Stroke Oral healthCare pLan Evaluation (SOCLE II)

February 27, 2017 updated by: Prof. Marian Brady, Glasgow Caledonian University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lanarkshire
      • East Kilbride, Lanarkshire, United Kingdom, G75 8RG
        • Hairmyres Hospital
      • Wishaw, Lanarkshire, United Kingdom, ML2 0DP
        • Wishaw General Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G21 3UW
        • Stobhill Hospital
      • Paisley, Scotland, United Kingdom, PA2 9PN
        • Royal Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients admitted to stroke care settings.

Exclusion Criteria:

  • Consent declined.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Dental plaque
Time Frame: Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
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.
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.
Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Death
Time Frame: Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
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).
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)
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).
Adherence
Time Frame: Weekly assessments for the duration of study (16 months).
Adherence to study protocol - including completed assessments, documented oral health care plans
Weekly assessments for the duration of study (16 months).
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
Weekly assessments for the duration of study (16 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glasgow Caledonian University

Collaborators

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

Investigators

  • Principal Investigator: Marian Brady, Glasgow Caledonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA 2012/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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