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

ISRCTN	ISRCTN05866587
DOI	https://doi.org/10.1186/ISRCTN05866587
Protocol serial number	FARM59NWKF
Sponsor	Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA])
Funder	Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) - operates within the Italian National Health Service

Submission date: 21/05/2007
Registration date: 07/06/2007
Last edited: 29/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicola Magrini
Scientific

Viale Muratori 201
Modena
41100
Italy

Email	n.magrini@ausl.mo.it

Study information

Primary study design	Interventional
Study design	Randomised controlled trial: the unit of randomisation will be PCGs in Emilia-Romagna and Friuli Venezia Giulia
Secondary study design	Randomised controlled trial
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
Study acronym	INFANT 1 (INformazione sui FArmaci e Nuove Terapie)
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	23/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	150
Key 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.
Key exclusion criteria	PCGs with more than 20 physicians (not a strict criterion, but justification will be needed).
Date of first enrolment	15/03/2007
Date of final enrolment	23/12/2007

Locations

Countries of recruitment

Italy

Study participating centre

Viale Muratori 201

Modena
41100
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/10/2014		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes