Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2022 Jul 25;12(7):e059440. doi: 10.1136/bmjopen-2021-059440.
Progressive chronic, non-malignant diseases (CNMD) like congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are of growing relevance in primary care. Most of these patients suffer from severe symptoms, reduced quality of life and increased numbers of hospitalisations. Outpatient palliative care can help to reduce hospitalisation rate by up to 50%. Due to the complex medical conditions and prognostic uncertainty of the course of CNMD, early interprofessional care planning among general practitioners who provide general palliative care and specialist palliative home care (SPHC) teams seems mandatory. The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse-patient consultation followed by an interprofessional telephone case conference.
Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. The study is located in Northern Germany and aims to recruit 616 patients in 56 GP practices (because of pandemic reasons reduced to 191 participants). Randomisation will take place on GP practice level immediately after inclusion (intervention group/control group). Allocation concealment is carried out on confirmation of participation. Patients diagnosed with CHF (New York Heart Association (NYHA) classification 3-4), COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage classification 3-4, group D) or dementia GDS stage 4 or above). Primary outcome is a reduced hospital admission within 48 weeks after baseline, secondary outcomes include symptom burden, quality of life and health costs. The primary analysis will follow the intention-to-treat principle. Intervention will be evaluated after the observation period using qualitative methods.
The responsible ethics committees of the cooperating centres approved the study. All steps of data collection, quality assurance and data analysis will continuously be monitored. The concept of KOPAL could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care.
DRKS00017795; German Clinical Trials Register.
充血性心力衰竭（CHF）、慢性阻塞性肺疾病（COPD）和痴呆等进行性慢性非恶性疾病（CNMD）在初级保健中越来越重要。这些患者大多患有严重症状、生活质量下降和住院次数增加。门诊姑息治疗可将住院率降低多达 50%。由于 CNMD 的复杂医疗条件和预后不确定，为提供一般姑息治疗的全科医生和专科姑息家庭护理（SPHC）团队之间进行早期跨专业护理计划似乎是强制性的。KOPAL 研究（加强有姑息治疗需求的患者的跨专业合作的概念）将测试 SPHC 护士-患者咨询后进行跨专业电话病例会议的效果。
多中心、两臂、集群随机对照试验 KOPAL，以常规护理作为对照组。该研究位于德国北部，旨在招募 56 家全科医生诊所的 616 名患者（由于大流行原因减少到 191 名参与者）。在纳入后立即在全科医生诊所层面进行随机分组（干预组/对照组）。分配隐藏在确认参与后进行。诊断为充血性心力衰竭（纽约心脏协会（NYHA）分类 3-4 级）、慢性阻塞性肺疾病（全球倡议慢性阻塞性肺疾病（GOLD）分期分类 3-4 级，D 组）或痴呆 GDS 分期 4 级或以上）。主要结局是在基线后 48 周内减少住院，次要结局包括症状负担、生活质量和健康成本。主要分析将遵循意向治疗原则。干预将在观察期后使用定性方法进行评估。
合作中心的负责伦理委员会批准了该研究。数据收集、质量保证和数据分析的所有步骤都将持续监控。KOPAL 的概念可以作为其他地区的蓝图，满足临终关怀中地理公平的挑战。
DRKS00017795；德国临床试验注册处。
