MAPPS: Mouth care to prevent pneumonia in older people study
| ISRCTN | ISRCTN63296676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63296676 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 291778 |
| Protocol serial number | CPMS50653, NIHR201110, IRAS 291778 |
| Sponsor | South Tees Hospitals NHS Foundation Trust |
| Funders | NIHR Central Commissioning Facility (CCF), National Institute for Health Research (NIHR) (UK) |
- Submission date
- 15/12/2021
- Registration date
- 04/01/2022
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Hospital acquired pneumonia (HAP) is the commonest healthcare associated infection in Europe. Up to 70% of patients with HAP may die. HAP occurs because certain bacteria start to live in the mouth when patients become unwell and travel to the lungs. Patients with HAP stay on average an extra 12 days in hospital which is unpleasant for patients and costly for the NHS.
Research suggests frequent mouth care might prevent pneumonia whilst in hospital. However the evidence is not strong enough to make changes to clinical care. A large trial is therefore needed, but some initial work is required to guide successful design and delivery.
This is a feasibility study, aiming to investigate the training, delivery and fidelity of the intervention, with particular emphasis on patients with delirium/dementia, and investigate collection of outcomes for a larger study.
Who can participate?
Four wards (3 trusts) that admit patients with hip fractures (and some medical patients) will participate.
What does the study involve?
The sites will be randomised to start the mouth care intervention every three months apart. Patients will receive three times a day tooth/tongue/denture brushing with an antiseptic mouthwash and recorded by trained healthcare assistants. Interviews will be held with staff and patients to record experiences of delivering and receiving mouth care.
What are the possible benefits and risks of participating?
Benefits:
More frequent mouth care will improve oral health and may be easier to eat, talk and socialise. It may be that it also will reduce risk of getting a pneumonia in hospital, reduced hospital stay and impact quality of life however, this will need to be proven. Sometimes mouth care is not consistently provided in hospitals, especially those who cannot do mouth care by themselves, so taking part in this study may mean they are more likely to access regular mouth care.
Risks:
The mouth wash (chlorhexidine – the same thing in the mouthwash Corsodyl) can cause tooth staining in some people. Staining can be minimised by avoiding tea or coffee in the hour after using chlorhexidine. If staining occurs, brushing with toothpaste an hour after using chlorhexidine can remove it. If staining persists then it can be removed by scale and polish by the patient's routine dentist.
Where is the study run from?
South Tees Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2021 to September 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Lucksy Cottam, lucksy.kottam@nhs.net
Contact information
Scientific
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
 ORCID ID |
0000-0002-7976-2416 |
|---|---|
| Phone | +44 1642 854814 |
| lucksy.kottam@nhs.net |
Scientific
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
| ORCID ID |
0000-0002-9462-4425 |
|---|---|
| Phone | +44 1642 835764 |
| natalie.clark17@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized study |
| Secondary study design | Non randomised study |
| Participant information sheet | 40818 MAPPS Consultee (Prospective) V1.1 16Nov2021.pdf |
| Scientific title | Mouth cAre to Prevent Pneumonia in older people Study (MAPPS): a feasibility study |
| Study acronym | MAPPS |
| Study objectives | It is feasible to deliver three times daily mouthcare (with an antiseptic mouthwash (Chlorhexidine 0.2%) and application of lip moisturiser) to hospital inpatients for up to 4 weeks consistently with existing staffing, provision of an education pack, a mouthcare pack, and premade documentation set |
| Ethics approval(s) | Approved 25/11/2021, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048083; bradfordleeds.rec@hra.nhs.uk), ref: 21/YH/0242 |
| Health condition(s) or problem(s) studied | Mouth care to prevent pneumonia in older people |
| Intervention | Patient: Three times daily tooth brushing with an antiseptic mouthwash (Chlorhexidine 0.2%) and application of lip moisturiser for a maximum 4 weeks. Patients will be encouraged to complete this independently however there will be trained healthcare assistants to help deliver the intervention for those requiring assistance due to lack of capacity or any other issues. Healthcare assistants will also offer and prompt patients to complete the mouth care intervention at the specified time points. Staff: Attending mouth care education and training as provided by the study team. Documentation - completing the daily mouth care and infection record. Intervention delivery - assisting the patients and prompting patients to complete the intervention. Mouth care champions will be identified at the start of the study for each participating site. The mouth care champion will usually be a healthcare assistant, ideally with an interest in mouth care. The mouth care champion will be asked to conduct weekly huddles with participating nursing staff to discuss and resolve problems, promote the intervention, and to act as a bridge to the study team to feedback concerns and ideas. Mouth care champions will feed back comments to the study team via electronic systems. Research nurses will log any significant comments from the staff delivering the intervention via the study log. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Proportion of mouth care episodes delivered out of eligible episodes, information will be collected daily via the daily mouth care record during their stay on the participating ward. This will be the proportion of mouth care episodes that were delivered (i.e. not coded as missed or forgotten). Participants could be in the intervention for up to 28 days, with 3 eligible mouth care episodes each day, unless they are discharged or withdrawn sooner. |
| Key secondary outcome measure(s) |
1. Mouth care delivery |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1470 |
| Total final enrolment | 248 |
| Key inclusion criteria | Mouth care intervention: 1. Aged over 18 years old 2. Admitted to unit in study (predominantly patients with hip fracture, but will include some medical/orthopaedic patients) 3. Consent or assent to take part in the study 4. Anticipated hospital stay of >3 days Qualitative interviews: 1. Ward staff 2. Senior nursing staff 3. Patients/carers |
| Key exclusion criteria | Mouth care intervention: 1. Patients on the end of life care pathway 2. Within 10 days of a positive COVID swab |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Middlesbrough
TS4 3BW
United Kingdom
Hexham
NE46 1QJ
United Kingdom
Ashington
NE63 9JJ
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Consultee (Prospective) version 1.1 |
16/11/2021 | 04/01/2022 | No | Yes |
| Participant information sheet | Consultee (Retrospective) version 1.1 |
16/11/2021 | 04/01/2022 | No | Yes |
| Participant information sheet | PIS (Prospective) version 1.1 |
16/11/2021 | 04/01/2022 | No | Yes |
| Participant information sheet | PIS (Retrospective) version 1.1 |
16/11/2021 | 04/01/2022 | No | Yes |
| Participant information sheet | Qualitative interview version 1.1 |
16/11/2021 | 04/01/2022 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.0 | 07/09/2021 | 04/01/2022 | No | No |
Additional files
- 40818 MAPPS Consultee (Retrospective) V1.1 16Nov2021.pdf
- Consultee (Retrospective)
- 40818 MAPPS Consultee (Prospective) V1.1 16Nov2021.pdf
- Consultee (Prospective)
- 40818 MAPPS PIS (Retrospective) V1.1 16Nov2021.pdf
- PIS (Retrospective)
- 40818 MAPPS PIS (Prospective) V1.1 16Nov2021.pdf
- PIS (Prospective)
- 40818 MAPPS PIS (Qualitative Interview) V1.1 16Nov2021.pdf
- Qualitative interview
- 40818 MAPPS Protocol V1.0 07Sep2021.pdf
- Protocol file
Editorial Notes
17/12/2024: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
12/09/2024: The intention to publish date was changed from 01/03/2024 to 31/12/2024.
30/03/2023: The overall end date was changed from 31/03/2023 to 30/09/2023.
07/03/2023: Total final enrolment added.
15/12/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
