Stroke Oral healthCare pLan Evaluation

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.

Conditions

• Cerebrovascular Disorders
• Stroke
• Pneumonia
• Oral Hygiene

Interventions

OTHER

Enhanced complex oral health care

Our proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention: 1. 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. 2. 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. 3. 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.

Sponsors & Collaborators

• Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit

  collaborator UNKNOWN

• University of Glasgow

  collaborator OTHER

• NHS Lanarkshire

  collaborator OTHER_GOV

• Glasgow Dental Hospital and School

  collaborator UNKNOWN

• University of Edinburgh

  collaborator OTHER

• Glasgow Caledonian University

  lead OTHER

Principal Investigators

• Marian Brady · Glasgow Caledonian University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2015-04-30

Completion

2016-04-30

Countries

• United Kingdom

Study Locations