Stroke Oral healthCare pLan Evaluation (SOCLE II)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Glasgow Caledonian University
Sponsor:
Collaborators:
Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit
University of Glasgow
NHS Lanarkshire
Glasgow Dental Hospital and School
University of Edinburgh
Information provided by (Responsible Party):
Prof. Marian Brady, Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT01954212
First received: August 21, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Disorders
Stroke
Pneumonia
Oral Hygiene
Other: Enhanced complex oral health care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Glasgow Caledonian University:

Primary Outcome Measures:
  • Pneumonia [ Time Frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Denture plaque [ Time Frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. ] [ Designated as safety issue: No ]
  • Antibiotics prescribed [ Time Frame: Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Length of hospital stay [ Time Frame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks). ] [ Designated as safety issue: No ]
  • Discharge destination [ Time Frame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    Oral health care equipment and product resource use questionnaire, and specialist services resource use questionnaire


Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  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.
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.


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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to stroke care settings.

Exclusion Criteria:

  • Consent declined.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954212

Contacts
Contact: Marian Brady +44 141 331 8102 m.brady@gcu.ac.uk

Locations
United Kingdom
Hairmyres Hospital Not yet recruiting
East Kilbride, Lanarkshire, United Kingdom, G75 8RG
Contact: Campbell Chalmers       Campbell.Chalmers@lanarkshire.scot.nhs.uk   
Wishaw General Hospital Not yet recruiting
Wishaw, Lanarkshire, United Kingdom, ML2 0DP
Contact: Campbell Chalmers       Campbell.Chalmers@lanarkshire.scot.nhs.uk   
Stobhill Hospital Not yet recruiting
Glasgow, Scotland, United Kingdom, G21 3UW
Contact: Christine McAlpine       Christine.McAlpine@ggc.scot.nhs.uk   
Royal Alexandra Hospital Not yet recruiting
Paisley, Scotland, United Kingdom, PA2 9PN
Contact: Lindsay Erwin       Lindsay.Erwin@rah.scot.nhs.uk   
Sponsors and Collaborators
Glasgow Caledonian University
Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit
University of Glasgow
NHS Lanarkshire
Glasgow Dental Hospital and School
University of Edinburgh
  More Information

No publications provided

Responsible Party: Prof. Marian Brady, Professor, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT01954212     History of Changes
Other Study ID Numbers: TSA 2012/09
Study First Received: August 21, 2013
Last Updated: September 26, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Glasgow Caledonian University:
Oral health

Additional relevant MeSH terms:
Cerebrovascular Disorders
Pneumonia
Stroke
Cerebral Infarction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014