Clinical trial NCT03549572: Validity and Feasibility of the CRSR-FAST
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Traumatic Brain Injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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. 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.


Eligibility 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

Primary outcomes:
measure: Diagnostic Agreement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
measure: CRSR-FAST Test-Retest Reliability
timeFrame: 48 hours
measure: CRSR-FAST Interrater Reliability
timeFrame: 48 hours
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.