Brief Alcohol Intervention in General Hospitals

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00423904
First received: January 17, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Alcohol Abuse
At-Risk-Drinking
Heavy Episodic Drinking
Behavioral: Brief intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Implementing Early Intervention for Alcohol Use Disorders in the General Hospital

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Reduced alcohol consumption
  • Increased alcohol-specific help-seeking

Secondary Outcome Measures:
  • Increased readiness to change drinking behaviour
  • Increased well-being

Estimated Enrollment: 1035
Study Start Date: October 2001
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423904

Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Jennis Freyer-Adam, Dr University Medicine Greifswald
Principal Investigator: Ulfert Hapke, Dr University of Applied Sciences Muenster
Study Director: Ulrich John, Prof Dr University Medicine Greifswald
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00423904     History of Changes
Other Study ID Numbers: E1_P1, 01EB0120, 01EB0420
Study First Received: January 17, 2007
Last Updated: January 17, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
Early intervention
Brief intervention
alcohol
general hospital

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 20, 2014