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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BETTER Transitional Care Intervention | Behavioral | Patient and family will receive pre- and post-discharge support and education from interventionist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Service Utilization Inventory | Health service utilization | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge |
| Change in Modified Caregiver Strain Index | Caregiver strain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tolu O Oyesanya, PhD, RN | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35174756 | Derived | Oyesanya TO, Loflin C, You H, Kandel M, Johnson K, Strauman T, Yang Q, Hawes J, Byom L, Gonzalez-Guarda R, Van Houtven C, Agarwal S, Bettger JP. Design, methods, and baseline characteristics of the Brain Injury Education, Training, and Therapy to Enhance Recovery (BETTER) feasibility study: a transitional care intervention for younger adult patients with traumatic brain injury and caregivers. Curr Med Res Opin. 2022 May;38(5):697-710. doi: 10.1080/03007995.2022.2043657. Epub 2022 Mar 2. |
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Please contact PI for underlying research materials.
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15 patient-caregiver dyads started the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Patient-Caregiver Dyad - Patient | BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist. |
| FG001 | Intervention Patient-Caregiver Dyad - Caregiver | BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Patient-Caregiver Dyad - Patient | BETTER Transitional Care Intervention: Patient will receive pre- and post-discharge support and education from interventionist. |
| BG001 | Intervention Patient-Caregiver Dyad - Family Caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Younger adults (age 18-64) with mild, moderate, or severe TBI discharged home from acute hospital care without inpatient rehabilitation. Not collected on caregivers. | Posted | Mean | Standard Deviation | score on a scale | Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge |
|
16 weeks post-discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tolu Oyesanya, PI of study | Duke University School of Nursing | 919-684-5292 | tolu.oyesanya@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2020 | Apr 24, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2021 | Apr 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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15 patient/family dyads will undergo intervention
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| Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge |
| Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge |
| Change in Self-efficacy for Managing Chronic Conditions | Self-efficacy | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge |
BETTER Transitional Care Intervention: Family will receive pre- and post-discharge support and education from interventionist. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
BETTER Transitional Care Intervention: Patient and family will receive pre- and post-discharge support and education from interventionist.
|
|
| 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. | Family caregivers of patients with TBI. Not collected on patients. | Posted | Mean | Standard Deviation | score on a scale | Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge |
|
|
|
| Other Pre-specified | Change in Health Service Utilization Inventory | Health service utilization | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Other Pre-specified | Change in Modified Caregiver Strain Index | Caregiver strain | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Other Pre-specified | Change in Self-efficacy for Managing Chronic Conditions | Self-efficacy | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in PART-O | Participation | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in Glasgow Outcome Scale-Extended | Global Outcome | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in PTSD Checklist | Psychiatric Status (PTSD) | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in Interpersonal Processes of Care | Perceived Discrimination in Health Settings | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in Satisfaction With Life | Satisfaction With Life | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | Change in Rivermead Post Concussion Questionnaire | TBI Symptoms | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| Post-Hoc | NeuroQOL Measures (Short Form) | Functional and cognitive status | Not Posted | 16 weeks post-discharge | Participants |
| Post-Hoc | Change in Patient Health Questionnaire (PHQ-9) | Psychiatric status | Not Posted | Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |