Abstract
BackgroundThe 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.MethodsThe 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.DiscussionThis 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.Trial registrationClinicalTrials.gov number NCT01984034.
Highlights
The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs, acid suppressive therapy, and antiplatelets
Printed educational materials have no apparent effect on processes of care, while educational meetings, educational outreach, local opinion leaders, audit and feedback, computerized reminders, and tailored interventions are associated with small but clinically significant improvements [8,9,10,11,12,13,14]
The unit of analysis will be the family physician. Aim and objectives This trial aims to assess whether educational outreach visits are superior to usual implementation of guidelines regarding the reduction of inappropriate prescribing
Summary
The study will be a parallel, cluster-randomized controlled trial comparing educational outreach visits with usual guideline implementation. If we were to measure outcomes from the allocation date, there would be up to a six-month time gap compared with intervention units In this relatively long interval, other factors influencing prescription of the study drugs could arise (e.g., new research or guidelines being published, changes in drug policy in the Portuguese NHS, seasonal trends of prescription of NSAIDs, etc.). Cost analysis Global prescription spending will be defined as the sum of the cost of all drug prescriptions of NSAIDs (ATC M01A), acid suppressive therapy (proton pump inhibitors ATC A02BC and their alternatives: H2-receptor antagonists ATC A02BA, antacids ATC A02A, misoprostol ATC A02BB01, and sucralfate ATC A02BX02), and antiplatelets (ATC B01AC), up to 18 months after the intervention These costs will be compared with the amount spent training the detailers, preparing and printing educational materials, travel expenses to intervention units, payment of detailers, program coordination, and physician time spent with a detailer rather than with a patient. The trial has been registered in ClinicalTrials.gov (NCT01984034) and ENCePP.eu (http://www.encepp. eu/encepp/viewResource.htm?id=5150)
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
