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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00314067
First received: April 10, 2006
Last updated: October 17, 2013
Last verified: June 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General practitioner
  • Possibility to use broad-band internet

Exclusion Criteria:

  • none
  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: 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:
Additional 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
Study First Received: April 10, 2006
Last Updated: October 17, 2013
Health Authority: Germany: Federal Ministry of Education and Research

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

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014