DysphagiaNCT04779710
How Does Dysphagia Assessment in Acute Stroke Affect Pneumonia?
An observational study of Dysphagia and Pneumonia, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
Stroke-associated pneumonia (SAP) is common in acute stroke. A significant risk factor is dysphagia. To identify dysphagia, patients are screened using a bedside tool and those suspected of dysphagia then have a specialist Speech and Language Therapy (SLT) assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Pneumonia, Acute Stroke
- What is being tested?
- Staff Survey
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Sep 2020to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Speech and Language Therapy Clinical Leads in Hyper/Acute Stroke Units in hospitals in England and Wales
Who may be able to join
- Speech and Language Therapist working in a National Health Service (NHS) Hospital Stroke Unit in England and Wales
Who cannot join
- Non speech and language therapists
- Speech and Language Therapists not working in a NHS Hospital Stroke Unit in England and Wales
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: How Does Variation in Assessment and Clinical Management of Dysphagia in Acute Stroke Affect Development of Stroke-associated Pneumonia (SAP)?
Stroke-associated pneumonia (SAP) is common in acute stroke. A significant risk factor is dysphagia. To identify dysphagia, patients are screened using a bedside tool and those suspected of dysphagia then have a specialist Speech and Language Therapy (SLT) assessment. Currently there is a wide range of screening protocols used. The aim of this research is to investigate the variation in dysphagia assessment and management to identify what factors affect the risk of SAP. The type of screen and other variations in management and practice (such as time from hospital admission to when the screen is done) will be investigated to identify any associations with higher risk of SAP. A mixed methods study will include a systematic review of the literature, interviews with patients, carers and staff and a review of medical records to investigate the patient journey during the first 72 hours from admission. Findings will be triangulated to inform a national survey of dysphagia screening and management in hospitals registered with the Sentinel Stroke National Audit Programme (SSNAP). Data from the survey will be cross-referenced with the SSNAP register and analysed to identify relationships. Results will inform development of an intervention to reduce SAP for subsequent feasibility testing.
Read the detailed description
Research Questions: 1. How do methods of dysphagia assessment and clinical management during the first 72 hours of admission affect the risk of stroke patients developing Stroke-Associated Pneumonia (SAP)? 2. During the first 72 hours of admission, what organisational factors (for example; oral hygiene routine, adherence of the speech and language therapy recommendations) affect the risk of stroke patients developing SAP? Aims and objectives: 1. To explore how variations in dysphagia assessment and management within the first 72 hours post stroke, impacts on developing SAP? 2. What and how do other organisational factors affect the development of SAP? Background to the project: Dysphagia (swallowing problems) occurs in 37-55% of acute stroke patients and is associated with difficulty swallowing foods, liquids and saliva. Inhalation of oral or gastric contents into the lungs (aspiration) can lead to pneumonia which increases the risk of mortality and is one of the main causes of death in the first few days and weeks after stroke. Aspiration pneumonia is also independently associated with worse rehabilitation outcomes, increased length of hospitalisation and associated healthcare costs. Aspiration pneumonia develops most frequently in the first few days of stroke, therefore timely detection and management of dysphagia is essential. In England and Wales, patients with acute stroke are recommended to have their swallow screened using a validated multi item screening tool within four hours of admission and a comprehensive speech and language therapy (SLT) assessment within 72 hours of admission. However, the Royal College of Physicians (RCP) National Clinical Guideline for Stroke does not specify the exact screening tool to be used (2016).
The Sentinel Stroke National Audit Programme (SSNAP) is the national register of stroke in England and Wales and collects data for stroke patients in the majority of acute hospitals. Using this national dataset, Bray et al. (2016) found an association between a delay in screening and specialist SLT assessment with an increased risk of stroke-associated pneumonia (SAP) and that reducing the risk of SAP might also reduce mortality after stroke. There are several possible mechanisms for why delays in dysphagia assessment might lead to an increased risk of SAP, including variation in who, when and how the screening is carried out. Anecdotal evidence from the clinical team has found that a number of patients who pass the screen, are subsequently referred to SLT because of ongoing concerns about risk of aspiration. This raises the question of whether the timing of the screen is too early for some patients whose neurological symptoms may still be evolving. Other possible reasons might be that the screen is not sufficiently sensitive to detect aspiration or the competencies of the staff undertaking the screen are inadequate. Further studies are required to test these uncertainties and confirm or refute a causal relationship not only between dysphagia assessment and management and development of SAP but other potential outcomes, including death, alternative nutrition and return to normal diet.
Methods: Ethical approval will be sought from the Yorkshire and the Humber Sheffield Research Ethics Committee and the Research Ethics Committee at Sheffield Hallam University. Most hospital (aggregate) level SSNAP data are publicly accessible. A data request will be submitted for non-publicly available aggregate data, if necessary. Accessing anonymised patient level data from SSNAP involves applying for data access from Healthcare Quality Improvement Programme (HQIP) who commission SSNAP and are the data controller. Phase 1 (6 months) Systematic search and review of the literature: A systematic search and review of the literature will be undertaken on the nature and evidence for early assessment and management of dysphagia in acute stroke and the risk of developing stroke aspiration pneumonia, using the Centre for Reviews and Dissemination guidance on systematic reviews . The search strategies adopted RCP clinical guideline for Stroke will be utilised and developed, following a building-block approach which will identify search terms for the different concepts of the search question and culminating in a search of electronic databases. Manual search methods will also be carried out. The findings from the literature will be synthesised and used as one of the methods to inform the development of a national survey. A peer-reviewed, open-access paper will be submitted for publication based on the findings of the literature. Alongside this, a review of the evidence on questionnaire design to inform the development of the national survey will be carried out. During this phase, participant information sheets and consent forms and data collection tools for Phase 2 will be developed. Service users feedback on the study protocol and design, information accessibility of participant materials and research outcomes will be sought from stroke survivors and carers. Phase 2 (18 months) Mixed Methods Study: This phase will further inform the development of the national survey across the 199 hospitals registered with the SSNAP. The survey will be to find out about the dysphagia screening protocols used and details of the comprehensive SLT assessments so as to understand the variations in patient management during the 72 hours from admission. In addition, the questionnaire will investigate other organisational factors (e.g. training protocols) or care processes (e.g. policies on positioning, oral hygiene, early mobilisation) which may affect the development of SAP. To inform this development phase, data will be collected using two methods; a medical note review and interviews. Patient information will be collected from the medical notes of 30 consecutive patients admitted to the Hyper Acute Stroke Unit (HASU) in Sheffield Teaching Hospitals NHS Foundation Trust. Information will be collected on time/day of admission and dysphagia screen, outcome of screen, other investigations and assessments during 4 hours from admission, outcome of SLT assessment if indicated and whether SAP is recorded within the first 7 days post stroke. The data collected from this 72-hour timeline will be descriptively analysed to identify key events which occur on the patient pathway during the 72-hours. Staff and patient interviews will explore the views of different groups about what happens during these first 72 hours and how different factors may impact on patients developing SAP. Patients will be asked if they would like a carer to attend the interview. The role of the carer would be to support the patient during the interview recognising that some patients may appreciate a carer being present. All participants will be provided information about the study and a consent form and asked to indicate their consent to be involved. Possible areas for investigation include: Are the SLT dysphagia management plans put in place? Are patients put nil by mouth (NBM)? Who is responsible for providing oral hygiene for patients and how frequently is it carried out? Are patients positioned appropriately at mealtimes? Fifteen local and regional interviews will be undertaken with different staff groups e.g. Stroke Nurse Specialists, staff trained in dysphagia screening, SLT Stroke Team Leaders, Ward Sisters, Dysphagia Trained Practitioners/SLTs working in HASUs in Sheffield Teaching Hospitals and other regional NHS Trust HASUs. User perspectives will be gathered from five interviews with stroke patients and carers of patients who have received the dysphagia screen and/or had a comprehensive SLT swallow assessment. Patient participants will be those who have been admitted via the Neurological Assessment Unit where I work as part of their care team and routinely have access to their records. All the interviews will be recorded and transcribed. A framework approach will be used to analyse the interview transcripts and textual data from the interviews will be managed and coded using QSR NIVO software. The findings from the 72 hour time line and interviews will be triangulated to gain a more complete picture and to inform the content of the survey for the follow-on cross-sectional study of national practice. Phase 3 (12 months) National Survey: This phase will involve the development of the survey, in the form of a questionnaire. Service users will be involved in reviewing the format and accessibility of the language used. The electronic questionnaire will be piloted across a target group of SLTs from the Trent Dysphagia Clinical Excellence Network (CEN) who will access the pilot questionnaire and provide feedback via their virtual Basecamp network. The questionnaire will be adapted following their feedback before being distributed nationally to the SLT Clinical Lead for Stroke working in each Hyper/Acute Stroke Unit (H/ASU) in hospitals in England and Wales registered on the Sentinel Stroke National Audit Programme (SSNAP) register. The SLT Clinical Lead for Stroke will be identified from the researcher and research team existing professional networks, wider research networks, for example, the Council for Allied Health Professions Research (CAPHR), social media networks such as Twitter, and information that is publicly available. In instances where there is no pre-existing professional relationship or the information about the appropriate person is not publicly available the researcher would contact a third party, with the request that they circulate information about the study with the researcher's contact details, with a further request that the most appropriate person contact the researcher about the survey if they are interested in receiving more information. Phase 4 (12 months) Data Analysis: The survey data will be analysed and data extracted from the SSNAP register. Cross-referencing information from the questionnaire with centre-level SSNAP data will explore associations between date, time and type of screen, SLT assessment and the risk of developing SAP. The adjusted odds of developing SAP will be estimated by fitting multivariable logistic regression models. The data sets from the seminal research by Bray et al. (2016) will be used for consistency and comparison of data. The findings of this analysis will be published in an open-access, peer reviewed journal. Phase 5: (1 year) Write up and development of future research projects: The programme of work will be written up and the next stages developed.
- Conditions
- Dysphagia, Pneumonia, Acute Stroke
- Being tested
- Staff Survey
- Keywords
- assessment, acute stroke, dysphagia, aspiration pneumonia, screening
- Medical subject headings
- Deglutition Disorders, Pneumonia, Stroke, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staff SurveyOther
A mixed mode survey design comprising of a self-administered electronic survey with a secondary option of a postal survey. The survey population was Speech and Language Therapy (SLT) Clinical Leads for Acute Stroke in Hyper/Acute Hospital Stroke Units in England and Wales. The sample frame was Routinely Admitting, and Non-Routinely Admitting Acute Stroke Hospital Teams registered on the Sentinel Stroke National Audit Programme (SSNAP) register. One hundred and sixty-six hospital teams were included after exclusions. Survey participants were asked to respond about assessment and management of dysphagia and other clinical processes during the first seven days of a person's admission to hospital following a stroke. Respondents were asked to respond about practice on behalf of the Stroke Unit rather than as an individual practitioner.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between incidence of stroke-associated pneumonia and hospital teams using dysphagia screening protocols which use water only compared to water and other consistencies
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Measured: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Relationship between incidence of stroke-associated pneumonia and hospital teams using written guidelines for the first specialist swallow assessment compared to hospital teams that do not use written guidelines for the first specialist assessment
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Measured: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Relationship between incidence of stroke-associated pneumonia and hospital teams that insert nasogastric tubes overnight compared to hospital teams that do not insert nasogastric tubes overnight
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Measured: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Relationship between incidence of stroke-associated pneumonia and hospital teams with a written oral care protocol compared to hospital teams that do not have a written oral care protocol
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Measured: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start2 Sep 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Stroke Association, United Kingdom
- Responsible party
- Principal investigator, Sabrina Eltringham, Manchester Metropolitan University
- Investigators
- Sabrina Eltringham, Principal investigator, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779710
- Sponsor's protocol ID
- 222255
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
PubMed 16269630Vernino S, Brown RD Jr, Sejvar JJ, Sicks JD, Petty GW, O'Fallon WM. Cause-specific mortality after first cerebral infarction: a population-based study. Stroke. 2003 Aug;34(8):1828-32. doi: 10.1161/01.STR.0000080534.98416.A0. Epub 2003 Jul 10.
PubMed 12855836Ingeman A, Andersen G, Hundborg HH, Svendsen ML, Johnsen SP. In-hospital medical complications, length of stay, and mortality among stroke unit patients. Stroke. 2011 Nov;42(11):3214-8. doi: 10.1161/STROKEAHA.110.610881. Epub 2011 Aug 25.
PubMed 21868737Katzan IL, Dawson NV, Thomas CL, Votruba ME, Cebul RD. The cost of pneumonia after acute stroke. Neurology. 2007 May 29;68(22):1938-43. doi: 10.1212/01.wnl.0000263187.08969.45.
PubMed 17536051Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.
PubMed 21933425Bray BD, Smith CJ, Cloud GC, Enderby P, James M, Paley L, Tyrrell PJ, Wolfe CD, Rudd AG; SSNAP Collaboration. The association between delays in screening for and assessing dysphagia after acute stroke, and the risk of stroke-associated pneumonia. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):25-30. doi: 10.1136/jnnp-2016-313356. Epub 2016 Jun 13.
PubMed 27298147Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.
PubMed 30199856Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Smith CJ, Pownall S. Factors Associated with Risk of Stroke-Associated Pneumonia in Patients with Dysphagia: A Systematic Review. Dysphagia. 2020 Oct;35(5):735-744. doi: 10.1007/s00455-019-10061-6. Epub 2019 Sep 6.
PubMed 31493069Eltringham SA, Smith CJ, Pownall S, Sage K, Bray B. Variation in Dysphagia Assessment and Management in Acute Stroke: An Interview Study. Geriatrics (Basel). 2019 Oct 25;4(4):60. doi: 10.3390/geriatrics4040060.
PubMed 31731452Eltringham SA, Pownall S, Bray B, Smith CJ, Piercy L, Sage K. Experiences of Dysphagia after Stroke: An Interview Study of Stroke Survivors and Their Informal Caregivers. Geriatrics (Basel). 2019 Dec 7;4(4):67. doi: 10.3390/geriatrics4040067.
PubMed 31817883Eltringham SA, Bray BD, Smith CJ, Pownall S, Sage K. Are Differences in Dysphagia Assessment, Oral Care Provision, or Nasogastric Tube Insertion Associated with Stroke-Associated Pneumonia? A Nationwide Survey Linked to National Stroke Registry Data. Cerebrovasc Dis. 2022;51(3):365-372. doi: 10.1159/000519903. Epub 2021 Dec 16.
PubMed 34915473
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Variation in Assessment and Clinical Management of Dysphagia in Acute Stroke Affect Development of Stroke-associated Pneumonia (SAP)?
- ClinicalTrials.gov ID
- NCT04779710
- Acronym / sponsor ID
- 222255
- Conditions
- Dysphagia, Pneumonia, Acute Stroke
- Keywords
- assessment, acute stroke, dysphagia, aspiration pneumonia, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- The Stroke Association, United Kingdom
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke-associated pneumonia (SAP) is common in acute stroke. A significant risk factor is dysphagia. To identify dysphagia, patients are screened using a bedside tool and those suspected of dysphagia then have a specialist Speech and Language Therapy (SLT) assessment. Currently there is a wide range of screening protocols used. The aim of this research is to investigate the variation in dysphagia assessment and management to identify what factors affect the risk of SAP. The type of screen and other variations in management and practice (such as time from hospital admission to when the screen is done) will be investigated to identify any associations with higher risk of SAP. A mixed methods study will include a systematic review of the literature, interviews with patients, carers and staff and a review of medical records to investigate the patient journey during the first 72 hours from admission. Findings will be triangulated to inform a national survey of dysphagia screening and management in hospitals registered with the Sentinel Stroke National Audit Programme (SSNAP). Data from the survey will be cross-referenced with the SSNAP register and analysed to identify relationships. Results will inform development of an intervention to reduce SAP for subsequent feasibility testing.
Detailed description
Research Questions: 1. How do methods of dysphagia assessment and clinical management during the first 72 hours of admission affect the risk of stroke patients developing Stroke-Associated Pneumonia (SAP)? 2. During the first 72 hours of admission, what organisational factors (for example; oral hygiene routine, adherence of the speech and language therapy recommendations) affect the risk of stroke patients developing SAP? Aims and objectives: 1. To explore how variations in dysphagia assessment and management within the first 72 hours post stroke, impacts on developing SAP? 2. What and how do other organisational factors affect the development of SAP? Background to the project: Dysphagia (swallowing problems) occurs in 37-55% of acute stroke patients and is associated with difficulty swallowing foods, liquids and saliva. Inhalation of oral or gastric contents into the lungs (aspiration) can lead to pneumonia which increases the risk of mortality and is one of the main causes of death in the first few days and weeks after stroke. Aspiration pneumonia is also independently associated with worse rehabilitation outcomes, increased length of hospitalisation and associated healthcare costs. Aspiration pneumonia develops most frequently in the first few days of stroke, therefore timely detection and management of dysphagia is essential. In England and Wales, patients with acute stroke are recommended to have their swallow screened using a validated multi item screening tool within four hours of admission and a comprehensive speech and language therapy (SLT) assessment within 72 hours of admission. However, the Royal College of Physicians (RCP) National Clinical Guideline for Stroke does not specify the exact screening tool to be used (2016).
The Sentinel Stroke National Audit Programme (SSNAP) is the national register of stroke in England and Wales and collects data for stroke patients in the majority of acute hospitals. Using this national dataset, Bray et al. (2016) found an association between a delay in screening and specialist SLT assessment with an increased risk of stroke-associated pneumonia (SAP) and that reducing the risk of SAP might also reduce mortality after stroke. There are several possible mechanisms for why delays in dysphagia assessment might lead to an increased risk of SAP, including variation in who, when and how the screening is carried out. Anecdotal evidence from the clinical team has found that a number of patients who pass the screen, are subsequently referred to SLT because of ongoing concerns about risk of aspiration. This raises the question of whether the timing of the screen is too early for some patients whose neurological symptoms may still be evolving. Other possible reasons might be that the screen is not sufficiently sensitive to detect aspiration or the competencies of the staff undertaking the screen are inadequate. Further studies are required to test these uncertainties and confirm or refute a causal relationship not only between dysphagia assessment and management and development of SAP but other potential outcomes, including death, alternative nutrition and return to normal diet.
Methods: Ethical approval will be sought from the Yorkshire and the Humber Sheffield Research Ethics Committee and the Research Ethics Committee at Sheffield Hallam University. Most hospital (aggregate) level SSNAP data are publicly accessible. A data request will be submitted for non-publicly available aggregate data, if necessary. Accessing anonymised patient level data from SSNAP involves applying for data access from Healthcare Quality Improvement Programme (HQIP) who commission SSNAP and are the data controller. Phase 1 (6 months) Systematic search and review of the literature: A systematic search and review of the literature will be undertaken on the nature and evidence for early assessment and management of dysphagia in acute stroke and the risk of developing stroke aspiration pneumonia, using the Centre for Reviews and Dissemination guidance on systematic reviews . The search strategies adopted RCP clinical guideline for Stroke will be utilised and developed, following a building-block approach which will identify search terms for the different concepts of the search question and culminating in a search of electronic databases. Manual search methods will also be carried out. The findings from the literature will be synthesised and used as one of the methods to inform the development of a national survey. A peer-reviewed, open-access paper will be submitted for publication based on the findings of the literature. Alongside this, a review of the evidence on questionnaire design to inform the development of the national survey will be carried out. During this phase, participant information sheets and consent forms and data collection tools for Phase 2 will be developed. Service users feedback on the study protocol and design, information accessibility of participant materials and research outcomes will be sought from stroke survivors and carers. Phase 2 (18 months) Mixed Methods Study: This phase will further inform the development of the national survey across the 199 hospitals registered with the SSNAP. The survey will be to find out about the dysphagia screening protocols used and details of the comprehensive SLT assessments so as to understand the variations in patient management during the 72 hours from admission. In addition, the questionnaire will investigate other organisational factors (e.g. training protocols) or care processes (e.g. policies on positioning, oral hygiene, early mobilisation) which may affect the development of SAP. To inform this development phase, data will be collected using two methods; a medical note review and interviews. Patient information will be collected from the medical notes of 30 consecutive patients admitted to the Hyper Acute Stroke Unit (HASU) in Sheffield Teaching Hospitals NHS Foundation Trust. Information will be collected on time/day of admission and dysphagia screen, outcome of screen, other investigations and assessments during 4 hours from admission, outcome of SLT assessment if indicated and whether SAP is recorded within the first 7 days post stroke. The data collected from this 72-hour timeline will be descriptively analysed to identify key events which occur on the patient pathway during the 72-hours. Staff and patient interviews will explore the views of different groups about what happens during these first 72 hours and how different factors may impact on patients developing SAP. Patients will be asked if they would like a carer to attend the interview. The role of the carer would be to support the patient during the interview recognising that some patients may appreciate a carer being present. All participants will be provided information about the study and a consent form and asked to indicate their consent to be involved. Possible areas for investigation include: Are the SLT dysphagia management plans put in place? Are patients put nil by mouth (NBM)? Who is responsible for providing oral hygiene for patients and how frequently is it carried out? Are patients positioned appropriately at mealtimes? Fifteen local and regional interviews will be undertaken with different staff groups e.g. Stroke Nurse Specialists, staff trained in dysphagia screening, SLT Stroke Team Leaders, Ward Sisters, Dysphagia Trained Practitioners/SLTs working in HASUs in Sheffield Teaching Hospitals and other regional NHS Trust HASUs. User perspectives will be gathered from five interviews with stroke patients and carers of patients who have received the dysphagia screen and/or had a comprehensive SLT swallow assessment. Patient participants will be those who have been admitted via the Neurological Assessment Unit where I work as part of their care team and routinely have access to their records. All the interviews will be recorded and transcribed. A framework approach will be used to analyse the interview transcripts and textual data from the interviews will be managed and coded using QSR NIVO software. The findings from the 72 hour time line and interviews will be triangulated to gain a more complete picture and to inform the content of the survey for the follow-on cross-sectional study of national practice. Phase 3 (12 months) National Survey: This phase will involve the development of the survey, in the form of a questionnaire. Service users will be involved in reviewing the format and accessibility of the language used. The electronic questionnaire will be piloted across a target group of SLTs from the Trent Dysphagia Clinical Excellence Network (CEN) who will access the pilot questionnaire and provide feedback via their virtual Basecamp network. The questionnaire will be adapted following their feedback before being distributed nationally to the SLT Clinical Lead for Stroke working in each Hyper/Acute Stroke Unit (H/ASU) in hospitals in England and Wales registered on the Sentinel Stroke National Audit Programme (SSNAP) register. The SLT Clinical Lead for Stroke will be identified from the researcher and research team existing professional networks, wider research networks, for example, the Council for Allied Health Professions Research (CAPHR), social media networks such as Twitter, and information that is publicly available. In instances where there is no pre-existing professional relationship or the information about the appropriate person is not publicly available the researcher would contact a third party, with the request that they circulate information about the study with the researcher's contact details, with a further request that the most appropriate person contact the researcher about the survey if they are interested in receiving more information. Phase 4 (12 months) Data Analysis: The survey data will be analysed and data extracted from the SSNAP register. Cross-referencing information from the questionnaire with centre-level SSNAP data will explore associations between date, time and type of screen, SLT assessment and the risk of developing SAP. The adjusted odds of developing SAP will be estimated by fitting multivariable logistic regression models. The data sets from the seminal research by Bray et al. (2016) will be used for consistency and comparison of data. The findings of this analysis will be published in an open-access, peer reviewed journal. Phase 5: (1 year) Write up and development of future research projects: The programme of work will be written up and the next stages developed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Speech and Language Therapy Clinical Leads in Hyper/Acute Stroke Units in hospitals in England and Wales
Key inclusion criteria (1 listed)
- Speech and Language Therapist working in a National Health Service (NHS) Hospital Stroke Unit in England and Wales
Key exclusion criteria (2 listed)
- Non speech and language therapists
- Speech and Language Therapists not working in a NHS Hospital Stroke Unit in England and Wales
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staff SurveyA mixed mode survey design comprising of a self-administered electronic survey with a secondary option of a postal survey. The survey population was Speech and Language Therapy (SLT) Clinical Leads for Acute Stroke in Hyper/Acute Hospital Stroke Units in England and Wales. The sample frame was Routinely Admitting, and Non-Routinely Admitting Acute Stroke Hospital Teams registered on the Sentinel Stroke National Audit Programme (SSNAP) register. One hundred and sixty-six hospital teams were included after exclusions. Survey participants were asked to respond about assessment and management of dysphagia and other clinical processes during the first seven days of a person's admission to hospital following a stroke. Respondents were asked to respond about practice on behalf of the Stroke Unit rather than as an individual practitioner. | Other | – |
Primary outcome
Relationship between incidence of stroke-associated pneumonia and hospital teams using dysphagia screening protocols which use water only compared to water and other consistencies
Time frame: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Relationship between incidence of stroke-associated pneumonia and hospital teams using written guidelines for the first specialist swallow assessment compared to hospital teams that do not use written guidelines for the first specialist assessment
Time frame: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Relationship between incidence of stroke-associated pneumonia and hospital teams that insert nasogastric tubes overnight compared to hospital teams that do not insert nasogastric tubes overnight
Time frame: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Relationship between incidence of stroke-associated pneumonia and hospital teams with a written oral care protocol compared to hospital teams that do not have a written oral care protocol
Time frame: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia
Stroke-associated pneumonia was defined as the administration of antibiotics for a new clinical diagnosis of pneumonia in the first 7 days of admission as recorded on the SSNAP register
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 16269630Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
- Background: PubMed 12855836Vernino S, Brown RD Jr, Sejvar JJ, Sicks JD, Petty GW, O'Fallon WM. Cause-specific mortality after first cerebral infarction: a population-based study. Stroke. 2003 Aug;34(8):1828-32. doi: 10.1161/01.STR.0000080534.98416.A0. Epub 2003 Jul 10.
- Background: PubMed 21868737Ingeman A, Andersen G, Hundborg HH, Svendsen ML, Johnsen SP. In-hospital medical complications, length of stay, and mortality among stroke unit patients. Stroke. 2011 Nov;42(11):3214-8. doi: 10.1161/STROKEAHA.110.610881. Epub 2011 Aug 25.
- Background: PubMed 17536051Katzan IL, Dawson NV, Thomas CL, Votruba ME, Cebul RD. The cost of pneumonia after acute stroke. Neurology. 2007 May 29;68(22):1938-43. doi: 10.1212/01.wnl.0000263187.08969.45.
- Background: PubMed 21933425Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.
- Background: PubMed 27298147Bray BD, Smith CJ, Cloud GC, Enderby P, James M, Paley L, Tyrrell PJ, Wolfe CD, Rudd AG; SSNAP Collaboration. The association between delays in screening for and assessing dysphagia after acute stroke, and the risk of stroke-associated pneumonia. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):25-30. doi: 10.1136/jnnp-2016-313356. Epub 2016 Jun 13.
- Results publication: PubMed 30199856Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.
- Results publication: PubMed 31493069Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Smith CJ, Pownall S. Factors Associated with Risk of Stroke-Associated Pneumonia in Patients with Dysphagia: A Systematic Review. Dysphagia. 2020 Oct;35(5):735-744. doi: 10.1007/s00455-019-10061-6. Epub 2019 Sep 6.
- Results publication: PubMed 31731452Eltringham SA, Smith CJ, Pownall S, Sage K, Bray B. Variation in Dysphagia Assessment and Management in Acute Stroke: An Interview Study. Geriatrics (Basel). 2019 Oct 25;4(4):60. doi: 10.3390/geriatrics4040060.
- Results publication: PubMed 31817883Eltringham SA, Pownall S, Bray B, Smith CJ, Piercy L, Sage K. Experiences of Dysphagia after Stroke: An Interview Study of Stroke Survivors and Their Informal Caregivers. Geriatrics (Basel). 2019 Dec 7;4(4):67. doi: 10.3390/geriatrics4040067.
- Results publication: PubMed 34915473Eltringham SA, Bray BD, Smith CJ, Pownall S, Sage K. Are Differences in Dysphagia Assessment, Oral Care Provision, or Nasogastric Tube Insertion Associated with Stroke-Associated Pneumonia? A Nationwide Survey Linked to National Stroke Registry Data. Cerebrovasc Dis. 2022;51(3):365-372. doi: 10.1159/000519903. Epub 2021 Dec 16.
- Centre for Reviews and DisseminationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dysphagia
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Eltringham principal investigator
Manchester Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Pneumonia, run by Manchester Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between incidence of stroke-associated pneumonia and hospital teams using dysphagia screening protocols which use water only compared to water and other consistencies (time frame: SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779710, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.