Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | March 2014 |
| End Date: | March 2019 |
The CONNECT Trial: A Randomized Pragmatic Clinical Trial Measuring the Effectiveness of a Remotely Provided Complex Brain Rehabilitation Intervention in Improving Participation Outcomes of Individuals With TBI, Their Families, and Local Primary Providers
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.
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.
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.
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.
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)
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Allen W Brown, MD
Phone: 507-255-3116
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