Stroke Oral healthCare pLan Evaluation "SOCLE II"

Active, not recruiting

Phase 2 Results N/A

Trial Description

Stroke associated pneumonia (SAP) affects a fifth of stroke survivors annually, tripling the risk of death at 30 days and contributing to poorer rehabilitation outcomes, prolonged hospital stays and dependency at discharge. Systematic review evidence indicates that enhanced oral health care (OHC) has a preventative effect on the incidence of pneumonia amongst nursing home populations (absolute risk reductions 6.6% to 11.7%; numbers needed to treat 8.6 to 15.3 individuals). There are strong theoretical reasons to suggest similar benefits might be observed in stroke care settings but current empirical evidence is weak - trial quality (randomisation, blinding, sample size, reporting), intervention description and thus feasibility of translation into clinical practice is very poor. Following an extensive pre-clinical programme of work, investigators now plan the pilot phase (Phase II) of a stepped-wedge cluster RCT of a well-developed and defined complex OHC intervention versus usual OHC. Investigators aim to establish a robust web-based randomisation process, refine the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage and sampling methodologies. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites.

Detailed Description

SOCLE II is the pilot phase (Phase II) of a stepped-wedge cluster randomised controlled trial (RCT) of a complex oral health care (OHC) intervention versus usual OHC.
SOCLE II aims to evaluate the feasibility of a full scale pragmatic trial of the clinical and cost effectiveness of a complex OHC package of care versus usual care for people in stroke care settings. Ward level cluster randomisation will progress in a stepped wedge manner where after a period of baseline data collection each ward in a randomly allocated order will 'convert' from usual care to an enhanced oral health care intervention.
This pilot trial will assess the feasibility of delivering this enhanced OHC intervention across four sites and will inform the trial design of a full scale phase III trial including refining the proposed intervention (training, tools, equipment), recruitment, adherence, record linkage, sampling methodologies, sample size calculations and pilot our health economic evaluation. Investigators also aim to establish the relationship between SAP and plaque and any diversity between sites. Our proposed pilot work will support an application for a planned Phase III definitive trial.
Principal Research Questions:
(i) Are the SOCLE intervention and data collection process viable across multiple sites? (ii) Can sample size calculations and estimates of recruitment and retention be refined? (iii) Can pneumonia event rates across several sites and distribution over time post stroke onset be determined? (iv) Can the association between dental and denture plaque and SAP be established? (v) Can the predetermined criteria for progression to Phase III definitive multi-centred stepped wedge cluster RCT with economic evaluation be met?

Conditions

Interventions

  • Enhanced complex oral health care Other
    Intervention Desc: Our proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention: Patient Level: An individualised OHC assessment on admission and individualised OHC plans for patients, which may involve staff-led OHC support, access to OHC equipment, products and specialist support services and OHC health promotion components. Staff Level: Specialist web-based OHC educational training, including information on the oral cavity and structures; oral health problems (e.g. decay, gum disease, dry mouth); instruction on OHC techniques, equipment and products; use of the SOCLE assessment and protocol tools. Service Level: Processes to facilitate access to specialist dental support services (e.g. dentist, hygienist, denture repair laboratory). Essential OHC equipment (toothbrushes, denture marking kits) and products (e.g. toothpaste, oral balance gel) on the ward will be available.
    ARM 1: Kind: Experimental
    Label: Enhanced complex oral health care intervention
    Description: The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Pneumonia Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. No
Secondary Oral Health Impact Profile Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. No
Secondary Dental plaque Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. No
Secondary Denture plaque Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. No
Secondary Antibiotics prescribed Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. No
Secondary Death Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks. No

Sponsors