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
Randomised controlled trial for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats in General Practice in Italy: INFANT 2
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/17903266/ (added 04/01/2021)