Clinical trial NCT04584554: Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Official title: Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Transitional Care
Family Members
Patients
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2020-10-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 15 patient/family dyads will undergo intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life as Measured by the Short Form-36 (SF-36)
timeFrame: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge
Secondary outcomes:
measure: Change in Preparedness for Caregiving Scale (CPS)
timeFrame: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge
Other outcomes:
measure: Change in Health Service Utilization Inventory
timeFrame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
measure: Change in Modified Caregiver Strain Index
timeFrame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
measure: Change in Self-efficacy for Managing Chronic Conditions
timeFrame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Tolu O Oyesanya, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oyesanya TO, Loflin C, You H, Kandel M, Johnson K, Strauman T, Yang Q, Hawes J, Byom L, Gonzalez-Guarda R, Van Houtven C, Agarwal S, Bettger JP. Design, methods, and baseline characteristics of the Brain Injury Education, Training, and Therapy to Enhance Recovery (BETTER) feasibility study: a transitional care intervention for younger adult patients with traumatic brain injury and caregivers. Curr Med Res Opin. 2022 May;38(5):697-710. doi: 10.1080/03007995.2022.2043657. Epub 2022 Mar 2.