Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

Study Overview
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Brief Summary
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Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI) discharged home from acute hospital care without inpatient rehabilitation. To enhance the standard of TBI care, we will develop and refine a patient- and family-centered TBI transitional care intervention that addresses specific needs and preferences for patients with TBI (age < 65 years) and families and will assess the feasibility, acceptability, and preliminary efficacy of the intervention.

Detailed Description
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Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI). Patients with moderate-to-severe TBI (age < 65 years) discharged home from acute hospital care without inpatient rehabilitation have cognitive, physical, behavioral, and emotional impairments that affect their abilities to independently self-manage their health, wellness, and activities of daily living. Activity limitations often result in increased family involvement for managing the person's care. The complexity of needs combined with the fragmentation of healthcare services creates the perfect storm for mismanaged symptoms, adverse health events, readmissions, and a lower likelihood of return to work and school. Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and continuity of healthcare for patients transferring between different locations or levels of care in close geographic proximity. In other patient groups who experience acute events (e.g., stroke, myocardial infarction), transitional care management has led to improved patient and family outcomes. Although preliminary research shows that patients with TBI and families desire and could benefit from interventions to support the transition from acute hospital care to home, the strength of evidence on this topic is low. TBI transitional care interventions developed to date are ineffective in improving functional outcomes and do not incorporate family needs. Thus, the purpose of our study is to first develop and refine a patient- and family-centered TBI transitional care intervention to support patients with moderate-to-severe TBI and their family caregivers during the transition home from acute hospital care. The intervention will aim to improve quality of life for patients with TBI, reduce strain for their family caregivers, and direct patients and families to appropriate resources and care that is concordant with their health-related goals. Second, we will examine the feasibility and acceptability and assess the preliminary efficacy of the TBI transitional care intervention. The primary outcome will be patient quality of life at 16 weeks post-discharge. This study will also examine secondary outcomes at 16 weeks post-discharge, including family caregiver strain and preparedness for the caregiving role, and patient and family caregiver self-efficacy and healthcare utilization. The new knowledge generated from the proposed research will guide the research team in designing and conducting an NIH R01 implementation-effectiveness clinical trial of the TBI transitional care intervention and will ultimately enhance the standard of care for patients with TBI discharged home from acute hospital care and families

Official Title
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Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

Conditions
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Brain Injuries, Traumatic, Transitional Care, Family Members, Patients

Intervention / Treatment
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* Behavioral: BETTER Transitional Care Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: age 18-64 years, diagnosis of mild-moderate TBI based on Glasgow Coma Scale score of 9-14; sufficient cognitive functioning and oral communication skills to participate (as determined by Galveston Orientation and Amnesia Test); set to be discharged directly home from acute hospital care; and has smart phone or computer with internet access. Family caregiver: age 18 years or older, primary caregiver for patient post-discharge (i.e., plans to live in same home as person or have direct contact with person >10 hours/week); and has smart phone or computer with internet access. Exclusion Criteria: Patients: who do not have a family caregiver who is willing to participate; prior neurological disorder affecting the brain or language or learning disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: 15 patient/family dyads will undergo intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: BETTER Transitional Care Intervention<br>* Patient and family will receive pre- and post-discharge support and education from interventionist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Form-36 (SF-36) | Quality of Life | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire (PHQ-9) | Psychiatric status | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Self-efficacy for managing chronic conditions | Self-efficacy | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Modified Caregiver Strain Index | Caregiver strain | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Preparedness for Caregiving Scale | Preparation for Caregiver Role | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Health Service Utilization Inventory | Health service utilization | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| NeuroQOL measures (short form) | Functional and cognitive status | 16 weeks post-discharge | 
| Change in Rivermead Post Concussion Questionnaire | TBI Symptoms | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Satisfaction With Life | Satisfaction With Life | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Interpersonal Processes of Care | Perceived Discrimination in Health Settings | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in PTSD Checklist | Psychiatric Status (PTSD) | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in Glasgow Outcome Scale-Extended | Global Outcome | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | 
| Change in PART-O | Participation | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge |