Addiction Health Evaluation And Disease Management (AHEAD) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00278447
First received: January 13, 2006
Last updated: November 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Alcoholism
Drug Dependence
Behavioral: Chronic Disease Management for substance abuse
Behavioral: Standard care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Linkage of Alcohol Abusers to Primary Care

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Alcohol and drug use [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Alcohol and drug-related problems [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Nights Hospitalized [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]
  • Emergency department visits [ Time Frame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Readiness to change [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Medical comorbidity [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Psychiatric comorbidity [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: 3, 6, and 12 months after baseline ] [ Designated as safety issue: No ]
  • Treatment utilization and costs [ Time Frame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: April 2006
Estimated Study Completion Date: March 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278447

Locations
United States, Massachusetts
Boston Medical Center / Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Richard Saitz, MD, MPH Boston University
  More Information

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00278447     History of Changes
Other Study ID Numbers: SAI-010870-06A2, P60AA013759, NIAAA Grant 2R01 AA010870-06A2, NIDA Grant 2R01 DA010019-07A1
Study First Received: January 13, 2006
Last Updated: November 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
Alcohol
Alcohol use
Alcohol dependence
Drug
Drug use
Drug dependence
Utilization
Hospitalization
Primary care
Chronic disease management
Care management
Comorbidity

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014