Organising Support for Carers of Stroke Survivors (OSCARSS): a cluster randomised controlled trial with economic evaluation

Abstract

ObjectiveInvestigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.DesignPragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.SettingClusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.ParticipantsAdult carers in participating clusters were referred to the study by cluster staff following initial support contact.InterventionsIntervention 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 measuresParticipants 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 maskingClusters 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.ResultsBetween 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.ConclusionsThe 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 numberISRCTN58414120.

Core Outcome Measures for Palliative and End-of-Life Research After Severe Stroke: Mixed-Method Delphi Study

“…One protocol for trial of a person-centered intervention for informal carers/caregivers of stroke survivors (Organising Support for Carers of Stroke Survivors [OSCARSS]) has been published since. 29 The steering group reviewed reports and helped assess inter-rater reliability. A data extraction table was created, but quality assessment using a risk of bias tool was not considered relevant or appropriate.…”

A Biopsychosocial Intervention for Stroke Carers (BISC): development and description of the intervention

“…A strength of this study is that the topics covered during all group sessions of the BISC intervention emerged from a review of the relevant literature, interviews with stroke carers and a nominal group consensus meeting with expert clinicians and researchers (Condon et al, 2019 ). Another key element of the intervention development process was patient and public involvement (PPI) and such a collaborative approach is recommended in intervention studies organising support for carers of stroke survivors (Patchwood et al, 2021 ). This allowed the tailoring of the intervention to the specific needs of the people providing care to stroke survivors as focused interventions have been found to be more effective and efficient (Panzeri et al, 2019 ).…”

“…Recently, many interventions aimed at supporting carers of stroke survivors have been evaluated with some preliminary positive results (Araújo, Lage, Cabrita, & Teixeira, 2018 ; Day et al, 2021 ) and others reported more conclusive findings but with no evidence on clinical or cost-effectiveness (Patchwood et al, 2021 ). However, many of these interventions often neglect to address the physical and psychological well-being of carers and focus more on the provision of information and practical support for preparing to manage the complex needs of stroke survivors for the transition from hospital to home care.…”

Systematic Review of the Evidence for Stroke Family Caregiver and Dyad Interventions

“…24 Caregiver anxiety and depression were measured in 5 studies using the Hospital Anxiety and Depression Scale. [24][25][26]28,29 Other anxiety and depression measures included the Center for Epidemiological Studies Depression Scale, 19,21,30 Patient-Reported Outcomes Measurement Information System-Depression Short Form 8b, 35 Patient Health Questionnaire-9, 31 Beck Depression Scale, 27 Zung Self-rating Anxiety Scale, 28 and the Zung Self-Rating Depression Scale. 28 Several studies measured caregiver health-related quality of life using the same measures that were used for stroke survivors (ie, Older People's Quality of Life Questionnaire, 35 the Satisfaction with Life Scale, 32 and the EuroQol European Quality of Life EuroQol 24,25 ).…”

“…30 Positive aspects of caregiving were measured by the Chinese Version of the Perceived Benefits of Caregiving Scale, 20 Chinese Version of Positive Aspects of Caregiver Questionnaire, 32 and a Positive Appraisal of the Impact of Caring subscale from the Family Appraisal of Caring Questionnaire. 24 Caregiver anxiety and depression were measured in 5 studies using the Hospital Anxiety and Depression Scale. [24][25][26]28,29 Other anxiety and depression measures included the Center for Epidemiological Studies Depression Scale, 19,21,30 Patient-Reported Outcomes Measurement Information System-Depression Short Form 8b, 35 Patient Health Questionnaire-9, 31 Beck Depression Scale, 27 Zung Self-rating Anxiety Scale, 28 and the Zung Self-Rating Depression Scale.…”