Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen 6500 HB, the Netherlands.
BMC Pulm Med. 2014 Apr 2;14:54. doi: 10.1186/1471-2466-14-54.
Proactive palliative care is not yet common practice for patients with COPD. Important barriers are the identification of patients with a poor prognosis and the organization of proactive palliative care dedicated to the COPD patient. Recently a set of indicators has been developed to identify those patients with COPD hospitalized for an acute exacerbation who are at risk for post-discharge mortality. Only after identification of these patients with poor prognosis a multi disciplinary approach to proactive palliative care with support of a specialized palliative care team can be initiated.
METHODS/DESIGN: The PROLONG study is a prospective cluster controlled trial in which 6 hospitals will participate. Three hospitals are selected for the intervention condition based on the presence of a specialized palliative care team. The study population consists of patients with COPD and their main informal caregivers. Patients will be included during hospitalization for an acute exacerbation. All patients in the study receive standard care (usual care). Besides, patients in the intervention condition who meet two or more criteria of the set of indicators for proactive palliative care will have additionally regular consultations with a specialized palliative care team. The objectives of the PROLONG study are: 1) to assess the discriminating power of the proposed set of indicators (indicator study) and 2) to assess the effects of proactive palliative care for qualifying patients with COPD on the wellbeing of these patients and their informal caregivers (intervention study). The primary outcome measure of the indicator study is time to death for any cause. The primary outcome measure of the intervention study is the change in quality of life measured by the St George Respiratory Questionnaire (SGRQ) three months after inclusion.
The PROLONG study may lead to better understanding of the conditions to start and the effectiveness of proactive palliative care for patients with COPD. Innovative aspects of the PROLONG study are the use of a set of indicators for proactive palliative care, the active involvement of a specialized palliative care team and the use of a patient-tailored proactive palliative care plan.
Netherlands Trial Register (NTR): NTR4037.
积极的姑息治疗在 COPD 患者中尚未普及。重要的障碍是识别预后不良的患者和组织专门针对 COPD 患者的积极姑息治疗。最近，已经开发了一组指标来识别因急性加重而住院的 COPD 患者，这些患者有出院后死亡的风险。只有在识别出这些预后不良的患者后，才能启动多学科积极姑息治疗方法，并得到专门姑息治疗团队的支持。
方法/设计：PROLONG 研究是一项前瞻性聚类对照试验，将有 6 家医院参与。根据是否有专门的姑息治疗团队，选择 3 家医院进行干预。研究人群包括 COPD 患者及其主要的非正式照顾者。患者将在因急性加重而住院期间被纳入研究。所有研究患者均接受标准护理（常规护理）。此外，在干预条件下符合积极姑息治疗标准的两项或多项指标的患者将定期与专门的姑息治疗团队进行咨询。PROLONG 研究的目的是：1）评估所提出的一组指标的区分能力（指标研究）；2）评估积极姑息治疗对符合条件的 COPD 患者的效果，以改善这些患者及其非正式照顾者的幸福感（干预研究）。指标研究的主要结局测量是任何原因导致的死亡时间。干预研究的主要结局测量是纳入后三个月通过圣乔治呼吸问卷（SGRQ）测量的生活质量变化。
PROLONG 研究可能有助于更好地了解启动积极姑息治疗的条件以及对 COPD 患者的有效性。PROLONG 研究的创新之处在于使用了一组积极姑息治疗的指标，专门的姑息治疗团队的积极参与以及使用了个体化的积极姑息治疗计划。
荷兰试验注册（NTR）：NTR4037。
