CHOSEN: A Randomized Controlled Feasibility Trial

Abstract

Background:
Improving oral health in acutely dysphagic stroke patients is a plausible approach to prevent pneumonia. We aimed to determine whether a phase 3, definitive trial of oral health care (OHC) treatments, supported by staff education and training, is feasible in stroke unit care.

Methods:
The trial was conducted and reported in line with the CONSORT 2010 statement extended to feasibility trials. We aimed to recruit 120 participants with acute stroke and dysphagia within 24 hours of admission, from 4 stroke units in the North-West of England, randomised (1:1:1:1) to one of 4 OHC treatments: manual toothbrush or powered toothbrush with either non-foaming toothpaste or chlorhexidine 1% gel. Stroke unit nursing staff received standardised education and training. Feasibility was assessed using a priori criteria.

Results:
Between January 2022 and end of January 2023, 626 patients were screened. 101 participants (median [IQR] age 73 [62-80] years, median [IQR] NIHSS 10 [5-18], 44% female) were enrolled (77% of eligible patients approached). Adherence was 91%, with no substantial difference between the OHC treatments. 88% completed follow-up. There were 19 serious adverse events but no marked differences between allocated OHC treatments. In exploratory secondary analyses, again there were no substantial differences in survival, incident pneumonia, modified Rankin Scale score or quality of life at 3 months between the OHC treatment allocations.

Conclusions:
OHC treatments incorporating chlorhexidine and powered brushing and supported by standardised staff training appeared feasible and safe in acutely dysphagic stroke patients. Progression criteria were met for a definitive trial of efficacy and cost-effectiveness.
ISRCTN52421361 https://doi.org/10.1186/ISRCTN52421361