Stroke Oral healthCare pLan Evaluation
SOCLE II
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.
1 other identifier
interventional
437
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 28, 2017
February 1, 2017
1.5 years
August 21, 2013
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pneumonia
Based on the Mann Criteria for Chest infection and evaluated based on concurrent review of case notes at each weekly data collection point and a retrospective review of case notes on discharge.
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary Outcomes (5)
Oral Health Impact Profile
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Dental plaque
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Denture plaque
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Antibiotics prescribed
Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Death
Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
Other Outcomes (5)
Length of hospital stay
Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Discharge destination
Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Knowledge and attitudes of staff
1. Prior to OHC training package (3 to 10 months after start of recruitment depending on randomised allocation). 2. After completion of training package. 3. At close of study (16 months after recruitment starts at the initial site).
- +2 more other outcomes
Study Arms (2)
Enhanced complex oral health care intervention
EXPERIMENTALThe complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.
Usual oral health care
NO INTERVENTIONOral 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All patients admitted to stroke care settings.
You may not qualify if:
- Consent declined.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glasgow Caledonian Universitylead
- Nursing Midwifery and Allied Health Profession (NMAHP) Research Unitcollaborator
- University of Glasgowcollaborator
- NHS Lanarkshirecollaborator
- Glasgow Dental Hospital and Schoolcollaborator
- University of Edinburghcollaborator
Study Sites (4)
Hairmyres Hospital
East Kilbride, Lanarkshire, G75 8RG, United Kingdom
Wishaw General Hospital
Wishaw, Lanarkshire, ML2 0DP, United Kingdom
Stobhill Hospital
Glasgow, Scotland, G21 3UW, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, PA2 9PN, United Kingdom
Related Publications (2)
Brady MC, Stott DJ, Weir CJ, Chalmers C, Sweeney P, Barr J, Pollock A, Bowers N, Gray H, Bain BJ, Collins M, Keerie C, Langhorne P. A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards. Int J Stroke. 2020 Apr;15(3):318-323. doi: 10.1177/1747493019871824. Epub 2019 Sep 30.
PMID: 31564241DERIVEDBrady MC, Stott D, Weir CJ, Chalmers C, Sweeney P, Donaldson C, Barr J, Barr M, Pollock A, McGowan S, Bowers N, Langhorne P. Clinical and cost effectiveness of enhanced oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol. Int J Stroke. 2015 Aug;10(6):979-84. doi: 10.1111/ijs.12530. Epub 2015 Jun 16.
PMID: 26079661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marian Brady
Glasgow Caledonian University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 21, 2013
First Posted
October 1, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2016
Last Updated
February 28, 2017
Record last verified: 2017-02