Tooth brushing to prevent pneumonia complicating stroke Nervous System Diseases Stroke
Conditions
Interventions
Following consent/declaration, the CRN practitioner will conduct Visit 1 - Baseline assessment. Once complete, the participant will be randomised to the Oral Healthcare (OHC) intervention arm - either
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main study 1. Aged 18 years or over 2. Within 24 hours of admission with acute ischaemic or haemorrhage stroke 3. Dysphagic* (failed bedside swallow or Speech & Language Therapy Assessment at any stage during admission when screened for inclusion, even if now resolved at time of screening) 4. At least one natural tooth 5. Informed consent available from participant and/or personal or professional consultee Focus group - Patients 1. Aged 18 years or over 2. Able to successfully engage in conversation by any means (receptive and/or expressive communication impairment with supported conversation techniques when required) 3. Dysphagic (failed bedside swallow or Speech & Language Therapy Assessment) at any stage during their stay 4. At least one natural tooth 5. Informed consent available from participant and/or personal or professional consultee Focus group -Relatives/Carers of Stroke Survivors 1. Aged 18 years or over 2. Carers or relatives of stroke survivors currently being cared for or previously cared for (last 3 months) on the stroke unit at one of the four hospital sites, who have been dysphagic at any time during their stay Focus group - staff 1. A member of clinical staff working on the stroke unit at one of the four hospital sites
Exclusion criteria
Exclusion criteria: Main study 1. Planned repatriation to non-participating site 2. Planned imminent mechanical ventilation or palliative care 3. No natural teeth 4. Known allergy to chlorhexidine 5. Confirmed SARS-Cov-2 infection at time of screening 6. Receiving antibiotic therapy for chest infection at time of screening 7. Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention 8. Patients currently participating in other Clinical Trial of an Investigational Medicinal Product (CTIMP) may be co-enrolled at the discretion of the PI of the relevant CTIMP Focus groups No specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome: Recruitment and set-up of sites within 6 months of study start measured as confirmation of Capacity & Capability (C&C) from each site | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Implementation of staff education and training at all four participating sites within 3 months of trial start date measured using Theoretical Domains Framework (TDF) to identify barriers and facilitators to implementation of the OHC interventions. 2. Recruitment of participants to work stream 1 (feasibility) within 15 months of trial start date measured as monthly recruitment of 8 participants 3. Retention of consented participants measured as those receiving allocated oral healthcare (OHC) intervention until discharge/repatriation from participating site for a maximum of 3 months from date of stroke symptom-onset and by completion of follow-up (by telephone or face-toface) at 3 months from date of stroke symptom-onset 4. Adherence to allocated OHC treatment measured as those receiving allocated OHC intervention twice-daily until discharge/repatriation from participating site for a maximum of 3 months from date of stroke symptom-onset 5. Measured weekly from 14 days from stroke-onset to maximum 3 months and discharge: 5.1. Swallow status will be measured weekly from 14 days from stroke-onset to maximum 3 months and discharge by capturing the result of any clinical Speech & Language Therapy (SLT) or bedside swallow assessment 5.2. Incident pneumonia based on CDC criteria 5.3. Oral health measured using the Geriatric Oral Health Assessment Index (GOHAI) 6. Condition of the oral cavity will be measured using THROAT score at 7-10 days from stroke-onset 7. Adverse events measured using patient records at 7-10 days from stroke-onset 8. Disability measured using the modified Rankin Scale score at 3 months from stroke-onset | — |
Countries
England, United Kingdom
Outcome results
None listed