Towards rational prescribing of antibiotics for acute rhinosinusitis: evaluation of the impact and costs of implementation strategies based on a multidisciplinary evidence-based guideline

ISRCTN	ISRCTN57375471
DOI	https://doi.org/10.1186/ISRCTN57375471
Protocol serial number	F6/12 - AV - F 681
Sponsor	Fund for Scientific Research, Flanders (Belgium)
Funder	Federal Belgian Ministry of Health and Fund for Scientific Research Flanders, Dossier nr. G.0617.05

Submission date: 18/03/2005
Registration date: 25/07/2005
Last edited: 15/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marc De Meyere
Scientific

De Pintelaan 185 1K3
Ghent
B-9000
Belgium

Email	marc.demeyere@ugent.be

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Antibiotic prescription rate, cost-effectiveness.
Key secondary outcome measure(s)	Choice of antibiotic, use of personalized non-drug prescriptions, clinical course of rhinosinusitis as reported in patient diaries.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	540
Key inclusion criteria	Local peer review groups of general practitioners in Flanders, Belgium (approximately 10-20 GPs per group) are invited to participate.
Key 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.
Date of first enrolment	01/07/2004
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Belgium

Study participating centre

De Pintelaan 185 1K3

Ghent
B-9000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/06/2007		Yes	No