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

Brain Injuries, Traumatic Clinical Trial

— R03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584554
• Other study ID #: Pro00103181
• Status: Completed
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Family Members
• Patients
• Transitional Care
• Wounds and Injuries

Intervention

Behavioral:
• BETTER Transitional Care Intervention
Patient and family will receive pre- and post-discharge support and education from interventionist.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Form-36 (SF-36)	Quality of Life	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Patient Health Questionnaire (PHQ-9)	Psychiatric status	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Self-efficacy for managing chronic conditions	Self-efficacy	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Modified Caregiver Strain Index	Caregiver strain	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Preparedness for Caregiving Scale	Preparation for Caregiver Role	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Health Service Utilization Inventory	Health service utilization	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	NeuroQOL measures (short form)	Functional and cognitive status	16 weeks post-discharge
Secondary	Change in Rivermead Post Concussion Questionnaire	TBI Symptoms	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Satisfaction With Life	Satisfaction With Life	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Interpersonal Processes of Care	Perceived Discrimination in Health Settings	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in PTSD Checklist	Psychiatric Status (PTSD)	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in Glasgow Outcome Scale-Extended	Global Outcome	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary	Change in PART-O	Participation	Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge