Trial Outcomes & Findings for Brain Injury Rehabilitation Improving the Transition Experience (NCT NCT03422276)

Last Updated: 2025-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1555 participants

Primary outcome timeframe

This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.

Results posted on

2025-03-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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: 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.	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: 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.	Rehabilitation Discharge Plan - Caregivers Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group	Rehabilitation Transition Plan - Caregivers Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group
Overall Study STARTED	462	463	296	295
Overall Study COMPLETED	407	405	246	254
Overall Study NOT COMPLETED	55	58	50	41

Reasons for withdrawal

Reasons for withdrawal
Measure	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: 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.	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: 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.	Rehabilitation Discharge Plan - Caregivers Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group	Rehabilitation Transition Plan - Caregivers Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group
Overall Study Withdrawal by Subject	21	25	14	16
Overall Study Death	14	21	3	1
Overall Study Discontinued, ineligible	4	3	0	0
Overall Study Lost to Follow-up	15	8	13	4
Overall Study Discontinued, researcher decided not in participant's best interest	1	0	1	0
Overall Study Incarcerated prior to first follow-up	0	1	0	0
Overall Study Discontinued, no longer caregiver for patient participant	0	0	10	3
Overall Study Discontinued, for caregiver, death of patient participant	0	0	8	17
Overall Study Discontinued, for caregiver, patient participant was determined to be ineligible	0	0	1	0

Baseline Characteristics

Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rehabilitation Discharge Plan n=462 Participants 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: 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.	Rehabilitation Transition Plan n=463 Participants 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: 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.	Rehabilitation Discharge Plan - Caregivers n=309 Participants Caregivers of patients randomized to the Rehabilitation Discharge Plan (RDP) group	Rehabilitation Transition Plan - Caregivers n=302 Participants Caregivers of patients randomized to the Rehabilitation Transition Plan (RTP) group	Total n=1536 Participants Total of all reporting groups
Age, Continuous Patients	48 years STANDARD_DEVIATION 20 • n=462 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.	47 years STANDARD_DEVIATION 20 • n=463 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.	—	—	47 years STANDARD_DEVIATION 20 • n=925 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.
Age, Continuous Caregivers	—	—	50 years STANDARD_DEVIATION 15 • n=309 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.	51 years STANDARD_DEVIATION 13 • n=302 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.	51 years STANDARD_DEVIATION 14 • n=611 Participants • Patient and Caregiver participants were analyzed separately, so each group is presented in a separate row.
Sex: Female, Male Female	134 Participants n=462 Participants	114 Participants n=463 Participants	218 Participants n=309 Participants	225 Participants n=302 Participants	691 Participants n=1536 Participants
Sex: Female, Male Male	328 Participants n=462 Participants	349 Participants n=463 Participants	91 Participants n=309 Participants	77 Participants n=302 Participants	845 Participants n=1536 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=449 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	29 Participants n=452 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	—	—	76 Participants n=901 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.
Ethnicity (NIH/OMB) Not Hispanic or Latino	402 Participants n=449 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	423 Participants n=452 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	—	—	825 Participants n=901 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=449 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	0 Participants n=452 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.	—	—	0 Participants n=901 Participants • Difference for RDP and RTP is due to missing values. For RDP-Caregivers and RTP-Caregivers, this item was not collected.
Race/Ethnicity, Customized Race · White	296 Participants n=458 Participants • Difference is due to missing values in measure.	314 Participants n=457 Participants • Difference is due to missing values in measure.	221 Participants n=303 Participants • Difference is due to missing values in measure.	214 Participants n=295 Participants • Difference is due to missing values in measure.	1045 Participants n=1513 Participants • Difference is due to missing values in measure.
Race/Ethnicity, Customized Race · Black	81 Participants n=458 Participants • Difference is due to missing values in measure.	79 Participants n=457 Participants • Difference is due to missing values in measure.	42 Participants n=303 Participants • Difference is due to missing values in measure.	44 Participants n=295 Participants • Difference is due to missing values in measure.	246 Participants n=1513 Participants • Difference is due to missing values in measure.
Race/Ethnicity, Customized Race · Hispanic	53 Participants n=458 Participants • Difference is due to missing values in measure.	33 Participants n=457 Participants • Difference is due to missing values in measure.	24 Participants n=303 Participants • Difference is due to missing values in measure.	13 Participants n=295 Participants • Difference is due to missing values in measure.	123 Participants n=1513 Participants • Difference is due to missing values in measure.
Race/Ethnicity, Customized Race · Other	28 Participants n=458 Participants • Difference is due to missing values in measure.	31 Participants n=457 Participants • Difference is due to missing values in measure.	16 Participants n=303 Participants • Difference is due to missing values in measure.	24 Participants n=295 Participants • Difference is due to missing values in measure.	99 Participants n=1513 Participants • Difference is due to missing values in measure.
Region of Enrollment United States	462 participants n=462 Participants	463 participants n=463 Participants	309 participants n=309 Participants	302 participants n=302 Participants	1536 participants n=1536 Participants
Education Level Less than High School	66 Participants n=454 Participants • Differences are due to missing values.	59 Participants n=457 Participants • Differences are due to missing values.	13 Participants n=300 Participants • Differences are due to missing values.	11 Participants n=293 Participants • Differences are due to missing values.	149 Participants n=1504 Participants • Differences are due to missing values.
Education Level HS Diploma or GED	161 Participants n=454 Participants • Differences are due to missing values.	152 Participants n=457 Participants • Differences are due to missing values.	85 Participants n=300 Participants • Differences are due to missing values.	79 Participants n=293 Participants • Differences are due to missing values.	477 Participants n=1504 Participants • Differences are due to missing values.
Education Level Some College	126 Participants n=454 Participants • Differences are due to missing values.	118 Participants n=457 Participants • Differences are due to missing values.	93 Participants n=300 Participants • Differences are due to missing values.	84 Participants n=293 Participants • Differences are due to missing values.	421 Participants n=1504 Participants • Differences are due to missing values.
Education Level College or more	101 Participants n=454 Participants • Differences are due to missing values.	128 Participants n=457 Participants • Differences are due to missing values.	109 Participants n=300 Participants • Differences are due to missing values.	119 Participants n=293 Participants • Differences are due to missing values.	457 Participants n=1504 Participants • Differences are due to missing values.
Married/Partner, yes	159 Participants n=458 Participants • Differences are due to missing values.	189 Participants n=458 Participants • Differences are due to missing values.	193 Participants n=303 Participants • Differences are due to missing values.	194 Participants n=296 Participants • Differences are due to missing values.	735 Participants n=1515 Participants • Differences are due to missing values.
Competitively employed, yes	268 Participants n=456 Participants • Differences are due to missing values.	284 Participants n=458 Participants • Differences are due to missing values.	202 Participants n=302 Participants • Differences are due to missing values.	203 Participants n=296 Participants • Differences are due to missing values.	957 Participants n=1512 Participants • Differences are due to missing values.
Earnings None	167 Participants n=418 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	155 Participants n=414 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	0 Participants n=201 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	0 Participants n=209 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	322 Participants n=1242 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.
Earnings Less than 30k	84 Participants n=418 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	84 Participants n=414 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	41 Participants n=201 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	54 Participants n=209 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	263 Participants n=1242 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.
Earnings 30K to less than 60K	87 Participants n=418 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	89 Participants n=414 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	84 Participants n=201 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	70 Participants n=209 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	330 Participants n=1242 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.
Earnings 60K or more	80 Participants n=418 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	86 Participants n=414 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	76 Participants n=201 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	85 Participants n=209 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.	327 Participants n=1242 Participants • Differences are due to missing values. Caregivers that had no annual earnings are included in the missing values.
English spoken at home, yes	433 Participants n=459 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	428 Participants n=458 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	—	—	861 Participants n=917 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.
Residence zone of discharge Urban/Suburban	314 Participants n=453 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	301 Participants n=453 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	—	—	615 Participants n=906 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.
Residence zone of discharge Rural	139 Participants n=453 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	152 Participants n=453 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.	—	—	291 Participants n=906 Participants • Differences for RDP and RTP are due to missing values. Caregiver data was not collected for this measure.
Ever used illicit drugs, yes	102 Participants n=452 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	120 Participants n=454 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	222 Participants n=906 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Ever had psychiatric hospitalization, yes	39 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers	40 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers	—	—	79 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers
Ever had mental health treatment, yes	112 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	136 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	248 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Ever attempted suicide, yes	25 Participants n=452 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	35 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	60 Participants n=908 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Ever served in military, yes	55 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	60 Participants n=458 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	115 Participants n=915 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Living alone at discharge, yes	23 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	15 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	38 Participants n=918 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Discharge to facility, yes	89 Participants n=462 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	89 Participants n=463 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	178 Participants n=925 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Spinal Cord Injury (SCI), yes	58 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	58 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	116 Participants n=916 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Limitations prior to injury, yes	222 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	209 Participants n=458 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	431 Participants n=915 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Alcohol use problem	111 Participants n=428 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	97 Participants n=437 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.	—	—	208 Participants n=865 Participants • Differences in RDP and RTP are due to missing values. Not collected from caregivers.
Cause of injury Vehicle (includes pedestrian/bike)	232 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	248 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	480 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Cause of injury Fall	168 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	146 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	314 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Cause of injury Violence	40 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	41 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	81 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Cause of injury Other	16 Participants n=456 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	22 Participants n=457 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	38 Participants n=913 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Rehab length of stay	26 days STANDARD_DEVIATION 23 • n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	26 days STANDARD_DEVIATION 26 • n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	26 days STANDARD_DEVIATION 24 • n=918 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Functional Independence Measure (FIM) Cognitive subscale at discharge	23 units on a scale STANDARD_DEVIATION 6.7 • n=419 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	22.9 units on a scale STANDARD_DEVIATION 6.7 • n=420 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	23 units on a scale STANDARD_DEVIATION 6.7 • n=839 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Functional Independence Measure (FIM) Motor subscale at discharge	63.3 units on a scale STANDARD_DEVIATION 20 • n=455 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	64.1 units on a scale STANDARD_DEVIATION 19.7 • n=455 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	63.7 units on a scale STANDARD_DEVIATION 19.8 • n=910 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Insurance type, yes Medicare	118 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	98 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	216 Participants n=918 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Insurance type, yes Medicaid	108 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	118 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	226 Participants n=918 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Insurance type, yes Private/self	180 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	199 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	379 Participants n=918 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Insurance type, yes Other, Workers Comp, Charity	53 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	44 Participants n=459 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	97 Participants n=918 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Glasgow Coma Scale (GCS) Severity Score Severe (3-8)	55 Participants n=427 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	65 Participants n=416 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	—	—	120 Participants n=843 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.
Glasgow Coma Scale (GCS) Severity Score Moderate (9-12)	41 Participants n=427 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	42 Participants n=416 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	—	—	83 Participants n=843 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.
Glasgow Coma Scale (GCS) Severity Score Mild (13-15)	159 Participants n=427 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	127 Participants n=416 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	—	—	286 Participants n=843 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.
Glasgow Coma Scale (GCS) Severity Score Sedated/Intubated	172 Participants n=427 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	182 Participants n=416 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.	—	—	354 Participants n=843 Participants • Differences for RDP and RTP are due to missing values. For RDP - Caregivers and RTP - Caregivers, this measure is not applicable.
Severity according to time in PTA 0 to 24h (mild)	73 Participants n=420 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	70 Participants n=416 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	143 Participants n=836 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Severity according to time in PTA 25h to 7 days (moderate)	43 Participants n=420 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	47 Participants n=416 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	90 Participants n=836 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Severity according to time in PTA More than 7 days (severe)	304 Participants n=420 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	299 Participants n=416 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.	—	—	603 Participants n=836 Participants • Differences in RDP and RTP are due to missing values. Not applicable to caregivers.
Country of birth, USA	—	—	278 Participants n=304 Participants • Patient data was not collected for this measure. Differences for caregiver groups are due to missing values.	260 Participants n=295 Participants • Patient data was not collected for this measure. Differences for caregiver groups are due to missing values.	538 Participants n=599 Participants • Patient data was not collected for this measure. Differences for caregiver groups are due to missing values.
Relationship to patient Spouse	—	—	117 Participants n=304 Participants • 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.	114 Participants n=295 Participants • 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.	231 Participants n=599 Participants • 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.
Relationship to patient Parent	—	—	86 Participants n=304 Participants • 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.	89 Participants n=295 Participants • 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.	175 Participants n=599 Participants • 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.
Relationship to patient Daughter or Son	—	—	48 Participants n=304 Participants • 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.	32 Participants n=295 Participants • 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.	80 Participants n=599 Participants • 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.
Relationship to patient Boyfriend, Girlfriend, Fiancé, Partner	—	—	23 Participants n=304 Participants • 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.	20 Participants n=295 Participants • 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.	43 Participants n=599 Participants • 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.
Relationship to patient Sibling	—	—	19 Participants n=304 Participants • 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.	23 Participants n=295 Participants • 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.	42 Participants n=599 Participants • 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.
Relationship to patient Other relative	—	—	7 Participants n=304 Participants • 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.	9 Participants n=295 Participants • 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.	16 Participants n=599 Participants • 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.
Relationship to patient Friend	—	—	1 Participants n=304 Participants • 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.	4 Participants n=295 Participants • 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.	5 Participants n=599 Participants • 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.
Relationship to patient Other	—	—	3 Participants n=304 Participants • 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.	4 Participants n=295 Participants • 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.	7 Participants n=599 Participants • 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.
Living in same household, yes	—	—	195 Participants n=303 Participants • 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.	189 Participants n=295 Participants • 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.	384 Participants n=598 Participants • 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.
Living in private residence, yes	—	—	302 Participants n=303 Participants • 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.	294 Participants n=295 Participants • 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.	596 Participants n=598 Participants • 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.
Person living with caregiver Spouse	—	—	188 Participants n=303 Participants • 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.	191 Participants n=295 Participants • 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.	379 Participants n=598 Participants • 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.
Person living with caregiver Significant Other	—	—	32 Participants n=303 Participants • 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.	27 Participants n=295 Participants • 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.	59 Participants n=598 Participants • 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.
Person living with caregiver Alone	—	—	23 Participants n=303 Participants • 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.	24 Participants n=295 Participants • 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.	47 Participants n=598 Participants • 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.
Person living with caregiver Child/Children	—	—	15 Participants n=303 Participants • 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.	27 Participants n=295 Participants • 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.	42 Participants n=598 Participants • 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.
Person living with caregiver Other relative(s)/Adult Children	—	—	23 Participants n=303 Participants • 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.	13 Participants n=295 Participants • 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.	36 Participants n=598 Participants • 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.
Person living with caregiver Parent(s)	—	—	16 Participants n=303 Participants • 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.	11 Participants n=295 Participants • 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.	27 Participants n=598 Participants • 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.
Person living with caregiver Siblings	—	—	3 Participants n=303 Participants • 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.	2 Participants n=295 Participants • 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.	5 Participants n=598 Participants • 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.
Person living with caregiver Roommate(s) or Friend(s)	—	—	3 Participants n=303 Participants • 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.	0 Participants n=295 Participants • 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.	3 Participants n=598 Participants • 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.
Years (decimal) know the patient	—	—	30.1 years STANDARD_DEVIATION 15.6 • n=301 Participants • 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.	30.0 years STANDARD_DEVIATION 15.6 • n=289 Participants • 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.	30.1 years STANDARD_DEVIATION 15.6 • n=590 Participants • 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.
Years (decimal) lived in the same house	—	—	19.3 years STANDARD_DEVIATION 16.3 • n=207 Participants • 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.	18.4 years STANDARD_DEVIATION 14.6 • n=203 Participants • 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.	18.8 years STANDARD_DEVIATION 15.4 • n=410 Participants • 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.

PRIMARY outcome

Timeframe: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.

Population: Individuals with complete data for this measure.

Outcome measures

Outcome measures
Measure	Rehabilitation Discharge Plan n=363 Participants 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: 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.	Rehabilitation Transition Plan n=372 Participants 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: 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.
Participation Assessment With Recombined Tools - Objective 17 (PART-O-17)	1.30 units on a scale Standard Deviation 0.61	1.33 units on a scale Standard Deviation 0.57

PRIMARY outcome

Timeframe: This outcome will be assessed via self-report instrument from the patient participant 6 months after discharge from inpatient rehabilitation care.

Population: Participants with complete data for this measure. This measure could only be collected from the patient (no proxy data).

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.

Outcome measures

Outcome measures
Measure	Rehabilitation Discharge Plan n=291 Participants 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: 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.	Rehabilitation Transition Plan n=315 Participants 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: 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.
Quality of Life After Brain Injury Scale (QoLIBRI)	68.3 score on a scale Standard Deviation 19.3	65.9 score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: 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.

Population: Individuals who had at least one follow-up interview.

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.

Outcome measures

Outcome measures
Measure	Rehabilitation Discharge Plan n=419 Participants 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: 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.	Rehabilitation Transition Plan n=418 Participants 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: 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.
Cornell Services Index Rehabilitation Medicine	260 Participants	266 Participants
Cornell Services Index Physical Therapy	325 Participants	324 Participants
Cornell Services Index Occupational Therapy	262 Participants	283 Participants
Cornell Services Index Primary Care Visits	347 Participants	365 Participants
Cornell Services Index Speech Therapy	247 Participants	261 Participants
Cornell Services Index Neurosurgery	162 Participants	156 Participants
Cornell Services Index Neuropsychology	119 Participants	146 Participants
Cornell Services Index Neurology	210 Participants	217 Participants
Cornell Services Index Neuro-optometry/Neuro-ophthalmology	118 Participants	124 Participants
Cornell Services Index Social Worker	83 Participants	88 Participants
Cornell Services Index Psychologist/Mental health	104 Participants	120 Participants
Cornell Services Index Vocational Counseling	46 Participants	62 Participants
Cornell Services Index Psychiatrist	88 Participants	101 Participants
Cornell Services Index Vision Therapy	32 Participants	31 Participants

SECONDARY outcome

Timeframe: 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.