Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy.
BACKGROUND
Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy.


METHODS
Two RCTs are planned:1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic).2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material.


CONCLUSIONS
The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve - in terms of independent information - in a National Health System, with special reference to Italy.


BACKGROUND
ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).
Magrini
Nicola
N
Centre for the Evaluation of the Effectiveness of Health Care, Azienda USL; Viale Muratori 201; 43100 Modena, Italy. n.magrini@ausl.mo.it
Formoso
Giulio
G
Marata
Anna Maria
AM
Capelli
Oreste
O
Maestri
Emilio
E
Voci
Claudio
C
Nonino
Francesco
F
Brunetti
Massimo
M
Paltrinieri
Barbara
B
Maltoni
Susanna
S
Magnano
Lucia
L
Bonacini
Maria Isabella
MI
Daya
Lisa
L
Viani
Nilla
N
D002983:Clinical Competence; D002985:Clinical Protocols; D004059:Diffusion of Innovation; D011307:Drug Prescriptions / Q000592:standards; D017723:Drug Utilization Review / Q000379:methods*; D019317:Evidence-Based Medicine; D005194:Family Practice / Q000193:education / Q000592:standards*; D006126:Group Processes; D006801:Humans; D033181:Information Dissemination / Q000379:methods; D007558:Italy; D010595:Pharmacists; D011320:Primary Health Care / Q000592:standards; D024382:Professional Role; D012107:Research Design