Physicians at the University of Chicago Medicine are participating in a national trial to study the most effective course of treatment for patients with traumatic brain injuries (TBI). The study will involve patients admitted to UChicago Medicine’s Level 1 Adult Trauma Center with injuries caused by motor vehicle collisions, falls or other incidents causing severe trauma to the brain.
Every year, approximately 3.5 million Americans sustain a TBI, of which 50,000 die. Another 300,000 are hospitalized, but survive the injury.
UChicago Medicine researchers will begin screening and enrolling patients in the study in early September; they expect to enroll approximately 30 patients over the course of the 5-year study.
UChicago Medicine is the only Level 1 Adult Trauma Center in Illinois to participate in the National Institutes of Health-funded study, which is named BOOST-3 and involves almost 50 participating hospitals nationwide. According to researchers, UChicago Medicine’s participation will ensure the study is representative of diverse populations and people who “are often ignored in research study.”
The BOOST-3 trial investigates patients that have severe brain injury after trauma and compares two treatment approaches for monitoring and treating patients with traumatic brain injuries in the intensive care unit (ICU). Both approaches are considered standard practices of care and are currently used to treat patients with TBI at UChicago Medicine.
In one strategy, doctors concentrate only on preventing high intracranial pressure (ICP) caused by a swollen brain. In the other strategy, doctors try to prevent high ICP and also try to prevent low brain oxygen.
“It is unknown if measuring and treating low brain oxygen is more effective, less effective, or the same as monitoring and treating high brain pressure alone,” said site investigator Christos Lazaridis, MD, a neurointensivist at UChicago Medicine who specializes in advanced monitoring in severe traumatic brain injury. “The results of this study will help doctors discover if one of these methods is more safe and effective.”
Research in emergency medicine can be challenging especially since patients may be unconscious when they arrive at a trauma center. That means they, or their families, may not be immediately available to provide informed consent for participating in a study.
“Fortunately, there is an approved ethical standard about doing this kind of research in emergency populations through a process known as Exception From Informed Consent (EFIC),” said David Beiser, MD, an emergency physician at UChicago Medicine and one of the local investigators. “The use of EFIC is necessary as TBI patients require immediate treatment and the two treatment approaches being studied through BOOST-3 need to start within 2 to 10 hours of injury.”
Still, once a family member or legal representative is located, patients enrolled in the study through EFIC can be withdrawn from participating if consent is not granted. The patient will still receive the standard treatment for TBI, but will not be monitored as part of the study. They will continue to receive appropriate medical care.
“Our community has not participated in an EFIC study since the Public Access Defibrillation trial almost 20 years ago. Studies like this are important for improving trauma care in our community,” said Beiser.
As part of the EFIC process, Beiser and his team conducted community outreach events and focus group discussions throughout South Side communities within UChicago Medicine’s service area. Venues included senior centers, athletic facilities and community centers. One session was designed specifically for bicyclists. Once the COVID-19 pandemic started, sessions were held virtually via Zoom.
The discussions were designed to learn about community attitudes and beliefs regarding medical research, to educate the community on the BOOST-3 study and, ultimately, determine if this type of trial would be acceptable to community members.
“The approach is to engage the community in discussions about the research before the research is actually implemented,” said Beiser. “And, we received overwhelmingly positive responses from these discussions, where we were able to talk about some of the issues involving research and our community.”
To further increase awareness for the study, researchers advertised on CTA and Metra and hosted information tables at community events.
