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

This study has been completed.
Sponsor:
Collaborators:
Local Health Authority, Parma
Local Health Authority, Modena
Change Institute, Turin
Information provided by (Responsible Party):
Regional Health and Social Care Agency, Italy
ClinicalTrials.gov Identifier:
NCT01604096
First received: May 17, 2012
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Upper Respiratory Tract Infections
Other: Multifaceted information campaign
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Regional Health and Social Care Agency, Italy:

Primary Outcome Measures:
  • Prescribing rate of antibiotics [ Time Frame: up to 03/12 ] [ Designated as safety issue: No ]
    Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice


Secondary Outcome Measures:
  • Antibiotic prescribing trends [ Time Frame: up to 04/13 ] [ Designated as safety issue: No ]
    Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)

  • Antibiotic expenditure [ Time Frame: up to 03/12 ] [ Designated as safety issue: No ]
    Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)

  • Knowledge/attitudes of the general population [ Time Frame: up to 02/12 ] [ Designated as safety issue: No ]
    Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.


Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • the campaign has been targeted at the general population in the intervention areas
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604096

Locations
Italy
Local Health Authority of Modena
Modena, Italy, 41100
Local Health Authority of Parma
Parma, Italy, 43100
Sponsors and Collaborators
Regional Health and Social Care Agency, Italy
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)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regional Health and Social Care Agency, Italy
ClinicalTrials.gov Identifier: NCT01604096     History of Changes
Other Study ID Numbers: FARM8FKC3H
Study First Received: May 17, 2012
Last Updated: May 22, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Regional Health and Social Care Agency, Italy:
Information
campaign
antibiotics
bacterial resistance
primary care

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014