Stroke Swallowing Screening Tool Validation (SSST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01559649
First received: March 19, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cerebrovascular Disorders
Deglutition Disorders
Behavioral: Establishing Validity and Reliability

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a VA Stroke Swallowing Screening Tool

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sensitivity and specificity of screening items [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Reliability of nurses administering and interpreting screening items [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

no samples will be collected


Estimated Enrollment: 305
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Veterans 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. 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.
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
Group 2
Nurse practitioners with expertise in stroke. Stroke ward nurses
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Veterans admitted with stroke symptoms Nurses working on the stroke ward Nurse practitioners with advanced practice skills in stroke

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559649

Contacts
Contact: Stephanie K Daniels, PhD (713) 794-7152 Stephanie.Daniels@va.gov
Contact: Jane A Anderson, PhD NP (713) 794-8079 ext 8079 jane.anderson@va.gov

Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Stephanie K Daniels, PhD    713-794-7152    Stephanie.Daniels@va.gov   
Contact: Jane A Anderson, PhD NP    (713) 794-8079 ext 8079    jane.anderson@va.gov   
Sub-Investigator: Jane A. Anderson, PhD NP         
Principal Investigator: Stephanie K Daniels, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Stephanie K Daniels, PhD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01559649     History of Changes
Other Study ID Numbers: C7242-R
Study First Received: March 19, 2012
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stroke
Deglutition
Deglutition Disorders
Nurse Screening

Additional relevant MeSH terms:
Cerebrovascular Disorders
Deglutition Disorders
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014