School of Nursing, McMaster University, Hamilton, Ontario, Canada.
Gladys Sharpe Chair in Nursing, School of Nursing, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2023 Oct 25;13(10):e073585. doi: 10.1136/bmjopen-2023-073585.
Despite the high mortality rates in long-term care (LTC) homes, most do not have a formalised palliative programme. Hence, our research team has developed the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) programme. The goal of the proposed study is to examine the implementation and effectiveness of the SPA-LTC programme.
A cross-jurisdictional, effectiveness-implementation type II hybrid cluster randomised control trial design will be used to assess the SPA-LTC programme for 18 LTC homes (six homes within each of three provinces). Randomisation will occur at the level of the LTC home within each province, using a 1:1 ratio (three homes in the intervention and control groups). Baseline staff surveys will take place over a 3-month period at the beginning for both the intervention and control groups. The intervention group will then receive facilitated training and education for staff, and residents and their family members will participate in the SPA-LTC programme. Postintervention data collection will be conducted in a similar manner as in the baseline period for both groups. The overall target sample size will be 594 (297 per arm, 33 resident/family member participants per home, 18 homes). Data collection and analysis will involve organisational, staff, resident and family measures. The primary outcome will be a binary measure capturing any emergency department use in the last 6 months of life (resident); with secondary outcomes including location of death (resident), satisfaction and decisional conflict (family), knowledge and confidence implementing a palliative approach (staff), along with implementation outcomes (ie, feasibility, reach, fidelity and perceived sustainability of the SPA-LTC programme). The primary outcome will be analysed via multivariable logistic regression using generalised estimating equations. Intention-to-treat principles will be used in the analysis.
The study has received ethical approval. Results will be disseminated at various presentations and feedback sessions; at provincial, national and international conferences, and in a series of manuscripts that will be submitted to peer-reviewed, open access journals.
NCT039359.
尽管长期护理(LTC)机构的死亡率很高,但大多数机构都没有制定正式的姑息治疗方案。因此,我们的研究团队开发了强化长期护理姑息治疗方法(SPA-LTC)方案。本研究旨在评估 SPA-LTC 方案的实施情况和效果。
采用跨司法管辖区、有效性-实施 II 型混合集群随机对照试验设计,对 18 家长期护理机构(每个省的六个机构)的 SPA-LTC 方案进行评估。每个省的长期护理机构内部将采用 1:1 的比例(干预组和对照组各三个机构)进行随机分组。基线员工调查将在干预组和对照组的前 3 个月进行。然后,干预组将为员工提供便利的培训和教育,居民及其家属将参与 SPA-LTC 方案。两组的随访数据收集方式与基线相同。总体目标样本量为 594 例(每组 297 例,每个机构 33 名居民/家属参与者,18 个机构)。数据收集和分析将涉及组织、员工、居民和家属措施。主要结局是捕捉居民在生命的最后 6 个月内是否使用过急诊(二分类测量);次要结局包括死亡地点(居民)、满意度和决策冲突(家属)、实施姑息治疗方法的知识和信心(员工),以及实施结局(即 SPA-LTC 方案的可行性、可及性、保真度和可持续性感知)。主要结局将通过使用广义估计方程的多变量逻辑回归进行分析。分析将采用意向治疗原则。
该研究已获得伦理批准。结果将在各种演讲和反馈会议、省级、国家级和国际会议上进行传播,并发表在一系列提交给同行评审、开放获取期刊的论文中。
NCT039359。