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

NCT ID: NCT02088099

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-12-31

Brief 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.

Detailed Description

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Complex clinical intervention

Group Type: EXPERIMENTAL

Complex clinical intervention

Intervention Type: OTHER

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.

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Treatment as usual

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• English speaking individuals who are at least 18 years old
• Hospitalized for a minimum of 24 hours (no maximum) with TBI during the recruitment window in one of the following: 1) Hospital in state of Minnesota, 2) Hospital in state of Iowa, 3) Regional Health, 4) Altru Health System
• Individuals with TBI who have (or their LAR has) at least telephone communication technology

Exclusion Criteria

• Non-English speaking individuals
• Individuals under a civil commitment order
• Individuals with TBI who are in coma or minimally conscious (not following commands)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minnesota Department of Health

OTHER_GOV

Sponsor Role: collaborator

Iowa Department of Public Health

UNKNOWN

Sponsor Role: collaborator

Rapid City Regional Hospital, Inc

OTHER

Sponsor Role: collaborator

Altru Health System

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Allen Brown

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Bergquist TF, Moessner AM, Mandrekar J, Ransom JE, Dernbach NL, Kendall KS, Brown AW. CONNECT: A pragmatic clinical trial testing a remotely provided linkage to service coordination after hospitalization for TBI. Brain Inj. 2022 Jan 28;36(2):147-155. doi: 10.1080/02699052.2022.2042601. Epub 2022 Feb 22.

Reference Type: DERIVED

PMID: 35192438 (View on PubMed)

Other Identifiers

NIDILRR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-008525

Identifier Type: -

Identifier Source: org_study_id