System-Specific and Module Studies

Mayo Clinic's Traumatic Brain Injury Model System is actively conducting two clinical trials that aim to remotely connect individuals and groups to Mayo Clinic brain rehabilitation specialists and to each other.

2017-2022 System-Specific Study — Testing an Integrated Medical and Resource Facilitation Intervention (MRFI): A Community-Based Pragmatic Clinical Trial

The system's immediate work will capitalize on longstanding collaborations with the Minnesota Brain Injury Alliance and Minnesota Department of Health (MDH) in a community-based randomized pragmatic clinical trial. Unmet needs persist for individuals with TBI and their families related to making reliable and lasting connections to medical, social and community services after hospital-based care despite their repeated identification and large-scale efforts to address them. MRFI is supported by research evidence and previous experience and will address:

  • Ineffective connection of individuals with TBI and their families to specialized medical and community resources after hospital-based care
  • Limited access to TBI experts
  • Variable knowledge by primary care providers about the complex needs of individuals with TBI

This clinical trial will test a complex behavioral intervention to determine whether outcomes over time are better in a group receiving the MRFI model of care compared with a group that receives usual care in their communities. MRFI group participants will have access to the remotely provided supportive, educational, care coordination and direct clinical services (including therapy) of the Mayo Clinic Brain Rehabilitation Clinic.

Services will be delivered by a multidisciplinary health care team via telemedicine (live two-way audiovisual interaction between providers and participants in their homes) and interactive communication technology (for example, web- and phone-based services). There will be no face-to-face visits. The specific modes used to interact with MRFI participants and the specific services provided will be determined by individual need, preference and technology.

Fundamental to MRFI is the family-centered nature of the intervention, which also relies on the involvement of the participant's primary care provider. Families in the MRFI group will have access to an array of Mayo Brain Rehabilitation Clinic supportive and educational services, primary care providers will have access to Mayo Clinic medical and rehabilitation expertise and related resources.

At the outset and throughout the 18-month study period, Mayo Brain Rehabilitation Clinic services will be integrated with the highly developed Minnesota Brain Injury Alliance Resource Facilitation program — a free two-year telephone support service offering assistance in navigating life after brain injury.

Target populations for MRFI are up to 500 Minnesotans with a history of TBI who are at least 18 years old, one year or less post-injury and eligible for the Resource Facilitation program along with equal numbers of their family members and primary care providers.

This integrated intervention appears essential to address the complex, intertwined, and long-lasting medical and social problems faced by individuals with TBI. An existing collaboration with the Minnesota Department of Health and the expertise of analysts in Mayo Clinic's Center for the Science of Health Care Delivery will allow for a comparison of costs between groups. Other Mayo Clinic collaborators include the Center for Connected Care, Center for the Science of Health Care Delivery, and the Mayo Clinic Social Media Network.

The trial will also continue collaboration with CareHubs Inc., a leading online community engagement platform for the health care industry. Mayo Clinic's TBI Regional Advisory Council participated in this trial's design and will provide research oversight.

The anticipated long-term results of this research are development of a sustainable model of care that uses technology to integrate medical rehabilitation with community expertise to improve TBI care and outcomes. Other expected outcomes include building TBI knowledge among primary care providers and families.

2017-2022 Module Studies

This cycle, Mayo Clinic will participate in four collaborative studies, known as Module Studies, with other funded centers:

  • Trajectories of cognitive functioning years after TBI
  • Return to driving after moderate-severe TBI
  • Physical activity and its relationship with disabling secondary conditions
  • Caregiver resilience: A longitudinal investigation

2017-2022 Collaborative Grant

Characterization and Treatment of Chronic Pain after Moderate to Severe Traumatic Brain Injury

2012-2018 System-Specific Study — The CONNECT Trial

Lack of access to specialized care is a common need identified by individuals hospitalized for TBI. Explosive advances in communication technology have brought telemedicine to the forefront of health care.

The CONNECT Trial aims to remotely connect groups and individuals to Mayo Clinic TBI rehabilitation specialists and to each other. This is done through using traditional methods (phone and mail) and other information communication technology (internet based, email, smartphone, text, social media and Skype).

Those groups joined together by the CONNECT Trial include:

  • Individuals recently hospitalized with TBI and their families
  • Local health care providers (primary care providers, psychologists, therapists, social service providers, job counselors)

Mayo Clinic's Traumatic Brain Injury Model System is testing the extent to which partnership with local providers for TBI-related assessment and treatment is feasible, effective and satisfying for everyone involved. Assessment is also being done to provide TBI-specific education, consultation on management of common problems and coordination of care to promote recovery and the return to work, school and family life.

To that end, Mayo Clinic's TBI Model System is conducting this first-of-its-kind study in Minnesota, Iowa, North Dakota and South Dakota. Research participants were identified through collaboration with the health departments in Minnesota and Iowa, Altru Health System in North Dakota and Regional Health in South Dakota.

The team is especially interested in learning more about the possible benefit of this approach for people who live in rural areas, older adults and Native Americans since these populations are at greater risk of TBI and may be more isolated from specialized services.

Participants were assigned to one of two groups — either the remote care group or to another group that is followed but receives the usual care available in the community. Individuals in both groups will complete select questionnaires and be contacted regularly to monitor their recovery and use of health care and other services.

The long-term outcome of this study is intended to reduce barriers to accessing specialized traumatic brain injury rehabilitation care.

Note: Recruitment for the CONNECT Trial has ended. The intervention and data collection phases of the study will continue through 2018. An article describing the project was recently published in Brain Injury Professional, an issue that featured practice innovations.

ClinicalTrials.gov

2012-2017 Module Studies

  • Internet use and online social participation among individuals with TBI
  • Resilience after TBI
  • Test-retest reliability of Traumatic Brain Injury Model System Form II measures with people with TBI
  • Understanding causes of death in the TBI Model Systems
  • Incorporating TBI Model System data into the Federal Interagency TBI Research (FITBIR) informatics system