N/A
N=1,516
Brain Injury Rehabilitation Improving the Transition Experience
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03422276 ↗Enrolled (actual)
1,516
Serious AEs
18.4%
Results posted
Mar 2025
Primary outcome: Primary: Participation Assessment With Recombined Tools - Objective 17 (PART-O-17) — 1.30; 1.33 units on a scale — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rehabilitation Discharge Plan (Other); Rehabilitation Transition Plan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participation Assessment With Recombined Tools - Objective 17 (PART-O-17) |
1.22; 1.20; 1.30; 1.33; 1.35; 1.34 | — |
| PRIMARY Quality of Life After Brain Injury Scale (QoLIBRI) |
67.5; 65.1; 68.3; 65.9; 68.3; 66.0 | — |
| SECONDARY Cornell Services Index |
260; 266; 325; 324; 262; 283 | — |
| SECONDARY Bakas Caregiving Outcomes Scale |
60.1; 60.0 | — |
| SECONDARY Zarit Burden Interview |
22.5; 22.8 | — |
| SECONDARY Short Form 12-Item Measure (SF-12) |
51.1; 50.1; 46.0; 46.9 | — |
| SECONDARY PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a |
51.2; 50.3 | — |
| SECONDARY Time Spent Caregiving - Required Assistance |
121; 120; 39; 40; 67; 72 | — |
| SECONDARY Participation Assessment With Recombined Tools - Objective 17 (PART-O-17) |
1.22; 1.20; 1.30; 1.33; 1.35; 1.34 | — |
| SECONDARY Quality of Life After Brain Injury Scale (QoLIBRI) |
67.5; 65.1; 68.3; 65.9; 68.3; 66.0 | — |
| SECONDARY Satisfaction With Care |
5.69; 5.74; 6.05; 5.99; 5.76; 5.81 | — |
| SECONDARY RTP Satisfaction Survey |
5; 3; 14; 5; 29; 13 | — |
| SECONDARY Time Spent Caregiving - Reason for Assistance |
39; 42; 33; 32; 82; 83 | — |
Summary
Each year, about 2.8 million people sustain a traumatic brain injury (TBI) in the United States, and at least 25 percent of these injuries are classified as moderate to severe. Nearly half of those hospitalized for TBI have long-term disability. Most have psychological, physical, social, or work-related problems, which often become chronic. By talking with patients and family members, we found that returning to daily activities and regaining quality of life are major concerns. Outcomes are affected by the type and severity of the TBI, but the type of treatment someone with TBI receives is also important. What resources are available, whether providers are experienced with the problems associated with TBI, and how much treatment is available can affect outcomes as well.
Currently, inpatient rehabilitation professionals are told to give people with TBI information, reassurance, advice, and referral resources. Some promising ways of helping people with TBI include using telephone and other mobile devices to reach patients after they leave the hospital, to regularly assess their individual needs and help them coordinate their health care, and to provide the information and resources that they need. These new strategies may lead to earlier return to activities and improved quality of life. No studies have compared the standard approach to discharge care with an approach that uses telecare to provide information and care coordination after discharge from inpatient rehabilitation for TBI.
The main goal of this project is to find out how improving the transition from the hospital to outpatient care can improve the lives of people with moderate to severe TBI and achieve better results that are important to patients with TBI, their families, and healthcare providers. In this study, patients with TBI who are discharged from inpatient rehabilitation at one of six national TBI Model Systems sites (University of Washington, Indiana University, Ohio State University, Mount Sinai Hospital, Moss Rehabilitation, and Baylor Institute for Rehabilitation) will be randomized (like the flip of a coin) to either the standard discharge plan or the standard discharge plan with additional telephone follow up from a TBI care manager for the first 6 months after discharge. The project team will compare patient and caregiver functioning and quality of life at 3, 6, 9, and 12 months after hospital discharge in these two groups.
Eligibility Criteria
Inclusion Criteria
- Hospitalized with a moderate-to-severe TBI defined by TBIMS and this study as damage to brain tissue caused by an external mechanical force as evidenced by medically documented loss of consciousness or post-traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination. Potential participants must meet at least one of the following criteria to be considered experiencing a moderate-to-severe TBI:
- PTA>24 hours;
- Trauma related intracranial neuroimaging abnormalities;
- Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); or
- Glasgow Coma Scale in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication).
- English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- At least 18 years old;
- Will be discharged from inpatient rehabilitation to community (private residence, adult home, hotel, homeless) or facility (nursing home, subacute care i.e. skilled nursing facility);
- Current admission to inpatient rehabilitation considered their first comprehensive rehabilitation experience, or extension thereof for most recent TBI (e.g. admitted to inpatient rehabilitation, discharged to acute care, then returns to inpatient rehabilitation to complete their initial stay);
- Able to provide informed consent, or if unable to provide consent have family or legal guardian to provide informed consent for the patient.
Inclusion Criteria- Caregiver Participants:
- Individuals who will have primary care giving responsibility post rehabilitation care discharge of enrolled patient participants;
- English speaking (we will track non-enrollment due to other language to determine common languages and have consumer dissemination materials translated for more broad use if time and resources permit.);
- At least 18 years old;
- Able to provide informed consent.
Exclusion Criteria
Exclusion criteria- Patient Participants:
- We will not enroll individuals who are in law enforcement custody at admission to the designated rehabilitation unit or who are taken into custody prior to discharge from the designated rehabilitation unit due to federal restrictions on inclusion of prisoners in research.
- We will not enroll individuals who do not have access to a phone.
- We will not enroll individuals who are unable to complete study procedures due to cognitive/verbal limitations AND do not have a proxy to assist with study procedures.
Exclusion criteria- Caregiver Participants:
- We will not enroll individuals who are in law enforcement custody due to federal restrictions on inclusion of prisoners in research.
- We will not enroll individuals who do not have access to a phone.
Data sourced from ClinicalTrials.gov (NCT03422276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.