Cerebrovascular DisordersSSSTNCT01559649
Stroke Swallowing Screening Tool Validation
An observational study of Cerebrovascular Disorders and Deglutition Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disorders, Deglutition Disorders
- What is being tested?
- Establishing Validity and Reliability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Veterans admitted with stroke symptoms * Nurses working on the stroke ward
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebrovascular Disorders, Deglutition Disorders
- Being tested
- Establishing Validity and Reliability
- Keywords
- Stroke, Deglutition, Deglutition Disorders, Nurse Screening
- Medical subject headings
- Cerebrovascular Disorders, Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishing Validity and ReliabilityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Establishing Validity and Reliability | |
| 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. Receives: Behavioral: Establishing Validity and Reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 years
Secondary outcomes (2)
Average Accuracy Rate for Nurse Administration for All Screening Procedures
Determine if current stroke-ward staff nurses can accurately administer screening items.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephanie K Daniels, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559649
- Sponsor's protocol ID
- C7242-R
- Acronym
- SSST
- Status last verified
- Jun 2016
- First submitted
- 19 Mar 2012
- Last updated
- 19 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26205434Daniels 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.
PubMed 27117382Anderson 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.
PubMed 27117381Freeland 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.
PubMed 26519043
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a VA Stroke Swallowing Screening Tool
- ClinicalTrials.gov ID
- NCT01559649
- Acronym / sponsor ID
- SSST / C7242-R
- Conditions
- Cerebrovascular Disorders, Deglutition Disorders
- Keywords
- Stroke, Deglutition, Deglutition Disorders, Nurse Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Posted 19 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Establishing Validity and ReliabilityVeterans 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 | – | Behavioral: Establishing Validity and ReliabilityStroke 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Veterans admitted with stroke symptoms * Nurses working on the stroke ward
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Establishing Validity and ReliabilityConsecutive 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 | Behavioural | Group 1, Group 2 |
Primary outcome
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.
2 secondary outcomes
Average Accuracy Rate for Nurse Administration for All Screening Procedures
Time frame: 3 years
Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26205434Daniels 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.
- Results publication: PubMed 27117382Daniels 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.
- Results publication: PubMed 27117381Anderson 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.
- Results publication: PubMed 26519043Freeland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie K Daniels, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disorders and Deglutition Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Screening Items (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01559649, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.