LoTS2Care Feasibility Trial - A Process Evaluation
Research type
Research Study
Full title
Feasibility of a longer-term care strategy to support stroke survivors and their carers (LoTS2Care) - A process evaluation
IRAS ID
212116
Contact name
Jane Dennison
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
The study is a Process Evaluation that runs alongside a feasibility cluster randomised controlled trial (LoTS2Care) that has been approved (Reference 16/YH/0068) by NRES Committee Yorkshire and The Humber (Leeds East).
Where the term ‘Process Evaluators’ is used it indicates research staff who will undertake the process evaluation.
The approved LoTS2Care feasibility trial involves delivery of a complex intervention (care strategy) called ‘New Start’ that seeks to improve quality of life (QoL) in the longer-term for stroke survivors living in the community by addressing unmet needs and enhancing participation. The intervention will be delivered by trained facilitators (who are part of the clinical team) to all survivors who wish to engage with the care strategy. Delivery of the care strategy will occur independently of whether a survivor wishes to participate in the completion of outcome measures as part of the trial. The process evaluation will seek to provide detailed understanding of how the New Start intervention has been implemented, delivered, and received by stroke survivors. It will focus on whether this has occurred as intended, and the influence of contextual factors. We will gain insight into survivors’ experience of participating in the intervention.
A mixed methods approach will involve observations, interviews and documentary analysis.
Observations of training sessions provided for facilitators will assess whether training had been delivered as intended. Process Evaluators will also observe facilitators delivering the intervention to survivors and consultees/carers to assess whether this happened as intended
Interviews with stroke survivors and carers will provide insight of how the intervention is interpreted and engaged with.
Exit interviews with facilitators and site colleagues will be undertaken to enhance our understanding of the intervention’s practical delivery.
Documentary analysis of intervention-specific records of activity (known as ‘activity records’) will inform understanding of what facilitators’ did to deliver the intervention and what interactions they had with stroke survivors.
Analysis of the reports of site visits and structured service surveys conducted as part of the feasibility trial will enable usual care and the wider context of the service to be described.
Documentary analysis of facilitators’ monthly reflective reports will capture their skills and learning development. Analysis of further reports generated by facilitators’ and service colleagues’ use of the Normalisation Process Theory (NPT) toolkit will help inform understanding of the practical dynamics of implementing the intervention.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0390
Date of REC Opinion
23 Sep 2016
REC opinion
Favourable Opinion