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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01604096
Acronym
LOCAAL
Enrollment
Unknown
Registered
2012-05-23
Start date
2011-11-30
Completion date
2012-03-31
Last updated
2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infections

Keywords

Information, campaign, antibiotics, bacterial resistance, primary care

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.

Interventions

OTHERMultifaceted 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

Sponsors

Local Health Authority, Parma
CollaboratorUNKNOWN
Local Health Authority, Modena
CollaboratorUNKNOWN
Change Institute, Turin
CollaboratorUNKNOWN
Regional Health and Social Care Agency, Italy
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prescribing rate of antibioticsup to 03/12Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice

Secondary

MeasureTime frameDescription
Antibiotic prescribing trendsup to 04/13Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
Antibiotic expenditureup to 03/12Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
Knowledge/attitudes of the general populationup to 02/12Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026