Overview

This trial is active, not recruiting.

Conditions cerebrovascular disorders, stroke, pneumonia, oral hygiene
Treatment enhanced complex oral health care
Phase phase 2
Sponsor Glasgow Caledonian University
Collaborator Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit
Start date October 2013
End date April 2015
Trial size 400 participants
Trial identifier NCT01954212, TSA 2012/09

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.
enhanced complex oral health care
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.
(No Intervention)
Oral health care (OHC) will be provided in the standard manner, with no change to usual care. Provision of this standard OHC will be sampled monthly. Surveys suggest that standard oral health care (OHC) in stroke care settings comprise poorly supported OHC interventions delivered by staff that lacked access to specialist training, products, equipment, assessments, protocols and dental services.

Primary Outcomes

Measure
Pneumonia
time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.

Secondary Outcomes

Measure
Oral Health Impact Profile
time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Dental plaque
time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Denture plaque
time frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Antibiotics prescribed
time frame: Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Death
time frame: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - All patients admitted to stroke care settings. Exclusion Criteria: - Consent declined.

Additional Information

Official title A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.
Principal investigator Marian Brady
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?
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Glasgow Caledonian University.