- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559649
Stroke Swallowing Screening Tool Validation (SSST)
June 24, 2016 updated by: VA Office of Research and Development
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, 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
284
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- Veterans admitted with stroke symptoms
- Nurses working on the stroke ward
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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.
|
3 years
|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephanie K Daniels, PhD, Michael E. DeBakey VA Medical Center, Houston, TX
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 21, 2012
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
June 24, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Disease
- Deglutition Disorders
- Cerebrovascular Disorders
Other Study ID Numbers
- C7242-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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