IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.
Hornsby Ku-ring-gai Health Service, Northern Clinical School, University of Sydney, Hornsby, New South Wales, Australia.
BMJ Open. 2019 Jan 28;9(1):e026177. doi: 10.1136/bmjopen-2018-026177.
Delirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group.
The study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial.
Ethical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies.
ACTRN12617001070325; Pre-results.
谵妄是住院患者的一种严重的医疗并发症。通过支持基本人类需求的非药物策略，如身体和认知活动、睡眠、水合作用、视力和听力，可以预防高达三分之一的老年住院患者的谵妄发作。我们假设，类似的多组分干预措施也可能降低晚期癌症住院患者的谵妄发生率，和/或其持续时间和严重程度。在进行 III 期试验之前，我们旨在确定一种多组分非药物性谵妄预防干预措施对于这一特定住院患者群体是否可行和可接受。
该研究是一项涉及澳大利亚 4 个姑息治疗住院病房的晚期癌症住院患者的 II 期集群随机等待名单对照试验。干预组将引入谵妄筛查、诊断评估和多组分谵妄预防干预，涵盖六个护理领域：保持自然睡眠；保持最佳视力和听力；优化水合作用；促进沟通、定向和认知；优化活动能力；促进家庭合作。跨学科团队将根据每个站点和患者的需求调整干预措施的实施。对照组将首先仅引入谵妄筛查和诊断，之后根据初步结果实施干预措施，根据初步结果进行修改。主要结局是在入院后的头 7 天内对 40 名连续入院的合格患者进行干预的依从性。次要结局涉及研究干预措施、在该患者群体中使用的程序和措施的保真度和可行性、可接受性和可持续性，使用定量和定性措施进行评估。将测量谵妄的发生率和严重程度，为未来的 III 期试验提供疗效计算依据。
所有四个站点都获得了伦理批准。试验结果、定性子研究结果和干预措施的实施将提交给同行评议期刊发表，并在会议上报告，报告对象包括研究站点和主要的高层机构。
ACTRN12617001070325；预结果。
