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

October 17, 2013 updated by: University Hospital Freiburg

Comprehensive Quality Management in Out-patient Care for Alcohol-related Disorders (AQAH). Transfer and Dissemination Into Routine Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, 79104
        • Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy
      • Tübingen, Germany, 72076
        • University Hospital for Psychiatry and Psychotherapy, Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General practitioner
  • Possibility to use broad-band internet

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Quality of care provided: Patients that are adequately treated and followed-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMBF-01EB0412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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