Status:
COMPLETED
Brain Injury Rehabilitation Improving the Transition Experience
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Moss Rehabilitation Research Institute
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United States, and at least 25 percent of these injuries are classified as moderate to severe. Nearly half of those ho...
Detailed Description
Screening The screening process involves a review of medical records by our research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion for further detail) who are...
Eligibility Criteria
Inclusion
- Hospitalized with a moderate-to-severe TBI defined by TBIMS and this study as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post-traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination. Potential participants must meet at least one of the following criteria to be considered experiencing a moderate-to-severe TBI:
- PTA\>24 hours;
- Trauma related intracranial neuroimaging abnormalities;
- Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); or
- Glasgow Coma Scale in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication).
- English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- At least 18 years old;
- Will be discharged from inpatient rehabilitation to community (private residence, adult home, hotel, homeless) or facility (nursing home, subacute care i.e. skilled nursing facility);
- Current admission to inpatient rehabilitation considered their first comprehensive rehabilitation experience, or extension thereof for most recent TBI (e.g. admitted to inpatient rehabilitation, discharged to acute care, then returns to inpatient rehabilitation to complete their initial stay);
- Able to provide informed consent, or if unable to provide consent have family or legal guardian to provide informed consent for the patient.
- Inclusion Criteria- Caregiver Participants:
- Individuals who will have primary care giving responsibility post rehabilitation care discharge of enrolled patient participants;
- English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- At least 18 years old;
- Able to provide informed consent.
Exclusion
- Exclusion criteria- Patient Participants:
- We will not enroll individuals who are in law enforcement custody at admission to the designated rehabilitation unit or who are taken into custody prior to discharge from the designated rehabilitation unit due to federal restrictions on inclusion of prisoners in research.
- We will not enroll individuals who do not have access to a phone.
- We will not enroll individuals who are unable to complete study procedures due to cognitive/verbal limitations AND do not have a proxy to assist with study procedures.
- Exclusion criteria- Caregiver Participants:
- We will not enroll individuals who are in law enforcement custody due to federal restrictions on inclusion of prisoners in research.
- We will not enroll individuals who do not have access to a phone.
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
1555 Patients enrolled
Trial Details
Trial ID
NCT03422276
Start Date
February 13 2018
End Date
November 10 2022
Last Update
March 12 2025
Active Locations (6)
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1
Indiana University School of Medicine/ Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254
2
Mount Sinai Health System (NY)
New York, New York, United States, 10002
3
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
4
Moss Rehab Hospital
Elkins Park, Pennsylvania, United States, 19027