Stroke Swallowing Screening Tool Validation (SSST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01559649
First received: March 19, 2012
Last updated: June 24, 2016
Last verified: June 2016
Results First Received: June 24, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Cerebrovascular Disorders
Deglutition Disorders
Intervention: Behavioral: Establishing Validity and Reliability

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Chart review-1042 suspected stroke patients . Excluded-636 (h/o neuro disease, etc). Eligible-406. 137-declined, d/c before approaching. Consented-269. Screening completed-258 (11-unable to complete screening-d/c, unstable, etc). VFSS completed-256-250 analyzed (6 excluded from analysis-equipment failure, h/o dysphagia, etc.). RNs-15 participated.

Reporting Groups
  Description
Patients With Suspected Stroke Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke 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 were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
Registered Nurses Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.

Participant Flow:   Overall Study
    Patients With Suspected Stroke     Registered Nurses  
STARTED     269     15 [1]
COMPLETED     250 [2]   9  
NOT COMPLETED     19     6  
[1] Started with 10 nurses. As an RN dropped out due to scheduling, etc, RN replaced with another RN
[2] Screening not completed in 11, VFSS not completed in 2, 6 excluded from analysis. N=250 analyzed



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
N=250 stroke patients with data analyzed

Reporting Groups
  Description
Suspected Stroke Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
Nurses Registered nurses working on MEDVAMC stroke wards
Total Total of all reporting groups

Baseline Measures
    Suspected Stroke     Nurses     Total  
Number of Participants  
[units: participants]
  250     15     265  
Age  
[units: years]
Mean (Standard Deviation)
  64  (9.5)     NA [1]   NA [1]
Gender  
[units: participants]
     
Female     7     13     20  
Male     243     2     245  
Race/Ethnicity, Customized  
[units: participants]
     
White     98     1     99  
African American     120     3     123  
Hispanic     32     5     37  
Asian     0     6     6  
Region of Enrollment  
[units: participants]
     
United States     250     15     265  
Previous History of Stroke  
[units: participants]
  60     NA [3]   NA [2]
National Institutes of Health Stroke Scale score [4]
[units: units on a scale]
Mean (Standard Deviation)
  2.6  (2.9)     NA [6]   NA [5]
Discharge Diagnosis  
[units: participants]
     
Imaging-confirmed stroke     140     NA [7]   NA [2]
Physician-confirmed stroke     16     NA [7]   NA [2]
Physician-confirmed TIA     49     NA [7]   NA [2]
Nonstroke/TIA     45     NA [7]   NA [2]
Stroke Type [8]
[units: participants]
     
Ischemic     137     NA [9]   NA [2]
Hemorrhagic     3     NA [9]   NA [2]
Stroke Location [10]
[units: participants]
     
right hemispheric damage     51     NA [11]   NA [2]
left hemispheric damage     50     NA [11]   NA [2]
bilateral     4     NA [11]   NA [2]
posterior circulation     35     NA [11]   NA [2]
[1] Age data were not collected for nurses.
[2] Total not calculated because data are not available (NA) in one or more arms.
[3] Number of strokes not collected in nurses.
[4] Scores range is 0-30. Lower scores indicates milder stroke.
[5] Scores not collected for nurses
[6] Scores not collected for nurses.
[7] discharge diagnosis not collected for nurses
[8] number obtained from the number of imaging confirmed stroke (n=140)
[9] stroke type not collected in nurses
[10] obtained from 140 imaging-confirmed strokes
[11] stroke location not collected in nurses



  Outcome Measures
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1.  Primary:   Sensitivity of Screening Items   [ Time Frame: 3 years ]

2.  Primary:   Specificity of Screening Items   [ Time Frame: 3 years ]

3.  Primary:   Negative Predictive Value of Screening Items   [ Time Frame: 3 years ]

4.  Secondary:   Average Accuracy Rate for Nurse Administration for All Screening Procedures   [ Time Frame: 3 years ]

5.  Secondary:   Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Large number of individuals excluded from participation due to stringent inclusion/exclusion criteria to ensure that stroke-related aspiration was being measured. Small number of women recruited. Inability to screen in the emergency department.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephanie Daniels
Organization: Michael E. DeBakey VA Medical Center
phone: 713-743-2570
e-mail: skdaniels@uh.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01559649     History of Changes
Other Study ID Numbers: C7242-R
Study First Received: March 19, 2012
Results First Received: June 24, 2016
Last Updated: June 24, 2016
Health Authority: United States: Federal Government