Condition category
Not Applicable
Date applied
23/05/2007
Date assigned
07/06/2007
Last edited
08/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ceveas.it/ceveas/ceveas/spaziofarmaci/farmacistafacilitatore/progetto1/Root.aspx

Contact information

Type

Scientific

Primary contact

Mr Giulio Formoso

ORCID ID

Contact details

Viale Muratori 201
Modena
41100
Italy
g.formoso@ausl.mo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FARM59NWKF

Study information

Scientific title

Acronym

INFANT 2 (INformazione sui FArmaci e Nuove Terapie)

Study hypothesis

Information meetings with single physicians, led by pharmacists and organised by Local Health Authorities within a large scale independent information program involving local General Practitioners (GPs), can be effective in changing physicians’ prescribing behaviour.

Ethics approval

Between November 2006 and March 2007, the protocol was sent to the Local Ethics Committees (LEC) of the Health Authorities involved. Some of the LEC have already approved the protocol (Olbia, Carbonia, Sassari, Nuoro), some specifying that it was unnecessary to analyse it formally since no ethical problems arise in carrying out a randomisation differentiating the kind of information actively discussed during the outreach visits.

Study design

Randomised controlled trial: the unit of randomisation will be single physicians in Sardinia.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Information to physicians

Intervention

Three groups of single physicians will be provided with one of the following:
1. One information meeting led by a pharmacist and supported by a bulletin developed ad hoc
2. One information meeting led by a pharmacist and supported by information already available (e.g., from the Italian translation of Medical Letter, or the Drug and Therapeutics Bulletin [DTB], etc)
3. No intervention

The information meetings will last half to one hour.

The process described above will be repeated a second time with different topics, so that the number of comparisons and indicators is doubled and more qualitative and quantitative data are available.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Difference (%) in NHS prescription of drugs under scrutiny (expressed as Defined Daily Dose [DDD] per thousand inhabitants/day), comparing those who have/ have not received the specific information.

Prescriptions within six months after the intervention will be evaluated.

Secondary outcome measures

1. Difference in the % of patients who were prescribed the specific drug(s)
2. Difference in the % of patients who were prescribed the specific drug(s) for the first time (in the previous 12 months)
3. Difference in expenditure for the specific drug (per 1000 patients/day)
4. Difference in NHS prescription of drugs under scrutiny (expressed as DDD per thousand inhabitants/day), comparing those who have received the “traditional” versus “enriched” format, and any information versus no information
5. Differences in the main and secondary outcomes according to the number of assisted population in the related PCG
6. Adjusted difference in prescribed DDD per 1000 patients/day according to a statistical model, considering as possible covariates:
6.1. Overall prescription in DDD per 1000 patients day at baseline
6.2. Number of assisted population
6.3. Geographical location (mountain, hill, plain, urban centre – according to definitions given by the Italian Statistics Institute)
6.4. Age distribution of assisted population (in quartiles)
6.5. % females in the assisted population
6.6. Physician age
6.7. Total physician drug expenditure (excluding drugs under scrutiny)
6.8. % assisted population with polyprescription (greater than or equal to three drugs of different classes)
6.9. Number of new prescriptions (in the last 12 months)
6.10. Month of evaluation
6.11. Participation to the information meetings
6.12. % exact answers to the questionnaire testing knowledge
7. Difference in knowledge (measured through the number of correct answers to a specific questionnaire)
8. Difference in attitudes (measured through the answers to a specific anonymous questionnaire)

Prescriptions within six months after the intervention will be evaluated.

Overall trial start date

15/03/2007

Overall trial end date

15/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All GPs are eligible, provided that their Local Health Authority has an organised system for tracking their prescriptions made within the Italian National Heath Service (NHS) till the 5th Anatomic Therapeutic Chemical (ATC) level, in order to evaluate these prescriptions and to provide doctors with feedback.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

900 GPs

Participant exclusion criteria

No exclusion criteria.

Recruitment start date

15/03/2007

Recruitment end date

15/02/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Viale Muratori 201
Modena
41100
Italy

Sponsor information

Organisation

Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA])

Sponsor details

Via della Sierra Nevada
60
ROMA
144
Italy

Sponsor type

Government

Website

http://www.agenziafarmaco.it/

Funders

Funder type

Government

Funder name

Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) - operates within the Italian National Health Service

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes