A pilot stepped-wedge, cluster randomised-controlled-trial (RCT) of the effectiveness of an oral health care (OHC) intervention compared to standard care in stroke wards (SOCLE II)

Background and Aims: Stroke survivors with stroke-associated pneumonia (SAP) experience poorer outcomes (length-of-stay, dependency at discharge, healthcare costs and risk of death). High quality, OHC may reduce the incidence of pneumonia and improve patients' oral health.We aimed to pilot a pragmatic, stepped-wedge, cluster RCT of clinical effectiveness of an enhanced OHC plan versus usual OHC in stroke wards. Method: Four stroke rehabilitation wards (clusters) were randomly allocated to receive the OHC intervention at specific time-points. All patients admitted and nursing staff (registered nurses, nursing assistants and student nurses) were eligible for inclusion. We evaluated our intervention (training, tools, protocol, assessment, equipment, costs), recruitment, adherence, record linkage, sampling methodologies and sample size calculations. We considered the relationship between SAP, dental plaque and site diversity. Results: Part-time researchers screened 1548/2613 patient admissions and 123 nurses. They recruited 325 patients (243 post-stroke) and 112 nurses. Data from usual care (patients =135; staff =108) and enhanced care periods (patients =147; staff =83) indicated our intervention was viable. The observed SAP rate (7% across sites) impacted on our ability to establish the association between dental/denture plaque and SAP and failed to meet predetermined (literature-based) rate for progression to full trial (10%). Our pilot logistic regression generalised linear mixed model analyses found no evidence of a difference in SAP rate between patients that received usual versus enhanced OHC (p=0.62, OR 0.61 CI (0.08 to 4.42). Conclusion: Our stepped-wedge cluster pilot RCT accommodated marked diversity between sites. We did not meet our predetermined criteria for progression to a definitive trial.