Stroke Swallowing Screening Tool Validation (SSST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01559649
Recruitment Status : Completed
First Posted : March 21, 2012
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Cerebrovascular Disorders
Deglutition Disorders
Intervention: Behavioral: Establishing Validity and Reliability

  Participant Flow

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
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 
[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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 250   15   265 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 64  (9.5)   NA [1]   NA [1] 
[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 [1] [2] 
[Units: Participants]
 60   NA [1]   NA [2] 
National Institutes of Health Stroke Scale score [1] [2] [3] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.6  (2.9)   NA [2]   NA [3] 
Discharge Diagnosis [1] [2] 
[Units: Participants]
Imaging-confirmed stroke   140   NA [1]   NA [2] 
Physician-confirmed stroke   16   NA [1]   NA [2] 
Physician-confirmed TIA   49   NA [1]   NA [2] 
Nonstroke/TIA   45   NA [1]   NA [2] 
[1] discharge diagnosis not collected for nurses
[2] Total not calculated because data are not available (NA) in one or more arms.
Stroke Type [1] [2] [3] 
[Units: Participants]
Ischemic   137   NA [2]   NA [3] 
Hemorrhagic   3   NA [2]   NA [3] 
[1] number obtained from the number of imaging confirmed stroke (n=140)
[2] stroke type not collected in nurses
[3] Total not calculated because data are not available (NA) in one or more arms.
Stroke Location [1] [2] [3] 
[Units: Participants]
right hemispheric damage   51   NA [2]   NA [3] 
left hemispheric damage   50   NA [2]   NA [3] 
bilateral   4   NA [2]   NA [3] 
posterior circulation   35   NA [2]   NA [3] 
[1] obtained from 140 imaging-confirmed strokes
[2] stroke location not collected in nurses
[3] Total not calculated because data are not available (NA) in one or more arms.

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT01559649     History of Changes
Other Study ID Numbers: C7242-R
First Submitted: March 19, 2012
First Posted: March 21, 2012
Results First Submitted: June 24, 2016
Results First Posted: July 19, 2016
Last Update Posted: July 19, 2016