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

Upper Respiratory Tract Infections Clinical Trial

— LOCAAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604096
• Other study ID #: FARM8FKC3H
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2012
• Last updated: May 22, 2012
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Regional Health and Social Care Agency, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Italy	Local Health Authority of Modena	Modena
Italy	Local Health Authority of Parma	Parma

Sponsors (4)

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

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescribing rate of antibiotics	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	No
Secondary	Antibiotic prescribing trends	Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)	up to 04/13	No
Secondary	Antibiotic expenditure	Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)	up to 03/12	No
Secondary	Knowledge/attitudes of the general population	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	No

External Links

•   Campaign home page
•   Published protocol