Department of Medicine, University of Melbourne, Melbourne, Australia.
Palliative Care Service, St Vincent's Hospital Melbourne, Melbourne, Australia.
BMC Health Serv Res. 2021 May 27;21(1):513. doi: 10.1186/s12913-021-06476-3.
Current international consensus is that 'early' referral to palliative care services improves cancer patient and family carer outcomes. In practice, however, these referrals are not routine. An approach which directly addresses identified barriers to early integration of palliative care is required. This protocol details a trial of a standardized model of early palliative care (Care Plus) introduced at key defined, disease-specific times or transition points in the illness for people with cancer. Introduced as a 'whole of system' practice change for identified advanced cancers, the key outcomes of interest are population health service use change. The aims of the study are to examine the effect of Care Plus implementation on (1) acute hospitalisation days in the last 3 months of life; (2) timeliness of access to palliative care; (3) quality and (4) costs of end of life care; and (5) the acceptability of services for people with advanced cancer.
Multi-site stepped wedge implementation trial testing usual care (control) versus Care Plus (practice change). The design stipulates 'control' periods when usual care is observed, and the process of implementing Care Plus which includes phases of planning, engagement, practice change and evaluation. During the practice change phase, all patients with targeted advanced cancers reaching the transition point will, by default, receive Care Plus. Health service utilization and unit costs before and after implementation will be collated from hospital records, and state and national health service administrative datasets. Qualitative data from patients, consumers and clinicians before and after practice change will be gathered through interviews and focus groups.
The study outcomes will detail the impact and acceptability of the standardized integration of palliative care as a practice change, including recommendations for ongoing sustainability and broader implementation.
Australian New Zealand Clinical Trials Registry ACTRN 12619001703190 . Registered 04 December 2019.
目前国际共识认为，将癌症患者及早转介至姑息治疗服务可改善患者及其家属的预后。然而，在实践中，这些转介并非常规操作。因此，需要采取一种方法来直接解决姑息治疗早期整合中存在的障碍。本方案详细介绍了一项针对癌症患者在疾病特定的关键定义时间点或过渡点引入标准化早期姑息治疗模式（Care Plus）的试验。该方案作为针对确诊晚期癌症的“全系统”实践改变，主要关注的是人口健康服务利用的变化。本研究的目的是检验 Care Plus 的实施对以下方面的影响：（1）生命最后 3 个月的急性住院天数；（2）获得姑息治疗的及时性；（3）临终护理的质量和（4）成本；以及（5）晚期癌症患者对服务的接受程度。
采用多站点阶梯式楔形实施试验，比较常规护理（对照组）与 Care Plus（实践改变组）。该设计规定了在观察常规护理的“对照”期间，以及实施 Care Plus 的过程，包括规划、参与、实践改变和评估阶段。在实践改变阶段，所有达到过渡点的目标晚期癌症患者默认接受 Care Plus。将从医院记录和州及国家卫生服务行政数据集收集实施前后的卫生服务利用和单位成本数据。通过访谈和焦点小组收集实施前后患者、消费者和临床医生的定性数据。
研究结果将详细说明姑息治疗标准化整合作为实践改变的影响和可接受性，包括对持续可持续性和更广泛实施的建议。
澳大利亚和新西兰临床试验注册中心 ACTRN 12619001703190。注册于 2019 年 12 月 4 日。
