Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System

NCT ID: NCT06188364

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-26
• Study Completion Date: 2027-08-31

Brief Summary

TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

Detailed Description

Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

The usual Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge, so the the delivery of traditional CHW outreach services such as finding health, community and social determinants referrals, problem-solving, and connecting care partners to long-term supports/services

Experimental

USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

Novel aspects of the CHW experimental intervention for TBI care partners include:

1. CHW services begin prior to inpatient rehabilitation discharge;

2. care partners get timely, useful health management materials;

3. encounters focus on unlimited, brief, situation-focused calls to help care partners assess and resolve pressing concerns; and

4. long-term support capacity for care partners is built by establishing a reliable referral network of medical, community, and social services that become foundational resources beyond study completion.

Interventions

Standard of Care

The usual Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge, so the the delivery of traditional CHW outreach services such as finding health, community and social determinants referrals, problem-solving, and connecting care partners to long-term supports/services

Intervention Type: OTHER

Experimental

Novel aspects of the CHW experimental intervention for TBI care partners include:

1. CHW services begin prior to inpatient rehabilitation discharge;

2. care partners get timely, useful health management materials;

3. encounters focus on unlimited, brief, situation-focused calls to help care partners assess and resolve pressing concerns; and

4. long-term support capacity for care partners is built by establishing a reliable referral network of medical, community, and social services that become foundational resources beyond study completion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants must be adults (age 18 or older).
• Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
• The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
• If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
• Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.

Exclusion Criteria

• Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Klyce

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Abbasi

Role: CONTACT

katherine.walker@vcuhealth.org

804-828-3703

Ronald Seel

Role: CONTACT

ronald.seel@vcuhealth.org

Facility Contacts

Katherine Abbasi

Role: primary

katherine.walker@vcuhealth.org

804-828-3703

Daniel Klyce

Role: backup

daniel.klyce@vcuhealth.org

Other Identifiers

HM20027800

Identifier Type: -

Identifier Source: org_study_id