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Completed

NCT Number: NCT01604096

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Health Authority of Modena, Modena, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Multifaceted information campaign

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Regional Health and Social Care Agency, Italy

Other Gov

Collaborators

  • Change Institute, Turin
  • Local Health Authority, Modena
  • Local Health Authority, Parma

Registry information

Official study 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

Acronym: LOCAAL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 23, 2012
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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