Organising Support for Carers of Stroke Survivors (OSCARSS): A Cluster Randomised Controlled Trial with embedded Process Evaluation

INTERVENTION: Participating Stroke Association services across England, Wales and Northern Ireland form independent clusters (N=36) to be randomised to either intervention or control in a 1:1 allocation ratio. Randomisation is stratified by size of service using random block sizes of two. Control group: Services will deliver standard practice for carer identification and support. Standard practice in Stroke Association services varies and the approach by which carers’ own needs are identified and supported is not yet standardised. Intervention group: Services will be trained to deliver the CSNAT‐Stroke to carers referred to their service. The intervention does not prescribe the amount of support to be delivered; it is a carer‐led, practitioner‐facilitated framework for how individualised support should be provided. CSNAT‐Stroke training and intervention covers: initial contact with carers; the use of a needs assessment tool; an assessment conversation; a shared action and review plan. Carers will receive support from Stroke Association as per cluster allocation and will be invited to enrol in OSCARSS after the first face‐to‐face support visit. Carers in both arms will be followed up three months after study entry (primary outcome) and again six months after study entry. Postal packs sent to carers' own home will be used to collect follow up data. A sub‐sample of carers (N=20‐30 in each arm of the trial) will also be invited to take part in two qualitative telephone interviews. The first will be at the point of study entry to explore their experiences of support received. The second will take place after primary outcomes have been collected at three months to explore their perceptions of the impact of support received. The embedded process evaluation in OSCARSS will explore intervention fidelity and service delivery closely and at multiple timepoints. Analysis of carer outcomes as they relate to intervention vs control, will only be meaningful if we have confidence tha CONDITION: Stroke ; Circulatory System ; Stroke PRIMARY OUTCOME: Caregiver Strain is measured by the Caregiver Strain subscale of the Family Appraisal of Caregiving Questionnaire (FACQ) at 3 months. SECONDARY OUTCOME: All of the following relate to the cluster randomised controlled trial component of OSCARSS and are completed by carer self‐report collected through postal questionnaires:; 1. Caregiver Strain is measured by the Caregiver Strain subscale of the FACQ 6 months; 2. Carergiver burden is measured using the Caregiver distress subscale of FACQ at 3 and 6 months; 3. Positive impact of caring is measured using the Positive caregiving appraisals subscale of FACQ at 3 and 6 months; 4. Satisfaction with stroke services provided is measured using the Pound Carer Satisfaction with Stroke Services Scale at 3 and 6 months; 5. Mood is measured by the Hospital Anxiety and Depression Scale (HADS) at 3 and 6 months; 6. Health is measured by the EQ‐5D 5L questionnaire at 3 and 6 months; 7. Economic burden of caring (for Health Economics evaluation), is measured using an adapted Service Receipt Inventory completed by carers to record healthcare services used and time spent caring at 3 and 6 months INCLUSION CRITERIA: Clusters/Staff: OSCARSS involves Stroke Association services and staff within those services whom: 1. Offer at least one face to face contact with carers as part of their service; 2. Have capacity to participate in the research; 3. For whom it would be meaningful and useful to perform a holistic carer needs assessment (some services only deliver a specific type of support) 4. Are likely to have at least five new client referrals per month. 'Clients' include both stroke survivors (who are likely to have associated carers ) and carers directly; 5. Are considered ‘independent’ of other clusters. Some Stroke Association staff across several services work closely in terms of geography and shared client caseload. To reduce between‐group contamination, these services will be aggregated to form one ‘cluster’ for OSCARSS. Carers of stroke survivors: 1. Referred to participating Stroke Association clusters (either research intervention or control