breath alcohol >100 mg/dL
  • Inability to provide informed consent determined by trained research associates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1) CDM
Chronic Disease Management
Behavioral: Chronic Disease Management for substance abuse
Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
Active Comparator: 2) Standard care
Standard care
Behavioral: Standard care
Referral to primary medical care for persons with substance dependence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alcohol and drug use
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Alcohol and drug-related problems
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Nights Hospitalized
Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Emergency department visits
Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Readiness to change
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Medical comorbidity
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Psychiatric comorbidity
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
HIV risk behaviors
Time Frame: 3, 6, and 12 months after baseline
3, 6, and 12 months after baseline
Treatment utilization and costs
Time Frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

October 1, 2014

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAI-010870-06A2
  • P60AA013759 (U.S. NIH Grant/Contract)
  • NIAAA Grant 2R01 AA010870-06A2
  • NIDA Grant 2R01 DA010019-07A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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