Addiction Health Evaluation And Disease Management (AHEAD) Study

Alcoholism Clinical Trial

Official title:

Linkage of Alcohol Abusers to Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278447
• Other study ID #: SAI-010870-06A2
• Secondary ID: P60AA013759NIAAA
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2006
• Last updated: October 1, 2014
• Start date: April 2006
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: April 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Drug Dependence

Intervention

Behavioral:
• Chronic Disease Management for substance abuse
Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
• Standard care
Referral to primary medical care for persons with substance dependence.

Locations

Country	Name	City	State
United States	Boston Medical Center / Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol and drug use		3, 6, and 12 months after baseline	No
Primary	Alcohol and drug-related problems		3, 6, and 12 months after baseline	No
Primary	Nights Hospitalized		3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled	No
Primary	Emergency department visits		3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled	No
Secondary	Health-related quality of life		3, 6, and 12 months after baseline	No
Secondary	Readiness to change		3, 6, and 12 months after baseline	No
Secondary	Medical comorbidity		3, 6, and 12 months after baseline	No
Secondary	Psychiatric comorbidity		3, 6, and 12 months after baseline	No
Secondary	HIV risk behaviors		3, 6, and 12 months after baseline	No
Secondary	Treatment utilization and costs		3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled	No