Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy (LOCAAL)
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|ClinicalTrials.gov Identifier: NCT01604096|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use.
Information has been provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists received specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians have been trained in patient counselling strategies.
The information campaign has been implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample.
This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Tract Infections||Other: Multifaceted information campaign||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Doctors and Local Media: a Synergy for Public Health Information? A Controlled Trial to Evaluate the Effects of a Multifaceted Campaign on Antibiotic Prescribing|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: Intervention areas
Provinces of Modena and Parma (about 1.100.000 inhabitants - campaign targeted to the general population), in Northern Italy (Emilia-Romagna Region)
Other: Multifaceted information campaign
Following is the description of the multifaceted intervention:
No Intervention: Control
All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented)
- Prescribing rate of antibiotics [ Time Frame: up to 03/12 ]Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice
- Antibiotic prescribing trends [ Time Frame: up to 04/13 ]Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
- Antibiotic expenditure [ Time Frame: up to 03/12 ]Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
- Knowledge/attitudes of the general population [ Time Frame: up to 02/12 ]Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604096
|Local Health Authority of Modena|
|Modena, Italy, 41100|
|Local Health Authority of Parma|
|Parma, Italy, 43100|
|Principal Investigator:||Giulio Formoso, MPH, MPharm||Regional Health and Social Care Agency, Emilia Romagna Region (Italy)|