Clinical trial NCT01604096: Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy
Official title: Doctors and Local Media: a Synergy for Public Health Information? A Controlled Trial to Evaluate the Effects of a Multifaceted Campaign on Antibiotic Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Respiratory Tract Infections
Keywords: Information
campaign
antibiotics
bacterial resistance
primary care
Lead sponsor: Regional Health and Social Care Agency, Italy
Sponsor class: OTHER_GOV
Collaborators: name: Local Health Authority, Parma
name: Local Health Authority, Modena
name: Change Institute, Turin
First posted: 2012-05-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Prescribing rate of antibiotics
timeFrame: up to 03/12
Secondary outcomes:
measure: Antibiotic prescribing trends
timeFrame: up to 04/13
measure: Antibiotic expenditure
timeFrame: up to 03/12
measure: Knowledge/attitudes of the general population
timeFrame: up to 02/12
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Local Health Authority of Modena
city: Parma
country: Italy
facility: Local Health Authority of Parma
Study officials:
affiliation: Regional Health and Social Care Agency, Emilia Romagna Region (Italy)
name: Giulio Formoso, MPH, MPharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.