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

Phase 2

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Other: Multifaceted information campaign

• Registration Number: NCT01604096
• Lead Sponsor: Regional Health and Social Care Agency, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-22
• Last Update Submitted: 2012-05-22
• Study First Posted: 2012-05-23
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prescribing rate of antibiotics	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

Secondary Outcome Measures

Name	Time	Method
Antibiotic prescribing trends	up to 04/13	Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
Antibiotic expenditure	up to 03/12	Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
Knowledge/attitudes of the general population	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.

Trial Locations

Locations (2)

Local Health Authority of Parma; 🇮🇹 Parma, Italy

Local Health Authority of Modena; 🇮🇹 Modena, Italy