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

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ClinicalTrials.gov Identifier: NCT00314067
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : October 18, 2013
Sponsor:
Information provided by:
University Hospital Freiburg

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date October 18, 2013
Study Start Date  ICMJE July 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
  • Acceptance of the CQM-system: Number of actively participating practices
  • Adherence to the system: relative numbers of screened, documented and followed-up patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00314067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
Quality of care provided: Patients that are adequately treated and followed-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Case Management to Improve the Outpatient Care of Alcohol-related Disorders
Official Title  ICMJE Comprehensive Quality Management in Out-patient Care for Alcohol-related Disorders (AQAH). Transfer and Dissemination Into Routine Practice
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Alcohol-related Disorders
Intervention  ICMJE
  • Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care
  • Procedure: Physician training
  • Procedure: Practice team training
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care
    • Procedure: Physician training
  • Experimental: 2
    Interventions:
    • Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care
    • Procedure: Physician training
    • Procedure: Practice team training
  • Active Comparator: 3
    Intervention: Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2008)
112
Original Enrollment  ICMJE
 (submitted: April 10, 2006)
90
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • General practitioner
  • Possibility to use broad-band internet

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314067
Other Study ID Numbers  ICMJE BMBF-01EB0412
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Freiburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital Freiburg
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP