NCT01559649

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 19, 2016

Completed
Last Updated

July 19, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

March 19, 2012

Results QC Date

June 24, 2016

Last Update Submit

June 24, 2016

Conditions

Cerebrovascular DisordersDeglutition Disorders

Keywords

StrokeDeglutitionDeglutition DisordersNurse Screening

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 years

Secondary Outcomes (2)

  • Average Accuracy Rate for Nurse Administration for All Screening Procedures

    3 years

  • Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items

    3 years

Study Arms (2)

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

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.

Behavioral: Establishing Validity and Reliability

Interventions

Establishing Validity and ReliabilityBEHAVIORAL

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

Group 1Group 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Veterans admitted with stroke symptoms * Nurses working on the stroke ward

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • 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.

    PMID: 26205434RESULT

  • Daniels 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.

    PMID: 27117382RESULT

  • Anderson 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.

    PMID: 27117381RESULT

  • Freeland 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.

    PMID: 26519043RESULT

Biospecimen

Retention: NONE RETAINED

no samples will be collected

MeSH Terms

Conditions

Cerebrovascular DisordersDeglutition DisordersStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Stephanie Daniels
Organization
Michael E. DeBakey VA Medical Center
skdaniels@uh.edu
713-743-2570

Study Officials

  • Stephanie K Daniels, PhD

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

July 19, 2016

Results First Posted

July 19, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)