- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04584554
Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families (R03)
November 22, 2021 updated by: Duke University
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Durham, North Carolina, United States, 27701
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
Patient and family will receive pre- and post-discharge support and education from interventionist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Short Form-36 (SF-36)
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
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)
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Psychiatric status
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
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
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Modified Caregiver Strain Index
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Caregiver strain
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Preparedness for Caregiving Scale
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Preparation for Caregiver Role
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Health Service Utilization Inventory
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Health service utilization
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
NeuroQOL measures (short form)
Time Frame: 16 weeks post-discharge
|
Functional and cognitive status
|
16 weeks post-discharge
|
Change in Rivermead Post Concussion Questionnaire
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
TBI Symptoms
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Satisfaction With Life
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Satisfaction With Life
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Interpersonal Processes of Care
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Perceived Discrimination in Health Settings
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in PTSD Checklist
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Psychiatric Status (PTSD)
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in Glasgow Outcome Scale-Extended
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Global Outcome
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Change in PART-O
Time Frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Participation
|
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tolu O Oyesanya, PhD, RN, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2021
Primary Completion (Actual)
October 15, 2021
Study Completion (Actual)
October 15, 2021
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 6, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
November 22, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00103181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Please contact PI for underlying research materials.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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