OPTIMISM: Outcome Prognostication in Traumatic Brain Injury Study
Supported by: Department
Principal Investigator at BMC: Courtney Takahashi, MD
Primary Research Contact: George Nardone, Volunteer
Summary
Traumatic brain injury (TBI) is a leading cause of permanent disability and death in the United States across all age groups, contributing to about 52,000 deaths annually. Moderate to severe TBIs can require critical care during hospital stay, but there is much variation in treatments across different institutions. A lack of standard care guidelines make it difficult to study factors that influence patient outcome, but specialized critical care units in some hospitals provide more consistency in management. Thus, these centers may be valuable in investigating variables that influence TBI patient health outcome. Contributing to the current OPTIMISM database will allow further examination of these factors and diversify the existing subject population.
BMC will be one of the collaborating sites enrolling TBI patients into OPTIMISM. This is an observational study whereby patients who undergo standard of care will be included. Potential subjects will be screened within 24 hours of admission and followed daily throughout hospitalization. Clinical data from electronic medical records, information from CT/MRI scans, and physiological and laboratory data will be collected and analyzed. Additionally, for patients with moderate to severe TBI, data will also be collected continuously through a MOBERG CNS device connected to the patient's bedside monitors as part of the OPTIMISM sub-study MOBERG, headed by the Massachusetts Institute of Technology (MIT). Data will be stored in a secure REDCap server hosted at the University of Massachusetts (UMASS) Medical School. Data entered into the REDCap portal will be de-identified. Mortality will be assessed at 3, 6, and 12 months post-discharge via phone.
The 3, 6, and 12-month follow-ups will consist of telephone interviews to measure functional outcome. We will assess changes in health status since discharge, in addition to scores on functional outcome scales and quality of life measures. Our site's contribution to the existing OPTIMISM database will represent a diverse subject population and help to assess differences of care and patient physiology after TBI.
Enrollment Criteria
Inclusion Criteria:
- Age 18 years and older
- Traumatic brain injury diagnosed on admission
- Enrolled within 24 hours of admission
Exclusion Criteria:
- There are no exclusion criteria for this study.
Status: Actively enrolling patients