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Validity and Feasibility of the CRSR-FAST (CRSR-FAST)

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ClinicalTrials.gov Identifier: NCT03549572
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Yelena G Bodien, Massachusetts General Hospital

Brief Summary:
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.

Condition or disease Intervention/treatment
Disorder of Consciousness Traumatic Brain Injury Behavioral: Coma Recovery Scale-Revised

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation and Feasibility of the Coma Recovery Scale-Revised for Accelerated Standardized Assessment (CRSR-FAST): a Brief, Standardized Assessment Instrument to Monitor Recovery of Consciousness in the Intensive Care Unit
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Severe Traumatic Brain Injury
We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury.
Behavioral: Coma Recovery Scale-Revised
Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 10 items organized into 4 subscales that address arousal, visual, motor and verbal/oromotor systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors.




Primary Outcome Measures :
  1. Diagnostic Agreement [ Time Frame: Within 3 weeks of injury ]
    Diagnostic agreement between the Coma Recovery Scale-Revised (CRS-R) and the CRSR For Accelerated Standardized Testing (CRSR-FAST). The CRS-R is a standardized neurobehavioral rating scale used to monitor recovery of consciousness in persons with severe traumatic brain injury. Total scores on the CRS-R range from 0 to 23 with high scores generally indicating greater recovery. Six subscales on the CRS-R are summed to provide the total score: auditory function (0-4), visual function (0-5), motor function (0-6), oromotor/verbal function (0-3), communication (0-2) and arousal (0-3). Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state, or emerged from minimally conscious state. The CRSR-FAST is an abbreviated version of the CRS-R that includes select items from the auditory, visual, motor, and oromotor subscales.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will enroll adults with a impaired level of consciousness resulting from severe traumatic brain injury who are recovering in the intensive care unit.
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Fluent in English
  • Surrogate available to provide informed consent
  • History of severe acquired brain injury
  • Sustained a traumatic brain injury (TBI, defined by damage to brain tissue caused by an external mechanical force),
  • Be within 3 weeks of injury
  • Have a total Glasgow Outcome Scale (GCS) score <9 within the first 48 hours of injury,
  • Be unable to follow simple commands consistently at the time of enrollment

Exclusion Criteria:

  • History of developmental, neurologic, or major psychiatric disorder resulting in ongoing functional disability up to the time of the current injury
  • Physician orders for comfort measures only

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549572


Contacts
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Contact: Yelena Bodien, PhD 6179526308 ybodien@partners.org
Contact: Michael Bergin, PhD mjbergin@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yelena Bodien    617-643-3956    ybodien@mgh.harvard.edu   
Principal Investigator: Yelena Bodien, PhD         
Sponsors and Collaborators
Massachusetts General Hospital

Publications:
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Responsible Party: Yelena G Bodien, Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03549572     History of Changes
Other Study ID Numbers: 2015P000147
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders