SOCLE II: (Stroke Oral healthCare pLan Evaluation) is a pilot trial of an enhanced oral health care service provision versus usual care. SOCLE II aims to evaluate the feasibility of a full trial of the clinical and cost effectiveness of a complex OHC service versus usual care for people in stroke care settings. After a period of baseline data collection each ward (in a randomly allocated order) will ‘convert’ from usual care to providing an enhanced OHC service. Our pilot will assess the feasibility of delivering this enhanced OHC service across four sites and will inform the trial design of a full scale phase III trial including refining our proposed intervention and pilot our health economic evaluation. We also aim to establish the relationship between stroke associated pneumonia (SAP) and plaque and any diversity between sites.
We want to find out whether our SOCLE intervention and data collection process is possible across multiple sites. We want to find out how common pneumonia is and whether there is any link between dental and denture plaque and stroke associated pneumonia.
Target Populations & Setting
Patients: All admitted to stroke care settings (Stroke rehabilitation or mixed rehabilitation/acute stroke wards). Nursing staff: Referring to registered nurses, nursing students and clinical support workers across all shifts and full and part-time nursing staff caring for patients in stroke care settings.
Services: Four Scottish stroke rehabilitation wards (Wishaw Hospital and Hairmyres Hospital NHS Lanarkshire (PI Mr Campbell Chalmers); Stobhill Hospital (PI Dr Christine McAlpine) and Royal Alexandra Hospital, Paisley (PI: Dr Lindsay Erwin) NHS Greater Glasgow & Clyde).
Patients: OHC will be provided as required and as per usual care on the various wards. Where a ward has been randomly allocated to receive the intervention the patients will receive enhanced OHC. Nursing staff will have the opportunity to participate in an online specialised training session to improve knowledge and attitudes towards OHC and practical information on how best to care for patients’ oral health. They will also have access to a piloted OHC assessment tool and protocol, an adequate range of OHC equipment and products on the ward (e.g. toothbrushes and toothpaste).
Services: Links between ward level care and specialist dental support services such as community based dentists, primary care dental health services and denture repair labs will be strengthened or where they are already in existence these will be highlighted to staff. Steps will also be taken to ensure adequate availability of the necessary equipment and products to provide OHC to patients in stroke care settings. Other aspects of healthcare will continue to be provided as per usual care after stroke.
Primary and secondary outcomes evaluating the effectiveness of the SOCLE intervention will be captured across the different dimensions of care. Unless otherwise specified, measures will be taken at baseline and weekly thereafter. In addition, we will examine the acceptability and feasibility of implementing the SOCLE intervention at each site via staff focus groups
We aim to recruit 400 patients over 13 months of data collection across the four wards and 60 members of staff. Furthermore, data gathered on the between and within-ward variability in pneumonia rates and oral health related quality of life outcomes will inform the design and sample size calculation of the Phase III trial.
Funder: Funded by the Stroke Association (TSA 2012/09). MB, AP and the NMAHP RU are funded by the Chief Scientist Office part of the Scottish Government’s Health Directorate.
Project Team: M Brady, D Stott, C Chalmers, MP Sweeney, C Weir, C Donaldson, A Pollock, J Barr, M Barr, P Langhorne.
Research Staff: Naomi Bowers, Sheena McGowan.