Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy (LOCAAL)

Regional Health and Social Care Agency, Italy

Status and phase: Completed; Phase 2

Conditions: Upper Respiratory Tract Infections

Treatments: Other: Multifaceted information campaign

Study type: Interventional

Funder types: Other

Identifiers

NCT01604096

FARM8FKC3H

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• the campaign has been targeted at the general population in the intervention areas

Trial design

0 participants in 2 patient groups

Intervention areas

Experimental group

Description:

Provinces of Modena and Parma (about 1.100.000 inhabitants - campaign targeted to the general population), in Northern Italy (Emilia-Romagna Region)

Treatment:

Other: Multifaceted information campaign

Control

No Intervention group

Description:

All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented)