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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04584554
Acronym
R03
Enrollment
31
Registered
2020-10-14
Start date
2021-02-17
Completion date
2021-10-15
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BEHAVIORALBETTER Transitional Care Intervention

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

Sponsors

University of North Carolina, Chapel Hill
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

15 patient/family dyads will undergo intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Quality of Life as Measured by the Short Form-36 (SF-36)Baseline (24-72 hours pre-discharge) and 16-weeks post-dischargeThe 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

MeasureTime frameDescription
Change in Preparedness for Caregiving Scale (CPS)Baseline (24-72 hours pre-discharge) and 16-weeks post-dischargeThe 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

MeasureTime frameDescription
Change in Modified Caregiver Strain IndexBaseline (24-72 hours pre-discharge) and 8- and 16-weeks post-dischargeCaregiver strain
Change in Self-efficacy for Managing Chronic ConditionsBaseline (24-72 hours pre-discharge) and 8- and 16-weeks post-dischargeSelf-efficacy
Change in Health Service Utilization InventoryBaseline (24-72 hours pre-discharge) and 8- and 16-weeks post-dischargeHealth service utilization

Countries

United States

Participant flow

Recruitment details

Trained research coordinators screened the electronic medical record daily to determine eligible patients. TCMs recruited the patient/family dyads. First, the TCM contacted eligible patients by phone 24-72 hours before discharge to determine interest in participating and obtain additional eligibility information. Interested and eligible patients were asked to identify the caregiver they preferred to participate with them and to share the caregiver's name and contact information.

Pre-assignment details

15 patient-caregiver dyads started the study.

Participants by arm

ArmCount
Intervention Patient-Caregiver Dyad - Patient
BETTER Transitional Care Intervention: Patient will receive pre- and post-discharge support and education from interventionist.
15
Intervention Patient-Caregiver Dyad - Family Caregivers
BETTER Transitional Care Intervention: Family will receive pre- and post-discharge support and education from interventionist.
16
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicIntervention Patient-Caregiver Dyad - PatientTotalIntervention Patient-Caregiver Dyad - Family Caregivers
Age, Continuous39.07 years
STANDARD_DEVIATION 15.15
41.25 years
STANDARD_DEVIATION 12.8
43.38 years
STANDARD_DEVIATION 10.45
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants31 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants17 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants12 Participants7 Participants
Region of Enrollment
United States
15 Participants31 Participants16 Participants
Sex: Female, Male
Female
5 Participants11 Participants6 Participants
Sex: Female, Male
Male
10 Participants20 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 31
other
Total, other adverse events
0 / 31
serious
Total, serious adverse events
0 / 31

Outcome results

Primary

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

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).

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

Population: Younger adults (age 18-64) with mild, moderate, or severe TBI discharged home from acute hospital care without inpatient rehabilitation. Not collected on caregivers.

ArmMeasureValue (MEAN)Dispersion
Intervention Patient-Caregiver Dyad - PatientChange in Quality of Life as Measured by the Short Form-36 (SF-36)47.97 score on a scaleStandard Deviation 24.93
Secondary

Change in Preparedness for Caregiving Scale (CPS)

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.

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

Population: Family caregivers of patients with TBI. Not collected on patients.

ArmMeasureValue (MEAN)Dispersion
Intervention Patient-Caregiver Dyad - PatientChange in Preparedness for Caregiving Scale (CPS)25.75 score on a scaleStandard Deviation 8.02
Post Hoc

Change in Glasgow Outcome Scale-Extended

Global Outcome

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

Other Pre-specified

Change in Health Service Utilization Inventory

Health service utilization

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

Post Hoc

Change in Interpersonal Processes of Care

Perceived Discrimination in Health Settings

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

Other Pre-specified

Change in Modified Caregiver Strain Index

Caregiver strain

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

Post Hoc

Change in PART-O

Participation

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

Post Hoc

Change in Patient Health Questionnaire (PHQ-9)

Psychiatric status

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

Post Hoc

Change in PTSD Checklist

Psychiatric Status (PTSD)

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

Post Hoc

Change in Rivermead Post Concussion Questionnaire

TBI Symptoms

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

Post Hoc

Change in Satisfaction With Life

Satisfaction With Life

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

Other Pre-specified

Change in Self-efficacy for Managing Chronic Conditions

Self-efficacy

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

Post Hoc

NeuroQOL Measures (Short Form)

Functional and cognitive status

Time frame: 16 weeks post-discharge

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026