Clinical trial NCT03700853: Validation and Reliability Testing of Dysphagia Trained Nurse Assessment
Official title: Validity And Reliability Of A Dysphagia Trained Nurse Assessment (DTNAx) Tool In Acute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia Following Cerebral Infarction
Dysphagia Following Nontraumatic Intracerebral Hemorrhage
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2018-10-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over 18 who have been admitted to the Acute Stroke Unit who have a clinical diagnosis of stroke, who have had a DTNAx. They are medically stable, able to sit out in a suitable chair and have no previous dysphagia

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of dysphagia on gold standard test
timeFrame: 24 hours
measure: Fluid Recommendation on gold standard test
timeFrame: 24 hours
measure: Diet Recommendation on gold standard test
timeFrame: 24 hours
Secondary outcomes:
measure: Outcome of SLT clinical bedside assessment (SLTAx)
timeFrame: 24 hours
measure: Outcome of 2nd Dysphagia Trained Nurse Assessment (DTNAx)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Timothy England
role: PRINCIPAL_INVESTIGATOR
References: