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Addiction Health Evaluation And Disease Management (AHEAD) Study

Phase 3
Completed
Conditions
Alcohol Dependence
Alcoholism
Drug Dependence
Interventions
Behavioral: Chronic Disease Management for substance abuse
Behavioral: Standard care
Registration Number
NCT00278447
Lead Sponsor
Boston Medical Center
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
569
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1) CDMChronic Disease Management for substance abuseChronic Disease Management
2) Standard careStandard careStandard care
Primary Outcome Measures
NameTimeMethod
Alcohol and drug use3, 6, and 12 months after baseline
Alcohol and drug-related problems3, 6, and 12 months after baseline
Nights Hospitalized3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Emergency department visits3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Secondary Outcome Measures
NameTimeMethod
Health-related quality of life3, 6, and 12 months after baseline
Readiness to change3, 6, and 12 months after baseline
Medical comorbidity3, 6, and 12 months after baseline
Psychiatric comorbidity3, 6, and 12 months after baseline
Treatment utilization and costs3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
HIV risk behaviors3, 6, and 12 months after baseline

Trial Locations

Locations (1)

Boston Medical Center / Boston University

🇺🇸

Boston, Massachusetts, United States

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