Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.
Lancet. 2013 Dec 21;382(9910):2069-76. doi: 10.1016/S0140-6736(13)61603-7. Epub 2013 Sep 18.
Most patients who have had a stroke are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Carers Training Course, LSCTC) on physical and psychological outcomes, including cost-effectiveness, for patients and caregivers after a disabling stroke.
We undertook a pragmatic, multicentre, cluster randomised controlled trial with a parallel cost-effectiveness analysis. Stroke units were eligible if four of five criteria used to define a stroke unit were met, a substantial number of patients on the unit had a diagnosis of stroke, staff were able to deliver the LSCTC, and most patients were discharged to a permanent place of residence. Stroke units were randomly assigned to either LSCTC or usual care (control group), stratified by geographical region and quality of care, and using blocks of size 2. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcome for patients was self-reported extended activities of daily living at 6 months, measured with the Nottingham Extended Activities of Daily Living (NEADL) scale. The primary outcome for caregivers was self-reported burden at 6 months, measured with the caregivers burden scale (CBS). We combined patient and caregiver costs with primary outcomes and quality-adjusted life-years (QALYs) to assess cost-effectiveness. This trial is registered with controlled-trials.com, number ISRCTN 49208824.
We assessed 49 stroke units for eligibility, of which 36 were randomly assigned to either the intervention group or the control group. Between Feb 27, 2008, and Feb 9, 2010, 928 patient and caregiver dyads were registered, of which 450 were in the intervention group, and 478 in the control group. Patients' self-reported extended activities of daily living did not differ between groups at 6 months (adjusted mean NEADL score 27·4 in the intervention group versus 27·6 in the control group, difference -0·2 points [95% CI -3·0 to 2·5], p value=0·866, ICC=0·027). The caregiver burden scale did not differ between groups either (adjusted mean CBS 45·5 in the intervention group versus 45·0 in the control group, difference 0·5 points [95% CI -1·7 to 2·7], p value=0·660, ICC=0·013). Patient and caregiver costs were similar in both groups (length of the initial stroke admission and associated costs were £13,127 for the intervention group and £12,471 for the control group; adjusted mean difference £1243 [95% CI -1533 to 4019]; p value=0·380). Probabilities of cost-effectiveness based on QALYs were low.
In a large scale, robust evaluation, results from this study have shown no differences between the LSCTC and usual care on any of the assessed outcomes. The immediate period after stroke might not be the ideal time to deliver structured caregiver training.
Medical Research Council.
大多数中风患者都依赖于非正规护理人员来进行日常生活活动。TRACS 试验研究了一种针对护理人员的培训计划(伦敦中风护理人员培训课程,LSCTC),该计划对残疾性中风患者及其护理人员的身体和心理结果(包括成本效益)进行了评估。
我们进行了一项实用的、多中心、集群随机对照试验,并进行了平行的成本效益分析。如果满足用于定义中风单元的五个标准中的四个,中风单元就有资格参与研究,该单元中有大量的中风患者,工作人员能够提供 LSCTC,并且大多数患者出院后都有永久性的住所。中风单元被随机分配到 LSCTC 或常规护理(对照组),按地理位置和护理质量分层,并使用大小为 2 的块。有中风诊断、可能因残疾而返回家庭并由护理人员提供支持的患者有资格参加。患者的主要结局是 6 个月时自我报告的扩展日常生活活动能力,使用诺丁汉扩展日常生活活动量表(NEADL)进行测量。护理人员的主要结局是 6 个月时自我报告的负担,使用护理人员负担量表(CBS)进行测量。我们将患者和护理人员的成本与主要结局和质量调整生命年(QALYs)结合起来,以评估成本效益。该试验在 controlled-trials.com 上注册,编号为 ISRCTN49208824。
我们评估了 49 个中风单元的资格,其中 36 个被随机分配到干预组或对照组。在 2008 年 2 月 27 日至 2010 年 2 月 9 日期间,注册了 928 名患者和护理人员对,其中 450 名在干预组,478 名在对照组。6 个月时,患者自我报告的扩展日常生活活动能力在两组之间没有差异(干预组的调整后的平均 NEADL 得分为 27.4,对照组为 27.6,差值为 -0.2 分[95%CI-3.0 至 2.5],p 值=0.866,ICC=0.027)。两组之间的护理人员负担量表也没有差异(干预组的调整后的平均 CBS 为 45.5,对照组为 45.0,差值为 0.5 分[95%CI-1.7 至 2.7],p 值=0.660,ICC=0.013)。两组患者和护理人员的成本相似(干预组的初始中风入院和相关费用为 13127 英镑,对照组为 12471 英镑;调整后的平均差异为 1243 英镑[95%CI-1533 至 4019];p 值=0.380)。基于 QALYs 的成本效益概率较低。
在一项大规模、稳健的评估中,该研究结果表明,LSCTC 与常规护理在任何评估结果上均无差异。中风后立即进行结构化护理人员培训可能不是理想的时机。
医学研究委员会。