Medical and Resource Facilitation Intervention After Traumatic Brain Injury

Summary

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs.

This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities.

Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.

Conditions

• Brain Injuries, Traumatic
• Family
• Physician's Role

Interventions

BEHAVIORAL

Medical Care and Resource Facilitation

The intervention expands on an established web-based platform and uses other information and communication technology (ICT) devices, incorporating synchronous direct clinical care and asynchronous intervention. Participants will use their own devices and internet access for any and all interactions with Mayo Clinic providers. The specific ICT modes used and services provided to interact with participants will be determined by clinical need, individual preference, and technological capacity.

OTHER

Usual Care

Participants will receive and provide usual and customary care in their communities.

Sponsors & Collaborators

• Minnesota Brain Injury Alliance

  collaborator UNKNOWN

• Minnesota Department of Health

  collaborator OTHER_GOV

• Mayo Clinic

  lead OTHER

Principal Investigators

• Dmitry Esterov, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-11

Primary Completion

2022-07-15

Completion

2022-12-03

Countries

• United States

Study Locations