Trial Outcomes & Findings for Stroke Swallowing Screening Tool Validation (NCT NCT01559649)
NCT ID: NCT01559649
Last Updated: 2016-07-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
284 participants
Primary outcome timeframe
3 years
Results posted on
2016-07-19
Participant Flow
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.
Participant milestones
| Measure |
Patients With Suspected Stroke
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
|
Registered Nurses
Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
|
|---|---|---|
|
Overall Study
STARTED
|
269
|
15
|
|
Overall Study
COMPLETED
|
250
|
9
|
|
Overall Study
NOT COMPLETED
|
19
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stroke Swallowing Screening Tool Validation
Baseline characteristics by cohort
| Measure |
Suspected Stroke
n=250 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
|
Nurses
n=15 Participants
Registered nurses working on MEDVAMC stroke wards
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
98 participants
n=5 Participants
|
1 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
120 participants
n=5 Participants
|
3 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 participants
n=5 Participants
|
5 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
250 participants
n=5 Participants
|
15 participants
n=7 Participants
|
265 participants
n=5 Participants
|
|
Previous History of Stroke
|
60 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
National Institutes of Health Stroke Scale score
|
2.6 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=7 Participants
|
NA units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
|
Discharge Diagnosis
Imaging-confirmed stroke
|
140 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Discharge Diagnosis
Physician-confirmed stroke
|
16 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Discharge Diagnosis
Physician-confirmed TIA
|
49 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Discharge Diagnosis
Nonstroke/TIA
|
45 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Type
Ischemic
|
137 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Type
Hemorrhagic
|
3 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Location
right hemispheric damage
|
51 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Location
left hemispheric damage
|
50 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Location
bilateral
|
4 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
|
Stroke Location
posterior circulation
|
35 participants
n=5 Participants
|
NA participants
n=7 Participants
|
NA participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Nurses were not assessed for this outcome measure
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.
Outcome measures
| Measure |
Patients With Suspected Stroke
n=250 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
|
Registered Nurses
Stroke ward nurses.
|
|---|---|---|
|
Sensitivity of Screening Items
Age >70
|
37.9 percentage of agreement
Interval 20.7 to 57.7
|
—
|
|
Sensitivity of Screening Items
Lethargy
|
3.5 percentage of agreement
Interval 0.087 to 178.0
|
—
|
|
Sensitivity of Screening Items
Dysarthria
|
62.1 percentage of agreement
Interval 42.3 to 79.3
|
—
|
|
Sensitivity of Screening Items
Nonswallow wet voice
|
10.3 percentage of agreement
Interval 2.19 to 27.4
|
—
|
|
Sensitivity of Screening Items
Abnormal volitional cough
|
27.6 percentage of agreement
Interval 12.7 to 47.2
|
—
|
|
Sensitivity of Screening Items
Combined water swallow items
|
72.4 percentage of agreement
Interval 52.8 to 87.3
|
—
|
|
Sensitivity of Screening Items
Dysarthria or Water swallow item
|
86.2 percentage of agreement
Interval 68.3 to 96.1
|
—
|
|
Sensitivity of Screening Items
Age >70 or Dysarthria or Water swallow item
|
93.1 percentage of agreement
Interval 77.2 to 99.2
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Nurses were not assessed for this outcome measure
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.
Outcome measures
| Measure |
Patients With Suspected Stroke
n=250 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
|
Registered Nurses
Stroke ward nurses.
|
|---|---|---|
|
Specificity of Screening Items
Age >70
|
82.8 percentage of agreement
Interval 77.2 to 87.5
|
—
|
|
Specificity of Screening Items
Lethargy
|
99.5 percentage of agreement
Interval 97.5 to 100.0
|
—
|
|
Specificity of Screening Items
Dysarthria
|
80.5 percentage of agreement
Interval 74.7 to 85.5
|
—
|
|
Specificity of Screening Items
Nonswallow wet voice
|
98.6 percentage of agreement
Interval 96.1 to 99.7
|
—
|
|
Specificity of Screening Items
Abnormal volitional cough
|
95.9 percentage of agreement
Interval 92.4 to 98.1
|
—
|
|
Specificity of Screening Items
Combined water swallow item
|
59.7 percentage of agreement
Interval 52.9 to 66.3
|
—
|
|
Specificity of Screening Items
Dysarthria or Water swallow item
|
49.3 percentage of agreement
Interval 42.6 to 56.1
|
—
|
|
Specificity of Screening Items
Age >70 or Dysarthria or Water swallow item
|
43.0 percentage of agreement
Interval 36.4 to 49.8
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Nurses were not assessed for this outcome measure
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.
Outcome measures
| Measure |
Patients With Suspected Stroke
n=250 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
|
Registered Nurses
Stroke ward nurses.
|
|---|---|---|
|
Negative Predictive Value of Screening Items
Combined water swallow itmes
|
94.3 percentage of agreement
Interval 89.1 to 97.5
|
—
|
|
Negative Predictive Value of Screening Items
Dysarthria or Water swallow item
|
96.5 percentage of agreement
Interval 91.2 to 99.0
|
—
|
|
Negative Predictive Value of Screening Items
Age >70
|
91.0 percentage of agreement
Interval 86.2 to 94.6
|
—
|
|
Negative Predictive Value of Screening Items
Lethargy
|
88.7 percentage of agreement
Interval 84.1 to 92.4
|
—
|
|
Negative Predictive Value of Screening Items
Dysarthria
|
94.2 percentage of agreement
Interval 89.8 to 97.1
|
—
|
|
Negative Predictive Value of Screening Items
Nonswallow wet voice
|
89.3 percentage of agreement
Interval 84.8 to 92.9
|
—
|
|
Negative Predictive Value of Screening Items
Abnormal volitional cough
|
91.0 percentage of agreement
Interval 86.6 to 94.3
|
—
|
|
Negative Predictive Value of Screening Items
Age >70 or Dysarthria or Water swallow item
|
97.9 percentage of agreement
Interval 92.7 to 99.7
|
—
|
SECONDARY outcome
Timeframe: 3 yearsDetermine if current stroke-ward staff nurses can accurately administer screening items.
Outcome measures
| Measure |
Patients With Suspected Stroke
n=15 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
|
Registered Nurses
Stroke ward nurses.
|
|---|---|---|
|
Average Accuracy Rate for Nurse Administration for All Screening Procedures
|
98.33 percentage of accuracy
Interval 95.42 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Patients With Suspected Stroke
n=15 Participants
Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
|
Registered Nurses
Stroke ward nurses.
|
|---|---|---|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Nonswallow wet voice
|
0.360 kappa
Interval -0.017 to 0.594
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Lethargy
|
0.394 kappa
Interval -0.152 to 0.94
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Dysarthria
|
0.717 kappa
Interval 0.667 to 0.754
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Abnormal volitional cough
|
0.645 kappa
Interval 0.594 to 0.712
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Cough after swallowing
|
0.911 kappa
Interval 0.824 to 0.997
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Throat clear after swallowing
|
0.837 kappa
Interval 0.76 to 0.914
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Wet voice after swallowing
|
0.727 kappa
Interval 0.567 to 0.888
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Inability to continuously drink 90ml of water
|
0.911 kappa
Interval 0.788 to 1.0
|
—
|
|
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
1 minute wet voice
|
1.000 kappa
Interval 1.0 to 1.0
|
—
|
Adverse Events
Patients With Suspected Stroke
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place