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Alcohol-related DisordersNCT00314067

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

A study testing Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care, Physician training and Practice team training in people with Alcohol-related Disorders, run by University Hospital Freiburg at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Alcohol-related Disorders
What is being tested?
Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care, Physician training and Practice team training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
2 sitesGermany
Study dates
Jul 2006to Aug 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • General practitioner
  • Possibility to use broad-band internet

Who cannot join

  • none

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Freiburg University Hospital, Dept. of Psychiatry and Psychotherapy

    Freiburg im Breisgau, 79104

  • University Hospital for Psychiatry and Psychotherapy, Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care, Physician training, Practice team training
Keywords
Quality of Health Care, Primary Health Care, Education, E-Learning, Alcohol-related Disorders
Medical subject headings
Alcohol-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary careProcedure or surgery

  • Physician trainingProcedure or surgery

  • Practice team trainingProcedure or surgery

Study groups in NCT00314067
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care; Procedure: Physician training
2ExperimentalNot described
Receives: Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care; Procedure: Physician training; Procedure: Practice team training
3Active comparatorNot described
Receives: Procedure: Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance of the CQM-system: Number of actively participating practices

  2. Adherence to the system: relative numbers of screened, documented and followed-up patients

Secondary outcomes (1)

  1. Quality of care provided: Patients that are adequately treated and followed-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionMay 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00314067
Sponsor's protocol ID
BMBF-01EB0412
Status last verified
Jun 2008
First submitted
10 Apr 2006
Last updated
18 Oct 2013
Results posted
No

Publications

  • 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.

    PubMed 14710670

  • 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.

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

  • 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.

    PubMed 14710664

  • 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.

    PubMed 15580534

  • 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, 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.

    PubMed 16528639

  • 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.

    PubMed 16899040

  • 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.

    PubMed 19889887

Questions about this trial

What is this clinical trial studying?

A study testing Online Comprehensive Quality Management System (CQM) of alcohol-related disorders in primary care, Physician training and Practice team training in people with Alcohol-related Disorders, run by University Hospital Freiburg at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance of the CQM-system: Number of actively participating practices. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00314067, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.

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