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How Does Dysphagia Assessment in Acute Stroke Affect Pneumonia?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779710
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : September 6, 2022
Sponsor:
Collaborator:
The Stroke Association, United Kingdom
Information provided by (Responsible Party):
Sabrina Eltringham, Manchester Metropolitan University

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.

Condition or disease Intervention/treatment
Dysphagia Pneumonia Acute Stroke Other: Staff Survey

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: How Does Variation in Assessment and Clinical Management of Dysphagia in Acute Stroke Affect Development of Stroke-associated Pneumonia (SAP)?
Actual Study Start Date : September 2, 2020
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : October 20, 2020



Intervention Details:
  • Other: Staff Survey
    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.


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Speech and Language Therapy Clinical Leads in Hyper/Acute Stroke Units in hospitals in England and Wales
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779710


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Manchester Metropolitan University
The Stroke Association, United Kingdom
Investigators
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Principal Investigator: Sabrina Eltringham Manchester Metropolitan University
  Study Documents (Full-Text)

Documents provided by Sabrina Eltringham, Manchester Metropolitan University:
Statistical Analysis Plan  [PDF] January 20, 2021

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Sabrina Eltringham, Principal Investigator, Manchester Metropolitan University
ClinicalTrials.gov Identifier: NCT04779710    
Other Study ID Numbers: 222255
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sabrina Eltringham, Manchester Metropolitan University:
assessment
acute stroke
dysphagia
aspiration pneumonia
screening
Additional relevant MeSH terms:
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Pneumonia
Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases