Validation and Reliability Testing of Dysphagia Trained Nurse Assessment

NCT ID: NCT03700853

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-03-31

Brief Summary

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Nurses at Royal Derby Hospital, UK have been trained to use a comprehensive protocol based dysphagia assessment (Dysphagia Trained Nurse Assessment (DTNAx)) to assess all acute stroke patients on admission. This study aims to validate the tool by comparing it to the gold standard assessment - Videofluoroscopy and usual assessment by a Speech and Language Therapist. Inter-rater and intra-rater reliability will also be tested by comparing the assessment results of two different nurses or the same nurse.

Detailed Description

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Speech and Language Therapists (SLTs) at Royal Derby Hospital (RDH) have developed a tool that trained nurses can use to carry out swallowing assessments with patients following a stroke. It consists of checks to ensure the patient is alert/well enough, checks any abnormalities in the muscles of the mouth or throat and trials different types of foods/drinks. If they 'pass' the assessment patients are started with regular diet and fluids. If they have dysphagia the nurses can recommend modified foods/drinks if they have found to be safe during the assessment. If the patients 'fail' with all trials - they remain nil by mouth. Around 50% of patients who have a stroke have difficulties swallowing (dysphagia). If dysphagia is identified early it reduces secondary complications such as pneumonia. There are no similar tools in the UK that have been tested to check they are doing what they say they are doing (validity) or the results are the same no matter which trained nurse uses the tool (reliability). This study aims to test the validity and reliability of the Dysphagia Trained Nurse Assessment DTNAx that is currently used in the acute stroke pathway at RDH.

Over an 18 month period we aim to recruit 50 patients admitted to RDH with a new stroke and who have had an initial DTNAx. The results of the DTNAx will be compared to the gold standard dysphagia assessment - videofluoroscopy - a video xray of swallowing and also compared to the usual SLT assessment. We can calculate whether the tool identifies dysphagia and whether the recommendations made by using the tool are accurate and safe. To test reliability - the DTNAx will be repeated by the same nurse or by a different nurse. The patients will be involved in the study for approximately 24 hours.

Conditions

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Dysphagia Following Cerebral Infarction Dysphagia Following Nontraumatic Intracerebral Hemorrhage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Dysphagia Trained Nurse Assessment (DTNAx)

Bedside swallowing assessment carried out by trained nurses

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 18
* Clinical diagnosis of stroke (ischaemic or haemorrhagic)

Exclusion Criteria

* Dysphagia of another cause
* Unable to tolerate VFS due to agitation or severe cognitive difficulties (patients need to be able to sit in a suitable chair - REA assist, 9L, Mangar Porter, Tilt and Space etc. for VFS)
* Not medically well enough to undertake assessments (as determined by the clinical care team)
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy England

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17027

Identifier Type: -

Identifier Source: org_study_id