title: An open cluster-randomized, 18-month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing.
abstract: BACKGROUND
  The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs, acid suppressive therapy, and antiplatelets. However, their effectiveness in changing actual practice is unknown.
  
  
  METHODS
  The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies. A cost-benefit analysis will also be conducted. We will carry out a parallel, open, superiority, randomized trial directed to primary care physicians. Physicians will be recruited and allocated at a cluster-level (primary care unit) by minimization. Data will be analyzed at the physician level. Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate. Physicians in intervention units will be offered individual educational outreach visits (one for each guideline) at their workplace during a six-month period. Physicians in the control group will be offered a single unrelated group training session. Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class, and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database. We estimated a sample size of 110 physicians in each group, corresponding to 19 clusters with a mean size of 6 physicians. Outcome collection and data analysis will be blinded to allocation, but due to the nature of the intervention, physicians and detailers cannot be blinded.
  
  
  CONCLUSIONS
  This trial will attempt to address unresolved issues in the literature, namely, long term persistence of effect, the importance of sequential visits in an outreach program, and cost issues. If successful, this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service.
  
  
  BACKGROUND
  ClinicalTrials.gov number NCT01984034.
authors.affiliation: Nova Medical School (Faculdade de Ciências Médicas-Universidade Nova de Lisboa), CEDOC, GIAI, Campo dos Mártires da Pátria 130, 1169-056 Lisbon, Portugal. daniel.pinto@fcm.unl.pt.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pinto
authors.forename: Bruno
authors.initials: B
authors.lastname: Heleno
authors.forename: David S
authors.initials: DS
authors.lastname: Rodrigues
authors.forename: Ana Luísa
authors.initials: AL
authors.lastname: Papoila
authors.forename: Isabel
authors.initials: I
authors.lastname: Santos
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Caetano
mesh_terms: D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003362:Cost-Benefit Analysis; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage; D006801:Humans; D009853:Omeprazole / Q000008:administration & dosage; D010821:Physicians, Family / Q000193:education*; D011174:Portugal; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D055656:Prescriptions / Q000191:economics / Q000706:statistics & numerical data*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012107:Research Design; D013192:Staff Development / Q000191:economics / Q000458:organization & administration*
chemical_list: D000893:Anti-Inflammatory Agents; D052246:Cyclooxygenase 2 Inhibitors; D054328:Proton Pump Inhibitors; D009853:Omeprazole