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Stroke Oral healthCare pLan Evaluation (SOCLE II)

Primary Purpose

Cerebrovascular Disorders, Stroke, Pneumonia

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Enhanced complex oral health care
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebrovascular Disorders focused on measuring Oral health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients admitted to stroke care settings.

Exclusion Criteria:

  • Consent declined.

Sites / Locations

  • Hairmyres Hospital
  • Wishaw General Hospital
  • Stobhill Hospital
  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced complex oral health care intervention

Usual oral health care

Arm Description

The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oral Health Impact Profile
Patient rated Oral Health Impact Profile (with activity and participation components, Locker et al 2002)
Dental plaque
Denture plaque
Antibiotics prescribed
The prescription of antibiotics and type of antibiotic prescription will be documented from the drug kardex.
Death

Full Information

First Posted
August 21, 2013
Last Updated
February 27, 2017
Sponsor
Glasgow Caledonian University
Collaborators
Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit, University of Glasgow, NHS Lanarkshire, Glasgow Dental Hospital and School, University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01954212
Brief Title
Stroke Oral healthCare pLan Evaluation
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glasgow Caledonian University
Collaborators
Nursing Midwifery and Allied Health Profession (NMAHP) Research Unit, University of Glasgow, NHS Lanarkshire, Glasgow Dental Hospital and School, University of Edinburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Stroke, Pneumonia, Oral Hygiene
Keywords
Oral health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced complex oral health care intervention
Arm Type
Experimental
Arm Description
The complex oral health care (OHC) intervention (SOCLE intervention) includes patient, staff and service level interventions.
Arm Title
Usual oral health care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced complex oral health care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pneumonia
Description
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.
Time Frame
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Secondary Outcome Measure Information:
Title
Oral Health Impact Profile
Description
Patient rated Oral Health Impact Profile (with activity and participation components, Locker et al 2002)
Time Frame
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Title
Dental plaque
Time Frame
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Title
Denture plaque
Time Frame
Weekly assessments for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Title
Antibiotics prescribed
Description
The prescription of antibiotics and type of antibiotic prescription will be documented from the drug kardex.
Time Frame
Weekly for the duration of ward stay until discharge, an expected average stay of no more than 3 weeks.
Title
Death
Time Frame
Participants will be followed for the duration of hospital stay, an expected average stay of no more than 3 weeks.
Other Pre-specified Outcome Measures:
Title
Length of hospital stay
Time Frame
Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Title
Discharge destination
Time Frame
Determined at point of discharge from hospital ward (expected average stay of no more than 3 weeks).
Title
Knowledge and attitudes of staff
Description
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)
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).
Title
Adherence
Description
Adherence to study protocol - including completed assessments, documented oral health care plans
Time Frame
Weekly assessments for the duration of study (16 months).
Title
OHC resource use
Description
Oral health care equipment and product resource use questionnaire, and specialist services resource use questionnaire
Time Frame
Weekly assessments for the duration of study (16 months).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients admitted to stroke care settings. Exclusion Criteria: Consent declined.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Brady
Organizational Affiliation
Glasgow Caledonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hairmyres Hospital
City
East Kilbride
State/Province
Lanarkshire
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
State/Province
Lanarkshire
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Stobhill Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
State/Province
Scotland
ZIP/Postal Code
PA2 9PN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31564241
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.
Results Reference
derived
PubMed Identifier
26079661
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.
Results Reference
derived

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Stroke Oral healthCare pLan Evaluation

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