Validity and Feasibility of the CRSR-FAST

Mass General Brigham

Status: Completed

Conditions: Traumatic Brain Injury; Disorder of Consciousness

Treatments: Behavioral: Coma Recovery Scale-Revised

Study type: Observational

Funder types: Other

Identifiers

NCT03549572

2015P000147

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 1 patient group

Severe Traumatic Brain Injury

Description:

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.

Treatment:

Behavioral: Coma Recovery Scale-Revised