An open cluster-randomized, 18 month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing (TEP (Trial Educational outreach Prescribing))

Study type

• Study type:
  Clinical trial
• Scope of the study:
  Drug utilisation

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Gastrooesophageal reflux disease

  Gastrointestinal disorder

  Cardiovascular disorder

  Pain

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  220

Study design details

• Main study objective:
  This trial aims to assess whether educational outreach visits are superior to usual implementation of guidelines regarding the reduction of inappropriate prescribing (compliance with prescription guidelines by family physicians). This for prescriptions of NSAIDs, Proton Pump Inhibitors, and anti platelets. The trial will also determine the cost-benefit of educational outreach visits.
• Outcomes:
  Two primary outcomes at physician´s level: The proportion of COX-2 inhibitors (anatomical therapeutic classification ATC M01AH) prescribed within the entire NSAID class (ATC M01A) in defined daily doses 18 months after the intervention. The proportion of omeprazole (ATC A02BC01) within the entire proton pump inhibitors class (ATC A02BC) in defined daily doses 18 months after the intervention. There are seven secondary outcomes, also measured at the physician´s level: The proportion of COX-2 inhibitors within the NSAID class at 1 and 6 months, the proportion of omeprazole within the proton pump inhibitors class at 1 and 6 months, and the number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 1, 6 and 18 months.
• Data analysis plan:
  Researchers will have access to prescription data through a data monitoring system operated by the Lisbon (Portugal) Regional Health Administration. Data will be collected and provided by employees from this Administration according to researcher defined specifications. Importantly, researchers will not be directly involved in data collection. This information arrives with a two month delay from the date the prescription is dispensed. Data of prescribing physicians will be analyzed according to their randomly allocated group regardless of adherence to the intervention (intention to treat analysis). Both groups will be compared on primary outcomes using generalized mixed-effects models. The ratio of COX-2 inhibitors to the entire NSAIDs class and the ratio of omeprazole to the entire proton pump inhibitors class and respective 95% confidence intervals will be calculated. Statistical significance will be assumed for a p-value less than 0.025.