Validation and Reliability Testing of Dysphagia Trained Nurse Assessment

NCT03700853 | Completed DMC

• 1 other identifier: 17027
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia Following Cerebral Infarction; Dysphagia Following Nontraumatic Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Outcome of SLT clinical bedside assessment (SLTAx)

  24 hours

• Outcome of 2nd Dysphagia Trained Nurse Assessment (DTNAx)

  24 hours

Interventions

Dysphagia Trained Nurse Assessment (DTNAx) DIAGNOSTIC_TEST

Bedside swallowing assessment carried out by trained nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Study Officials

• Timothy England

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 9, 2018
• Study Start: December 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

GB (1)