A Phase 2 interventional study of Multifaceted information campaign in Upper Respiratory Tract Infections, sponsored by Regional Health and Social Care Agency, Italy. Completed at 2 sites in Italy. Per ClinicalTrials.gov, last updated 2012-05-23.
Sponsored by Regional Health and Social Care Agency, Italy · Phase 2 and Interventional
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
Browse Respiratory Tract Infections studies →This is the only study on the registry with Regional Health and Social Care Agency, Italy as lead sponsor.
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Inclusion Criteria:
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
All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented)
Following is the description of the multifaceted intervention: * brochures targeted at the general population and available in general practices, pharmacies, local health services and on the web (also translated in eight languages) * posters (same distribution as brochures) * short videos transmitted in local TVs, websites of Local Health Authorities and in video terminals in some pharmacies * radio-spots transmitted in local radio stations * advertisements in local newspapers * banners on websites of local newspapers * newsletter on antibiotic resistance in Emilia- Romagna, available to physicians and pharmacists * training courses in counselling strategies, directed to a subgroup of GPs and paediatricians
Prescribing rate of antibiotics
Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice
Time frame: up to 03/12
Antibiotic prescribing trends
Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
Time frame: up to 04/13
Antibiotic expenditure
Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
Time frame: up to 03/12
Knowledge/attitudes of the general population
Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.
Time frame: up to 02/12
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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