Brain Concussion Clinical Trial
Official title:
The Effect of Telephone Follow-Up on Outcome After Mild TBI
The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.
This study examines the effect of scheduled telephone calls on the outcome after mild
traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused
counseling, and referrals. MTBI is extremely common in the United States, numbering well over
a million cases per year. Although recovery for most is quite good, 10-20% of persons have
persisting symptoms that affect employment, quality of life, and health care expenses. We are
examining one means to decrease persisting symptoms by offering early, consistent
intervention before symptoms become persistent.
The subjects are enrolled in the emergency departments (ED) of the hospital and receive the
baseline assessment while still in the ED. Subjects are randomly assigned to two groups:
Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled
telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects
are contacted again at 6 months for an outcome assessment that is done over the telephone.
On the telephone, subjects are asked about current problems, and are given both information
about recovery from MTBI and some counseling on dealing with symptoms or other complaints.
They are also given community resources to obtain assistance if needed. Telephone call are
reviewed by supervisors (physician and psychologist) for adherence to protocol and for
training purposes.
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