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

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ClinicalTrials.gov Identifier: NCT01604096
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Other: Multifaceted information campaign Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Prescribing rate of antibiotics [ Time Frame: up to 03/12 ]
    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 :
  1. Antibiotic prescribing trends [ Time Frame: up to 04/13 ]
    Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)

  2. Antibiotic expenditure [ Time Frame: up to 03/12 ]
    Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)

  3. Knowledge/attitudes of the general population [ Time Frame: up to 02/12 ]
    Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • the campaign has been targeted at the general population in the intervention areas
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604096


Locations
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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
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Principal Investigator: Giulio Formoso, MPH, MPharm Regional Health and Social Care Agency, Emilia Romagna Region (Italy)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regional Health and Social Care Agency, Italy
ClinicalTrials.gov Identifier: NCT01604096    
Other Study ID Numbers: FARM8FKC3H
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Regional Health and Social Care Agency, Italy:
Information
campaign
antibiotics
bacterial resistance
primary care
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases