Objectives To test the hypothesis that a multifaceted, local public campaign could be feasible and influence antibiotic prescribing for outpatients.Design Community level, controlled, non-randomised trial.Setting Provinces of Modena and Parma in Emilia-Romagna, northern Italy, November 2011 to February 2012.Population 1 150 000 residents of Modena and Parma (intervention group) and 3 250 000 residents in provinces in the same region but where no campaign had been implemented (control group).Interventions Campaign materials (mainly posters, brochures, and advertisements on local media, plus a newsletter on local antibiotic resistance targeted at doctors and pharmacists). General practitioners and paediatricians in the intervention area participated in designing the campaign messages.Main outcomes measures Primary outcome was the average change in prescribing rates of antibiotics for outpatient in five months, measured as defined daily doses per 1000 inhabitants/day, using health districts as the unit of analysis.Results Antibiotic prescribing was reduced in the intervention area compared with control area (−4.3%, 95% confidence interval −7.1% to −1.5%). This result was robust to “sensitivity analysis” modifying the baseline period from two months (main analysis) to one month. A higher decrease was observed for penicillins resistant to β lactamase and a lower decrease for penicillins susceptible to β lactamase, consistent with the content of the newsletter on antibiotic resistance directed at health professionals. The decrease in expenditure on antibiotics was not statistically significant in a district level analysis with a two month baseline period (main analysis), but was statistically significant in sensitivity analyses using either a one month baseline period or a more powered doctor level analysis. Knowledge and attitudes of the target population about the correct use of antibiotics did not differ between the intervention and control areas.Conclusions A local low cost information campaign targeted at citizens, combined with a newsletter on local antibiotic resistance targeted at doctors and pharmacists, was associated with significantly decreased total rates of antibiotic prescribing but did not affect the population’s knowledge and attitudes about antibiotic resistance. Trial registration ClinicalTrials.gov NCT01604096.

IntroductionInformation on benefits and risks of drugs is a key element affecting doctors’ prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours.ObjectivesTesting the short and long-term effectiveness on general practitioners’ prescribing of small groups meetings led by pharmacists.MethodsTwo cluster open randomised controlled trials (RCTs) were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach - TEA, with information materials on osteoporosis or prostatic hyperplasia - and a single drug oriented approach - SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners) were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months) were also evaluated.ResultsIn the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio −8.5%, p = 0.03). Another primary outcome (prescription of risedronate) showed a reduction at 24 and 48 months (−7.6%, p = 0.02; and −9,8%, p = 0.03), but not at six months (−5.1%, p = 0.36). In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine −9.8%, p = 0.02; prescription of prulifloxacin −11.1%, p = 0.04), which persisted or increased over time.InterpretationThese two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially relevant long-term impact on prescribing habits, in particular when focusing on a single drug. National Health systems should invest in independent drug information programs.Trial RegistrationControlled-Trials.com ISRCTN05866587

BackgroundSuboptimal 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/DesignTwo 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.DiscussionThe 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 registrationISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT)

Aim To assess the feasibility and effectiveness of a low-complexity, low-cost model of caregiver education in primary care, targeted to reduce hospitalizations of heart failure patients. Methods A cluster-randomized, controlled, open trial was proposed to general practitioners, who were invited to identify patients with heart failure, exclusively managed at home and continuously attended by a caregiver. Participating general practitioners were then randomized to: usual treatment; caregiver education (educational session for recognizing early symptoms/signs of heart failure, with recording in a diary of a series of patient parameters, including body weight, blood pressure, heart rate). The patients were observed at baseline and during a 12-month follow-up. Results Three hundred and thirteen patients were enrolled (163 in the intervention, 150 in the usual care group), 63% women, mean age 85.3 ± 7.7 years. At the end of the 12-month follow-up, a trend towards a lower incidence of hospitalizations was observed in the intervention group (hazard ratio 0.73; 95% CI 0.53–1.01 P = 0.061). Subgroup analysis showed that for patients with persistent/permanent atrial fibrillation, age less than 90 years or Barthel score equal to or greater than 50 a significant lower hospital admission rate occurred in the intervention group (hazard ratio 0.63; 95% CI 0.39–0.99; P = 0.048, hazard ratio 0.66; 95% CI 0.45–0.97; P = 0.036 and hazard ratio 0.61; 95% CI 0.41–0.89; P = 0.011, respectively). Conclusion Caregivers training for early recognition of symptoms/signs of worsening heart failure may be effective in reducing hospitalizations, although the benefit was evident only in specific patient subgroups (with persistent/permanent atrial fibrillation, age <90 years or Barthel score ≥ 50), with only a positive trend in the whole cohort. Trial registration ClinicalTrials.gov Identifier: NCT03389841.

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A longer period for the capture of medication data yielded higher congruence. A degree of mismatch was observed between the two methods most likely related to factors of drug use and questionnaire reliability. Nonetheless, the benefits of using easily accessible population data prevail, and further studies are warranted.

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