Stroke Swallowing Screening Tool Validation

Cerebrovascular Disorders Clinical Trial

— SSST  

Official title:

Development and Validation of a VA Stroke Swallowing Screening Tool

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01559649
• Other study ID #: C7242-R
• Status: Active, not recruiting
• Phase: N/A
• First received: March 19, 2012
• Last updated: October 19, 2015
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. Dysphagia, swallowing problems, are a major source of disability following stroke affecting quality of life, nutrition, hydration, and pulmonary status. Development and implementation of an accurate and consistent nursing swallowing screening tool to identify risk of dysphagia 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 dysphagia in individuals admitted with suspected stroke.

Description:

Early detection of dysphagia 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 dysphagia 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 dysphagia 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 dysphagia 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. Nurse practitioners with advanced practice skills in stroke and 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Deglutition Disorders
• Disease

Intervention

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. 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. Nurse practitioners with advanced practice skills in stroke and 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

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of screening items	Identify the combination of screenings items that provide the highest level of both sensitivity and specificity in the identification of dysphagia risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.	3 years	Yes
Secondary	Reliability of nurses administering and interpreting screening items	Determine if current neurology-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	No