Objective Investigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.
Design Pragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.
Setting Clusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.
Participants Adult carers in participating clusters were referred to the study by cluster staff following initial support contact.
Interventions 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).
Outcome measures Participants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff. Primary outcome: 3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ). Secondary outcomes: 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.
Randomisation and masking 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.
Results 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. Primary outcome measure: 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.
Conclusions 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.
Trial registration number ISRCTN58414120.
- health economics
- education & training (see medical education & training)
- mental health
- primary care
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Contributors EP and AB are co-chief investigators of OSCARSS and conceived the study. EP wrote the first draft of the paper and all authors substantially contributed to revisions. KW-N project managed OSCARSS. SAR and EB performed statistical analysis. EC performed economic analysis. SK and SD led the process evaluation in OSCARSS and contributed to interpretation of the implementation data presented in this paper. GG and GE developed the original CSNAT intervention and contributed substantially to descriptions of the adapted CSNAT-Stroke intervention in this paper.
Funding This study was funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester (NIHR CLAHRC GM), grant number (N/A), partnered with Stroke Association Funding, grant number (N/A).
Competing interests AB, GG, SAR, EB and GE held grants with NIHR during the course of the OSCARSS Study. AB and EP additionally hold grants with Stroke Association outside of this work. There are no other relationships or activities that could appear to have influenced the submitted work.
Patient consent for publication Not required.
Ethics approval Ethics approvals were obtained from Lancaster Research Ethics Committee (ref: 16/NW/0657).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Requests for data and statistical code should be made to the corresponding author and will be considered by members of the original trial management group, including the co-chief investigators, who will release data on a case-by-case basis. Data will be shared following the principles for sharing patient-level data as described by Smith et al (2015). The data will not contain any direct identifiers, we will minimise indirect identifiers and remove free text data, to minimise the risk of identification.
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