Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS
Phase: NA
Conditions: Traumatic Brain Injury, Post-Traumatic Stress Disorder
Sponsor: VA Office of Research and Development

Executive Functioning in TBI From Rehabilitation to Social Reintegration: COMPASS 
 
NCT01816061 (D0637-R) 
 
August 7, 2015 

1 
Title: Executive Functioning in TBI from Rehabilitation to Social Reintegration: COMPASS  
Grant: 1I01RX000637-01A3 
 
STUDY PROTOCOL 
 
Study Summary 
Traumatic brain injury (TBI) is a major health problem that leads to deficits in executive function, a term used for the 
cognitive operations responsible for planning, decision making, and other aspects of goal management. Executive 
functions are akin to the self-regulation processes by which humans manage their own thoughts, behaviors, and emotions 
in order to identify, prioritize, and meet goals.0F1 After TBI, which often affects the frontal regions of the brain and their 
connections, self-regulation processes become disordered and behavior may lose its goal-directed quality.1F2 This, along 
with other cognitive, physical, and behavioral deficits that follow TBI, contributes to injured Veterans’ reduced ability to 
return to work or school and to regain satisfactory personal lives. Our understanding of the neurological disabling impact 
of TBI on executive function is necessary for both the accurate diagnosis of impairment and individual-tailoring of 
rehabilitation processes aimed at recovery of independent function in returning service members. 2F3 
 
Goal-setting and goal management concepts are part of the “natural language” of rehabilitation. However, 
collaborative goal-setting between clinician/case manager and client can be difficult because of the cognitive deficits that 
follow TBI, and because clients with TBI have heterogeneous problems and diffuse goals that are difficult even for 
experienced clinicians to address. It might be argued that re-training returning Veterans with TBI how to self-manage their 
goals, with appropriate help and support, would essentially treat deficits in executive function. Such treatment would have 
multiple benefits: Practical, real-life goals would be achieved, and injured Veterans would re-learn the skills needed to 
manage their own goals in the future. A structured approach to goal self-management would foster greater independence 
and self-efficacy, help clients to gain insight into goals that are realistic for them at a given time, and help clinicians and 
clients to work more effectively as true collaborators. 
 
The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing 
and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-
integration comparative effectiveness research. The COMPASSgoal intervention will be developed and implemented to 
meet these needs. COMPASSgoal will   integrate principles and best practices of goal self-management. Goal setting is a 
core skill in self-management training by which persons with chronic health conditions learn to improve their status and 
decrease symptom impact.3F4 One important mechanism of action of this program appears to be its positive effect on self-
efficacy, or confidence in one’s ability to attain goals and solve problems.4F5  
 
The study goal is to gather data on the efficacy of a novel approach to psychosocial rehabilitation for Veterans with 
executive function impairment due to traumatic brain injury (TBI), and to explore over time, through relevant measures, 
Veteran responsiveness to intervention. Veterans with mild TBI will be randomized into two groups: the COMPASS 
(Community Participation through Self-Efficacy Skills Development) goal-management intervention group and the 
supported discharge group.  
 
110 participants with residual deficits in executive function due to TBI will be recruited at a minimum of 3 months post-
injury from the TBI program at the DC VAMC over the three-year period of the study. The operational definition of 
executive dysfunction/ inclusion into the study is based on both clinical diagnosis by a study physician and a standardized 
executive dysfunction measure, the Frontal Systems Rating Scale (FrSBe score), such that a total score or any of the 3 
subscale scores < 1 SD compared to the normative score would indicate executive dysfunction sufficient to include in the 
study. The treatment phase for the Veterans enrolled in the intervention group will continue for two consecutive months (8 
weekly sessions). Each participant in the intervention and control group will be assessed at baseline (enrollment), post-
intervention, and at 3 months post-treatment follow up. 
 
The COMPASS patient-centered intervention framework then can be utilized as a platform for VA community reintegration 
comparative effectiveness psychosocial research.

2 
Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA.  
Mild traumatic brain injury in U.S. Soldiers returning from 
Iraq.N Engl J Med. 2008;358(5):453-63. 
 
SPECIFIC AIMS 
 
The study main objective is to determine whether Operation Enduring Freedom/Operation Iraqi 
Freedom/Operation New Dawn (OEF/OIF/OND) Veterans with executive dysfunction due to traumatic brain 
injury (TBI) will benefit from a novel goal self-management intervention (Community Participation through Self-
efficacy Skills Development, COMPASS
goal) compared to Veterans who receive case management support 
representing the current standard of care enhanced  by an increased number of communication prompts as 
specified by the study protocol. 110 participants with residual deficits in executive function due to TBI will be 
recruited at least 3 months post-injury from the TBI program at the DC VAMC over the three year period of the 
study.  
 
The specific aim and hypotheses of this project are:  
 
Study Specific Aim 1: To develop, implement, and evaluate a new goal self-management 
intervention (COMPASS) for Veterans with executive dysfunction due to mTBI, and to investigate how 
executive functioning is linked to the performance of everyday tasks and community functioning. 
 
Study Hypotheses:  
Study Hypothesis 1:  Participants in the COMPASSgoal group will have higher TBI self-efficacy and higher 
community integration scores over time than participants in the supported discharge group matched on 
executive dysfunction score;  
Study Hypothesis 2:  Individual psychosocial profile (emotional status, resilience, and level of post-traumatic 
stress disorder, PTSD) will mediate the responsiveness to the COMPASSgoal intervention, measured through 
the standardized experimental performance of everyday tasks, in Veterans with impaired executive function 
due to TBI. 
 
Research Plan 
BACKGROUND AND SIGNIFICANCE 
 
BACKGROUND. Traumatic brain injury (TBI) is a direct cause of long-term cognitive disability in returning 
Veterans.5F6 TBI is also an established risk factor for psychological health and community re-integration.3,
6F7 
Studies emphasize the dramatic impact of neurological injuries among OEF/OIF/OND active duty troops (see 
Figure 1). There is mounting evidence to suggest 
that executive dysfunction due to central nervous 
system (CNS) insult causes both short-term and 
long-term consequences resulting in poor goal-
directed behavior7F8,
8F9,
9F10,
10F11,
1F12 and significant decrease in 
independent 
functioning 
in 
both 
soldiers 
and 
returning 
Veterans. 
Given 
the 
necessity 
for 
operational 
effectiveness 
in 
the 
battlefield 
environment, executive function symptoms become 
significant for the military because they jeopardize 
active duty troops’ executive function for crucial 
decision making.3,
12F13,
13F14 At the same time, while 
remaining undetected, neurological problems cause 
poor 
self-management 
skills 
resulting 
in 
maladjustment and low quality of life in returning 
military Veterans.3,
14F15 In this study we will use the 
Individuals with Disabilities Education Improvement  
Act of 2004 definition of the traumatic brain injury that describes it as “...an acquired injury to the brain caused 
by an external physical force, resulting in total or partial functional disability or psychosocial impairment, or 
both, that adversely affects a person’s professional and educational performance in one or more areas, such 
as cognition; language; memory; attention; reasoning; abstract thinking; judgment; problem-solving; sensory, 
perceptual, and motor abilities; physical functions; information processing; and speech. The term does not 

3 
apply to brain injuries that are congenital or degenerative, or to brain injuries induced by birth trauma.” 15F16 The 
exposure to stressors from combat including explosive blasts and loss or injury to self or comrades can lead to 
significant problems when translating back to civilian life post-combat.16F17,
17F18 Due to advances in medicine and 
body armor, soldiers are surviving blasts or explosions that may have previously resulted in severe injury or 
death during combat.  Following the US defense causality report in November 2009,  the Institute of Medicine 
updated its statistics to show that “casualty-to-wounded ratios have been found for OEF as 1:5.52 and for OIF 
as 1:7.2318,
18F19 compared with 1:2.6 in Vietnam and 1:1.7 in World War II18,
19F20.”  
 
Many Veterans returning from the wars in Iraq and Afghanistan Operation Enduring Freedom (OEF), Operation 
Iraqi Freedom (OIF), and Operation New Dawn (OND) may have experienced TBI,20F21 the significance of which 
is underscored by a national study, undertaken by the RAND corporation commissioned by the Office of the 
Secretary of Defense for Health Affairs, to gage the impact of TBI on the lives of Veterans and their families.
21F22  
Even if there are no other co-existing physical impairments, TBI and PTSD are enough to significantly hinder a 
Veteran’s successful progression into active community participation and employment. Physical factors 
affecting community re-integration in Veterans with polytrauma and traumatic brain injury include pain, PTSD-
related anger, and depression. Among psychosocial factors that affect community functioning in returning 
Veterans are social isolation, poor problem-solving of everyday difficulties, and lack of motivation to change.  
 
 
EXECUTIVE FUNCTIONING SYSTEM IN TBI: A MULTIFACTORIAL MODEL  
 
Executive dysfunction is the core condition underlying neurologic impairments resulting from central nervous 
system (CNS) insult such as traumatic brain injury,6 dual TBI-spinal cord injury9,
2F23 and stroke,23F24 as well as a 
distinct feature of CNS degenerative disorders such as Parkinson’s disease. 24F25  As a central clinical syndrome, 
executive functioning is defined as a network of processes that are responsible for initiating, guiding, and 
regulating psychomotor, cognitive, emotional, and behavioral functions, particularly, during active and novel 
problem-solving.11,
25F26,
26F27  
 
EXECUTIVE SYSTEM: NEUROANATOMICAL - NEUROCOGNITIVE DIMENSION  
 
Executive processes are thought of as part of the system that acts in a supervisory capacity in the overall brain 
hierarchy27F28 and provide for purposeful, goal-directed behavior.28F29,
29F30,
30F31 There is a plethora of neurologic and 
behavioral data demonstrating that individual performance processes are deeply involved with changes in what 
can be named the executive functional system (EFS) (see Figure 2 below).31F32,
32F33 Recent studies emphasize that 
executive processes do not have a single neuroanatomical representation in the central nervous system,10,
3F34 
rather they present as patterns merging different brain structures (e.g., the brain’s prefrontal zone and limbic 
system) and their peripheral counterparts (e.g., motor apparatus). Existing interlinkages in the brain-peripheral 
system are currently explored by measuring various aspects of executive functioning through standardized 
neuropsychological assessments, magnetic-resonance imaging (MRI) and a more precise assessment, 
diffusion tensor imaging (DTI). 34F35 The conceptual definition of the EFS proposes two major subsystems: the  
central executive subsystem,35F36 that includes higher level processes such as selective attention, working 
memory, and decision-making capacity10 and the peripheral executive subsystem, composed mainly of 
psychomotor processes associated with central executive performance. 36F37,
37F38 Executive functioning can break 
down at any stage in the behavioral sequence be it volition control, planning, purposeful behavior, or effective 
performance.38F39 Deficiencies in self-initiated behaviors may result from neurological damage to the frontal-
subcortical or fronto-limbic circuitry (see areas C and D, Figure 2),39F40,
40F41 to the right hemisphere, or in diffuse 
neurologic conditions (see area A, Figure 2).41F42 The dorsal prefrontal cortex is critical to allocating attentional 
resources involved with working memory tasks,42F43 or to the attentional controller43F44 – a system responsible for 
maintaining and switching attention.4F45  
 
 Cognitive and psychomotor goal-directed activity  

4 
Motor 
performance 
is 
an 
instrumental component of the 
executive functional system.32,33  
In the classic methodology of 
motor 
examination 
tasks 
developed by Luria and his 
successors45,
45F46 the ability to copy 
hand movements paced by a 
metronome46F47  was found to be 
sensitive to frontal damage and 
to temporal lesions (see area C, 
Figure 2). Inability to move 
rapidly through a repetitive or 
mixed-movement 
sequence, 
combined 
with 
errors 
and 
perseverations, was found to be 
characteristic of patients with left 
hemisphere lesions (see area B, 
Figure 2).47F48  Motor regulation 
deficits are often associated with 
withholding responses,48F49 based  
on a “go/no-go” rule where a 
Figure 2. Central-Peripheral Dysregulation in Executive                            subject should respond only to  
Functional System (EFS) 
 
 
 
 
 
 
       one of two presented signals  
 
 
 
 
 
 
 
 
 
   
       (see area A, Figure 2).31                          
Patients with subcortical involvement display executive dysfunction that includes impairments in cognitive            
flexibility, memory recall, and psychomotor slowing. 49F50,
50F51,
51F52  Impairment of executive processes often presents 
the major challenge in individual ability to perform activities of daily living (ADLs), 52F53 management of disability,53F54 
and community reintegration.54F55  
 
EXECUTIVE SYSTEM: TBI, PTSD AND COMMUNITY RE-INTEGRATION 
 
There is an overlap of symptoms between TBI and PTSD.  This issue is most pertinent in the chronic TBI 
population where there are higher rates of PTSD.  Sustaining any kind of physical injury is known to increase a 
person’s risk for PTSD.5F56  There are several symptoms that are found in both PTSD and TBI, such as deficits 
in attention and memory, irritability, and sleep disturbance. However in the acute assessment of TBI, some of 
the distinguishing symptoms such as headache, dizziness, balance problems, and nausea/vomiting may help 
to elucidate TBI from PTSD. Another distinguishing factor is the history that is obtained from the patients about 
the course of events before, during, and after the traumatic event. Loss of consciousness (LOC) and post-
traumatic amnesia are less common in PTSD and is the distinguishing historical factor to diagnose mild and 
moderate TBI.  
 
Research has suggested a range of post-injury cognitive, somatic, and behavioral symptoms including 
headache, anxiety, dizziness, and memory difficulties immediately following TBI,56F57,
57F58,
58F59 as well as decreased 
educational attainment and limitations in work performance. 59F60,
60F61 The effects of cognitive and behavioral 
impairment on independence and societal participation following TBI is well established.  At the same time the 
gaps between research and everyday life continue to exist. As the recent report on the needs of returning 
IOF/OEF Veterans, published by the U.S. Institute of Medicine, indicates, “little research has been conducted 
to evaluate whether service members who undergo third location decompression (that is, for service members 
to have time with their comrades and peers in a restful situation and prepare themselves for going back to their 
families and communities) have better outcomes than those who do not.”18  
 
Strengthening the community integration of Veterans with TBI requires a collaborative effort bringing together 
Veterans and their families, Veterans Health Administration case managers and social workers, and the 
broader research community to address barriers that prevent Veterans with serious injures such as TBI from 

5 
effectively pursuing opportunities in life that are available to others. In one of the first national surveys of 
OIF/OEF combat Veterans enrolled in the Department of Veterans Affairs health care system, Sayer and 
colleagues (2009)61F62 explored the prevalence and types of community re-integration problems faced by Iraq and 
Afghanistan war Veterans, while assessing preferences for interventions to promote adaptation to civilian life. 
Stratified Poisson regression was used to determine whether the number of community reintegration problems 
and the number of services of interest were associated with the presence of probable PTSD, gender, or race. 
An estimated 25% to 56% of the population had some to extreme difficulty in social functioning, productivity, 
community involvement, and self-care domains. At least one third reported divorce, dangerous driving, 
increased substance use, and anger control problems since returning from deployment. An estimated 41% had 
probable PTSD and each type of reintegration problem was more prevalent among Veterans with probable 
PTSD. The vast majority (96%) of Iraq/Afghanistan veterans expressed interest in services to help them 
readjust to civilian life. The most commonly preferred ways to receive reintegration service or information was 
at a VA facility, through the mail, and over the internet. Interest in self-help techniques and yoga/meditation 
was particularly common.62F63   Penk and colleagues (2010)63F64 in their VHA comparative effectiveness study 
discussed the need for research that identifies ways to aid Veterans with dual diagnoses attain competitive 
jobs.  Community re-integrations tools were found to be key to the effectiveness of employment programs 
providing Veterans not only with income-earning work but also with skills to help them secure employment. 
 
INTERNATIONAL CLASSIFICATION OF FUNCTION, DISABILITY AND HEALTH (ICF) 
 
In COMPASSgoal, we will consider function and disability, as well as activity and participation (including 
employment), based upon the widely-used International Classification of Function, Disability, and Health (ICF) 
framework64F65 developed under the auspices of the World Health Organization . Through this inclusive approach, 
we will best be able to document the natural process of recovery in TBI, including the occurrence of 
accelerated recovery, thereby addressing the needs of people with chronic TBI and providing potential benefit. 
At each assessment time point, participants (and their families and/or caregivers, if appropriate) will complete 
validated, standardized scales that capture outcomes in four central domains as defined by the ICF model: 
function, health, participation, and employment. The ICF presents an interaction of several basic concepts in 
disability that is widely used as a methodological tool for studying physical disability in general and TBI in 
particular. Relevant to the present project’s conceptual integration is the ICF proposed model of contextual 
(personal and environmental) factors as they relate to the individual health condition.65     
 
OPERATIONAL DEFINITION OF EXECUTIVE FUNCTIONING 
 
The operational definition of executive dysfunction/ inclusion into the study is based on both clinical diagnosis 
by a study physician and a standardized executive dysfunction measure, the FrSBe score, such that a total 
score or any of the 3 subscale scores < 1 SD compared to the normative score would indicate executive 
dysfunction sufficient to include in the study. 
 
SIGNIFICANCE. Studies emphasize the dramatic impact of neurological injuries among OEF/OIF active duty 
troops, as well as difficulties that such impairments present for returning service members.3,6,13,17 An 
understanding of the neurological disabling impact on executive function is necessary for both the accurate 
diagnosis of impairment and individual-tailoring of rehabilitation processes aimed at recovery of independent 
function.3,18,
65F66    
 
Significance and Alignment with RR&D Priority Area: The proposed study directly supports the RR&D main 
goal to maximize functional recovery in Veterans as well as such additional goals as: 
Topic area 1: integrating the Veteran back into work and society (Hypothesis 1) 
Topic area 2: developing research that has strong potential for translation into clinical practice 
(Hypothesis 2) 
 
The proposed goal self-management intervention COMPASSgoal promises to be effective for service members 
and their families, as well as for the civilian population, by timely detection of impaired decision-making due to 
executive dysfunction, facilitation of clinical behavioral monitoring, and promotion of the effectiveness of 

6 
neurorehabilitation and psychosocial procedures aimed at restoration of independent functioning and further 
community re-integration. 
 
RESEARCH DESIGN AND METHODS 
 
Overall Study Design  
 
The proposed 3-year multi-phase   study will test two inter-related hypotheses. Hypothesis 1 is explored 
through a randomized controlled trial (RCT) testing the efficacy of a newly developed intervention 
COMPASSgoal in 110 young to middle aged Veterans with mild TBI assigned to intervention goal self-
management or supported discharge groups. Hypothesis 2 is aimed at studying the multilevel relationships 
between four set of variables (neurological, psychological, behavioral, and social) measured repeatedly for the 
duration of the project. Assessments for the Veterans with mTBI involved with the project will be performed at 
baseline (pre-intervention for the COMPASSgoal group), 2 months after enrollment (or post-intervention for the 
COMPASSgoal group), and 3 months post-intervention/follow up.  
 
Overall Study Population 
 
One hundred and ten Veterans with residual deficits in executive function due to mild TBI will be recruited from 
the TBI clinics at the DC VAMC over the three-year period of the study. Severity of TBI will be determined by 
the DC VAMC attending clinician using the VHA TBI Comprehensive Evaluation electronic template. 6F67 The 
Frontal Systems Rating Scale (FrSBe) will be used to identify individuals with differing levels of executive 
dysfunction. The operational definition of executive dysfunction/ inclusion into the study is based on both 
clinical diagnosis by a study physician and a standardized executive dysfunction measure, the FrSBe score, 
such that a total score or any of the 3 subscale scores < 1 SD compared to the normative score would indicate 
executive dysfunction sufficient to include in the study. Prior history of known bipoloar disorder, schizophrenia 
or severe psychiatric illness will be determined first by review of the medical history.  If the potential 
participant’s medical record has no documentation of mental health evaluation within the year prior to 
enrollment, the M.I.N.I. Neuropsychiatric Interview will be administered for exclusionary screening purposes..  
 
  
We will make every effort to balance the sample by age, gender, and education following the study inclusion-
exclusion criteria. Based on previous studies conducted with the VA population in the Greater Washington 
Area, we expect that approximately 10% of the study participants will be female, and 70% will be African-
American. The total number of study participants (N = 110) accounts for a 20% attrition rate in a neurologically-
disabled population due to their health condition and related problems. 
 
Inclusion-exclusion criteria 
 
One hundred and ten medically stable individuals with various levels of TBI severity who are not currently 
evaluated at weekly meetings by the Polytrauma Interdisciplinary team for TBI-related skilled therapy 
management will be enrolled into the study according to the following inclusion and exclusion criteria: 
 
  Table 1. Study inclusion-exclusion criteria 
 
Inclusion Criteria 
Exclusion Criteria 
 
 
 
COMPASS: 
community re-
integration study 
TBI of at least mild severity using 
criteria related to disturbance of 
consciousness 
(VHA TBI Comprehensive 
Evaluation screening tool)  
Unable to provide informed consent and 
no proxy available 
Obtained informed consent  
 
Severe impairment of language or day-
to-day memory  that would preclude 
participation in a verbally-based therapy 
Males or females of working age, 
between the ages of 18 and 55 
Life expectancy of less than 36 months 

7 
Medically stable with physician 
approval to participate 
Severe multiple trauma (as judged by 
the attending physicians and/or 
investigators that is too severe to 
participate in this study) such as severe 
burns, serious organ damage, 
amputations, multiple fractures. 
Ability to comprehend and 
communicate in English at a 6th 
grade level  
History of  substance abuse severe 
enough to cause neurologic damage, 
pre-morbid history of neurologic disease 
(e.g., stroke) 
Executive dysfunction as identified 
by Frontal Systems Rating Scale 
(FrSBe) and/or other study 
assessments (see Table 2)  
Prior history of known bipolar disorder 
or schizophrenia or severe psychiatric 
illness as determined by clinical 
judgment and the medical record.  The 
MINI assessment will be administered if 
no clinical judgment is on record within 
year prior to enrollment.  
 
 
POWER AND SAMPLE SIZE CALCULATION 
 
Sampling  
 
During revision, we reversed our changes for the selection criteria following reviewers’ suggestion to refocus 
our efforts on Veterans with mild TBI. The TBI clinic is held on a daily basis at the DC VAMC.    This clinic 
evaluates 150-200 new Veterans per year who are identified with a positive TBI screen.  Currently, the positive 
TBI diagnosis rate is approximately 50% for the DC VAMC site.  In addition, other Veterans with known TBI are 
referred to the clinic resulting in additional 50-100 referrals per year. Frequency of follow-up visits is 
determined on an individualized basis. In addition to the Veterans with TBI who are hospitalized at the DC 
VAMC each year, many Veterans seen at the Richmond Polytrauma Rehab Center and discharged to the 
Washington DC Metro area are then seen in the DC VAMC TBI clinic. Everyone who consents to the study will 
be examined using the FrSBe. It is estimated that 50-75% of Veterans with mild TBI, have impaired decision-
making/executive dysfunction and will be eligible and willing to participate in the study. 
 
Power and sample size calculation  
 
110 participants with executive dysfunction due to diagnosed TBI will be randomized into the COMPASSgoal 
intervention or supported discharge groups, as assessed via the VHA TBI Comprehensive Evaluation 
screening tool.   Participants in the supported discharge group will not receive the intervention, but will receive 
usual care provided by case managers with increased intensity of communication prompts. Participants in the 
intervention group will receive 8 goal self-management sessions over a period of approximately 10 weeks. We 
don’t expect a significant change from post-intervention to 3 month post-intervention, the sample size calculations 
are based on a t-test for comparisons of mean change in the Community Reintegration of Service members 
(CRIS) subscale from pre- to post-intervention between two groups. 
 
Hypothesis: 
H0: μ1= μ2 where μ1= mean change in CRIS subscale from time 1 to time 2 in self-management 
group and μ2= mean change in CRIS subscale from time 1 to time 2 in supported discharge group 
H1: μ1≠ μ2 
Power Calculation: PASS (Power Analysis and Sample Size Software, Kaysville, UT, 2008) was 
used for the power calculation. The primary outcome of this study is the frequency of social 
interactions measured via the Extent of Participation subscale of the CRIS..6 The power calculation was 
performed based on the hypothesis listed above by using a two-sided t-test with assumption of normality. The 
level of significance was set at 0.05 and power was set at 90%. The effect size and standard deviation used for 
the power calculation were estimated based on a previous VA study and clinical judgment.744 subjects in each 

8 
group, for a total of 88 subjects will provide 90% power to test an effect size of 0.71 with a SD of 7 for 
difference in CRIS subscale score between groups with α=0.05 (two sided). After adjustment for 20% loss to 
follow-up, we will recruit 55 subjects in each group of this study, a total of 110 subjects. 
 
 
COMPASS PROCEDURES AND IMPLEMENTATIONS 
 
Study procedures will take place at the DC VAMC in Washington, DC either face-to-face or over the VA 
Telehealth System (see Study Algorithm, Figure 5). All research procedures, including assessments, may be 
completed over the phone, not including informed consent.  Over the 3-year course of the COMPASSgoal 
project, we will screen, consent, and baseline 110 Veterans, aged 18-55 years, who have been diagnosed with 
MTBI. All participating Veterans will undergo a battery of tests measuring executive function, real-world 
performance, TBI self-efficacy, emotional status and PTSD resilience, community integration, and quality of 
life. Each will receive additional screening of TBI and executive dysfunction to determine intervention eligibility. 
COMPASSgoal investigators will discuss each participating Veteran with his/her VA case manager. 
Subsequently, Veterans will be randomized to intervention and control groups. The former will receive the 
COMPASSgoal self-management intervention developed to support vulnerable transitions identified during the 
first 6 months of the project. The latter will receive focused, but standard-of-care, support from the VA TBI 
Clinic team. Intervention group Veterans will receive 8, weekly, up to 90-minutes, one-on-one goal 
management sessions over a period of 2 months.  Goal sessions with coaches, as well as control group 
interactions and assessments, will be audio recorded to better inform the researchers about the effectiveness 
of the interventions.  These sessions may occur in person or over the phone. Veterans in both the intervention 
and control groups will receive assessments pre-, post-, and 3 months following completion of the 
COMPASSgoal intervention or supported discharge process. Data will be modeled longitudinally and on multiple 
levels to identify vulnerable transitions and predictors of community integration/participation outcomes. 
Findings will form the basis for clinical practice guidelines. 
 
Figure 5. COMPASS Study Algorithm                                                                          
 
Recruitment Process 

9 
 
Participants will be recruited from DC VAMC by Dr. Alexander Libin (PI), Dr. Joel Scholten (Co-PI; Polytrauma 
Clinic Director, and their clinical associates. Consecutive patients approaching discharge from multi-
disciplinary care who meet the inclusion/exclusion criteria will be notified of the study and approached for 
informed consent.  If necessary, participants will be recruited using recruitment flyers. Following consent 
procedures, individuals agreeing to participate in the study will be asked a series of screening questions to 
ensure that they have met all inclusion/exclusion criteria. In addition, study investigators will take special 
precautions to ensure that potential study participants fully understand the consent form and authorization for 
the release of Protected Health Information (e.g., by reviewing the consent form and answering any questions 
the individual may have - see details in the Human Subjects section).  
 
Screening for exclusion-inclusion criteria 
 
Potential participants will be approached at least three months after TBI for informed consent. The results of 
the VHA TBI Comprehensive Evaluation electronic template will be reviewed following IRB approved and 
HIPAA compliant data collection procedures. The first data collection will take place within the first 14 days 
after screening and enrollment into the project. 
 
Informed Consent Process 
 
Upon identifying a potential subject in the DC VAMC TBI database or through the TBI Case Manager, the 
study PI and Co-PI (Dr. Scholten) or treating physician will speak with the TBI patient and family, as 
appropriate to each Veteran’s circumstances, about the study. In addition, the treating physician will introduce 
the research team to the families of patients. Special care will be taken to explain the nature of the study and 
all risks/benefits to the individual in language that is appropriate for his/her comprehension level. Once written 
consent has been obtained, subjects will be assigned a de-identified study number for data collection purposes 
by the PI. 
 
Testing setting 
 
For both standard and computerized testing, participants will be provided with a quiet room, a desk, and a 
chair. We will make every effort to standardize testing conditions.  Assessments will be audio recorded for 
quality control purposes. 
 
Patient retention and PI prior recruiting experiences  
 
Based on the PI’s prior experiences, we are confident in the success of study recruitment and retention 
procedures. In addition, we will be using a motivational technique that previously proved to be very useful in 
participant recruitment and retention. An IRB approved Certificate of Participation (Thank You letter) template 
will be used to provide participants and family members with appreciation for participation in the study in 
comprehensible, “layman” language. This will not only keep participants engaged with the study, but will also 
potentially create a study atmosphere that will motivate them to bring other potential participants to the study to 
benefit from the same experience.  
 
To encourage ongoing patient engagement between assessment sessions T2 and T3, Veterans will receive  
IRB-approved Engagement Templates as reminders of COMPASS participation.  This will remind participants 
that they are enrolled in the COMPASS study without providing information that may influence study variables.  
Further, participants who initially engaged with the study team, but are lost to follow-up will also receive an 
IRB-approved Follow-up Letter asking them to contact the study team to confirm continued participation in the 
study. See Appendix 4 for the letter templates. 
 
Overall rationale for the assessment model 
 
While assembling the study assessment battery we considered the following rules: a) relevance of the 
proposed measure to the study Specific Aim and Hypotheses; b) the balance of the proposed measures by 

10 
modes of expression and assessment quality (self-reported assessment vs. experimental technique vs. 
observation by a clinician or a family member); c) the possibility of premorbid executive functioning evaluation 
and sequential charting of executive function over time as it returns to the estimate; and d) possibility of linking 
performance at the baseline with executive performance over time, using reliable change models to determine 
if the change meets criteria for some a priori "recovery threshold".   
 
Included in Table 2 below and Appendix 1 (Assessment Schedule), core TBI measures were suggested by the 
TBI Common Data Elements work group and/or were used in community integration TBI studies while 
implementing a multilevel approach to data analysis. The National Institute of Neurological Disorders and 
Stroke (NINDS), the Department of Veterans Affairs (VA), the National Institute on Disability and 
Rehabilitation Research (NIDRR), the Defense Centers of Excellence for Psychological Health and 
Traumatic Brain Injury (DCoE), and the Defense and Veterans Brain Injury Center (DVBIC) have co-
sponsored this scientific initiative to develop common data elements (CDEs) for TBI research. 
 
In accordance with the study Specific Aim, we also considered psychosocial individual assessments that 
capture the subjective aspects of recovery including resilience, amount of stress (PTSD), functional capacity, 
emotional status (including depression and anxiety levels), TBI self-efficacy, coping, and life 
satisfaction. These measures have proved external validity and are commonly used in TBI studies (see Table 
2, Assessment Schedule).  The behavioral assessment focuses on individual performance of real-world tasks. 
The community integration measures focus on different aspects of societal participation and individual 
productivity including educational attainment and employment.  These measures also have good construct 
validity, test-retest reliability, and importantly, they are sensitive to change.  Most measures employ alternate 
forms or demonstrate low practice effect which makes them appropriate for repeated administration. We are 
also aware that the types of measures included are complementary such that "recovery" on the objective 
measures might not reflect "recovery" on the subjective measures.  
 
STUDY ASSESSMENT SCHEDULE 
 
Assessments will be performed at baseline (termed as "pre-intervention" for the COMPASSgoal group), 2 
months (or post-intervention for the intervention group), and 3 months follow up for both intervention and 
supported discharge groups. Participants involved with the COMPASSgoal intervention (see relevant section 
below) will receive 8 goal self-management sessions over a 2-month period. The data will include 
demographics, level of TBI severity as confirmed by duration of post-traumatic amnesia and alteration of 
consciousness based on the VHA TBI Comprehensive Evaluation screening tool, executive dysfunction, 
PTSD, resilience, emotional status, coping, TBI self-efficacy, real-world tasks, and community integration.  
Family members will be invited to participate and answer the family-report FrSBe assessment either in person 
or over the telephone after being contacted through an IRB-approved letter. 
 
 
Table 2: Multifactorial Executive Functioning, Psychological, Behavioral, and Community 
Integration Measures (for a detailed description see Appendix 1, Assessment Schedule)  
NOTE. Table 2 was significantly revised; therefore changes are not italicized. 
Domain 
Test 
Description 
Study Protocol 
Time 
Cognitive 
functioning 
and TBI 
severity 
 
TBI screening 
(VHA TBI 
Comprehensive 
Evaluation 
screening tool) 
Reliable measure for 
detecting cognitive 
impairment in service 
members. If the 
Veteran does not 
have a CTBIE 
available in the 
medical record, 
questions 6-8 will be 
collected by an IRB-
Screening for 
exclusion 
* 

11 
Domain 
Test 
Description 
Study Protocol 
Time 
approved member of 
the Polytrauma team. 
Executive 
dysfunction 
 
FrSBe** 80, 82 
Frontal systems 
Behavioral Scale, 46-
items. Both self-report 
and Family-report. 
Executive 
dysfunction due 
to TBI 
10 min 
 
 
Demographic 
Information 
Patient Information 
Form 
8 questions about 
demographics  
Collected once 
during 
exclusionary 
screening 
5 minutes 
Mental Health 
MINI International 
Neuropsychiatric 
Interview (MINI) 
7.0.067F68 
Reliable measure of 
Mental Disorders from 
DSM-V, including 
depression, suicidal 
ideation, manic and 
hypomanic episodes, 
panic disorder, 
agoraphobia, social 
phobia, obsessive-
compulsive disorder, 
post traumatic stress 
disorder, alcohol 
dependence/abuse, 
substance 
dependence/abuse, 
psychotic and mood 
disorders, anorexia 
nervosa, bulimia 
nervosa, generalized 
anxiety disorder, and 
antisocial personality 
disorder.   
Determination of 
mental health 
disorders in 
absence of 
clinical judgment 
within past year.  
15 min 
Executive 
dysfunction 
 
TMT Trail Making 
Test 
Trail Making Test 
(Part A and B) 
This is a measure of 
cognitive processing 
speed, mental 
sequencing, visual 
search and motor 
speed and consists 
of two components: 
Part A and Part B. 
Part A requires the 
subject to connect 
15 encircled numbers 
that are randomly 
arranged on a page 
in numerical order. 
Part B requires 
Executive 
dysfunction due 
to TBI 
5 min 

12 
Domain 
Test 
Description 
Study Protocol 
Time 
the subject to 
connect 15 encircled 
numbers and letters 
in alternating order. 
The score provided is 
time required to 
complete the task. 
Executive 
dysfunction 
 
COWAT Controlled 
Oral Word 
Association Test 
Controlled Oral Word 
Association Test 
(COWAT) 
This is a measure of 
word generation and 
is considered an 
executive functioning 
measure. Letter 
Fluency requires the 
person to generate 
words that start with 
a specific letter. 
Category Fluency 
requires generation 
of words from within 
a specific category 
(e.g., animals). Each 
trial lasts for 
one minute and the 
score is based on the 
number of words 
provided. 
Executive 
dysfunction due 
to TBI 
5 min 
TBI Self-
efficacy 
TBI Self-efficacy 
Questionnaire           
15-item TBI-specific 
scale of self-efficacy 
with regard to trauma 
Measure of 
individual 
abilities to 
manage TBI 
consequences 
5 min 
Emotional 
status and 
resilience 
  
 
BSI-18 assessment  
 Paper-and-pencil 
scale that consists of 
18 items; 5-point rating 
scale and is part of the 
Common Data 
Elements set 
Measures 
depression, 
anxiety, somatic 
concerns, and 
general distress  
5 min 
Post-traumatic 
Stress Disorder 
Checklist (PCL)  
 
Presence of PTSD 
symptoms. PCL is a 20 
item self-report scale, 
updated for DSM-V.  
Stress signs: 
intrusive 
thoughts, 
avoidance 
behavior, arousal 
symptoms 
5 min 
Community 
Reintegration for 
Service Members 
107 – items assessing 
Extent of Participation, 
Perceived Limitation in 
Veteran-specific 
measure utilizing 
3 unidimensional 
25 mins 

13 
Domain 
Test 
Description 
Study Protocol 
Time 
(CRIS, Fixed Form; 
Resnik L.) 81, 82,83,84** 
Participation, and 
Participation 
Satisfaction 
scales 
Social participation 
via ICF qualifiers: 
return to work and/or 
to school as defined 
by the ICF 
framework 
Work 
status/educational 
attainment confirmed 
by a family 
member/immediate 
caregiver or other 
reliable source. 
Categorical 
variables 
* 
 *Tests performed by attending clinician or as part of the routine care at the DC VAMC  
** If patients participate in the recruitment assessment within 1 month of participating in clinical trial, the test 
will not be repeated. 
 
RANDOMIZATION OF THE COMPASS PARTICIPANTS 
 
Randomization of the study participants will occur after all the baseline data are collected. The mTBI diagnosis 
including operational definition of executive dysfunction will be determined by the study Co-PI, Dr. Joel 
Scholten, Director of the TBI Program at the DC VAMC with the participation of the DC VAMC 
neuropsychologist as part of the routine evaluation of Veterans referred with suspected TBI. Staff performing 
all outcome assessments will be blinded to group assignment throughout the study, and participants will be 
asked at each assessment not to reveal their group assignment to data collectors. 
 
 
GOAL SELF-MANAGEMENT INTERVENTION (COMPASSgoal ) DEVELOPMENT 
 
The purpose of the study is to develop and implement an innovative treatment program called COMPASSgoal 
which will teach goal self-management to Veterans with executive dysfunction due to TBI. This will include a 
systematic, written protocol for therapists and “user-friendly” materials for clients, to be used in individual 
treatment with clients with TBI. This treatment protocol will be used to guide Veterans and their therapists in 
the process of defining, setting, and tracking progress towards goals throughout the study timeframe.  
 
As an aid to developing the intervention materials, focus groups and semi-structured interviews will be held 
with Veterans with mTBI who come from a variety of backgrounds. The purpose of these interviews and focus 
groups is to assure that the content and format of the COMPASS intervention is broadly relevant to both 
Veterans’ goals in the context of their lived experiences.. The focus groups and interviews will be audio 
recorded. Focus group/interview scripts are found in Appendix 2. 
 
As another aid to developing the intervention materials, focus groups and semi-structured interviews will be 
held with VA clinicians from practices representative of how the VA delivers services nationwide.  The purpose 
of these interviews and focus groups is to assure the content and format of the COMPASS intervention in 
broadly relevant to the constraints of clinicians’ practice across VA service environments.  The focus groups 
and interviews will be audio recorded.  Focus group/interview scripts are found in Appendix 2. 
 
In addition to the modifications described above, we will conduct a recruitment assessment prior to 
implementing the intervention.  This portion of the study will not be audio recorded.  The assessment will be 
part of routine clinical treatment and participation is mainly a release of records. In this assessment, we will 
document the approximate number (and thus, proportions) of new patients presenting for clinic services 
(without keeping personal identifiers associated with those data). Among this consecutive series of new 
patients, we will use an informed consent process to invite participation in a single, brief testing session, for 
those who screen positive for mild TBI, but do not have documented serious mental health co-morbidity (e.g., 
schizophrenia, major depressive disorder, clinically significant PTSD). Thus, these latter participants will 
grossly resemble those who might be invited into the COMPASS trial on discharge from rehabilitation team 

14 
treatment. Following informed consent, these participants will be given the main measure used for inclusion in 
the intervention study, the FrSBe, the primary outcome measure, the CRIS, and a short interview. Total 
participation is expected to take no more than 30 minutes and may be done either in person or by phone at the 
convenience of the Veteran (these 2 modes of administration have been shown to be psychometrically 
equivalent.68F69 In addition to consenting to answering the questions on these 2 measures, participants will be 
asked to consent to have their routine clinical data (age, gender, presenting symptoms, severity of TBI, records 
from the current episode of treatment) used as needed to correlate with the psychometric findings (without 
personal identifiers attached). 
 
The rationale for this recruitment assessment is as follows. The FrSBe is a self-report measure of executive 
dysfunction that was developed originally to measure neurobehavioral symptoms in dementia. It has been 
carefully validated and normed, and has favorable psychometric characteristics. Despite being selected as a 
relevant measure for TBI by the TBI Common Data Elements Outcome Measures Working Group, it has been 
used little in studies of mild TBI in Veterans, which is the target population of the investigation. One study 
(Schiehser et al., 2011) administered the pre- and post-onset versions of the FrSBe to 71 non-combat military 
personnel who were <3 months post mild to moderate TBI. On average, the pre-injury ratings were within 
normal limits but post-injury scores were elevated, especially on apathy and executive dysfunction. However, 
on average, even the elevated scores were within the normal or borderline ranges.69F70 This reinforces the need 
to examine the distribution of FrSBe scores in a sample of Veterans with remote mTBI and to relate specific 
score elevations to other sources of symptom report. The only other study examining FrSBe scores exclusively 
in mild TBI sustained in adulthood did show scale elevations in a non-military convenience sample of 76 
persons presenting with symptomatic, self-reported mild TBI years after injury; actual TBI severity could not be 
determined in most cases and symptom exaggeration could not be ruled out.70F71 Thus, from prior literature we 
cannot predict with certainty (1) whether our current inclusion criterion of ≥ SD on any FrSBe subscale is overly 
restrictive, overly inclusive, or appropriate for this population; nor can we judge (2) the proportion of available 
participants who would meet this criterion, which has important implications for our ability to meet recruitment 
benchmarks within the study time frame. The proposed assessment will enable us to determine the sensitivity 
of the FrSBe to mild TBI sustained months or years prior to intervention and, by revealing the approximate 
proportion of clinic patients who would meet inclusion criteria, will help us to plan how to recruit adequate 
numbers of Veterans into the trial. 
 
The CRIS, our primary outcome measure, is equally important to assess in this sample in order to address the 
following objectives: (1) Determine the time needed to administer the measure, which is quite lengthy. 
Recently, the CRIS was converted to a computer-adapted (CAT) version which may substantially reduce 
participant burden.71F72 Before starting the assessment, we will contact the primary author of the measure to 
determine if the CAT and/ or validated short forms are available; (2) Verify that this measure, too, is sensitive 
to the community integration problems experienced by those with mild TBI. The CRIS has been validated thus 
far on Veterans with severe, mixed type injuries; homeless Veterans; and those with mental health diagnoses 
such as depression and PTSD, but not in our target population; (3) Derive preliminary data on the relationship, 
if any, between the FrSBe and the CRIS measures. Reid-Arndt et al. (2007) found that the FrSBe predicted 
community integration only weakly.72F73 However, that study used the Community Integration Questionnaire, a 
measure with known psychometric difficulties. 
 
Conceptual Framework 
 
 
The proposed new interventional framework, COMPASSgoal, aims at addressing unmet needs of OIF/OEF 
Veterans for successful return to civilian life.3,8-14 Employing the proven elements from self-management 
training and other goal management programs successfully implemented with civilian clinical populations, 
COMPASSgoal will guide participating Veterans, their families, and rehabilitation specialists through the process 
of negotiating goals, establishing hierarchies of long-, mid-, and short-range goals, and developing 
individualized, measurable ways of tracking progress. A skill that will be emphasized is the ability to break 
distal, or long-term goals, into proximal or short-term goals, and to use one’s performance on proximal goals to 
modify the distal ones as necessary.73F74  Other specific components to be incorporated into the COMPASSgoal 
protocol include three over-arching self-regulation strategies that have been shown in meta-analyses to be 
effective: goal manipulations; arousal management (both relaxation and increasing arousal/ motivation); and 

15 
cognitive self-regulation, which includes self-monitoring, evaluating, and adjusting performance to meet a 
selected standard.74F75 A meta-cognitive technique called “mental contrasting”—simultaneously considering both 
the positive aspects of the goal state with the negative aspects of one’s current state—will also be employed.75F76 
Finally, self-monitoring skills will be incorporated as these also have a strong evidence base. 76F77 
 
Procedures and Implementation 
 
The COMPASSgoal intervention will be developed with the assistance of the study Chief TBI Rehabilitation 
Research Consultant, Tessa Hart, PhD. Dr. Hart is a recognized expert on executive function/ dysfunction after 
TBI, and its treatment.7F78,
78F79,
79F80,
80F81,
81F82,
82F83,
83F84,
84F85,
85F86,
86F87,
87F88,
8F89,
89F90,
90F91,
91F92,
92F93,
93F94  She is also an expert in the process of developing 
treatment manuals,94F95,
95F96 and is leading an NIH-funded 3-center study to test a treatment protocol for anger self-
management in TBI. Dr. Hart also recently published a review of the literature on goal and self-regulation 
theories applied to TBI rehabilitation. 96F97 She will be primarily responsible for organizing the COMPASS 
treatment manual and will also assist with solving the inevitable challenges that emerge in the process of 
implementing a rigorous trial in a clinical setting.97F98 Researchers will work as an integral part of the DC VAMC 
TBI clinic in partnership with Dr. Joel Scholten, Director, VA TBI case manager. Dr. Scholten specializes in TBI 
rehabilitation and has previously served as Medical Director of the Brain Injury Rehabilitation Program and the 
Polytrauma Network Site Director at James A. Haley Veterans Hospital in Tampa, FL.  Dr. Scholten is currently 
the Associate Chief of Staff for Rehabilitation Services at the DC VA Medical Center.   
The project team will participate in VA TBI clinic weekly meetings discussing potential participants, Veterans 
nearing discharge, to approach for informed consent. 
Each client in the intervention group will receive up to 90 minutes per week of treatment, called goal self-
management intervention, which will follow the written protocol. This treatment will be conducted by trained 
research staff.  In the course of these weekly sessions, each client will develop his or her goal planner. The 
planner is conceived as a portfolio containing the written materials generated during goal planning with various 
tabs for long- mid-, and short-term goals and activities relating to them -- and all the materials designed 
collaboratively with each client for goal tracking. Depending on the individual client’s comfort with and access 
to technology, materials may be managed through a secure online portal. The goal planner will be updated 
weekly during intervention sessions.  
 
Significant others (spouses or other close friends/ relatives) will be invited to participate in the assessments 
and the sessions at the discretion of each participant, in order to provide support outside of treatment for 
implementing the procedures learned in each session. They will also be asked to answer the FrSBe Family-
Rating questionnaire on the behalf of their family member/significant other.  If family members/significant 
others are not physically present to consent and answer the FrSBe family member assessment, the Veteran 
will be asked to provide a mailing address and phone number for a family member/significant other.  The family 
member/significant other will be mailed a letter with the contact information for the study team, asking him or 
her to call the study team.  The letter will also state that the family member/significant other will receive a call 
from the study team in 2-3 weeks if he or she does not contact the team.  An opt-in/opt-out form will be 
included in the letter to be returned to the study team.  A waiver of informed consent and HIPAA waiver have 
been submitted to the IRB for approval. 
 
Note about the Manual: The COMPASS Advisor will have a certain amount of flexibility when it comes to 
implementing the manual in order to tailor the program to participants and individualize the approach.  The 
following are appropriate adaptations that the COMPASS Advisor is authorized to implement: 
1. Flexibility in presenting information while maintaining structure to fit the natural flow of the sessions.  
For example, because this is a verbally-based therapy, the Advisor may find that an individual Veteran 
directs the session toward discussing the brain graphic before discussing the COMPASS graphic.  This 
represents a change the order of the information presented in the sessions, but not a change in the 
protocol or structure of the manual.  The same information will be provided each time, albeit in a 
different order.  If the Advisor finds he or she consistently has to change the order in numerous 
sessions, the change will be implemented for all participants and this will be reported to the IRB.   
2. If the Advisor and the participant run short on time in a session, parts of the session may be covered in 
the first few minutes of the next session.  For example, if the participant has to leave Session 2 early 
and the Advisor cannot introduce the Objective Planning and Evaluation sheet, this will be addressed in 

16 
the beginning of Session 3.  This is necessary because, based on clinical experience, Veterans may 
show up late to sessions or have a family emergency that requires them to leave early. 
3. The Advisor will not be required to read the manual word-for-word in the session.  It will be difficult to 
connect with the Veteran if the Advisor spends time reading word-for-word.  The interventions will be 
recorded for quality improvement purposes to ensure the same protocol is followed in every case. 
4. In the same vein, wording changes in the text of the manual that best suits the participant can be 
implemented in the meetings.  For example, if the COMPASS Advisor finds a Veteran reacts better to 
the term “goal” as opposed to “objective,” the Advisor can use the words that are most appropriate to 
the situation throughout the intervention with that particular Veteran.  If the Advisor finds that a series of 
Veterans react more positively to particular words that differ from the wording in the manual, the 
change will be implemented for all participants and this will be reported to the IRB. 
 
Updates to forms and homework sheets for the Veteran will be submitted to the IRB before being implemented 
in the manual.  If changes to the manual are so significant to change the nature of the intervention, the manual 
will be submitted to the IRB as well.  Cumulative changes will be submitted to the IRB upon request. 
 
Integration of the COMPASSgoal Intervention with the VA Individualized Rehabilitation and Community Re-
Integration Care Plan 
 
To successfully implement the proposed intervention as a complementary service to participating Veterans 
with TBI, the study staff will  employ the framework developed in the VHA Handbook5  1172.04, Physical 
Medicine and Rehabilitation: Individualized Rehabilitation and Community Re-Integration Care Plan (2010). 
This Veterans Health Administration (VHA) Handbook defines procedures for development and implementation 
of the Individualized Rehabilitation and Community Reintegration Care Plan for Veterans and military Service 
members who receive inpatient or outpatient rehabilitative care for functional deficits or needs related to 
Traumatic Brain Injury (TBI) and polytrauma. The COMPASSgoal protocol will interplay at each phase of 
development and implementation with the procedures for Individualized Rehabilitation and Community 
Integration Care Plans specified by the VHA Handbook and carried out at the DC VAMC. 
  
Research staff will undergo intensive training during months 9-11 of Year 1 and receive ongoing relevant 
education. Supervision of the COMPASSgoal staff involved with the intervention delivery is the responsibility of 
the PIs and study consultant, who will also provide mentoring regarding specific medical, family, and 
community issues as needed. Initially, daily meetings among the research team will be held to address 
operational, procedural, and scheduling issues. These meetings will decrease to weekly consultations to 
address difficult cases and share successful management strategies and new resources. Data collection will 
be regularly verified and audited by the study coordinator.  
 
Supported Discharge (Control) Group activities 
 
Participants randomized into the supported discharge group, serve as controls for the intervention group and 
will not receive the COMPASSgoal intervention. It was suggested by the reviewers to increase both the intensity 
and duration of interactions between the Veterans involved with the COMPASS control group to offset the 
possible effects of the additional time and attention devoted to participants in the COMPASS group models.   
 
To address this issue, we held a special meeting at the DC VAMC with the TBI Case Managers, Social 
Worker, and the study’s newly added PI (Joel Scholten, MD). The result of the meeting was a proposal to 
structure communication procedures for the Veterans involved with the COMPASS control group through the 
increase and standardization of the intensity and duration of their interactions with the research team acting as 
Case Managers. Each control group participant will receive additional prompts to address just-in-time concerns 
as documented in their treatment plans. This strategy will result in increased frequency of the phone calls and 
other means of contact. 
 
Veterans enrolled in the control group will be contacted by the study team every two weeks over the eight 
week period corresponding with their counterparts randomized to the intervention arm.  During the point of 
contact, the Veteran in the supported discharge group will answer the Mayo-Portland Adaptability Inventory-4 

17 
Participation Index (M2PI).  The test will be a self-report by the person with TBI.  The M2PI is currently used by 
the DC VAMC TBI clinic team when the Veteran is initially evaluated in team meeting, when the Veteran is 
discharged from team treatment, and 6 months post-discharge.  Thus, the administration of the M2PI will  
mimic interactions with a case manager.  The M2PI will function as a checklist for the research team and will 
fulfil the role of increased interactions with a case manager.  It encourages Veterans to reflect upon their 
community integration and will offset the possible effects of the additional time and attention devoted to 
participants in the COMPASS group models.  The M2PI will be administered through one of two means. The 
default means to contact the Veteran will be through a Secure Message asking to set-up a time to answer the 
M2PI over the phone.  If the Veteran does not respond within a week, the study team will call the Veteran to 
either collect the M2PI or set up a time to collect the M2PI.  If the Veteran does not have Secure Messaging, 
he or she will only be contacted through a phone call, which will be audio recorded to enable discourse 
analysis as in the intervention group.  If the Veteran feels more comfortable interacting through secure 
messaging and is enrolled in myHealtheVet, he or she will receive a secure message with the M2PI at the 
same time intervals as the phone call.  In addition control subjects will receive case management support as 
requested upon initiation by the Veteran (standard practice). Please see Appendix 3 for the M2PI and study 
team email/phone call script. 
 
Data Collections and Storage 
Data will be collected into an Access Database and analyzed through SPSS on the VINCI server.  If data is 
downloaded from VINCI to share with non-VA collaborators, the data will be deidentified.  VINCI will be used to 
upload and store data, but no data will be requested from the national databases supplied through VINCI.  The 
following information comes from VINCI: 
“VA Informatics and Computing Infrastructure (VINCI) 
The VA Informatics and Computing Infrastructure (VINCI) is a major informatics initiative of the Department 
of Veterans Affairs (VA) that provides a secure, central analytic platform for performing research and 
supporting clinical operations activities. It is a partnership between the VA Office of Information Technology 
(OI&T) and the Veterans Health Administration Office of Research and Development (VHA ORD). VINCI 
includes a cluster of servers for securely hosting suites of databases integrated from select national VA data 
sources. VINCI servers for data, applications and virtual sessions are physically located at the VA Austin 
Information Technology Center (AITC), located in Austin, Texas. This secure enclave with 105 high-
performance servers and 1.5 petabytes of high-speed data storage has multiple layers of security and disaster 
recovery to prevent data loss. 
 
To ensure the protection of Veteran data, VINCI maintains compliance with the guidelines set forth by 
Veterans Health Administration (VHA) Handbook 1200.12, Use of Data and Data Repositories in VHA 
Research, and all other applicable VA and VHA policies and regulations. In addition, VINCI has undergone all 
security certification activities in support of obtaining an Authorization to Operate (ATO). Access to VINCI 
resources are approved in accordance with the requirements of National Data Systems (NDS), VHA Handbook 
1200.12, Use of Data and Data Repositories in VHA Research, and all other applicable VA and VHA policies 
and regulations. All data transferred from VINCI is subject to audit for compliance. 
 
VA-credentialed research or operations staff are granted access to study-specific data along with tools for 
analysis and reporting in the secure, virtual working environment through a certified VHA network computer 
within the VA.  If not working within a VA or VHA hosted office environment containing VA network access, 
researchers may apply for and then access VINCI through an approved Virtual Private Network (VPN) and 
Remote Desktop application. The remote computing environment enables data analysis to be performed 
directly on VINCI servers, offering a number of advantages: uniform security standards for access; a common 
point of entry for all investigators who use the data; tools for analysis and reporting; tighter and more 
consistent control of data quality; and the ability to standardize and update terminology and format as 
technology and methodology improve.  
 
Data Collection 
VA provides care to Veterans at over 1,400 points of care. At the core of virtually all care processes is a broadly 
scoped and extensively used electronic health record system known as the Veterans Information System 
Technology Architecture (VistA). VistA provides a longitudinal view for patients receiving care nationwide 
including diagnoses, procedures, medications, labs, physiologic measurements, and text notes and reports. VA 

18 
uses 130 VistA implementations to provide electronic health record services nationwide for just over 20 million 
Veterans historically. The aggregate content of these 130 VistA systems includes 2.3 billion documents (e.g., 
Progress Notes, Discharge Summaries, Reports) accumulating at a rate of 696,000 each day; 6.2 billion lab 
values (+1.5 million each day), 3.4 billion orders (+845,000 each day), and 1.7 billion medication 
administrations and prescription fills (+390,000 each day). 
 
Data are aggregated from individual VistA systems to the VA Corporate Data Warehouse where it is modeled 
and prepared for use. Data published by the VHA Decision Support System (DSS), Inpatient and Outpatient 
Medical SAS (MedSAS), VA Health Economics Resource Center (HERC) cost data, Vital Status and VA-CMS 
linked data files maintained by VA Information Resource Center (VIReC), CDC National Death Index VA-
linked data, and several other specialty data sets can be requested through VINCI. VA National Data Services 
and other data stewards regulate the right to use the data, but VINCI facilitates the process. When study 
requests are approved, project-specific data are extracted from source databases and placed in SQL tables 
accessible only to the research team and VINCI data managers. 
 
Storage of Study Data 
Study data will be kept in accordance with the Department of Veterans Affairs Record Control Schedule 10-1 
(RCS 10-1). Storage and transfer of any Personally Identifiable Information (PII) or Protected Health 
Information (PHI) must be done in accordance with applicable VA and VHA policies and directives, state and 
federal regulations, and applicable statutes including the Health Insurance Portability and Accountability ACT 
(HIPAA). Unless explicitly requested and approved by data stewards, all sensitive patient data must remain on 
VINCI project servers and only aggregate data without PII / PHI may be transferred from VINCI. Any desired 
change in data storage location or transfer requires amending the original data request with an updated of 
disposition of study data. The amendment must be approved by all data stewards before data may be 
transferred.  
 
Violations of data policy or approved use of data will be subject to full penalty of law, which may include 
suspension of access privileges, reprimand, suspension from work, demotion, removal, and criminal and civil 
penalties. 
 
Upon completion of the research project, the study principal investigator in conjunction with the VA 
Information Security Officer (ISO), and in accordance with VA policy, will ensure that, study data containing 
sensitive, confidential information will be returned to the VA, sanitized and removed from all servers, desktops, 
removable storage devices, etc. 
 
Data Access 
Only study team personnel explicitly authorized by data stewards will have access to project data. The study 
principal investigator has the responsibility for security of study. VINCI data managers and VA OI&T personnel 
not under the purview of the study principal investigator control the servers, network, processors, firewall and 
software in the VINCI environment, including access rights granted to study personnel. 
 
When study personnel are no longer part of the research team, the study principal investigator will amend the 
data access request to terminate that person’s access to all study data and notify the VA Information Security 
Officer of such action. No sensitive patient data may be shared with anyone who does not have a VA 
appointment. All study team personnel with access to sensitive patient data must stay current on required VA 
information security and privacy policy trainings. 
 
Data Storage Location 
Study data stored on VINCI servers is located at the Austin Information Technology Center, 1615 Woodward 
St., Austin, TX 78772-0001. The specific server where the data are stored within the VINCI environment will be 
chosen by VINCI personnel. The server name and location within the Austin Information Technology Center 
may be changed at any time at the discretion of VINCI personnel. 
 
Specialized Software 
All software used to access sensitive patient data, whether provided by VINCI, or developed by the study team, 
will run in virtual desktop sessions on VINCI servers within the Austin Information Technology Center.” 98F99 

19 
 
 
STATISTICAL ANALYSIS PLAN 
 
Overview 
For this project, we plan to collect three major types of data assessed at times 1-3 (baseline/pre-intervention, 2 
months/post-intervention, and 3 months follow up): community integration parameters including educational 
attainment and employment, individual characteristics such as PTSD; TBI self-efficacy, emotional status, 
coping, performance of real-world tasks, resilience and life satisfaction, and neuropsychological parameters 
including overall cognitive and executive functioning. Though we have removed the physical function 
assessments from future data collection, previously collected data on physical function may still be used for 
data analysis and subsequent publication and presentation purposes. The primary outcome will be the change 
in the three major types of parameters from pre- to post-intervention. Depending upon the hypothesis being 
tested (see Specific Aims section), participants will be stratified according to level of executive functioning, 
severity of conditions secondary to TBI (PTSD, level of functioning, emotional status), or degree of societal 
participation.  Dependent variables will include TBI-self-efficacy, community integration indices, educational or 
work attainment as defined by the ICF qualifiers, and life satisfaction.  Both objective (e.g. executive 
performance) and subjective (e.g., perceived TBI self-efficacy) data will then be obtained based on repeated 
measures over the three-year period.  Multiple regression models will be fitted to explore continuous primary 
and secondary outcomes differentiating between groups at each time point and changes at the intra-individual 
and inter-individual levels over time. For categorical outcomes (e.g., low/high executive performance, or work 
status such as unemployed/employed, part-time/full-time), unconditional logistic and/or multinomial regression 
models will be implemented.  
 
The basic testing of the hypotheses will involve ANOVA test and repeated measures ANOVA test. Bonferroni 
adjustments will be made to account for multiple testing.  
 
Hypothesis 1: Outcome Variables Main Effects for Community Re-integration Factors  
This algorithm is based on the assumption that an interaction between the intervention group and control 
groups can be modeled as a fixed effect. An LMM will then be used to evaluate whether the intervention had 
an effect at any time point or whether the intervention influenced change (growth, trajectory) in the outcome 
over the course of the study. The following will be considered for the analytical strategy: 
 
o ANOVA, Repeated-measures ANOVA as well as MANCOVA will be used to compare the effect of the 
COMPASS
goal intervention vs. supported discharge group determined via baseline assessment. 
ANOVA will be used to compare the change from pre- to post-intervention between the two groups. 
Furthermore, in order to analyze the main effect of the COMPASS
goal intervention over time, a two-way 
repeated measures parametric ANOVA, as well as a non-parametric repeated measures Friedman 
ANOVA, will be performed, using the baseline time point, levels of TBI self-efficacy, or real-world tasks 
performance as the dependent variables. The levels of the repeated measures factor correspond to the 
number of assessments: baseline (pre-intervention) and 2 months post-intervention. The between-
groups factor will be the intervention group vs. the supported discharge group. MANCOVA analysis will 
focus on the contrast in TBI self-efficacy between the intervention and supported discharge groups 
while accounting for a specified covariate: level of executive impairment as defined by FrSBE. In the 
case of non-normal residuals, we will use a nonparametric repeated measures approach. In the case of 
missing data, an LMM, which uses a maximum likelihood estimate to correct for unequal number of 
measures per subject, will be employed.  
o We will use Linear mixed models to control for potential confounding variables and baseline values will 
be utilized as a covariate. These models will allow for the additional control of potential within subjects 
clusters. These clusters, though not part of the formal hypothesis testing but byproducts of these 
models, will allow for conceptualization of additional future hypotheses.   
 
Hypothesis 2: Psychosocial Profile as Mediator of the Reponsiveness to the Intervention Over Time 
Course  

20 
To explore Hypothesis 2, we will utilize a multistage analytic strategy. Because of the possibility of missing 
data due to non-responses, missed visits, attrition, and mortality over the course of the study, the statistical 
analysis presents certain challenges. At the first stage, a linear mixed model 9F100 will be used to incorporate all 
available data, evaluate trends, and estimate change of outcome variables without discarding cases that have 
missing data points. Furthermore, linear mixed models (LMM) control for confounding effects of other 
repeatedly measured covariates while accounting for the correlation among repeatedly measured outcomes. 
SAS PROC MIXED will be used to estimate a LMM for each outcome of interest. For categorical outcomes, 
generalized estimating equations (GEEs) will be used to evaluate trends over time while accounting for the 
dependency among the repeatedly measured outcomes. GEEs will be solved using SAS PROC GENMOD. 
 
Also for Hypothesis 2 analysis the following will be considered: 
o Linear mixed models (LMM) will be used to control for confounding effects of other repeatedly 
measured covariates while accounting for the dependency among the repeated measured outcomes 
and covariance matrix.  
o We will construct a model which only includes the repeated measures variables to obtain means, 
variances, and covariances.  
o We will add time-invariant variables such as treatment group into the multi-level model (MEME) to 
predict the change over time in executive dysfunction and associated real-life task performance. 
Therefore, this method will allow us to address individual growth, identify latent trajectories of growth, 
relate the observed changes to pre-existing differences between TBI subjects, and determine treatment 
effects. 
 
Then, we will use linear growth curves to assess individual differences as well as group differences by 
following a two-stage LGM. At the second stage, we will construct a model that only includes the repeated 
measures variables to obtain means, variances, and covariances. At stage three, we will add time-invariant 
variables such as age, gender, and education into the model to predict change over time in executive function 
and real- world performance. We will also be able to refine our model at any level by assessing the fit after 
additional variables are inserted. The obtained covariance structure will allow us to draw inferences with 
regards to linear increases or decreases in executive dysfunction and real-world performance over time. 
Therefore, this method will allow us to address individual growth, identify latent trajectories of growth, and 
finally, relate the observed changes to pre-existing differences between TBI subjects. 
 
Missing Data 
Rigorous methods to address loss to follow-up and missing data will also likely be of importance.  As in 
many studies with vulnerable populations, participant dropout or censoring may be informative.  For example, 
sicker patients and those with sub-optimal treatment results may opt to discontinue participating or providing 
samples or questionnaire responses. Thus, the probability of missing outcome data may be dependent on 
covariate data and, hence, "non-ignorable."  To assess the probable type of missing data, baseline covariates 
among patients with and without missing data will be compared.  If missing data are judged as Missing 
Completely at Random (MCAR), the typical strategy will be to conduct a complete case analysis, recognizing a 
loss of precision.  The exception to this strategy will be when considerable data (i.e. >15%) are missing on a 
particular covariate that is judged to be critical for inclusion in the analysis. In this instance, imputation by 
unconditional or conditional mean imputation will be used; these simple approaches perform well when the 
overall percent of missing data is low. In rare instances when the percentage of missing data is not low (i.e. 
>15%), more sophisticated multiple imputation methods may be employed.  Imputation methods will not be 
used to fill in values for missing outcome data. 
 
COMPASS PROJECT TIMELINE AND EVALUATION 
Program evaluation (Years 1-3) 
 
Ongoing program evaluation will begin in Year 1 and continue through Year 3. Monthly project meetings will 
continue among project staff for the duration of the project so that issues can be addressed and evaluated, and 
solutions can be implemented as a team. In addition, yearly project reports will be submitted to DC VAMC IRB 
to approve continuation of the project.  Any modifications to this protocol will be submitted to DC VAMC IRB for 
approval. A Veteran Advisory Panel will also be formed during Year 1 and will be kept abreast of program 

21 
progress on a bi-annual basis, to ensure that feedback from Veterans with TBI will be considered in the 
ongoing evaluation and implementation of the program. Year 3 will be dedicated to refining the COMPASS 
program and working towards implementation of the program outside of the DC VAMC and the greater 
Washington, DC community (see Figure 7).  
 
 
 
 
 
 
 
 
 
 
 

22 
 
Figure 7. COMPASS Project Timeline 
 
Discussion of the Timeline phases 
The first 6 months of the study constitute a preparative phase. During this time we will secure IRB approval, 
train project staff, develop the COMPASSgoal intervention and build the study database. Recruitment, 
implementation of the intervention, data collection, and formative evaluation of the project will take place during 
the subsequent 26 months. An interim analysis of data (both qualitative and quantitative) will take place 13 
months into the project. Presentations and publications, based initially on interim data and finally on summative 
data, will be produced for the duration of the project following the preparative and early intervention phases 
(approximately 8 months into the study). A Clinical Practice Guideline will be a deliverable completed during 
the final quarters of the last year of the COMPASSgoal project. 
 
 
Knowledge Translation: Dissemination and Utilization of Study Results 
 
COMPASS staff and the DC VAMC public relations office will work together to ensure that objectives are met 
and information gained from this study is translated directly back to clinical services at DC VAMC through a 
variety of mechanisms. Appropriate Knowledge Tools for the given audience will be determined and will 
include, but not be limited to 4 peer-reviewed publications, 4 national presentations, and integration into 
existing websites. All of this information will be shared with the Psychological Health and Community 
Integration office at the VA RR&D in Washington, DC. 
 
Potential Utilization of COMPASS findings for MyHealtheVet application 
 
MyhealtheVet. (www.MyHealthe.va.gov), a self-help/management tool has been available but very much 
underutilized. One of the reasons for this is that MyHealtheVet, the online, VA personal health record (PHR), is 
still in a developmental stage with new functionality accruing in an incremental fashion. At present, 
MyHealtheVet allows Veterans to download self-entered health information to share with both VA and non-VA 
providers as a print or electronic text file. If a Veteran has authenticated his or her identity in person at a VA 
Medical Center, portions of his/her VA (VistA) medical record that have been “abstracted” to MyHealtheVet can 
also be downloaded. This information is referred to as the “Blue Button” data set. There is no mechanism for 
Veterans to “delegate” (e.g., share electronically in a secure manner) their MyHealtheVet information to health 
care providers and other trusted individuals. They are, therefore, on their own if they want to leverage the 
benefits of MyHealtheVet for health surveillance and coordination of care. Survey data collected from the 
general public, 10F101a randomized controlled trial of PHR effectiveness 101F102 and the experience of a large managed 
care provider102F103 show that interaction with care providers motivates individuals to use available personal health 

23 
tools. At present, MyHealtheVet does not provide interactive self-management functions. COMPASSgoal differs 
from MyHealtheVet in that it is a guided intervention in which health care providers engage Veterans, offer goal 
management exercises and provide personalized feedback. The Department of Veterans Affairs Innovation 
Initiative (http://www.va.gov/vai2/) issued a request for proposals in the spring of 2011 to enhance 
MyHealtheVet with such functionality as the ability to import outside data into the PHR space, and to access 
applications that leverage that data to help in Veteran health decision-making and self-management. 
COMPASSgoal is, potentially, one such application. To assure that COMPASSgoal develops in such a way as to 
facilitate interworking with MyHealtheVet, we have added Manon Schladen MSE EdS, to the project staff (at no 
increase to budget). Ms. Schladen is a doctoral candidate in computing technology in education exploring use 
of technology to enhance self-management and engagement of health teams to promote continuity of care. 
She is presently MedStar National Rehabilitation Hospital’s knowledge translation and disparities fellow and 
chairs the Knowledge Translation and Training Committee at NARRTC. 
 
 
Future steps and plans for continuing support 
 
The proposed project may be regarded as a first stage project in which the efficacy of the method is 
demonstrated, and the efficiency of each component is tested. The next phase, which will follow this study, 
would involve the development of several projects aimed at exploring the mechanisms underlying successful 
vs. non-successful adaptation of Veterans to everyday life, as well as routes for transferring the ongoing 
delivery of intervention to the daily routine of community dwelling Veterans with TBI. 
 
The proposed study will prepare the field of creating supportive care environments for necessary future studies 
on the utilization of best clinical practice guidelines for the everyday life of Veterans and their families. Clinical 
and applied research will concentrate on the utility of goal self-management interventions in routine care in 
both home and institutional settings, such as VA hospitals and community centers.  These studies will also 
examine the cost benefits of this approach, which are expected to be substantial because the approach will 
lessen the time health service providers (e.g., TBI case managers or TBI social workers) must devote to their 
clients. In the basic research venue, studies need to explore the links between neuroanatomical structure, 
executive function, and everyday problem-solving in the context of both comparative effectiveness 
interventional research. This research would help not only to improve quality of life for Veterans with TBI and 
other neurological deficits, but would also have important social benefits, such as training relatives and 
immediate caregivers on how to engage their loved ones in meaningful, healthy, and productive activities.  The 
methodology proposed could be utilized with technology-based and other non-pharmacological interventions to 
better understand the needs and preferences of different clinical populations with chronic illnesses, or physical, 
cognitive, and behavioral disabilities (i.e., persons with PTSD, substance abuse, disturbing behaviors, etc.).  
This particular extension may elucidate the commonalities and differences among various clinical groups, and 
provide additional tools to improve individual care of returning Veterans. 
 
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