Dept of Public Health and Primary Care, Leiden University Medical Centre, P.O. Box 9600 2300 RC, Leiden, The Netherlands.
BMC Pulm Med. 2013 Mar 23;13:17. doi: 10.1186/1471-2466-13-17.
Favorable effects of formal pulmonary rehabilitation in selected moderate to severe COPD patients are well established. Few data are available on the effects and costs of integrated disease management (IDM) programs on quality of care and health status of COPD patients in primary care, representing a much larger group of COPD patients. Therefore, the RECODE trial assesses the long-term clinical and cost-effectiveness of IDM in primary care.
METHODS/DESIGN: RECODE is a cluster randomized trial with two years of follow-up, during which 40 clusters of primary care teams (including 1086 COPD patients) are randomized to IDM or usual care. The intervention started with a 2-day multidisciplinary course in which healthcare providers are trained as a team in essential components of effective COPD IDM in primary care. During the course, the team redesigns the care process and defines responsibilities of different caregivers. They are trained in how to use feedback on process and outcome data to guide implement guideline-driven integrated healthcare. Practice-tailored feedback reports are provided at baseline, and at 6 and 12 months. The team learns the details of an ICT program that supports recording of process and outcome measures. Afterwards, the team designs a time-contingent individual practice plan, agreeing on steps to be taken in order to integrate a COPD IDM program into daily practice. After 6 and 12 months, there is a refresher course for all teams simultaneously to enable them to learn from each other's experience. Health status of patients at 12 months is the primary outcome, measured by the Clinical COPD Questionnaire (CCQ). Secondary outcomes include effects on quality of care, disease-specific and generic health-related quality of life, COPD exacerbations, dyspnea, costs of healthcare utilization, and productivity loss.
This article presents the protocol and baseline results of the RECODE trial. This study will allow to evaluate whether IDM implemented in primary care can positively influence quality of life and quality of care in mild to moderate COPD patients, thereby making the benefits of multidisciplinary rehabilitation applicable to a substantial part of the COPD population.
Netherlands Trial Register (NTR): NTR2268.
在选定的中重度 COPD 患者中，规范的肺康复治疗效果良好。然而，关于综合疾病管理（IDM）计划对初级保健中 COPD 患者的护理质量和健康状况的影响和成本的数据有限，因为 IDM 计划主要针对的是更大的 COPD 患者群体。因此，RECODE 试验评估了 IDM 在初级保健中的长期临床和成本效益。
方法/设计：RECODE 是一项为期两年的随访的集群随机试验，在此期间，40 个初级保健团队（包括 1086 名 COPD 患者）被随机分为 IDM 组或常规护理组。干预措施从为期两天的多学科课程开始，在此期间，医疗保健提供者作为一个团队接受有关在初级保健中有效管理 COPD 的 IDM 的基本内容的培训。在课程期间，团队重新设计了护理流程并确定了不同护理人员的职责。他们接受了如何使用流程和结果数据的反馈来指导实施基于指南的综合医疗的培训。在基线时、6 个月和 12 个月时提供针对实践的反馈报告。团队了解支持记录流程和结果措施的 ICT 计划的详细信息。然后，团队设计了一个基于时间的个人实践计划，就将 COPD IDM 计划纳入日常实践的步骤达成一致。在 6 个月和 12 个月后，所有团队同时参加复习课程，以相互学习经验。12 个月时患者的健康状况是主要结局，通过临床 COPD 问卷（CCQ）进行测量。次要结局包括对护理质量、疾病特异性和一般健康相关生活质量、COPD 加重、呼吸困难、医疗保健利用成本和生产力损失的影响。
本文介绍了 RECODE 试验的方案和基线结果。这项研究将评估在初级保健中实施的 IDM 是否可以积极影响轻度至中度 COPD 患者的生活质量和护理质量，从而使多学科康复的益处适用于 COPD 患者的大部分人群。
荷兰试验注册处（NTR）：NTR2268。
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