DOI: 10.3886/icpsr39094.v1
title: Improving Transition from Acute to Post-Acute Care following Traumatic Brain Injury (BRITE), United States, 2018-2022
title: Version 1

description: The BRITE study (<em>B</em>rain Injury <em>R</em>ehabilitation: <em>I</em>mproving the <em>T</em>ransition <em>E</em>xperience) was a six-center, 1:1 randomized controlled pragmatic trial with masked outcome assessment that compared the effectiveness of two established approaches to managing transition from inpatient rehabilitation facility discharge to the next phase of care for individuals with moderate-to-severe traumatic brain injury (TBI). The two established transition methods were (1) a standardized version of existing discharge procedures used at all six sites and (2) a standardized remotely-delivered case management approach that extended beyond the point of discharge, based on the protocol used within the Veteran's Health Administration and enhanced with input from patient and family stakeholders. The sample was stratified by site and discharge location (skilled nursing facility vs. discharge to home/community) based on the relatively lower frequency of discharge to facility (22 percent across all six study sites in 2015) and the expectation of high impact of discharge destination on outcomes. When a caregiver was available for an enrolled patient, they were also approached for consent to be surveyed, with some patients having up to two caregivers enrolled to account for changes in primary caregiver.
The following key outcome domains were assessed: (1) ability of patients to participate in the home and community as independently as possible, (2) health-related quality of life, (3) access to appropriate healthcare and reduced emergent or urgent healthcare, and (4) caregiver outcomes. These outcomes were assessed at 3, 6, 9 and 12 months after discharge from inpatient care. Participants were also given the standard TBI Model Systems follow-up assessment one-year post-injury. Types of medical insurance coverage and satisfaction with healthcare were examined at 6 and 12 months post-discharge.
description: The study included the following aims:
To compare the effectiveness of rehabilitation discharge plan (RDP) and rehabilitation transition plan (RTP) on two patient-reported outcomes: societal participation and health-related quality of life.
To compare the trajectories of improvement across first year post-discharge on patient-reported outcomes of participation and quality of life.
To compare differences in healthcare utilization between RDP and RTP across first year post-discharge.
To compare the effectiveness of RDP and RTP on caregiver outcomes of caregiver burden, health-related quality of life, and satisfaction with roles and activities.
description: This pragmatic comparative effectiveness study was designed to examine the effects of two established methods of managing transitions from inpatient rehabilitation facility (IRF) discharge to the next stage of care for moderate to severe traumatic brain injury (TBI). All participants received a rehabilitation discharge plan (RDP) providing an accredited-recommended model of patient/family education and training, with referrals for further care. Half of the sample was randomized to also receive a rehabilitation transition plan (RTP) during the first 6 months after discharge. This included individualized care management and support that focused on education regarding TBI recovery, identification of unmet needs, facilitation of resources toward meeting their needs, and coordination of care delivered by phone or secure videoconference. Randomization to RDP or RTP occurred at discharge from the IRF and was based on a permuted block design with even-numbered block sizes of 4 to 20, stratified by site and discharge position (home vs. skilled nursing facility). Outcome assessments were completed at 3, 6, 9, and 12 months after discharge from inpatient rehabilitation and were conducted by phone by site-specific data collectors who were masked to treatment allocation.
description: Baseline variables were extracted from medical records or supplied by participants and include demographics, cultural variables, socioeconomic variables, and data pertaining to social and medical history. Details of the patient's injury and treatment were also collected, including date of injury, cause and severity of injury, dates of acute care and inpatient rehabilitation, discharge destination, and discharge status. Caregivers were asked to provide many of the same baseline variables, as well as the type and duration of the relationship to the patient. Outcome assessment variables include items from various scales and measures.
description: Response Rates: A total of 936 patients were enrolled from February 13, 2018 to August 31, 2021, with 31 percent of eligible participants declining to participate. 925 patients were randomized. A total of 741 participants completed an outcomes assessment at the 6-month primary outcome time point (374 (81 percent) in the rehabilitation transition plan (RTP) group and 367 (79 percent) in the rehabilitation discharge plan (RDP) group).
A total of 611 caregivers were enrolled (591 first caregivers and 20 second caregivers) to 591 randomized patient participants. A total of 463 caregiver participants completed an outcomes assessment at the 6-month primary outcome time point, with 234 (80 percent) in the RTP group and 229 (77 percent) in the RDP group completing the assessment.
description: Presence of Common Scales: Brief Test of Adult Cognition (BTACT)
Participation Assessment with Recombined Tools-Objective-17 items (PART-O-17)
Quality of Life after Brain Injury (QOLIBRI)
Cornell Services Index
Bakas Caregiving Outcomes Scale
Zarit Burden Interview
Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles and Activities, 8-item short form
Short Form-12 Health Survey (SF-12)
Continuity Assessment Record and Evaluation (CARE) Tool
Functional Independence Measure (FIM)
Internal measures for 'Required Assistance and Time Spent in Caregiving' and Likert-type scales
description: The six study sites were Traumatic Brain Injury Model Systems (TBIMS) centers, which tend to have similar treatment protocols and staffing ratios. The study sites included two centers in the Northeast, two in the Midwest, one in the South, and one in the Pacific Northwest.
Two types of participants were recruited through multi-stage eligibility screening: people with moderate to severe traumatic brain injury (TBI) and their identified caregivers who would assist them after discharge. Participants were recruited from consecutive admissions at each site's inpatient rehabilitation facility (IRF) following their site's admission policy. The following inclusion criteria was used for participants with TBI:
Diagnosis of moderate to severe TBI
English-speaking
Aged 18-years or older
Discharged from an IRF to community (private residence, adult home, hotel, homeless) or facility (nursing home, skilled nursing facility)
Able to provide informed consent directly or through a legally authorized representative
Participants were excluded if they were in custody of law enforcement at or during admission to the rehabilitation unit, lacked access to a telephone after discharge, or were unable to participate in the intervention due to cognitive or communication limitations, and there was no one available or willing to provide consent as a proxy informant.
Every effort was made to enroll a caregiver for each participant enrolled in the trial. Caregiver participants were individuals who would have primary caregiving responsibility for the enrolled patient following hospital discharge. The following inclusion criteria was used for caregiver participants:
English-speaking
Aged 18-years or older
Provided informed consent
Caregiver participants were also excluded if they were in custody with law enforcement or lacked access to a telephone.
description: Datasets: 
DS0: Study-Level Files
DS1: Patient Baseline and Follow-Up Data
DS2: Imputed Patient Data: PART-O-17 Outcome at 6-Month Follow-Up
DS3: Imputed Patient Data: PART-O-17 Outcome at 12-Month Follow-Up
DS4: Imputed Patient Data: QOLIBRI Outcome at 6-Month Follow-Up
DS5: Imputed Patient Data: QOLIBRI Outcome at 12-Month Follow-Up
DS6: Caregiver Baseline Data
DS7: Caregiver 3-Month Follow-Up Data
DS8: Caregiver 6-Month Follow-Up Data
DS9: Caregiver 9-Month Follow-Up Data
DS10: Caregiver 12-Month Follow-Up Data
DS11: Combined Caregiver Follow-Up Data
DS12: Longitudinal Caregiver Data
description: Adults with moderate to severe traumatic brain injury receiving inpatient rehabilitation in the United States.
description: record abstracts; cognitive assessment test; face-to-face interview; mail questionnaire; self-enumerated questionnaire; on-site questionnaire; telephone interview