Clinical trial NCT00278447: Addiction Health Evaluation And Disease Management (AHEAD) Study
Official title: Linkage of Alcohol Abusers to Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-01-18
Enrollment: 569
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alcohol and drug use
timeFrame: 3, 6, and 12 months after baseline
measure: Alcohol and drug-related problems
timeFrame: 3, 6, and 12 months after baseline
measure: Nights Hospitalized
timeFrame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
measure: Emergency department visits
timeFrame: 3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 3, 6, and 12 months after baseline
measure: Readiness to change
timeFrame: 3, 6, and 12 months after baseline
measure: Medical comorbidity
timeFrame: 3, 6, and 12 months after baseline
measure: Psychiatric comorbidity
timeFrame: 3, 6, and 12 months after baseline
measure: HIV risk behaviors
timeFrame: 3, 6, and 12 months after baseline
measure: Treatment utilization and costs
timeFrame: 3, 6, and 12 months after baseline, and up to 2 years after the last subject is enrolled
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center / Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Richard Saitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.