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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Standard of Care
Other interventionThe 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 interventionNovel 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
Department of Health and Human Services
Collaborator
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator