背景:葡萄牙国家卫生局发布了有关消炎药处方的临床实践指南,酸抑制疗法,和抗血小板。然而,他们在改变实际实践中的有效性是未知的。
方法:该研究将比较教育外展访问对初级保健临床指南依从性的改善与常规传播策略的有效性。还将进行成本效益分析。我们将进行平行,打开,优越性,针对初级保健医生的随机试验。将通过最小化在集群级别(初级保健单元)招募和分配医师。数据将在医生级别进行分析。初级保健单位将有资格,如果他们使用电子处方,并有至少四名医生愿意参加。在六个月的时间内,将为干预单位的医生在其工作场所提供个人教育外展访问(每个指南一个)。对照组的医生将接受一次无关的小组培训。主要结果将是抗炎类别中规定的环氧合酶-2抑制剂的比例,以及干预后18个月奥美拉唑在质子泵抑制剂类别中的比例。处方数据将从区域药房索赔数据库中收集。我们估计每组有110名医生,对应于19个集群,平均规模为6名医生。结果收集和数据分析将对分配视而不见,但是由于干预的性质,医生和细节不能蒙蔽。
结论:本试验将尝试解决文献中尚未解决的问题,即,长期持续的效果,连续访问在外展计划中的重要性,和成本问题。如果成功,该试验可能是在葡萄牙国家卫生服务局内部署大规模教育推广计划的基石.
背景:ClinicalTrials.gov编号NCT01984034。
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.