Validity and Feasibility of the CRSR-FAST



Status:Recruiting
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/9/2018
Start Date:August 28, 2018
End Date:October 1, 2022
Contact:Yelena Bodien, PhD
Email:ybodien@partners.org
Phone:6179526308

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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

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 In conjunction with the developers of the Neuroscore (an unpublished,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.


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
We found this trial at
1
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Yelena Bodien, PhD
Phone: 617-643-3956
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