Condition category
Respiratory
Date applied
18/03/2005
Date assigned
25/07/2005
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marc De Meyere

ORCID ID

Contact details

De Pintelaan 185 1K3
Ghent
B-9000
Belgium
marc.demeyere@ugent.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

F6/12 - AV - F 681

Study information

Scientific title

Acronym

Study hypothesis

In Belgium consumption of antibiotics is among the highest in Europe. As a result antimicrobial resistance rates are alarming. Recently a number of evidence-based guidelines on rational use of antibiotics have been produced and disseminated by the scientific organisations in collaboration with the Belgian Co-ordinating Committee for Antibiotic Policy. International research has shown that merely distributing guidelines to professionals in the field does not lead to behaviour change. In Belgium several strategies for implementation of good clinical practice, i.e. local peer review groups and academic detailing, have been initiated. However, the (local) effectiveness and cost-effectiveness of these strategies has not been evaluated. This project will investigate the impact of each of the strategies separately and the combination of both strategies in general practice, following the publication of a guideline on the management of acute rhinosinusitis. This guideline aims at rationalizing (i.e. reducing) the prescription rate for this condition in primary care.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Implementation of a practice guideline for acute rhinosinusitis in general practice

Intervention

Cluster randomised factorial trial with 4 study arms.
Interventions: academic detailing visits to individual GPs and/or group sessions of GPs on the key messages of the guideline.
Control: no specific intervention

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Antibiotic prescription rate, cost-effectiveness.

Secondary outcome measures

Choice of antibiotic, use of personalized non-drug prescriptions, clinical course of rhinosinusitis as reported in patient diaries.

Overall trial start date

01/07/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Local peer review groups of general practitioners in Flanders, Belgium (approximately 10-20 GPs per group) are invited to participate.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

135 patient registrations are aimed for in each study arm

Participant exclusion criteria

Groups that have participated in the field testing of the guideline, groups that have been visited by academic detailers more than once in the past, groups located at >1 hour drive from the study centres.

Recruitment start date

01/07/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Belgium

Trial participating centre

De Pintelaan 185 1K3
Ghent
B-9000
Belgium

Sponsor information

Organisation

Fund for Scientific Research, Flanders (Belgium)

Sponsor details

Egmontstraat 5
Brussels
B-1000
Belgium

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Federal Belgian Ministry of Health and Fund for Scientific Research Flanders, Dossier nr. G.0617.05

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/17545346

Publication citations

  1. Results

    van Driel ML, Coenen S, Dirven K, Lobbestael J, Janssens I, Van Royen P, Haaijer-Ruskamp FM, De Meyere M, De Maeseneer J, Christiaens T, What is the role of quality circles in strategies to optimise antibiotic prescribing? A pragmatic cluster-randomised controlled trial in primary care., Qual Saf Health Care, 2007, 16, 3, 197-202, doi: 10.1136/qshc.2006.018663.

Additional files

Editorial Notes