ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems
Primary Purpose
Alcohol Dependence, Alcohol Consumption
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention (adaptation of motivational interviewing)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Alcohol abuse, Alcohol dependence, Utilization, Alcohol consumption, Unhealthy alcohol use, Hospitalization, Screening, Brief Intervention, Motivational Interviewing, Randomized trial, Effectiveness, Unhealthy alcohol use (Risky alcohol consumption amounts, problem alcohol use, hazardous alcohol use, alcohol abuse and alcohol dependence)
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Fluent in English or Spanish Consume risky amounts of alcohol 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)
Sites / Locations
- Boston Medical Center
Outcomes
Primary Outcome Measures
Linkage to alcohol assistance
Change in drinks per day
Secondary Outcome Measures
Change in the number of times a subject exceeded per occasion limits
Abstinence (dichotomous)
Change in drinks per day
Drinking risky amounts (dichotomous)
Binge drinking (dichotomous)
Hospitalization
Emergency Department visits
Health related quality of life
Readiness to change alcohol use
Full Information
NCT ID
NCT00183105
First Posted
September 9, 2005
Last Updated
May 5, 2010
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Boston University
1. Study Identification
Unique Protocol Identification Number
NCT00183105
Brief Title
ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems
Official Title
Hospital-based Brief Intervention for Alcohol Problems
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Boston University
4. Oversight
5. Study Description
Brief Summary
The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.
Detailed Description
In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.
We conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Consumption
Keywords
Alcohol, Alcohol abuse, Alcohol dependence, Utilization, Alcohol consumption, Unhealthy alcohol use, Hospitalization, Screening, Brief Intervention, Motivational Interviewing, Randomized trial, Effectiveness, Unhealthy alcohol use (Risky alcohol consumption amounts, problem alcohol use, hazardous alcohol use, alcohol abuse and alcohol dependence)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention (adaptation of motivational interviewing)
Primary Outcome Measure Information:
Title
Linkage to alcohol assistance
Title
Change in drinks per day
Secondary Outcome Measure Information:
Title
Change in the number of times a subject exceeded per occasion limits
Title
Abstinence (dichotomous)
Title
Change in drinks per day
Title
Drinking risky amounts (dichotomous)
Title
Binge drinking (dichotomous)
Title
Hospitalization
Title
Emergency Department visits
Title
Health related quality of life
Title
Readiness to change alcohol use
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
Consume risky amounts of alcohol
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Saitz, M.D., M.P.H.
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15908848
Citation
Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. doi: 10.1097/01.mlr.0000163644.97251.14.
Results Reference
result
PubMed Identifier
17283347
Citation
Saitz R, Palfai TP, Cheng DM, Horton NJ, Freedner N, Dukes K, Kraemer KL, Roberts MS, Guerriero RT, Samet JH. Brief intervention for medical inpatients with unhealthy alcohol use: a randomized, controlled trial. Ann Intern Med. 2007 Feb 6;146(3):167-76. doi: 10.7326/0003-4819-146-3-200702060-00005.
Results Reference
derived
Learn more about this trial
ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems
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