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Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families (R03)

Primary Purpose

Brain Injuries, Traumatic, Transitional Care, Family Members

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BETTER Transitional Care Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Brain Injuries, Traumatic

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in Short Form-36 (SF-36)
Quality of Life

Secondary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9)
Psychiatric status
Change in Self-efficacy for managing chronic conditions
Self-efficacy
Change in Modified Caregiver Strain Index
Caregiver strain
Change in Preparedness for Caregiving Scale
Preparation for Caregiver Role
Change in Health Service Utilization Inventory
Health service utilization
NeuroQOL measures (short form)
Functional and cognitive status
Change in Rivermead Post Concussion Questionnaire
TBI Symptoms
Change in Satisfaction With Life
Satisfaction With Life
Change in Interpersonal Processes of Care
Perceived Discrimination in Health Settings
Change in PTSD Checklist
Psychiatric Status (PTSD)
Change in Glasgow Outcome Scale-Extended
Global Outcome
Change in PART-O
Participation

Full Information

First Posted
October 6, 2020
Last Updated
November 22, 2021
Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT04584554
Brief Title
Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Acronym
R03
Official Title
Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Transitional Care, Family Members, Patients

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
15 patient/family dyads will undergo intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
BETTER Transitional Care Intervention
Intervention Description
Patient and family will receive pre- and post-discharge support and education from interventionist.
Primary Outcome Measure Information:
Title
Change in Short Form-36 (SF-36)
Description
Quality of Life
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
Psychiatric status
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Self-efficacy for managing chronic conditions
Description
Self-efficacy
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Modified Caregiver Strain Index
Description
Caregiver strain
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Preparedness for Caregiving Scale
Description
Preparation for Caregiver Role
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Health Service Utilization Inventory
Description
Health service utilization
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
NeuroQOL measures (short form)
Description
Functional and cognitive status
Time Frame
16 weeks post-discharge
Title
Change in Rivermead Post Concussion Questionnaire
Description
TBI Symptoms
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Satisfaction With Life
Description
Satisfaction With Life
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Interpersonal Processes of Care
Description
Perceived Discrimination in Health Settings
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in PTSD Checklist
Description
Psychiatric Status (PTSD)
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in Glasgow Outcome Scale-Extended
Description
Global Outcome
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge
Title
Change in PART-O
Description
Participation
Time Frame
Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tolu O Oyesanya, PhD, RN
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Please contact PI for underlying research materials.
Citations:
PubMed Identifier
35174756
Citation
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.
Results Reference
derived

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

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