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

ISRCTN ISRCTN28525676
DOI https://doi.org/10.1186/ISRCTN28525676
Secondary identifying numbers FARM59NWKF
Submission date
23/05/2007
Registration date
07/06/2007
Last edited
04/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Giulio Formoso
Scientific

Viale Muratori 201
Modena
41100
Italy

Email g.formoso@ausl.mo.it

Study information

Study designRandomised controlled trial: the unit of randomisation will be single physicians in Sardinia.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeOther
Scientific titleRandomised 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
Study acronymINFANT 2 (INformazione sui FArmaci e Nuove Terapie)
Study objectivesInformation 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(s)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.
Health condition(s) or problem(s) studiedInformation to physicians
InterventionThree 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 typeOther
Primary outcome measureDifference (%) 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 measures1. 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 study start date15/03/2007
Completion date15/02/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants900 GPs
Key inclusion criteriaAll 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.
Key exclusion criteriaNo exclusion criteria.
Date of first enrolment15/03/2007
Date of final enrolment15/02/2008

Locations

Countries of recruitment

  • Italy

Study participating centre

Viale Muratori 201
Modena
41100
Italy

Sponsor information

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

Via della Sierra Nevada, 60
ROMA
144
Italy

Website http://www.agenziafarmaco.it/
ROR logo "ROR" https://ror.org/01ttmqc18

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 28/09/2007 04/01/2021 Yes No

Editorial Notes

04/01/2021: Publication reference added.