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Completed

NCT Number: NCT04584554

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BETTER Transitional Care Intervention

Behavioral

Patient and family will receive pre- and post-discharge support and education from interventionist.

Primary outcomes

  1. Change in Quality of Life as Measured by the Short Form-36 (SF-36)

    Time frame: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

    The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best).

Secondary outcomes

  1. Change in Preparedness for Caregiving Scale (CPS)

    Time frame: Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

    The CPS is a caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). Total score range is 0 to 32, where a higher score indicates the caregiver feels more prepared for caregiving.

Other outcomes

  1. Change in Health Service Utilization Inventory

    Time frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

    Health service utilization

  2. Change in Modified Caregiver Strain Index

    Time frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

    Caregiver strain

  3. Change in Self-efficacy for Managing Chronic Conditions

    Time frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

    Self-efficacy

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Acronym: R03

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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