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Stroke Swallowing Screening Tool Validation

Development and Validation of a VA Stroke Swallowing Screening Tool

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01559649
Acronym
SSST
Enrollment
284
Registered
2012-03-21
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disorders, Deglutition Disorders

Keywords

Stroke, Deglutition, Deglutition Disorders, Nurse Screening

Brief 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.

Interventions

BEHAVIORALEstablishing 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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of Screening Items3 yearsIdentify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.
Specificity of Screening Items3 yearsIdentify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.
Negative Predictive Value of Screening Items3 yearsIdentify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.

Secondary

MeasureTime frameDescription
Average Accuracy Rate for Nurse Administration for All Screening Procedures3 yearsDetermine if current stroke-ward staff nurses can accurately administer screening items.
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items3 yearsDetermine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.

Countries

United States

Participant flow

Pre-assignment details

Chart review-1042 suspected stroke patients . Excluded-636 (h/o neuro disease, etc). Eligible-406. 137-declined, d/c before approaching. Consented-269. Screening completed-258 (11-unable to complete screening-d/c, unstable, etc). VFSS completed-256-250 analyzed (6 excluded from analysis-equipment failure, h/o dysphagia, etc.). RNs-15 participated.

Participants by arm

ArmCount
Suspected Stroke
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
250
Nurses
Registered nurses working on MEDVAMC stroke wards
15
Total265

Baseline characteristics

CharacteristicSuspected StrokeTotalNurses
Age, Continuous64 years
STANDARD_DEVIATION 9.5
NA yearsNA years
Discharge Diagnosis
Imaging-confirmed stroke
140 participantsNA participantsNA participants
Discharge Diagnosis
Nonstroke/TIA
45 participantsNA participantsNA participants
Discharge Diagnosis
Physician-confirmed stroke
16 participantsNA participantsNA participants
Discharge Diagnosis
Physician-confirmed TIA
49 participantsNA participantsNA participants
National Institutes of Health Stroke Scale score2.6 units on a scale
STANDARD_DEVIATION 2.9
NA units on a scaleNA units on a scale
Previous History of Stroke60 participantsNA participantsNA participants
Race/Ethnicity, Customized
African American
120 participants123 participants3 participants
Race/Ethnicity, Customized
Asian
0 participants6 participants6 participants
Race/Ethnicity, Customized
Hispanic
32 participants37 participants5 participants
Race/Ethnicity, Customized
White
98 participants99 participants1 participants
Region of Enrollment
United States
250 participants265 participants15 participants
Sex: Female, Male
Female
7 Participants20 Participants13 Participants
Sex: Female, Male
Male
243 Participants245 Participants2 Participants
Stroke Location
bilateral
4 participantsNA participantsNA participants
Stroke Location
left hemispheric damage
50 participantsNA participantsNA participants
Stroke Location
posterior circulation
35 participantsNA participantsNA participants
Stroke Location
right hemispheric damage
51 participantsNA participantsNA participants
Stroke Type
Hemorrhagic
3 participantsNA participantsNA participants
Stroke Type
Ischemic
137 participantsNA participantsNA participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 250
serious
Total, serious adverse events
0 / 250

Outcome results

Primary

Negative Predictive Value of Screening Items

Identify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.

Time frame: 3 years

Population: Nurses were not assessed for this outcome measure

ArmMeasureGroupValue (NUMBER)
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsAge >7091.0 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsLethargy88.7 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsDysarthria94.2 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsNonswallow wet voice89.3 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsAbnormal volitional cough91.0 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsCombined water swallow itmes94.3 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsDysarthria or Water swallow item96.5 percentage of agreement
Patients With Suspected StrokeNegative Predictive Value of Screening ItemsAge >70 or Dysarthria or Water swallow item97.9 percentage of agreement
Primary

Sensitivity of Screening Items

Identify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.

Time frame: 3 years

Population: Nurses were not assessed for this outcome measure

ArmMeasureGroupValue (NUMBER)
Patients With Suspected StrokeSensitivity of Screening ItemsAge >7037.9 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsLethargy3.5 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsDysarthria62.1 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsNonswallow wet voice10.3 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsAbnormal volitional cough27.6 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsCombined water swallow items72.4 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsDysarthria or Water swallow item86.2 percentage of agreement
Patients With Suspected StrokeSensitivity of Screening ItemsAge >70 or Dysarthria or Water swallow item93.1 percentage of agreement
Primary

Specificity of Screening Items

Identify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.

Time frame: 3 years

Population: Nurses were not assessed for this outcome measure

ArmMeasureGroupValue (NUMBER)
Patients With Suspected StrokeSpecificity of Screening ItemsAge >7082.8 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsLethargy99.5 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsDysarthria80.5 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsNonswallow wet voice98.6 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsAbnormal volitional cough95.9 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsCombined water swallow item59.7 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsDysarthria or Water swallow item49.3 percentage of agreement
Patients With Suspected StrokeSpecificity of Screening ItemsAge >70 or Dysarthria or Water swallow item43.0 percentage of agreement
Secondary

Average Accuracy Rate for Nurse Administration for All Screening Procedures

Determine if current stroke-ward staff nurses can accurately administer screening items.

Time frame: 3 years

ArmMeasureValue (MEAN)
Patients With Suspected StrokeAverage Accuracy Rate for Nurse Administration for All Screening Procedures98.33 percentage of accuracy
Secondary

Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items

Determine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.

Time frame: 3 years

ArmMeasureGroupValue (NUMBER)
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsLethargy0.394 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsDysarthria0.717 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsAbnormal volitional cough0.645 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsNonswallow wet voice0.360 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsCough after swallowing0.911 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsThroat clear after swallowing0.837 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsWet voice after swallowing0.727 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of ItemsInability to continuously drink 90ml of water0.911 kappa
Patients With Suspected StrokeReliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items1 minute wet voice1.000 kappa

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026