Clinical trial NCT06188364: Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System
Official title: Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Traumatic Brain Injury
Keywords: Community Health Services
Rehabilitation Care Transitions
Caregiver Supports
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-01-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a single center, randomized clinical trial (RCT). We will use a block-randomization design with two arms:

1. Usual Care Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge and
2. Experimental USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners:

   1. beginning within one week of inpatient rehabilitation discharge,
   2. active services (initiated by CHW or Care Partner) extending over 1- 12 weeks post-discharge, and
   3. passive services (initiated by care partner request only) 13-24 weeks post-discharge.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Managing Your loved Ones Health - Care Partner Activation
timeFrame: Measured at 12-weeks post-discharge
Secondary outcomes:
measure: Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing
timeFrame: Measured at 24-weeks post-discharge
measure: Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress
timeFrame: Measured at 12- and 24-weeks post-discharge.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Daniel Klyce
role: PRINCIPAL_INVESTIGATOR
References: