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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke will be 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 will be excluded from participation. Individuals who are obtunded, medically unstable, greater than 5 days post-admission will be excluded. Patients 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. Patients will undergo swallowing screening and videofluoroscopic swallowing study to establish validity of screening items |
| |
| Group 2 | Stroke ward nurses. The nurses will administer and interpret the swallowing screening items. Speech pathologists will also make blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation will be used to establish nursing reliability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Establishing Validity and Reliability | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| 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. | 3 years |
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Average Accuracy Rate for Nurse Administration for All Screening Procedures | Determine if current stroke-ward staff nurses can accurately administer screening items. | 3 years |
| Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie K Daniels, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26205434 | Result | Daniels SK, Pathak S, Stach CB, Mohr TM, Morgan RO, Anderson JA. Speech Pathology Reliability for Stroke Swallowing Screening Items. Dysphagia. 2015 Oct;30(5):565-70. doi: 10.1007/s00455-015-9638-x. Epub 2015 Jul 24. | |
| 27117382 | Result | Daniels SK, Pathak S, Rosenbek JC, Morgan RO, Anderson JA. Rapid Aspiration Screening for Suspected Stroke: Part 1: Development and Validation. Arch Phys Med Rehabil. 2016 Sep;97(9):1440-1448. doi: 10.1016/j.apmr.2016.03.025. Epub 2016 Apr 23. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
N=250 stroke patients with data analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Suspected Stroke | Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke. |
| BG001 | Nurses | Registered nurses working on MEDVAMC stroke wards |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Nurses were not assessed for this outcome measure | Posted | Number | 95% Confidence Interval | percentage of agreement | 3 years |
|
30 days post-discharge
Only suspected stroke patients were monitored for pulmonary complications.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Suspected Stroke | Individuals admitted with suspected ischemic or hemorrhagic stroke |
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Large number of individuals excluded from participation due to stringent inclusion/exclusion criteria to ensure that stroke-related aspiration was being measured. Small number of women recruited. Inability to screen in the emergency department.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Daniels | Michael E. DeBakey VA Medical Center | 713-743-2570 | skdaniels@uh.edu |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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no samples will be collected
|
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. |
| 3 years |
| 27117381 | Result | Anderson JA, Pathak S, Rosenbek JC, Morgan RO, Daniels SK. Rapid Aspiration Screening for Suspected Stroke: Part 2: Initial and Sustained Nurse Accuracy and Reliability. Arch Phys Med Rehabil. 2016 Sep;97(9):1449-1455. doi: 10.1016/j.apmr.2016.03.024. Epub 2016 Apr 24. |
| 26519043 | Result | Freeland TR, Pathak S, Garrett RR, Anderson JA, Daniels SK. Using Medical Mannequins to Train Nurses in Stroke Swallowing Screening. Dysphagia. 2016 Feb;31(1):104-10. doi: 10.1007/s00455-015-9666-6. Epub 2015 Oct 30. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Previous History of Stroke | Number | participants |
|
| National Institutes of Health Stroke Scale score | Scores range is 0-30. Lower scores indicates milder stroke. | Mean | Standard Deviation | units on a scale |
|
| Discharge Diagnosis | Number | participants |
|
| Stroke Type | number obtained from the number of imaging confirmed stroke (n=140) | Number | participants |
|
| Stroke Location | obtained from 140 imaging-confirmed strokes | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Nurses were not assessed for this outcome measure | Posted | Number | 95% Confidence Interval | percentage of agreement | 3 years |
|
|
|
| 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. | Nurses were not assessed for this outcome measure | Posted | Number | 95% Confidence Interval | percentage of agreement | 3 years |
|
|
|
| Secondary | Average Accuracy Rate for Nurse Administration for All Screening Procedures | Determine if current stroke-ward staff nurses can accurately administer screening items. | Posted | Mean | Full Range | percentage of accuracy | 3 years |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | kappa | 3 years |
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
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| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Title | Measurements |
|---|---|
|
| Nonswallow wet voice |
|
| Abnormal volitional cough |
|
| Combined water swallow item |
|
| Dysarthria or Water swallow item |
|
| Age >70 or Dysarthria or Water swallow item |
|
| Title | Measurements |
|---|---|
|
| Nonswallow wet voice |
|
| Abnormal volitional cough |
|
| Combined water swallow itmes |
|
| Dysarthria or Water swallow item |
|
| Age >70 or Dysarthria or Water swallow item |
|
| Title | Measurements |
|---|---|
|
| Nonswallow wet voice |
|
| Cough after swallowing |
|
| Throat clear after swallowing |
|
| Wet voice after swallowing |
|
| Inability to continuously drink 90ml of water |
|
| 1 minute wet voice |
|