NCT04779710

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

February 24, 2021

Last Update Submit

March 12, 2024

Conditions

Keywords

assessmentacute strokedysphagiaaspiration pneumoniascreening

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    SSNAP 2019 Patient Centred Post 72 hour cohort data will be used for stroke-associated pneumonia

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Speech and Language Therapy Clinical Leads in Hyper/Acute Stroke Units in hospitals in England and Wales

You may qualify if:

  • Speech and Language Therapist working in a National Health Service (NHS) Hospital Stroke Unit in England and Wales

You may not qualify if:

  • Non speech and language therapists
  • Speech and Language Therapists not working in a NHS Hospital Stroke Unit in England and Wales

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (11)

  • 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.

    PMID: 16269630BACKGROUND
  • Vernino 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.

    PMID: 12855836BACKGROUND
  • Ingeman 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.

    PMID: 21868737BACKGROUND
  • Katzan 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.

    PMID: 17536051BACKGROUND
  • Westendorp 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.

    PMID: 21933425BACKGROUND
  • Bray 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.

    PMID: 27298147BACKGROUND
  • Eltringham 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.

  • Eltringham 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.

  • Eltringham 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.

  • Eltringham 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.

  • Eltringham 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.

Related Links

MeSH Terms

Conditions

Deglutition DisordersPneumoniaStrokePneumonia, Aspiration

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sabrina Eltringham

    Manchester Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 3, 2021

Study Start

September 2, 2020

Primary Completion

October 20, 2020

Study Completion

October 20, 2020

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations