Traumatic Brain InjuryBRITENCT03422276
Brain Injury Rehabilitation Improving the Transition Experience
A study testing Rehabilitation Discharge Plan and Rehabilitation Transition Plan in people with Traumatic Brain Injury, run by University of Washington at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Rehabilitation Discharge Plan and Rehabilitation Transition Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,555 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Feb 2018to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.);
Show all 14Show fewer
- 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.
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
Moss Rehab Hospital
Elkins Park, Pennsylvania, 19027
Indiana University School of Medicine/ Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
Mount Sinai Health System (NY)
New York, New York, 10002
University of Washington
Seattle, Washington, 98195
About this study
Official title: Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
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.
Read the detailed description
Screening
The screening process involves a review of medical records by our research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion for further detail) who are admitted to the inpatient rehabilitation unit at the study sites.
Recruitment
Patient Participants: If a potential participant meets eligibility criteria based on medical record review, research staff will approach him/her on the inpatient rehabilitation unit to determine whether the patient is cognitively capable of providing consent by administering a measure of orientation/ emergence from PTA. If the patient is deemed oriented, the research staff will introduce the study using a talking points script, and if the potential participant is interested, provide him/her with a brochure and a consent form.
Research staff will initiate the informed consent process if: a) the patient is deemed oriented per definition above, and b) the patient expresses interest in participating. Research staff will visit the patient on a subsequent day and re-administer the orientation test prior to consent if needed.
If the patient is not deemed oriented as per the outline above, the patient is deemed not yet oriented and unable at that time to provide informed consent. Research staff may administer the orientation test multiple times to determine capacity to consent. Research staff may talk with a Legally Authorized Representative (LAR) if one is willing and available to attempt to obtain their consent if a patient is not deemed oriented prior to discharge.
The investigators plan to enroll a total of 900 patient participants.
Caregiver Participants:
Caregiver participants will be those individuals who will have primary care giving responsibility following rehabilitation care discharge of patients with moderate to severe TBI. Caregivers may be recruited while the patient is in the hospital or by telephone, if not available during hospitalization. Research staff may enroll more than one individual as a caregiver following subject enrollment should a different individual assume the role of caregiver at a later time point.
The investigators plan to enroll a total of 607 caregiver participants.
Basic Demographic Information: All Potential Patient Participants
Basic demographic information including age, sex, and race will be collected via medical record review without consent from all patients including those who do not enroll to determine differences between enrolled patients participants and those who do not enroll.
Consent
For patient participants, the informed consent process will take place during the participants inpatient rehabilitation stay with our research staff while they are inpatients.
Potential participants will be fully informed of all risks and benefits prior to giving their written informed consent and prior to enrollment in the study. Participants may take time to think about participating and render a decision in a subsequent visit. Potential participants will be asked to repeat back understanding of this material as necessary.
Research staff will also review a HIPAA authorization form with the participant that permits research staff to collect data from his/her medical records regarding injury and medical history.
Caregiver Participants: Caregiver participants may be initially recruited by telephone or in person. Caregivers will provide written consent if enrolled in person.
All participants approached for possible enrollment in this study will be clearly informed that if they choose not to participate in this project, they and/or their loved one will still be able to receive any of the routine medical and rehabilitation services available to them. They will be informed that their participation is voluntary and that they may withdraw their consent and discontinue participation in the study at any time. Any new information developed during the course of the study that might affect a participant's understanding of the research and willingness to continue to participate will be brought to their attention by study staff.
Baseline Assessment
Contact Information Sheet Research staff will collect the following information from both caregiver and patient participants: (1) contact information; (2) best way to reach an individual if they have more than one line; best times/days to reach participant; and (3) names and contact information of people staff are allowed to contact if participant is lost to follow-up or otherwise cannot be contacted (i.e. collateral contacts).
Baseline Information: Demographic and injury related data will be collected from the electronic medical record, and additional demographic and clinical history will be collected in interview format. A cognitive assessment focused on memory, concentration, and problem solving will be given. These data will be entered in de-identified form into the NDSC centralized database by research staff.
Discharge Information: Research staff will collect information from a patient participant's medical record regarding the presence/absence of recommended and/or scheduled appointments to different medical disciplines/services. Specific information regarding the recommended/scheduled appointments (e.g. name, phone number, email address, date of scheduled appointment, etc.) of patient participants randomized to the rehabilitation transition phase (RTP) group will be stored locally in a database used by the TBI care managers for referential purposes.
The investigators will collect information regarding the nature of the caregiver's relationship to the patient participant, as well as basic demographic information. These data will be entered in de-identified form into the NDSC centralized database by research staff.
Randomization/ Post-Discharge Transition Phase
After the patient participant has been discharged, s/he will be randomly assigned 1:1 into one of two study arms: Rehabilitation Discharge Plan (RDP) group or the Rehabilitation Transition Plan (RTP) group.
The investigators will stratify randomization on study site and discharge destination (another facility vs. home/ community). Once randomization occurs, their random assignment will be communicated to the TBI Care Manager (TCM). The TCM will then send out a letter to the patient participant and caregiver (if applicable).
RTP Process Variables
Individual elements of the RTP will be measured as they are administered to each patient/ caregiver or other recipient in the form of a treatment note as captured in a secure database, incorporating documentation elements used in the field. Measures will include the clock time devoted to each contact, the recipient of each contact, total number of attempts/contacts, the type of need or issue discussed, and actions planned and implemented.
Follow Up Data Collection
3, 6, 9 and 12 Months Post Hospital Discharge: Patient Participant The 3, 6, 9 and 12 month post-hospital discharge questionnaire will take approximately 45-60 minutes to complete, and will be completed by phone or in person. This questionnaire includes both the primary and secondary outcomes described below.
- Conditions
- Traumatic Brain Injury
- Being tested
- Rehabilitation Discharge Plan, Rehabilitation Transition Plan
- Keywords
- Transition, Rehabilitation Discharge
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Discharge PlanOther
CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
- patient and family education about TBI, both general and individualized to each person's symptoms and level of function, as well as education on medications and symptoms to monitor following discharge;
- written discharge care instructions, including recommended appointments with primary care, rehabilitation medicine and outpatient therapies, and medication list which are reviewed with the patient and family prior to discharge; and
- a phone call from an inpatient care provider within a few days of discharge to address any immediate problems and ensure that equipment has arrived, medications are being taken, etc.
Rehabilitation Transition PlanOther
Participants and their caregivers (if applicable) randomized to the Rehabilitation Transition Plan group will receive up to 12 scheduled contacts 6 months post-discharge from a TBI care manager familiar with the care and resource networks at the respective sites. The contacts will at minimum be by telephone, although a HIPAA-compliant video conferencing option will also be available.
The content of these contacts will include:
- Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans;
- Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Discharge Plan | Active comparator | Commission on Accreditation of Rehabilitation Facilities (CARF) standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury, including patient and family education, written discharge care instructions, and telephone follow up from a clinical provider. Receives: Other: Rehabilitation Discharge Plan |
| Rehabilitation Transition Plan | Active comparator | Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. Receives: Other: Rehabilitation Transition Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
The Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) assesses participation in usual roles and social activities. There are 17 items with 0-5 response scales. Those items are combined and averaged into three domain subscale scores that range from 0-5: Productivity (3 items), Social Relations (7 items), and Out and About (7 items). The Averaged Total score, used here, is calculated by averaging the three domain scores. Higher values represent a better outcome.
Measured: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
Quality of Life After Brain Injury Scale (QoLIBRI)
A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI. The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life.
Measured: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
Secondary outcomes (11)
Cornell Services Index
A patient-reported instrument created to assess healthcare services utilization. This reports the number and percentage of individuals who attended at least one visit of a specialty during follow-up, regardless of whether they had been recommended and/or scheduled at discharge.
Measured: This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.
Bakas Caregiving Outcomes Scale
A 15-item measure, each with a 7-point scale that assesses change in social functioning, emotional well-being, and physical health related to caregiving. Item scores are transformed to 1-7, then summed to provide total scale scores ranging from 15 - 105, with a higher score indicating a better outcome.
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Zarit Burden Interview
12 item version addresses the concerns that our stakeholders feel are most important and that we feel are most relevant to our study interventions. The minimum and maximum values are 0 to 88, with 88 representing the most burden (worst outcome).
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Short Form 12-Item Measure (SF-12)
The SF-12 is a measure of health-related quality of life (HRQOL) and allows for 2 component scores to be determined: physical health and mental health. The scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a
A measure that assesses engagement in roles and activities apart from those related to caregiving. Raw scores are converted to scale scores, with a range of 26.2 to 65.6, with the higher score indicating better outcome.
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Time Spent Caregiving - Required Assistance
A measure developed by the study team to describe the use of caregivers for individuals with TBI. The "Required Assistance" portion of the measure asks how much oversight or supervision the patient needs on a daily basis, ranging from 1) "Need someone in the room awake at all time" to 12) "Lives independently with minimal assistance". Responses were categorized into three levels with 1-8 equaling "Need supervision", 9-10 equaling "Need assistance", and 11-12 equaling "Independent".
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
The Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) assesses participation in usual roles and social activities. There are 17 items with 0-5 response scales. Those items are combined and averaged into three domain subscale scores that range from 0-5: Productivity (3 items), Social Relations (7 items), and Out and About (7 items). The Averaged Total score, used here, is calculated by averaging the three domain scores. Higher values represent a better outcome.
Measured: This outcome will be assessed longitudinally via self-report instrument from the patient participant 3,6, 9 and 12 months after discharge from inpatient rehabilitation care.
Quality of Life After Brain Injury Scale (QoLIBRI)
A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI. The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life.
Measured: This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.
Satisfaction With Care
A measure developed by the study team to assess satisfaction with health care received by the patient participant. Patients, caregivers, both, or another appropriate proxy could rate their satisfaction with different domain's of the patient's care on a 1-7 scale, where 1 = Very dissatisfied, 7 = Very satisfied, and 4 = Neutral. Higher scores indicate higher satisfaction (better outcome).
Measured: This outcome will be assessed via self-report instrument from the patient participant 6 and 12 months after discharge from inpatient rehabilitation care. 6-month outcomes are reported.
RTP Satisfaction Survey
A measure developed by the study team to assess satisfaction with RTP (intervention), measured through Likert-scaled and open-ended questions.
Measured: This outcome was assessed via self-report instrument from both patient and caregiver participants (if applicable) randomized to the RTP group 6 months after discharge from inpatient rehabilitation care (if they consented to complete the survey).
Time Spent Caregiving - Reason for Assistance
The "Reason for Assistance" measure asks which category captures the reason the patient cannot be alone (if in the "Need supervision" or "Need assistance" category for Required Assistance).
Measured: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start13 Feb 2018
- Primary completion30 Apr 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Moss Rehabilitation Research Institute, Ohio State University, Baylor Institute for Rehabilitation, Indiana University, Craig Hospital, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jeanne Hoffman, University of Washington
- Investigators
- Jeanne Hoffman, PhD, Principal investigator, University of WashingtonJesse Fann, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422276
- Sponsor's protocol ID
- STUDY00002859
- Other IDs
- PCS-1604-35115
- Acronym
- BRITE
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2018
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fann JR, Hart T, Ciol MA, Moore M, Bogner J, Corrigan JD, Dams-O'Connor K, Driver S, Dubiel R, Hammond FM, Kajankova M, Watanabe TK, Hoffman JM. Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial. Contemp Clin Trials. 2021 May;104:106332. doi: 10.1016/j.cct.2021.106332. Epub 2021 Feb 27.
PubMed 33652127Polnaszek KL, Chu SH, Kempthorne L, Conrick KM, Hoffman JM, Fann JR, Self A, Weingarten G, Moore M. Strategies for engaging individuals with traumatic brain injury and cognitive impairment in virtual research settings. Res Involv Engagem. 2026 Jan 10;12(1):17. doi: 10.1186/s40900-025-00835-8.
PubMed 41519799Moore M, Kempthorne L, Fann JR, Shulein O, Dams-O'Connor K, Kajankova M, Conrick KM, Seeliger J, Hoffman JM. Patient and Caregiver Satisfaction With the Brain Injury Rehabilitation: Improving the Transition Experience (BRITE) Intervention. J Head Trauma Rehabil. 2024 Nov-Dec 01;39(6):E550-E563. doi: 10.1097/HTR.0000000000000949. Epub 2024 May 13.
PubMed 38758094
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03422276
- Acronym / sponsor ID
- BRITE / STUDY00002859
- Conditions
- Traumatic Brain Injury
- Keywords
- Transition, Rehabilitation Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Moss Rehabilitation Research Institute, Ohio State University, Baylor Institute for Rehabilitation, Indiana University, Craig Hospital, Patient-Centered Outcomes Research Institute
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening
The screening process involves a review of medical records by our research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion for further detail) who are admitted to the inpatient rehabilitation unit at the study sites.
Recruitment
Patient Participants: If a potential participant meets eligibility criteria based on medical record review, research staff will approach him/her on the inpatient rehabilitation unit to determine whether the patient is cognitively capable of providing consent by administering a measure of orientation/ emergence from PTA. If the patient is deemed oriented, the research staff will introduce the study using a talking points script, and if the potential participant is interested, provide him/her with a brochure and a consent form.
Research staff will initiate the informed consent process if: a) the patient is deemed oriented per definition above, and b) the patient expresses interest in participating. Research staff will visit the patient on a subsequent day and re-administer the orientation test prior to consent if needed.
If the patient is not deemed oriented as per the outline above, the patient is deemed not yet oriented and unable at that time to provide informed consent. Research staff may administer the orientation test multiple times to determine capacity to consent. Research staff may talk with a Legally Authorized Representative (LAR) if one is willing and available to attempt to obtain their consent if a patient is not deemed oriented prior to discharge.
The investigators plan to enroll a total of 900 patient participants.
Caregiver Participants:
Caregiver participants will be those individuals who will have primary care giving responsibility following rehabilitation care discharge of patients with moderate to severe TBI. Caregivers may be recruited while the patient is in the hospital or by telephone, if not available during hospitalization. Research staff may enroll more than one individual as a caregiver following subject enrollment should a different individual assume the role of caregiver at a later time point.
The investigators plan to enroll a total of 607 caregiver participants.
Basic Demographic Information: All Potential Patient Participants
Basic demographic information including age, sex, and race will be collected via medical record review without consent from all patients including those who do not enroll to determine differences between enrolled patients participants and those who do not enroll.
Consent
For patient participants, the informed consent process will take place during the participants inpatient rehabilitation stay with our research staff while they are inpatients.
Potential participants will be fully informed of all risks and benefits prior to giving their written informed consent and prior to enrollment in the study. Participants may take time to think about participating and render a decision in a subsequent visit. Potential participants will be asked to repeat back understanding of this material as necessary.
Research staff will also review a HIPAA authorization form with the participant that permits research staff to collect data from his/her medical records regarding injury and medical history.
Caregiver Participants: Caregiver participants may be initially recruited by telephone or in person. Caregivers will provide written consent if enrolled in person.
All participants approached for possible enrollment in this study will be clearly informed that if they choose not to participate in this project, they and/or their loved one will still be able to receive any of the routine medical and rehabilitation services available to them. They will be informed that their participation is voluntary and that they may withdraw their consent and discontinue participation in the study at any time. Any new information developed during the course of the study that might affect a participant's understanding of the research and willingness to continue to participate will be brought to their attention by study staff.
Baseline Assessment
Contact Information Sheet Research staff will collect the following information from both caregiver and patient participants: (1) contact information; (2) best way to reach an individual if they have more than one line; best times/days to reach participant; and (3) names and contact information of people staff are allowed to contact if participant is lost to follow-up or otherwise cannot be contacted (i.e. collateral contacts).
Baseline Information: Demographic and injury related data will be collected from the electronic medical record, and additional demographic and clinical history will be collected in interview format. A cognitive assessment focused on memory, concentration, and problem solving will be given. These data will be entered in de-identified form into the NDSC centralized database by research staff.
Discharge Information: Research staff will collect information from a patient participant's medical record regarding the presence/absence of recommended and/or scheduled appointments to different medical disciplines/services. Specific information regarding the recommended/scheduled appointments (e.g. name, phone number, email address, date of scheduled appointment, etc.) of patient participants randomized to the rehabilitation transition phase (RTP) group will be stored locally in a database used by the TBI care managers for referential purposes.
The investigators will collect information regarding the nature of the caregiver's relationship to the patient participant, as well as basic demographic information. These data will be entered in de-identified form into the NDSC centralized database by research staff.
Randomization/ Post-Discharge Transition Phase
After the patient participant has been discharged, s/he will be randomly assigned 1:1 into one of two study arms: Rehabilitation Discharge Plan (RDP) group or the Rehabilitation Transition Plan (RTP) group.
The investigators will stratify randomization on study site and discharge destination (another facility vs. home/ community). Once randomization occurs, their random assignment will be communicated to the TBI Care Manager (TCM). The TCM will then send out a letter to the patient participant and caregiver (if applicable).
RTP Process Variables
Individual elements of the RTP will be measured as they are administered to each patient/ caregiver or other recipient in the form of a treatment note as captured in a secure database, incorporating documentation elements used in the field. Measures will include the clock time devoted to each contact, the recipient of each contact, total number of attempts/contacts, the type of need or issue discussed, and actions planned and implemented.
Follow Up Data Collection
3, 6, 9 and 12 Months Post Hospital Discharge: Patient Participant The 3, 6, 9 and 12 month post-hospital discharge questionnaire will take approximately 45-60 minutes to complete, and will be completed by phone or in person. This questionnaire includes both the primary and secondary outcomes described below.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Discharge Plan | Active comparator | Other: Rehabilitation Discharge PlanCommission on Accreditation of Rehabilitation Facilities (CARF) standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury, including patient and family education, written discharge care instructions, and telephone follow up from a clinical provider. |
| Rehabilitation Transition Plan | Active comparator | Other: Rehabilitation Transition PlanApproximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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);
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation Discharge PlanCARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following: 1. patient and family education about TBI, both general and individualized to each person's symptoms and level of function, as well as education on medications and symptoms to monitor following discharge; 2. written discharge care instructions, including recommended appointments with primary care, rehabilitation medicine and outpatient therapies, and medication list which are reviewed with the patient and family prior to discharge; and 3. a phone call from an inpatient care provider within a few days of discharge to address any immediate problems and ensure that equipment has arrived, medications are being taken, etc. | Other | Rehabilitation Discharge Plan |
| Rehabilitation Transition PlanParticipants and their caregivers (if applicable) randomized to the Rehabilitation Transition Plan group will receive up to 12 scheduled contacts 6 months post-discharge from a TBI care manager familiar with the care and resource networks at the respective sites. The contacts will at minimum be by telephone, although a HIPAA-compliant video conferencing option will also be available. The content of these contacts will include: 1. Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans; 2. Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population. | Other | Rehabilitation Transition Plan |
Primary outcome
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
Time frame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
The Participation Assessment with Recombined Tools - Objective 17 (PART-O-17) assesses participation in usual roles and social activities. There are 17 items with 0-5 response scales. Those items are combined and averaged into three domain subscale scores that range from 0-5: Productivity (3 items), Social Relations (7 items), and Out and About (7 items). The Averaged Total score, used here, is calculated by averaging the three domain scores. Higher values represent a better outcome.
Quality of Life After Brain Injury Scale (QoLIBRI)
Time frame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.
A patient-reported instrument specifically created to measure the patient's perception of their health-related quality of life following TBI. The QOLIBRI scores are reported on a 0-100 scale, where 0=worst possible quality of life and 100=best possible quality of life.
11 secondary outcomes
Cornell Services Index
Time frame: This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.
Bakas Caregiving Outcomes Scale
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Zarit Burden Interview
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Short Form 12-Item Measure (SF-12)
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
PROMIS (Patient-Reported Outcomes Measurement Information System) Satisfaction With Social Roles and Activities 8a
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Time Spent Caregiving - Required Assistance
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)
Time frame: This outcome will be assessed longitudinally via self-report instrument from the patient participant 3,6, 9 and 12 months after discharge from inpatient rehabilitation care.
Quality of Life After Brain Injury Scale (QoLIBRI)
Time frame: This outcome will be assessed via self-report instrument from the patient participant 3, 6, 9 and 12 months after discharge from inpatient rehabilitation care.
Satisfaction With Care
Time frame: This outcome will be assessed via self-report instrument from the patient participant 6 and 12 months after discharge from inpatient rehabilitation care. 6-month outcomes are reported.
RTP Satisfaction Survey
Time frame: This outcome was assessed via self-report instrument from both patient and caregiver participants (if applicable) randomized to the RTP group 6 months after discharge from inpatient rehabilitation care (if they consented to complete the survey).
Time Spent Caregiving - Reason for Assistance
Time frame: This outcome was assessed via self-report instrument from the caregiver participant at 3, 6, 9 and 12 months after the patient is discharged from inpatient rehabilitation care. This is reporting the 6-month outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33652127Fann JR, Hart T, Ciol MA, Moore M, Bogner J, Corrigan JD, Dams-O'Connor K, Driver S, Dubiel R, Hammond FM, Kajankova M, Watanabe TK, Hoffman JM. Improving transition from inpatient rehabilitation following traumatic brain injury: Protocol for the BRITE pragmatic comparative effectiveness trial. Contemp Clin Trials. 2021 May;104:106332. doi: 10.1016/j.cct.2021.106332. Epub 2021 Feb 27.
- Derived from this study: PubMed 41519799Polnaszek KL, Chu SH, Kempthorne L, Conrick KM, Hoffman JM, Fann JR, Self A, Weingarten G, Moore M. Strategies for engaging individuals with traumatic brain injury and cognitive impairment in virtual research settings. Res Involv Engagem. 2026 Jan 10;12(1):17. doi: 10.1186/s40900-025-00835-8.
- Derived from this study: PubMed 38758094Moore M, Kempthorne L, Fann JR, Shulein O, Dams-O'Connor K, Kajankova M, Conrick KM, Seeliger J, Hoffman JM. Patient and Caregiver Satisfaction With the Brain Injury Rehabilitation: Improving the Transition Experience (BRITE) Intervention. J Head Trauma Rehabil. 2024 Nov-Dec 01;39(6):E550-E563. doi: 10.1097/HTR.0000000000000949. Epub 2024 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Hoffman, PhD principal investigator
University of Washington
Jesse Fann, MD, MPH principal investigator
University of Washington
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Discharge Plan and Rehabilitation Transition Plan in people with Traumatic Brain Injury, run by University of Washington at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17) (time frame: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.