Division of Neuroscience and Experimental Psychology, The University of Manchester, Manchester Academic Health Sciences Centre (MAHSC), Manchester, UK.
National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester (NIHR CLAHRC GM), Manchester, UK.
BMJ Open. 2021 Jan 12;11(1):e038777. doi: 10.1136/bmjopen-2020-038777.
Investigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.
Pragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.
Clusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.
Adult carers in participating clusters were referred to the study by cluster staff following initial support contact.
Intervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable).
Participants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff.
3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ).
FACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L.
Clusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only.
Between 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced.
intention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of -0.04 (95% CI -0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention.
The intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers' research and service development, staff training and organisational support would need to be enhanced.
ISRCTN58414120.
调查针对脑卒中幸存者的非专业照护者的以患者为中心的干预措施的临床效果和成本效益。
实用群组随机对照试验（cRCT），同时进行经济和过程评估。
群组为服务单位，来自英国一家志愿部门的专业提供商，主要在脑卒中幸存者和非专业照护者的家中提供支持。
参与群组的成年照护者在接受群组工作人员的初步支持联络后，由群组工作人员转介至研究。
干预措施是脑卒中患者照护者支持需求评估工具：一种由工作人员促进、以照护者为主导的方法，旨在帮助识别、确定优先级并满足照护者的具体支持需求。它需要至少一次专门针对照护者的面对面支持接触，并根据需要进行审查。对照组为常规护理，包括非结构化和可变的照护者支持。
参与者在首次接触后 3 和 6 个月，通过邮寄问卷提供了研究入组和自我报告的结果数据。
3 个月的照护者压力（家庭照护评估问卷，FACQ）。
FACQ 中照护者困扰和积极照护评估、情绪（医院焦虑和抑郁量表）以及对脑卒中服务的满意度（Pound）的子量表。经济评估包括自我报告的医疗保健利用情况、干预成本和 EQ-5D-5L。
在随机分组为干预组或对照组之前，对群组进行了招募，同时进行了服务规模的分层。由于需要参与培训，因此群组工作人员无法设盲。照护者研究参与者在不知道分配的情况下提供了自我报告的结果数据；他们仅同意进行随访数据收集。
在 2017 年 2 月 1 日至 2018 年 7 月 31 日期间，35 个随机群组（18 个干预组；17 个对照组）招募了 414 名 cRCT 照护者（208 名干预组；206 名对照组）。研究入组特征均衡。
对 84%保留的参与者（175 名干预组；174 名对照组）进行意向治疗分析发现，对照组 3 个月时 FACQ 照护者压力的平均（SD）值为 3.11（0.87），而干预组为 3.03（0.90），调整后的平均差异为-0.04（95%CI-0.20 至 0.13）。次要结局也有类似的微小差异和紧密的 CI。敏感性分析表明结果稳健。干预的实施情况未达到。干预相关组的成本略高，但在 EQ-5D-5L 上未观察到额外的健康益处。没有与干预相关的不良事件。
在这项实用试验中，干预措施未得到充分实施。按照实施情况，与脑卒中专科服务机构提供的常规护理相比，它并未带来临床益处，且不太可能具有成本效益。目前仍不清楚如何最好地支持脑卒中幸存者的照护者。为了克服在照护者研究和服务开发中实施以患者为中心的护理的实施挑战，需要加强工作人员培训和组织支持。
ISRCTN58414120。
