Addiction Health Evaluation And Disease Management (AHEAD) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Linkage of Alcohol Abusers to Primary Care

Conditions
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Alcohol Dependence, Alcoholism, Drug Dependence

Intervention / Treatment
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* Behavioral: Chronic Disease Management for substance abuse
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization, Primary care, Chronic disease management, Care management, Comorbidity