NCT01559649

Stroke Swallowing Screening Tool Validation

Development and Validation of a VA Stroke Swallowing Screening Tool

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 284 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Stroke is a major medical problem in the United States, and veterans are at significant risk given that the most critical risk factors of stroke, older age and associated medical problems such as high blood pressure, are common. Dysphagia, swallowing problems, can lead to aspiration which in turn may result increased pneumonia, particularly in stroke patients. Development and implementation of an accurate and consistent nursing swallowing screening tool to identify risk of aspiration in individuals admitted with suspected stroke is critical as it allows for immediate intervention, thereby reducing associated medical complications, length of stay, and healthcare costs. The availability of such screening tools, however, is limited. The primary objective of this study is to construct a reliable and valid swallowing screening tool to identify risk of aspiration in individuals admitted with suspected stroke.

Detailed description

Early detection of aspiration risk in acute stroke is critical as it allows for immediate intervention, thereby reducing mortality, morbidity, length of hospitalization, and healthcare costs. Screening of swallowing prior to the administration of food, liquid or medication, including aspirin, in individuals presenting with stroke symptoms is a guideline American Heart Association/American Stroke Association. In accordance with this guideline, the Veterans Health Administration (VHA) has advocated the screening of swallowing be a quality performance measure in acute stroke. Moreover, the Office of the Inspector General recently issued VHA Directive 2006-032 mandating that the initial nurse assessment must include a screening of swallowing. In response to the directive, many VHA facilities created and implemented some version of a nursing swallowing screening tool (SST), but to our knowledge, none have been validated using an instrumental swallowing examination nor has reliability been established. In developing and establishing a valid and reproducible SST for patients with stroke, clinicians are divided on the need to include trial water swallows as part of the SST. The current notion is that administering trial swallows by disciplines without expertise in dysphagia would compromise patient safety, thus this step is opposed by many speech pathologists and nurses. The prudency of introducing non-validated, non-reproducible SSTs is questionable. The primary objective of this study is to construct a reliable and valid SST to identify risk of aspiration in individuals admitted with suspected stroke. The specific aims of this proposal are to: 1) determine if nurses can make reliable inter-rater judgments of swallowing and non-swallowing features historically used by speech pathologists to make judgments of aspiration, and 2) identify the combination of items that provide the highest level of both sensitivity and specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke. Outcomes of this research will inform as to the execution of a multi-site feasibility study on the implementation of a reliable and valid SST by nurses Methods: Consecutive individuals admitted with suspected stroke (N = 270) will be recruited to participate. Individuals will undergo screening of swallowing and a VFSS. Screening items selected for validation in the identification of risk of aspiration in patients presenting with stroke symptoms were based on extensive literature review using Cochrane and QUADAS guidelines. Eight screening items will be tested for validity and inter-rater reliability: 6 non-swallowing features and 2 swallowing features. Reliability in nursing observations of each screening item will be completed in all participants. Speech pathologists will serve as the reference standard from which to compare reliability with registered nurses who routinely work on the hospital ward with stroke patients.

Conditions

• Cerebrovascular Disorders
• Deglutition Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Establishing Validity and Reliability	Consecutive individuals admitted with suspected stroke will be recruited to participate. Individuals will undergo screening of swallowing and a videofluoroscopic swallow study within two hours. Eight screening items will be tested for validity and inter-rater reliability: 6 nonswallowing features and 2 swallowing features. Reliability in nursing observations of each screening item will be completed in all participants. Speech pathologists trained in the screening items will serve as the reference standard from which to compare reliability with registered nurses who routinely work on the hospital ward with stroke patients

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2012-03-21
• Last updated: 2016-07-19
• Results posted: 2016-07-19

Locations

1 site across 1 country: United States