Validation and Reliability Testing of Dysphagia Trained Nurse Assessment

Dysphagia Following Cerebral Infarction Clinical Trial

Official title:

Validity And Reliability Of A Dysphagia Trained Nurse Assessment (DTNAx) Tool In Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700853
• Other study ID #: 17027
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Deglutition Disorders
• Dysphagia Following Cerebral Infarction
• Dysphagia Following Nontraumatic Intracerebral Hemorrhage
• Hemorrhage
• Infarction

Intervention

Diagnostic Test:
• Dysphagia Trained Nurse Assessment (DTNAx)
Bedside swallowing assessment carried out by trained nurses

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of dysphagia on gold standard test	Cut off scores as per Standardised and reliability assessment: Modified Barium Swallow Impairment Profile on Videofluoroscopy assessment	24 hours
Primary	Fluid Recommendation on gold standard test	On Videofluoroscopy - Least restrictive fluid with Penetration Aspiration Scale of 1 or 2, MBSImP pharyngeal residue rating of <3, number of swallows < 3.	24 hours
Primary	Diet Recommendation on gold standard test	On Videofluoroscopy - Least restrictive fluid with Penetration Aspiration Scale of 1 or 2, MBSImP pharyngeal residue rating of <3, number of swallows < 3. • If solid bolus trialled (forkmashable/normal) - mastication needs to be timely and complete - therefore MBS-Imp score on Component 3 Bolus preparation/mastication = 0	24 hours
Secondary	Outcome of SLT clinical bedside assessment (SLTAx)	This is not a standardised test - but it is usual practice. Information will be collected on the subtest carried out in the assessment. Ultimately the outcomes that are measured are SLT judgement of: presence of dysphagia, safe diet recommendation, safe fluid recommendation	24 hours
Secondary	Outcome of 2nd Dysphagia Trained Nurse Assessment (DTNAx)	The DTNAx standardised assessment and is the assessment that is being validated in this study. To measure intra and inter rater reliability this outcome measure is the outcome of a second DTNAx assessment - specifically the safe diet recommendation and safe fluid recommendation.	24 hours