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Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy.

Magrini N, Formoso G, Marata AM, Capelli O, Maestri E, Voci C, Nonino F, Brunetti M, Paltrinieri B, Maltoni S, Magnano L, Bonacini MI, Daya L, Viani N - BMC Health Serv Res (2007)

Bottom Line: 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.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.ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for the Evaluation of the Effectiveness of Health Care, Azienda USL; Viale Muratori 201; 43100 Modena, Italy. n.magrini@ausl.mo.it

ABSTRACT

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/design: 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.

Discussion: 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.

Trial registration: ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).

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Design of the single doctor study (Sardinia): effectiveness of outreach visits and of two different formats.
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Figure 2: Design of the single doctor study (Sardinia): effectiveness of outreach visits and of two different formats.

Mentions: A three-arm RCT is planned: single GPs will be randomised so that they may receive: an outreach visit from a trained pharmacist, supported by information material in a 'traditional' format as background material; the same kind of visit supported by an 'enriched' format (the type of bulletin used in the cluster study) [17]; or no visit at all (Fig. 2). Both the effectiveness of the outreach visit and of the information format will be evaluated (see outcomes).


Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy.

Magrini N, Formoso G, Marata AM, Capelli O, Maestri E, Voci C, Nonino F, Brunetti M, Paltrinieri B, Maltoni S, Magnano L, Bonacini MI, Daya L, Viani N - BMC Health Serv Res (2007)

Design of the single doctor study (Sardinia): effectiveness of outreach visits and of two different formats.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2100051&req=5

Figure 2: Design of the single doctor study (Sardinia): effectiveness of outreach visits and of two different formats.
Mentions: A three-arm RCT is planned: single GPs will be randomised so that they may receive: an outreach visit from a trained pharmacist, supported by information material in a 'traditional' format as background material; the same kind of visit supported by an 'enriched' format (the type of bulletin used in the cluster study) [17]; or no visit at all (Fig. 2). Both the effectiveness of the outreach visit and of the information format will be evaluated (see outcomes).

Bottom Line: 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.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.ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for the Evaluation of the Effectiveness of Health Care, Azienda USL; Viale Muratori 201; 43100 Modena, Italy. n.magrini@ausl.mo.it

ABSTRACT

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/design: 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.

Discussion: 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.

Trial registration: ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).

Show MeSH