Clinical trial NCT01954212: Stroke Oral healthCare pLan Evaluation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Disorders
Stroke
Pneumonia
Oral Hygiene
Keywords: Oral health
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit
name: University of Glasgow
name: NHS Lanarkshire
name: Glasgow Dental Hospital and School
name: University of Edinburgh
First posted: 2013-10-01
Enrollment: 437
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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?

Eligibility criteria: Inclusion Criteria:

* All patients admitted to stroke care settings.

Exclusion Criteria:

* Consent declined.

Primary outcomes:
measure: Pneumonia
timeFrame: 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
timeFrame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
measure: Dental plaque
timeFrame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
measure: Denture plaque
timeFrame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
measure: Antibiotics prescribed
timeFrame: Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
measure: Death
timeFrame: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
Other outcomes:
measure: Length of hospital stay
timeFrame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
measure: Discharge destination
timeFrame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
measure: Knowledge and attitudes of staff
timeFrame: 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).
measure: Adherence
timeFrame: Weekly assessments for the duration of study (16 months).
measure: OHC resource use
timeFrame: Weekly assessments for the duration of study (16 months).
Locations:
city: East Kilbride
country: United Kingdom
facility: Hairmyres Hospital
state: Lanarkshire
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Stobhill Hospital
state: Scotland
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
state: Scotland
Study officials:
affiliation: Glasgow Caledonian University
name: Marian Brady
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Brady 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.