Stroke Oral healthCare pLan Evaluation

Stroke Clinical Trial

— SOCLE II  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954212
• Other study ID #: TSA 2012/09
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2013
• Last updated: February 27, 2017
• Start date: October 2013
• Est. completion date: April 2016

Study information

• Verified date: February 2017
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients admitted to stroke care settings.

Exclusion Criteria:

• Consent declined.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Oral Hygiene
• Pneumonia
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Hairmyres Hospital	East Kilbride	Lanarkshire
United Kingdom	Stobhill Hospital	Glasgow	Scotland
United Kingdom	Royal Alexandra Hospital	Paisley	Scotland
United Kingdom	Wishaw General Hospital	Wishaw	Lanarkshire

Sponsors (6)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Glasgow Dental Hospital and School, NHS Lanarkshire, Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit, University of Edinburgh, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay		Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Other	Discharge destination		Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Other	Knowledge and attitudes of staff	In this stepped-wedge randomised controlled trial design staff will be asked to complete knowledge and attitudes questionnaires (Frenkel 2001) at the 3 stated time points. (Ref: Frenkel HF et al. Improving oral health of institutionalised elderly people by educating caregivers. Community Dent Oral Epidemiol 2001;29:289-97)	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).
Other	Adherence	Adherence to study protocol - including completed assessments, documented oral health care plans	Weekly assessments for the duration of study (16 months).
Other	OHC resource use	Oral health care equipment and product resource use questionnaire, and specialist services resource use questionnaire	Weekly assessments for the duration of study (16 months).
Primary	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	Oral Health Impact Profile	Patient rated Oral Health Impact Profile (with activity and participation components, Locker et al 2002)	Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary	Dental plaque		Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary	Denture plaque		Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary	Antibiotics prescribed	The prescription of antibiotics and type of antibiotic prescription will be documented from the drug kardex.	Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary	Death		Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.