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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01604096
Other study ID # FARM8FKC3H
Secondary ID
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
Accepts healthy volunteers
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


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
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