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

Alcohol-related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314067
• Other study ID #: BMBF-01EB0412
• Status: Completed
• Phase: N/A
• First received: April 10, 2006
• Last updated: October 17, 2013
• Start date: July 2006
• Est. completion date: August 2007

Study information

• Verified date: June 2008
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• General practitioner

• Possibility to use broad-band internet

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alcohol-related Disorders

Intervention

Procedure:
• Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care

• Physician training

• Practice team training

Locations

Country	Name	City	State
Germany	Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy	Freiburg
Germany	University Hospital for Psychiatry and Psychotherapy, Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Berner M, Mundle G, Lorenz G, Härter M. Möglichkeiten der Frühintervention bei alkoholbezogenen Störungen in der hausärztlichen Praxis. Suchttherapie 5: 70-75, 2004.

Berner MM, Bentele M, Kriston L, Mänz C, Clement HW, Härter M, Mundle G. DOVER and QUVER-new marker combinations to detect and monitor at-risk drinking. Alcohol Clin Exp Res. 2006 Aug;30(8):1372-80. — View Citation

Berner MM, Habbig S, Härter M. [Quality of guidelines for the treatment of alcohol related disorders -- a systematic review and content analysis]. Fortschr Neurol Psychiatr. 2004 Dec;72(12):696-704. German. — View Citation

Berner MM, Zeidler C, Kriston L, Mundle G, Lorenz G, Härter M. [Diagnostic and treatment approaches to alcohol-related disorders]. Fortschr Neurol Psychiatr. 2006 Mar;74(3):157-64. German. — View Citation

Härter M, Bermejo I, Kratz S, Schneider F. [Continuing education and quality management measures for the implementation of clinical practice guidelines]. Z Arztl Fortbild Qualitatssich. 2003 Nov;97 Suppl 4:67-73. German. — View Citation

Härter M, Bermejo I, Schneider F, Gaebel W, Niebling W, Berger M. [Comprehensive ambulatory care quality management for patients with depressive disorders]. Z Arztl Fortbild Qualitatssich. 2003 Nov;97 Suppl 4:9-15. German. — View Citation

Mänz C, Berner M, Härter M, Lorenz G, Mundle G. Akzeptieren Patienten Screening-Fragebögen für alkoholbezogene Störungen? Nervenarzt 74(2): 261, 2003.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of the CQM-system: Number of actively participating practices
Primary	Adherence to the system: relative numbers of screened, documented and followed-up patients
Secondary	Quality of care provided: Patients that are adequately treated and followed-up

External Links

•   homepage of the Research Group of Clinical Epidemiology and Health Care Research