Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial

Summary

Mayo Clinic has been funded by the National Institute on Disability Independent Living \& Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes.

Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are:

* Individuals recently hospitalized with TBI;
* Their families;
* Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors).

The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities.

The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.

Conditions

• Traumatic Brain Injury

Interventions

OTHER

Complex clinical intervention

The complex intervention in CONNECT will be tested in 3 target populations: (1) Individuals hospitalized for TBI; (2) their family members; (3) their local health care providers. All intervention components will be delivered remotely: there will be no face-to-face interaction with the research subjects. The complex intervention tested in CONNECT is comprised of the clinical direction and advice to local providers, educational, and supportive services of the Mayo Brain Rehabilitation Clinic (BRC). The specific communication modes used to interact with individual study subjects, and the specific clinical and educational support services that are provided to an individual subject by these modes, will be determined by clinical need, individual preference, and technological capacity.

OTHER

Treatment as usual

Participants in this arm will receive, experience, or provide the care that is usual and customary in their communities.

Sponsors & Collaborators

• Minnesota Department of Health

  collaborator OTHER_GOV

• Iowa Department of Public Health

  collaborator UNKNOWN

• Rapid City Regional Hospital, Inc

  collaborator OTHER

• Altru Health System

  collaborator OTHER

• Mayo Clinic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2017-09-30

Completion

2018-12-31

Countries

• United States

Study Locations