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Addiction Health Evaluation And Disease Management (AHEAD) Study

Primary Purpose

Alcohol Dependence, Alcoholism, Drug Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Management for substance abuse
Standard care
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization, Primary care, Chronic disease management, Care management, Comorbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center / Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1) CDM

2) Standard care

Arm Description

Chronic Disease Management

Standard care

Outcomes

Primary Outcome Measures

Alcohol and drug use
Alcohol and drug-related problems
Nights Hospitalized
Emergency department visits

Secondary Outcome Measures

Health-related quality of life
Readiness to change
Medical comorbidity
Psychiatric comorbidity
HIV risk behaviors
Treatment utilization and costs

Full Information

First Posted
January 13, 2006
Last Updated
October 1, 2014
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00278447
Brief Title
Addiction Health Evaluation And Disease Management (AHEAD) Study
Official Title
Linkage of Alcohol Abusers to Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcoholism, Drug Dependence
Keywords
Alcohol, Alcohol use, Alcohol dependence, Drug, Drug use, Drug dependence, Utilization, Hospitalization, Primary care, Chronic disease management, Care management, Comorbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1) CDM
Arm Type
Active Comparator
Arm Description
Chronic Disease Management
Arm Title
2) Standard care
Arm Type
Active Comparator
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Management for substance abuse
Intervention Description
Referral to primary medical care & longitudinal, multidisciplinary care for persons with substance dependence.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Referral to primary medical care for persons with substance dependence.
Primary Outcome Measure Information:
Title
Alcohol and drug use
Time Frame
3, 6, and 12 months after baseline
Title
Alcohol and drug-related problems
Time Frame
3, 6, and 12 months after baseline
Title
Nights Hospitalized
Time Frame
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Title
Emergency department visits
Time Frame
3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Secondary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
3, 6, and 12 months after baseline
Title
Readiness to change
Time Frame
3, 6, and 12 months after baseline
Title
Medical comorbidity
Time Frame
3, 6, and 12 months after baseline
Title
Psychiatric comorbidity
Time Frame
3, 6, and 12 months after baseline
Title
HIV risk behaviors
Time Frame
3, 6, and 12 months after baseline
Title
Treatment utilization and costs
Time Frame
3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Saitz, MD, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center / Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25524751
Citation
Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.
Results Reference
derived
PubMed Identifier
25219686
Citation
Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.
Results Reference
derived
PubMed Identifier
24045740
Citation
Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.
Results Reference
derived
PubMed Identifier
23276300
Citation
D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.
Results Reference
derived

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Addiction Health Evaluation And Disease Management (AHEAD) Study

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