Centre for Family and Community Medicine, Faculty of Medical Sciences, Medical University of Lodz, Kopcinskiego 20, 90-153, Lodz, Poland.
Trials. 2021 Feb 25;22(1):161. doi: 10.1186/s13063-021-05103-0.
The third most frequent chronic condition, and the fourth most common cause of death, in Poland is chronic obstructive pulmonary disease (COPD). The diagnosis and treatment of COPD is the responsibility of the general practitioner (GP); the GP also serves as gatekeeper, referring patients to the other levels of public health care system when necessary. Undertreatment of COPD can result in a greater frequency of exacerbations and hospitalizations. Elderly patients require special attention due to the increased prevalence of COPD and systemic comorbidities. However, both the occurrence of exacerbations and the quality of life of the patients may be improved by developing and implementing guidelines for practice and ensuring their adherence. This proposal concerns the development of a checklist-based educational program to assist general practitioners in managing COPD patients.
No less than eighty-four general clinics in the Lodz region, Poland (28 clusters in each of three study arms), will be identified, randomized, and included in the trial. The trial will be based on anonymized data in electronic health records within the national public health care system. The educational intervention program will consist of GPs in two intervention arms being provided with a COPD management checklist: those in the first intervention arm with receive the checklist once at the beginning, while those in the second with receive it twice. The third (control) arm receives standard care without the checklist. The study used the International Code of Diseases (ICD)-10 for COPD. The primary aim is to determine the effect of interventions delivered to general practitioners (GPs) in primary health care. These interventions are aimed at decreasing the hospitalization of elderly patients with medical code J-44 (COPD) as the main reason for hospital admission.
The results of this trial will be directly applicable to primary care in Poland and add new data to the growing body of evidence regarding interventions aimed at improving chronic illness care.
This trial has been registered with the Clinical Trials Protocol Registration System. Please see in ClinicalTrial.gov identifier (NCT Number): NCT04301505 . Registered on 10 March 2020.
在波兰，第三常见的慢性疾病和第四大常见死因是慢性阻塞性肺疾病（COPD）。COPD 的诊断和治疗是全科医生（GP）的职责；GP 还担任守门人，必要时将患者转介到公共卫生保健系统的其他层级。COPD 治疗不足会导致发作和住院的频率增加。老年患者由于 COPD 和全身合并症的患病率增加，需要特别关注。然而，通过制定和实施实践指南并确保其遵守，可以改善发作的发生和患者的生活质量。本建议涉及制定基于清单的教育计划，以帮助全科医生管理 COPD 患者。
将在波兰罗兹地区确定不少于 84 家全科诊所（每个研究臂 28 个集群），并对其进行随机分组和纳入试验。试验将基于国家公共卫生保健系统中电子健康记录中的匿名数据。教育干预计划将包括两个干预臂的全科医生提供 COPD 管理清单：第一干预臂的医生在开始时获得一次清单，而第二干预臂的医生则获得两次清单。第三（对照）臂接受无清单的标准护理。该研究使用了国际疾病分类（ICD）第 10 版的 COPD 编码。主要目的是确定干预措施对初级卫生保健中全科医生的影响。这些干预措施旨在减少以医疗代码 J-44（COPD）为主要入院原因的老年患者的住院率。
本试验的结果将直接适用于波兰的初级保健，并为旨在改善慢性病护理的干预措施提供更多的证据。
本试验已在临床试验方案注册系统中注册。请在 ClinicalTrial.gov 标识符（NCT 编号）中查看：NCT04301505。于 2020 年 3 月 10 日注册。
