The purpose of Mayo Clinic’s Traumatic Brain Injury Model System Center (TBIMSC) is to provide comprehensive, integrated, team-based rehabilitation to individuals with traumatic brain injury (TBI) and their families to promote full personal and societal participation, and to fill gaps in research knowledge and service delivery. TBI-related impairment can affect an individual’s participation in life’s roles over the long term, increasing risk for chronic medical conditions that can be minimized with early identification and treatment. Missing this early connection to services after TBI is the most common need identified by individuals hospitalized for TBI and their families, indicating a lack of capacity in our health care delivery system which increases risk for poor outcomes, while adding to personal and societal costs. In the upper Midwest, rural dwellers, the elderly, and Native Americans have the highest risk for TBI and are more likely to become isolated after acute care due to the nature of their impairment, distance from services, and socioeconomics. A critical need exists to test a model of care that connects individuals hospitalized with TBI, their families, and their local health care providers remotely to specialized brain rehabilitation resources to determine if this increases system capacity and access to services for those in a broader geographic region. Explosive developments in communication technology and its application to providing medical care remotely have brought tele-rehabilitation to the forefront of medical practice. However, rigorous controlled clinical trials are needed to provide evidence that applying this technology is more effective than usual care in improving outcome following TBI.
The proposed CONNECT trial aims to remotely connect the target populations to brain rehabilitation services using traditional (ie, phone) and customized information and communication technology (ICT)(eg, web-based, social media, virtual world platforms) in partnership with Mayo Clinic’s creative and technological expertise in pioneering remote health care delivery. The target populations are individuals hospitalized for TBI, their families, and their local health care providers. The goal of CONNECT is to test the extent to which a complex brain rehabilitation intervention delivered remotely improves participation outcomes and satisfaction compared to a matched group receiving usual care in their communities.
The CONNECT trial will use a randomized pragmatic clinical trial methodology, testing the intervention in 4 upper Midwest states (MN, IA, ND, SD), focusing on rural dwellers, the elderly, and Native Americans. The trial’s complex intervention includes remote clinical assessments and service provision, partnering with local providers, care coordination, education, and supportive services. Service type and delivery mode will be determined by need, local technology, and technical skill. The goal is to use all available resources to remotely CONNECT individuals discharged from hospitals with TBI, their families and their community providers to a specialized brain rehabilitation practice and to each other. Objectives are to: (1) pilot and refine ICT platforms and satisfaction measures in small target population groups during Phase 1; and (2) test CONNECT hypotheses during Phase 2, following outcomes over 3 years after hospital discharge. Anticipated outcomes are improved participation and greater satisfaction among the target populations in the intervention group and increasing comfort and competence with TBI care among local clinical providers when compared to those participating in usual care.
If results support our hypotheses, a multi-center hub-based trial of this complex intervention among other TBI Model System Centers will allow testing of this model in multiple geographic regions, with a potential for increasing brain rehabilitation service capacity nation-wide.