Brief Alcohol Intervention in General Hospitals
Primary Purpose
Alcohol Dependence, Alcohol Abuse, At-Risk-Drinking
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Brief intervention
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Alcohol Dependence focused on measuring Early intervention, Brief intervention, alcohol, general hospital
Eligibility Criteria
Inclusion Criteria:
- Alcohol dependence
- Alcohol abuse
- At-risk drinking
- Heavy episodic drinking
Exclusion Criteria:
- Persons physically and mentally not capable of participating in study
- Persons with a hospital stay of less than 24 hours
Sites / Locations
Outcomes
Primary Outcome Measures
Reduced alcohol consumption
Increased alcohol-specific help-seeking
Secondary Outcome Measures
Increased readiness to change drinking behaviour
Increased well-being
Full Information
NCT ID
NCT00423904
First Posted
January 17, 2007
Last Updated
January 17, 2007
Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00423904
Brief Title
Brief Alcohol Intervention in General Hospitals
Official Title
Implementing Early Intervention for Alcohol Use Disorders in the General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Medicine Greifswald
Collaborators
German Federal Ministry of Education and Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to reveal the most promising procedure for implementing alcohol screening and intervention in general hospitals and to find out, if and to which extent non-specialist health professionals can be qualified to carry out motivational intervention on their own or if there is a need for a specialized counseling services. In a randomized controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to three conditions: (1) Intervention by a liaison service (LC): Counselling based on the Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI, and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be conducted after 12 months and includes abstinent point prevalence rates, drinks per day, help-seeking, stage progress and cost-effectiveness analysis.
Detailed Description
Background: High prevalence rates (10 - 25 %) and a promising setting for proactive intervention strategies make the general hospital a first choice setting for secondary prevention of alcohol-related disorders. Efficient screening instruments have been developed for early detection. With regard to the severity of alcohol problem (e.g. alcohol dependence vs. heavy episodic drinking) and the motivation to change, the target group is very heterogeneous. Although there are counseling strategies that take into account this heterogeneity, there is still a lack of implementation and poor knowledge about different implementation strategies in routine care. Objectives: To evaluate the effectiveness of a proactive secondary preventive intervention based on the TTM and on MI in a representative sample of general hospital patients carried out by a liaison service versus non-specialist physicians trained in counseling techniques by staff of the study. Methods: A sample of 1,479 alcohol at-risk-drinking, alcohol abusing or alcohol dependent patients from four general hospitals detected by screening questionnaires will be assigned to (1) a group counseled by an addiction liaison service, (2) a group counseled by the physicians of the ward, and (3) to an assessment-only condition with treatment as usual. Outcome will be measured one year later and will include abstinence point prevalence rates, stage progress, help seeking, and cost-effectiveness analysis. Expected impact: The project will yield new scientific knowledge on how to implement early intervention for alcohol at-risk-drinking and alcohol use disorders in the general hospital. Results of the study shall be transferred to nationwide practice guideline proposals. The study will contribute to the improvement of the health care system as well as the education of medical students. The study is designed to reveal empirical evidence for proactive TTM-based interventions for individuals suffering from a prevalent substance use disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Abuse, At-Risk-Drinking, Heavy Episodic Drinking
Keywords
Early intervention, Brief intervention, alcohol, general hospital
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
1035 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Primary Outcome Measure Information:
Title
Reduced alcohol consumption
Title
Increased alcohol-specific help-seeking
Secondary Outcome Measure Information:
Title
Increased readiness to change drinking behaviour
Title
Increased well-being
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Eligibility Criteria
Inclusion Criteria:
Alcohol dependence
Alcohol abuse
At-risk drinking
Heavy episodic drinking
Exclusion Criteria:
Persons physically and mentally not capable of participating in study
Persons with a hospital stay of less than 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennis Freyer-Adam, Dr
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulfert Hapke, Dr
Organizational Affiliation
University of Applied Sciences Muenster
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich John, Prof Dr
Organizational Affiliation
University Medicine Greifswald
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15993545
Citation
Freyer J, Bott K, Riedel J, Wedler B, Meyer C, Rumpf HJ, John U, Hapke U. Psychometric properties of the 'Processes of Change' scale for alcohol misuse and its short form (POC-20). Addict Behav. 2006 May;31(5):821-32. doi: 10.1016/j.addbeh.2005.06.007. Epub 2005 Jul 1.
Results Reference
background
PubMed Identifier
16979304
Citation
Freyer J, Coder B, Bischof G, Baumeister SE, Rumpf HJ, John U, Hapke U. Intention to utilize formal help in a sample with alcohol problems: a prospective study. Drug Alcohol Depend. 2007 Mar 16;87(2-3):210-6. doi: 10.1016/j.drugalcdep.2006.08.018. Epub 2006 Sep 18.
Results Reference
background
PubMed Identifier
16868869
Citation
Freyer J, Coder B, Pockrandt C, Hartmann B, Rumpf HJ, John U, Hapke U. [General hospital patients with alcohol problems welcome counselling]. Gesundheitswesen. 2006 Jul;68(7):429-35. doi: 10.1055/s-2006-926908. German.
Results Reference
background
PubMed Identifier
15700519
Citation
Freyer J, Tonigan JS, Keller S, John U, Rumpf HJ, Hapke U. Readiness to change versus readiness to seek help for alcohol problems: the development of the Treatment Readiness Tool (TReaT). J Stud Alcohol. 2004 Nov;65(6):801-9. doi: 10.15288/jsa.2004.65.801.
Results Reference
background
PubMed Identifier
16186144
Citation
Freyer J, Tonigan JS, Keller S, Rumpf HJ, John U, Hapke U. Readiness for change and readiness for help-seeking: a composite assessment of client motivation. Alcohol Alcohol. 2005 Nov-Dec;40(6):540-4. doi: 10.1093/alcalc/agh195. Epub 2005 Sep 26.
Results Reference
background
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Brief Alcohol Intervention in General Hospitals
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