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| ID | Type | Description | Link |
|---|---|---|---|
| PCS-1604-35115 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Moss Rehabilitation Research Institute | OTHER |
| Ohio State University | OTHER |
| Baylor Institute for Rehabilitation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation Discharge Plan | Other | CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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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:
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:
Exclusion Criteria:
Exclusion criteria- Patient Participants:
Exclusion criteria- Caregiver Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne Hoffman, PhD | University of Washington | Principal Investigator |
| Jesse Fann, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine/ Rehabilitation Hospital of Indiana | Indianapolis | Indiana | 46254 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33652127 | Background | 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. | |
| 41519799 |
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11 patients were enrolled but not randomized in the study for the following reasons: Determined to be ineligible, death, withdrew, and other. The majority (8) were determined to be ineligible. 8 caregivers were enrolled to patients that were not randomized. So a total of 19 of the 1555 enrolled patients and caregivers were not part of the randomized cohort.
Patient participants were recruited from 6 IPR facilities starting in Feb 2018 through Aug 2021. Caregivers (CG) of enrolled patients were recruited from the first patient enrollment through the end of patient participation. The final CG enrolled in February 2022. Patients could have more than one CG enrolled in the study due to changes in primary caregiver responsibility. Only one CG completed each follow up (max N at any follow up 591), but a total of 611 CG were enrolled throughout the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rehabilitation Discharge Plan | 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. Rehabilitation Discharge Plan: CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
|
| FG001 | Rehabilitation Transition Plan | Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. Rehabilitation Transition Plan: 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:
|
| FG002 | Rehabilitation Discharge Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group |
| FG003 | Rehabilitation Transition Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There are 20 additional caregiver participants that were enrolled to patient participants who already had one caregiver enrolled. 13 additional caregivers were enrolled to patient participants in RDP and 7 in RTP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rehabilitation Discharge Plan | 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. Rehabilitation Discharge Plan: CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row. |
| 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 | 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. | Individuals with complete data for this measure. | Posted | Mean | Standard Deviation | units on a scale | This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care. |
|
Adverse event data were collected throughout the participant's participation, approximately 12 months.
Adverse events were recorded when brought up by participants during data collection and intervention activities, and categorized as Serious or non-serious. SAE's were categorized into five categories: Death, life threatening, hospitalization - initial or prolonged, disability/incapacity, or required intervention to prevent permanent impairment. Each event had a brief description of the nature collected. No events were determined to be related to study activities.
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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 | Rehabilitation Discharge Plan | 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. Rehabilitation Discharge Plan: CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanne Hoffman | University of Washington | (206) 221-6511 | jeanneh@uw.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 | Jan 23, 2023 | Sep 26, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Consent | Apr 5, 2021 | Sep 26, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Caregiver Consent | Apr 5, 2021 | Sep 26, 2023 | ICF_002.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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Not provided
| OTHER |
| Indiana University | OTHER |
| Craig Hospital | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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This study uses masked outcome assessment, which means study researchers will make every effort to ensure that staff members who collect outcomes data from both patient and caregiver participants at 3-, 6-, 9- and 12 months are unaware of patient participants' treatment group allocation.
|
| Rehabilitation Transition Plan | Other | 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:
|
|
| 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. | 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). | 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. | 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. | 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". | 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. | 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. | 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). | 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. | 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). | 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. |
| Mount Sinai Health System (NY) |
| New York |
| New York |
| 10002 |
| United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Moss Rehab Hospital | Elkins Park | Pennsylvania | 19027 | United States |
| Baylor Institute for Rehabilitation | Dallas | Texas | 75246 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Derived |
| Polnaszek 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. |
| 38758094 | Derived | Moore 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. |
| Death |
|
| Discontinued, ineligible |
|
| Lost to Follow-up |
|
| Discontinued, researcher decided not in participant's best interest |
|
| Incarcerated prior to first follow-up |
|
| Discontinued, no longer caregiver for patient participant |
|
| Discontinued, for caregiver, death of patient participant |
|
| Discontinued, for caregiver, patient participant was determined to be ineligible |
|
| BG001 | Rehabilitation Transition Plan | Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. Rehabilitation Transition Plan: 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:
|
| BG002 | Rehabilitation Discharge Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group |
| BG003 | Rehabilitation Transition Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Difference is due to missing values in measure. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education Level | Differences are due to missing values. | Count of Participants | Participants |
|
| Married/Partner, yes | Differences are due to missing values. | Count of Participants | Participants |
|
| Competitively employed, yes | Differences are due to missing values. | Count of Participants | Participants |
|
| Earnings | Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values. | Count of Participants | Participants |
|
| English spoken at home, yes | Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure. | Count of Participants | Participants |
|
| Residence zone of discharge | Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure. | Count of Participants | Participants |
|
| Ever used illicit drugs, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Ever had psychiatric hospitalization, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers | Count of Participants | Participants |
|
| Ever had mental health treatment, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Ever attempted suicide, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Ever served in military, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Living alone at discharge, yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Discharge to facility, yes | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Count of Participants | Participants |
|
| Spinal Cord Injury (SCI), yes | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Limitations prior to injury, yes | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Count of Participants | Participants |
|
| Alcohol use problem | Differences in RDP and RTP are due to missing values. Not collected from caregivers. | Count of Participants | Participants |
|
| Cause of injury | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Count of Participants | Participants |
|
| Rehab length of stay | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Mean | Standard Deviation | days |
|
| Functional Independence Measure (FIM) Cognitive subscale at discharge | The Functional Independence Measure (FIM) is an instrument that measures level of disability and required assistance. It is an 18-item scale with motor and cognitive subscales. This captures the cognitive subscale score at discharge (the baseline time point), which can range from 5-35. Higher scores indicate higher functional independence. | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Mean | Standard Deviation | units on a scale |
|
| Functional Independence Measure (FIM) Motor subscale at discharge | The Functional Independence Measure (FIM) is an instrument that measures level of disability and required assistance. It is an 18-item scale with motor and cognitive subscales. This captures the motor subscale score at discharge (the baseline time point), which can range from 13-91. Higher scores indicate higher functional independence. FIM Motor was either collected with FIM instrument or was transformed from the Continuity Assessment Record and Evaluation (CARE) tool to FIM Motor, according to the crosswalk developed by Dave Mellick. | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Mean | Standard Deviation | units on a scale |
|
| Insurance type, yes | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Count of Participants | Participants |
|
| Glasgow Coma Scale (GCS) Severity Score | Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable. | Count of Participants | Participants |
|
| Severity according to time in PTA | Differences in RDP and RTP are due to missing values. Not applicable to caregivers. | Count of Participants | Participants |
|
| Country of birth, USA | Patient data was not collected for this measure. Differences for caregiver groups are due to missing values. | Count of Participants | Participants |
|
| Relationship to patient | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to missing values. | Count of Participants | Participants |
|
| Living in same household, yes | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to missing values. | Count of Participants | Participants |
|
| Living in private residence, yes | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to missing values. | Count of Participants | Participants |
|
| Person living with caregiver | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to missing values. | Count of Participants | Participants |
|
| Years (decimal) know the patient | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to missing values. | Mean | Standard Deviation | years |
|
| Years (decimal) lived in the same house | Patient data was not collected for this measure. Measure only included in/or applicable to caregiver demographics. Differences for caregiver groups are due to removing those that did not live in the same household and missing values. | Mean | Standard Deviation | years |
|
| OG001 | Rehabilitation Transition Plan | Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. Rehabilitation Transition Plan: 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:
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| Primary | 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. | Participants with complete data for this measure. This measure could only be collected from the patient (no proxy data). | Posted | Mean | Standard Deviation | score on a scale | This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care. |
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| Secondary | 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. | Individuals who had at least one follow-up interview. | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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. | Caregiver participants with complete data for the measure at the 6 month follow-up timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Secondary | 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). | Caregiver participants with complete data for the measure at the 6 month follow-up timepoint. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | 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. | Caregiver participants with complete data for the measure at the 6 month follow-up timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Secondary | 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. | Caregiver participants with complete data for the measure at the 6 month follow-up timepoint. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Secondary | 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". | Caregiver participants with complete data for the measure at the 6 month follow-up timepoint. | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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. | Total participants randomized | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Secondary | 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. | Total participants randomized | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Secondary | 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). | Participants with complete data for this measure at 6 months post-discharge. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | RTP Satisfaction Survey | A measure developed by the study team to assess satisfaction with RTP (intervention), measured through Likert-scaled and open-ended questions. | The 16 patients and caregivers who jointly completed the survey are represented in both groups, however the data table shows data for the combined surveys only in the patient column, therefore the number of caregivers represented in the caregiver column is only 104. | Posted | Count of Participants | Participants | 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). |
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| Secondary | 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). | Caregivers who reported the patient in the "Need supervision" or "Need assistance" category for Required Assistance measure. | Posted | Count of Participants | Participants | 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. |
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|
|
| 14 |
| 462 |
| 127 |
| 462 |
| 107 |
| 462 |
| EG001 | Rehabilitation Transition Plan | Approximately 12 scheduled contacts from a TBI care manager 6 months following discharge in addition to the CARF standards for discharge. Rehabilitation Transition Plan: 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:
| 21 | 463 | 141 | 463 | 158 | 463 |
| EG002 | Rehabilitation Discharge Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group | 3 | 296 | 4 | 296 | 10 | 296 |
| EG003 | Rehabilitation Transition Plan - Caregivers | Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group | 1 | 295 | 9 | 295 | 13 | 295 |
| EG004 | Death Prior to Randomization | Patient who expired after enrollment but prior to randomization. | 1 | 11 | 0 | 11 | 0 | 11 |
| Cardiac disorders | Cardiac disorders | Non-systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| General disorders | General disorders | Non-systematic Assessment | Events that do not fall into a specific category |
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| Hepatobiliary disorders | Hepatobiliary disorders | Non-systematic Assessment |
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| Immune system disorders | Immune system disorders | Non-systematic Assessment |
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| Infections and infestations | Infections and infestations | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | Non-systematic Assessment |
|
| Vascular disorders | Vascular disorders | Non-systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | Non-systematic Assessment |
|
| Eye disorders | Eye disorders | Non-systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| General disorders | General disorders | Non-systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | Non-systematic Assessment |
|
| Immune system disorders | Immune system disorders | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | Non-systematic Assessment |
|
| Vascular disorders | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
|
| Male |
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| Unknown or Not Reported |
|
| Black |
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| Hispanic |
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| Other |
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| HS Diploma or GED |
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| Some College |
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| College or more |
|
| Less than 30k |
|
| 30K to less than 60K |
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| 60K or more |
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| Violence |
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| Other |
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| Private/self |
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| Other, Workers Comp, Charity |
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| Mild (13-15) |
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| Sedated/Intubated |
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| More than 7 days (severe) |
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| Daughter or Son |
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| Boyfriend, Girlfriend, Fiancé, Partner |
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| Sibling |
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| Other relative |
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| Friend |
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| Other |
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| Alone |
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| Child/Children |
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| Other relative(s)/Adult Children |
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| Parent(s) |
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| Siblings |
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| Roommate(s) or Friend(s) |
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| Physical Therapy |
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| Occupational Therapy |
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| Primary Care Visits |
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| Speech Therapy |
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| Neurosurgery |
|
|
| Neuropsychology |
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| Neurology |
|
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| Neuro-optometry/Neuro-ophthalmology |
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| Social Worker |
|
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| Psychologist/Mental health |
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|
| Vocational Counseling |
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| Psychiatrist |
|
|
| Vision Therapy |
|
|
| Independent |
|
| 6 month |
|
|
| 9 month |
|
|
| 12 month |
|
|
| 6 month |
|
|
| 9 month |
|
|
| 12 month |
|
|
| Attend appointments |
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| Get answers about healthcare |
|
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| Connect with community resources/services |
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| Receive help when it's needed |
|
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| A little bit |
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| Moderately |
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| A lot |
|
| Extremely |
|
| NA/Not Answered |
|
| RTP helped with practical, day-to-day adjustment to life with a brain injury |
|
|
| RTP helped with emotional adjustment to life with a brain injury |
|
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| RTP helped accomplish the things you wanted to do |
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| It was valuable to talk with someone who understands TBI |
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|
| Both |
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| Other |
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