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

May 22, 2012 updated by: Regional Health and Social Care Agency, Italy

Doctors and Local Media: a Synergy for Public Health Information? A Controlled Trial to Evaluate the Effects of a Multifaceted Campaign on Antibiotic Prescribing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • Local Health Authority of Modena
      • Parma, Italy, 43100
        • Local Health Authority of Parma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  • 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
No Intervention: Control
All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 03/12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic prescribing trends
Time Frame: up to 04/13
Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
up to 04/13
Antibiotic expenditure
Time Frame: up to 03/12
Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
up to 03/12
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.
up to 02/12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Health and Social Care Agency, Italy

Collaborators

Local Health Authority, Parma
Local Health Authority, Modena
Change Institute, Turin

Investigators

  • Principal Investigator: Giulio Formoso, MPH, MPharm, Regional Health and Social Care Agency, Emilia Romagna Region (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FARM8FKC3H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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