Stroke Swallowing Screening Tool Validation



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:October 2012
End Date:December 2015

Use our guide to learn which trials are right for you!

Development and Validation of a VA Stroke Swallowing Screening Tool

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, are a
major source of disability following stroke affecting quality of life, nutrition, hydration,
and pulmonary status. Development and implementation of an accurate and consistent nursing
swallowing screening tool to identify risk of dysphagia 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 dysphagia in
individuals admitted with suspected stroke.

Early detection of dysphagia 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 dysphagia 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
dysphagia 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 dysphagia 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. Nurse practitioners with advanced
practice skills in stroke and 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.

Inclusion Criteria:

- Male and female Veterans of all ethnicities admitted to MEDVAMC with a new suspected
ischemic or hemorrhagic stroke will be eligible to participate.

- Individuals with a history of prior strokes without dysphagia will be eligible to
participate.

- Patients must be medically stable as determined by the attending neurologist.

- Participants with language or cognitive deficits who are judged by the attending
neurologist to not have capacity to provide informed consent will be eligible to
participate but they must have an authorized representative available within 24 hours
of admission to provide consent.

Exclusion Criteria:

- Individuals with a history of neurological disease other than stroke, head and neck
structural surgery, or history of dysphagia unrelated to the current stroke will be
excluded from participation.

- Individuals who are obtunded (unable to maintain wakefulness), currently diagnosed
with pneumonia, or on ventilator support will be excluded.

- Veterans who are more than 72 hours past MEDVAMC admission will be excluded.
We found this trial at
1
site
?
mi
from
Houston, TX
Click here to add this to my saved trials