search
Back to results

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
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 64 Years (Adult)All Sexes

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

    First Posted
    January 17, 2007
    Last Updated
    January 17, 2007
    Sponsor
    University Medicine Greifswald
    Collaborators
    German Federal Ministry of Education and Research
    search

    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

    Learn more about this trial

    Brief Alcohol Intervention in General Hospitals

    We'll reach out to this number within 24 hrs