Duong Victor, Tirant Kirstin, Raza Khan Urooj, Marsden Pierce, Steinfort Daniel, Wilsmore Nicholas, Faisal Wasek, Suleiman Mani, Tran-Duy An, Amores Paul, Hannan Liam M, Muruganandan Sanjeevan
Department of Respiratory Medicine Northern Health Melbourne Victoria Australia.
Faculty of Medicine, Dentistry and Health Sciences University of Melbourne Melbourne Victoria Australia.
Respirol Case Rep. 2025 Jun 18;13(6):e70194. doi: 10.1002/rcr2.70194. eCollection 2025 Jun.
The management of malignant pleural effusion (MPE) is inconsistent across health services. Many centres do not routinely offer all treatment options for MPE, with indwelling pleural catheter (IPC) being a primary example. This may be due to lack of specialist expertise or nursing capability to support the community-based treatment. New approaches are required to improve access to MPE treatments. This proof-of-concept study examines the feasibility of a virtual model of care for MPE, known as the specialist ambulatory pleural service (SAPS) model of care. This model will be compared with current approaches at other health services in the state, in terms of healthcare utilisation and costs. It will also assess health-related quality of life in individuals with MPE and report patient, carer and nurse experiences with the SAPS model of care.
A prospective, multi-centre, mixed-methods study will be performed. Participants with symptomatic MPE requiring intervention will be consecutively enrolled. The primary outcome is pleural effusion-related hospitalisation from enrolment to death or end of study participation. Secondary outcomes include: Overall hospitalisation, unplanned pleural effusion-related outpatient and emergency department (ED) visits, pleural-related healthcare costs, adverse events, overall survival, percentage of screened patients recruited, percentage dropped out/lost to follow up, percentage of scheduled home visits carried out, percentage of teleultrasound assessments completed, technical issues, percentage of symptom logbooks completed, quality of life, longitudinal symptom monitoring, participant and nursing attitudes to the SAPS model of care, patient activation measure and a stakeholder interview of the SAPS model of care implementation.
Digital health may improve access to MPE treatments by reducing barriers to specialist care and facilitating training and support for community staff. This trial assesses the SAPS model of care, providing data on barriers and facilitators to its implementation, its efficacy, costs and qualitative outcomes. Australia New Zealand Clinical Trial Registry: ACTRN12623000063617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384448&isReview=true.
恶性胸腔积液(MPE)的管理在各医疗服务机构中并不统一。许多中心并未常规提供MPE的所有治疗选择,留置胸腔导管(IPC)就是一个主要例子。这可能是由于缺乏专业知识或护理能力来支持基于社区的治疗。需要新的方法来改善MPE治疗的可及性。这项概念验证研究考察了一种针对MPE的虚拟护理模式,即专科门诊胸腔服务(SAPS)护理模式的可行性。将在医疗利用和成本方面,将该模式与该州其他医疗服务机构的现行方法进行比较。它还将评估MPE患者的健康相关生活质量,并报告患者、护理人员和护士对SAPS护理模式的体验。
将进行一项前瞻性、多中心、混合方法研究。对有症状且需要干预的MPE患者进行连续入组。主要结局是从入组到死亡或研究参与结束期间与胸腔积液相关的住院治疗。次要结局包括:总体住院治疗、与胸腔积液相关的计划外门诊和急诊科就诊、与胸腔相关的医疗费用、不良事件、总生存期、招募的筛查患者百分比、退出/失访百分比、已进行的预定家访百分比、已完成的远程超声评估百分比、技术问题、已完成的症状日志百分比、生活质量、纵向症状监测、参与者和护士对SAPS护理模式的态度、患者激活测量以及对SAPS护理模式实施情况的利益相关者访谈。
数字健康可能通过减少专科护理障碍并促进对社区工作人员的培训和支持来改善MPE治疗的可及性。该试验评估了SAPS护理模式,提供了有关其实施的障碍和促进因素、疗效、成本和定性结局的数据。澳大利亚新西兰临床试验注册中心:ACTRN12623000063617;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384448&isReview=true。