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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Other intervention

    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

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Standard of CareOther 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Managing Your loved Ones Health - Care Partner Activation

Based on 32 self-report items prompt care partners to rate agreement with caregiving activity and engagement statements. Rated "1-Completely Agree" to "4-Completely Disagree" or "0 - Not My Responsibility." Used because: Good full-scale reliability (α=0.95). Sufficiently unidimensional for Rasch modeling with acceptable fit statistics, low standard error of measurement, and good range of item difficulty (23.8 - 71.8). Good concurrent validity: (a) positive correlations w/ care partner preparedness, self-competence, and self-confidence, and (b) negative correlations with stress, anxiety, and poor mental health

Time frame
Measured at 12-weeks post-discharge

Secondary outcomes

1

Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing

Based on 16 self-report items prompt care partners to rate representativeness of basic needs met and keeping up with day-to-day activities Rated from "1 - Rarely" to "5 - Usually." Used Because: Good full-scale reliability (α=0.83). Items have low redundancy; average inter-item r=.25 (range: .01 - .49). Good fit with two-factor model: (1) Basic Needs and (2) Implementation of Met Needs.

Time frame
Measured at 24-weeks post-discharge
2

Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress

Based on 4 self-report items prompt respondents to rate their depression and anxiety over last two weeks. Rated from "0 - Not at All" to "3 - Nearly Every Day." Used because: Good full-scale reliability (α=0.85). Clear 2-factor structure (anxiety and depression) explaining 84% of variance. High sensitivity as a screening scale.

Time frame
Measured at 12- and 24-weeks post-discharge.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Department of Health and Human Services

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator