Stroke Swallowing Screening Tool Validation (SSST)
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ClinicalTrials.gov Identifier: NCT01559649 |
Recruitment Status :
Completed
First Posted : March 21, 2012
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
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Condition or disease | Intervention/treatment |
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Cerebrovascular Disorders Deglutition Disorders | Behavioral: Establishing Validity and Reliability |
Study Type : | Observational |
Actual Enrollment : | 284 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Development and Validation of a VA Stroke Swallowing Screening Tool |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort | Intervention/treatment |
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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
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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 |
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.
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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 |
- Sensitivity of Screening Items [ Time Frame: 3 years ]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.
- Specificity of Screening Items [ Time Frame: 3 years ]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.
- Negative Predictive Value of Screening Items [ Time Frame: 3 years ]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.
- Average Accuracy Rate for Nurse Administration for All Screening Procedures [ Time Frame: 3 years ]Determine if current stroke-ward staff nurses can accurately administer screening items.
- Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items [ Time Frame: 3 years ]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.
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
- Veterans admitted with stroke symptoms
- Nurses working on the stroke ward
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559649
United States, Texas | |
Michael E. DeBakey VA Medical Center, Houston, TX | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Stephanie K Daniels, PhD | Michael E. DeBakey VA Medical Center, Houston, TX |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01559649 |
Other Study ID Numbers: |
C7242-R |
First Posted: | March 21, 2012 Key Record Dates |
Results First Posted: | July 19, 2016 |
Last Update Posted: | July 19, 2016 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Stroke Deglutition Deglutition Disorders Nurse Screening |
Deglutition Disorders Cerebrovascular Disorders Disease Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |