MAYO CLINIC TRAUMATIC BRAIN INJURY MODEL SYSTEM CENTER:
The CONNECT Trial
Connecting the upper Midwest traumatic brain injury community to Mayo Clinic and each other: providing research evidence of effectiveness for remote support and care coordination
Problem: Traumatic brain injury (TBI) is a common injury and cause of disability in the US, yet there are few medical practices specialized in treating post-acute and chronic impairment, activity limitations, and restrictions to community participation and employment that often result from TBI. This is of particular concern in rural areas, among the elderly, and in the Native American population.
Gap in knowledge: Evidence exists for the effectiveness of care provided by multi-discipline clinical rehabilitation teams in treating the complex medical, cognitive, and psychosocial sequelae of TBI and improving outcome. Some evidence exists for the effectiveness of remotely provided services, such as cognitive rehabilitation. Mayo Clinic's specialty brain rehabilitation practice has experience with assembling treatment teams in remote communities and providing clinical guidance, with positive anecdotal reports of effectiveness. However, there currently exists no research evidence indicating such intervention is superior to treatment as usual (TAU).
Research design: In collaboration with the Departments of Health in Iowa and Minnesota, Regional Health in South Dakota, and Altru Health System in North Dakota, Mayo Clinic's TBI Model System Center will recruit 500 individuals discharged from the hospital over a year's time with an ICD-9/10 diagnosis of TBI. Subjects will be randomized by demographic and urban/rural status into two groups: an intervention group and a TAU group. Subjects in the intervention group will be remotely interviewed and evaluated by Mayo's clinical team. Their rehabilitation needs will be assessed and connections made to local health care and community providers who will receive TBI-specific education and consultative support from Mayo's TBI Model System Center staff. The target populations who will be consented are: 1) individuals with TBI; 2) their family members or caregivers; and 3) their local care providers. All consented subjects will be followed regularly for up to 3 years. All available resources in an individual's community, and within Mayo's TBI Model System Center, will be used to: 1) CONNECT the coordinating team with subjects and their families; 2) CONNECT the coordinating team with local medical, rehabilitation and community providers; and 3) CONNECT individuals with TBI, their families, and local providers with each other. Patient and family education, long term support, care coordination and clinical advice will be provided to intervention group subjects, their families and local clinicians remotely via traditional, web based, and social media platforms. Subjects in the usual care group will receive the care they would normally receive in their respective communities (TAU). Clinical, demographic, subject-reported outcomes, medical economic estimates, and satisfaction/competence measures will occur at baseline, midpoint, and at study end. Primary outcome measures will include measures of impairment, activity limitations, and participation with a primary focus on outcomes related to independent living, employment, and quality of life. The hypothesis is that outcomes in the remotely coordinated intervention group will be superior to outcomes in the group that received TAU.
If study results support this hypothesis, a hub-based system of remotely coordinated brain rehabilitation care could be considered, using the TBI Model System Centers as test sites that could revolutionize the provision of medical care and post acute support for individuals with TBI and their families.
