An interventional study of BETTER Transitional Care Intervention in Brain Injuries, Traumatic, Transitional Care and Family Members, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
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
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 31 is below the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: BETTER Transitional Care Intervention
Patient and family will receive pre- and post-discharge support and education from interventionist.
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
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
Change in Health Service Utilization Inventory
Health service utilization
Time frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Change in Modified Caregiver Strain Index
Caregiver strain
Time frame: Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
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
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.
| Milestone | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Caregiver |
|---|---|---|
| Started | 15 | 16 |
| Completed | 13 | 14 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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).
| score on a scale | Intervention Patient-Caregiver Dyad - Patient |
|---|---|
| Change in Quality of Life as Measured by the Short Form-36 (SF-36) | 47.97 ± 24.93 |
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.
| score on a scale | Intervention Patient-Caregiver Dyad - Caregiver |
|---|---|
| Change in Preparedness for Caregiving Scale (CPS) | 25.75 ± 8.02 |
Health service utilization
Results for this outcome have not been posted.
Caregiver strain
Results for this outcome have not been posted.
Self-efficacy
Results for this outcome have not been posted.
Participation
Results for this outcome have not been posted.
Global Outcome
Results for this outcome have not been posted.
Psychiatric Status (PTSD)
Results for this outcome have not been posted.
Perceived Discrimination in Health Settings
Results for this outcome have not been posted.
Satisfaction With Life
Results for this outcome have not been posted.
TBI Symptoms
Results for this outcome have not been posted.
Functional and cognitive status
Results for this outcome have not been posted.
Psychiatric status
Results for this outcome have not been posted.
Collected over 16 weeks post-discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Family Caregivers | Total |
|---|---|---|---|
| Mean | 39.07 ± 15.15 | 43.38 ± 10.45 | 41.25 ± 12.8 |
| Sex: Female, Male(Participants) | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Family Caregivers | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Family Caregivers | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 16 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Family Caregivers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 8 | 17 |
| White | 5 | 7 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention Patient-Caregiver Dyad - Patient | Intervention Patient-Caregiver Dyad - Family Caregivers | Total |
|---|---|---|---|
| United States | 15 | 16 | 31 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Please contact PI for underlying research materials.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.