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

NCT ID: NCT01604096

Last Updated: 2012-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Upper Respiratory Tract Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Intervention areas

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

Group Type EXPERIMENTAL

Multifaceted information campaign

Intervention Type OTHER

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* the campaign has been targeted at the general population in the intervention areas
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Local Health Authority, Parma

UNKNOWN

Sponsor Role collaborator

Local Health Authority, Modena

UNKNOWN

Sponsor Role collaborator

Change Institute, Turin

UNKNOWN

Sponsor Role collaborator

Regional Health and Social Care Agency, Italy

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giulio Formoso, MPH, MPharm

Role: PRINCIPAL_INVESTIGATOR

Regional Health and Social Care Agency, Emilia Romagna Region (Italy)

Locations

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Local Health Authority of Modena

Modena, , Italy

Site Status

Local Health Authority of Parma

Parma, , Italy

Site Status

Countries

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Italy

References

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LOcal Campaign on Antibiotics ALliance (LOCAAL) study group. Doctors and local media: a synergy for public health information?: a controlled trial to evaluate the effects of a multifaceted campaign on antibiotic prescribing (protocol). BMC Public Health. 2011 Oct 19;11:816. doi: 10.1186/1471-2458-11-816.

Reference Type BACKGROUND
PMID: 22011332 (View on PubMed)

Formoso G, Paltrinieri B, Marata AM, Gagliotti C, Pan A, Moro ML, Capelli O, Magrini N; LOCAAL Study Group. Feasibility and effectiveness of a low cost campaign on antibiotic prescribing in Italy: community level, controlled, non-randomised trial. BMJ. 2013 Sep 12;347:f5391. doi: 10.1136/bmj.f5391.

Reference Type DERIVED
PMID: 24030722 (View on PubMed)

Related Links

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Other Identifiers

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FARM8FKC3H

Identifier Type: -

Identifier Source: org_study_id

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