Improving Transition From Acute to Post-Acute Care Following Traumatic Brain Injury
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: University of Washington

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BRITE Study Protocol  
Version 15.0 
 
Contract Title: Improving Transition from Acute to Post-
Acute Care following Traumatic Brain Injury 
 
Brain injury Rehabilitation Improving the Transition 
Experience (BRITE) 
 
A 1:1 randomized controlled trial design will compare the effectiveness of two 
established methods of managing transition from Inpatient Rehabilitation Facility (IRF) 
discharge to the next phase of care, stratifying by site and discharge to another facility 
(e.g., skilled nursing facility) vs. discharge to home/community. 
 
Principal Investigator:   
Jeanne M. Hoffman, Ph.D., University of Washington, Department of Rehabilitation 
Medicine 
Co-Principal Investigator:   
Jesse R. Fann, M.D., M.P.H., University of Washington, Department of Psychiatry and 
Behavioral Sciences 
 
Supported by:  
Patient-Centered Outcomes Research Institute, Award # PCS-1604-35115 
 

 
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Contents 
TOOL REVISION HISTORY ......................................................................................................................... 7 
STUDY ROSTERS ...................................................................................................................................... 18 
Professional Stakeholder Roster ......................................................................................................... 18 
Patient and Family Stakeholder Roster ............................................................................................... 20 
Study Sites and Investigator Roster .................................................................................................... 21 
Data Coordinating Center ..................................................................................................................... 21 
Data Safety Monitoring Board .............................................................................................................. 21 
ABSTRACT ................................................................................................................................................ 22 
BACKGROUND (Criterion 1, RQ-1, RQ-3) ............................................................................................... 24 
SIGNIFICANCE (Criterion 2, 4, RQ-1) ...................................................................................................... 28 
PATIENT POPULATION (PC-2, RQ-3, IR-1) ............................................................................................. 30 
Data Sources and Resources (IR-1) .................................................................................................... 31 
STUDY DESIGN OR APPROACH (Criterion 3) ........................................................................................ 31 
Specific Aims and Hypotheses ............................................................................................................ 33 
Heterogeneity of Treatment Effects (HT-1, HT-2, HT-4, RQ-4) ........................................................... 34 
Study Timeline ....................................................................................................................................... 35 
Pre-Enrollment Activities (Months 1-6) ............................................................................ 35 
Enrollment/Study Protocol Activities (Months 7-48) [RQ-2] ........................................... 35 
STUDY METHOD ....................................................................................................................................... 36 
Participants ............................................................................................................................................ 36 
Patient Participants ............................................................................................................ 36 
Caregiver Participants ....................................................................................................... 36 
Identification .......................................................................................................................................... 36 
Inclusion Criteria-Patient Participants ............................................................................. 36 
Exclusion Criteria-Patient Participants ............................................................................ 37 
Inclusion Criteria-Caregiver Participants ......................................................................... 37 
Exclusion Criteria-Caregiver Participants........................................................................ 37 
Screening ............................................................................................................................................... 37 
Recruitment ............................................................................................................................................ 38 
Patient Participants: Determining Orientation/ Emergence from PTA .......................... 38 
Patient Unable to Provide Consent ................................................................................... 39 
Caregiver Participants ....................................................................................................... 40 
Basic Demographic Information: All Potential Patient Participants .............................. 40 
Barriers to Recruitment ..................................................................................................... 40 
Table 1. Recruitment/Enrollment Assessment Timeline ................................................................... 41 
Tracking Potential Participant Flow .................................................................................. 42 

 
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Sampling Enrollment ............................................................................................................................. 42 
Consent (PC-1) ....................................................................................................................................... 44 
Determining Patient Participant Capacity for Consent ................................................... 44 
Patient Participant Capable of Consent while Inpatient (In-Person approach) ............ 44 
Patient Participant Incapable of Consent while Inpatient (In-person Approach) ......... 45 
Patient Participant Incapable of Consent while Inpatient or Directly After (Telephone 
Approach) ........................................................................................................................... 46 
Patient Participant Capable of Consent Following Discharge ....................................... 46 
Caregiver Participants ....................................................................................................... 46 
Baseline Assessment (RQ-2, IR-1) ....................................................................................................... 47 
Contact Information Sheet ................................................................................................. 47 
Baseline Information: Patient Participants ...................................................................... 47 
Non-TBIMS: Form I (aka ‘Baseline’) .................................................................................. 47 
Discharge Information: Patient Participants .................................................................... 47 
Randomization/ Post-Discharge Transition Phase ............................................................................ 48 
Interventions and Comparators (RQ-5, PC-1) ..................................................................................... 49 
(A) Rehabilitation Discharge Plan (RDP) .......................................................................... 49 
(B) Rehabilitation Transition Plan (RTP) .......................................................................... 49 
Scheduling of Contacts ..................................................................................................... 49 
Content of Scheduled Contacts ........................................................................................ 50 
Recipient of Contacts......................................................................................................... 51 
Other Components of RTP ................................................................................................ 51 
RTP Process Variables ...................................................................................................... 52 
Training and Quality Assurance .......................................................................................................... 52 
Fidelity to Intervention ....................................................................................................... 53 
Follow Up Data Collection .................................................................................................................... 54 
3, 6, 9 and 12 Months Post Hospital Discharge Questionnaires: Patient Participant .. 54 
One Year Following Injury Questionnaire: Patient Participant ...................................... 55 
3, 6, 9 and 12 Months Post Hospital Discharge Questionnaire: Caregiver ................... 55 
Rehabilitation Transition Plan (RTP) Survey: Caregiver and Patient Participant ........ 56 
Data Quality Targets – Assessment Completion ............................................................................... 58 
Study Completion .................................................................................................................................. 58 
Participant Retention (MD-1, MD-4) ..................................................................................................... 58 
Participant Flow Tracking ..................................................................................................................... 59 
Masking (or Blinding) ............................................................................................................................ 59 
Withdrawal/Discontinuation of Participants from Study Procedures .............................................. 60 
Withdrawal .......................................................................................................................... 60 
Withdrawal from Transition Plan ......................................................................................................... 60 

 
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Withdrawal from Data Collection / Entire Study ................................................................................. 61 
Caregiver Withdrawal ............................................................................................................................ 62 
Discontinuation .................................................................................................................. 62 
Documentation of Withdrawal/Discontinuation ................................................................................. 62 
Incarceration .......................................................................................................................................... 62 
ClinicalTrials.gov Requirements .......................................................................................................... 66 
Maintenance of IRB Approval .............................................................................................................. 66 
Major Decisions Documentation .......................................................................................................... 67 
STUDY DATA ............................................................................................................................................. 68 
Descriptive/Demographic Variables .................................................................................................... 68 
Study Outcomes (RQ-6, PC-3, IR-4) .................................................................................. 69 
Primary Outcomes ............................................................................................................. 69 
Secondary Outcomes......................................................................................................... 70 
Assessment of Variability of Resources and Processes .................................................................. 72 
Power Analysis ...................................................................................................................................... 72 
Power for Secondary Outcomes .......................................................................................................... 73 
Power Analysis Revisited by Marcia Ciol, Ph.D., Study Biostatistician, January 28, 2019 ........... 76 
Data Analysis Plan Specific to Each Aim (IR-3, IR-5) ........................................................................ 79 
Analysis of heterogeneity of treatment effects (HT-1, HT-3, HT-4) .................................................. 80 
Data Management (IR-2, MD-1) ............................................................................................................. 81 
REPLICATION AND REPRODUCIBILITY OF RESEARCH AND DATA SHARING ................................ 82 
Location of Facilities, Forms, and Materials ....................................................................................... 84 
Facilities .............................................................................................................................. 84 
Forms .................................................................................................................................. 84 
Materials .............................................................................................................................. 85 
Pertinent Websites ............................................................................................................. 85 
Pertinent List serves .......................................................................................................... 85 
SAFETY MONITORING .............................................................................................................................. 86 
Adverse Event  and Serious Adverse Event Information: Definitions ............................................. 86 
AE Attribution Scale .............................................................................................................................. 87 
AE Documentation ................................................................................................................................ 87 
SAE Reporting and Documentation .................................................................................................... 87 
Unanticipated Problems Information: Definition ............................................................................... 88 
Unanticipated Problems: Documentation and Reporting ................................................................. 88 
Protocol Deviations, Violations, Other Pertinent Documentation .................................................... 89 
Data Safety Monitoring Board (DSMB) ................................................................................................ 89 
Bi-Annual DSM Report ....................................................................................................... 89 
Table 1. Frequency of Data Review, External ..................................................................................... 91 

 
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Data Quality Assurance and Monitoring ............................................................................................. 91 
Description of Plan for Data Quality and Management ................................................... 91 
Internal Monthly Report ..................................................................................................... 92 
Internal Quarterly Report ................................................................................................... 92 
Frequency of Data Review ................................................................................................. 92 
Table 2. Frequency of Data Review, Internal ...................................................................................... 92 
Study Discontinuation .......................................................................................................................... 92 
ENGAGEMENT PLAN (Criterion 2, 4, 5, PC-1, PC-3, PC-4, RQ-1, RQ-3, RQ-6) ................................... 93 
Patient Partner and Stakeholder Engagement Activities .................................................................. 93 
Investigator & Stakeholder Meetings .................................................................................................. 94 
Planning the Study ................................................................................................................................ 95 
Conducting the Study ........................................................................................................................... 96 
Monthly SAC Patient and Family Stakeholder Meetings ................................................ 96 
Annual Study-Wide Meeting .............................................................................................. 96 
Funding Support................................................................................................................. 96 
Disseminating the Study Results ........................................................................................................ 97 
Principles for Engagement ................................................................................................................... 97 
Reciprocal Relationships................................................................................................... 97 
Co-learning ......................................................................................................................... 97 
Partnership ......................................................................................................................... 98 
Trust, Transparency, Honesty ........................................................................................... 98 
Program Evaluation ............................................................................................................................... 98 
RESEARCH TEAM AND ENVIRONMENT ................................................................................................ 99 
The TBIMS Partnership ......................................................................................................................... 99 
The TBI Model System National Data and Statistical Center and Knowledge Translation Center 99 
The TBI Model System Investigators ................................................................................................. 100 
Dissemination of Intervention Materials ........................................................................ 100 
Knowledge Translation .................................................................................................... 101 
Implementation ................................................................................................................. 101 
Possible Barriers to Dissemination and Implementation ................................................................ 101 
REFERENCES CITED .............................................................................................................................. 102 
ADDITIONAL TABLES AND FIGURES ................................................................................................... 109 
Table 3. Patient Participant Involvement .......................................................................................... 109 
Table 4. Caregiver Participant Involvement ...................................................................................... 110 
Figure 2. Study Assessment Schedule ............................................................................................. 111 
Figure 3. BRITE Intervention Schedule ............................................................................................. 112 
Appendix 1: Milestone Schedule ....................................................................................................... 113 
Appendix 2: Data Quality Guidelines ................................................................................................ 119 

 
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BRITE Study Data Quality Guidelines ................................................................................................... 119 
Appendix 3: Engagement Evaluation Funding (Starting on following page) ................................ 123 
Funding for COVID-19 Related Engagement Evaluation ................................................................................. 124 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TOOL REVISION HISTORY  
 
Version Number: 2.0 (Revisions made prior to human subject involvement) 
Version Date: 01-03-18 
Summary of Revisions Made:  
 
1. Added reference of “Rehabilitation Discharge Plan” and “RehabilitationTransition Plan” 
when discussing Standardized Discharge Care and Optimized Transition Care, 
respectively; 
2. Added name of patient member of DSMB; 
3. Deleted reference to requirement that only blind researchers could participate in 
recruitment procedures; 
4. Deleted reference to UWMC and HMC in Screening procedures given protocol applies to 
all sites; 
5. Revised language to indicate de-identified basic demographic information of all potential 
participants will be entered and stored in the centralized NDSC database rather than in 
local databases; 
6. Revised language to indicate de-identified screening and recruitment outcome 
information of all potential participants will be entered and stored in the centralized 
NDSC database rather than in local databases; 
7. Added reference to mailing copy of signed consent form to patient participants enrolled 
following discharge (i.e. LAR provided original consent) 
8. Added language clarifying use of information statement sheet to obtain verbal consent 
from caregivers; 
9. Added language identifying the name of data collection forms; 
10. Updated language regarding what data is collected as part of the discharge information 
form; 
11. Changed frequency of TCM supervision meetings to “regular” vs. “bi-weekly”; 
12. Update names of study sites; 
13. Specified when site and discharge destination are entered into the NDSC database; 
14. Added language clarifying that the relationship between adverse events and study 
procedures will be determined by study researchers; 
15. Eliminated language regarding classification of severity of AEs (too confusing); 
16. Clarified timelines of reporting to PCORI; 
17. Clarified timeline of entering AE/SAE/Unanticipated Problem  data into the NDSC 
database; 
18. Revised description of data review (both external and internal) to be consistent with 
revised DSMP. 
19. Added reference to provision of response key to both patient and caregiver participants. 
20. Added reference to provision of medical services log to patient participants. 
21. Added reference to possibility of sending reminder letters to participants in advance of 
questionnaires. 
22. Added reference to possibility of sending letters to participants we cannot reach for 
questionnaires or RTP phase. 
23. Added reference to research staff informing participants that their study participation has 
been completed. 
24. Added reference to completion of study completion form by staff when participant 
completes study. 
25. Added clarifying language for tables 3 and 4. 
 
 

 
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Version Number: 2.1 (Revisions made prior to human subject involvement) 
Version Date: 02-05-18 
Summary of Revisions Made:  
 
1. Added language clarifying timing of Form II relative to post-discharge questionnaires; 
2. Added language clarifying eligibility criteria for both patient and caregiver participants, 
specifically: 
a. revised this study’s eligibility criterion in the following manner: 
 
“will be discharged from inpatient rehabilitation to home or nursing facility”; 
to 
“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).” 
 
b. added the following inclusion criterion: 
“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).” 
 
c. revised this study’s eligibility criterion in the following manner: 
 
“We will be unable to enroll individuals who are incarcerated due to federal restrictions 
on inclusion of prisoners in research”; 
to 
“We will not enroll individuals who are in law enforcement custody at admission to the 
designated rehabilitation unit or who are taken into custody prior to discharge from the 
designated rehabilitation unit due to federal restrictions on inclusion of prisoners in 
research.”  
 
d. eliminated the non-English speaking exclusion criterion, given its redundancy with 
the English speaking inclusion criterion. 
 
e. revised this study’s eligibility criterion in the following manner: 
 
“We will need to limit enrollment to individuals who either have access to a phone or a 
computer with Wi-Fi” 
to 
“We will not enroll individuals who do not have access to a phone.” 
 
f. 
Eliminated the following exclusion criterion: 
 
“Participants will be excluded if there are contraindications to being in the treatment trial, 
such as TBI resulting from self-inflicted injury or acute psychosis.” 
 
g. added the following basic eligibility criteria for the caregiver participants: 
Inclusion Criteria-Caregiver Participants 
 (1) individuals who will have primary care giving responsibility post rehabilitation care 
discharge of enrolled patient participants; 

 
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(2) 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.); 
(3) at least 18 years old; 
(4) able to provide informed consent. 
  
Exclusion Criteria-Caregiver Participants 
 (1) We will not enroll individuals who are in law enforcement custody due to federal 
restrictions on inclusion of prisoners in research. 
(2) We will not enroll individuals who do not have access to a phone. 
 
3. Added language indicating that all documentation of AEs/SAEs/Unanticipated 
Problems/Note-to-Files will be done by TCMs to minimize risk of unblinding/unmasking; 
4. Added language indicating access to a phone will be assessed via the recruitment 
talking points; 
5. Added language that certain eligibility criteria may be confirmed via conversation with 
clinical staff and family members; 
6. Added language indicating different sub-categories of discharge destination; 
7. Add language regarding completion of the Rehabilitation Plan Completion form by 
TCMs; 
8. Added language clarifying that caregiver participants may be discontinued if the patient 
participant has a new caregiver; 
9. Clarified proper documentation of both active and passive suicidal ideation; 
10. Clarified proper documentation of unsafe living environments; 
11. Clarified proper documentation of adverse change in mental/medical status; 
12. Revised language regarding definition of adverse event that will be documented by 
research team; 
13. Clarified that DSM chair will be contacted for all unanticipated problems and study-
related SAEs. 
14. Indicated location of various electronic forms on NDSC BRITE Website. 
15. Added reference to the fact that each site will assign each potential participant assessed 
for eligibility an ID number unique to that research site.  The patient participant will keep 
the same ID number if enrolled in the study. 
16. Added reference to the fact that all sites will assign a patient participant’s ID number to 
their respective caregivers.  The caregiver participant will keep the same ID number if 
enrolled in the study. 
17. Revised language regarding TCM supervision and fidelity to intervention procedures. 
18. Updated IRB approval information across sites. 
19. Revised language regarding baseline data for patient and caregiver participants to clarify 
the data will not be de-identified when entered into the NDSC database; data will be 
entered with study ID i.e. not name. 
20. Revised ‘Data Management’ section to indicate identifiable data (street address, audio 
recordings, DOB, dates of injury and admission) that will be stored with the study data in 
the NDSC database. 
 
 
 
 
 
 
 

 
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Version Number: 3.0  
Version Date: 03-12-18 
Summary of Revisions Made:  
 
1. Changed the number from 3.5 to 2.8 million individuals who sustain a traumatic brain 
injury (TBI) in the US annually based on more recent data; 
2. Used reference of “Rehabilitation Discharge Plan” and “RehabilitationTransition Plan” 
when discussing Standardized Discharge Care and Optimized Transition Care 
throughout entire protocol; 
3. Added language indicating TCMs may contact health care and service providers on 
behalf of participants as part of the RTP process. These contacts will only be made if the 
participant gives the TCM permission to do so; 
4. Added language about uploading directly TCM process data on a semi-regular basis 
from sites to NDSC website; 
5. Revised language describing participant flow via a consort diagram; 
6. Added language regarding the letters sent to both the participants and relevant 
healthcare providers following completion of the RTP phase.  The TCM would only send 
the letter with the permission of the participant; 
7. Added reference to TCM sending participants randomized to RTP a general description 
of the role of the TCM and description of the particular TCM; 
8. Added reference to TCM sending participants the needs assessment that will be 
reviewed during scheduled contacts as a point of reference to facilitate conversation; 
9. Added reference that we will obtain information regarding recommended and received 
equipment; 
10. Added language that injury date is recorded as part of the discharge destination and 
date form; 
11. Added more detailed information regarding discharge destinations; 
12. Removed IRB approval record from protocol (to be included only as part of MOP); 
13. Removed Decisions Log from protocol (to be included only as part of MOP); 
14. Added language indicating that the access to a telephone eligibility criterion may be 
assessed via observation and discussion with clinical staff in addition to the recruitment 
talking points; 
15. Revised ‘Data Management’ section to indicate identifiable data (street address, audio 
recordings, DOB, dates of injury and admission) will be stored with the study data in the 
NDSC database. 
16. Added language explaining the content of group supervision meetings. 
17. Revised language providing overview of content of TCM manual. 
18. Revised language regarding TCM fidelity supervision to describe initial fidelity review 
(first 4 scheduled contacts) and subsequent monitoring (24 contacts per year per TCM), 
and who will be reviewing recordings for fidelity purposes. 
19. Added language indicating that research staff will attempt to complete the follow-up 
questionnaires with both patient and caregiver participants 15 days before and 30 days 
after 3, 6, 9, month assessment, use TBIMS window of 60 days either side of one year 
assessment with rule that at least 30 days pass between 9 month and 12 month 
assessments. 
20. Eliminated reference to documenting receipt of basic elements of Rehabilitation 
Discharge Plan given all sites are meeting CARF standards. 

 
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21. Corrected study site names throughout protocol. 
 
 
 
Version Number: 4.0  
Version Date: 07-18-18 
Summary of Revisions Made:  
 
Deleted reference to one stakeholder who no longer is part of the study (Shafi); 
1. Revised ‘Rehabilitation Discharge Plan’ section to reflect the actual commonalities of 
care  across all sites; 
2. Added all caregiver domains and measures to description of Aim 4.  
3. Added the following exclusion criterion: We will not enroll individuals who are unable to 
complete study procedures due to cognitive/verbal limitations AND do not have a proxy 
to assist with study procedures; 
4. Added language regarding approach with patient participants who are unable to provide 
consent in the ‘Recruitment’ section of the protocol;  
5. Added language outlining our sampling enrollment approach to manage sites that have 
more participants eligible than they are able to handle relative to TCM availability, as 
well as provide example scenarios; 
6. Added language indicating only one caregiver can be enrolled at any given time;  
7. Provided an example of when the caregiver participant could change during study 
participation; 
8. Added reference to the toll-free number ‘BRITE helpline’ will be local in nature, i.e. each 
site has own number; 
9. Indicated scheduled contact between TCM and participant(s) may be in person if 
convenient for both participant(s) and TCM; 
10. Added language indicating research staff will not complete a Form II with patient 
participants not enrolled into TBIMS if the patient is enrolled outside the Form II window 
described below, specifically more than 60 days after the ideal administration date (12 
months following injury);  
11. Added language indicating staff will continue with a post-discharge questionnaire even if 
unblinded during the questionnaire administration, but will attempt to have another staff 
member (if available) administer subsequent questionnaires; 
12. Added language indicating we will record potential unblinding incidents by asking 
assessors during each post-discharge questionnaire: 1. if they believe they were 
unblinded during the questionnaire or any previous questionnaire; and 2. to guess which 
study arm they believe the participant was assigned to; 
 
13. Added language indicating that staff will record unmasking/unblinding with the study 
note-to-file form only if an incident takes place between questionnaires and has no 
impact on any questionnaire/data (e.g. blinded staff member who has not been assigned 
to complete post-discharge questionnaires with patient participant is unblinded by patient 
participant during a clinic visit). 
14. Added a description of unvalidated items developed by the study team to assess for the 
assistance each patient participant requires as well as time spent interacting with the 
patient participant. These items are administered as part of the caregiver post-discharge 
questionnaire; 
 
15. Added language indicating a caregiver participant will remain enrolled in the study and 
kept on the schedule for data collection even if the respective patient participant 

 
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withdraws from the study unless the caregiver participant explicitly states s/he wishes to 
withdraw as well. Originally we had stated that staff would request permission from the 
patient participant to keep the caregiver participant enrolled if the patient participant 
withdrew; 
16. Clarified that all protocol changes requiring IRB approval will be recorded in the ‘Tool 
Revision History’ section of this document; 
17. Made minor revision to introduction of description of demographic data for caregiver 
participants;  
18. Made minor revisions to ‘Forms’ subsection, including reference to where current CRFs 
exist on the BRITE website and indicated there were eCRFs;  
19. Updated language regarding length of study questionnaires to make language consist 
across all study forms; 
20. Added language indicating that the baseline caregiver questionnaire, post-discharge 
questionnaires, and the one year following injury questionnaire (“Form II”) may be 
completed via postal mail if necessary. Added language clarifying when the “mailout 
option” should be initiated; 
21. Added language indicating that the follow-up questionnaires that have been started or 
completed prior to the window start date should have a call back during the window to 
review the completed items to make sure nothing has changed. The date of the call back 
occurring within the follow-up window should be used as the questionnaire date. If a call 
back cannot be completed, the original questionnaire date outside the follow-up window 
should be used;  
22. Added language regarding the “Two-Week Extension Rule”: Follow-up questionnaires 
that have been started but cannot be completed by the time the data collection window 
closes can be completed within two weeks after the window closes. The questionnaire 
date should be the date the questionnaire was started; 
23. Added language regarding the “Four-Week Completion Rule”: Follow-up questionnaires 
that have been started but not completed during the first contact should be completed 
within 4 weeks. The follow-up date should be the date of initial data collection. If it takes 
longer than 4 weeks to complete the follow-up, data collected during the initial data 
collection period should be verified, and the follow-up date should be the second date 
that data was collected. In the unusual case where the 2 week extension window is used 
to complete the follow-up beyond the 4 week time frame, (e.g. interview started January 
1st, follow-up window closes January 30th, interview completed February 5th), the 
follow-up date should be the date of data collection that was in the follow-up window 
(January 1st in this example);  
24. Added language indicating that the mailing of the questionnaire will trigger the 2 week 
extension to the questionnaire window. Example if you mail the questionnaire July 18, 
2018, and the end of the window is August 31st, you can then receive/collect data 
through September 14th;   
 Added language indicating that the mailouts are exempt from the four-week extension 
rule listed above;  
 
25. Added language indicating that if adequate data are not obtained from the participant by 
telephone or by mailout two weeks before the end of the window, the mailout 
questionnaire should be sent a significant other after personalized information has been 
added to the form, along with a self-addressed return envelope. Like the mailing of the 
questionnaire to the patient participant, the mailing will trigger the 2 week extension to 
the questionnaire window. Example if you mail the questionnaire July 18, 2018, and the 
end of the window is August 31st, you can then receive/collect data through September 
14th;   

 
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26. Added language indicating that missing data may not be filled in using data obtained 
outside the follow-up window and two-week extension rule unless approved by the lead 
site; 
27. Added language indicating that, to classify a questionnaire as “followed”, an interview or 
mailout must be started. There is no minimum number of data elements that need to be 
answered; 
28. Clarified that the enrollment goal for caregiver participants is 607, not 675; 
29. Added language indicating staff should follow Standard Operating Procedures 105B 
from the TBIMS for  the One Year Following Injury Questionnaire (“Form II”) completed 
by non-TBIMS patient participants; 
30. Added language indicating that we will collect insurance type/coverage during the 6- and 
12-month post-discharge questionnaires; 
31. Removed incorrect reference from “STUDY DATA” section that caregiver participants 
will have demographic data collected either as part of TBIMS or BRITE- all caregiver 
participants will be enrolled in the BRITE study only. 
32. Eliminated language regarding a monthly report sent to investigators outlining protocol 
deviations/violations and AEs/SAEs.  These types of events will be outlined as part of 
the quarterly reports that will be sent to investigators; 
33. We revised Figure 2 to reflect the addition of measures/items to the post-discharge 
questionnaires. 
 
 
Version Number: 5.0  
Version Date: 09-04-18 
Summary of Revisions Made:  
 
 
1. Added Summer Ibarra and Oscar Guillamondegui, removed Lance Trexler from 
Professional Stakeholder list. 
2. Replaced with ‘discharge plan’/eliminated reference to the Comprehensive Individualized 
Care Plan (CICP) in the Abstract, ‘Interventions and Comparators’ and ‘Planning the 
Study sections; 
3. Clarified in the Abstract, ‘Interventions and Comparators’ and ‘Planning the Study 
sections that we will provide a telephone number staffed by the TCM during business 
hours to all patients/ families in the RTP group as well as others involved in their care so 
that they may contact the TCM between regularly scheduled calls. Originally we made 
reference to a helpline, which was confusing/inaccurate. 
4. Clarified that multiple caregiver participants can be enrolled at the same time to 
accommodate if the caregiver role is assumed by different individuals at different points 
in time during participation (e.g. mother is caregiver at 3- and 9-months post-discharge, 
significant other is caregiver at 6- and 12-months post-discharge). Research staff will 
assess who has primary caregiving responsibilities both at each questionnaire period 
and the RTP phase (if applicable), and engage accordingly the particular participant who 
most clearly fits the role of primary caregiver. Originally we had planned to only have 
one caregiver participant enrolled at any given time, i.e. disenroll a caregiver participant 
if s/he does not fit the role of caregiver at any time during study participation.   
5. Clarified that study researchers will cease to engage participants in study activities (i.e. 
RTP phase, study questionnaires) if they become incarcerated following randomization.  
Incarcerated participants will remain enrolled in the study, however. Study researchers 
will resume study activities with participants only once they are no longer incarcerated.  
Originally we planned to discontinue participants who were incarcerated due to federal 

 
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restrictions on inclusion of prisoners in research, but determined this approach was 
unnecessary as long as incarcerated participants were not engaged in study activities, 
i.e. study questionnaires or the RTP phase.  
6. Revised sampling enrollment approach to factor in caregiver enrollment rate to the 
sampling enrollment equation (i.e. creates a combined projected patient and caregiver 
enrollment rate threhold), as well as base the formula on cumulative data rather than 
previous quarter data for a more accurate reflection of overall numbers. 
7. Added reference to the satisfaction with care items administered during the 6- and 12-
month patient post-discharge questionnaires. 
8. Added a description of  procedures regarding the RTP participant survey and cover letter 
sent to both caregiver and patient participants randomized to the RTP arm of the study 
about 6 months following discharge.   
9. Added language indicating that study researchers will attempt to collect via telephone 
data from patients that complete the self-administration version of Form II via postal 
mail.   The self-administration form does not include address, information regarding 
injuries to head/neck, the Supervision Rating Scale, the GOSE, and the FIM. Also, 
included language referring to a cover sheet that will allow study researchers to collect 
the data described above as well as administrative items if a site is using a paper 
version of the form for data collection.  
 
Version Number: 6.0  
Version Date: 02-19-19 
Summary of Revisions Made:  
 
 
1. Added two new stakeholders, removed Clingan and Kissinger, alphabetically 
ordered stakeholders;  
2. Changed PI at Moss Rehabilitation from Tessa Hart to Thomas Watanabe, MD, 
added Monica Vaccaro as co-investigator at Moss;  
3. Updated language in sampling enrollment approach to emphasize identification 
of eligible patients/ rate of eligible patients identified and/or enrolled within the 
sampling enrollment approach; 
4. Revised language about TCM supervision, regarding frequency of supervision as 
well as the fact that investigators will no longer provide monthly feedback based 
on fidelity ratings; 
5. Revised windows for 12 month post-discharge questionnaire and Form II non-
TBIMS from 60 days to two months on either side of the ideal administration 
date.  
6. Revised the description of  procedures regarding the RTP participant survey; 
7. Added revised power analysis by Dr. Ciol on 1/28/19; 
8. Revised the “SAFETY MONITORING” section in the following ways: 
a) 
Made minor wording revisions to match the DSMP; 
b) 
Clarified that study researchers will contact the Chair of the DSMB 
when an unanticipated problem is discovered within one week of 
discovery; 
c) 
Eliminated language indicating that NDSC staff will send a reminder 
email to study coordinators to enter data for unanticipated problems 
within the past month- not necessary given training of staff; 
d) 
Indicated that a closed session of the annual DSM meeting may take 
place if desired by the DSMB members whereby the secretary and study 
statistician will be present during the closed session.  They would discuss 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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the contents of the report, any concerns they might have, any unblinded 
analyses the DSMB members want the statistician to conduct, whether 
the study warrants continuation based on its risk/benefit ratio, and 
formulate any recommendations moving forward.  The DSMB may opt not 
to conduct a closed session if deemed unnecessary; 
e) 
Removed language indicating unblinded information would not be 
discussed during the “open” session of the DSM meeting. Rationale: no 
members present are blinded to assignment, thereby negating the need 
to discuss only blinded information;  
f) Clarified that the meeting secretary OR DSM chair will send the meeting 
summary to the lead site PIs within two weeks of the meeting;   
9. Updated Tables 3 and 4 to reflect the RTP Satisfaction survey. 
10. Updated Figure 2 to reflect all assessments 
 
 
Version Number: 7.0  
Version Date: 03-28-19 
Summary of Revisions Made:  
 
 
1. Added language clarifying that the TCMs may share with medical providers/community 
resources information learned during the RTP phase that would maximize addressing 
any needs, including but not limited to contact information, details regarding the patient’s 
TBI, and any other pertinent information. The TCMs will make it clear to the participants 
in advance what information will be shared during any contacts with medical 
providers/community resources.   
 
 
Version Number: 8.0  
Version Date: 10-17-19 
Summary of Revisions Made:  
 
1. Removed Scott Bloom and William Dane as professional stakeholders, and Kelly Gilliam 
as a patient and family stakeholder; 
2. Revised Dr. Seidner’s place of employment and title; 
3. Decreased the targeted caregiver enrollment number from 607 to 540 participants given 
the actual percentage of potential eligible caregivers is 67% as opposed to the original 
projected percentage of 75%; 
4. Decreased the targeted monthly caregiver enrollment number from 17-18 to 13-14 
participants given the actual percentage of potential eligible caregivers is 67% as 
opposed to the original projected percentage of 75%; 
5. Decreased the estimated number of eligible caregivers from 675 to 600 given the actual 
percentage of potential eligible caregivers is 67% as opposed to the original projected 
percentage of 75%; 
6. Increased the number of lost patient participants from 90 to 180 participants given we 
anticipate having a more difficult time with retaining participants and therefore are 
planning for an 80% retention mark versus the original proposed 90% retention mark.   
7. Increased the number of lost caregiver participants from 60 to 110 participants given we 
anticipate an 80% retention mark versus the original proposed 90% retention mark AND 
the decreased anticipated number of enrolled caregivers.   

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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8. Clarified in the “Engagement Plan” section that the stakeholders will be involved in 
developing data collection procedures rather than actual data checking; 
9. Removed reference to Dr. Hart as a TBIMS investigator (retired); 
10. Added reference to the “Security of Records” section regarding a listing of exceptions to 
the separation of identifiers and study data in the “Data Management” section; 
11. Clarified that staff will record an occurrence as an adverse event if the occurrence is a 
new symptom/condition for the participant, OR a symptom/condition that began before 
enrollment yet has become significantly worse following enrollment; 
12. Added language that planned surgeries with no complications will not be documented as 
adverse events. 
13. Revised the “REPLICATION AND REPRODUCIBILITY OF RESEARCH AND DATA 
SHARING” section to reflect PCORI’s policy approved by the Board of Governors of 
PCORI on September 7, 2018 regarding data management and data sharing.  
 
 
Version Number: 9.0  
Version Date: 04-06-20 
Summary of Revisions Made: 
 
1. Added Taylor Obata to study roster given expanded capacity; 
2. Added Rebecca Chung and David Minor to the stakeholder roster, alphabetized the 
patient and family stakeholder; 
3. Revise sampling enrollment approach to specify the recruitment/enrollment data 
reviewed on a quarterly basis will be based on recruitment/enrollment data from the 
previous six months. Also, broaden the language to allow sites to request initiation of 
the sampling enrollment approach even if they don’t meet criteria/ specify that sites may 
decline to initiate the sampling enrollment approach even if they qualify; 
4. Added to the “Consent (PC-1)” section an explanation of the consent by phone process; 
5. Updated “Randomization/Post-Discharge Transition Phase” to account for patients 
enrolled after discharge. 
 
Version Number: 10.0  
Version Date: 09-24-20 
Summary of Revisions Made: 
 
1. Added Monica Lichi as Co-I for Ohio 
2. Removed Kevin Gertz as Research Manager 
3. Removed Kelsey Hurm as Clinical Research Technician from Indiana 
4. Replaced Emergency Problems Response Protocol with Suicidal Ideation Response 
Protocol 
 
Version Number: 10.1  
Version Date: 09-25-20 
Summary of Revisions Made:  
 
1. Corrected Monica Lichi’s title from Co-I to Research Team Director 
 
Version Number: 11.0  
Version Date: 02-08-21 
Summary of Revisions Made:  
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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1. Updated Milestone Schedule in Appendix 1 
2. Added Data Quality Guidelines to Appendices 
3. Added “Data Quality Targets – Enrollment” description to Recruitment section 
4. Added “Data Quality Targets – Assessment Completion” description to Follow-up Data 
Collection section 
 
Version Number: 12.0 
Version Date: 06-24-21 
Summary of Revisions Made: 
 
1. Updated Milestone Schedule in Appendix 1 
2. Updated “Table 1. Recruitment/Enrollment Assessment Timeline” to reflect changes to 
timeline 
3. Added “Plan for analysis of COVID-19 Pandemic impact” section to Data Analysis Plan 
4. Removed Stella Mandl from Study Roster 
 
Version Number: 13.0 
Version Date: 10-19-21 
Summary of Revisions Made: 
 
1. Updated Milestone Schedule in Appendix 1 
2. Added Appendix 3: Engagement Evaluation Funding 
3. Removed Christine MacDonnell from Professional Stakeholders and replaced with Terry 
Carolan 
 
Version Number: 14.0 
Version Date: 01-14-22 
Summary of Revisions Made: 
 
1. Updated Beverley Laubert description in Professional Stakeholder Roster 
 
Version Number: 15.0 
Version Date: 01-23-23 
Summary of Revisions Made: 
 
1. Removed Monica Lichi from Professional Stakeholder Roster and Study Sites and 
Investigator Roster 
2. Updated Milestone Schedule in Appendix 1 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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STUDY ROSTERS 
 
 
Professional Stakeholder Roster  
 
Nicole Adams, Pennsylvania DOH, Acting Public Health Program Manager; PA Brain Injury 
Advocacy  
 
Greg Ayotte, Brain Injury Association of America, Director of Consumer Services, US Brain 
Injury Advocacy  
 
Jane Boutte, MA/SLP, Baylor Institute for Rehabilitation (BIR), Program Manager; TX Brain 
Injury Advocacy  
 
Michael Choo, MD, MBA, Paradigm Management Services, LLC, CMO; Private Insurance  
 
Maureen Correia, RN, Molina Health Care, Supervisor, Case Management; Medicaid  
 
Deborah Crawley, CBIS, Brain Injury Alliance of Washington, Executive Director; WA Brain 
Injury Advocacy  
 
Robert Fraser, PhD, University of Washington, Professor, Vocational Rehabilitation  
 
Brian Giddens, LICSW, ACSW, University of Washington Medical Center, Director, Social Work 
and Care Coordination & University of Washington School of Social Work, Clinical Professor; 
Social Work/Case Management  
 
Oscar Guillamondegui, MD, MPH; Vanderbilt University Medical Center Professor of Surgery, 
Medical Director, Trauma ICU, Director Multidisciplinary Traumatic Brain Injury Clinic 
 
Summer Ibarra, PhD, Dept. of Rehab Neuropsychology, Rehabilitation Hospital of Indiana, 
Clinical Neuropsychologist and Director,  IN Brain Injury Advocacy  
 
Kurt Kroenke, MD, MACP, Indiana University School of Medicine, Professor of Medicine & 
Regenstrief Institute, Senior Scientist; Primary Care  
 
Beverly Laubert, RN, Ohio Department of Aging, State Long-Term Care Ombudsman, Long 
Term Care  
 
Jeff Lilly, MPA, Brain Injury Association of Indiana, Board President; IN Brain Injury Advocacy  
 
Terry Carolan, CARF International, Managing Director, Medical Rehabilitation and International 
Aging Services/Medical Rehabilitation; Rehabilitation Accreditation  
 
David Minor, MIPM, TBI Council and Fund Coordinator, Home and Community Services 
Aging & Long-Term Support Administration 
 

 
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Lisa Perla, MSN, Veteran's Health Administration, National Polytrauma Coordinator; Veterans 
Administration  
 
Stephanie Ramsey, BSN and MPH, Brain Injury Association of Ohio, President; OH Brain Injury 
Advocacy  
 
Risa Richardson, PhD, Polytrauma Program, James A. Haley VAMC, Clinical 
Neuropsychologist & Department of Medicine, University of South Florida, Associate Professor; 
Veterans Administration  
 
Joel Scholten, MD, Veterans Health Administration, National Director, Physical Medicine and 
Rehabilitation & Associate Chief of Staff for Rehab Services, Washington DC VA Medical 
Center; Veterans Administration  
 
Adam Seidner, MD, MPH, The Hartford, Chief Medical Officer; Workers Compensation 
Insurance  
 
Caitlin Synovec, MS, OTD, Health Care for the Homeless, Occupational Therapist 
 
Karen Thomas, CBIST, Brain Injury Association of New York State, Director of Family Services 
 
Monica Vaccaro, MS, CBIS, Brain Injury Association of Pennsylvania, Programs Manager; PA 
Brain Injury Advocacy  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Patient and Family Stakeholder Roster 
 
Irene Ziaya, Patient and Family Stakeholder Board Member - Chair 
 
Richard Anderson 
 
Cavin Balaster 
 
Rebecca Chung 
 
Deborah Fandel 
 
Susie Fitt 
 
Paul Howard 
 
Elaine Howard 
 
Jonathan Leiser 
 
Audrey Self 
 
Julie Self 
 
William Svihla 
 
Gail Weingarten 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Study Sites and Investigator Roster 
 
 
LEAD SITE: University of Washington 
PI: Jeanne Hoffman, PhD 
PI: Jesse Fann, MD, MPH 
Co-I: Megan Moore, PhD, MSW 
Statistician: Marcia Ciol, PhD 
Research Manager: Leslie Kempthorne 
Research Coordinator: Taylor Obata 
 
 
Baylor Institute for Rehabilitation 
PI: Simon Driver, PhD 
Co-I: Randi Dubiel, DO 
Indiana University School of Medicine/ Rehabilitation Hospital of 
Indiana 
PI: Flora Hammond, MD 
Moss Rehab Hospital 
PI: Thomas Watanabe, MD 
Co-I: John Whyte, MD, PhD 
Co-I: Monica Vaccaro  
Mount Sinai Health System (NY) 
PI: Kristen Dams-O'Connor, PhD 
Co-I: Maria Kajankova, PhD 
Ohio State University Wexner Medical Center 
PI: Jenny Bogner, PhD 
Co-I: John Corrigan, PhD 
 
 
 
 
 
 
 
Data Coordinating Center 
Cindy Harrison Felix, PhD 
Dave Mellick, MA 
 
 
 
 
 
 
Data Safety Monitoring Board 
Thomas Novack, PhD, ABPP  
Lillian Lin, Ph.D. 
Scott Beckett – Patient Member 
 
 
 
 
 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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ABSTRACT 
Background and Significance: 
Each year about 2.8 million people sustain a traumatic brain injury (TBI) in the US, and at least 
25% of these injuries are classified as moderate to severe. Nearly half of those hospitalized for 
TBI have long-term disability. The majority experience psychological, physical, social, or 
vocational problems, many of which become chronic. TBI outcomes are affected by the type, 
location and severity of injury and are impacted by the availability, expertise, and intensity, 
duration, and timing of rehabilitation treatment. Following inpatient rehabilitation, Interventions 
for TBI-related symptoms and impairments are not consistently delivered to those in need and 
individuals are challenged to manage their own care because of the nature of their brain injuries 
(e.g., poor memory, behavioral problems, social isolation). Community resources are limited and 
primary care providers are unprepared to care for TBI-related problems, leaving many TBI 
survivors with unmet healthcare needs. There is a dearth of comparative effectiveness research 
examining patient-centered approaches to overcome the personal and organizational barriers to 
receipt of appropriate care. Current clinical practice guidelines prescribe hospital-based 
education, reassurance, advice, and referral after TBI. Given the heterogeneity in severity and 
range of problems, more assistance following discharge may be required to improve outcomes. 
Recently, models that use (1) telehealth to reduce barriers to care and (2) case management to 
improve coordination of care have been found to be acceptable and effective in improving 
quality of life after TBI. Therefore, we plan to compare the effectiveness of Standardized 
Discharge Care (SDC) as labeled in our original application and grant proposal, henceforth 
referred to as the “Rehabilitation Discharge Plan” (RDP), vs. RDP plus Optimized Transition 
Care (OTC) as labeled in our original application and grant proposal, henceforth referred to as 
“Rehabilitation Transition Plan” (RTP) in improving patient-centered outcomes in people with 
recent moderate to severe TBI. 
 
Study Goals: 
The overall goal of our research is to determine the features of healthcare transition approaches 
that are most effective for improving outcomes of importance to patients after discharge from 
inpatient rehabilitation for TBI, as well as outcomes of importance to their families, caregivers, 
and healthcare providers. This project will provide critical information that will help optimize and 
guide the future of healthcare for survivors of TBI. 
 
Specific Aims: 
1. To compare the effectiveness of the Rehabilitation Discharge Plan (RDP) vs. Rehabilitation 
Transition Plan (RTP) on improving patient-reported outcomes of (1) participation and (2) 
health-related quality of life for individuals with moderate to severe TBI who receive inpatient 
rehabilitation 
2. To compare the trajectory of improvement across the first year post-discharge (with 
measurement at 3,6, 9, and 12 months post-discharge) on patient-reported outcomes of (1) 
participation and (2) quality of life 
3. To compare differences in healthcare utilization between RDP vs. RTP across the first year 
post discharge. 
4. To compare the effectiveness of RDP vs. RTP on caregiver-reported caregiver outcomes 
including burden, quality of life, and caregiver participation. 
 
Study Description: 
We plan to enroll approximately 900 adults with moderate to severe TBI who are discharged 
from inpatient rehabilitation at one of six participating TBI Model Systems sites (WA, NY, PA, 
TX, OH, IN). Eligible patients will be recruited, consented and randomized into one of two 
treatment groups. We plan to enroll approximately 607 caregivers.  

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Randomization will be blocked on study site and discharge to another facility vs. 
home/community. 
 
 
Treatment Conditions: 
(1) Rehabilitation Discharge Plan (RDP): will consist of the standard elements of discharge care 
that are already in place at participating centers; these include: (1) patient and family education, 
(2) written discharge care instructions, (3) a follow-up plan, and (4) a brief phone call from an 
inpatient care provider within 3 days of discharge. 
(2) Rehabilitation Transition Plan (RTP): RTP will include TBI case management, provided by a 
TBI Care Manager (TCM) who will contact the patient/ family by phone (or mobile 
teleconferencing) to provide assistance to connect them with resources, overcome obstacles to 
following the discharge plan, and address any new needs reported. With the participants’ 
permission, the TCMs may contact healthcare and service providers on behalf of the participant 
to provide assistance with logistical (e.g. scheduling an appointment) and/or healthcare issues 
(e.g. informing a provider of an issue the participant is experiencing but has difficulty expressing 
to the provider).Calls will occur over 6 months: weekly, starting 1 week after discharge, for 4 
weeks; biweekly for 2-3 months, depending on individual progress and needs; then monthly for 
2-3 months. Patients, families, caregivers, as well as others involved in the patient’s care may 
be provided the TCM’s telephone number to contact her during business hours. The TCM can 
also be accessed via e-mail or text message. 
 
Outcomes Assessment: 
Early engagement with patients, family and other stakeholders revealed that survivors of TBI 
are primarily concerned about: (1) returning to pre-injury roles and activities and (2) regaining 
quality of life. We chose the Participation Assessment with Recombined Tools-Objective 17 
(PART-O) and the Quality of Life after Brain Injury Scale (QoLIBRI) as primary outcomes 
because they capture content important to our stakeholders and are recommended by national 
TBI outcomes experts. Secondary outcomes will include assessment of healthcare utilization, 
caregiver burden, and process variables. Outcomes will be assessed at 3, 6, 9, and 12 months 
following discharge, with the primary outcome at 6 months. Analysis will be by intent to treat. 
 
Dissemination: 
In preparation for this project, we have engaged a team of patient and family stakeholders who 
participated in defining the study aims, study population, interventions, assessment strategies, 
and outcome measures and will participate in all phases of the study. We have also identified 
and sought partnerships with clinical, health system, policy/advocacy, and payer stakeholders 
who have agreed to work with us to implement and disseminate findings in order to improve 
standards of care and optimize healthcare systems for persons with TBI. 
 
 
 
 
 
 
 
 
 
 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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BACKGROUND (Criterion 1, RQ-1, RQ-3) 
Traumatic Brain Injury is a common condition 
which can have lifelong consequences. About 2.8 
million individuals annually in the United States sustain 
a TBI,2 and at least 25% of these injuries are classified 
as moderate-to-severe.3 According to the most recent 
data, there was a 19.5% increase in TBI-related 
hospitalizations from 2002 to 2006.4 A recent estimate 
based on hospital discharge data suggested that 
116,000 Americans older than 15 years of age are 
discharged each year after a moderate-to-severe TBI.5  
Nearly half of those who are hospitalized for TBI have 
long-term disability.6 Moderate-to-severe TBI 
commonly results in a complex mix of physical, 
cognitive, behavioral, and psychosocial difficulties; the 
cognitive sequelae in particular may limit the ability of 
survivors to adjust to functional changes and to 
manage their long-term health and rehabilitation 
needs.6 Growing evidence also suggests that moderate-to-severe TBI frequently evolves into a 
chronic disease process characterized by reduced life span and many secondary conditions, 
including the onset of Parkinson’s disease.7-9 Extensive reviews of the literature demonstrate 
that TBI outcome is affected by the type, location and severity of injury, mitigated by (1) 
treatment expertise; (2) intensity, duration, timing, setting and scope of rehabilitation; and (3) the 
availability of follow-up services.10-19 Each of these mitigating factors is potentially modifiable. 
The over-arching goal of the proposed project is to impact outcome by identifying the best 
discharge planning and transitional care services model for maximizing functional gains for TBI 
survivors while minimizing burden on caregivers as patients with TBI make the transition from 
inpatient rehabilitation facilities (IRFs) to the next level of care (community or skilled nursing 
facility). In doing so, we will address gaps that commonly emerge during this transition.  
 
Gaps in the evidence exist for transition from IRF to next level of care for individuals with 
moderate-to-severe TBI (RQ-1, RQ-3). The standard of care within IRFs has been defined by 
the Commission on Accreditation of Rehabilitation Facilities (CARF)20 and includes key 
elements such as education related to a patient’s diagnosis and ongoing impairments, 
medications, and planning for follow up after discharge. These elements have been 
incorporated into evidence-based interventions such as Project RED (Re-Engineered 
Discharge),21 BOOST (Better Outcomes for Older Adults through Safe Transitions),22 and Care 
Transition Intervention23 designed primarily to address the core pitfalls that frequently resulted in 
unplanned rehospitalizations. For example, Project RED includes recommendations for 
organizing outpatient follow-up and discharge medications, providing education on medication 
and the patient’s condition (diagnosis) as well as the discharge plan, and ensuring the discharge 
summary gets to the patient’s outpatient provider. While these recommendations were not 
standard for acute hospital discharges prior to the development of these programs, they are 
consistently followed at discharge from inpatient rehabilitation and are part of the CARF 
standards.20   However, despite being the standard of care in CARF accredited IRFs, the 
standard discharge model has not been evaluated systematically for individuals with TBI.  
A more intensive form of case management is a standard of care for complex populations, such 
as TBI, within the Veterans Health Administration (VHA)24, 25 as well as in several organizations 
around the United States such as through some state Brain Injury organizations and through 
Labor and Industries for work injuries.26, 27  
Frequent Abbreviations  
CARF Commission on Accreditation of 
Rehabilitation Facilities 
IRF 
Inpatient Rehabilitation Facility 
KTC 
Knowledge Translation Center 
NIDILRR National Institute on Disability, 
Independent Living & 
Rehabilitation Research 
PTA 
Post-traumatic amnesia 
RDP  Rehabilitation Discharge Plan 
RTP 
Rehabilitation Transition Plan 
SAC 
Study Advisory Committee 
TBI 
Traumatic Brain Injury 
TBIMS TBI Model Systems 
TCM TBI Care Manager 
VHA 
Veterans Health Administration 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
Page 25 of 129 
 
There has been increasing use of case management to assist in the transition of care between 
acute and post-acute activities for a variety of diagnoses.28, 29 Research suggests that the use of 
case management can result in a reduction in 30-day readmission as well as improvement in 
function, and decreased health service use and spending.30, 31 However, there is little 
consistency in the content, level of personal assistance, or timing of services. Systematic 
reviews of the impact of case management to facilitate the transition between IRF and 
community for individuals with TBI have been conducted and results suggest that the evidence 
remains mixed, due in large part to inconsistent definitions of case management, inadequate 
comparators and statistical power, selection bias, and varied follow up time periods.32, 33 While 
research has not been extensive, in a report to Congress, there has been a call to “develop and 
evaluate service models that will assist patients to better navigate the post-acute rehabilitation 
setting.”34 
 
Given that both more and less intensive approaches to discharge from IRF support are currently 
in use, this poses a decisional dilemma for patients, their families, as well as providers and 
health care systems as to which method is most effective for the majority of individuals to 
maximize health and function as well as reduce complications and healthcare utilization and 
costs. As our group sought input from stakeholders, including patients, family members, 
clinicians, healthcare administrators, insurers, and advocacy organizations in the community, 
we consistently heard that individuals with moderate-to-severe TBI and their families often fall 
through the cracks in the system. Comparative evidence from well-defined approaches to 
transition of care would allow for improvements in the healthcare system. 
 
Currently healthcare service delivery for 
individuals with moderate-to-severe TBI is 
“front-loaded” to deal with the injury event, 
followed by fragmented and inconsistent long-
term care. Injured individuals require acute 
hospitalization and intensive inpatient 
rehabilitation, as well as individualized outpatient 
services to support continued recovery and 
community integration. Optimal outcomes depend 
upon individualized services being delivered with 
sufficient intensity and duration. Due to the 
fragmented system of outpatient care in the United 
States, even patients who are treated in 
specialized TBI rehabilitation units may be lost to 
follow up thereafter. The TBI care system in the 
United States currently is focused on the acute 
event, such that resources are expended on 
emergency and acute hospital-based care with 
little attention to the long-term needs of survivors. 
 
 
 
 
 
 
 
 
 
Figure 1. Average length of stay (LOS; days) and 
FIM™ gain from admission to discharge for TBI 
inpatient rehabilitation admissions, 1990-2008. 
(Data from the Uniform Data System for Medical 
Rehabilitation.1 Data for 1996-98 have not been 
published.) 
0
5
10
15
20
25
30
35
40
45
50
LOS
FIM gain

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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As the duration of inpatient rehabilitation has declined dramatically since 1990, patients with TBI 
are discharged “quicker and sicker” (see Figure 1). While there are many factors which 
contribute to variability in both length of stay (e.g., insurance coverage, discharge plan, etc.) and 
FIM gain (e.g., severity of injury, comorbid conditions, etc.), those admitted to inpatient 
rehabilitation for TBI continue to experience reduced lengths of stay, and are discharged from 
intensive rehabilitation at lower levels of functioning with less time to adjust to disability. More 
than half of individuals with moderate-to-severe TBI who receive inpatient rehabilitation are still 
in post-traumatic amnesia (PTA) one month after the injury,35 which means they are still 
confused and disoriented to person, place and/or time, and are unable to remember daily 
events. Many individuals with TBI are discharged from acute care hospitals within this time 
frame.36 The burden then falls on the patient and family to coordinate care, seek specialized 
services, and manage care needs, which may be extensive. A recent study of outcomes of over 
9,000 patients within the National Institute for Disability, Independent Living and Rehabilitation 
Research (NIDILRR)-funded TBI Model Systems (TBIMS) found that reduction in IRF length of 
stay was accompanied by a decrease in the level of cognitive functioning upon inpatient 
rehabilitation discharge, as measured by the Disability Rating Scale, and reduction in the 
number of patients achieving higher levels of functional independence (measured using the 
FIM™) at one year post injury.37 The implications of short hospital stays on functional outcomes 
not captured in the FIM™ and DRS (e.g., psychosocial adaptation, burden on families) are not 
known. However, our stakeholders have helped us to appreciate how abbreviated hospital care 
after a TBI affects the patient, family and community, particularly the stages of recovery that 
occur after discharge.  
 
Inadequate transition from hospital-based care to the community negatively affects 
patients, their families, and their communities. Not surprisingly, TBI can have a profound 
effect on the family, as living with and caring for a TBI survivor can result in ruptured 
interpersonal relationships, high rates of divorce and separation, caregiver distress, caregiver 
burden, and depression among family members.38 The literature is replete with evidence 
gathered from patients, families, caregivers, clinicians and other stakeholders that indicates a 
dire need for enhanced discharge planning and transitional care services following discharge 
from the hospital after TBI.39-42 Discharge is often experienced as a chaotic and stressful time 
during which patients and families who have only recently emerged from the trauma of the injury 
are suddenly faced with the responsibility of caring for (or finding care for) a loved one with 
severe functional deficits. A recent study reported that more than half of caregivers felt that they 
were not provided enough information about TBI, and most felt that discharge planning services 
were inadequate.43  
 
Similarly, population-based studies have documented a high rate of unmet needs following 
hospital care for TBI.44 Numerous other survey, interview, and focus group studies of individuals 
with TBI and their caregivers indicate that after discharge from an IRF patients struggle with 
how to find information about TBI, how to manage their symptoms, and how to access relevant 
services.45, 46 Specific needs identified after discharge from the acute or rehabilitation hospital 
include information about community resources, greater understanding of individualized 
prognosis and long-term outcomes, information about school or job re-entry, techniques for 
managing TBI-related symptoms, information on coping, adjustment and self-care for 
caregivers, financial assistance, and information about home-based services and assistive 
equipment.45, 47-50  
 
 
 

 
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While CARF regulation of rehabilitation facilities has helped to ensure that discharge planning 
guidelines are followed, the research literature and our stakeholders have affirmed that these 
protocols are insufficient.  Indeed, for individuals with traumatic injuries who receive inpatient 
rehabilitation at a CARF-accredited Model System of care, 28% are rehospitalized within the 
first year of injury, and rehospitalization rates remain high up to ten years post-injury.51, 52 
 
Current models of transition inadequately support individuals with TBI and their families. 
The need for help with care transitions is not unique to individuals with TBI, and we reviewed 
the general research literature for data that might inform the ideal content and timing of 
transitional services. However, some of the commonly recommended approaches to patient 
education may not be ideally suited for some or all TBI survivors and their families. For 
example, it is frequently recommended that patient and family education about home care begin 
almost immediately after hospital admission.53 However, individuals who are in PTA for all or 
most of their hospital stay are by definition unable to retain information provided during this time. 
Throughout our focus groups we heard patients tell us that their hospital stay was a traumatic 
and chaotic time for their families and consequently, much of what was “taught” was soon 
forgotten. Similarly, in-hospital education guidelines suggest addressing both present and future 
needs,53 but our focus group participants told us they were easily overwhelmed by discussions 
of future needs such that instead of feeling prepared or empowered, they felt burdened and 
sometimes hopeless. We also heard that accessing help in person was often a barrier even if 
the help was available. Therefore having access via the telephone or email was highly 
recommended. Consistent with these reports, a study of TBI survivors and their caregivers 
found that poor recall of information provided at hospital discharge was associated with 
perceived lack of personal relevance of the information, the timing of information provision, the 
manner of teaching, and the emotional state of the patient/caregiver at the time of information 
receipt.45 Together these findings suggest that transitional planning and support would optimally 
extend beyond the time of hospital discharge and be available at a distance (via telephone or 
other method). Once patients and their families begin to develop a better sense of what their 
needs are in the weeks following discharge, individualized information about care strategies and 
resources could help address those needs as they unfold.  
 
The study team is well-poised to successfully conduct a comparative effectiveness trial 
given their experience and prior collaborative engagement. All six study sites are NIDILRR-
funded TBIMS sites.54 NIDILRR competitively awards TBIMS grants to institutions that are 
national leaders in medical research. Each TBIMS enrolls individuals who receive inpatient 
rehabilitation for TBI into a longitudinal outcome study and contributes detailed data to 
the Traumatic Brain Injury Model Systems National Data and Statistical Center (TBI NDSC). 
These centers have demonstrated the ability to track outcomes of their patients for up to 25 
years post-injury with excellent retention rates (average of 90% successful follow-up across 
years 1, 2, 5, 10, 15, 20, 25 years, with 94% successfully followed at 1 year for the six sites 
involved in this grant) and over 15,000 patients enrolled. The TBIMS has a long history of 
conducting innovative projects and research in the delivery, demonstration, and evaluation of 
medical, rehabilitation, vocational, and other services designed to meet the needs of individuals 
with TBI. More than 500 peer-reviewed publications have been authored by TBIMS investigators 
since 1987. A central goal of the TBIMS Knowledge Translation Center (TBIMS KTC) is to 
provide information and resources to individuals with TBI, their families, caregivers, and friends, 
health care professionals, and the general public.  
 
The six collaborating centers involved in the current grant represent six states: Washington 
(WA; lead center), New York (NY), Ohio (OH), Indiana (IN), Texas (TX), and Pennsylvania (PA).  

 
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This existing infrastructure demonstrates: (a) prior experience with enrolling individuals with TBI 
and their families into research studies that begin at the time of inpatient rehabilitation, (b) 
successful tracking of outcomes over time, (c) an extensive track record of multi-center 
collaboration, and (d) extensive resources for disseminating knowledge gained through our 
research.  
 
Our study team has experience with transitional care and evidence that telephone-
delivered information and referrals after hospital discharge improves functional 
outcomes. The lead center on the current application (WA/University of Washington) conducted 
a telephone intervention from 1999 to 2002 (which enrolled 95% of eligible participants), which 
was delivered after discharge from inpatient rehabilitation. The intervention attempted to bridge 
the gap between hospital and community by proactively providing information, problem-solving 
advice, and referral services while also addressing survivor and family concerns early after 
discharge and as they unfolded.55 Those who received the telephone intervention had better 
functional outcomes and quality of life56 and fewer depression symptoms57 than participants who 
received standard follow-up. Results suggested that telephone follow-up may enhance service 
provision after TBI, and 81% of the problems identified by patients and caregivers were able to 
be addressed via telephone (through psychoeducation and resource facilitation) as opposed to 
community medical referrals, tertiary care referrals or emergency services.55 This study 
demonstrates: a) telephone follow-up is feasible in the weeks and months after discharge from 
inpatient rehabilitation, b) individual contact allows for the provision of tailored information and 
referrals to local resources, and c) the lead center has been successful in conducting a 
transitional care intervention. 
 
SIGNIFICANCE (Criterion 2, 4, RQ-1)  
This grant addresses PCORI’s priority topic on TBI to “Compare the effectiveness of 
multidisciplinary rehabilitation programs for moderate-to-severe TBI in non-military or veteran 
adults.” Consistent with this priority, we seek to improve the “transition between acute inpatient 
rehabilitation and subsequent care, and examine the impact on a patient’s functional status.” By 
leveraging our existing TBIMS infrastructure, which includes a high volume of patients with 
moderate-to-severe TBI, we can readily examine “pre-specified patient and clinical subgroups.” 
Our grant is also consistent with several IOM priorities, e.g., to compare the effectiveness of 
comprehensive care coordination programs; diverse models of transition support services for 
adults with complex health care needs; different quality improvement strategies in disease 
prevention, acute care, chronic disease care, and rehabilitation services for diverse populations; 
and different strategies to engage and retain patients in care and to delineate barriers to care, 
especially for members of populations that experience health disparities. Our grant is also 
consistent with AHRQ priorities including outpatient case management for adults with medical 
illnesses and complex care needs, and multidisciplinary rehabilitation programs for moderate-to-
severe TBI in adults.  
 
Equally important if not more so, improving transition care is a high priority for our stakeholders. 
Given that our study team has been examining TBI as a chronic condition for several years, we 
have sought input from individuals with brain injury to understand how they interact with the 
healthcare system and this made us aware of the significance of getting individuals help early 
after TBI to connect them with resources and also with others with brain injury. We have heard 
from individuals with TBI and their families that even when they received excellent hospital care, 
the transition to the community was difficult. In addition, clinicians describe even more concern 
for those individuals who do not have available and invested family members to assist as they 
transition out of the hospital.  
  

 
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Our Professional Stakeholders who work for advocacy organizations describe a struggle in 
knowing the best approach to supporting members of the TBI community. For example, one of 
our Professional Stakeholders stated “I have attended conferences to learn how we can best 
provide assistance to individuals with brain injury, but when I read about ‘case management’ 
everyone is describing something different. If you could provide evidence for a standardized 
approach following discharge you can improve how transitional care is given across the country. 
We will immediately adopt it.” 
 
Evidence from this comparative effectiveness study will aid in decision making for health 
care systems and advocacy groups on best practices for transition and coordination of 
care (RQ-3, RQ-5).  Rehabilitation administrators are faced with the question of how they can 
provide patients with discharge care that will reduce the likelihood of readmission into the 
hospital while optimizing patients’ ability to successfully resume community living. Currently, 
accredited rehabilitation units utilize a discharge care plan that meets CARF standards under 
the assumption that these standards maximize outcome. However, the discharge approach 
within the VHA and other systems suggest that more intensive and temporally distributed case 
management as in our Rehabilitation Transition Plan (RTP) may be a more effective model.  
Unfortunately, while similar models have been shown to be effective with other populations, they 
have not been directly compared to the current standard approach used across the country. 
While requiring additional personnel, the RTP could reduce hospital readmissions that incur 
penalties levied by the Centers for Medicare and Medicaid Services which may balance any 
cost differential.  In preparation for the current application, researchers from the six TBIMS sites 
partnering for this grant conducted a series of focus groups with patients, family members, and 
caregivers. Our group’s preliminary data suggest that, despite following current CARF standards 
for discharge, there are unacceptably high rates of missed follow-up clinical visits, gaps or 
lapses in clinical care, and overall dissatisfaction with the information, education, and resource 
facilitation available. Additional discussion with our Patient and Family Stakeholders highlighted 
the need for improved follow up including education, communication, and support during the 
transition from inpatient rehabilitation to the next level of care.  
 
In addition to our Patient and Family Stakeholders, members of our study team have been 
leading the research agenda on conceptualizing TBI as a chronic condition which requires 
setting individuals on an early positive trajectory to maximize their function and quality of life and 
reduce secondary conditions. The annual Galveston Brain Injury Conference (GBIC) convenes 
a group of experts in TBI with a goal of advancing research and clinical care. In the last 5 years, 
experts including consumer representatives, clinicians, researchers, and policy members 
focused on the topic of “Brain Injury as a Chronic Condition.”58, 59 GBIC leaders, including 
numerous members of our research team, actively participated in this initiative. Case 
management that supports a tailored comprehensive discharge plan was identified as an 
important component to improve outcomes and reduce chronic conditions. Conceptualizing TBI 
as a chronic condition given the vast, complex array of problems and the lack of centralized TBI 
care in the community makes the prevention or delay of chronic conditions through early 
detection and intervention an important goal.  
 
As part of the GBIC, investigators from two study sites (WA and NY) conducted a series of 
focus groups to learn how individuals with brain injury seek and access health care.  
Groups were asked a series of open-ended questions about their experiences with health care 
after brain injury, including any barriers or facilitators that have affected their ability to access 
and manage health care. Participants were, on average, 17 years post-injury, and qualitative 
analysis of focus group content identified key themes.  

 
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Discharge from the hospital, whether from an acute care hospital, rehabilitation unit, or nursing 
facility, was frequently identified as a challenging time for the patient and family, with several 
participants reporting that they were given insufficient information or poorly timed information. 
Several focus group participants remembered having been given a packet or binder of 
information upon discharge from the unit, but indicated that they (or their families) were too 
overwhelmed to recall the information provided, and many indicated that they had never even 
looked at the materials. Another commonly identified theme centered on gaps in care in the 
community, and most of the examples given by participants occurred during the transition from 
IRF to the next level of care. Some participants acknowledged missing follow-up appointments 
and not knowing how to reschedule, others indicated they were never given follow-up 
appointments, and still others reported considerable lags in accessing rehabilitation therapies 
(such as physical therapy) because they were unsure how to find specialty providers in their 
communities.60 
 
There has also been research to indicate access to care and TBI-related services are 
primary needs in the first years after injury. One study site (NY) conducted a survey of 
individuals with TBI (or their caregiver) to evaluate satisfaction across 26 aspects of daily life 
and identify unmet needs that contribute to dissatisfaction. Although the interview asked about a 
wide range of social roles and activities, some of the most commonly identified unmet needs in 
the first year post-injury were in access to information and resources about TBI or disability, 
access to TBI-related services, and understanding the challenges related to TBI.61 This study 
was cross-sectional and did not follow participants over time, but individuals who were many 
years post-injury and reported similar needs for information, resources and services also 
reported dissatisfaction with their physical health and interpersonal relationships. These findings 
demonstrate that: (a) Insufficient information about TBI and inadequate access to local 
resources and services are common areas of unmet need and sources of dissatisfaction in the 
early post-acute stage after TBI, (b) failure to meet these needs early in the post-acute stage of 
recovery may represent a missed opportunity to help a person with TBI and his/her family 
establish systems of care and other resources needed for longer term medical management 
and maintenance of interpersonal relationships. In addition, there is evidence to suggest that 
assistance is needed to “negotiate the rehabilitation maze”39 and in tailoring education to be 
specific to each individual’s injury at the transition from hospital to the community.40, 62, 63 
 
PATIENT POPULATION (PC-2, RQ-3, IR-1) 
The target population is composed of all patients with moderate-to-severe TBI age 18 and older 
receiving inpatient rehabilitation in the United States. The sample will be composed of 
consecutive neurorehabilitation admissions of patients with moderate-to-severe TBI to one of six 
existing NIDILRR funded TBI Model System Centers, whose data have been shown to 
be representative of the target population (PC-2).5, 36 Using the data from the six TBIMS sites for 
2015, the gender and racial breakdown of the proposed sample is described below in the 
Human Subjects Section. The sample is expected to include individuals with TBI of sufficient 
severity to warrant inpatient rehabilitation. Those with TBI enrolled in the TBIMS have a median 
age of 38 years with predominantly moderate-to-severe TBI using Emergency Room Glasgow 
Coma Scale (GCS) scores which are captured in TBIMS data collection (Mean GCS= 9.91) in 
addition to multiple other severity indicators (imaging, duration of coma, PTA).  
 
Data from the TBI National Data Center, which is the repository of longitudinal data from all 
TBIMS centers, provided historical data from 2015 across the six study sites. Rehabilitation 
admissions, TBIMS eligibility, and consent rates show that there were 764 individuals who were 
discharged from inpatient rehabilitation across the six study sites.  

 
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Of those discharges, 430 were found to meet eligibility criteria for the TBIMS as described in the 
Research Plan inclusion/exclusion criteria, which is a very conservative estimate of our volume 
as we will not limit enrollment in the current study to only those admitted into the system of care 
within 72 hours of injury (as required for TBIMS enrollment). The enrollment rate for the six sites 
involved in this grant is 81% from October 2015 through October 2016. In 2015 alone, 345 
individuals who had a TBI and were eligible enrolled into the TBIMS across the 6 study sites. 
Over 3 years of enrollment, we conservatively estimate that 900 participants will consent to 
enroll into the proposed study.  
 
Due to the existing infrastructure of the TBIMS at each study site, identification of eligible TBIMS 
participants is already in place. Each study site follows TBIMS Standard Operating Procedures 
(SOP) for enrollment, consent, and tracking of reasons for non-consent. Data regarding 
eligibility, enrollment success, and missing data are put into site-specific reports that are 
reviewed at each site and at the national level to ensure that barriers to successful enrollment 
and follow-up are addressed. This infrastructure will be utilized for the current project to monitor 
ongoing study enrollment and attrition. We will also use the existing TBIMS meeting 
infrastructure (teleconferences and TBIMS Project Director face-to-face meetings) to address 
study conduct on an ongoing basis. Finally, barriers such as patient inability to consent to the 
study are well addressed in the existing TBIMS infrastructure. Due to the cognitive impairments 
common after TBI, TBIMS staff have a SOP in place for determining patient capacity to consent 
or to obtain proxy medical consent. Once a patient has regained the capacity to consent, they 
are re-consented for TBIMS purposes. This study will use the same SOP for consenting 
participants. 
 
Data Sources and Resources (IR-1)  
Data collected as part of the national longitudinal TBIMS database during inpatient rehabilitation 
and at 12-months post-injury will be available for the majority of participants in the proposed 
study. These uniform data elements will be collected from individuals who are not enrolled in 
TBIMS but who enroll in the current study to ensure consistency. TBIMS data elements include 
demographic variables, information about pre-injury social history, detailed data on injury type 
and severity, and functional status at rehabilitation admission and discharge 
(https://www.tbindsc.org/Syllabus.aspx). 
 
STUDY DESIGN OR APPROACH (Criterion 3) 
A 1:1 randomized controlled trial design will compare the effectiveness of two established 
methods of managing transition from IRF discharge to the next phase of care, stratifying by site 
and discharge to another facility (e.g., skilled nursing facility) vs. discharge to home/community. 
We are stratifying on discharge destination based on the relatively lower frequency of discharge 
to facility (22% across all 6 TBIMS sites in 2015). However, we chose to include discharge to 
facility for inclusiveness and because our stakeholders encouraged it. For example, we heard “It 
would be nice to have an extra advocate” from a focus group member whose family member 
was discharged to a skilled nursing facility and experienced poor follow-through of rehabilitation 
recommendations. 
 
Reporting of the results will follow the CONSORT guidelines (IR-6). The extent to which a study 
design is explanatory vs. pragmatic lies along a continuum, which Tosh64 and Thorpe65 have 
operationalized into evaluation tools. Using the Pragmascope tool,64 which is an adaptation of 
Thorpe’s PRECIS tool modified for mental health studies,65 our study design is highly 
pragmatic as determined by the 10-item tool.   

 
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For example, our design ensures that our study includes the entire target population and allows 
for noncompliance based on participant preference. Both interventions are happening in 
everyday practice in other settings such as in CARF-accredited IRFs and the VHA, and both 
allow for flexibility based on participant needs and does not require high level expertise of the 
TBI Care Manager to be delivered. However, our primary outcomes are chosen by our Patient 
and Family Stakeholders, which will require patient-report and cannot be abstracted from 
medical records. Our secondary outcomes include objective indicators such as healthcare 
utilization and unplanned hospital readmissions. We also plan to compensate participants and 
their caregivers for the time spent to complete our outcome assessments. 
 
The two established methods, described below (RQ-5), are (1) a standardized version of 
existing discharge procedures used at all six sites and (2) a standardized telephone-delivered 
case management approach that extends beyond the point of discharge, based on the protocol 
used within the VHA and enhanced with input from our Patient and Family Stakeholders. 
Research assistants (RA) will be blinded to participant group assignment and will conduct 
outcome assessments at 3, 6, 9, and 12 months post-discharge, with primary outcome of group 
comparison at the end of the intervention period (6 months post-discharge). The success of the 
blinding will be evaluated by having the outcome data collectors complete an assessment of 
each participant’s group assignment after completing the outcome assessments and those will 
be reviewed for accuracy and reported with the final outcomes. We have successfully 
maintained blinding of outcomes assessment in trials previously.56, 66 
 
The Rehabilitation Discharge Plan (RDP) condition is the CARF standard method20 to prepare 
the patient and family for discharge from inpatient TBI rehabilitation. The RDP is already in 
place with few variations at the six participating TBIMS centers. This RDP approach is 
consistent with evidence-based approaches to discharge planning that have been supported by 
PCORI, AHRQ and NIH.67 Considerable evidence exists demonstrating that this form of 
discharge planning results in reduced 30-day hospital readmissions and improved follow-up with 
outpatient appointments,21 improved patient satisfaction,68 and decreased duration of inpatient 
readmission and all-cause mortality compared to a non-standardized approach.69  
 
The RDP includes elements common to all centers: specific details on follow up for ongoing 
medical care, safety recommendations, medication lists and instructions, common symptoms to 
monitor, and information on healthy behaviors such as an individual’s home exercise program 
and diet. Recommended follow up care, such as physician visits, therapies, and/or home health 
care, is collected upon discharge to allow comparison between groups.  
 
The Rehabilitation Transition Plan (RTP) protocol will include RDP with the addition of 
transitional care. RTP was chosen based on literature supporting a more intensive, temporally 
extended and coordinated approach for patients likely to experience significant and prolonged 
problems after injury,27, 70, 71 i.e., those with moderate-to-severe TBI. The RTP intervention will 
be delivered by a TBI Care Manager (TCM) primarily via telephone. Focus group members 
emphasized the need for assistance beyond providing discharge education. As described in 
more detail below, the RTP comparator incorporates treatment elements with known efficacy 
from the VHA with input from our stakeholders.  
 
 
 
 
 
 

 
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Case management, including needs assessment and resource facilitation to address unmet 
needs, has been an important element in several successful post-acute TBI trials.56, 66  
Importantly, in response to the recent influx of war casualties that included many patients with 
TBI and polytrauma, the VHA established Case Management Standards of Practice designed to 
“avoid duplication, poor timing, or missed care opportunities” using a  “process that assesses, 
advocates, plans, implements, monitors, and evaluates health care options and services so that 
they meet the needs of the individual patient” (p.2).72  The VHA model is similar to the RTP 
model to be used in the proposed study, but has not been empirically tested against standard 
care. Resource facilitation, which is included as a key component of RTP, has been used 
successfully in TBI to improve community participation and return to work compared to standard 
care.73 While these strategies have been recommended by several consensus practice 
guidelines,70, 71 implementation and provision of such interventions are not consistent, therefore 
research is needed to examine a well-defined approach to resource facilitation. Telephone-
based interventions have been successfully used to assist in transitioning from IRF to the 
community following TBI.56 Like the RDP comparator, the RTP intervention has been 
standardized for the purposes of this trial, and we plan to measure individual elements provided 
to each patient to maximize our ability to associate care elements with primary and secondary 
outcomes.  
 
Specific Aims and Hypotheses 
Aim 1:  To compare the effectiveness of Standardized Discharge Care (SDC) as labeled in our 
original application and grant proposal, henceforth referred to as the “Rehabilitation Discharge 
Plan” (RDP), vs. SDC plus Optimized Transition Care (OTC) as labeled in our original 
application and grant proposal, henceforth referred to as “Rehabilitation Transition Plan” (RTP), 
RTP on improving patient-reported outcomes of (1) participation, as measured by the 
Participation Assessment with Recombined Tools-Objective 17 (PART-O-17) and (2) health-
related quality of life, as measured by the Quality of Life after Brain Injury Scale (QoLIBRI), for 
individuals with moderate-to-severe TBI who are discharged from inpatient rehabilitation. 
Hypothesis 1: Patients randomized to RTP will report better participation and health-related 
quality of life at the end of intervention (6-months post-discharge; primary outcome) and one 
year post-discharge compared to patients randomized to RDP. 
Aim 2: To compare the trajectory of improvement across the first year post-discharge (with 
measurement at 3, 6, 9, and 12 months post-discharge) on patient-reported outcomes of (1) 
participation and (2) quality of life.  
Hypothesis 2: Patients randomized to RTP will experience a steeper trajectory of improvement 
in participation and quality of life over 12 months compared to patients randomized to RDP.  
Aim 3: To compare differences in healthcare utilization between RDP vs. RTP across the first 
year post-discharge. 
Hypothesis 3: Patients randomized to RTP will complete a higher proportion of planned 
outpatient visits and have fewer urgent care visits or unplanned hospitalizations across the first 
year post-discharge, compared to patients randomized to RDP. 
Aim 4: Caregiver outcomes: To compare the effectiveness of RDP vs. RTP on caregiver 
burden, health-related quality of life (HRQOL), satisfaction with roles and activities as measured 
by the Bakas Caregiving Outcomes Scale104, the Zarit Burden Interview129, SF-12130, the 
PROMIS Satisfaction with Social Roles and Activities131 and assessment of Required 
Assistance and Time Spent Caregiving. 
Hypothesis 4a: Caregivers of patients randomized to RTP will report lower caregiver burden at 
6-months post-discharge, compared to caregivers of patients randomized to RDP. 
Hypothesis 4b: Caregivers of patients randomized to RTP will report a steeper trajectory of 
improvement in caregiver burden over time, compared to caregivers of patients randomized to 
RDP.  

 
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Heterogeneity of Treatment Effects (HT-1, HT-2, HT-4, RQ-4) 
The interventions being compared in this study are highly patient-centered and will be tailored to 
each patient’s individual needs. The analytic plan will compare the two approaches 
(Rehabilitation Discharge Plan, RDP vs. Rehabilitation Transition Plan, RTP), as opposed to 
compare the specific elements which will vary across all participants based on their individual 
needs.  Consequently, we expect that some patient subgroups may be more or less likely to reap 
maximal benefit from the interventions under study. We will examine the effects of the 
intervention on patient subgroups defined by factors known or hypothesized in the literature to 
have associations with poorer TBI outcome and which are relevant to the implementation of the 
RTP in a clinical setting: discharge to facility (as opposed to community), being of minority race/ 
ethnicity, older age, male, with lack of or low degree of caregiver involvement, high level of 
severity of TBI, presence of pre-injury psychosocial limitations (e.g., unemployment, substance 
abuse) and having medical or psychiatric comorbidity.  In addition, we will explore whether there 
were differences according to study site, resource variability (e.g., community resources 
available) and insurance type.  
 
For the subgroup analysis, the models for the primary outcome variables (Part-O and QoLIBRI) 
will include the intervention group, all the covariates that define the subgroups, and interactions 
between each covariate and the intervention group.  Test of interactions will reveal if there are 
subgroups based on a certain covariate (or factor) that respond differently to the RDP or RTP 
intervention. It is possible that for some covariates, we will not have enough individuals to give 
information on the outcomes variation in a certain subgroup and that we will not be able to 
assess the effect for that covariate, while for other covariates, the sample size in each subgroup 
will be enough to provide information for the data analysis.  These numbers cannot be 
determined a priori.  For example, facility discharges are expected to occur in approximately 198 
participants (22%) of our sample which will allow adequate sample size for comparison, and 
males are expected to make up approximately 612 participants and can be compared to females. 
We may have difficulty comparing race/ethnicity on more specific subgroups such as Asians 
(expected to be approximately 2% of our participants) and Hawaiian/Pacific Islander (expected to 
be <1%), but will likely have an adequate sample size to compare Hispanic (11%) to non-
Hispanic and Black (17%), White (73%), and other (10%). In this situation, we may have to 
collapse the categories into a smaller number, such as White, non-Hispanic Black, Hispanic, and 
Other. Given multiple insurance options across the population as well as across the sites we may 
not have adequate power to detect differences between every provider, but will explore the effect 
of relevant subgroups such as private insurance vs. Medicaid vs. Medicare, for example.    
 
We will explore the effects of the intervention on patient subgroups defined by factors known or 
hypothesized to have associations with poorer TBI outcome: facility vs. community discharge, 
race/ ethnicity (White, non-Hispanic Black, Hispanic, Other), age (as continuous), male vs. 
female, lack of or lower degree of caregiver involvement (yes or no), severity of TBI (moderate 
vs. severe), presence of pre-injury psychosocial limitations (e.g., unemployment, substance 
abuse, categorized in yes or no) and medical or psychiatric comorbidity (yes or no), as well as 
study site, resource variability and insurance type (private insurance vs. Medicaid vs. Medicare). 
These factors will be entered in a single linear regression model in addition to the intervention 
group, using PART-O-17 as the response variable.  Interactions between each factor and the 
intervention group will be entered in the model and test of interaction will be the test of 
heterogeneity.  Before constructing the model, we will assess whether the explanatory variables 
(factors) are correlated to each other.  

 
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When two or more variables are deemed highly correlated, to avoid problems with collinearity, 
we will construct the model with the variable that provides the best model (from fit and 
diagnostic tests).   
From previous research,74-80 we hypothesize that severity of TBI and presence of pre-injury 
psychosocial limitations will interact with the intervention group.  With our expected sample size, 
we anticipate being able to address these questions.  Some of the factors might not have a 
statistically significant effect, but have the effect in the expected direction.  Effect sizes and 
confidence intervals will be calculated to express the potential effect of those factors.  The 
results of these analyses will be valuable in designing future studies.   
 
Study Timeline 
Pre-Enrollment Activities (Months 1-6) 
Startup activities will include hiring personnel, developing a formal study protocol, Institutional 
Review Board submission and approval, trial registration on Clinicaltrials.gov, and training of all 
study personnel on study procedures (see Milestones Schedule appendix). TCMs will be trained 
at a kick-off meeting to coincide with an investigator meeting during a regularly scheduled 
TBIMS Project Director’s meeting. Research staff will be trained via teleconference and via a 
study dedicated website to increase familiarity with the measures and procedures. Once training 
of TCMs and RAs is completed, participant recruitment will begin. 
 
Enrollment/Study Protocol Activities (Months 7-48) [RQ-2] 
The methods used to identify and recruit participants, collect data, and minimize attrition and 
missing data will be drawn from the SOPs and data dictionary developed by the TBIMS National 
Data and Statistical Center (NDSC) and successfully employed by the TBIMS (see 
https://www.tbindsc.org/SOP.aspx). The success of these procedures is demonstrated by the 
80% recruitment rate, 93% retention rate (and 94% retention rate at 1 year by our six sites), and 
<10% missing data rate of the TBIMS as a whole (while 10% is the missing data benchmark 
used by the TBIMS, actual missing data rates are considerably lower). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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STUDY METHOD 
 
Participants 
Patient Participants  
The target population is composed of inpatients on the rehabilitation unit and their caregivers (if 
available) who are aged 18 and older and have a diagnosis of moderate-to-severe TBI.  
 
The case definition for TBI will be that used by the TBI Model System (TBIMS): TBI is defined 
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 for moderate-to-severe TBI: (1) PTA>24 hours; (2) Trauma related intracranial 
neuroimaging abnormalities; (3) Loss of consciousness exceeding 30 minutes (unless due to 
sedation or intoxication); or (4) Glasgow Coma Scale in the emergency department of less than 
13 (unless due to intubation, sedation, or intoxication).  
 
Caregiver Participants 
Caregiver participants will be those individuals who will have primary care giving responsibility 
post rehabilitation care discharge of patients with moderate to severe TBI. Identifying the 
primary caregiver will be done in consultation and collaboration with rehabilitation care staff, the 
TBI patient and the TBI patient’s involved family and friends. All these sources will be involved 
in helping us to determine which individual will be most responsible for caregiving following 
discharge. 
 
Identification 
To identify participants, we will review medical records for individuals admitted to inpatient 
rehabilitation with a primary diagnosis of TBI as defined above. Research study staff will 
approach patients who meet basic eligibility criteria noted below.  
 
Inclusion Criteria-Patient Participants 
 (1) 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: 
(a) PTA>24 hours;  
(b) Trauma related intracranial neuroimaging abnormalities;  
(c) Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication); 
or  
(d) Glasgow Coma Scale in the emergency department of less than 13 (unless due to 
intubation, sedation, or intoxication). 
(2) 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.); 
(3) at least 18 years old;  
(4) 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);  
 

 
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(5) 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);  
(6) able to provide informed consent, or if unable to provide consent have family or legal 
guardian to provide informed consent for the patient. 
 
 
Exclusion Criteria-Patient Participants 
 (1) We will not enroll individuals who are in law enforcement custody at admission to the 
designated rehabilitation unit or who are taken into custody prior to discharge from the 
designated rehabilitation unit due to federal restrictions on inclusion of prisoners in research.  
(2) We will not enroll individuals who do not have access to a phone. 
(3) We will not enroll individuals who are unable to complete study procedures due to 
cognitive/verbal limitations AND do not have a proxy to assist with study procedures. 
 
Inclusion Criteria-Caregiver Participants 
 (1) individuals who will have primary care giving responsibility post rehabilitation care discharge 
of enrolled patient participants;  
(2) 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.); 
(3) at least 18 years old;  
(4) able to provide informed consent.  
 
Exclusion Criteria-Caregiver Participants 
 (1) We will not enroll individuals who are in law enforcement custody due to federal restrictions 
on inclusion of prisoners in research.  
(2) We will not enroll individuals who do not have access to a phone. 
 
 
Screening 
As noted above, the screening process involves an initial review of medical records by our 
research staff for patients with a diagnosis of TBI, or suspected TBI, (see inclusion/exclusion 
above for further detail) who are being admitted to the inpatient rehabilitation unit at the different 
study sites. Once a potential participant is confirmed initially eligible based on medical record 
review, a member of our research team will approach him/her using study talking points to make 
certain the subject has access to a telephone to participate in the study. The criterion regarding 
access to a telephone also may be confirmed via observation or via conversation with clinical 
staff and family members. In addition, certain eligibility criteria may be confirmed or 
corroborated further via conversation with clinical staff and family members (e.g. discharge 
destination).  
 
Each site will assign each potential participant identified an ID number unique to that particular 
site.  The patient participant will keep the same ID number if enrolled in the study. 
 
Our research staff members have established communication lines with the clinical staff to 
ensure patients are approached at appropriate times that do not interfere with clinical care. 
 
 
 

 
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Recruitment 
Patient Participants: Determining Orientation/ Emergence from PTA 
If a potential participant meets eligibility criteria based on medical record review, our 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: the Galveston Orientation and Amnesia Test (GOAT), the Revised GOAT, the full 
version of the  Orientation-Log (O-Log), or the non-verbal version of the O-Log(orientation 
scores are not entered as data, but used only to determine orientation.)81, 82 It is the choice of 
each site which version to use while assessing orientation/ emergence from PTA. Alternating 
use of the scales in an individual patient is not acceptable, however. 
 
Please note that administration of the orientation test(s) is also a procedure for consenting into 
the TBIMS. As typically enrollment for BRITE will occur immediately following enrollment for 
TBIMS, for purposes of subject burden, the orientation test will not be repeated prior to BRITE 
enrollment. 
 
Study researchers will follow the same procedures as TBIMS to assess for orientation/ 
emergence from PTA as outlined below:  
 
“With prospective tracking, emergence from PTA is defined as:  
1) two consecutive GOAT scores of 76 or greater with no more than 2 full calendar days 
between assessments (Assessment 1 = Friday, Assessment 2 = Monday, two full days = 
Saturday, Sunday) 
2) two consecutive scores of 11 or greater on the Revised GOAT with no more than 2 full 
calendar days between assessments (Assessment 1 = Friday, Assessment 2 = Monday, two full 
days = Saturday, Sunday) 
3) two consecutive scores of 25 or greater on the Orientation-Log with no more than 2 full 
calendar days between assessments (Assessment 1 = Friday, Assessment 2 = Monday, two full 
days = Saturday, Sunday) 
4) two consecutive scores of 8 or greater on the Non-Verbal version of the Orientation-Log with 
no more than 2 full calendar days between assessments (Assessment 1 = Friday, Assessment 
2 = Monday, two full days = Saturday, Sunday), or  
5) in the judgment of a qualified clinician (i.e., speech-language pathologist, physician, 
neuropsychologist), the person has cleared PTA but administration of an orientation test is not 
possible due to language functioning. 
 
 
The day of clearance of PTA is the first day the person gets the first of 2 consecutive scores of 
76 or greater on the GOAT, the first of 2 consecutive scores of 11 or greater on the Revised 
GOAT, the first of 2 consecutive scores of 25 or greater on the Orientation-Log, or the first of 2 
consecutive scores of 8 or greater on the Non-Verbal version of the Orientation-Log.” 
 
As per standard TBIMS procedure, 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. 
 

 
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Patient Unable to Provide Consent  
If the patient is not deemed oriented as per the outline above, the patient is unable at that time to 
provide informed consent. Research staff may administer the orientation test multiple times to 
determine capacity to consent.  
 
If patient is unable to provide consent either due to aphasia, non-emergence from PTA, and/or 
being non-verbal: 
1. Staff will determine if patient has a Legally Authorized Representative (LAR) who is 
willing and available to provide consent as a proxy for the patient; 
a. If Yes:  Staff may enroll the patient participant via proxy- go to #2 below; 
b. If No: Staff will deem the patient ineligible due to not being able to provide 
consent/no proxy- stop here. 
 
2. Staff will determine if patient has an individual who is willing and available to assist with 
both participation in the RTP (if randomized to that arm)* AND the follow-up 
questionnaires** for the foreseeable future.  Specifically, the individual would need to be 
present for all potential RTP contacts and questionnaires. This individual does not need 
to be the same person that provided proxy consent; 
a. If Yes:  Staff may enroll the patient participant via proxy-stop here; 
b. If No: Staff will consult with trained clinical staff to conclude whether it is more 
likely than not that the patient participant will be able to participate on his/her own 
within one month following discharge given nature and degree of severity of 
limitations; 
i. If Yes:  Staff may enroll the patient participant via proxy;*** 
ii. If No: Staff will deem the patient ineligible due to inability to complete 
study procedures due to cognitive/verbal limitations AND not having a 
proxy to assist with study procedures.  
*If the proxy individual is not enrolled as a caregiver participant in the study, the TCM would only 
engage the proxy individual in resource facilitation and the needs assessment as it specifically 
pertains to the patient participant.  The TCM will not conduct a caregiver needs assessment with 
the proxy or provide resources that pertain specifically to the proxy individual as they are not 
enrolled as a caregiver. If the TCM infers that the proxy individual would like to participate in the 
needs assessments/resource facilitation as it pertains to them (e.g., as the caregiver), the TCM 
would remind the proxy individual in a non-coercive manner of the opportunity to participate as a 
caregiver participant.  This would require the completion of the informed consent process with 
the proxy individual as per study protocol.   
 
**In this scenario, the proxy individual would not complete the QOLIBRI as part of the post-
discharge questionnaire. In addition, the individual would not complete the following items on 
the Form II: SWLS, GEN, GNHLTH, PHQ, GAD 
 
***Staff will withdraw the patient participant following randomization if the participant is deemed 
unable to participate due to limitations within the following timeframes: 
1. The TCM will withdraw the patient participant one month following discharge if 
randomized to RTP arm of the study; 
2.  Blinded staff will withdraw the patient participant three months following discharge if 
randomized to RDP arm of the study; 

 
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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 
(e.g. mother pre-discharge, significant other 3 months post-discharge).  Multiple caregiver 
participants may be enrolled at the same time to accommodate if the caregiver role is assumed 
by different individuals at different points in time during participation (e.g. mother is caregiver at 
3- and 9-months post-discharge, significant other is caregiver at 6- and 12-months post-
discharge). Research staff will assess who has primary caregiving responsibilities both at each 
questionnaire period and the RTP phase (if applicable), and engage accordingly the particular 
participant who most clearly fits the role of primary caregiver.  
 
Each site will assign a patient participant’s ID number to their respective caregivers.  The 
caregiver participant will keep the same ID number if enrolled in the study. Research staff will 
record which caregiver completes each questionnaire if more than one caregiver participant is 
enrolled at any given time. 
 
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. These data will be entered in 
de-identified form into the TBIMS National Data and Statistical Center at Craig Hospital. 
  
Screening procedures do not require a physical examination or laboratory procedures. 
 
Barriers to Recruitment 
We anticipate minimal barriers to recruitment beyond those which exist within our current 
recruitment and enrollment into the TBIMS at each site. Given the nature of the current grant, 
and strong interest and support from our Patient and Family Stakeholders and Professional 
Stakeholders, we expect that our current rate of 80% enrollment of eligible participants will 
continue. To maximize enrollment we will offer the proposed study concurrently with TBIMS 
enrollment for those eligible for TBIMS to reduce patient and staff burden. Existing barriers to 
enrollment include competition by other research studies which can result in participant burn-out 
in research and enrollment into studies which limit participation in intervention studies. 
Each site will work with known research studies to ensure minimal overlap or development of 
plans to ensure meeting enrollment numbers in all studies. Finally, we will work with our Patient 
and Family Stakeholders to gather ideas on any modifications needed should we have 
lower than expected enrollment. 
Data Quality Targets - Enrollment 
Target enrollment rate is set at 73%, and will be reviewed on a quarterly basis beginning 
December 2020. The lead site will review the rate for cases entered into the website screening 
form within the previous six months (e.g. 6/1/20-11/30/20 for the December 2020 check). Sites 
not reaching their target will be required to develop a written remediation plan for increasing 
enrollment numbers. This plan should be submitted to the lead site. The effectiveness of this 
plan will be reviewed at subsequent quarterly checks. 
 
 

 
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 Table 1. Recruitment/Enrollment Assessment Timeline 
 
Begin Recruitment 
2/1/18 
Recruit 25% of total study participants  
11/30/18 
Complete 25% of 3-month follow-
2/28/19 
Complete 25% of 6-month follow-
5/31/19 
Complete 25% of 9-month follow-
8/31/19 
Recruit 50% of total study participants 
9/30/19 
Complete 50% of 3-month follow-
11/30/19 
Complete 50% of 6-month follow-
2/28/20 
Complete 50% of 9-month follow-
5/31/20 
Recruit 75% of study participants 
7/31/20 
Complete 50% of 12-month follow-
9/30/20 
Complete recruitment 
10/31/21 
Complete 100% of 3-month follow-
1/31/22 
Complete 100% of 6-month follow-
4/30/22 
Complete 100% of 9-month follow-
7/31/22 
Complete 100% of 12-month follow-
10/31/22 
Primary Completion Date 
10/31/22 
 
 
Targeted total participant 
enrollment N 
 
900 
Targeted total caregiver 
enrollment N 
 
540 
Number of sites 
 
6 
Site Names 
- University of Washington 
- Indiana University School of 
Medicine/Rehabilitation Hospital of Indiana 
- Einstein Healthcare Network / Moss Rehab 
Hospital 
- Baylor Institute for Rehabilitation 
- Ohio State University Wexner Medical Center 
- Mount Sinai Health System (NY) 
 
Estimated patient volume 
In 2015, 764 individuals with TBI were 
discharged from inpatient rehabilitation across 
the six study sites.  In 3 years of recruitment in 
our study, a conservative estimate for screening 
would be approximately 2200 individuals 
 
 
 
 
2200 
 
Estimated number of eligible 
patients 
 
Of those discharges in 2015, 430 (56%) would 
meet the eligibility criteria for the TBIMS as 
described in the Research Plan 
inclusion/exclusion criteria.  We would expect 
 
1230 

 
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that approximately 1230 (about 56%) would be 
eligible for our study. 
Estimated number of eligible 
caregivers 
 
600 
Estimated yield/consent of 
patients 
Enrollment rate for the six sites was 81% from 
October 2015 through October 2016.  In 2015, 
345 individuals who had a TBI and were eligible 
enrolled into the TBIMS across the 6 study sites. 
Over 3 years of enrollment, we conservatively 
estimate that at least 900 (73% of the eligible) 
participants will consent to enroll into our study.  
900 
Estimated yield/consent of 
caregivers 
 
540 
Estimated lost to follow 
up/attrition of patients 
Historically, the procedures for participant 
recruitment and retention used in TBIMS sites 
has a 90% retention benchmark, and <10% 
missing data. Given this is a more complex trial 
requiring increased engagement over time, we 
anticipate having a more difficult time with 
retaining participants and therefore are planning 
for an 80% retention mark.   
180 
Estimated lost to follow 
up/attrition of caregivers 
 
110 
Estimated monthly enrollment of 
patients 
 
23-24 
Estimated monthly enrollment of 
caregivers 
 
13-14 
 
 
Our 80% estimate is based on both our benchmark expectation for enrollment into the TBIMS 
as well as recruitment rates from the prior intervention studies completed by our team detailed 
below that have enrolled from the TBIMS population.  
Given the broad inclusion criteria and flexibility and provision of treatment that is standard care 
or higher in both intervention groups, we anticipate meeting our planned recruitment rate. 
 
(1) The six TBIMS centers in this grant have an average enrollment of 81.35% for TBIMS.  
(2) Bell et al.56 had a 95% enrollment rate into a single-site study with similar study population 
and methodology.   
(3) In a multi-site study83 among 3 TBIMS sites with similar study population and methodology, 
we had a 90% enrollment rate among those who were eligible.  
 
Tracking Potential Participant Flow 
All data pertaining to the recruitment outcome and screening information for each patient will be 
entered by all study sites in de-identified form into the NDSC centralized database via the 
‘Screen’ tab. 
 
Sampling Enrollment 
Study researchers have devised the following systematic approach to manage enrollment for 
sites that enroll more patient and caregiver participants than they are able to handle relative to 
TCM availability: 

 
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1. Determine a projected annual enrollment threshold of combined patient and caregiver 
participants that, if surpassed, would cause the sampling enrollment approach to be 
considered (based on likely maximum caseload for the TCM and staff):  Study 
Researchers concluded that the projected annual enrollment threshold of combined 
patient and caregiver participants should be 90 participants per year (54 patient 
participants and 36 caregiver participants); 
 
2. Review recruitment/enrollment data for all sites on a quarterly basis to determine if a site 
has surpassed the projected threshold by using the following formula: 
 
1) Subtract the number of pending eligible patients and those randomly selected not to 
be approached (if a sampling enrollment approach has already been initiated) from 
the total number of eligible patients over the past six months to get a true number of 
potential eligible patients  that could have been enrolled over the past six months; 
2) Divide actual patient participant enrollment by #1 above to get the rate of enrollment 
of the potential eligible patients over the past six monthsfor that particular site; 
3) Divide number of enrolled caregiver participants by number of enrolled patient 
participants over the past six monthsto get rate of enrollment of caregiver 
participants for enrolled patient participants at the site; 
4) Divide total eligible patients approached by number of days over the past six months 
to get daily rate of eligible patients identified; 
5) Multiply #4 above by 30 days to get projected monthly number of eligible patients 
identified; 
6) Multiply monthly rate of patients approached (#5) by rate of enrollment of the 
potential eligible patients described above (#2) to get projected monthly enrollment of 
patient participants; 
7) Multiply projected monthly enrollment of patient participants by enrollment rate of 
caregiver participants to get projected monthly enrollment of caregiver participants; 
8) Add #s 6 and 7 above to get overall projected monthly enrollment rate of participants 
(patient and caregiver combined); 
9) Calculate the overall monthly enrollment goal- we are hoping for 4.5 patient 
participants and 67% of patient participants to have a caregiver participant enrolled, 
which is 3 for a total of 7.5 participants enrolled per month; 
10) Divide 7.5 by #8.   
 
3. The result of this formula is the random sampling enrollment rate, i.e. the percentage of 
eligible patients that should be approached to meet the annual projected threshold. Any 
percentage above 100% indicates the center is under enrolling- no sampling enrollment 
is needed to be implemented as a result. Any percentage below 100% indicates the site 
should approach at maximum the percentage of eligible patients listed to equal the 
annual projected threshold. Example: if  the result for #10 above for a particular site is 
80%, than that particular site should approach at random 80% of all eligible patients to 
meet the annual projected threshold; 
  
 
4. The lead site will approach any sites that are deemed to be overenrolling based on the 
formula above to see if they want to implement the sampling enrollment approach;  
 

 
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5.  If a site elects to implement the sampling enrollment approach, the site will utilize local 
TCM backup when necessary for those weeks when unable to adequately cover 
caseload; 
 
6. Once sampling is in place, the approach for each site will be reviewed each quarter by 
the lead site to determine whether to return to full enrollment, continue with sampling 
enrollment but with a different rate, or continue with sampling enrollment at the same 
rate based on the previous six months recruit/enrollment data. 
 
Please note: Sites may decline to implement the sampling enrollment approach described 
above even if they are above the enrollment threshold but believe they can accommodate 
current enrollment numbers.  Likewise, sites may request implementation of the sampling 
enrollment approach even if they don’t meet the enrollment threshold but believe they cannot 
accommodate current enrollment numbers.  It is left to the discretion of the lead site to 
approve/deny requests regarding sampling enrollment implementation. 
 
Please see the section below for instructions on how to implement the sampling enrollment 
approach on the NDSC website. 
 
 
Consent (PC-1)  
Research staff will participate in and obtain informed consent from research participants after 
screening but prior to commencement of any further study procedures. For most patient 
participants, the informed consent process will take place during the participants’ inpatient 
rehabilitation stay with our research staff, and for some patient participants it will occur directly 
after discharge when approaching in person or by phone durin their inpatient stay is not 
possible.  
 
Determining Patient Participant Capacity for Consent 
Due to the cognitive impairments common after TBI, TBIMS staff have a SOP in place for 
determining patient capacity to consent or to obtain proxy medical consent.  Please see 
description of procedures regarding assessment for orientation/ emergence from PTA in the 
section ‘Patient Participants: Determining Orientation/ Emergence from PTA’ above. 
 
Patient Participant Capable of Consent while Inpatient (In-Person approach) 
If the patient is deemed able to provide consent, a research staff member will review each 
section of the informed consent form (ICF) approved by the site IRB. Staff members are trained 
to ensure competency to discuss informed consent and strategies to ensure there is no 
coercion.  
 
Participants will be provided with as much time as needed to review the ICF and ask the 
research staff member questions about the ICF, their rights as participants, and participation in 
the study. 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.  
If during the course of this contact the potential participant has questions that cannot be 
addressed by research staff, one of the study investigators or the research manager (depending 
on the nature of the questions) will follow up with the potential participant to answer the 
questions. Participants may take time to think about participating and render a decision in a 

 
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subsequent visit. Potential participants will be asked to repeat back understanding of this 
material as necessary.  
The participant will then be asked to sign and date the ICF. Research staff will also date and 
sign the ICF. All participants will be offered a copy of the signed ICF for their records. 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. 
 
The patient participant may be given a response key to assist with completing the 
questionnaires described in the “Follow Up Data Collection” section below.  The response key 
may be given in person following consent, or mailed at a separate time with a cover letter.  
 
The patient participant may also be given a log to assist with keeping track of use of medical 
services during study participation.  Medical services utilization will be assessed as part of the 
Cornell Services Index described in the “Follow Up Data Collection” section below.  The log may 
be given in person following consent, or mailed at a separate time with a cover letter.  
 
Patient Participant Incapable of Consent while Inpatient (In-person Approach) 
If the patient is deemed unable to provide consent, consent of a legally authorized 
representative (LAR) will be sought and a family member or caregiver will be asked to provide 
consent on the patient’s behalf. The caregiver/family member giving assent will be provided with 
as much time as needed to review the form and ask the research staff member questions about 
the form, the patient’s rights as a participant, and participation in the study. The respective party 
will be fully informed of all risks and benefits prior to giving his/her written informed assent and 
prior to enrollment in the study.  
 
The individual will then be asked to sign and date the form. Research staff will also date and 
sign the form. All individuals will be offered a copy of the signed form for their records.  
 
Research staff will also review a HIPAA authorization form with the individual that permits 
research staff to collect data from the patient’s medical records regarding injury and medical 
history. 
 
Patient Participant Capable of Consent while Inpatient or Directly After (Telephone Approach) 
If the patient is deemed able to provide consent, a research staff member will review each 
section of the Patient Information Sheet approved by the site IRB. Staff members are trained to 
ensure competency to discuss informed consent and strategies to ensure there is no coercion.  
 
Participants will be provided with as much time as needed to review the information sheet and 
ask the research staff member questions about the sheet, their rights as participants, and 
participation in the study. 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.  
If during the course of this contact the potential participant has questions that cannot be 
addressed by research staff, one of the study investigators or the research manager (depending 
on the nature of the questions) will follow up with the potential participant to answer the 
questions. Participants may take time to think about participating and render a decision in a 
subsequent telephone call. Potential participants will be asked to repeat back understanding of 
this material as necessary.  
 
The participant will then be asked to give verbal consent to participate. Research staff will 
document receipt of verbal consent per site protocol, as well as update the BRITE website 
Screening form to indicate consent and enrollment. 

 
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The patient participant may be mailed or emailed a response key along with a cover letter to 
assist with completing the questionnaires described in the “Follow Up Data Collection” section 
below. 
 
The patient participant may also be mailed or emailed a log along with a cover letter to assist 
with keeping track of use of medical services during study participation.  Medical services 
utilization will be assessed as part of the Cornell Services Index described in the “Follow Up 
Data Collection” section below. 
 
Patient Participant Incapable of Consent while Inpatient or Directly After (Telephone Approach) 
If the patient is deemed unable to provide consent, consent of a legally authorized 
representative (LAR) will be sought and a family member or caregiver will be asked to provide 
verbal consent on the patient’s behalf. The caregiver/family member giving assent will be 
provided with as much time as needed to review the Patient Information Sheet and ask the 
research staff member questions about the form, the patient’s rights as a participant, and 
participation in the study. The respective party will be fully informed of all risks and benefits prior 
to giving his/her written informed assent and prior to enrollment in the study.  
The individual will then be asked to give verbal consent to participate. Research staff will 
document receipt of verbal consent per site protocol, as well as update the BRITE website 
Screening form to indicate consent and enrollment.  
 
Patient Participant Capable of Consent Following Discharge 
Research staff will re-assess all patients who enrolled into the study via LAR to determine 
capacity to consent as described in the section ’Patient Participants: Determining Orientation/ 
Emergence from PTA’ above, albeit conducted by telephone. A research staff member will 
arrange a time to conduct the informed consent process via telephone.  
The research staff member will then send a self-addressed, stamped envelope along with two 
copies of the consent form, the HIPAA authorization form and a cover letter.  
 
The cover letter will specify that, although subjects may review the consent form in advance, 
they should not sign or complete the forms until they have reviewed the forms with research 
staff at the scheduled informed consent session via telephone.  At the scheduled phone contact, 
a research staff member will follow the informed consent procedures as described above. 
 
The patient participant will be instructed to sign one copy each of the consent form and HIPAA 
authorization form. The subject will then be asked to return all the signed, completed forms to 
the study staff via a self-addressed, stamped envelope previously mailed with the forms. The 
informed consent acquired directly from the participant will render the LAR consent obsolete. 
 
Research staff will send a copy of the signed consent form to the patient participant with a cover 
letter. 
 
Caregiver Participants 
Caregiver participants may be initially recruited by telephone or in person. If the caregiver is not 
local and/or able to come in readily, or approach in person is not feasible, we request 
permission to waive written consent and instead obtain oral consent via use of an oral 
information statement sheet. Research staff may send an information statement sheet along 
with a cover letter if the caregiver will be enrolled following the discharge of the patient 
participant. Research staff would review the information statement sheet with the potential 
participant, then request verbal consent if the individual is interested in participating. Otherwise 

 
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the informed consent process may take place in person and will take place during the 
participant’s inpatient rehabilitation stay with our research staff. 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. 
 
The caregiver participant may be given a response key to assist with completing the 
questionnaires described in the “Follow Up Data Collection” section below.  The response key 
may be given in person following consent, or mailed at a separate time with a cover letter. 
 
Baseline Assessment (RQ-2, IR-1)  
 
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). The purpose of this is to maximize the likelihood of reaching a participant to 
complete the study procedures. Furthermore, asking permission to leave a voicemail at a 
specified contact number ensures a greater level of privacy for the participant.  
 
The information may be completed following enrollment either in person or over the telephone at 
a later time if more convenient for the participant. This information will be retained in a local, 
password-protected database on a secure server. 
 
Baseline Information: Patient Participants 
For those subjects who are also enrolled into the TBIMS, there will be no additional baseline 
measures to complete via self-report for this study.   
 
Non-TBIMS: Form I (aka ‘Baseline’) 
For those not enrolled into TBIMS, a Form I will be collected. The Form I collects demographic 
and injury related data from the electronic medical record (‘Medical Record Abstraction’). 
Additional demographic and clinical history will be collected in interview format (‘Pre-Injury 
History Interview’). The Form I also includes some cognitive tests focused on memory, 
concentration, and problem solving (‘Brief Test of Adult Cognition by Telephone  or BTACT’). 
The interview and cognitive testing will take about 25-35 minutes to complete.  
These data will be entered with the participant’s ID, i.e. not name into the NDSC centralized 
database by research staff. 
 
Discharge Information: Patient Participants 
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 as well as documenting received/recommended equipment using the BRITE 
Study Discharge Information data collection form. These data will be entered into the NDSC 
centralized database by research staff. Specific information regarding the 

 
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recommended/scheduled appointments (e.g. name, phone number, email address, date of 
scheduled appointment, etc.) of patient participants randomized to the RTP intervention arm will 
be stored locally in a database used by the TBI care managers for referential purposes.   
 
 
Research staff will also enter discharge destination and date as well as injury date into the 
NDSC database using the BRITE Study Discharge Destination and Date data collection form 
 
Baseline Information: Caregiver Participants 
If there is a caregiver enrolled, we may collect their baseline data in person, by phone or via 
postal mail (see ‘Mailout Option’ section below for more detail).   
 
Baseline data collection will take approximately 5-10 minutes to complete. Specifically, we will 
collect information regarding the nature of the caregiver’s relationship to the patient participant, 
as well as basic demographic information. We will ask that the patient participant not be present 
during their assessment so as to eliminate potential response bias.  
These data will be entered with the participant’s ID, i.e. not name into the NDSC centralized 
database by research staff. 
 
All data described above unless specified will be entered into the NDSC centralized database 
via the ‘Data’ tab.   
 
Randomization/ Post-Discharge Transition Phase 
After the patient participant has been discharged or after they are consented post-discharge, 
s/he will be randomly assigned 1:1 into one of two study arms: RDP or RTP.  We will stratify 
randomization on study site and discharge destination (another facility vs. home/ community): 
 
Home/ Community  
• 
private residence (includes house, apartment, mobile home, foster home, condominium, 
dormitory, military barracks, boarding school, boarding home, rooming house, bunk-
house, boys ranch, fraternity/sorority house, commune, migrant farmworkers camp) 
• 
adult home (includes adult foster care, independent living center, transitional living 
facility, assisted living, supported living, group home) 
• 
hotel (includes YWCA, YMCA, guest ranch, inn) 
• 
homeless (includes a shelter for the homeless) 
 
Facility  
• 
nursing home (includes med-center, residential, institutions licensed as hospitals but 
providing essentially long-term, custodial, chronic disease care, etc.) 
• 
subacute care (includes subacute hospital bed, skilled nursing facility) 
 
 
The actual act of randomization will be automated via the NDSC BRITE website. Specifically, 
research staff will click the ‘Randomize’ button located in the ‘Keys’ tab  of the ‘Patient Post-
Discharge Information’ section under the ‘Data’ tab once the discharge destination has been 
entered.  The randomization assignment will be automatically recorded in the BRITE website 
database.  
 
These randomization procedures have been used by our team in prior studies where telephone 
follow-up was randomly assigned following discharge.56, 83 

 
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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).  
 
 
For those who are randomized to the RDP arm, the letter will state that they will be contacted for 
follow-up at 3, 6, 9 and 12 months post hospital discharge and one year following injury (if 
applicable).  
 
For those who are randomized to the RTP arm, in addition to a reminder of the follow-up data 
points as above, the letter will include a reminder of the specific goals of the study and the plan 
for follow-up calls with the TCM.  
 
The meeting schedule will be modified throughout the intervention time period to fit the needs of 
both the patient and caregiver participants and may include evening or weekend appointments. 
 
The TCM will also send patient and caregiver participants assigned to the RTP group a brief 
description of the general role of the TCM as well as a description of the specific TCMs at each 
site including education and work experience. This form may be mailed with the randomization 
letter, or part of a subsequent mailing.  
 
 
Interventions and Comparators (RQ-5, PC-1) 
 (A) Rehabilitation Discharge Plan (RDP) 
All participants will receive RDP, which will be documented in the medical record.  
RDP will consist of the standard elements of discharge care that are already in place at 
participating centers; these include:  
(1) patient and family education about TBI, both general and individualized to each person’s 
symptoms and level of function, along with hands-on training for caregivers as needed as well 
as education on medications and symptoms to monitor following discharge;  
(2) written discharge care instructions, which will include the follow-up plan, including 
recommended appointments with primary care, physiatry (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 or staff member within a few days of 
discharge to address any immediate problems and ensure that equipment has arrived, 
medications are being taken, etc.  
Results of our preliminary work indicate these elements are already in place in each center, but 
specific content (e.g., educational materials, checklists, and templates) will be individualized for 
each patient and their family members.  
 
 
 (B) Rehabilitation Transition Plan (RTP) 
This approach is based on the model successfully employed by the VHA.  
 
Scheduling of Contacts 
Participants randomized to the RTP comparator at the point of hospital discharge will receive 
about 12 scheduled contacts over the next 6 months from a TCM. The TCM will be a contract 
employee hired specifically for this study. The TCM will be responsible for managing both the 

 
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logistics and content of the treatment with the support of a team of experienced TBI clinicians. 
Training of the TCM will be a key aspect of this study. The TCM will be either an MSW or have 
comparable experience in health care and/or social services but will not necessarily be experts 
in the field of TBI.  The contacts will at minimum be by telephone; although many of our patient 
and family partners were also enthusiastic about the idea of using a HIPAA-compliant screen-to-
screen feature (e.g., Zoom®) based on individual preference. Contacts may be in person if 
convenient for both participant(s) and TCM, e.g. the patient has a medical appointment near the 
TCM’s office. A typical schedule of contacts that was vetted through our Patient and Family 
Stakeholders will be as follows: weekly, starting 1 week after discharge, for 4 weeks; biweekly 
for 2-3 months, depending on individual progress and needs; then monthly for 2-3 months.  
 
The duration of each contact will depend on the needs of the patient/caregiver. For example, if 
the patient is not reporting unmet needs on the needs assessment, the contact may be very 
brief. However, it was the emphatic recommendation of the Patient and Family Stakeholders 
that all 12 scheduled contacts take place. As one stakeholder put it, ‘If you’re under water, you 
don’t know if it’s raining!’ 
Additional Interim contacts may also take place during RTP, e.g., for TCM follow-ups or urgent 
questions, respectively, depending on the needs of the patient/caregiver (see below for more 
details). 
 
Content of Scheduled Contacts 
The content of these contacts may include:  
 
(1) 
Review of Discharge Plan: 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: Assessment of unmet needs, which has been standardized 
into a checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment 
in this population, will take place at each scheduled contact.44, 84 As one stakeholder with TBI 
stated: “One thing I'm concerned about is if the care manager just asks basic questions to 
people such as "are things going well?" You will actually miss out on a lot of important detail 
about people's lives problems and the issue they are having.” (Patient Stakeholder) This 
checklist assesses specific needs for help with practical issues such as medication 
management and coordinating rehabilitation services; managing problematic symptoms such as 
pain, or addressing substance use; emotional issues such as managing daily stress and 

 
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controlling temper; psychosocial issues such as re-engaging with friends and leisure activities; 
caregiver issues such as role changes and caregiver stress; and participation-related issues 
such as finding employment. 
 
For each area of unmet need, the TCM will provide practical assistance and will connect the 
patient/ family with appropriate resources in the healthcare network, the resources available 
through the state Brain Injury Association/ Alliance, and/ or resources in the wider community. 
When appointments need to be made with service providers, the TCM will assist with 
scheduling those appointments, ensure transportation is available, and provide a reminder 
phone call to the participant to encourage them to attend the appointment.  
The TCM may share with medical providers/community resources information learned during 
the RTP phase that would maximize addressing any needs, including but not limited to contact 
information, details regarding the patient’s TBI, and any other pertinent information. The TCM 
will get the participants’ permission first before contacting these providers, and make it clear to 
the participants in advance what information will be shared during the contact.   
A system for organizing the patient’s schedule will be developed based on patient and family 
preference (e.g., phone or computer organizing apps vs. hard copy calendars, etc.). 
 
The TCM may also send to both patient and caregiver participants a basic version of the needs 
assessment (e.g. daily living, physical status, mood &behavior, etc.) that will be assessed during 
scheduled contacts.  
 
Recipient of Contacts 
In terms of the recipients of contact, we will follow the emphatic recommendation of our patient 
and family partners, that each person responsible for the patient’s care (i.e., not only the patient 
but a family member or caregiver) be contacted separately, at least at first, to allow for the 
possibility of differing viewpoints (or lack of awareness of problems on the part of the person 
with TBI). We will also follow their recommendation that for persons discharged to a nursing 
facility, the phone contacts should include not only a family member but also a member of the 
facility staff if family provides permission and the facility is willing to allow contact (e.g., nurse 
manager or patient/ resident advocate).   
 
  
Other Components of RTP 
We will include several other components of the RTP condition to help establish continuity of 
care and to provide a “safety net” for patients experiencing problems between calls.  
• 
A Follow-up letter will be sent by post or electronically (email, text) immediately after each 
scheduled contact summarizing the discussion points and mutually agreed-upon plans.  
• 
A final letter will be sent to the patient and/or caregiver participant following the end of the 
RTP phase that provides a summary of the follow up plan, a list of resources provided 
during the contacts, and any reminders/suggestions/strategies moving forward. 
• 
In addition, with the participants’ permission, a letter may be sent to a primary care provider 
or other relevant provider after completion of the RTP phase to assist with coordination of 
care, provide updates, and explain participant has concluded study participation. 
• 
Based on feedback from our stakeholders, we will provide a telephone number staffed by 
the TCM during business hours to all patients/ families in the RTP group as well as others 
involved in their care so that they may contact the TCM between regularly scheduled calls. 
“A week for the introductory call is fine as long as we send them home with a telephone 
number to call in case something comes up sooner. A week can feel like a year when you 
need help.” (Family Stakeholder).  

 
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• 
The TCM will also be available during business hours via e-mail or text message.  Reminder 
email or text messages may be sent by the TCM to patient or caregiver participants to 
remind of appointments or follow-up plans as requested  
 
The TCMs will attempt to reach participants to complete the RTP scheduled contacts until: 1) a 
planned number of contacts have been completed, 2) the participant declines or is deemed 
unable to complete the RTP contacts (withdrawal, death, etc.), or 3) the RTP window expires six 
months following discharge. The TCMs will strategize with their supervisors ways to manage 
participants that are difficult to reach on a case-by-case basis. In addition, TCMs may send a 
letter to both patient and caregiver participants indicating that they have been unable reach 
them and request the participant contact research staff to arrange for upcoming contacts. 
 
Documentation of RTP completion regardless of completion status (i.e. withdrawal, 
discontinuation, completion per protocol, etc.) should be entered in the NDSC database by the 
TCM using the Rehabilitation Plan completion form. These data will be entered into the NDSC 
database by the TCM within one week of rehabilitation plan completion.   
 
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. These data will be uploaded in de-identified form to the BRITE website on a semi-
regular basis. 
 
Training and Quality Assurance 
Our study’s subject matter experts across all sites will assist in educating the TCMs regarding 
the effects of TBI on symptoms, cognition, and behavior, and will train them in how to help the 
participant address common TBI-related problems. In addition, TCMs will be trained in the 
practice of telephone administration, monitoring response to treatment, and dealing with medical 
emergencies. Initial training will take place in the kick-off meeting and include didactic 
instruction and role-play.  
 
Regular individual and group supervision will be provided by study investigators from multiple 
sites to give support and guidance to TCMs as they work with a variety of patients and 
caregivers (resource facilitation and intervention supervision), ensure study protocols are 
followed at each site (study protocol supervision), and to ensure fidelity to the intervention 
(fidelity supervision, described below). 
 
Update: As of February 2019,given that TCMs from 5 of the 6 sites have been fully trained and 
monitored for fidelity to current standards, group supervision consists of a monthly meeting with 
study investigators, and a separate monthly meeting with only the TCMs and Dr. Moore from the 
UW. TCMs may also meet as needed among themselves to discuss cases. Although all sites 
may differ, the recommendation is that an additional supervision meeting between the TCM and 
each site’s investigators will take place on at least a monthly basis and as needed to discuss 
caseloads. Rationale: decreasing overall study supervision reflects a more pragmatic and 
sustainable approach that would be taken in a normal clinical setting. 
 

 
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Resource Facilitation and Intervention 
Topics will be decided before each group supervision meeting via discussion with TCMs and 
supervisors about common questions and issues arising related to the intervention delivery. 
Possible topics may include understanding the flow of the phone calls, TBI sequelae and 
recovery in the context of patient presentation(s) that are confusing or challenging for the TCM 
(disinhibition, anger, etc.) complex caregiver/family dynamics that are interfering with TCM role, 
boundaries and the relationship to intervention goals. Supervision may include didactic 
trainings, videos, review of audio recorded contacts with patients and caregivers, role plays, 
modeling, among other strategies to enhance competence and confidence in intervention. 
 
Study staff with the help of collaborating state Brain Injury Associations/Alliances will research 
and organize regional health care referral information for each participating state. Both this initial 
training and ongoing TCM supervision will be continued via telephone and video conferences.  
 
Study Protocol Supervision 
The TCM will be responsible for managing both the logistics and content of the treatment with 
the support of a team of experienced TBI clinicians. A training manual outlining the key 
components of care management has been created and will include the following key 
components:  
1. TCM Training Activities 
2. Development of Resources 
3. Overview of Post-Discharge Activities 
4. Overview of TCM Contacts for Patients Randomized to RTP 
5. Details of RTP Protocol 
6. Participant Engagement 
7. Risk Management (mental health, physical) 
8. TCM Supervision  
Fidelity to Intervention 
All RTP scheduled contacts will be digitally recorded and stored on a secure server. A random 
selection of  these recorded contacts for each TCM will be reviewed and scored by study 
investigators,TCMs, and unblinded study personnel from multiple sites using standardized study 
fidelity measures.  We expect that the needs to be addressed in the calls will be specific to each 
participant. Therefore, we are not attempting to assess fidelity to the provision of specific 
materials or resources, but to the process of the intervention as described above, including 
follow through on discharge instructions, standardized assessment of needs at each call; 
appropriate referral to locally available resources; and appropriate follow up of issues discussed 
on prior calls. 
 
Fidelity Supervision 
The first four recorded contacts for each TCM will be reviewed by study investigators to assess 
for fidelity to the RTP protocol. Following review of the initial four recorded contacts, the study 
fidelity team consisting of study investigators, TCMs, and unblinded personnel across all sites 
will review on average two scheduled contacts per month for each TCM, or a total of 24 
contacts per year.  Of the 24 recorded contacts that will be reviewed, approximately a third (8 
contacts) will be with a caregiver. In addition, about 16 of the contacts that will be reviewed will 
be first  and final contacts(4 each), with the 8 remaining sessions reviewed consisting of 
contacts 2-11. 
 

 
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The outcomes of these fidelity ratings and areas of strength and improvement will be conveyed 
to each TCM by study investigators responsible for study supervision (i.e. not other TCMs or 
non-investigators) on a monthly basis on average. The ratings and any appropriate feedback 
will be provided to the TCM via email if the fidelity percentage is >90%, or via telephone if 
<90%. Supervision may include role plays, modeling or other strategies to improve fidelity to 
model.  
 
Update: As of February 2019, study investigators will continue to rate fidelity for each TCM, but 
will no longer provide regular feedback to each TCM based on fidelity ratings.  Rationale: 
decreasing overall study supervision reflects a more pragmatic and sustainable approach that 
would be taken in a normal clinical setting. 
We will select one recorded contact to review each month for the backup TCMs if a TCM  
completes at least one scheduled contact for the month under review. We will not attempt to 
control which type of contact will be reviewed (e.g. caregiver versus patient, first contact vs. final 
contact, etc.).  
 
In addition, we will review the first two recorded contacts if the backup TCM has not conducted 
a scheduled contact in three months or more (example: backup TCM completes a scheduled 
contact March 30, then does not complete another scheduled contact until July 20.  The fidelity 
reviewers will review the first two contacts starting with the one conducted July 20).   
 
Language describing the audio recording procedure can be found in the study consent forms. 
Subjects can refuse to have any or all contacts recorded and still remain in the study.  
 
Follow Up Data Collection 
 
3, 6, 9 and 12 Months Post Hospital Discharge Questionnaires: Patient Participant  
The 3, 6, 9 and 12 months post hospital discharge questionnaire will take approximately 25-30 
minutes to complete, and will be completed by phone, in person, or via postal mail (see ‘Mailout 
Option’ section below for more detail).   
 
The post-discharge questionnaire will consist of the following measures:  
1. Participation Assessment with Recombined Tools-Objective 17 (PART-O) - 
measure of community participation. 
2. Quality of Life after Brain Injury Scale (QoLIBRI) - The QoLIBRI is a patient-reported 
instrument specifically created to measure the patient’s perception of their health-related 
quality of life following TBI. 
3. Cornell Services Index- The Cornell Service Index is a widely used measure of 
healthcare services utilization, and will include number of hospitalizations and days 
hospitalized, number of emergency department visits, as well as number and type of 
clinic visits. We will be providing each participant at baseline a tool that will help 
participant’s collect this information. 
4. Street Address:  We will collect street address for data analysis purposes during each 
of the discharge questionnaires. We would then send each participant's address to the 
national database at the National Data and Statistical Center.  
The National Data and Statistical Center uses the address to get information about the 
socioeconomic status of each participant based on the communities they reside, 
contracting with a service that helps with obtaining data from neighborhood databases. 
Both the National Data and Statistical Center and the contractor are required by law to 
keep the information confidential.  

 
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5. Insurance Type/Coverage:  We will collect insurance type/coverage for data analysis 
purposes during the 6- and 12-month discharge questionnaires.  
6. Satisfaction with Care:  We will collect information about how satisfied participants 
were with their healthcare during the 6- and 12-month discharge questionnaires. 
 
One Year Following Injury Questionnaire: Patient Participant 
Patient participants not enrolled into TBIMS concurrently will complete a questionnaire about 
one year following injury (“Form II”). The questionnaire collects demographic and injury related 
data and clinical history will be collected in interview format. The questionnaire will take about 
45-60 minutes to complete.  
 
 
Research staff will attempt to administer the one year following injury questionnaire in tandem 
with one of the BRITE post-discharge questionnaires depending on the timing of the discharge 
relative to injury. Specifically, research staff will attempt to collect the Form II during a specific 
BRITE questionnaire period (e.g. 9 month questionnaire period) when the ideal date of that 
BRITE questionnaire period and the open date of the Form II are closest relative to the other 
BRITE questionnaire periods. Research staff would start attempting to collect data for both 
Form II and that BRITE questionnaire at either the open date of the BRITE window or the open 
date for Form II window, whichever comes last. The questionnaire may be done at a separate 
time, however, if necessary. 
 
Research staff will not complete a Form II with non-TBIMS patient participants if the patient is 
enrolled outside the Form II window described below, specifically more than two months after 
the ideal administration date (12 months following injury).  
 
Please follow Standard Operating Procedures 105B from the TBIMS for  the One Year 
Following Injury Questionnaire (“Form II”) completed by non-TBIMS patient participants: 
 
https://www.tbindsc.org/StaticFiles/SOP/105b%20-
%20Guidelines%20for%20Collection%20of%20Follow-up%20Data.pdf 
 
 
3, 6, 9 and 12 Months Post Hospital Discharge Questionnaire: Caregiver  
The 3, 6, 9 and 12 months post hospital discharge questionnaire will take approximately 15-30 
minutes to complete, and will be completed by phone, in person, or via postal mail (see ‘Mailout 
Option’ section below for more detail).   
 
The post-discharge questionnaire will consist of the following measures: 
1. Bakas Caregiving Outcomes Scale- The Bakas scale is 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. 
2. Zarit Burden Interview - A 22 item measure that focuses on burden in caregiving. 
3. PROMIS Satisfaction with Social Roles and Activities Short Form-8 - An 8 item 
measure that asks about satisfaction with social roles and activities 
4. SF-12- The SF-12 is a well-known health questionnaire that will be used to characterize 
the overall health of the caregiver. 
5. Required Assistance and Time Spent Caregiving- unvalidated items developed by 
the study team to assess the assistance each patient participant requires as well as time 
spent interacting with the patient participant.  
 

 
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Rehabilitation Transition Plan (RTP) Survey: Caregiver and Patient Participant 
We will conduct a telephone survey with both caregiver and patient participants who were 
randomized and participated in the RTP arm of the study about 6 months following discharge.  
The survey consists of questions soliciting feedback about the RTP arm of the study.   The 
interview should take about 10-20 minutes to complete depending on the responses of the 
participants. Participants will not be compensated for completing this survey. 
 
 
 
A trained research staff member at Mount Sinai, one of the study’s sites, will perform the 
interview described above. Contact information (e.g., name, phone number, email) for UW 
participants will be uploaded on a restricted access website at the TBI National Data and 
Statistical Center (NDSC) managed by study personnel at the Craig Hospital. Only Craig 
Hospital staff who manage the website and the staff conducting the interviews at Mount Sinai 
will have access to this identifying information.   
 
All data listed above will be entered into the NDSC centralized database by research staff. 
 
Mailout Option: Baseline Caregiver Questionnaire, All Post-Discharge Questionnaires, Year 
Following Injury Questionnaire 
The postal mail or ‘mailout’ option will not be offered initially to participants; rather, this approach 
will be taken only with a participant who either: 
 
1) has difficulty completing the questionnaire via telephone or in person; or  
2) research staff has difficulty reaching via telephone to complete the questionnaire.  
 
Regarding #1: Research staff may offer the mailout option to the participant if s/he either 
expresses difficulty completing the questionnaire via telephone, or s/he repeatedly re-schedules 
appointments to complete the questionnaire. 
 
Regarding #2: Research staff should send the participant the mailout version of the 
questionnaire to him/her if research staff has not been able to reach a participant after two 
telephone attempts to schedule the questionnaire. 
 
 Research staff should send the participant the mailout version of the questionnaire after SUBID 
and date of mailing has been added to the form. The questionnaire would be mailed via postal 
mail along with a self-addressed envelope and the appropriate cover letter depending on the 
circumstances. Research staff should continue to call the participant until the questionnaire is 
received. Research staff should review the questionnaire thoroughly upon receipt, and contact 
the participant to solicit responses for unanswered/unclear items following the guidelines listed 
in the ‘Questionnaire Scheduling and Timing’ section below. 
 
Study researchers will attempt to collect via telephone data from patients that complete the self-
administration version of Form II via postal mail.   The self-administration form does not include 
address, information regarding injuries to head/neck, the Supervision Rating Scale, the GOSE, 
and the FIM. A cover sheet has been created that study researchers can use to collect the data 
described above as well as administrative items if a site is using a paper version of the form for 
data collection.  
 
 

 
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Questionnaire Scheduling and Timing 
Research staff will begin attempting to contact participants (patient and caregiver) for 
scheduling purposes one month prior to the ideal administration date for the 3-, 6- and 9-month 
post-discharge questionnaires. Research staff will attempt to complete the questionnaire no 
more than 15 days before or 30 days after the ideal administration date for the 3-,6-, and 9-
month post-discharge questionnaires, with the  exception of the two-week extension rule listed 
below).  Research staff should attempt to complete each questionnaire as close to the ideal 
administration date as possible(e.g.  3 months following discharge for the 3-month post-
discharge questionnaire).  
 
Research staff will begin attempting to contact participants (patient and caregiver) for 
scheduling purposes two months  prior to the ideal administration date for the 12-month post-
discharge and one year following injury questionnaires. Research staff will attempt to complete 
these questionnaires no more than two months before or after the ideal administration date for 
the 12-month questionnaire and Form II (see two-week extension rule below). In addition, a 
minimum of 30 days must pass between the 9- and 12-month questionnaires. 
 
Patient participants that started or completed the post-discharge questionnaires prior to the 
window start date should be contacted by research staff during the window to review the 
completed items to make sure nothing has changed. The date of the call back occurring within 
the follow-up window should be used as the questionnaire date. If a call back cannot be 
completed, the original questionnaire date outside the follow-up window should be used.  
 
Two-Week Extension Rule: Post-discharge questionnaires that have been started but cannot be 
completed by the time the data collection window closes can be completed within two weeks 
after the window closes. The questionnaire date should be the date the questionnaire was 
started.  
Four-Week Completion Rule: Post-discharge questionnaires that have been started but not 
completed during the first contact should be completed within 4 weeks. The questionnaire date 
should be the date of initial data collection. If it takes longer than 4 weeks to complete the 
questionnaire, data collected during the initial data collection period should be verified, and the 
questionnaire date should be the second date that data was collected. In the unusual case 
where the 2 week extension window is used to complete the questionnaire beyond the 4 week 
time frame, (e.g. questionnaire started January 1st, questionnaire window closes January 30th, 
questionnaire completed February 5th), the questionnaire date should be the date of data 
collection that was in the questionnaire window (January 1st in this example).  
 
Mailout Option: The mailing of the questionnaire will trigger the 2 week extension to the 
questionnaire window. Example: if research staff mail the questionnaire July 18, 2018, and the 
end of the window is August 31st, research staff can then receive/collect data through 
September 14th.    
 
Mailouts are exempt from the four-week extension rule listed above.  
 
Patient Participants Only (i.e. Not Caregiver Participants):  If adequate data are not obtained 
from the participant by telephone or by mailout two weeks before the end of the window, the 
mailout questionnaire should be sent a significant other SUBID and mailing date have been 
added to the form, along with a self-addressed return envelope. Like the mailing of the 
questionnaire to the patient participant, the mailing will trigger the 2 week extension to the 
questionnaire window. Example if research staff mail the questionnaire July 18, 2018, and the 

 
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end of the window is August 31st, research staff can then receive/collect data through 
September 14th.    
 
Missing data may not be filled in using data obtained outside the questionnaire window and two-
week extension rule unless approved by the lead site.  
 
To classify a questionnaire as “followed” an interview or mailout must be started. There is no 
minimum number of data elements that need to be answered.  
 
 
Research staff will attempt to reach participants to complete these questionnaires until: 1) the 
questionnaire is completed, 2) the participant declines or is deemed unable to complete the 
questionnaire (withdrawal, death, etc.), or 3) the questionnaire window (and two-week extension 
rule, if applicable) expires.  
 
Research staff may send out a letter in advance to both patient and caregiver participants 
reminding them of the upcoming questionnaires.   
 
Any administrations that fall outside of the windows described above will be documented as 
protocol deviations using the study note-to-file form.  
 
All follow-up data described above will be entered in with the participant’s ID, i.e. not name into 
the NDSC centralized database via the ‘Data’ tab.  
 
Data Quality Targets – Assessment Completion 
Target Assessment Completion rate is set at 80%, and will be reviewed on a quarterly basis 
beginning December 2020. The lead site will review the rate for cases with open windows 
during the previous six months (e.g. 6/1/20-11/30/20 for the December check). Sites not 
reaching their target will be required to develop a written remediation plan for increasing 
enrollment numbers. This plan should be submitted to the lead site. The effectiveness of this 
plan will be reviewed at subsequent quarterly checks. 
  
 
Study Completion  
All participants will be informed that their participation in the study has been completed once the 
final questionnaire window has ended regardless of questionnaire completion. This notification 
may take place via telephone and/or email/postal mail.   
 
Documentation of study completion should be entered in the NDSC database using the Study 
completion form; the electronic form can be found under the ‘Data’ tab on the NDSC website. 
These data will be entered into the NDSC database by research staff within one week of study 
completion.   
 
Participant Retention (MD-1, MD-4) 
We will use participant retention strategies that we have refined in the TBIMS with specific SOP. 
We anticipate at least 80% enrollment rate in this study due to the broad eligibility criteria and 
flexible interventions being offered. In addition, the six TBIMS sites included in the study have a 

 
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retention rate of 94% at one-year follow up for TBIMS participants even though there is less 
contact with the patient across the first year than we will have in the current study, which may 
increase our ability to retain subjects over time. We will use culturally sensitive, evidence-based 
practices derived from other successful real-world trauma treatment trials.85  
 
Key strategies include: attempting contacts at multiple times of the day and multiple days of the 
week, including weekends; collecting contact information on three or more people who will know 
the whereabouts of the patient one year later; obtaining multiple means of contacting each 
person (home phone, work phone, email), updating contact information frequently; sending 
birthday/holiday cards, requesting change of address notification from the post office; providing 
financial incentives for participation; and using fee-based Internet search engines such as TLO. 
In addition, research staff may send a letter to both patient and caregiver participants indicating 
that they have been unable to reach them and request the participant contact research staff to 
arrange for upcoming questionnaires. For any participants who do not complete a follow-up 
questionnaire, reasons for the lack of follow-up will be recorded (e.g., physically or cognitively 
unable and proxy not available, not available [e.g., hospitalized, incarcerated], death, withdrawal 
from study, no response to contact despite repeated attempts, etc. 
 
Participant Flow Tracking 
We will report the study participant flow following the Consolidated Standards of Reporting 
Trials (CONSORT) guidelines (http://www.consort-statement.org/CITE). The consort diagram 
will illustrate a) number of potential patients screened for eligibility, b)  number of patients 
deemed eligible, and the final recruitment outcome for all patients screened(ineligible, declined, 
unable to consent, enrolled).  The diagram will also illustrate the same information for caregiver 
participants, as well as outcome regarding questionnaire completion. 
 
 
Masking (or Blinding) 
This study uses masked outcome assessment, which means that staff members who collect 
outcomes data from both patient and caregiver participants at 3-, 6-, 9- and 12 months must be 
unaware of patient participants’ treatment group allocation. Several procedures are used to help 
outcomes staff to remain unaware of group assignment. 
 
Randomization will be automated via a NDSC database to minimize unblinding. Specifically, 
research staff or the TCM will enter discharge destination and study site into the specified 
NDSC database as part of the discharge destination and date form.  Subsequently the TCM will 
be notified via email of group assignment. Ideally, group assignment will be known only by 
coordinators and the TCM(s) at a given site, and the data coordinator at Craig Hospital. 
 
In addition, only TCMs will have access to the ‘Notes’ tab on the NDSC database where 
adverse events, serious adverse events (SAE), unanticipated problems and note-to-files are 
entered.  The reason is that blinded assessors would be unblinded if they observed entries for 
these events if entered by a TCM. As a result, all  information relating to adverse events, SAEs, 
unanticipated problems and note-to-files will be sent by blinded assessors to the TCMs at each 
site for entry into the database. 
 
Other procedures for preventing inadvertent unmasking will be used such as ensuring that data 
collectors and TCMs are not using office spaces in close proximity while TCMs are contacting 
patient participants, and minimizing the meetings that data collectors and TCMs attend in 

 
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common. Also, data collectors will not have access to the treatment list serve to prevent 
inadvertent unmasking from that source. 
 
Staff will continue with a post-discharge questionnaire even if unblinded during the 
questionnaire administration, but will attempt to have another staff member (if available) 
administer subsequent questionnaires. 
We will record on each post-discharge questionnaire any potential unblinding incidents by 
asking assessors: 1. if they believe they were unblinded during the questionnaire or any 
previous questionnaire; and 2. to guess which study arm they believe the participant was 
assigned to. 
 
Staff will record unmasking/unblinding with the study note-to-file form only if an incident takes 
place between questionnaires and has no impact on any questionnaire/data (e.g. blinded staff 
member who has not been assigned to complete post-discharge questionnaires with patient 
participant is unblinded by patient participant during a clinic visit). 
 
 
Withdrawal/Discontinuation of Participants from Study Procedures 
There are two ways in which a participant (patient and caregiver) may cease participation in the 
study after being consented: 
1. WITHDRAWAL: The patient and/or caregiver voluntarily terminates his/ her 
participation, and withdraws: 
a. From the transition plan portion of the study (RTP only); or 
b. From both the transition plan portion and the remaining outcome assessments. 
2. DISCONTINUATION: The patient and/or caregiver are discontinued by study staff (for 
reasons detailed below): 
a. From remaining treatment portion. 
b. The patient and caregiver are never discontinued from remaining data collection 
by study staff except  
i. in the unlikely event that further data collection would be against their 
best interests in the judgment of the site PI and the study PI; or 
ii. the patient participant has a new caregiver participant. 
 
Documentation is also necessary to capture what aspect of participation is affected (transition 
plan, or both transition plan and data collection) and who is ceasing participation (patient, 
caregiver, both).  
 
Withdrawal 
Participants may elect to withdraw from the study at some point after they have signed consent.  
 
Withdrawal from Transition Plan 
Participants may wish to withdraw from (discontinue) the transition plan portion (RTP only). This 
is not the same as withdrawing from the study, which includes outcome assessments in 
addition to the transition plan phase. Once participants have been randomized, every effort 
should be made to follow participants with all of the subsequent outcome assessments, even if 
they do not attend any scheduled sessions. 
 

 
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It is highly advisable for the person who first hears of a desire to withdraw (TCM, assessor, etc.) 
to discuss the situation as soon as possible with the local and/ or national study team. 
 
If a participant expresses a desire to discontinue the transition plan portion (usually, this will be 
brought up with the TCM): 
• 
Never express disappointment or imply this is a bad thing for them to bring up. It 
happens in every research study, so expect it to happen. Be sympathetic to their wishes, 
take it in stride, and ask if they would be willing to discuss it a little further. 
• 
Ask if they would give their reasons. Offer to have another person, such as the PI, 
contact them to hear their reasons if they would prefer. 
o Reasons will be documented via use of the ‘Rehabilitation Transition Plan 
Completion’ form. 
• 
Sometimes participants wish to withdraw based on a misunderstanding or mis-
remembering of their obligations. Try to explain the study procedures to make sure they 
understand expectations. 
• 
If there is concern about confidentiality, remind the participant of the measures that are 
taken to protect his/ her privacy and emphasize that these are taken seriously. Offer a 
conversation with the PI as warranted. 
• 
Depending on the reasons, ask if there is any kind of accommodation that would help 
enable them to continue.  
 
There are obviously certain changes we cannot make (e.g., switching to a different TCM 
if only one TCM at the site), but the attitude should be one of exploring concerns so that 
we might try to work around them—to make it easy and comfortable for them to continue 
participation.   
• 
If the participant mentions any accommodations that might be helpful and are feasible, 
you may authorize them on the spot or, if you are unsure, ask for a short period of time 
(48 or 72 hours) to meet with your team and then respond to his/ her concerns. 
 
 
If the participant is definite about stopping the transition plan phase, 
• 
Let him/ her know that this is fine, and that future contacts will be cancelled. 
• 
Remind him/ her that the study also includes periodic questionnaires which can be done 
over the phone. 
• 
As appropriate, 
o Tell him/ her that continuing the questionnaires, if s/he is willing, will help to 
ensure the scientific validity of the study. 
o Remind him/ her that we will compensate him/her for her time completing the 
questionnaire. 
o Remind him/ her that s/he can always refuse to complete a questionnaire at the 
point of contact. 
 
Withdrawal from Data Collection / Entire Study 
If the participant expresses a desire to withdraw during a follow up assessment, offer to break it 
up or reschedule the questionnaire for a different day; emphasize that a bad day need not be a 
reason to discontinue the entire study and that we are committed to making his/ her participation 
as easy and as meaningful as possible. 
 

 
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While trying to work with the participant to make things better, do not pressure him/ her, and 
remember that s/he has a right to withdraw and is not obligated to explain his/ her decisions. 
This can be a balancing act for which consultation with the team may be helpful. 
The participant may be withdrawn from the entire study if, after encouragement to continue,  
s/he says definitively that s/he does not wish to be contacted any longer by anyone involved in 
the study, even for outcome data collection.  
• 
Let the participant know that s/he may speak with the PI if there are any concerns about 
his/ her experiences in the study. 
• 
As above, ask for reasons and document them on the study completion form. 
 
Caregiver Withdrawal  
Caregivers may withdraw from the study independently from participants. The principles are the 
same as to encouraging the caregiver to remain involved for data collection. A caregiver 
participant will remain enrolled in the study and kept on the schedule for data collection even if 
the respective patient participant withdraws from the study unless the caregiver participant 
explicitly states s/he wishes to withdraw as well.  
 
Also, after discussion with both the patient and caregiver participant, a caregiver participant may 
be discontinued if another individual has become the clear caregiver.  For instance, the 
caregiver participant at the time of discharge could be the mother, but then the patient’s 
significant other is the true caregiver at the time of the 3-month questionnaire.  
In this scenario, the mother should be discontinued, and the significant other should be enrolled 
as the new caregiver participant. 
 
Discontinuation 
Although rare, we anticipate the following circumstances may take place to warrant withdrawal 
of a participant without consent: 
1. A participant/family member becomes verbally abusive/inappropriate with research staff 
members and/or TCMs.  
2. At the discretion of the PI.  
When possible, staff will notify participants of withdrawal via telephone. If this is not possible or 
prudent, research staff will send a letter informing the subject that s/he has been withdrawn. 
We do not anticipate partial withdrawal; once withdrawn, participants will no longer participate in 
any study procedures. 
 
Documentation of Withdrawal/Discontinuation 
Documentation of withdrawal/discontinuation from (a) RTP or (b) the whole study should be 
entered in the database using either the  ‘RTP’ or ‘Study’ completion form. These data will be 
entered into the NDSC database by research staff within one week of withdrawal.  Blinded 
assessors will not be able to see entries into the RTP completion form to ensure proper masking 
(TCMs will complete this form). The site PI will subsequently be notified of this occurrence. 
Withdrawals will also be documented in the quarterly reports generated by the NDSC.   
 
The electronic form for the RTP Completion form can be found under the ‘TCM’ tab on the 
NDSC website. The electronic form for the Study Completion form can be found under the 
‘Data’ tab on the NDSC website. 
 
Incarceration 
Study researchers will cease to engage participants in study activities (i.e. RTP phase, study 
questionnaires) if they become incarcerated following randomization.  Incarcerated participants 

 
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will remain enrolled in the study, however. Study researchers will resume study activities with 
participants only once they are no longer incarcerated.   
 
 
 
 
 
 
 
 
 
 

 
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Suicidal Ideation Response Protocol 
 
 
 
Jeanne Hoffman, PhD: PI 
BRITE Study 
Suicide Protocol 
Adapted from  Bombardier 
rev. 07-30-2020
“Have you talked with a 
doctor or clinician about this?”
If No,
“Would it be ok for one of our
study clinicians call you?*
If Yes,
“Are you getting 
enough help?”
If Yes,
Offer Crisis Line 
number*
If No,
“Would it be ok for one of our
clinicians to call you about
getting more help?”*
Document if accepted or
refused. Email study 
clinician, 
cc research manager 
Document if accepted or
refused. Email study clinician, 
cc research manager 
Document if accepted
or refused
If No intent and
No plan
If Yes to
intent or plan
“Are you in danger of killing
yourself right now?
Will you be safe until one
of our clinicians calls you?”
If not safe, ask location. 
Hold them on the phone.
Call 911 first, then call 
or page clinician.
If safe, 
“I will have one of our 
Study clinicians call you
within one hour.” 
Call or page clinician.
If >0 on PHQ item 9/Or expresses suicidal ideation in other way, 
Ask, “Do you have thoughts of killing yourself?”
If NO,
Confirm no thoughts of self harm. Offer Crisis Line, just in case
Document if accepted or refused
If YES,
“Is this something you intend to do? 
Do you have a plan? Tell me more”
  
 
REMEMBER: Log suicidal ideation as an adverse event according to protocol. 
 
 

 
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Suicidal Ideation Response Protocol 
 
 
 
Jeanne Hoffman, PhD: PI 
BRITE Study 
 
 
IMPORTANT PHONE NUMBERS: 
Jeanne Hoffman, PhD (PI/Study Clinician): Office 206-221-6511; Cell 206-409-2654 
Megan Moore, PhD, MSW: Office 206-616-2862 ; Cell 510-684-6053 
Leslie Kempthorne (Research Manager): Office 206-685-1082; Cell 206-898-7025 
Crisis Connections (King County Area): 206-461-3222 or 1-866-4-CRISIS (1-866-427-4747) 
National Suicide Prevention Hotline:  1-800-273-8255; Spanish: 1-888-628-9454 
 
What is Suicidal Ideation (SI)? 
Suicidal Ideation (SI) includes passive or active suicidal thoughts. If the person in any way expresses a desire to hurt or kill 
themselves, you should follow the flow chart above. This often comes up during the PHQ-9. 
 
OTHER INCIDENTS OF CONCERN 
 
Unsafe living environment 
→ Clarify details of problem with the participant and/or informant. Are they aware of unsafe environment? 
o If they are unaware (in the neurological sense of the term) and in immediate danger (e.g., fire risk, hypothermia), call 
Adult Protective Services and report situation after consultation with site PI. 
o If they are aware but in immediate danger and don’t know what to do, assist them in finding emergency shelter until 
the problem can be addressed. 
o If they are not in immediate danger, guide them in problem-solving and offer referrals if appropriate. 
 
Incidents of an unsafe living environment that are life threatening and result in an adverse event will be considered an SAE and will 
be documented using the “Problems Report” form. Please review timing of entering SAEs below. 
Incidents of an unsafe living environment that are not life threatening and do not result in an adverse event will be documented using 
the “Note-to-File” form. Please review timing of entering Note-to-File data below. 
 
All other concerns 
If you ever have any concerns for the immediate safety of the participant, contact the research manager and site PI right away to 
discuss the situation and take any necessary steps. Document the situation in a Note-to-File, and if applicable, as an AE or SAE.

 
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ClinicalTrials.gov Requirements 
The study will be registered on ClinicalTrials.gov, with the PI (Hoffman) named as the 
responsible party. 
 
 
Maintenance of IRB Approval 
All six sites will be responsible for obtaining and maintaining IRB approval from their respective 
institutions. This includes submission and approval of annual renewals. All sites will send annual 
renewal approvals to the University of Washington, the coordinating site of the grant, upon 
receipt.  The University of Washington will maintain a list of approval dates for all sites in its 
MOP, and remind each site of upcoming approval expirations.  
 
In addition, all changes to study materials and protocol requiring IRB approval will be initiated 
and coordinated by research staff at the University of Washington.  Specifically, research staff at 
the UW will be responsible for finalizing any changes to  the study protocol/study materials, 
submitting the revised materials to all respective sites, then monitor progress to ensure any 
significant protocol changes are approved at all sites prior to being initiated at that site. 
 
All protocol changes requiring IRB approval will be recorded in the ‘Tool Revision History’ 
section of this document.

 
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Major Decisions Documentation 
All major decisions made during the implementation of this research study will be recorded in 
the MOP. In addition, research staff at the lead site (UW) will post any major decisions to the 
study’s website list serve to ensure all study researchers are kept abreast of any major 
decisions that will affect some or all sites.

 
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STUDY DATA  
The following is a list and description of the data measures included in the study.  
We list the demographic and descriptive information we propose to collect from the study 
participants in the next paragraph. Details regarding the measures are provided below. All 
outcome measures will be administered by research staff members blind to group allocation. 
 
Descriptive/Demographic Variables   
All patient participants will be asked to provide demographic data for descriptive purposes either 
as part of TBIMS or the BRITE study if not enrolled in TBIMS, including the following: 
• 
Age 
• 
Gender/Sex 
• 
Height/Weight 
• 
Race 
• 
Primary Language 
• 
Country of Birth 
• 
Length in U.S. 
• 
Marital Status 
• 
Residential Status 
• 
Years of Education 
• 
Employment Status and History Prior to Injury 
• 
Annual Earnings Prior to Injury 
• 
Co-morbid Medical Conditions 
• 
Cognitive Limitations Prior to Injury 
• 
Tobacco/ Alcohol/ Illicit Substance Use Prior to Injury 
• 
Psychiatric Conditions Prior to Injury 
• 
Military/ Deployment Status 
• 
Date of Injury 
• 
Date of Discharge 
• 
Cause of Injury 
• 
Basic Functioning while Inpatient 
• 
Insurance Type/Coverage 
 
All caregiver participants will be asked to provide demographic data for descriptive purposes, 
including the following: 
• 
Age 
• 
Gender/Sex 
• 
Race 
• 
Country of Birth 
• 
Length in U.S. 
• 
Marital Status 
• 
Residential Status 
• 
Years of Education 
• 
Employment Status  
• 
Annual Earnings  
• 
Relationship to Patient Participant 
• 
Length of Relationship with Patient Participant 
• 
Cohabitation Status with Patient Participant  
 

 
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Study Outcomes (RQ-6, PC-3, IR-4) 
 Our selection of outcomes was informed by focus groups held with patients and family 
members as well as discussions with our Patient and Family Stakeholders (see Engagement 
Plan below). The following key outcome domains were identified: (1) ability of patients to 
participate in the home and community as independently as possible, (2) health-related quality 
of life, (3) access to appropriate healthcare and reduced emergent or urgent healthcare, and (4) 
caregiver burden and stress. We will assess these outcomes at 3, 6, 9 and 12 months after 
discharge from inpatient care. We plan to combine the 12-month post-discharge outcome 
assessment interview with the standard TBIMS 12-month post-injury assessment, known as the 
Form II when the follow-up time periods overlap and participants are willing to do both 
assessments during the same phone call.  
 
Primary Outcomes 
 Aims 1 and 2 will address the primary outcomes of 1) Participation in Usual Roles and 
Activities: Participation Assessment with Recombined Tools-Objective 17 (PART-O)86 and 2) 
Health-related Quality of Life: Quality of Life after Brain Injury Scale (QoLIBRI)87 
 
Participation Assessment with Recombined Tools – Objective 17 (PART-O-17):88 Since the 
resumption of life roles and re-integration into the community drives patient and family decisions 
regarding rehabilitation care,89 community participation, as measured by the PART-O-17,88 was 
chosen as the primary outcome variable in the current study(RQ-6, PC-1, PC-3). The PART-O-
17 is a patient-reported (or family member proxy-reported) measure of the International 
Classification of Functioning (World Health Organization90) construct of “participation,” which is 
defined as involvement in life situations at the societal level as reflected in fulfillment of 
developmentally and culturally appropriate roles such as worker, student, spouse, parent, or 
citizen.  All major conceptual models of disability (see, for example, Institute of Medicine’s 
Disablement Model91) place considerable emphasis on fulfillment of social roles similar to the 
manner in which participation is defined in the International Classification of Functioning. The 
PART-O instrument is based on items derived or modified from three measures most commonly 
found in the TBI literature: Community Integration Questionnaire;92 Participation Objective, 
Participation Subjective;93  and the Craig Handicap and Assessment Reporting Technique.94  
 
The PART-O-17 was chosen for the current study because: (1) consumer stakeholders provided 
input into its development, (2) it is a patient-reported outcome, (3) it has established reliability 
and validity, and (4) our Patient and Family Stakeholders felt that it and the QoLIBRI captured 
the outcomes that were most important to them. The measure maintains the strengths and 
overcomes some of the weaknesses of its component measures. Persons with brain injury, 
family members, and advocates assisted in the development of the PART-O-17, helping to 
ensure that it captured key roles and activities important to persons with TBI and their families 
(including important domains of participation: productivity, social relations, and being out and 
about in the community), and contributing to the development of an abbreviated version (PART-
O-17, original version had 24 items).  Test-retest reliability is strong for both the total score and 
the domain scores (ICC=.90 for total score and ranges from .79 to .87 for the domain scores, 
personal communication, Bogner, manuscript under review).  Construct validity has been 
demonstrated in TBI populations through principal component analysis suggesting that the 
PART-O measures a unidimensional construct, and through correlations of the expected 
strength and direction with legacy measures of participation, as well as with measures of injury 
severity, functional limitations, subjective well-being, and mental and physical health.88, 95-97  
In addition, the PART-O-17 was found to be sensitive to disability status in a population-based 
study.98   

 
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A content analysis of the most frequently used participation measures (7 in total) indicated that 
the PART-O is the most representative of the ICF categories of participation.99 A recent rating 
scale analysis created a new scoring algorithm for the total score that reflects a unidimensional 
numeric measure.100 The PART-O 17 is a recommended outcome measure in the NIH Common 
Data Elements101 and has been used in the NIDILRR TBIMS National Dataset since 2007 
(https://commondataelements.ninds.nih.gov/tbi.aspx#tab=Data_Standards). 
 
In preparation for the grant, we asked our Patient and Family Stakeholders to review a case 
example of a small change from baseline to 6-months post discharge. They stated that the 
change was meaningful and emphasized that “any improvement after TBI is important.” 
 
Quality of Life after Brain Injury Scale (QoLIBRI):87 The QoLIBRI is a patient-reported instrument 
specifically created to measure the patient’s perception of their health-related quality of life 
following TBI. It was developed by an international work group and subjected to rigorous 
validation in large samples of persons with TBI.87 The resulting scale has 37 items in 6 
subscales confirmed by factor analysis: Self, Daily life and autonomy, Social relationships, 
Emotions, Restrictions and problems, and Physical condition. Test-retest reliability is good to 
excellent for all subscales and the total score (.91).87 Validity studies have shown strong 
associations between QoLIBRI scores and level of disability, as well as moderate associations 
to generic health-related quality of life measures (e.g., SF-36); however, the QOLIBRI is more 
strongly related to TBI outcomes than are the generic quality of life measures.102 It has been 
noted that many of the items on the QoLIBRI, which ask about satisfaction with one’s status in 
several domains and the degree to which one is bothered by various symptoms, reflect 
modifiable states that could change with interventions102 such as the one in the proposed study. 
The QoLIBRI was selected as an outcome measure for the multi-agency TBI Common Data 
Elements and is part of the outcome assessment in the TRACK-TBI study. 
(https://tracktbi.ucsf.edu/sites/tracktbi.ucsf.edu/files/Outcome%20Assessment%20SOP.pdf) 
 
 
Secondary Outcomes 
Aim 3 is focused on Healthcare utilization: Cornell Services Index;103 Aim 4 addresses Caregiver 
burden: Bakas Caregiving Outcomes Scale104, Zarit Burden Interview129, SF-12130, and PROMIS 
Satisfaction with Social Roles and Activities131 and assessment of Time Spent Caregiving. 
Program process evaluation will include process variables: e.g., rate of call completion, number 
of additional calls needed, call duration and calls initiated by the patient/caregiver.  
 
Cornell Services Index:103 The Cornell Service Index is a widely used measure of healthcare 
services utilization, and will include number of hospitalizations and days hospitalized, number of 
emergency department visits, as well as number and type of clinic visits (both routine and those 
that address medical complications). It has been used in a number of TBI studies.66, 105 The 
instrument allows one to modify it as needed, including specifically asking if a patient saw a 
provider for issues related to TBI. We will also modify it to include assessment of TBI-specific 
care, since our stakeholders were particularly interested in whether RTP improves the ability to 
access and follow through with care.  
 
Bakas Caregiving Outcomes Scale:104, 106 Since there are no TBI-specific caregiver quality of life 
(QoL) measures, the Bakas Caregiving Outcomes Scale, which was developed for use in 
stroke, will be adapted by replacing “stroke” with “traumatic brain injury” similar to a prior 
study.107   

 
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The Bakas is 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. It has been shown 
to have good internal consistency (Cronbach α = 0.90), test-retest reliability (intraclass 
correlation = 0.68), and construct validity.106 Following the recommendation from PCORI 
reviewers, we are currently exploring with our research team, including our patient and family 
stakeholders, other important caregiver domains (e.g., caregiver quality of life, role functioning 
and burden) as outcomes. 
 
Zarit Burden Interview:129 The Zarit Burden Interview was initially developed for caregivers of 
individuals with dementia.108  Short forms have been developed,109 and the 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 Zarit Burden Interview has been used previously in 
studies on caregivers of individuals with TBI.110-114 We hypothesize that caregivers for 
participants randomized into the RTP arm of the study will report lower burden compared to 
those caregivers of participants randomized into the RDP arm.  
 
Prior research with this scale has been primarily descriptive and did not exactly match the 
timeline111, 112 (within one year of TBI) nor injury severity113 of our study population.  We can use 
the published data to estimate a possible standard deviation and given our expected sample 
size, we have 80% power to detect approximately a 2.29 difference if one exists. This is based 
on data from a study conducted on caregivers of Veterans with TBI112 who are broadly similar to 
our population with an average score of 15 and standard deviation of 10 on the 12 item Zarit 
Burden Interview. An assumption was made of equal sample sizes between the two groups 
which, with 80% power, alpha of .05, would require a .229 effect size to detect a difference 
between the two groups at 6 months post injury.  
 
SF-12: 130  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 SF-12 has been 
used in examining HRQOL in caregiver populations for other disorders,115-117 but not as 
frequently assessed in caregivers of individuals with TBI.118 However, the 36-item version has 
been found to show change over time in caregivers of persons with TBI.119 We hypothesize that 
caregivers for participants enrolled in the RTP arm of the study will report better HRQOL in both 
physical and mental health domains compared to those caregivers of participants enrolled in 
RDP alone.  
 
 
PROMIS Satisfaction with Social Roles and Activities:131 The PROMIS Satisfaction with Social 
Roles and Activities has not been used in the study of caregivers in any population to date.  
Given the other measures that we are including that specifically assess caregiver functioning 
and engagement in activities directly related to caregiving, we chose this measure to add an 
understanding of engagement in roles and activities apart from those related to caregiving.  We 
hypothesize that caregivers for participants enrolled in the RTP arm of the study will report 
better satisfaction with social roles and activities compared to those caregivers of participants 
enrolled in RDP alone. 
 
Required Assistance and Time Spent in Caregiving has been assessed in a variety of studies to 
describe the use of caregivers for individuals with TBI. This measure was developed internally 
with input from our Patient and Family Stakeholder group and experience from prior studies. 
 
 

 
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Assessment of Variability of Resources and Processes 
For RDP: During the preparation of our grant, we performed an assessment of the key 
resources and processes that are available at each of our inpatient rehabilitation sites, which 
include: (1) Patient and family education on diagnosis and anticipated needs, (2) written 
discharge instructions, (3) organization of outpatient services and appointments, (4) medication 
teaching and prescriptions, (5) discharge summary sent to primary care provider, and (6) post-
discharge telephone call within a few days of discharge to reinforce discharge plan.  
 
For RTP: We are aware that community resources will vary among our sites. Our patient and 
family stakeholders reported that the most important factors which contributed to them not 
getting their needs met following discharge from inpatient rehabilitation, were (1) lack of 
services to direct them to what resources were available or relevant to them and (2) limitations 
in insurance coverage (e.g., limiting availability of helpful services such as physical therapy, 
mental health treatment, etc.). Therefore, we will examine insurance coverage as a potential 
source of variability in outcomes. Moreover, during the start-up phase of the study, the TBI Care 
Manager (TCM) at each site will work closely with clinical and community stakeholders to 
familiarize themselves with all available resources at each site and across sites to increase the 
likelihood that all potential resources will be identified. Because the TCMs at all sites will be 
meeting via phone or videoconference on an ongoing basis, new resources that may be 
identified will also be shared to maximize awareness for all TCMs. We have agreement from our 
patient and family stakeholders and professional stakeholders to work with us to develop a list 
of key community resources across all sites, such as the availability of transportation, 
Department of Vocational Rehabilitation resources, support groups for patient and family, etc. 
that they feel may be relevant for individuals with TBI and their family/caregivers.   
 
Also, during some sessions between the TCM and participant/ caregiver, the TCM will be using 
a checklist to determine needs as well as which patient-identified needs are met or unmet. If a 
need is unmet, we plan to document whether lack of available resources was the cause. While 
we cannot account for all variability in resources across the six sites/states, we will examine 
potential confounding and heterogeneity of treatment effects by study site and insurance 
coverage, which has significant influence on the resources available to patients. Finally, as 
described above, intervention fidelity will be closely monitored. 
 
 
Power Analysis 
As can be seen in the Recruitment/Enrollment table above (p. 26), we expect to enroll a 
minimum of 300 individuals per year for 3 years (total N = 900). We based our power calculation 
on the PART-O-17, the primary outcome for which we have the most relevant data in TBI. 
Unpublished data from a sample discharged from inpatient TBI rehabilitation showed a PART-
O-17 Total (which can range from 0 to 5) average score of 1.51 (SD=0.65) at 3-months follow-
up and 1.66 (0.72) at 9-months follow-up (publication in preparation). Minimal detectable 
differences (MDD) were 0.57 and 0.63 at 3 and 9 months, respectively. Using these results, we 
calculated the power of finding a difference of 0.60 (average of the two MDDs) between the two 
groups under various assumptions as follows:  
Test: t-test for independent samples, two-tailed, allocation ratio=1 
Significance level=0.05 
Common standard deviations: 0.75 (higher than the observed in previous studies to be 
conservative) 
 
 

 
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Mean PART-O scores (Intervention mean minus control mean):  The minimal detectable 
difference of the instrument is 0.6. To be more conservative, we started the difference between 
the two means at 0.4. Assuming SD=0.75 (in the higher side of previous studies) the calculated 
effect size based on this mean and SD is 0.5333. Therefore, we used values of 0.5 to 0.8 by 
increments of 0.05 for the effect sizes.  
Sample sizes: from 500 to 900 individuals (by 100) 
 
The graph shows that even with an effect size of 0.5 (corresponding to a difference of 0.4 points 
between the two groups and under an SD larger than those observed in prior studies), we have 
practically 100% power to detect the difference between the two groups with sample sizes of 
500 and above (we expect to have 900). 
 
 
 
Power for Secondary Outcomes 
For Aim 3, we consulted our stakeholders to determine what would represent meaningful 
differences in healthcare utilization. Based on these discussions, we will categorize completed 
planned outpatient visits in “less than 50%,” “between 50 and 75%,” and “more than 75%.” 
Based on highly conservative estimates from data collected on patients who were eligible 
(based on insurance, geography and preference) and referred to Moss Rehab Hospital (one of 
our study sites), 4%, 17%, and 79% of the individuals received “less than 50%,” “between 50 
and 75%,” and “more than 75%” of their scheduled physical therapy, occupational therapy, and 
speech therapy care visits (these data do not include other outpatient visits, such as mental 
health and primary care visits, that are known to have low adherence rates). Under the 
assumptions that our RDP group would have a proportion of 0.79 of people going to more than 
75% of their scheduled visits, with a significance level of 0.05, power of 0.80, and varying the 
sample size from 500 to 900, we calculated the size of change in the proportion of people 
receiving 75%+ visits in the RTP group that we would be able to detect. We would be able to 
statistically detect a proportion of 0.88 in the RTP group with a sample size of 500 and a 
proportion of 0.86 with 900 (see graph below). Therefore, we would have enough power to 
detect a small change in proportions. 
500
550
600
650
700
750
800
850
900
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 0.5
 = 0.55
 = 0.6
 = 0.65
 = 0.7
 = 0.75
 = 0.8
Effect size d
t tests - Means: Difference between two independent means (two groups)
Tail(s) = Two. α err prob = 0.05. Allocation ratio N2/N1 = 1
Total sample size

 
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We will also test differences in number of hospitalizations, number of emergency department 
visits, and number of unplanned outpatient visits per year. These outcomes will be compared 
using a Poisson model. For the power analysis, we adjusted the significance level to 0.017 after 
using Bonferroni adjustment (0.05/3), and we considered sample sizes of 700, 800, and 900 (to 
assess the effect of attrition of roughly 10% and 20%).  From our previous work, we only have 
rough estimates of the events of interest (0.42 hospitalizations per year from Dams-O’Connor et 
al.52 and 2.25 medical encounters of any type (not distinguished as planned or unplanned) per 
year from Salisbury et al.120). Therefore, we considered the base rates of 1-5 events per year for 
the RDP group and calculated the power of detecting a decrease in that rate of 10%, 20%, 30%, 
and 40% in the RTP group. Using G*Power and the specifications above, the summary of the 
findings are as follows: 
- 
The higher the base rate for the RDP group, the higher the power to find a difference; 
- 
Power is at least 80% to find a decrease of 20% in the number of events, except when the 
base rate is 1, in which case the decrease would need to be 22-25% to be detected; 
- 
Attrition (represented by sample sizes of 800 and 700) have an effect but might be important 
only for a small base rate (such as 1 visit/year); 
- 
Power for secondary analysis will be high to find a decrease of 20% in mean number of 
events (equivalent to odds ratio of .8 when comparing the RTP to the RDP group), even 
when sample size is depleted by attrition. 
 
The analyses will be repeated adjusting for other factors (age, sex, race/ethnicity, education, 
injury severity, for example), to explore the effect of those factors on the outcomes (we are not 
powering the study for these analyses as they are exploratory in nature). 
 
The graphs below show the power for each base rate (odds ratio in x-axis and power in the 
y-axis). 
 
500
550
600
650
700
750
800
850
900
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Proportion p2
 = 0.8
 = 0.85
 = 0.9
Power (1-β err prob)
z tests - Proportions: Difference between two independent proportions
Tail(s) = Two. Proportion p1 = 0.79. α err prob = 0.05. Allocation ratio N2/N1 = 1
Total sample size

 
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Page 75 of 129 
 
Base rate = 1 visit/year   
 
 
 
 
Base rate = 2 visits/year 
 
Base rate = 3 visits/year  
 
 
 
 
Base rate = 4 visits/year 
 
Base rate = 5 visits/year 
 
 
For Aim 4, the sample of caregivers is expected to have a size of 675. From Powell et al.107, 
the estimated Bakas Caregiving Outcome Scale (BCOS) was 56.6 (SD=12.8) in the RDP group 
and 58.9 (10.7) in the RTP group.  If we assume an attrition of 10% and 20%, we would have 
samples of 607 and 540 respectively. Assuming significance level of 0.05, power of 80%, 
SD=13 for both groups (based on the higher SD in Powell et al.), and a t-test (two-tailed), we 
calculated the power to find a change from 56 in RDP group to 59 - 70 in the RTP group, 
corresponding to about 5% to 20% increase in the BCOS (effect sizes of 0.23 to 1.08). The 
power was at least 80% (and mostly close to 100%) for all possible combinations of sample and 
effect sizes, except for the single circumstance of a very large attrition (n=540) and a low effect 
size (0.23), when the power was 0.76 (see graph below). Therefore, we will have enough power 
to test differences of at least 3 points in the BCOS. 
 
 
0.6
0.62
0.64
0.66
0.68
0.7
0.72
0.74
0.76
0.78
0.8
0.82
0.84
0.86
0.88
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 700
 = 800
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 1. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.6
0.62
0.64
0.66
0.68
0.7
0.72
0.74
0.76
0.78
0.8
0.82
0.84
0.86
0.88
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 700
 = 800
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 2. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.6
0.62
0.64
0.66
0.68
0.7
0.72
0.74
0.76
0.78
0.8
0.82
0.84
0.86
0.88
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 700
 = 800
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 3. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.6
0.62
0.64
0.66
0.68
0.7
0.72
0.74
0.76
0.78
0.8
0.82
0.84
0.86
0.88
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 700
 = 800
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 4. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.6
0.62
0.64
0.66
0.68
0.7
0.72
0.74
0.76
0.78
0.8
0.82
0.84
0.86
0.88
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 700
 = 800
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 5. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.23
0.33
0.43
0.53
0.63
0.73
0.83
0.93
1.03
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 540
 = 607
 = 674
Total sample size
t tests - Means: Difference between two independent means (two groups)
Tail(s) = Two. α err prob = 0.05. Allocation ratio N2/N1 = 1
Effect size d

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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For the Zarit Burden Interview, we can use the published data to estimate a possible standard 
deviation and given our expected sample size, we have 80% power to detect approximately a 
1.14 difference if one exists. This is based on data from a study conducted on caregivers of 
Veterans with TBI112 who are broadly similar to our population with an average score of 15 and 
standard deviation of 10 on the 12 item Zarit Burden Interview. An assumption was made of 
equal sample sizes between the two groups which, with 80% power, alpha of .05, would require 
a .23 effect size to detect a difference between the two groups at 6-month post-injury. As with 
the Zarit Burden Questionnaire, there are no prior studies which allow us to precisely estimate 
power to detect a difference between groups. No prior research has been conducted with the 
final two caregiver measures to provide data to conduct power calculations. 
 
Power Analysis Revisited by Marcia Ciol, Ph.D., Study Biostatistician, January 28, 2019 
 
Power Analysis for primary outcome: 
The following reproduces the power analysis performed in the original proposal, except that it 
extends the range of sample size from 100 to 900 (by 100) and that we looked at smaller effect 
sizes (starting at 0.3 instead of 0.5).  The specific parameters used in the calculations are as 
follows: 
Test: t-test for independent samples, two-tailed, allocation ratio=1 
Significance level=0.05 
Mean PART-O scores (Intervention mean minus control mean):  Effect sizes of 0.3 to 0.75 by 
increments of 0.05.  
Sample sizes: from 100 to 900 individuals (by 100) 
 
 
 
For the primary outcome, even a small sample size of 300 will have 0.80 power to detect a 
small effect size of 0.3.  Therefore, it is unlikely that we would not find a difference between the 
two groups if the difference exists. 
 
Power for Secondary Outcomes: 
 
For Aim 3, under the assumptions that our SDC group would have a proportion of 0.79 of 
people going to more than 75% of their scheduled visits, we calculated the size of change in the 
proportion of people receiving 75%+ visits in the OTC group that we would be able to detect 
with a significance level of 0.05 (two-tailed proportion test), power of 0.80, and varying the 
sample size from 100 to 900. 
100
200
300
400
500
600
700
800
900
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 0.3
 = 0.35
 = 0.4
 = 0.45
 = 0.5
 = 0.55
 = 0.6
 = 0.65
 = 0.7
 = 0.75
Effect size d
t tests - Means: Difference between two independent means (two groups)
Tail(s) = One. α err prob = 0.05. Allocation ratio N2/N1 = 1
Total sample size

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
Page 77 of 129 
 
 
With 80% power, we would be able to statistically detect a proportion in the OTC group of 0.91 
with a sample of 300 individuals, 0.88 with a sample size of 500, and of 0.86 with 900 (see 
graph below).   
 
 
 
We will also test differences in number of hospitalizations, number of emergency department 
visits, and number of unplanned outpatient visits per year. These outcomes will be compared 
using a Poisson model. For the power analysis, we adjusted the significance level to 0.017 after 
using Bonferroni adjustment (0.05/3), and we considered sample sizes of 300, 500, 700, and 
900.  We considered the base rates of 1-4 events per year for the SDC group and calculated the 
power of detecting a decrease in that rate from 10% to 50% in the OTC group. Using G*Power 
and the specifications above, the summary of the findings are as follows: 
- 
The higher the base rate for the SDC group, the higher the power to find a difference; 
- 
Power is at least 80% to find a decrease of 20% in the number of events, except when the 
base rate is 1, in which case the decrease would need to be 22-25% to be detected; 
- 
Attrition or low enrollment (represented by sample sizes of 300, 500 and 700) have an effect 
but might be important only for a small base rate (such as 1 visit/year) and sample size 300 
(unlikely to happen); 
- 
Power for secondary analysis will be high to find a decrease of 20% in mean number of 
events (equivalent to odds ratio of .8 when comparing the OTC to the SDC group), except 
for sample lower than 500 (which is unlikely to happen). 
The graphs below show the power for each base rate (odds ratio in x-axis and power in the y-
axis). 
 
 
 
 
 
 
 
 
 
 
 
100
200
300
400
500
600
700
800
900
0
0.2
0.4
0.6
0.8
1
Proportion p2
 = 0.8
 = 0.85
 = 0.9
Power (1-β err prob)
z tests - Proportions: Difference between two independent proportions
Tail(s) = Two. Proportion p1 = 0.79. α err prob = 0.05. Allocation ratio N2/N1 = 1
Total sample size

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
Page 78 of 129 
 
Base rate = 1  
 
 
 
 
Base rate =2 
 
 
 
Base rate =3   
 
 
 
 
Base Rate = 4 
 
 
For Aim 4, for caregiver outcome, we assumed the following parameters: 
- 
Sample sizes from 250 to 600 (by 50); 
- 
Significance level of 0.05,  
- 
SD=13 for both groups (based on the higher SD in Powell et al.), 
- 
T-test (two-tailed) 
- 
Change in Bakas Caregiving Outcome Scale (BCOS) from 56 in SDC group to at least 
59 in the OTC group, corresponding to at least 5% increase in the BCOS (effect sizes of 
0.25 or more).  
 
 
 
0.5
0.55
0.6
0.65
0.7
0.75
0.8
0.85
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 300
 = 500
 = 700
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 1. Mean exposure = 1. R² other X = 0. X distribution = Binomial. X 
parm π = 0.5. α err prob = 0.017
Exp(β1)
0.5
0.55
0.6
0.65
0.7
0.75
0.8
0.85
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 300
 = 500
 = 700
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 2. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.5
0.55
0.6
0.65
0.7
0.75
0.8
0.85
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 300
 = 500
 = 700
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 3. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
0.5
0.55
0.6
0.65
0.7
0.75
0.8
0.85
0.9
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 300
 = 500
 = 700
 = 900
Total sample size
z tests - Poisson regression
Tail(s) = Two. Base rate exp(β0) = 4. Mean exposure = 1. R² other X = 0. X distribution = Binomial. 
X parm π = 0.5. α err prob = 0.017
Exp(β1)
250
300
350
400
450
500
550
600
0
0.2
0.4
0.6
0.8
1
Power (1-β err prob)
 = 0.25
 = 0.3
 = 0.35
 = 0.4
 = 0.45
 = 0.5
 = 0.55
 = 0.6
 = 0.65
 = 0.7
Effect size d
t tests - Means: Difference between two independent means (two groups)
Tail(s) = Two. α err prob = 0.05. Allocation ratio N2/N1 = 1
Total sample size

 
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At the moment we have 142 caregivers and if we continue to enroll in the same rate, we will 
have about 471 caregivers by the end of the study.  For that sample size, except when the 
effect size is smaller than 0.3, we will be able to detect a change in BCOS. If the effect size is 
larger, we will be able to detect it with 80% power even for smaller sample sizes (350 for an 
effect of at least 0.3, 275 for an effect of at least 0.35, and 250 for an effect of at least 0.4).  For 
the smallest effect size of 0.25, we would need to have about 500 caregivers for a power of 80% 
to find that small difference.  Given our current estimates of the total sample size for the 
caregivers, we are likely to have power to find a difference, if the difference exists. 
 
 
 
 
Data Analysis Plan Specific to Each Aim (IR-3, IR-5) 
 
General approach: The expected sample size is very large and we anticipate 100% power to 
find a difference in PART-O-17, if a difference exists. In addition, the sample size will allow us 
adequate power to examine our other aims and heterogeneity of treatment effects. We will use 
a significance level of 0.05 for all the analyses we will perform. Given the large sample size and 
the extremely high power for the primary outcome, we will not adjust the significance level for 
multiple comparisons for all the other tests, since it is highly likely that the p-values for those 
tests will be small. As it is well known and now stated in a publication by the American Statistical 
Association,121 the p-value should not be the single deciding measure of the significance of a 
result. Therefore, we will interpret the results of all non-primary outcomes with caution and will 
examine effect sizes as well as explicitly report the secondary outcomes status when presenting 
the results. We will obtain input from our stakeholders regarding the meaningfulness and 
importance of the effects. 
 
The analysis plan will conform to the intent-to-treat principle: all randomized cases will be 
included based on their assigned treatment group regardless of actual intervention received. 
Missing values will be prevented and minimized by implementing the following steps in the 
manual of operations: 1) Prompt data entry to allow timely detection of any missing data, 2) 
Procedures for monitoring and tracking data completeness will be in the manual of operations, 
3) When missing data are identified, research staff will contact the participant to collect them (if 
not time-contingent or outside the specified time range for collection).  At the end of the study, 
participants not assessed at the end of intervention will be considered as having missing 
outcome values.  
 
When missing values are present we will check the missing mechanism,122 and if it allows for 
imputation, we will do so according to the appropriate methods for a continuous variable, using 
multiple imputation strategies (most likely using maximum likelihood methods).   We will perform 
sensitivity analysis of the results by performing the data analysis using the most conservative 
approach of removing the data from individuals with missing outcome values from the analysis, 
or if it a missing value in a covariate, removing the covariate from the model.  The results of the 
analysis with imputed data and complete data will be compared to assess whether they differ 
and both results will be reported.  The analyses for aims related to longitudinal trajectory rely on 
statistical methods (mixed generalized linear models) that are robust to missing data at 
individual time points.  In addition, all reasons for drop-out and missing data will be recorded 
and will be reported in all reports and publications (MD-2, MD-3, MD-5). 
 
Plan for analysis of COVID-19 Pandemic impact: We propose to add the following steps to 
the data analysis in order to take the pandemic into account: 1) Analyze the patterns and 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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causes of refusal to participation in the study before and during the pandemic to determine if the 
populations in the two periods are coming from the same base population; 2) Analyze the 
patterns of missing data, comparing them between before and during the pandemic to 
determine whether we need to additionally add an indicator of the time of data collection (before 
or during pandemic) as another factor in the generation of the imputed outcome data; 3) analyze 
the primary and secondary outcomes in an intention-to-treat manner as proposed in the 
protocol. We will follow with another data analysis that will add in the model time of data 
collection (pre/post pandemic) and its interaction with intervention type  as possible explanatory 
factors to determine the potential impact of change in timing of enrollment or unaccounted for 
changes in the intervention.   
 
 
Aim 1, Hypothesis 1:  Both the PART-O-17 and the QoLIBRI measures are numeric with a 
fairly large range that can be considered as continuous for data analysis. We will test the 
difference in means for PART-O-17 and QoLIBRI between the two groups at 6-month post-
discharge using a two-sided t-test for independent samples. We will also test if the intervention 
has a long-term effect by comparing the two groups at 12-months post discharge using the 
same type of t-test. 
 
Aim 2, Hypothesis 2: To compare the trajectory of improvement for 3-, 6-, 9- and 12-months 
post-discharge, we will plot individual trajectories over time and if it appears that the majority of 
people are leveling off over time we will consider a growth model.  Otherwise, we will use a 
linear mixed model, with the outcome (PART-O-17 or QoLIBRI) as the response variable, and 
time and  other factors (such as age, sex, race/ ethnicity, education,  injury severity) as 
explanatory variables, and add intervention group and its interaction with time to test whether 
the interventions and time had an effect in the trajectory of the outcome.  
 
Aim 3, Hypothesis 3:  To compare the healthcare utilization in the first-year post discharge, the 
two groups will be compared on the distribution of categories of completed planned outpatients 
visits (less than 50%, between 50 and 75%, and more than 75%) by using a Chi-Square test. 
Both, the number of urgent care visits and the number of unplanned hospitalizations will be 
compared by means of a Poisson regression, which will include group and possibly adjusting for 
other factors (age, sex, race/ethnicity, education, injury severity). A statistically significant 
coefficient for intervention groups will show that the two groups differ in emergency and 
unplanned medical visits. 
 
Aim 4, Hypothesis 4a: To compare caregiver burden, HRQOL, and satisfaction with roles and 
activities, we will apply t-tests for difference of means for independent samples for those 
measures that are found to have a normal distribution. We will also conduct heterogeneity of 
treatment effects analyses as we planned for other measures. 
 
Aim 4, Hypothesis 4b: Using the Bakas Caregiving Outcomes Scale, Zarit Burden Interview, Sf-
12, and the PROMIS Satisfaction with Social Roles and Activities for caregivers at 3-, 6-, 9- and 
12-month follow-ups as response variables, we will fit a linear mixed model or growth model 
similar to the ones in hypothesis 2.  
 
 
Analysis of heterogeneity of treatment effects (HT-1, HT-3, HT-4) 
We will explore the differential effects of the intervention on patient subgroups defined by factors 
known or hypothesized to have associations with poorer TBI outcome: facility vs. community 
discharge, minority race/ ethnicity, older age, male gender, lack of or lower degree of caregiver 

 
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involvement, greater severity of TBI, presence of pre-injury psychosocial limitations (e.g., 
unemployment, substance abuse) and medical or psychiatric comorbidity, as well as study site, 
resource variability and insurance type. These factors will be entered in a single linear 
regression model in addition to the intervention group, using PART-O-17 as the response 
variable. Before constructing the model, we will assess whether the explanatory variables are 
correlated to each other. When two or more variables are deemed highly correlated, to avoid 
problems with collinearity, we will construct the model with the variable that provides the best 
model (from fit and diagnostic tests).  From previous research,74-80 we hypothesize that severity 
of TBI and presence of pre-injury psychosocial limitations will interact with the intervention 
group, and those interactions will be included in the model.  With our expected sample size we 
anticipate being able to address these questions.   
 
Data Management (IR-2, MD-1) 
 The database will be developed by the National Data and Statistical Center (NDSC) at Craig 
Hospital which has the existing infrastructure and IRB-approved clearances to accept both 
civilian and VA data for the TBIMS program. Only registered TBIMS users will be assigned a 
password to access the database for online data entry. Once data collection is complete, study 
information (recruitment and screening outcome, basic demographic information, data collected 
to test study hypotheses)  will be entered with a participant’s study ID, i.e. not name into a 
password protected NDSC database accessible via secured-internet connection.  
 
Site-specific identifiable information such as name, address, medical record number, email or 
phone numbers will be stored on a secure server at each site in a password-protected database 
separate from study data.  Study data that will be used for data analysis purposes will be stored 
separately on a restricted access server managed by the NDSC. We will maintain a link 
between the identifiers and study data via use of a unique subject identification number.  The 
crosswalk between identifying information and the subject identification number will reside in the 
password-protected databases on a secure server at each site only accessible by study 
personnel. 
 
There are a few exceptions to the separation of identifiers and study data as described above. 
One exception is street address, which will be collected at each time point and stored with 
identifying information on a secure server at each local site for contact purposes AND on a 
restricted access server at the NDSC at the Craig Hospital. 
 
Another exception, as described above, will be the audio recordings of contacts between the 
patient and/or caregiver participants and the TCM. The audio recordings will be labeled with the 
subject’s identification number. The only identifying information that will be contained in each 
recording will be the participant’s voice and if the TCM or other parties state the participant’s 
name during the contact. These recordings will be kept on a secure server of the NDSC which 
can only be accessed by study personnel. 
 
Also, some data regarding “process variables” collected by the study TCMs during contacts with 
participants in the RTP group, e.g. time on phone calls, resources provided to subjects, basic 
needs assessed, etc., will be stored with some identifying information in the password-protected 
TCM database on a secure local server. These data will eventually be sent to the NDSC with 
subject identification number only for permanent storage. 
 
Finally, certain dates that may identify subjects (e.g. date of birth, date of injury, date of 
admission) will also be obtained and entered into the NDSC database along with other study 
data. 

 
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Study databases will be automatically linked to existing TBIMS databases with demographic, 
injury severity, and rehabilitation outcome data collected as part of the TBIMS infrastructure.  
Study researchers will create a crosswalk between the BRITE ID number and original TBIMS ID 
number for all participants enrolled in both studies to allow for merging of the data between the 
proposed study and TBIMS data elements. Project investigators will audit all data entry prior to 
final submission as part of routine TBIMS study procedures. The database sits behind a Cisco 
ASA 5520 firewall on a separate Microsoft SQL 2013 Server and will utilize whole database 
encryption technology using NetLib Encryptionizer (FIPS 140.2 compliant). All local information 
security practices will be implemented.  
 
Due to HIPAA and Institutional Review Board (IRB) guidelines, any personal identifying 
information transmitted from the participant to the research office needs to remain private and 
confidential. As a result, personal identifiable information (PII) of patients approached/enrolled 
at each study site used for contacting and tracking participants will be stored locally in a 
password-protected database on a secure server at each site.  
 
To ensure data quality and minimize missing data, data collectors will be trained and tested on 
established criteria on both medical record abstraction and the measures used in the follow-up 
interview.  In addition several levels of data checks will be implemented. First, when data 
collectors enter data into the web based data entry program they will be notified which fields 
have been skipped. In general all fields, with the exception of some text fields, will have valid 
codes associated with them, so no true blank variables should exist in the database. 
Furthermore, when appropriate, skip patterns will exist for some variables, which can 
automatically populate variables that would then be considered "not applicable".  
The data entry program will also not allow an entry that isn't considered valid mostly through the 
use of drop down controls in which only valid answers are presented.  
 
Second, while data is being entered there will be a process for a data collector to run various 
data checks like logical errors (e.g. injury date occurring before birth date) or data 
inconsistencies (e. g. currently working, but hours of work past week = 0) can be programmed 
into the system to alert the data collector to variables that need attention. Above and beyond the 
notifications of errors and missingness that occurs while a data collector is entering data, all 
authorized people of the study can run real time reports that reflect not only missingness by 
variable, but missingness by person as well. Missing data reports will be reviewed on a quarterly 
basis by staff at the NDSC as well as coordinators at each site. The success of the data quality 
management methods used by the TBIMS is demonstrated in the low levels of missing data 
typically observed. Among TBIMS participants in the 2012-2017 funding cycle, 94% completed 
their 1 year interview and of those, <3% had missing PART-O-17 data.  We would anticipate 
similarly low rates of missing data with the current study (MD-1). 
 
 
REPLICATION AND REPRODUCIBILITY OF RESEARCH AND DATA SHARING 
 
Procedures for the current study will be carefully documented in a Manual of Procedures (MOP) 
document which will be created at the start of the project and updated as needed throughout the 
project period. Adherence to the MOP will be regularly monitored by the lead site, and each site 
PI will ensure adherence to the SOP at their study site. As described above, RDP is already 
being performed at all study sites and will be documented during the study. Likewise, the RTP 
protocol will be carefully delineated in the MOP to ensure the same core ingredients are 
implemented across sites. By using a detailed MOP and documenting procedures in such a way 

 
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that they can be followed uniformly across 6 study sites, it will be possible for other investigators 
to replicate the findings of the current study. Most importantly, it will be possible for other clinical 
teams to replicate the discharge planning protocol that is associated with optimal outcomes. 
 
The MOP will include: (1) an overview of the study, including background information, study 
aims, and hypotheses to be tested; (2) a step-by-step description of recruitment procedures, 
including procedures for initial contact with potential participants, for determining participant 
eligibility (inclusion and exclusion criteria), and for tracking potential participant flow; (3) 
procedures for the informed consent process; (4) participant scheduling procedures; (5) 
randomization procedures; (6) outcome assessment protocols, including timing of assessments, 
detailed descriptions of all of the measures; (7) treatment procedures and logistics;  
(8) strategies for handling participants who drop-out or are unable to be contacted for treatment 
or outcome assessments; (9) a rationale for and strategies to ensure outcome assessors remain 
unaware of participants’ group assignments; (10) general telephone procedures and etiquette; 
(11) data entry procedures, including rules for handling of missing data; (12) data management 
(data definitions, scoring syntax, coding instructions) and planned analyses procedures; (13) 
participant flow tracking procedures (CONSORT); (14) the location of facilities, forms, and 
materials; (15) strategies for handling and recording protocol deviations; (16) the data safety 
monitoring plan; (17) a plan for handling emergent situations (e.g., suicidal ideation in a study 
participant); and (18) procedures for maintaining Human Subjects approvals. Once Human 
Subjects approval is granted at each site, a log of all Human Subjects protocol changes and 
approvals will be kept as a supplement to the MOP. We will also include a tracking log of 
decisions made throughout the study that will be contained within the MOP. 
 
 
Additional sections will be included in this study’s MOP. The manual will include a section 
describing the Stakeholder Engagement Plan, which will include a list of all stakeholders and 
investigators, a governance plan, and a detailed description of the plan itself (e.g., engagement 
activities, frequency, and type). A final copy of the manual will be available to the public on our 
study website within six months of the end of Year 5.  
 
Data Management and Data Sharing  
Study investigators will comply with PCORI’s policy for data management and data sharing. 
Specifically, investigators will make available at the end of the study the following: (1) a full data 
package which includes a final clean and locked data set containing all the data used in the 
analyses described in the PCORI final research report; (2) the study protocol including 
descriptions of study design, procedures and full statistical analysis plan (including all 
amendments); (3) data dictionaries; and (4) and any analytic code used. The study protocol will 
be submitted to the sponsor as a deliverable, whereas the remaining items will be depositied 
into a PCORI-designated repository. Study investigators will participate in a Data Contributor 
Agreement (DCA) with the PCORI-designated repository by  the data when the study 
investigators submit the draft of the final research report to PCORI. The data set must be 
provided to the repository by the date the final research report is accepted by PCORI. The data 
will then become available to outside researchers when the final research report is uploaded to 
the PCORI website, or when the primary paper for the study has been published in a peer-
reviewed journal, whichever comes first. Subsequently an independent committee representing 
the repository will review requests for the data by researchers outside the study.    
 
Specific details regarding PCORI’s policy for data management and sharing here: 
 
 

 
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https://www.pcori.org/sites/default/files/PCORI-Policy-for-Data-Management-and-Data-
Sharing.pdf 
 
 
 
 
 
 
 
 
Location of Facilities, Forms, and Materials 
Facilities 
The six TBIMS sites involved in the current project (University of Washington, Indiana University 
School of Medicine/Rehabilitation Hospital of Indiana, Moss Rehab Hospital, Baylor Institute for 
Rehabilitation, Ohio State University Wexner Medical Center, and Mount Sinai Health System 
(NY)) will enroll participants and collect primary data for this project. The TBIMS infrastructure 
with its demonstrated history of successful enrollment and research infrastructure is well 
positioned to participate in this project. All subcontracted organizations have had extensive 
experience in the TBIMS highlighting organizational support for TBI rehabilitation research. 
Investigators at each of these locations have already been identified and are identifying all 
eligible members of the target population and enrolling the majority who meet the eligibility 
criteria into TBI rehabilitation research projects.  
 
In addition to participating in the primary research data collection, the Traumatic Brain Injury 
Model Systems National Data and Statistical Center at Craig Hospital, CO, will manage data 
collected using established data management and quality standards.  
 
The six TBIMS sites agree that any Confidential Information obtained that is protected health 
information (PHI) of a patient will be kept confidential pursuant to the Standards for Privacy of 
Individually Identifiable Health Information at 45 CFR Parts 160 and 164 (“Privacy Rule”) and all 
other applicable federal, state, and local laws, statutes and regulations, as well as each sites 
own internal rules and regulations governing the confidentiality of patient records and 
information.  
 
Forms 
The case report forms will follow guidelines set forth by the NDSC to align with the database. 
Access to the paper CRFs /eCRFs will be limited to personnel directly participating in the study. 
Data should be entered into the CRFs/eCRFs completely by examining personnel or the study 
coordinator. The CRFs/eCRFs must be completed as soon as possible after any subject 
evaluation or communication.  
 
Copies of the most recent CRFs are located on the BRITE website in the ‘Study 
Materials’ folder under the ‘SOP’ tab. 
 
Security of records: The following protocol will be used to ensure the security on non-electronic 
study documents: a) Signed  consent forms will be stored in a locked filing cabinet in a non-
public area; b) All confidential documents that are disposed of will be placed in a locked 
confidential document–recycling container; c) All electronic identifying information will be stored 
in separate files from other data; and d) All files will be password protected and stored on a 
secured and restricted server. 
 

 
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Please see the “Data Management” section above for a listing of exceptions to the separation of 
identifiers and study data as described above. 
 
Materials  
Portions of medical charts will be reviewed to determine participant eligibility. These procedures 
will be approved by IRBs at all sites for TBIMS and meet HIPAA regulations. Once informed 
consent takes place, additional data regarding the injury will be gathered from the medical 
record including severity and cause of injury, demographic information (such as age), and 
comorbid diagnoses. All data obtained from participants or their proxies will be collected via 
interviews (either in person or over the phone).  
The interviews will contain questions about current and past psychiatric history, current mood, 
post TBI symptoms, and need for assistance. Study data will be stored at the TBI National Data 
Center while all identifying personal contact and/or health information will be stored at each 
local site. These data will be linked via study code number and research staff will have access 
to participant identities.  
 
Pertinent Websites  
 
National Data and Statistical Center Main Support Website:  
 
https://www.tbindsc.org/Contact.aspx 
 
This website serves as the portal for all data collected for the TBIMS study, as well as basic 
SOPs pertaining to TBIMS. 
 
National Data and Statistical Center BRITE Study Website: 
 
https://brite.tbindsc.org/Default.aspx 
 
This website serves as the portal for all data collected specifically for the BRITE study. It also 
houses all study materials, study protocol, and MOPs pertaining to TBIMS. 
 
Pertinent List serves  
Study researchers have created list serves to facilitate effective communication during the 
course of the study.  Study researchers can sign up for each pertinent list serve to send and 
receive regular updates pertinent to study implementation. 
 
Study staff: brite_studystaff@lists.osu.edu 
 
Data Collectors: brite_datacollectors@lists.osu.edu 
 
Investigators: Brite_investigators@lists.osu.edu 
 
TCMs: Brite_tcm@lists.osu.edu  
 
Professional Stakeholders: brite_professionalstakeholders@lists.osu.edu 
 
Patient and Caregiver Stakeholders: brite_consumerstakeholders@lists.osu.edu 
 
Website, Subscription to List serves: https://lists.osu.edu/mailman/listinfo/XXX  
 

 
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Example: 
https://lists.osu.edu/mailman/listinfo/brite_professionalstakeholders 
 
 
 
 
 
 
 
 
SAFETY MONITORING 
Adverse Event  and Serious Adverse Event Information: Definitions 
Adverse Event 
An adverse event (AE) is any untoward medical occurrence in a participant during participation 
in the study regardless of randomization assignment. An adverse finding can include a sign, 
symptom, abnormal assessment (laboratory test value, vital signs, electrocardiogram finding, 
etc.), or any combination of these. Staff will document any occurrence that: 
1) meets the definition above; 
2) is a new symptom/condition for the participant, OR a symptom/condition that began 
before enrollment yet has become significantly worse following enrollment;  and  
3) results in or warrants treatment by a health care provider.  
  
The relationship between the event and study procedures will be determined by research staff.  
Research staff will be instructed to seek counsel from study investigators if the relationship is 
unclear. 
 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is any AE as described above which results in one or more of 
the following outcomes: 
• 
Death 
• 
A life-threatening event 
• 
Inpatient hospitalization or prolongation of existing hospitalization  
• 
A persistent or significant disability/incapacity that began following enrollment 
• 
A congenital anomaly or birth defect 
• 
An important medical event based upon appropriate medical judgment 
 
An AE is also considered serious when medical, surgical, behavioral, social or other intervention 
is needed to prevent such an outcome.  
 
We do not document a planned surgery as an AE UNLESS the surgery stems from an acute 
untoward medical occurrence, i.e. surgery as an intervention to prevent a worse outcome based 
on the acute occurrence. Also, we will document a planned surgery if there are complications 
from the surgery that require hospitalization.  In this scenario, the complications rather than the 
surgery itself is the SAE, but we will document the surgery as the primary factor that contributed 
to the SAE.  
  
Any unplanned surgery will still be documented as an adverse event.  
 

 
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AE Attribution Scale  
Relationship of event to study procedures:  
None – the event can be readily explained by some other cause or no relationship exists 
between the study procedures and the event. 
Unlikely – the temporal relationship between the event and the administration of the study 
procedures is uncertain and it is likely that the event can be explained by other causes. 
Possible – there is some logical temporal relationship between the event and the administration 
of the study procedures and the event is unlikely to be explained by other causes. This category 
may include incidents that arise from use or attempted use of a strategy prescribed in a case 
management session. 
Probable – the temporal relationship is compelling between the administration of the study 
procedures and the event cannot be explained by other causes. This category may include 
incidents that arise from use or attempted use of a strategy prescribed in a case management 
session. 
 
AE Documentation 
Each incident that meets the definition of an AE as listed above will be documented via entry 
into the appropriate data form on the NDSC website within a  month of when the incident was 
detected by research staff. NDSC staff will send a reminder email to study coordinators to enter 
data for AEs within the past month.  
 
SAE Reporting and Documentation 
SAEs that are unanticipated and possibly related to the study intervention will be reported to the 
respective site PI, the lead site PI, chair of the DSMB, the respective IRB, and the PCORI 
Program Official in accordance with requirements.   
1. Unanticipated fatal or life-threatening SAEs related to study procedures will be reported 
all parties listed above immediately. 
2. Other unanticipated SAEs related to study procedures will be reported to the respective 
site PI and lead site PI within 24 hours.  The SAE will be reported to the respective IRB 
according to that institution’s requirements. The event will be reported to PCORI 
promptly but no later than 10 days after reporting the event to the IRB. 
3. Anticipated or unrelated SAEs will be reported to the DSMB and PCORI  as part of the 
bi-annual and annual DSM reports.  These DSM reports will also be submitted to each 
site’s IRB.  
Study researchers will contact the Chair of the DSMB when an SAE that fits into the first two 
categories listed above is discovered within one week of discovery.  The Chair of the DSMB will 
use his discretion to determine whether the other DSMB members should also provide 
additional consultation. The chair will then provide any suggestions for corrective action within 
two weeks of notification. 
 
Each incident that fits into the first two categories listed above will be documented via entry into 
the appropriate data form on the NDSC website within 5 business days of when the incident 
was detected by research staff. Each incident that fits into the third category listed above will be 
documented via entry into the appropriate data form on the NDSC website within one month of 
when the incident was detected by research staff.  
 

 
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As per PCORI guidelines, any decision, finding, recommendation or action of the DSMB or IRB 
relating to any SAEs will  reported to PCORI promptly but no later than 10 days after the 
decision, finding, recommendation or action has been made. 
 
 
 
 
 
 
Unanticipated Problems Information: Definition 
Study researchers consider unanticipated problems, in general, to include any incident, 
experience, or outcome that meets all of the following criteria: 
• 
unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the characteristics 
of the participant population being studied; 
• 
at least possibly related to participation in the research (in this guidance document, 
possibly related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); and 
• 
suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized.* 
• 
An adverse event is an unanticipated problem if it meets the three criteria described 
above. 
 
For the purposes of this study, breach of confidentiality or inappropriate access to protected 
health information are considered serious unanticipated problems and will be shared with the 
DSMB. 
 
 
* Source: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-
unanticipated-problems/index.html#Q2 
 
Unanticipated Problems: Documentation and Reporting 
Any event that is unanticipated, places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized, 
and possibly related to the study procedures will be reported to the respective site PI, the lead 
site PI, chair of the DSMB, the respective IRB, and the PCORI Program Official in accordance 
with requirements.   
1. Breaches of confidentiality or inappropriate access to protected health information will be 
reported to all parties listed above immediately. 
2. Other serious unanticipated problems related to study procedures will be reported to the 
respective site PI and lead site PI, within 24 hours.  The unanticipated problem will be 
reported to the respective IRB according to that institution’s requirements. The event will 
be reported to PCORI promptly but no later than 10 days after reporting the event to the 
IRB.   
 

 
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Study researchers will contact the Chair of the DSMB when an unanticipated problem is 
discovered within one week of discovery.  The Chair of the DSMB will use his discretion to 
determine whether the other DSMB members should also provide additional consultation. The 
chair will then provide any suggestions for corrective action within two weeks of notification. 
 
Each incident that meets the definition of an unanticipated problem will be entered into the 
appropriate data form on the NDSC website within 5 business days of when the incident was 
detected by research staff.  
 
 
 
As per PCORI guidelines, any decision, finding, recommendation or action of the DSMB or IRB 
relating to any SAEs will be reported to PCORI promptly but no later than 10 days after the 
decision, finding, recommendation or action has been made. 
 
Protocol Deviations, Violations, Other Pertinent Documentation 
Study researchers will document any protocol deviations, violations or events that may 
jeopardize the integrity of the study in a ‘Note-to-File’ using a standardized template across all 
sites. Regarding protocol deviations: staff will document only deviations that are within the 
control of research staff, for example completing a questionnaire outside of the questionnaire 
window. Research staff will not document deviations outside of  the staff’s control, however, for 
example when a patient fails to be available for a study questionnaire. Each incident will be 
entered into the appropriate data form on the NDSC website within a  month of when the 
incident was detected by research staff. NDSC staff will send a reminder email to study 
coordinators to enter data for any pertinent incidents within the past month.  
 
Data Safety Monitoring Board (DSMB) 
A Data Safety and Monitoring Board (DSMB) will be led by Thomas Novack, PhD, PI of the 
University of Alabama Birmingham TBIMS, Lillian Lin, PhD a biostatistician from Montana State 
University and a currently unidentified TBI patient and family member. The DSMB will monitor 
the study and review the following: a) participant recruitment, accrual, retention, and withdrawal 
information; b) adverse events (AEs) and serious adverse events (SAEs); c) comparison of 
events that occur between treatment arms; d) individual events of particular concern; e) 
participant interview and/or performance status outcomes; f) other safety-supporting data 
requested by the DSMB; and g) summary of protocol violations, completeness and timeliness of 
study visit data, enrollment eligibility and ineligibility information, noncompliance, and 
unanticipated problems. Safety monitoring will focus on detection and monitoring of adverse 
events at the individual participant level.  
 
Bi-Annual DSM Report 
Starting six months following the onset of recruitment, research staff will generate a report that 
includes the rate of participant accrual and compliance with inclusion/exclusion criteria to ensure 
that a sufficient number of participants are being enrolled to allow for an adequate test of the 
primary study hypothesis and that they meet eligibility criteria. The report will also include 
information regarding the frequency, type and details of AEs, SAEs, unanticipated problems and 
protocol deviations/violations that warrant a note-to-file that occurred since the onset of 
recruitment. The report will also include information regarding participant progress and retention 

 
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in the form of a CONSORT diagram. This report will be provided to the chair of the DSMB for 
review.  The chair of the DSMB may solicit input from the other DSMB members if he detects 
anything of concern (e.g., higher rates of AEs than anticipated). The Chair of the DSMB will 
generate a summary of concerns and recommendations, and sign the summary. The Bi-Annual 
DSM report (along with the DSM chair’s summary if applicable) will be provided to all study 
researchers (excluding unblinded information), and respective IRBs as needed.  
In addition, the DSM report will be submitted to PCORI as part of the subsequent interim 
progress report. This bi-annual report will take place every six months between annual reports.  
 
 
 
Annual DSM Report and Meeting 
One year following the onset of recruitment, research staff will generate a report that includes all 
information covered in the bi-annual report described above. In addition, the annual DSM report 
will address (1) whether AE rates are consistent with pre-study assumptions; (2) reason for 
dropouts from the study; (3) whether continuation of the study is justified based on the adverse 
events observed up to the specific meeting; and (4) conditions whereby the study might be 
terminated prematurely.  
 
The Annual Report will be sent to all members of the DSMB to review two weeks prior to the 
meeting that will be conducted via phone or Zoom. The report will also be provided to the 
funder, PCORI, at the same time. PCORI will be informed of the date and time of the meeting 
should a representative(s) wish to attend.  
 
Subsequently the DSMB along with the Lead PIs (Hoffman and Fann), PCORI program 
members (if desired), and an individual independent of the study serving as the secretary will 
convene via teleconference to review and discuss the report. The meeting may consist of the 
following sessions: 
 
Open Session: This session will take place at the beginning of the meeting.  The DSMB 
members, DSMB meeting secretary, lead site principal investigators (Hoffman and Fann), study 
statistician (Ciol) and site investigators as well as PCORI representative(s), if desired, will attend 
this session. The open session will consist of the investigators and study statistician reviewing 
the report with the DSMB members, and answering any questions from the DSMB members 
about any incidents/study procedures that warrant further investigation.  
 
Closed Session (if desired by DSMB):  Only the DSMB members, secretary and study 
statistician will be present during the closed session.  They will discuss the contents of the 
report, any concerns they might have, any unblinded analyses the DSMB members want the 
statistician to conduct, whether the study warrants continuation based on its risk/benefit ratio, 
and formulate any recommendations moving forward.  The DSMB may opt not to conduct a 
closed session if deemed unnecessary. 
 
The meeting secretary or DSM chair will send the meeting summary, including summary of 
topics discussed and DSMB recommendations, to the lead site PIs within two weeks of the 
meeting.  The lead investigators will then compose responses to each of the DSM’s 
recommendations including any follow-up plans.  These responses will then be sent to the 
DSMB chair for review and approval within four weeks of the meeting.  The DSMB chair may 
request clarification or changes to the summary as needed.  The DSMB chair will sign the 
summary to indicate approval. 
 

 
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The annual DSMB report along with the DSMB summary will be provided to study researchers 
(excluding unblinded information), and respective IRBs as needed. In addition, the DSM report 
will be submitted to PCORI as part of the subsequent interim progress report. This annual report 
and meeting will take place once annually following commencement of recruitment. The final 
report and meeting will take place on the anniversary that follows the end of all subject 
participation. 
 
 
 
 
 
 
Table 1. Frequency of Data Review, External 
 
Data type 
Frequency of review 
External Reviewer 
Study-Related SAEs* 
Per occurrence 
DSMB Chair, PCORI, 
IRB 
Unanticipated Serious Problems* 
Per occurrence 
DSMB Chair, PCORI, 
IRB 
Participant accrual, eligibility criteria* 
Monthly 
PCORI 
Participant Progress and Retention** 
Bi-Annual 
DSMB Chair, PCORI, 
IRB 
Anticipated, Unrelated SAEs** 
Bi-Annual 
DSMB Chair, PCORI, 
IRB 
AEs** 
Bi-Annual 
DSMB Chair, PCORI, 
IRB 
Protocol Deviations/Violations** 
Bi-Annual 
DSMB Chair, PCORI, 
IRB 
Reason for Drop Outs** 
Bi-Annual 
DSMB Chair, PCORI, 
IRB 
Justification Continuation of Study, 
Risk/Benefit Ratio 
Annual 
DSMB Chair, PCORI, 
IRB 
 
*These elements will also be included in the bi-annual and annual DSMB reports. 
**These elements will also be included in the annual DSMB reports. 
 
Data Quality Assurance and Monitoring 
Description of Plan for Data Quality and Management    
Research staff will review all data collected on an ongoing basis for data completeness and 
accuracy as well as protocol compliance.  
TCM contacts with patients and caregivers will be audio recorded to ensure compliance to 
treatment procedures.   A portion of these contacts will be randomly selected to be reviewed by 
study researchers to ascertain fidelity to protocol. TCMs will receive feedback as needed if they 
diverge from protocol. 
 

 
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In addition, research study staff will review the study data in detail on a quarterly basis to detect 
any systematic issues with data collection.   
 
Internal Monthly Report 
Review of the rate of participant accrual and compliance with inclusion/exclusion criteria will 
occur monthly to ensure that a sufficient number of participants are being enrolled to a) allow for 
an adequate test of the primary study hypothesis; and b) ensure all enrolled participants meet 
eligibility criteria. These reports will be shared across all sites and with PCORI.  
 
 
 
 
Internal Quarterly Report 
Each quarter NDSC staff will generate a report that includes the information contained in the 
monthly report as well as information regarding the frequency, type and details of AEs, SAEs, 
unanticipated problems and protocol deviations/violations that warrant a note-to-file that 
occurred per site for that particular quarter. The report will also include information regarding 
participant progress and retention in the form of a consort diagram. This report will be provided 
to all study researchers. 
 
Frequency of Data Review 
The frequency of data review for this study differs according to the type of data and can be 
summarized in the following table: 
 
 
Table 2. Frequency of Data Review, Internal  
 
Data type 
Frequency of review 
Reviewer 
Study-Related SAEs* 
Per occurrence 
Site and Lead Site PI 
Unanticipated Serious Problems* 
Per occurrence 
Site and Lead Site PI 
Participant accrual, eligibility criteria* 
Monthly 
All Study Researchers 
Participant Progress and Retention 
Quarterly 
All Study Researchers 
Anticipated, Unrelated SAEs 
Quarterly 
All Study Researchers 
AEs 
Quarterly 
All Study Researchers 
Protocol Deviations/Violations 
Quarterly 
All Study Researchers 
Reason for Drop Outs 
Quarterly 
All Study Researchers 
 
*These elements will also be included in the quarterly reports. 
 
Study Discontinuation  
Participation in the study will be stopped prior to its completion if: (1) the RTP approach is 
associated with adverse effects that call into question the safety of this approach; (2) any new 
information becomes available during the trial that necessitates stopping the trial; or (3) other 
situations occur that might warrant stopping the trial. 
 
 
 
 
 

 
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 ENGAGEMENT PLAN (Criterion 2, 4, 5, PC-1, PC-3, PC-4, RQ-1, RQ-3, RQ-6) 
 
Patient Partner and Stakeholder Engagement Activities 
 Members of our research team have over 20 years of experience conducting Participatory 
Action Research (PAR) in which people with TBI have participated actively on Consumer 
Advisory Boards that guide our research. The current grant grew out of focus groups held 3 
years ago for the Galveston Brain Injury Conference (GBIC; mentioned above) by the Study PI 
(Hoffman) and Mount Sinai Health System (NY) Site PI (Dams-O’Connor). The themes that 
arose led us to want to address the fact that many people in our own communities were not 
getting the care they needed or were unaware of key resources in the community which would 
maximize their function. Their stories have been heard again and again as we have sought 
more specific guidance for this grant. We began by running focus groups at 4 of the 6 study 
sites to ensure that the concerns raised initially about transitions were still meaningful and what 
we learned only increased our desire to design a study which could make a meaningful impact 
for TBI Survivors and their families. We decided to recruit TBI survivors and family members to 
work with us on the design and focus of our grant. We have been overwhelmed by the desire 
and passion we have seen  to participate with us as key personnel for research (including 
participating as they have with study decision making) and as members of our Study Advisory 
Committee (SAC). We were easily able to identify patient stakeholders who are part of our 
specific target population. That is, they include those with moderate-to-severe TBIs, all of whom 
had input on difficulties they experienced after being discharged from inpatient rehabilitation. 
The Patient and Family Stakeholders (which includes 8 TBI Survivors and 5 family members) 
will form one arm of our SAC. Irene Zaiya, a TBI survivor and social worker, will serve as Chair 
of the Patient and Family Stakeholder arm of the SAC and will be directly supported by the 
study PIs (Hoffman & Fann). The Patient and Family stakeholders will have ongoing direct 
support from our Project Manager (Kempthorne) to 
assist with all study related activities (including 
managing stipends, travel arrangements, managing 
information, training in technology, etc.).  
 
Next, we recruited Clinical, Policy/Advocacy and 
Payer stakeholders to form the Professional 
Stakeholder arm of the SAC. One subset includes 
clinicians that serve people with TBI. This group has 
already shared important insights into the strengths 
and gaps in the system of care and will be crucial to 
enabling our comparator systems of care and in 
guiding dissemination and implementation of study 
results. Members of our team have reached out 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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systematically to regional and national advocacy groups and policy leaders to form an 
unprecedented collaboration between the TBI, healthcare, and payer communities. These 
individuals include leaders from hospital administration, state TBI Council and Support Systems, 
and national and state advocacy and policy leaders such including key persons at the Brain 
Injury Association of America, CARF, State Brain Injury Associations/Alliances, and the 
American College of Surgeons. 
 
 
We have already gained stakeholders from large payer groups including Molina Healthcare, The 
Hartford / Labor and Industries, Paradigm Outcomes and Centers for Medicare and Medicaid 
Services.  Study Co-Principal Investigator Fann chairs the Professional Stakeholder arm for the 
study.  
 
Together, Ms. Zaiya and Dr. Fann co-direct the engagement process. They will be 
responsible for chairing regularly scheduled meetings and for maintaining the Engagement Log. 
As illustrated by the figure above, the Patient and Family Stakeholder and Professional 
Stakeholder arms of the SAC have a collaborative partnership with the research investigators 
and consultants. Because Patient and Family Stakeholder partners will participate in research 
decision making we will have more frequent meetings with them (once per month) and will meet 
for the first year separately in quarterly meetings to ensure that each group of stakeholders is 
able to have adequate time to contribute their expertise to the research process. The entire SAC 
will meet in person once a year to provide in person updates and allow for interaction around 
new issues or potential results as they arise. To ensure ongoing close communication between 
the investigators and stakeholders, the PI, Co-PI and site PIs will be ex officio members of the 
SAC and will be invited to attend all SAC meetings. Patient partners may attend monthly 
investigator team meetings to remain engaged in the research process and provide input and 
assist with decision making throughout the study, and Ms. Zaiya and Dr. Fann will have primary 
responsibility for ensuring robust communication among investigators and SAC members.  Initial 
meetings will include some training to all interested SAC members (Patient and Family 
Stakeholders as well as Professional Stakeholders) on the research process to ensure that we 
are all speaking the same language around the conduct of the study. We have provided some 
initial education on the research process to our Patient and Family Stakeholders during planning 
teleconferences and plan to have another teleconference to conduct a training on research 
(such as a “Research 101” lecture) and the specifics around this grant, including timelines and 
requirements from PCORI. The figure below illustrates our meeting schedule and the 
overlapping attendance of our investigators and both groups of stakeholders to ensure robust 
communication across groups.  
 
 
Investigator & Stakeholder Meetings 
 
 
Patient & 
Family (P&F) 
Stakeholders 
Professional 
Stakeholders 
Lead Site 
PIs 
Site PIs 
Weekly/Monthly 
Investigator 
Meetings 
X 
(P&F Chair to 
attend at least 
1x/mo. and 
review all 
minutes.) 
 
X 
X 
Monthly Patient 
& Family 
X 
 
X 
X 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Stakeholder 
Meetings 
(invited, 
particularly 
for targeted 
topics) 
Quarterly 
Professional 
Stakeholder 
Meetings 
 
(P&F Chair to 
attend) 
X 
X 
X 
(invited) 
Annual In-
Person SAC 
Meetings 
 
X 
X 
X 
X 
 
We held meetings early in the study timeline to focus on study development (reviewing informed 
consent materials, recruitment materials, resource list development) and creation of materials to 
assist the TCMs. Mid-study we anticipate ongoing input in the study and assistance in 
addressing any issues with recruitment or retention as well as development and dissemination 
of consumer focused materials. Towards the end of the study we plan to have the SAC involved 
with interpretation of study findings and input on plans for dissemination and implementation of 
results.  
 
Planning the Study 
The present study design is informed by over 20 years of patient-centered research conducted 
by our team, extensive literature review, and input from focus groups and individual and group 
meetings with our Patient and Family Stakeholder members. Patient and Family Stakeholders 
provided critical input on how the interventions should be delivered. The investigators were 
enthusiastic about using the telephone, as well as computers and mobile devices to deliver the 
interventions. However, several patient partners pointed out that knowing who to contact in case 
of problems was a significant concern. This led to us ensuring all parties had access to the TCM 
via telephone during regular business hours, and making sure all key contacts will be included 
in the TBI Care Plan. Another patient partner emphasized the importance of helping them 
connect with and inform their primary care provider about their TBI. Consequently, we have 
included primary care in our Professional Stakeholder group and will ensure that the discharge 
plan is communicated to each patient’s primary care provider.  
 
The upshot of these conversations has been that transition care must be flexible and tailored to 
individual patient needs and preferences. As we meet in the future we are certain to discover 
other ways the protocol will need to be adapted to the needs of this patient population.  
 
Meetings with Patient and Family Stakeholders also led to the decision to have two primary 
outcomes: participation in roles and activities and quality of life. Input from clinician 
stakeholders, which included primary care, confirmed the notion that existing systems of care 
are inconsistent and inadequate to meet the requirements of people with TBI and that efficient, 
well-defined case management models of care should be used to facilitate a comprehensive TBI 
care plan to help those in need. Our patient partners and stakeholders all agreed that the lack of 
consistent and evidence-based patient-centered guidelines required the inclusion of at least 2 
comparators: one that used a brief in-hospital approach and one that used a remote, temporally 
extended case management approach.  
 

 
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In addition to input from our Patient and Family Stakeholder members, we gathered information 
about experiences with different health care systems after TBI from patient and family/caregiver 
focus groups. Focus groups with patients highlighted the need for better patient and provider 
education (“I feel like I've spent a lifetime educating providers about a TBI”) and support (“I felt 
totally abandoned after leaving the hospital”).  
 
 
Conducting the Study 
Patient and family partners, clinicians and TBI advocacy/policy representatives have agreed to 
participate in the conduct of the study as members of the SAC. During the start-up phase, 
Patient and Family Stakeholders and Professional Stakeholders will be recruited to be on the 
teams assigned to develop, refine or confirm aspects of the study such as consent forms, 
satisfaction assessment questions, intervention rollout, study advertisement and patient/provider 
information materials and care plans.  
 
They will participate in conducting the study as follows:  
 
Monthly SAC Patient and Family Stakeholder Meetings  
The patient partners will be asked to help problem-solve issues that arise regarding patient 
satisfaction, utility of patient care resources, and recruitment. They will also be involved in 
helping to develop data collection procedures, interpretation of data, and implementation and 
dissemination activities.  
 
Quarterly SAC Professional Stakeholder Meetings:  Professional Stakeholders will participate in 
recruitment and developing the resources needed for the TCM at each site and ensuring 
consistent resources are sought in each area of the country. They will also be involved in data 
procedures and the interpretation of the data analyses. Stakeholders will meet to review 
progress toward study goals and discuss ways of improving study implementation and 
dissemination.  
 
Annual Study-Wide Meeting 
All key investigators and SAC members will attend an annual meeting in which study progress 
and problems are discussed. Workgroups will be formed to address study problems or lead 
work toward upcoming milestones. Every effort will be made to facilitate in-person attendance 
among patient stakeholders, although due to medical limitations it is expected that some patient 
SAC members may need to attend via teleconference or videoconference. Due to scheduling 
and work demands, some of our Professional Stakeholders can more conveniently attend via 
tele/videoconference. 
 
Funding Support  
Given that implementation of effective clinical interventions is a goal both for PCORI as well as 
for our stakeholders, we have partnered with key stakeholders that will be influential in 
developing a sustainable plan for future funding. We sought support from several hospital 
administrators at our sites (such as Peter Esselman, MD and Brian Giddens, LICSW, ACSW at 
UW Medicine; Alberto Esquenazi, MD and Thomas Smith, OTL/R, MBA at MossRehab Hospital; 
W. Jerry Mysiw, MD and Amanda Lucas, Med, MBA at Ohio State University Wexner Medical 
Center; and Fabien Polo, PhD, MBA at Baylor Institute for Rehabilitation). These individuals 
have endorsed the RTP intervention and have assured us that we are collecting the specific 
data needed to secure funding for TBI Care Manager positions if results of the study are 
favorable.  
 

 
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In addition, we have partnered with stakeholders from Labor and Industries (The Hartford) and 
the Veterans Health Administration to provide input on how the TCM is implemented within their 
system; from large insurers including Medicare (Centers for Medicare and Medicaid Services) 
and Medicaid (Molina Health) to address how an effective TBI transitional care intervention may 
be added to insurance plans; and from our state Brain Injury Associations/Alliances and 
Councils and CARF who provide input to policy makers in each state and at a national level on 
funding for individuals with TBI. In addition, we have heard from groups such as the WA State 
TBI Council that they would be interested in funding such a position in the future to cover the 
entire state, and would consider funding the research process, but would only be able to fund 
one (WA) site if they have funds available.  
 
 
Disseminating the Study Results 
During monthly meetings with investigators, including Patient and Family Stakeholder partners, 
and quarterly Professional SAC meetings, we will devote time to discussion of dissemination 
activities.  
 
Patient and Family Stakeholders and other advisors will participate in all aspects of 
dissemination including authorship as appropriate (consumer/staff have previously authored 
papers with us).123-125 In year 1, during the start-up phase, we will solicit input on how the study 
materials should be designed.  
 
Input will be sought on content, wording and other media outlet options. We will discuss what 
information patients and other stakeholders might want to know about, optimal media types, and 
editing for other audiences. In year 5, we will solicit help to understand the implications of the 
study for different stakeholder groups. Following that, together we will design dissemination 
products that target different audiences and media. We will leverage our group’s significant 
leadership positions in key organizations and platforms, such as the TBIMS Knowledge 
Translation Center, national (Ayotte) and state (various study members) Brain Injury 
Associations/Alliances, annual Galveston Brain Injury Conference (several study members), the 
National Association of State Head Injury Administrators (Rogers) to advance policy and clinical 
practice guidelines. We also plan to include at least one stakeholder from the American College 
of Surgeons and its Committee on Trauma to assist with dissemination and implementation 
activities. See Dissemination and Implementation Potential for more details. 
 
 
Principles for Engagement 
Reciprocal Relationships 
Our approach is to operate on a non-hierarchical, team-based organizational model where all 
Patient and Family Stakeholders, Professional Stakeholders and investigators contribute equally 
and decision-making is by consensus. We use an evidence-based approach to creating smarter 
teams and better decisions.126 That is, we emphasize that as far as possible in meetings, all 
team members participate equally, that teams have good representation of women, minorities 
and team members with diverse areas of expertise and opinions and pay special attention to the 
feelings, knowledge and beliefs of other team members. SAC Patient and Family Stakeholder 
and Professional Stakeholder chairs will be responsible for promoting and following these 
principles.  
 
Co-learning 
While it would be too cumbersome to include all investigators, Patient and Family Stakeholder 
and other Professional Stakeholders in all telephone-based meetings, we will ensure that there 

 
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is committee membership crossover and regular opportunities for interactions among 
investigators, Patient and Family Stakeholders and Professional Stakeholders. As noted above, 
selected investigators, patients and other stakeholders will routinely attend each other’s 
committee meetings. The annual study-wide Investigator-SAC meeting will feature the 
perspectives and work of each of the teams as a means of co-learning. 
  
Partnership 
Patient and Family Stakeholder partners and other stakeholders will receive similar annual 
financial remuneration from the study for their participation and additional funds for travel to our 
annual in-person meeting.  
We are asking patient partners to meet for shorter times but more frequently because we 
anticipate needing their input on an ongoing basis given their role as co-investigators.  
The Professional Stakeholder group will meet quarterly as they will be engaged less in day-to-
day operations and more attuned to overall trends in progress toward major milestones.  
 
We have arranged to pay Patient and Family Stakeholders as consultants on this grant--not 
paid staff. This is because our study sites are equal opportunity employers and cannot lawfully 
limit job candidates to people with TBI. We are paying stipends for the time they will spend 
participating in the study and will make travel arrangements for all of our Patient and Family 
Stakeholders to reduce any financial burden. At this time we anticipate paying all of our Patient 
and Family Stakeholders as equal partners in our grant.  However, we understand that some 
patients, due to funding for their medical care or disability related needs, may not be able to 
accept payment and will work with each member to address this individually.  
 
We have also budgeted to compensate study participants for the time it takes them to complete 
their assessments. Our core budget will pay for teleconferences.  
 
Trust, Transparency, Honesty 
We will embody these principles in several ways. We will survey all study team members 
annually to measure their satisfaction with their engagement with the study, barriers and 
facilitators to engagement and opportunities to improve engagement and decision-making. 
Minutes of all study team meetings and raw data on study performance metrics (e.g., accrual, 
retention, satisfaction, engagement) will be disseminated to all team members to promote 
transparency. The roles and responsibilities of each member of the research, Patient and 
Family Stakeholder and Professional Stakeholder teams, as well as the rules for decision-
making and conflict resolution will be developed by consensus and codified in the Manual of 
Procedures. Travel costs will be provided for all in-person SAC meetings.  
The study website that will be designed for this study will contain a private chat function where 
members of our study team, including Patient and Family Stakeholders and Professional 
Stakeholders, can share ideas and concerns. 
 
 
Program Evaluation 
We will conduct a summative program evaluation with groups of stakeholders (i.e., patients, 
caregivers, clinicians) at the end of the study period and follow the Centers for Disease Control 
Framework for Program Evaluation on Public Health.127 This program evaluation will (1) 
evaluate the effectiveness (merit, worth, and significance) of the intervention to stakeholders, 
and (2) identify suggested modifications to the intervention based on stakeholder experiences. 
Each site will randomly recruit 15-20 stakeholders who were involved with the intervention 
(participants, interventionist, clinicians, researchers) and complete a structured focus group to 

 
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discuss topics including barriers and facilitators to the intervention, positive and negative 
outcomes of participation, cultural applicability, and recommendations for modification (e.g., 
intervention intensity, duration, mode). Results from each site will be aggregated into a final 
report so that lessons learned can be shared with stakeholders to inform future iterations of the 
intervention and ensure appropriate modifications are made to maximize the benefit for 
stakeholders.128 
 
 
 
 
RESEARCH TEAM AND ENVIRONMENT 
The six study sites were chosen based on interest and patient engagement early in the process 
of the development of the grant. All sites, as mentioned previously, are TBIMS centers who 
have had experience working with each other through multi-site projects funded within the 
NIDILRR TBIMS (module projects) as well as with external funding (NIH, etc.). Specific interest 
in the comparative effectiveness trial is high for TBIMS sites that don’t currently have a case 
management or other type of discharge model. But all six sites included have excellent 
resources.).    
 
The TBIMS Partnership 
The proposed project is enhanced by the fact that it will leverage resources and known 
collaborators from the multi-institutional TBIMS Program of research funded by NIDILRR. The 
TBIMS program is a longitudinal multi-center study which examines the course of recovery and 
outcomes following the delivery of a coordinated system of acute neurotrauma care and 
inpatient rehabilitation. To date, over 15,000 participants have been enrolled over the past 25 
years in the civilian TBIMS centers.54 The TBIMS lifetime study conducts annual follow-up at 1, 
2, 5, 10, 15 and every 5 years thereafter. The TBIMS infrastructure has successfully yielded 
collaborations receiving additional funding from the Department of Defense, Centers for Disease 
Control, and National Institute of Health. To date, over 713 peer-review publications have been 
generated from TBIMS data and are logged in a registry online 
(http://www.msktc.org/publications?sys=T). This historical and well-established infrastructure will 
serve as an invaluable resource for completion of this proposed study.  
 
The TBI Model System National Data and Statistical Center and Knowledge Translation 
Center 
The NIDILRR TBIMS infrastructure includes a National Data and Statistical Center 
(www.tbindsc.org) that currently houses all TBIMS data with rigorous data quality procedures 
already in place. The National Data and Statistical Center organizes meetings for principal 
investigators and co-investigators meet twice per year in Washington DC for project 
management, collaboration, and strategic planning. Further, the NIDILRR funded Model System 
Knowledge Translation Center (MSKTC) which meets with TBIMS investigators in Washington, 
DC, is a resource for translating model systems science into products for various stakeholders 
including patients, caregivers, administrators, and policymakers. Their MSKTC website 
(www.msktc.org/tbi) is accessed internationally with downloadable material on topics generated 
by stakeholders with input from TBIMS scientists. Products generated on the topic of TBI 
include slideshows, fact sheets, short patient-focused videos on topics of interest, systematic 
reviews, publications database, research summaries, and links to other resources. The MSKTC 
meets with the TBIMS investigators in Washington DC twice yearly for input and development 
on new topics. This project will continue to leverage this resource for dissemination and 
implementation activities proposed in this project. Several study investigators serve on the TBI 
Model System Knowledge Translation Committee.  

 
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The TBI Model System Investigators 
The TBIMS infrastructure with its demonstrated history of successful enrollment and research 
infrastructure is well positioned to support study investigators. TBIMS Principal Investigators 
(Hoffman, Bogner, Hammond, and Dams O’Connor) and co-investigators (Corrigan, Fann, 
Driver, Dubiel, Whyte, and Watanabe) from six TBIMS centers (WA, IN, TX, OH, NY, PA) are 
collaborators in this study and all have engaged in prior multi-site collaborations either funded 
through NIDILRR or other mechanisms highlighting organizational support for TBI rehabilitation 
research. 
 
These investigators have already identified and are enrolling the population for this study into 
TBI rehabilitation research projects. The sites are members of a special interest group (SIG) 
within the TBIMS center which has been meeting for more than one year to develop the current 
project, including twice per year in Washington DC for face-to face meetings. The meeting 
schedule includes both teleconferences as well as face-to-face meetings built upon the pre-
existing infrastructure. 
 
Potential for disseminating and implementing the results of this research in other 
settings 
As healthcare systems are incentivized to improve the health of populations and reduce longer-
term costs and complications, programs like these that facilitate return to optimum functioning 
will be increasingly valuable to these entities. The evidence generated by the proposed study 
will be highly meaningful to our target audiences because our target audiences includes our 
stakeholders and their constituents (PC-4). Because the proposed trial emphasizes external 
validity, the results will have high generalizability for our target audiences. The inclusion criteria 
are broad and highly feasible to measure. Thus, the findings will be actionable by our target 
audience. Our VHA Stakeholders have also expressed interest in utilizing knowledge gained on 
more effective methods of case management delivery and plan to feed information back into 
their system. Comparative effectiveness trials are rarely conducted in TBI populations, and thus 
there is an enormous gap in the evidence base. With little information about how best to 
improve the management of patients with TBI following discharge from inpatient rehabilitation, 
there will be a high demand for the evidence that we will be disseminating.  
 
The diffusion of our findings will be also expedited by our dissemination strategies that will be 
effectively tailored to our target audiences. Because the stakeholders in the SAC will have an in-
depth understanding of both our target audience and our research findings, they will be 
particularly adept at customizing the dissemination messages and materials for our target 
audiences. We will work with our partners to develop policy briefs, plain language fact sheets, 
blogs and videos for distribution via stakeholder organization websites and other social media 
outlets (i.e., Twitter, Facebook, YouTube). We will also have the opportunity to give 
presentations at events hosted by our stakeholder organizations. 
Dissemination of Intervention Materials 
We plan to make available to other clinicians and healthcare systems the following RDP and 
RTP intervention materials: manual of procedures; needs assessment; outcome measures; 
patient, family/caregiver, and provider educational materials; and case management manuals. 
We have a strong partnership with NIDILRR’s TBIMS Knowledge Translation Center 
(www.msktc.org), which specializes in dissemination of scientific research findings. The TBIMS 
KTC website will serve as a platform for many dissemination activities. Findings will also be 
disseminated through the recently formed Cochrane Physical and Rehabilitation Medicine 
collaboration.129 Following study completion, our multi-purpose study website will serve as a 

 
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platform for many dissemination activities. For example, treatment manuals and educational 
materials will be available to clinicians and healthcare systems who want to implement or adapt 
components of our interventions to their unique system of care.  
 
 
 
 
 
 
 
Knowledge Translation 
We will work with influential national and international organizations involved with TBI 
knowledge translation and dissemination to inform clinical practice and policy development.  
 
This will be accomplished by leveraging our research team’s current leadership roles in 
rehabilitation organizations. Examples include the National Center for Medical Rehabilitation 
Research (NIH), NIDILRR TBIMC KTC, American Congress of Rehabilitation Medicine (ACRM), 
Galveston Brain Injury Conference, American Psychological Association, American Psychiatric 
Association, Society of General Internal Medicine, National Association of Social Workers, and 
Academy of Certified Brain Injury Specialists.  
 
We will also work with the Brain Injury Association of American, the largest TBI advocacy group 
in the country, to disseminate key findings. Involvement in scientific presentations, committees, 
and working groups will lead to dissemination of study findings and adaptation of practice 
guidelines. 
 
Implementation 
Immediate efforts to implement key findings will include collaboration with regional TBI 
stakeholders, such as state Brain Injury Associations/Alliances and state TBI Councils and with 
our own hospital administrators. We will work with state and national payers, including those in 
our Study Advisory Committee (CMS, DSHS, Molina, the Hartford, L&I) to implement the most 
effective transition programs. Study findings will dictate whether and at what level clinical 
service enhancements should be provided in existing healthcare systems.  
 
Possible Barriers to Dissemination and Implementation 
 
A potential barrier to dissemination and implementation of study results in this trial is limited 
involvement by potential stakeholders who will be key for dissemination including administrators 
in key positions to approve funding as well as additional other organizational stakeholders who 
we may not have considered. As noted by Olkin,130 people with disabilities are under-
represented in teams designing and conducting research, resulting in a “rift between research 
and practice” and “a schism between those studied and those doing the studying” (p. 320). 
Accordingly, we have received excellent input from our Patient and Family Stakeholders who 
have all agreed to be key research partners in this grant and contribute to decision making 
throughout the study. Evidence from the rehabilitation and public health literatures suggests that 
extensive consumer involvement may maximize research quality, social validity, and knowledge 
translation,131 and we will be learning how best to utilize our consumers to dissemination and 
implement results from the research. In preparation for this PCORI application, we have already 
had meaningful involvement of patient, family, clinician, policy, advocacy, payer, and 
organizational stakeholders; we believe that this plan engagement throughout the study with our 

 
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stakeholders will be a facilitator to dissemination and implementation of study findings.  
 
Additional barriers to dissemination include a lack of financial resources for dissemination 
activities and implementation in clinical and community settings. We will brainstorm with 
stakeholders the potential for future research to address implementation barriers via such 
activities as implementation and dissemination research and cost-effectiveness research. 
Several of our stakeholders have committed to assisting with dissemination and 
supporting funding. In addition, all of our site PIs have considerable experience in knowledge 
translation of disability and rehabilitation research through their leadership in the TBIMS and will 
guide the team on knowledge translation. 
 
 
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ADDITIONAL TABLES AND FIGURES 
 
Table 3. Patient Participant Involvement 
 
*Compensation amounts reflect UW compensation amounts only. Compensation amounts will vary across 
sites. 
**These questionnaires are completed and compensated as part of the TBIMS study if enrolled in that 
study as well. Otherwise, they will be completed and compensated as part of BRITE. 
***Participants randomized to RTP only. 
Time Point 
When/How Often 
Time Required 
Compensation*  
Baseline 
Information**  
Once following consent 
session  
25-35 minutes 
$15** 
Discharge 
Summary 
Information 
Once following consent 
session 
None 
$0 
Post-Discharge 
Transition 
Phase 
After discharge 
About 12 contacts, 10-
60 minutes each 
contact over 6 
months*** 
$0 
3 Month Post-
Discharge 
Questionnaire 
Once about three months 
after discharge 
25-30 minutes 
$25 
6 Month Post-
Discharge 
Questionnaire 
Once about six months after 
discharge 
25-30 minutes 
$25 
Rehabilitation 
Transition Plan 
Group Phone 
Survey*** 
Once about six months after 
discharge 
10-20 minutes 
$0 
9 Month Post-
Discharge 
Questionnaire 
Once about nine months after 
discharge 
25-30 minutes 
$25 
One Year 
Following 
Injury 
Questionnaire** 
Once about one year after 
injury 
45-60 minutes 
$15* 
12 Month Post-
Discharge 
Questionnaire 
Once about 12 months 
following discharge 
25-30 minutes 
$25 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Table 4. Caregiver Participant Involvement 
 
 
*Compensation amounts reflect UW compensation amounts only. Compensation amounts will vary across 
sites. 
**Participants randomized to RTP only. 
 
Time Point 
When/How Often 
Time Required 
Compensation*  
Baseline 
Questionnaire  
Once following consent 
session  
5-10 minutes 
$25 
Post-
Discharge 
Transition 
Phase 
After patient discharge 
About 12 contacts, 
10-60 minutes each 
contact over 6 
months** 
$0 
3 Months 
Post-
Discharge 
Questionnaire 
Once about three months 
after patient discharge 
15-30 minutes 
$25 
6 Months 
Post-
Discharge 
Questionnaire 
Once about six months 
after patient discharge 
15-30 minutes 
$25 
Rehabilitation 
Transition 
Plan Group 
Phone  
Survey** 
Once about six months 
after patient discharge 
10-20 minutes 
$0 
9 Months 
Post-
Discharge 
Questionnaire 
Once about nine months 
after patient discharge 
15-30 minutes 
$25 
12 Months 
Post-
Discharge 
Questionnaire 
Once about 12 months 
after patient discharge 
15-30 minutes 
$25 

 
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Figure 2. Study Assessment Schedule 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Figure 3. BRITE Intervention Schedule 
 
 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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Appendix 1: Milestone Schedule 
 
MODIFIED MILESTONE SCHEDULE – 1/23/2023 
 
Milestone 
Deliverable ID 
Milestone Name 
Description 
Due Date 
E 
Interim Progress 
Report Submission 
Complete 24-month interim progress 
report (IPR) and submit via PCORI 
Online. 
7/31/2019 
F1 
Complete 25% of 9-
month follow-ups  
Complete 25% of 9-month follow-ups 
(180 patient and 108 caregiver 
participants). 
8/31/2019 
F2 
Recruit 50% of total 
study participants 
Recruit 450 patient and 270 caregiver 
participants (50% of total). 
9/30/2019 
F3 
IRB Annual Review 
for lead site (UW) 
Submit IRB annual review approval 
letter to PCORI 
10/31/2019 
F4 
Complete 25% of 12-
month follow-ups. 
Complete 25% of 12-month follow-
ups (180 patient and 108 caregiver 
participants). 
11/30/2019 
F5 
Complete 50% of 3-
month follow-ups. 
Complete 50% of 3-month follow-ups 
(360 patient and 216 caregiver 
participants). 
11/30/2019 
F6 
Monthly SAC Patient 
and Family AND 
Quarterly 
Professional 
Stakeholder 
meetings 
Include a summary of the monthly 
SAC patient and family and quarterly 
professional stakeholder meetings in 
the interim progress report. 
1/31/2020 
F 
Interim Progress 
Report Submission 
Complete 30-month interim progress 
report (IPR) and submit via PCORI 
Online. 
1/31/2020 
G1 
Complete 50% of 6-
month follow-ups. 
Complete 50% of 6-month follow-ups 
(360 patient and 216 caregiver 
participants). 
2/28/2020 
G2 
Complete 50% of 9-
month follow-ups. 
Complete 50% of 9-month follow-ups 
(360 patient and 216 caregiver 
participants). 
5/31/2020 
G3 
Annual in-person 
meeting for patient 
and family 
stakeholders  and 
investigators (SAC) 
Annual Stakeholder Meeting Meeting. 
Include a summary of the discussion 
in the interim progress report.  
6/30/2020 
G4 
Recruit 75% of study 
participants 
Recruit 675 patient and 405 caregiver 
participants (75% of total). 
7/31/2020 
G5 
Conduct 
administrative 
review 
PCORI will evaluate whether or not 
the study has everything in place to 
continue project progress. 
7/31/2020 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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G 
Interim Progress 
Report Submission 
Complete 36-month interim progress 
report (IPR) and submit via PCORI 
Online. 
7/31/2020 
H1 
Complete 50% of 12-
month follow-ups.  
Complete 50% of 12-month follow-
ups (360 patient and 216 caregiver 
participants). 
9/30/2020 
H2 
IRB Annual Review 
for lead site (UW) 
Submit IRB annual review approval 
letter to PCORI. 
10/31/2020 
H3 
Monthly SAC Patient 
and Family AND 
Quarterly 
Professional 
Stakeholder 
meetings 
Include a summary of the monthly 
SAC patient and family and quarterly 
professional stakeholder meetings in 
the interim progress report. 
1/31/2021 
H 
Interim Progress 
Report Submission 
Complete 42-month interim progress 
report (IPR) and submit via PCORI 
Online. 
1/31/2021 
I 
Interim Progress 
Report Submission 
Complete 48-month interim progress 
report (IPR) and submit via PCORI 
Online. 
7/31/2021 
J1 
IRB Annual Review 
for lead site (UW) 
Submit IRB annual review approval 
letter to PCORI. 
10/31/2021 
J4 
Complete 
recruitment 
Recruit 900 patient and 540 caregiver 
participants (100% of total). 
10/31/3021 
J5 
EEF - Schedule and 
conduct qualitative 
interviews with 
stakeholders, staff, 
investigators 
Patient (N~5), family (N~5), 
professional stakeholders (N~5), 
study staff and investigators (N~5) 
interviews completed . 
12/31/2021 
J6 
Annual in-person 
meeting for patient 
and family 
stakeholders  and 
investigators (SAC) 
Annual Stakeholder Meeting Include a 
summary of the discussion in the 
interim progress report. 
12/31/2021 
J7 
Complete 100% of 3-
month follow-ups 
Complete 100% of 3-month follow-
ups (720 patient and 432 caregiver 
participants). 
1/31/2022 
J 
Interim Progress 
Report Submission 
Complete 54-month interim progress 
report (IPR) and submit via PCORI 
Online. 
1/31/2022 
K1 
Complete 100% of 6-
month follow-ups 
Complete 100% of 6-month follow-
ups (720 patient and 432 caregiver 
participants). 
4/30/2022 
K2 
EEF - Data analysis 
complete 
Interview data is audio-recorded, 
transcribed, entered into Dedoose 
mixed methods software and analysis 
complete.  
6/30/2022 

 
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K3 
Complete 100% of 9-
month follow-ups 
Complete 100% of 9-month follow-
ups (720 patient and 432 caregiver 
participants). 
7/31/2022 
K4 
Monthly SAC Patient 
and Family AND 
Quarterly 
Professional 
Stakeholder 
meetings 
Include a summary of the monthly 
SAC patient, family and quarterly 
professional stakeholder meetings in 
the interim progress report. 
7/31/2022 
K 
Interim Progress 
Report Submission 
Complete 60-month interim progress 
report (IPR) and submit via PCORI 
Online. 
7/31/2022 
L1 
IRB Annual Review 
for lead site (UW) 
Submit IRB annual review approval 
letter to PCORI. 
10/31/2022 
L2 
Complete 100% of 
12-month follow-ups 
Complete 100% of 12-month follow-
ups (720 patient and 432 caregiver 
participants). 
10/31/2022 
L3 
Primary Completion 
Date 
The last day the last participant is 
evaluated for the primary outcome. 
10/31/2022 
L4 
EEF - Tip Sheets  
 Tip sheets providing guidance on 
thematic topics to improve the 
equitable engagement with 
individuals who have cognitive 
difficulties to accompany video fully 
completed. 
10/31/2022 
L5 
EEF - Video 
Production and 
Editing 
Engagement implementation guide in 
audio-visual format (video) 
completed. 
11/30/2022 
L6 
EEF - Manuscript 
Preparation and Final 
Report 
Manuscript completed and final 
report due. 
12/31/2022 
L7 
Annual in-person 
meeting for patient 
and family 
stakeholders  and 
investigators (SAC) 
Annual Stakeholder Meeting. Include 
a summary of the discussion in the 
final progress report. 
12/31/2022 
L8 
Ensure all follow-up 
data is complete and 
conduct quality 
check 
Data complete and quality check is 
done. 
12/31/2022 
L9 
Convene groups 
(study participants, 
TCM, clinicians, 
researchers) at each 
site (UW, IN, PA, TX, 
NY, OH) 
Convene Groups to gather 
information for Process Evaluation. 
12/31/2022 

 
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L10 
Aggregate 
summative Program 
Evaluation feedback 
Aggregate summative feedback. 
12/31/2022 
L11 
Prepare cleaned 
dataset, annotated 
data dictionary, and 
codebook for sharing 
Prepare data for sharing. Copies of 
the study codebook will be made 
available per PCORI's open science 
policy, if requested. 
1/31/2023 
L12 
Begin development 
of manual 
delineating the 
discharge planning 
protocol found to be 
most effective 
Begin development of a manual for 
discharge planning. 
1/31/2023 
L 
Interim Progress 
Report Submission 
Complete 66-month interim progress 
report (IPR) and submit via PCORI 
Online. 
1/31/2023 
M1 
Submit Conference 
Presentations 
Submit conference presentations. 
6/30/2023 
M2 
Complete Analyses 
  
7/15/2023 
M3 
Present to each 
BIA/TBI 
Council/HRSA group 
at each site 
Present to relevant stakeholder 
groups at each site. 
7/31/2023 
M4 
Present to hospital 
administration at 
each site 
Provide update to PCORI on efforts to 
identify channels of distribution and 
incorporating findings into 
sustainable clinical practice. 
7/31/2023 
M5 
Begin development 
of plans to adopt 
research findings 
into practice 
Begin creation of a plan that includes 
a description of how the intervention 
was refined and provide examples of 
how it can be sustainable. 
7/31/2023 
M 
Final Progress 
Report 
Complete final progress report (FPR) 
and submit via PCORI Online. This 
report should cover activities since 
the last report through the end of 
the research project period. 
7/31/2023 
N 
Results submitted to 
ClinicalTrials.gov or 
Awardee ensures results are 
submitted to ClinicalTrials.gov or 
9/30/2023 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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appropriate 
database. 
appropriate database. For 
ClinicalTrials.gov, the generated 
tables are a required section in the 
Draft Final Research Report. Results 
must be submitted no later than 30 
days before Draft Final Research 
Report Submission Milestone to 
provide time for ClincialTrials.gov to 
conduct quality checks. 
O 
Draft Final Research 
Report Submission 
Submit Draft Final Research Report 
according to instructions found at 
http://www.pcori.org/awardee-
resources. *All Draft Final Research 
Reports must be submitted no later 
than 30 days from when results are 
posted to clinicaltrials.gov or other 
applicable website. Refer to 
Contract. 
10/31/2023 
P 
Initial Data Sharing 
Conference Call with 
Data Repository 
Hold initial data sharing conference 
call with Data Repository to set 
expectations for data deposition and 
curation, discussion of Data 
Contributor Agreement, and 
identification of any technical and/or 
governance issues. 
10/31/2023 
Q 
Submit signed Data 
Contributor 
Agreement 
Obtain signed Data Contributor 
Agreement and submit in PCORI 
Online 
11/21/2023 
R 
Transfer initial Data 
Package 
Transfer initial Data Package to Data 
Repository, and submit proof of 
submission in PCORI Online. 
11/28/2023 
S 
Submit Verification 
of Data Package 
Completion 
Mutual agreement between 
Awardee and Data Repository that 
curation of the Data Package is 
complete. Submit verification of 
completion in PCORI Online. 
4/1/2024 
T 
Complete data 
sharing activities 
and provide update 
to PCORI. 
Submit 3-page report* to PCORI 
summarizing experience and lessons 
learned from data sharing activities 
in PCORI Online. 
4/15/2024 
U 
Complete all Draft 
Final Research 
Report Revisions 
(FRR Accepted)" 
PI will respond to all requests to 
revise their DFRR within the given 
timeframe, until the Program 
Director for Peer Review accepts the 
report as final on behalf of PCORI.         
7/31/2024 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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V 
Approval / sign off 
of the Lay Abstract 
PI to approve/sign off Lay Abstract 
no later than 5-7 calendar days after 
receipt of the draft from PCORI.  
No date 
W 
Contract Term Date 
 The last day of the contract. 
11/30/2024 
X 
Notification of 
Publication 
Acceptance 
See Contract for Instructions 
  
 
 
 
 
 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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Appendix 2: Data Quality Guidelines 
BRITE Study Data Quality Guidelines 
Version 1.0 
 
Introduction: 
The BRITE study has established data quality guidelines and strategies to ensure that all study 
data are of the highest quality, and are being collected in the same way across the collaborating 
sites. 
Purpose: 
Integrity of data will be preserved through standardized practices for data quality. 
Scope: 
University of Washington is the lead site for the BRITE study. The TBIMS National Data and 
Statistical Center (NDSC), located at Craig Hospital serves as the Data Coordinating Center 
(DCC) for this study. BRITE sites that participate in data collection for this project are: 
• 
University of Washington, Jeanne Hoffman, Jesse Fann, Site PIs 
• 
Indiana University School of Medicine/Rehabilitation Hospital of Indiana, Flora Hammond, 
Site PI 
• 
Baylor Institute for Rehabilitation, Simon Driver, Site PI 
• 
Moss Rehab Hospital, Thomas Watanabe, Site PI 
• 
Mount Sinai Health System, Kristen Dams-O’Connor, Site PI 
• 
Ohio State University Wexner Medical Center, Jenny Bogner, Site PI 
Responsibilities: 
The lead site, with assistance from the DCC, is responsible for overall coordination and 
monitoring of data quality for this study, including review of this SOP with the data collectors at 
each site during the biweekly Data Collectors teleconference. Each Site Principal Investigator 
(PI) is responsible for the integrity of data being collected within his/her site. The Site PI is also 
responsible for tracking and assuring that the Data Quality Guidelines outlined below are 
followed in his/her site. A copy of this Standard Operating Procedure (SOP), signed by each 
Site PI, will serve as documentation that these guidelines are being followed and will be 
submitted to the lead site. 
 
 

 
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Procedural Steps 
1. Screening Data 
• 
Demographic data should be entered into the website the same day the subject is first 
screened 
• 
Eligibility status should be entered as soon as possible after it is determined 
• 
Consent, decline, or other final enrollment status should be updated as soon as it is 
determined 
• 
Lead site will communicate as needed about screening entry issues outside of the 
quarterly cleanup 
 
2. Baseline Data (Non-TBIMS Pre-Injury, BTACT, and Medical Abstraction; Caregiver 
Baseline) 
• 
Non-TBIMS Patient Participants 
o Pre-injury and BTACT data should be entered within two weeks of collection 
o Medical Abstraction data should be entered within 3 months post-randomization 
• 
Caregiver Participants 
o Caregiver Baseline Questionnaire should be entered within two weeks of 
collection 
• 
Lead site will conduct monthly checks of the Baseline Status Report, and email 
sites about pending data collection/entry and status updates 
 
3. Post-Discharge Data (Patient Post-Discharge Information, Patient Post-Discharge 
Questionnaire, Year 1 Interview Non-TBIMS; Caregiver Post-Discharge Questionnaire) 
• 
Patient Participants 
o Post-Discharge Destination data should be entered and saved when the 
participant is randomized 
o Post-Discharge Information data should be entered within two weeks of 
randomization 
o Post-Discharge Questionnaires and Non-TBIMS Year 1 (Form II) interviews 
should be entered within two weeks of collection or receipt of mailout survey 
• 
Caregiver Participants 
o Post-Discharge Questionnaires should be entered within two weeks of collection 
or receipt of mailout survey 
• 
Lead site will conduct monthly checks of cases past the ideal date or window 
close using the Cases Due Report, and email sites about any pending cases that 
are overdue or ≤10 days from window close 
 
4. Note-to-Files 
• 
Note-to-Files should be completed and entered within 30 days of detection of event 
requiring the NTF 
 
5. Problems Reports 
• 
Problems Reports should be completed and entered within 30 days of detection 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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• 
Reminder: SAEs that are unanticipated and possibly related to the study intervention will 
be reported to the respective site PI, the lead site PI, chair of the DSMB, the respective 
IRB, and the PCORI Program Official in accordance with requirements.  
o Unanticipated fatal or life-threatening SAEs related to study procedures will be 
reported all parties listed above immediately. 
o Other unanticipated SAEs related to study procedures will be reported to the 
respective site PI and lead site PI within 24 hours.  The SAE will be reported to 
the respective IRB according to that institution’s requirements. The event will be 
reported to PCORI promptly but no later than 10 days after reporting the event to 
the IRB.  
o Anticipated or unrelated SAEs will be reported to the DSMB and PCORI as part 
of the bi-annual and annual DSM reports. These DSM reports will also be 
submitted to each site’s IRB. 
 
6. Data Checks by the Lead Site 
• 
The lead site will conduct quarterly checks of the data to look for missing and 
inconsistent data. Each site will be notified of any data issues, and asked to correct 
those issues within 60 days of notification.  
Data Cleanup Calendar 
We will conduct staggered quarterly cleanups of the following data collection forms. 
 
Jan 
Feb 
Mar 
Apr May 
Jun 
Jul 
Aug Sep Oct 
Nov Dec 
Caregiver 
Baseline 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Patient Post-
Discharge 
Questionnaire 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Caregiver Post-
Discharge 
Questionnaire 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Patient Post-
Discharge 
Information 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Medical Record 
Abstraction 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Non-TBIMS Year 
1 Follow-up 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Screening Data 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Note-to-File* 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Problems Report* 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
RTP Completion* 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Study Completion 
Form 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
RTP Satisfaction* 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
*Unblinded forms 
 
7. Data Quality Targets 

 
PCORI TBI Protocol v.15.0 01-23-23 
 
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• 
Each site should attempt to meet the data quality targets established by the lead site as 
follows: 
o Target enrollment rate is set at 73%, and will be reviewed on a quarterly basis 
beginning December 2020. The lead site will review the rate for cases entered 
into the website screening form within the previous six months (e.g. 6/1/20-
11/30/20 for the December check). Sites not reaching their target will be required 
to develop a written remediation plan for increasing enrollment numbers. This 
plan should be submitted to the lead site. The effectiveness of this plan will be 
reviewed at subsequent quarterly checks. 
o Target Assessment Completion rate is set at 80%, and will be reviewed on a 
quarterly basis beginning December 2020. The lead site will review the rate for 
cases with open windows during the previous six months (e.g. 6/1/20-11/30/20 
for the December check). Sites not reaching their target will be required to 
develop a written remediation plan for increasing enrollment numbers. This plan 
should be submitted to the lead site. The effectiveness of this plan will be 
reviewed at subsequent quarterly checks. 
Enrollment & Assessment Completion Rate Checks; Reports Calendar 
 
Jan 
Feb 
Mar 
Apr 
May Jun 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
6-month Follow-
up Rate Check 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
6-month 
Enrollment Rate 
Check 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Sampling 
Enrollment Rate 
Adjustment 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Quarterly 
Internal 
Reports, Data 
and Safety 
 
 
 
 
X 
 
 
 
 
 
X 
 
DSM Reports 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
8. Guidelines Sign-off by Site PIs: Each Site PI should submit a signed copy of this SOP to 
the lead site, to indicate their assurance that these guidelines are being followed within 
his/her site. The submission of this document will be due at the end of November 2020. 
 
Signature of PI:  
 
___________________________        ________________________________________  
Print PI Name  
 
 
PI Signature   
 
 
Date 
 
 
 
 

 
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Appendix 3: Engagement Evaluation Funding (Starting on following page) 
 
 
 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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Hoffman, Jeanne M. 
PCS-1604-35115 
PI Full Name:  
Contract Number: 
Funding for COVID-19 Related Engagement Evaluation 
Directions: Through responses to the specific questions below, provide a brief summary of the request and rationale. Please limit your 
responses to each question to no more than a paragraph. Please make relevant changes to your Budget and Budget Justification 
documents to reflect this work. 
 
PCORI is offering projects the opportunity to receive funding to document and evaluate their engagement practices 
during the COVID-19 pandemic.  This opportunity is suitable for projects that have: 
• 
Developed innovative engagement approaches in response to the pandemic, or 
• 
Redesigned their existing engagement approaches and/or goals in response to the pandemic, or 
• 
Demonstrated a commitment to maintaining engagement with groups experiencing disproportionate impact 
from COVID-19 (e.g., historically under-represented populations, vulnerable populations, healthcare and public 
health professionals, etc) 
 
Evaluations should utilize a systematic approach, relying on quantitative, qualitative, or mixed methods for the 
evaluation of engagement, drawing on perspectives from various stakeholders.  The final deliverable will be a 
manuscript or white paper that makes findings available to the public. More information about this engagement 
evaluation funding can be found here. 
 
Original Engagement Approach  
1. Provide a brief summary of the original engagement goals and approach for your study. 
 
The Brain Injury Rehabilitation: Improving the Transition Experience (BRITE) study is a six site, 
pragmatic, randomized clinical trial aimed at improving the transition from inpatient rehabilitation to 
community following moderate to severe traumatic brain injury (TBI). Our stakeholder advisory 
committee is comprised of a patient and family (n=13) group which includes individuals who have 
personally experienced TBI or cared for someone who has had a brain injury, and a group of multi-
disciplinary professionals (n=22) who represent clinical practice, hospital administration, state TBI 
Councils, national and state advocacy and policy leaders such as the Brain Injury Association of 
America, CARF International, state Brain Injury Associations/Alliances, the American College of 
Surgeons, and payer groups. The groups meet over Zoom monthly (patient and family) and quarterly 
(professional). Our lead stakeholder from the patient and family stakeholder group, Irene Ziaya, acts 
as liaison across the SAC groups and investigator steering committee by attending all stakeholder 
and steering committee meetings and reporting progress among groups. In addition, our full SAC 
comes together for our annual meeting. Our original engagement goals were to ensure our 
stakeholders were involved throughout all phases of the research, including planning, conducting and 
dissemination. Our approach to engagement includes best practices and incorporates the six PCOR 
Engagement Principles, including reciprocal relationships, co-learning, partnership, transparency, 
honesty, and trust (1).   
 
Modified Engagement as a Result of COVID   
2. For projects changing engagement goals or approach as a result of the COVID-19 pandemic: What are the 
new engagement goals or approaches that your project is utilizing?  Describe if/how stakeholders were involved in 
determining these changes.  Projects not changing engagement goals or approaches: please skip this item and proceed to question 3.  
 
Prior to the COVID-19 pandemic our approach to engagement included conducting monthly and quarterly SAC 
meetings virtually due to the fact that our study involved stakeholders from across the country. The pandemic 
highlighted the effective strategies that we had been using to engage with our stakeholders. As a result, much 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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of our engagement work was uninterrupted due to the pandemic. One notable exception was converting our in-
person Annual Engagement Meeting to a virtual format. Moving the meeting from in-person to online raised 
new complexities that we had not yet addressed despite our smaller group meetings being online. In the 
smaller group format, our engagement challenges had centered around equitable engagement with individuals 
with cognitive difficulties who have limited experience using computers or being live on-screen. For our large 
virtual annual meeting that included all study stakeholders, staff, investigators, and funders, we specifically 
needed to consider the negative cognitive impact of extended screen time on persons with TBI, the challenge 
of internet connectivity issues, as well as how to manage having many people on the screen (versus the 
smaller group format for our regular monthly patient and family meetings), and discomfort with online meeting 
participation in large groups that included both patients/families and professional stakeholders.  
The patient and family advisory group was critical to developing the virtual meeting and working with 
the study team to proactively address these challenges. In particular, based on their recommendations, we 
shortened the meeting to reduce online, live screen time. In place of our typical all-day meeting, we opted for a 
half day meeting that was preceded by engagement in several ways to prepare for and benefit from the online 
annual meeting. The patient and family group collaborated with the engagement study staff (Moore, 
Kempthorne) and our study case managers to create a video that described challenges they faced during their 
rehabilitation transition and how the BRITE intervention addresses these challenges. The patient and family 
group worked closely with the engagement study staff to develop the concepts for the video and many were 
filmed for the video itself. The video served as an important primer for the meeting attendees, allowed for 
participation from the stakeholders in a comfortable and less intense environment than the live online setting, 
and will serve as an educational tool during our dissemination efforts.  
Additional strategies were suggested by the patient and family advisory group and the professional 
advisory group to increase the interactive nature of the Annual Engagement Meeting. These included 
incorporating smaller breakout sessions that were planned, discussed, and prepared for by members of the 
patient and family advisory group in pre-conference meetings with study staff and case managers. Discussion 
questions were provided ahead of time to allow participants to prepare for discussion. The synergy developed 
among the stakeholders, study staff, and case managers during these pre-conference meetings was critical to 
our successful meeting. Everyone was prepared and many potential issues or questions were addressed in 
these small group meetings so that during the Annual Engagement Meeting, participants were able to focus on 
and engage with the meeting content. All of the sessions were recorded so that participants could review 
sessions and also listen to sessions that they could not attend. We were also able to take advantage of the 
virtual platform of the Annual Engagement Meeting by inviting ‘guest’ stakeholders (chosen with input from 
investigators and stakeholders) who provided important information and recommendations related to our 
meeting themes of dissemination and implementation. For example, Rebeccah Wolfkiel, Executive Director of 
the National Association of State Head Injury Administrators (NASHIA) attended to discuss dissemination 
opportunities provided by her organization and their interest in being a key partner going forward, and Peter 
Thomas, an attorney with unique experience in TBI legislation and policy, gave his presentation from Boston 
on current and future opportunities and challenges for policy change to improve the long-term care of persons 
with TBI.  
Some of the strategies we employed were not as successful as we had hoped, and we learned from 
those experiences as well. For instance, our small breakout sessions were not long enough or small enough to 
allow for maximal participation and engagement. We did not prepare speakers sufficiently in strategies to 
increase accessibility of slides and other materials, and we did not provide a closed captioning option for 
presentations, a practice that is now common on Zoom meetings. These experiences helped us realize that we 
needed to increase the level of adaptation in our regular meetings as well, not just in the Annual Engagement 
Meeting. We believe the information we have learned from our successful engagement strategies will be useful 
for other groups working to engage patient stakeholders with cognitive difficulties, including those with TBI, 
other neurological disorders, or intellectual and developmental disabilities. 
 
3. Describe how your engagement strategies will support or have supported stakeholder engagement in your 
project during the COVID-19 pandemic.  What challenges will these strategies address?  If applicable, how 
will your strategies strengthen engagement with groups experiencing disproportionate impact from 
COVID-19 (e.g., historically under-represented populations, vulnerable populations, healthcare and public 
health professionals, etc)?  

 
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Many persons with TBI face challenges to engagement that stem from their injury, and some face 
challenges that stem from conditions that were present before their injury such as limited access to 
resources, isolation, poverty, and other social determinants of health. All of these challenges have 
been exacerbated during the COVID-19 pandemic. Because BRITE is a multi-site trial with 
participating centers across the country, following best practices for engagement necessitated pre-
COVID participation using a secure tele-video communication platform (Zoom) and collaboration on 
study development and ongoing science via phone and email. Additionally, the BRITE intervention 
delivery is via telemedicine, so the study was well-poised to maintain communications remotely 
during the COVID-19 pandemic. Our study team has developed specific strategies to provide direct 
support to patient and family stakeholders regarding computer and phone access issues and offers 
opportunities for participation in study-related activities via a variety of mechanisms (phone 
conversation, Zoom, written documents), depending on stakeholder preference. We also video record 
all of our stakeholder sessions and calls and provide detailed minutes that are posted on our study 
website so that stakeholders can review the meetings later as desired. We integrate unique and 
specific engagement strategies to meet the needs of our patient stakeholders who may have ongoing 
cognitive challenges in their rehabilitation journey. Our strategies aim to both value the strengths and 
honor any accommodations needed for active engagement; we incorporate frequent reminders to 
attend meetings via text, phone, and email and provide collaboration opportunities in multiple aspects 
of the project and in multiple formats (e.g. audio-visual, written). This has led to genuine relationship 
building within the patient and family stakeholders and between the group and the steering 
committee. Having regular contact with the stakeholders and the ability to call/text/email has been 
critical to maintaining engagement. In addition, there are times when some stakeholders have not 
been able to attend to BRITE-related activities as challenges have emerged in their lives. We 
maintain engagement with stakeholders via phone/text/email during these times, and check in with 
them at the beginning of each call, which has been critical for sustaining participation during the 
stressful COVID-19 pandemic and after temporary absences. In addition to genuine professional 
relationships with the advisory boards and study staff and steering committee members, our 
stakeholders have developed supportive and professional relationships with each other. This support 
has been important for ongoing engagement over the course of the study and during the pandemic. 
 
Proposal for Study of Engagement  
4. Briefly describe your plan for evaluation of your engagement strategies. What questions about your engagement 
goals or approach will you answer? What methodologies, data sources, and analytic approaches will you utilize?  
 
The goals of this Engagement Evaluation project are to identify and disseminate specific patient-
centered strategies and processes employed in our study that enabled our stakeholders, investigators 
and study staff to remain mutually engaged during the COVID-19 pandemic. As noted above, we 
anticipated and prepared for engagement challenges, identified some new challenges, and adjusted 
our engagement strategies throughout the study and during the pandemic. In this application, we 
propose to rigorously answer engagement questions in three domains: 1) Challenges, 2) Strategies 
and Processes to address challenges, and 3) Impact. See Table 1. Members of the Patient and 
Family and Professional stakeholder groups as well as the investigator team will participate in the 
Engagement Evaluation project as part of their current roles. In addition, study investigator (Moore) 
and study staff (Kempthorne, Research Coordinator and Research Assistant TBD), and stakeholders 
(N=4) will contribute additional effort.  
 
Table 1. Research Questions to Identify Successful Engagement Strategies for Persons with Cognitive Difficulties 
CHALLENGES 
• 
What were the unique and specific engagement challenges faced by individuals with brain injury and 
their families before and during the COVID-19 pandemic? 

 
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• 
How do we engage equitably with stakeholders in different roles (patient, family, provider or 
researcher), different life stages, or different socioeconomic or cultural groups? 
STRATEGIES and 
PROCESSES 
• 
Which successful engagement strategies and processes were used by BRITE stakeholders, investigators, 
and study staff to address engagement challenges? 
• 
Which strategies addressed equitable engagement across stakeholders facing different challenges? 
Which strategies were effective for stakeholders in different roles, life stages, socioeconomic or cultural 
groups? 
IMPACT 
• 
How did maximizing engagement for individuals with cognitive difficulties benefit the scientific goals 
and protocols of the BRITE study (e.g., via the opportunity to interact with the study case managers who 
are working with individuals with TBI)? 
• 
What new engagement impacts were seen during the COVID-19 pandemic? 
• 
Which engagement strategies were not effective or need modification? 
 
To answer these questions, we will conduct semi-structured qualitative interviews or focus groups, 
depending on stakeholder preference, by Zoom videoconference with patient (N~5), family (N~5), 
professional stakeholders (N~5), and study staff and investigators (N~5) to elucidate in detail the 
specific engagement challenges faced at different time points throughout the study, strategies or 
processes used to address challenges, and what impact these strategies had on the study and on 
stakeholder engagement before and during the COVID-19 pandemic. We will purposively sample 
from our stakeholder groups to incorporate the perspectives of those from diverse regions, time since 
injury, age, and profession; we will continue to conduct interviews until we have reached saturation. 
The interview guide will be developed iteratively using the expertise of the team and will elucidate 
information about each of the engagement questions listed above. Interview data will be audio-
recorded, transcribed, and entered into Dedoose mixed methods software for analysis (1). We will 
utilize thematic analysis (2) to identify common experiences as well as unique challenges and 
strategies that were particularly useful. We will also identify impact of these strategies. To ensure 
trustworthiness of the analysis, we will incorporate member checking with the stakeholder and study 
team groups (3), use of multiple coders, and iterative group dialogue (4). We have utilized similar 
methods in previous research (5-8). The main goal of the analytic process is to identify and 
operationalize common and innovative themes in participant responses. Those will then be 
incorporated into an engagement implementation guide in an audio-visual format to highlight the 
unique and specific strategies used to successfully engage and maintain engagement with BRITE 
stakeholders throughout the study and specifically during the COVID-19 pandemic. We anticipate 
creating a series of short videos and tip sheets to provide guidance on major thematic topics to 
improve the equitable engagement with individuals who have cognitive difficulties. We will also submit 
a manuscript for peer-review to a rehabilitation, trauma or TBI journal. Content of the videos and tips 
sheets will be focused on the target audiences including patients, families, healthcare stakeholders, 
providers, and researchers. We plan to disseminate the findings via collaboration with PCORI, at the 
national presentation at the Society of Social Work Research and via our stakeholders at the National 
Association of State Head Injury Administrators (NASHIA) and the Case Management Society of 
America (CMSA) conferences. These products will assist other groups to successfully engage with 
people who have had a TBI and their families, as well as those working with others who may face 
similar cognitive challenges, such as those impacted by neurological disorders or intellectual and 
developmental disabilities. 
 
Table 2. Deliverables and Impact 
Deliverable 
Purpose 
Target Audience 
Impact 
Engagement 
Implementation Guide 
in Audio-Visual Format 
Provide guidance on equitable 
engagement with individuals 
who have cognitive difficulties 
using accessible format 
We will create videos that target 
1) patient and family 
stakeholders to provide 
strategies on how to engage 
when you have cognitive 
difficulties, 2) researchers and 
professional stakeholders on to 
Engagement tool for PCORI’s Resource 
Repository focused on equitable 
engagement across diverse stakeholders 
in accessible format (video) 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
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engage with individuals with 
cognitive difficulties in research 
partnership  
Creation of written 
material to accompany 
videos 
Provide guidance on key 
practices for equitable 
engagement with individuals 
who have cognitive difficulties 
using simple and straightforward 
language 
We will create written material 
for the target audience to 
summarize key points from  each 
video 
Engagement tool for PCORI’s Resource 
Repository focused on equitable 
engagement guidance available in a 
simple and straightforward format 
(summary)  
Peer Reviewed 
Manuscript 
Disseminate findings to 
professional audience   
Researchers, Funders, 
Professional Stakeholders 
 
Advancing shared commitment to 
advancing patient-centered, stakeholder-
engaged research 
 
 
 
5. How will this work contribute to transferable knowledge for the science of engagement and the PCOR community?  
The deliverables of this Engagement Evaluation project are an engagement implementation guide to improve 
engagement with researchers, individuals with cognitive difficulties including TBI, neurological disorders or 
intellectual and developmental disabilities and their family members, as well as professional stakeholders who 
are invested in improving the health of this population, which we plan to disseminate in an audio-visual format 
and a peer-reviewed manuscript in an academic journal. We anticipate creating a series of short videos 
featuring our stakeholders and study staff and accompanying tips sheets on major thematic topics. We 
anticipate that some of the content will be targeted towards researchers and professional stakeholders 
developing patient-centered research projects, and some will be targeted towards patient and family 
stakeholders engaging in this work. Developing a guide in an audio-visual format is aligned with the 
preferences of our patient and family stakeholders, for whom extensive written documents can be challenging. 
This guide will contribute to the science of patient-centered engagement in research related to TBI, 
neurological disorders or intellectual and developmental disabilities. 
 
6. Provide supporting evidence of appropriate patient and stakeholder engagement to help plan your evaluation.  
 
This proposal has been developed in collaboration with our large and diverse patient, family and professional 
stakeholders. The initial challenges and strategies, as well as ideas for the proposal were developed via 
discussion with our stakeholders at our monthly (patient and family stakeholders) and quarterly meetings 
(professional stakeholders). We plan to continue to collaborate with all of the stakeholders at these regular 
meetings at each stage of the Engagement Evaluation project, including interview guide development, 
interviews, analysis and member checking, and development of the engagement implementation guide. The 
stakeholders will be featured in the audio-visual engagement guide. In addition, four patient and family 
stakeholders have agreed to join the Engagement Evaluation project team to guide the research and to liaison 
with the larger stakeholder groups. This smaller group of stakeholders will be trained to conduct qualitative 
research, including foundational concepts, interviewing skills, and analysis. With guidance from the study 
investigators, they will participate in two half day trainings on methods and ongoing bi-monthly training and 
analysis sessions for the duration of the study. They will assist with developing the interview guide, conducting 
the interviews, identifying the themes to be featured in the implementation guide from the primary data, and 
conducting the member checking with the larger stakeholder groups. This Engagement Evaluation project will 
be stakeholder driven and the work will be completed concurrently and within the timeframe of the overall 
BRITE study. This proposal is also in alignment with PCORI’s research priorities. 
 
1. 
Dedoose Mixed Methods software: Dedoose Version 8.0.35, web application for managing, analyzing, and presenting 
qualitative and mixed method research data (2018). Los Angeles, CA: SocioCultural Research Consultants, 
LLC www.dedoose.com. 
2. 
Thematic analysis: https://journals.sagepub.com/doi/full/10.1177/1609406917733847 
3. 
Member checking: https://journals.sagepub.com/doi/10.1177/1049732316654870 
4. 
Iterative group dialogue: https://methods.sagepub.com/reference/encyc-of-case-study-research/n185.xml 

 
PCORI TBI Protocol v. 15.0 01-23-23 
 
Page 129 of 129 
 
5. 
Conrick, K.M., Davis, A., Rooney, L., Bellenger, M.A., Rivara, F.P., Rowhani-Rahbar, A., Moore, M. Extreme Risk Protection 
Orders in Washington State: Understanding the Role of Health Professionals. (epub ahead of print.). Journal of the Society for 
Social Work Research. 
6. 
Erlick, M.R. Vavilala, M.S., Jaffe, K.M., Blayney, C.B., Moore, M. (2021). Provider Perspectives on Early Psychosocial 
Interventions after Pediatric Severe Traumatic Brain Injury: an Implementation Framework. Journal of Neurotrauma, 38(4): 
513-518. 
7. 
Moore, M., Conrick, K.M., Reddy, A., Allen, A. & Jaffe, C. (2019). From their Perspectives: The Connection between Life 
Stressors and Healthcare Service Use Patterns for Homeless Frequent Users of the Emergency Department. Health and 
Social Work. 
8. 
Moore, M., Cristofalo, M., Dotolo, D., Torres, N., Lahdya, A., Ho, L., …Fouts, S. (2017). When high pressure, system 
constraints, and a social justice mission collide: a socio-structural analysis of emergency department social work 
services. Social Science and Medicine, 178, 104-114.  
  
 
 
 
Project Timeline & Milestones  
7. Describe an expected timeline for this new work, by month, resulting in a final deliverable of a draft manuscript or 
white paper and including any relevant milestones. Please note the proposed evaluation should not increase the current 
project timeline.   
 
Timeline (months) and Milestones 
(IRB will be submitted and approved prior to start of project) 
Month/Yr 
Sept 
21 
Oct 
21 
Nov 
21 
Dec 
21 
Jan 
22 
Feb 
22 
March 
22 
Apr 
22 
May 
22 
June 
22 
July 
22 
Aug 
22 
Sept 
22 
Oct 
22 
Nov 
22 
Dec 
22 
Milestone 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
IRB 
Modification 
Submitted  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Development 
of interview 
guide  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Schedule and 
Conduct 
Interviews 
with 
Stakeholders, 
Staff, 
Investigators 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Video 
Production 
and Editing 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Creation of 
Tips Sheets 
to 
Accompany 
Videos 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Manuscript 
Preparation 
and Final 
Report 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X