Condition category
Not Applicable
Date applied
21/05/2007
Date assigned
07/06/2007
Last edited
29/07/2015
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

Dr Nicola Magrini

ORCID ID

Contact details

Viale Muratori 201
Modena
41100
Italy
-
n.magrini@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 1

Acronym

INFANT 1 (INformazione sui FArmaci e Nuove Terapie)

Study hypothesis

Information meetings with small groups of physicians (Primary Care Groups [PCGs] in Emilia-Romagna and Friuli Venezia Giulia), 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. Most of the LEC have already approved the protocol (Parma, Reggio Emilia, Modena, Bologna, Forlì, ASL n° 2 Isontina, Trieste, ASL n° 5 Bassa Friulana), 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 PCGs in Emilia-Romagna and Friuli Venezia Giulia

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

Both the intervention and control groups will have information meetings led by a pharmacist on one specific topic versus another topic, both supported by a drug bulletin developed ad hoc. The prescription of drug A will be compared in physicians randomised to receiving information on topic A versus those who received information on topic B (i.e., not receiving information on topic A) and vice versa.

The information meetings will last two to three hours.

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. Differences in the main and secondary outcomes in each of the regions involved
5. Differences in the main and secondary outcomes according to the number of assisted population in the related PCG
6. Differences in the main and secondary outcomes according to the terziles of physicians age
7. Adjusted difference in prescribed DDD per 1000 patients/day according to a statistical model, considering as possible covariates:
7.1. Overall prescription in DDD per 1000 patients day at baseline
7.2. Number of physicians in the specific PCGs
7.3. Number of assisted population
7.4. Region (Emilia-Romagna or Friuli Venezia Giulia)
7.5. Geographical location (mountain, hill, plain, urban centre – according to definitions given by the Italian Statistics Institute)
7.6. Age distribution of assisted population (in quartiles)
7.7. % females in the assisted population
7.8. Physician age
7.9. Total physician drug expenditure (excluding drugs under scrutiny)
7.10. % assisted population with polyprescription (greater than or equal to three drugs of different classes)
7.11. Number of new prescriptions (in the last 12 months)
7.12. Month of evaluation
7.13. Participation to the information meetings
7.14. % exact answers to the questionnaire testing knowledge
8. Difference in the variability (expressed as standard deviations) of prescription of drugs under scrutiny within PCGs
9. Difference in knowledge (measured through the number of correct answers to a specific questionnaire)
10. 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

23/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

PCGs are defined as small groups, ranging from about 10 to 20 General Practitioners (GPs) and assisting about 8,000 to 25,000 people in a defined area. A general rule is to include PCGs with less than or equal to 20 physicians.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150 PCGs

Participant exclusion criteria

PCGs with more than 20 physicians (not a strict criterion, but justification will be needed).

Recruitment start date

15/03/2007

Recruitment end date

23/12/2007

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
Rome
00144
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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25329386

Publication citations

Additional files

Editorial Notes