MedDataX Logo

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

NCT ID: NCT00314067

Last Updated: 2013-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol-related Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Quality of Health Care Primary Health Care Education E-Learning Alcohol-related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Physician training

Intervention Type PROCEDURE

2

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Physician training

Intervention Type PROCEDURE

Practice team training

Intervention Type PROCEDURE

3

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Physician training

Intervention Type PROCEDURE

Practice team training

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* General practitioner
* Possibility to use broad-band internet

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Freiburg

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Härter, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy

Michael Berner, Dr.

Role: PRINCIPAL_INVESTIGATOR

Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy

Daniela Ruf, Dipl. Psych.

Role: STUDY_CHAIR

Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy

Götz Mundle, PD Dr.

Role: STUDY_CHAIR

Oberbergklinik, Hornberg and University Hospital for Psychiatry and Psychotherapy, Tübingen

Monika Lohmann, Dipl. Psych.

Role: STUDY_CHAIR

University Hospital for Psychiatry and Psychotherapy, Tübingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy

Freiburg im Breisgau, , Germany

Site Status

University Hospital for Psychiatry and Psychotherapy, Tübingen

Tübingen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Harter 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.

Reference Type BACKGROUND
PMID: 14710670 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Harter 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.

Reference Type BACKGROUND
PMID: 14710664 (View on PubMed)

Berner MM, Habbig S, Harter 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. doi: 10.1055/s-2004-830097. German.

Reference Type BACKGROUND
PMID: 15580534 (View on PubMed)

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

Reference Type BACKGROUND

Berner MM, Zeidler C, Kriston L, Mundle G, Lorenz G, Harter M. [Diagnostic and treatment approaches to alcohol-related disorders]. Fortschr Neurol Psychiatr. 2006 Mar;74(3):157-64. doi: 10.1055/s-2005-870949. German.

Reference Type BACKGROUND
PMID: 16528639 (View on PubMed)

Berner MM, Bentele M, Kriston L, Manz C, Clement HW, Harter 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. doi: 10.1111/j.1530-0277.2006.00163.x.

Reference Type BACKGROUND
PMID: 16899040 (View on PubMed)

Ruf D, Berner M, Kriston L, Lohmann M, Mundle G, Lorenz G, Niebling W, Harter M. Cluster-randomized controlled trial of dissemination strategies of an online quality improvement programme for alcohol-related disorders. Alcohol Alcohol. 2010 Jan-Feb;45(1):70-8. doi: 10.1093/alcalc/agp079. Epub 2009 Nov 4.

Reference Type DERIVED
PMID: 19889887 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMBF-01EB0412

Identifier Type: -

Identifier Source: org_study_id