Stroke Oral healthCare pLan Evaluation (SOCLE II)
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|ClinicalTrials.gov Identifier: NCT01954212|
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Disorders Stroke Pneumonia Oral Hygiene||Other: Enhanced complex oral health care||Phase 2|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||437 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||October 2013|
|Primary Completion Date :||April 2015|
|Study Completion Date :||April 2016|
Experimental: Enhanced complex oral health care intervention
The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.
Other: Enhanced complex oral health care
Our proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention:
No Intervention: Usual oral health care
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.
- Pneumonia [ Time Frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. ]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.
- 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. ]Patient rated Oral Health Impact Profile (with activity and participation components, Locker et al 2002)
- 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. ]The prescription of antibiotics and type of antibiotic prescription will be documented from the drug kardex.
- Death [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks. ]
- Length of hospital stay [ Time Frame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks). ]
- Discharge destination [ Time Frame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks). ]
- Knowledge and attitudes of staff [ Time Frame: 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). ]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)
- Adherence [ Time Frame: Weekly assessments for the duration of study (16 months). ]Adherence to study protocol - including completed assessments, documented oral health care plans
- OHC resource use [ Time Frame: Weekly assessments for the duration of study (16 months). ]Oral health care equipment and product resource use questionnaire, and specialist services resource use questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954212
|East Kilbride, Lanarkshire, United Kingdom, G75 8RG|
|Wishaw General Hospital|
|Wishaw, Lanarkshire, United Kingdom, ML2 0DP|
|Glasgow, Scotland, United Kingdom, G21 3UW|
|Royal Alexandra Hospital|
|Paisley, Scotland, United Kingdom, PA2 9PN|
|Principal Investigator:||Marian Brady||Glasgow Caledonian University|