An Open Cluster-randomized, 18 Month Trial to Compare the Effectiveness of Educational Outreach Visits With Usual Guideline Dissemination to Improve Family Physician Prescribing

The trial will be a parallel, cluster-randomized, unblinded, trial in primary care, with a 1:1 allocation ratio. This study will assess the effect of educational outreach visits on physician compliance with prescription guidelines. The general study hypothesis is whether educational outreach visits are superior to usual implementation of guidelines regarding the reduction of inappropriate prescribing (compliance with prescription guidelines). All National Health Service primary care units in the Lisbon (Portugal) region will be invited to participate. Units will be eligible if they are using an Electronic Health Record to issue prescriptions and have at least four doctors willing to participate. Doctors in intervention units will receive three educational outreach visits (one for each guideline) during a six months period, while the control group doctors will be offered an unrelated group training session (on using the international classification for primary care). Intervention visits will be one on one 15 minutes discussions conducted by guideline authors or trained family physicians at the physician's workplace. There are two primary outcomes, measured at the physician's level. One is the proportion of COX-2 inhibitors prescribed within the entire NSAID class, in defined daily doses 18 months after the intervention. The other is the proportion of omeprazole within the entire proton pump inhibitors class, in defined daily doses at 18 months post-intervention.Besides the above primary endpoints, the secondary outcomes will be the short (1 month) and medium-term (6 months) effects of educational outreach visits in the prescription of these two drug classes. Other secondary endpoints will be the short, medium and long-term effects of educational outreach visits in the prescription of clopidogrel. Finally, the trial will determine the cost effectiveness of educational outreach visits.

Allocation to intervention and blinding:

Clusters will be enrolled and allocated sequentially. To achieve a good balance regarding baseline characteristics, the allocation sequence will be determined by minimization (Ivers NI 2012). The units will be minimized by number of doctors (4 or 5, 6 or 7, 8 to12), median baseline prescription of COX-2 inhibitors (above or below the regional median), median baseline prescription of omeprazole (above or below the regional median), proportion of doctors with less than 10 years of practice after completing vocational training (above or below 50%), and type of primary care unit (family health unit or personalized care unit). All doctors sending the consent statement before the cluster allocation will be included in the study.

The sequence of intervention visits for each unit will be determined by simple randomization.

Allocation concealment will be ensured by the following procedures: the trial manager (hired and not part of the authors research team) will assign a sequential number to each unit as participation forms are received; only anonymized data about participating units will be sent to the trial statistician (sequential number and minimization variables); data will be sent in two batches, one for each half of all units; the statistician will allocate units to each trial arm using minimization; the sequence of visits will be determined using the random sequence generator from Random.org (http://www.random.org/sequences/); the statistician will return allocation information to the trial manager.