Medical and Resource Facilitation Intervention After Traumatic Brain Injury

NCT03429322 | Completed

• 2 other identifiers: 17-00930090DPTB0012-01-00
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs. This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities. Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.

Conditions

Brain Injuries, Traumatic; Family; Physician's Role

Keywords

traumatic brain injury; pragmatic clinical trial; telemedicine; cost

Outcome Measures

Primary Outcomes (3)

• Change in Mayo-Portland Participation Index (M2PI)

  A primary participation assessment and outcome measure for phone follow-up

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

• Change in Traumatic Brain Injury-Quality of Life (TBI-QOL)

  Measures health-related patient-reported quality of life measurement specific to TBI

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

• Change in Participation Assessment with Recombined Tools-Objective (PART-O)

  Measures long-term outcomes and function at the societal level

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Secondary Outcomes (6)

• Change in Vocational Independence Scale

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

• Change in Telemedicine Perception Questionnaire (TMP-Q)

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

• EQ-5D™

  Assessed at study end (18 months)

• Change in Zarit Burden Inventory (ZBI)

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

• Change in Family Needs Questionnaire (FNQ)

  Collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Study Arms (2)

Medical Care and Resource Facilitation

EXPERIMENTAL

All intervention components will be delivered remotely: there will be no face-to-face interaction with the participants. The intervention is comprised of the clinical, educational, and supportive services of Mayo's Brain Rehabilitation Clinic integrated with the MN BIA RF program.

Behavioral: Medical Care and Resource Facilitation

Usual care

ACTIVE COMPARATOR

Individuals with TBI, their family members and PCPs assigned to the usual care group will receive care and provide services as usual in their communities. Individuals with TBI assigned to the usual care group will receive RF as routinely provided by MN BIA.

Other: Usual Care

Interventions

Medical Care and Resource Facilitation BEHAVIORAL

The intervention expands on an established web-based platform and uses other information and communication technology (ICT) devices, incorporating synchronous direct clinical care and asynchronous intervention. Participants will use their own devices and internet access for any and all interactions with Mayo Clinic providers. The specific ICT modes used and services provided to interact with participants will be determined by clinical need, individual preference, and technological capacity.

Medical Care and Resource Facilitation

Usual Care OTHER

Participants will receive and provide usual and customary care in their communities.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of traumatic brain injury
• Minnesota resident
• Access to at least a telephone
• Functional English speaker
• Eligible for MN BIA Resource Facilitation participant

You may not qualify if:

• Age \< 18 years
• Diagnosis of acquired brain disorder other than traumatic brain injury
• No telephone or on-line/internet access

Sponsors & Collaborators

• Mayo Clinic: lead
• Minnesota Brain Injury Alliance: collaborator
• Minnesota Department of Health: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dmitry Esterov, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Community-based randomized pragmatic clinical trial of a complex behavioral intervention delivered remotely

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 12, 2018
• Study Start: January 11, 2019
• Primary Completion: July 15, 2022
• Study Completion: December 3, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (1)