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Evaluation of Case Management to Improve the Outpatient Care of Alcohol-related Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314067
First Posted: April 12, 2006
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Freiburg
  Purpose
The purpose of this study is to disseminate and transfer the comprehensive quality management interventions (CQM) for alcohol-related disorders in primary care developed during the first funding phase into routine care. The two steps are (1) to optimize the CQM approach and (2) to investigate the dissemination and transfer into routine care in a randomized controlled trial.

Condition Intervention
Alcohol-related Disorders Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care Procedure: Physician training Procedure: Practice team training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comprehensive Quality Management in Out-patient Care for Alcohol-related Disorders (AQAH). Transfer and Dissemination Into Routine Practice

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Acceptance of the CQM-system: Number of actively participating practices
  • Adherence to the system: relative numbers of screened, documented and followed-up patients

Secondary Outcome Measures:
  • Quality of care provided: Patients that are adequately treated and followed-up

Enrollment: 112
Study Start Date: July 2006
Study Completion Date: August 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care Procedure: Physician training
Experimental: 2 Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care Procedure: Physician training Procedure: Practice team training
Active Comparator: 3 Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care

Detailed Description:

In the first funding phase the project AQAH ("Ambulantes Qualitätsmanagement alkoholbezogener Störungen in der hausärztlichen Praxis"-"comprehensive quality management for alcohol-related disorders in primary care") systematically investigated three issues: (1) the outpatient care system and evidence-base for screening, diagnosis and treatment was examined; it developed (2) a comprehensive quality management system (CQM) consisting of documentation material, a pathway of care and evidence-based practice guidelines; (3) the effects of the CQM on the detection and treatment of alcohol-related disorders were investigated in a randomized controlled pre-post design and the results show positive effects of the CQM. In the second funding phase (a 3 year bi-center project) the purpose is now to disseminate and transfer the CQM into routine care. The two steps are (1) to optimize the CQM approach and (2) to investigate the dissemination and transfer into routine care in a randomized trial. (1) The paper-based AQAH-practice guidelines are transformed into an interactive electronic version with online patient documentation and evaluation, decision support measures as well as links to specialists and an e-learning tool. (2) After pilot testing in the AQAH-study-networks, an active transfer to the greater regions of Südbaden and Südwürttemberg will be performed in a parallel group cluster randomized controlled trial with GP practices as unit of randomization. Outcome data will be collected concerning the acceptance of the system and the quality of care delivered.

Comparison(s): (1) Use of the interactive electronic version of the CQM for alcohol-related disorders with a special training for general practitioners, compared to (2) use of the CQM with additional education for the whole practice team and organizational re-structuring advice, compared to (3) a control group who uses the CMQ without any special training.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General practitioner
  • Possibility to use broad-band internet

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314067


Locations
Germany
Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy
Freiburg, Germany, 79104
University Hospital for Psychiatry and Psychotherapy, Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Martin Härter, Prof. Dr. Dr. Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy
Principal Investigator: Michael Berner, Dr. Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy
Study Chair: Daniela Ruf, Dipl. Psych. Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy
Study Chair: Götz Mundle, PD Dr. Oberbergklinik, Hornberg and University Hospital for Psychiatry and Psychotherapy, Tübingen
Study Chair: Monika Lohmann, Dipl. Psych. University Hospital for Psychiatry and Psychotherapy, Tübingen
  More Information

Additional Information:
Publications:
Mänz C, Berner M, Lorenz G, Härter M, Bermejo I, Berger M, Buchkremer G, Mundle G. Projekt AQAH: Ambulantes Qualitätsmanagement alkoholbezogener Störungen beim Hausarzt. Suchtmedizin 5(1): 1-8, 2003.
Mänz C, Berner M, Härter M, Lorenz G, Mundle G. Akzeptieren Patienten Screening-Fragebögen für alkoholbezogene Störungen? Nervenarzt 74(2): 261, 2003.
Berner M, Mundle G, Lorenz G, Härter M. Möglichkeiten der Frühintervention bei alkoholbezogenen Störungen in der hausärztlichen Praxis. Suchttherapie 5: 70-75, 2004.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314067     History of Changes
Other Study ID Numbers: BMBF-01EB0412
First Submitted: April 10, 2006
First Posted: April 12, 2006
Last Update Posted: October 18, 2013
Last Verified: June 2008

Keywords provided by University Hospital Freiburg:
Quality of Health Care
Primary Health Care
Education
E-Learning
Alcohol-related Disorders

Additional relevant MeSH terms:
Disease
Alcohol-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs