CONNECT trial tests effectiveness, feasibility of remote TBI care

Between 2001 and 2010, traumatic brain injury (TBI)-related emergency department visits rose 70 percent, with the greatest increase occurring among young children and adults older than 65. Many of these vulnerable patients lack access to specialized post-acute care, especially in rural areas.

Mayo Clinic's specialty brain rehabilitation practice has provided services to patients around the region, often in remote communities, with positive results. Now, Mayo's TBI Model System Center is undertaking a first-of-its-kind study funded by the National Institute on Disability and Rehabilitation Research. Called the CONNECT Trial, it will determine whether partnering remotely with local providers for TBI-related treatment is feasible and effective.

"The CONNECT Trial is totally aligned with our mission of reaching out to regional health systems and other providers around the country that may not have the specialty care that Mayo has," explains Thomas Bergquist, Ph.D., L.P., a clinical neuropsychologist and specialist in brain rehabilitation at Mayo Clinic's campus in Rochester, Minnesota.

Dr. Bergquist says local providers have expressed great interest in getting real-time advice from Mayo specialists through traditional means, such as phone calls, as well as through Web-based and social media platforms. "Patients may not get exactly the same treatment they would at Mayo, but through these connections, they get something very close to it in their own communities," he says.

This model of care has not been directly tested, however, and no published data indicate whether it provides any advantage over treatment as usual. The CONNECT Trial aims to fill that gap.

Patient recruitment and care

Working with partners in Minnesota, Iowa, and North and South Dakota, CONNECT will recruit 500 patients recently discharged from the hospital with a diagnosis of TBI. Half will receive the usual care available in their community. The rest will be treated by local providers receiving TBI-specific education and consultative support from resources at Mayo's Brain Rehabilitation Center.

Patients in the intervention group will receive a comprehensive evaluation and needs assessment from the clinical team before being connected to local physicians, therapists and community agencies.

In addition to partnering with providers, the Mayo team will connect with patients and families. "The family is extremely important in any patient's recovery, and we will provide families with support and education," Dr. Bergquist explains. "If family members are disengaged, with no defined roles or relationships, they can really struggle. And patients are less likely to have a positive outcome for reasons unrelated to their medical condition. As a brain injury rehabilitation provider, I see this every day."

The CONNECT Trial will also connect patients and families with each other for peer support and the opportunity to discuss common experiences and problems. Patients in both groups will be followed for up to 18 months and will be assessed on a variety of measures based on the International Classification of Functioning, Disability and Health, which captures how people function in daily life rather than focusing on the presence or absence of disease.

Primary outcome measures for patients will include impairment, activity limitations and participation (independent living, employment and quality of life) as well as satisfaction with the services provided. Families will also be asked about their satisfaction with services along with any changes in their coping and caregiver burden. And providers will report whether the provided services have improved their confidence and competence in working with patients with brain injuries. The combined responses will help determine whether outcomes among remote care patients are superior to those in the treatment-as-usual group.

"If the data support this model of care, our hope is that it will become the standard of care for what we do every day," Dr. Bergquist says. "We will have a hub-based system of remotely coordinated brain rehabilitation services with different providers that will provide the same model of care that patients receive here."

For more information

Mayo Clinic Traumatic Brain Injury Model System Program. The CONNECT Trial.