Clinical trial NCT02088099: Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Telehealth
ehealth
Mobile Health
social participation
patient participation
consumer participation
Patient Outcome Assessment
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Minnesota Department of Health
name: Iowa Department of Public Health
name: Rapid City Regional Hospital, Inc
name: Altru Health System
First posted: 2014-03-14
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Traumatic Brain Injury - Quality of Life (TBI-QOL)
timeFrame: At enrollment, at 6 months, and at 18 months
measure: Change in measure of patient impression of Telemedicine (TMP-Q)
timeFrame: At enrollment, at 6 months, and at 18 months
measure: Change in Caregiver Appraisal Scale (CAS)
timeFrame: At enrollment, at 6 months, and at 18 months
measure: Change in Clinical Satisfaction and Competency Rating (CSCR)
timeFrame: At enrollment, at 6 months, and at 18 months
Secondary outcomes:
measure: Change in the Activity Measure for Post-Acute Care™ (AM-PAC™)
timeFrame: At enrollment, at 6 months, and at 18 months
measure: Change in self-reported use of health care and other community support services
timeFrame: Every 3 months after consenting until the end of study period at 18 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: 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.