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

NCT01604096 | Completed Phase 2

• 1 other identifier: FARM8FKC3H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Respiratory Tract Infections

Keywords

Information; campaign; antibiotics; bacterial resistance; primary care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Antibiotic prescribing trends

  up to 04/13

• Antibiotic expenditure

  up to 03/12

• Knowledge/attitudes of the general population

  up to 02/12

Study Arms (2)

Intervention areas

EXPERIMENTAL

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

Control

NO INTERVENTION

All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented)

Interventions

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

Intervention areas

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Regional Health and Social Care Agency, Italy: lead
• Local Health Authority, Parma: collaborator
• Local Health Authority, Modena: collaborator
• Change Institute, Turin: collaborator

Study Sites (2)

Local Health Authority of Modena

Modena, 41100, Italy

Location

Local Health Authority of Parma

Parma, 43100, Italy

Location

Related Publications (2)

• 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.

  PMID: 22011332 BACKGROUND

• 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.

  PMID: 24030722 DERIVED

Related Links

• Published protocol
• Campaign home page

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Giulio Formoso, MPH, MPharm

  Regional Health and Social Care Agency, Emilia Romagna Region (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 23, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

IT (2)