Feasibility study of the Free Water Protocol in acute stroke
Research type
Research Study
Full title
A feasibility study of the implementation of the FRee WAter Protocol for stroke survIvors with Dysphagia in acute Stroke unit setting (RAPIDS)
IRAS ID
343095
Contact name
Sabrina Eltringham
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
CRD42023470349, PROSPERO
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Background
The Free Water Protocol (FWP) gives patients at risk of aspiration the option to drink water between meals after thorough mouth care. There is a lack of evidence about the use of the FWP in acute stroke units. The aim of this preliminary feasibility study is to develop and test an implementation strategy for a FWP and explore the feasibility of delivering the FWP to stroke patients with dysphagia in an acute stroke unit setting.
Method
The research programme has four stages. In Stage 1, the developmental work to inform national stakeholder co-design workshops will include a systematic review, a national survey, and interviews with health professionals to inform contextual factors and determinants to implementation of the FWP in an acute stroke unit setting. Collective data about the barriers and enablers to implementation will feed into stakeholder workshops (Stage 2) that will discuss implementation strategies and inform the training to deliver the intervention (Stage 3). Thirty patients will be recruited to participate in the FWP using a pre/post intervention design and will complete a satisfaction questionnaire. Data collection will include level of fluid intake and development of pneumonia. In Stage 4, the process evaluation will involve interviews with clinician and patient participants to identify barriers and facilitators to implementing the FWP. The Consolidated Framework for Implementation Research will underpin implementation science throughout the study and be used to analyse the data. Patients and the public will be involved throughout the research.
Results
Primary feasibility outcomes will investigate acceptability, feasibility, fidelity, and barriers and facilitators to implementing the FWP. Secondary intervention outcomes will include level of fluid intake, hydration, and development of pneumonia.
Conclusion
The results of the study will inform a larger multi-site feasibility study to determine whether a phase 3 multicentre trial is feasible in NHS acute care.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0165
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion