Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families
Phase: NA
Conditions: Brain Injuries, Traumatic, Transitional Care, Family Members, Patients
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
Study Protocol with Analysis Plan 
 
 
 
Study Title: Enhancing the Transition From Hospital to Home 
for Patients With Traumatic Brain Injury and Families 
 
 
NCT Number: NCT04584554 
 
 
 
Document Date: 02/01/2020 
 

A. SPECIFIC AIMS  
 
Traumatic brain injury (TBI) is defined as “a bump, blow or jolt to the head or a penetrating head injury that 
disrupts the normal function of the brain.”1 Each year, more than 2.7 million U.S. people sustain a TBI.1 Despite 
high risks of readmission and complex medical needs, there are no U.S. standards of care for patients with 
moderate-to-severe TBI discharged home from acute hospital care without inpatient rehabilitation.2 Research 
suggests up to 65% of patients with moderate-to-severe TBI (age < 65 years) nationwide are discharged home 
from acute hospital care into a fragmented environment that does not integrate healthcare, community, and 
social services.3 These patients have cognitive, physical, behavioral, and emotional impairments that affect 
their abilities to independently self-manage their health, wellness, and activities of daily living and are often 
dependent on family who have difficulty managing the patient’s care and needs.4–9  
 
Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and 
continuity of healthcare for patients transferring between different locations or levels of care in close 
geographic proximity.10 There are many factors that contribute to gaps in the transition from hospital to home, 
including inadequate planning, insufficient patient/family education, and limited and fragmented access to 
essential services.11 These gaps are often compounded by limited financial resources such as lack of 
insurance12 and lack of social support.13 Transitional care interventions can address these gaps with a variety 
of strategies, including individualized transitional care plans, post-discharge care coordination, and community-
based service referrals.14–16 Currently, there are no transitional care standards for TBI. The discharge 
home from the hospital is an ideal intervention point to guide improvements in health and quality of life for 
patients with TBI and families;10–12,16–18 however, the current state of “usual care” has limited provider support 
or engagement to help patients and families navigate and access fragmented health and community-based 
services,19,20 is ineffective in improving functional outcomes,21 and does not incorporate family needs.22–24  
 
Thus, the purpose of our study is to develop, examine the feasibility and acceptability, and assess the 
preliminary efficacy of a patient- and family-centered TBI transitional care intervention to support patients with 
moderate-to-severe TBI and their family caregivers during the transition home from acute hospital care.  
 
The proposed specific aims are: 
 
Specific Aim 1: To develop and refine a patient- and family-centered TBI transitional care 
intervention. The intervention will aim to improve functional status for patients with TBI, reduce strain for 
family caregivers, and direct patients and families to appropriate resources and care that is concordant with 
their health-related goals. We will use a combination of existing clinical guidelines, our prior and ongoing 
research, and a scoping review of care transitions literature to guide intervention development. We will 
create a manualized, intervention protocol that will undergo iterative user-testing with 6 focus groups (total 
45-60 people) of patients with TBI, families, and healthcare providers to determine acceptability and to 
refine to ensure the intervention meets specific needs and preferences of patients with TBI and families. 
 
Specific Aim 2: To examine the feasibility and acceptability and assess the preliminary efficacy of 
the TBI transitional care intervention. The intervention will be tested with 15 dyads of patients with TBI 
discharged home from acute hospital care and their family caregivers. Recruitment, enrollment, data 
collection feasibility and intervention fidelity will be used to assess feasibility of implementation. We will 
develop a survey to assess acceptability. Preliminary efficacy will be estimated based on changes from 
baseline to intervention endpoint in the primary outcome of patient functional status at 8 weeks post-
discharge (using Functional Status Examination).25 We will also examine secondary outcomes at 8 weeks 
post-discharge, including family caregiver strain26 and preparedness for the caregiving role27 and patient 
and family caregiver self-efficacy28 and healthcare utilization.29  
 
The proposed research is being submitted in response to NCMRR PAR-18-211 Early Career Research Award 
and directly aligns with the funding opportunity due to an early career scientist’s focus on repair and recovery 
of function in patients with TBI and behavioral modifications of patients with TBI and families. As directed by 
the funding opportunity announcement, the preliminary data generated from this proposed research will guide 
our team in designing and conducting an NIH R01 implementation-effectiveness clinical trial of the TBI 
transitional care intervention. Our team’s program of research has the potential to enhance the standard of 
care for patients with TBI discharged home from acute hospital care and their families.  
 

RESEARCH STRATEGY 
 
B. SIGNIFICANCE 
 
Devastating Effects of TBI. Annually, more than 275,000 people sustain a moderate or severe TBI 
that requires hospitalization for >2 days immediately after injury.1 For those receiving TBI acute hospital care, 
typical discharge destinations include inpatient rehabilitation, skilled nursing facilities, or home.31 After acute 
hospital care, patients with TBI would ideally receive interdisciplinary, inpatient rehabilitation before returning 
home.3 Yet, up to 65% of patients with moderate-to-severe TBI nationwide are discharged directly home from 
acute hospital care without inpatient rehabilitation.3 Many patients with TBI who follow this care pathway are 
racial/ethnic minorities.33 Regardless of race, these individuals often return home with residual impairments in 
cognition,34 coordination and balance,35 and awareness and judgment3 and have increased risks for poor long-
term outcomes.36 Up to 1 year after acute hospital care discharge home, patients with TBI have significant 
physical, mental, and social challenges that prevent return to pre-injury levels of functioning6: 43% have long-
term disabilities,37 55% become depressed,38 and 60% never return to work.39 As the majority of patients with 
moderate-to-severe TBI sustain their injury at a young age,1 they must deal with these chronic physical, 
mental, and social challenges across their lifespan.6 These poor post-acute outcomes have tremendous 
implications for families of patients with TBI, especially for patients who were in school or working, may not yet 
be financially secure, and/or have small children.40 National data suggest TBI is also very expensive at multiple 
levels: the annual cost of TBI care is $76.5 billion,1 of informal caregiving is $6.1 billion,41 and lost productivity 
due to low rates of return to work equates to $521 million.42 Recovery from TBI is a significant public health 
problem with harmful effects at multiple levels.  
Unmet Family Needs after TBI. Family members of patients with TBI play a major role in supporting 
patients after discharge,43 yet, families report 30-60% of their needs after hospital discharge go unmet7–9 and 
that they feel ill-prepared to support the patient with TBI.44,45 Family members perceive the healthcare system 
to be difficult to navigate, unorganized, uncaring, and unresponsive.9,46 Research on family caregivers of 
patients with TBI also indicates family caregivers can have substantial unmet mental health needs.4,47 
However, there is limited knowledge on family needs during the transition from acute hospital care to home, 
which is needed to provide guidance on how to manage the person with TBI’s care and support their family. 
Gaps in Clinical Guidelines on Discharge and Follow-Up of Patients with TBI. There are gaps in 
clinical guidelines related to transitional care of patients with TBI, regardless of severity, discharged home from 
acute hospital care. Although multiple U.S. guidelines have been published on care of patients with mild, 
moderate, or severe TBI,48–52 these guidelines have limited recommendations on discharge and follow up plans 
for supporting patients as they transition home from acute hospital care. In contrast, clinical guidelines from the 
United Kingdom (U.K.) do address transitional care needs related to discharge and follow-up of patients with 
TBI; the U.K. National Health and Care Excellence (NICE) clinical guidelines on discharge and follow-up of 
children, young people, and adults with head injury provide detailed guidance for healthcare providers involved 
in caring for patients with TBI in-hospital as they transition home or after discharge.53 The terms head injury 
and TBI are often used interchangeably.54 Although there are differences in health systems in the U.S. and the 
U.K., the patient population described in the U.K. NICE clinical guidelines are similar to the U.S. patients with 
moderate-to-severe TBI that are the focus of our study; the NICE clinical guidelines can provide a foundation 
for development of TBI transitional care interventions. 
Limitations of Current Transitional Care Research. Effective transitional care can bring important 
benefits to patients and families. Transitional care interventions tested with patients with stroke, myocardial 
infarction, and heart failure have been effective in improving health outcomes and reducing disability and 
readmissions.12,55 However, the transition needs of patients with TBI discharged home from acute hospital care 
and their families are thought to be unique compared to other patient populations with acute conditions due to 
issues with: patient cognitive functioning, complex medical needs, and limitations in activities of daily living; 
family difficulty in managing care; and fragmented care and services with limited provider support.2,7,19,20,56 The 
few available TBI transitional care interventions were ineffective in improving functional outcomes for all 
patients with TBI;21 these interventions also did not include family needs or address patient and family behavior 
change or self-efficacy.21–24 In addition, the strength of evidence on TBI transitional care interventions is low 
due to shortcomings in study design and analysis, like: 1) lack of sufficient power to determine effectiveness12 
and 2) use of multiple primary outcomes, which increases risk of false-positive errors.57 The transition from 
hospital to home after acute care is a critical period where appropriate supports and resources are necessary 
to increase the likelihood of successful recovery;58 however, research indicates coordinated transitional care, 
supports, and resources are lacking for patients with TBI and their families.21 Thus, new insights are needed to 
direct interventions to improve the TBI transition from acute hospital care to home for patients and families.  

Preliminary Research Related to Transitional Care of Patients with TBI and Their Families. Our 
team’s research provides evidence of the need for interventions to support the unique issues12,15 of patients 
with TBI and families in the transition home from acute hospital care,4,47 as well as effectiveness of transitional 
care interventions in improving functional status and quality of life in other patient populations.12,15 Table 1 
summarizes the 12 studies our research team has conducted, design/analytic approaches used, and key 
findings. Our team’s research shows patients with TBI and families could benefit from interventions during the 
transition home that address issues with: 1) patient safety, independence, cognition, and communication; 2) 
management of the patient’s mental health, overall health and wellness, and medications; 3) family needs; 4) 
access to community resources; and 5) behavior change and health-related goal activation. However, we have 
not yet developed or assessed the feasibility, acceptability, or preliminary efficacy of a transitional care 
intervention that addresses the above-listed areas, and research is limited on these topics. 
 
Table 1. Our Research Team’s Preliminary Research that Informs the Proposed Study 
Study Name 
 Team Member 
Design/Approach 
Key Findings 
Mental health in 
w omen w ith TBI59 
Dr. Oyesanya  
(PI of R03) 
Systematic 
literature review  
Although being female is a risk factor for mental health issues, there is 
limited literature on sex-based disparities in mental health after TBI.  
Hospital experience 
for patients and 
families60 
Dr. Oyesanya  
(PI of R03) 
Systematic 
literature review  
Studies show ed during the hospital stay, patients w ith ABI and families 
had a high need for information, difficulty adjusting, a desire to be 
prepared for life after discharge, and mixed feelings on staff support. 
Role of families in the 
TBI hospital stay61,62 
Dr. Oyesanya  
(PI of R03) 
Qualitative: 
Grounded Theory 
N=16. Families of patients w ith TBI perceived their role pre-discharge 
w as to protect the patient’s emotional and physical safety and had 
concerns about the patient’s post-discharge independence.  
Patient/family health, 
w ellness, & safety63,64 
Dr. Oyesanya  
(PI of R03) 
Qualitative:   
content analysis 
N=27. Patients w ith TBI and families had a desire for provider support 
early post-discharge to manage mental health, overall health and 
w ellness, medications, and patient safety.  
Med. Management 
intervention65 
Dr. Oyesanya  
(PI of R03) 
Experimental 
design 
N=205. Patients w ith ABI and families in the treatment group had 
increased know ledge and confidence after educational intervention but 
had difficulty managing medications at 60-days post-discharge.  
Nurses’ perceptions 
of caring for TBI66–70 
Dr. Oyesanya  
(PI of R03) 
Instrument + latent 
class analysis 
N=713. 1) Instrument is reliable/valid for assessing nurses’ perceptions 
of TBI care; and 2) Nurses had inaccurate perceptions and little 
know ledge of post-discharge resources for patients w ith TBI & families. 
Consensus on 
provider discharge 
criteria 71 
Dr. Oyesanya  
(PI of R03) 
Survey research, 
descriptive  
N=27. Criteria w ith majority consensus providers use to determine if a 
patient w ith TBI should go home from acute hospital care: 1) therapist 
recommendations (N=26); 2) plans for post-discharge family support 
(N=25); and 3) patient independence in activities of daily living (N=23). 
Transition of care for 
acute stroke and MI12 
Dr. Bettger  
(Co-I of R03) 
Systematic 
literature review   
Studies show ed hospital-initiated transitional care can improve some 
outcomes in adults w ith stroke or MI. More interventions are needed 
that improve function and prevent readmissions for this patient group. 
The Transition of Care Taxonomy w as also developed in this study, 
w hich describes the 8 domains of a transitional care intervention. 
Interventions for 
caregivers of patients 
w ith TBI4 
Dr. Van Houtven  
(Co-I of R03) 
Systematic 
literature review  
Studies show ed mixed patterns of intervention effects on caregiver and 
patient outcomes; strength of evidence ranged from moderate to very 
low  and intervention impact is inconclusive.  
Neural correlates of 
personal goal 
activation72 
Dr. Strauman 
(Co-I of R03) 
Event-related fMRI 
design 
N = 75. Participants rapidly exposed to their self-identified goals had 
significant neural activation compared to exposure to yoked-control 
w ords. Findings extend understanding of how  goals influence behavior. 
Cognitive 
performance  
of adults w ith TBI56 
Dr. Byom 
(Co-I of R03) 
Experimental 
design 
N = 44. Adults w ith TBI compared to matched healthy peers 
demonstrated social communication and discourse impairments that 
w ere influenced by the cognitive demands of the communication task.  
Social communication 
of adults w ith TBI73 
Dr. Byom 
(Co-I of R03) 
Systematic 
literature review  
Communication needs of adults w ith TBI should be prioritized and 
assessment approaches should be contextual and feasible. 
Abbreviations: TBI = traumatic brain injury; ABI = acquired brain injury; med = medication; MI = myocardial infarction 
 
Ongoing Research Related to TBI Transitional Care. Dr. Oyesanya (PI of R03) is currently PI of an 
ongoing pilot award [co-investigator Dr. Bettger] funded by Duke School of Nursing. The aim of the study is to 
obtain perspectives of patients with TBI, families, and providers on needs and goals during the transition from 
acute hospital care to home. Findings will inform development of the TBI transitional care intervention. Dr. 
Bettger is currently co-investigator of the Comprehensive Post-Acute Stroke Services (COMPASS) study, a 40-
site pragmatic trial funded by PCORI to assess the effectiveness of a comprehensive, evidence-based, post-
acute care model on patient-centered outcomes for patients with stroke.16 Patients with stroke discharged from 
intervention hospitals receive a 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that 
includes a neurological evaluation; assessments of social and functional determinants of health; and an 
individualized care plan integrated with community-specific resources. Findings from Dr. Bettger’s study will be 
used to inform the patient-centered portion of the TBI transitional care intervention. Dr. Byom is currently PI of 

a retrospective study of factors contributing to cognitive-communication needs of adults with TBI. Findings will 
inform the patient-centered cognitive, communication, and social aspects of the TBI transitional care 
intervention. Dr. Van Houtven is currently PI of HI-FIVES, an evidence-based skills training program for family 
caregivers of veterans referred to home care services, funded by a VA HSR&D grant, which is currently 
undergoing an 8-site RCT. HI-FIVES includes group classes for family caregivers to learn clinical, 
psychological, and support-seeking skills to improve caregiver functioning. Findings from Dr. Van Houtven’s 
study will inform the family-centered key processes of the TBI transitional care intervention. 
 
Impact of Proposed Research. Despite advances in transitional care, we are without data to inform 
development and testing of a TBI transitional care intervention that addresses specific needs and preferences 
of patients with TBI discharged home from acute hospital care and their family caregivers. Input from patients, 
families, and providers on the acceptability of an intervention of this nature is critical, as is data on the 
intervention’s feasibility and preliminary efficacy. With this proposed work, by 2021, we will have assessed the 
feasibility, acceptability, and preliminary efficacy of a TBI transitional care intervention that aims to improve 
patient functional status, decrease caregiver strain, and direct patients and families to appropriate resources 
and care that is concordant with their health-related goals. 
 
C. INNOVATION 
 
 
Our proposed work aims to develop a transitional care intervention to improve patient functional status 
and decrease caregiver strain. This research is novel as very little transitional care research addresses 
functional status or incorporates the needs of family caregivers. In addition, there is low strength of evidence 
for transitional care interventions to support patients with TBI discharged home from acute hospital care and 
families; our research aims to address the unique needs and preferences of this patient population. Finally, this 
study seeks to shift the paradigm of how care is provided to patients with TBI and families as they transition 
home, from interventions that separately focus on discharge preparation or on community needs to 
interventions that optimize and coordinate pre- and post-discharge care and needs to enhance care continuity. 
 
 
E. APPROACH 
 
 
Setting and Population. All patients with TBI meeting inclusion criteria admitted to Duke University 
Hospital (DUH) neuro units 8W and 4100 and the 6 DUH medical-surgical/trauma units will be invited to 
participate in studies for aim 1 and 2. Collaborators on this award, Dr. Jodi Hawes, MD, neurologist and Vice 
Chair of Neurology Clinical Operations and Dr. Suresh Agarwal, MD, trauma surgeon and Chief of Trauma and 
Critical Care Surgery, have agreed to facilitate recruitment from their respective areas (see letters of support). 
 
Inclusion Criteria. Patients with TBI will be eligible if they meet the following requirements: a) age 18-
64 years; b) diagnosed with moderate or severe TBI [admission Glasgow Coma Scale score of 3-12];74 c) 
admitted to a DUH inpatient unit; d) plans to be discharged home from DUH; e) sufficient cognitive functioning 
to participate (i.e., able to follow 2-step commands), as determined by the Galveston Orientation and Amnesia 
Test (score >76 eligible);75 f) sufficient oral communication skills to participate, as determined by the Bedside 
Western Aphasia Battery-Revised (score >93.8 eligible);76 and g) English speaking (see Appendix A). Dr. 
Oyesanya has successfully interviewed patients with TBI pre- and post-discharge with these criteria.61,62 Family 
members of patients with TBI will include biological relatives and friends77 and are eligible if they: a) are an 
anticipated primary caregiver after discharge (i.e., plans to live in same home as person or have direct contact 
with person >10 hours/week);78 b) age >18; and c) English speaking. Healthcare providers will be eligible if 
they: a) self-identify as a licensed provider and b) provide care to patients with TBI during the transition home 
(in hospital or within 8 weeks of discharge). All participants must be able to consent to participate. 
 
Sample Size Justification (Aim 1 and 2). In Aim 1, we selected 45 to 60 total participants across 6 
focus groups, guided by stage 1 of the NIH Stage Model for Intervention Development guidelines of including 
15-30 participants per interviewee group (i.e., patients with TBI, family caregivers, providers).79 In accordance 
with historical qualitative research, we will hold >3 focus groups, each with 6-10 participants, to yield rich 
data.80 For Aim 2, we propose a reasonable sample size so we can sufficiently assess feasibility, acceptability, 
and preliminary efficacy of the intervention by using the rule of thumb of at least 12 participants per group for 
pilot studies.81 Our desired sample size for Aim 2 is 30 total participants (15 patient/family dyads) who 
complete the full intervention. Based on prospective TBI studies with follow up to one year, attrition can be up 
to 33% attrition.5 To be conservative, we plan to enroll 40 total participants (20 patient/family dyads), expecting 
33% attrition, to reach our desired sample size of 30 total participants (15 patient/family dyads). We will recruit 
males and females and racial/ethnic minorities to explore sex- and racial/ethnicity-based differences. In 2018, 
DUH admitted 663 patients with TBI and discharged 380 patients with moderate-to-severe TBI (age < 65 

years) home from acute hospital care.82 Based on DUH estimates, a similar number should receive care 
annually.82 Typical recruitment of persons with TBI is >50%,83 leaving >190 patients/year and >15 
patients/month to recruit. DUH does not collect family data, but research suggests family recruitment is 
>50%.83 Dr. Oyesanya’s research shows pre-discharge recruitment of patients with TBI and family caregivers 
in another hospital system was >60%.61,62 DUH also employs >100 healthcare providers that care for patients 
with TBI during the transition (in the hospital or within 8 weeks of hospital discharge) for recruitment.82  
 
Recruitment and Informed Consent (Aim 1 and 2). DUH staff identified by clinical leaders specified 
above will identify eligible patients with TBI, family members, and healthcare providers and ask if the PI or 
research assistant may discuss the study with them.84 The PI or research assistant will then meet with the 
potential participant to inform them about the study. If the potential participant is interested in participating in 
the study, the PI or research assistant will walk the participant through the informed consent, clearly explaining 
the study purpose and planned activities and will answer all questions. Finally, the PI or research assistant will 
obtain a signed informed consent and will provide the participant with a copy for their own records. The primary 
threat to attrition in this study is loss to follow-up.83 To reduce and prevent attrition, participants will receive $15 
each after completion of each interview and each data collection time point. 
 
 
Aim 1 Study Overview. We will use a combination of existing clinical guidelines, our prior and ongoing 
research, and a scoping review of care transitions literature to guide intervention development. Potential 
intervention components are described below in the section titled “Developing the Intervention (Aim 1).” We will 
create a manualized intervention protocol, which we will then refine with focus groups with patients with TBI, 
families, and healthcare providers. A trained research assistant will assist with intervention development and 
refinement. Intervention development (3 months) and refinement (6 months) will take 9 total months. 
 
Description of U.K.’s NICE Clinical Guidelines on Discharge and Follow-Up of Patients with TBI. 
We will use the U.K. NICE clinical guidelines specific to discharge and follow-up of children, young people, and 
adults with head injury53 as a guide for developing our TBI transitional care intervention. The U.K. NICE clinical 
guidelines were initially developed for patients with head injury discharged home from the emergency 
department or observation wards (also known as an inpatient units) without inpatient rehabilitation.53  We 
elected to use the U.K. NICE clinical guidelines as our guide for development of our intervention because 
limited U.S. clinical guidelines on discharge and follow up exist for patients with TBI. The U.K. NICE clinical 
guidelines provide 7 recommendations for healthcare providers to follow when discharging patients with head 
injury home and providing subsequent follow up, listed in Table 2. The recommendations of the U.K. NICE 
clinical guidelines will serve as intervention components and as guidelines for intervention development. 
 
Table 2. Recommendations on discharge and follow  up of patients w ith head injury from U.K. NICE clinical guidelines53 
Recommendations  
1. Give verbal and printed age-appropriate discharge advice to patients w ith any degree of head injury w ho are discharged from an 
emergency department or observation w ard, and their families and carers.  
2. Offer information and advice on alcohol or drug misuse to patients w ho presented to the emergency department w ith drug or 
alcohol intoxication w hen they are fit for discharge. 
3. Inform patients and their families and carers about the possibility of persistent or delayed symptoms follow ing head injury and 
w hom to contact if they experience ongoing problems. 
4. For all patients w ho have attended the emergency department w ith a head injury, w rite to their GP [general practitioner] w ithin 48 
hours of discharge, giving details of clinical history and examination and provide a copy of the letter for the patient and their family. 
5. All patients w ith any degree of head injury should only be transferred to their home if it is certain that there is somebody suitable at 
home to supervise the patient. If no carer is at home, discharge only if suitable supervision arrangements have been organized. 
6. When a patient w ho has undergone imaging of the head and/or been admitted to hospital experiences persisting problems, refer 
from primary care to an outpatient appointment w ith a professional trained in assessment and management of brain injury. 
7. Patients w ho return to an emergency department w ithin 48 hours of transfer to the community w ith any persistent complaint 
relating to the initial head injury should be seen by or discussed w ith a senior clinician experienced in head injuries, and 
considered for a CT scan. 
 
 
Developing the Intervention (Aim 1). We will first use the NICE clinical guidelines53 as a starting point 
to develop our TBI transitional care intervention. Then, we will combine our prior and ongoing research and a 
scoping review of care transitions literature to guide intervention development. Our prior research indicates that 
patients with TBI and their families could benefit from a transitional care intervention that addresses issues 
with: 1) patient safety, independence, cognition, and communication; 2) management of the patient’s mental 
health, overall health and wellness, and medications; 3) family needs; 4) access to community resources; and 
5) behavior change and health-related goal activation. The intervention will be built to address these issues. In 
addition, the AHRQ funded evidenced synthesis generated the Transition of Care Taxonomy, a framework 
describing 8 domains of transitional care interventions12 developed by Dr. Bettger (co-investigator) and 
colleagues, will be used to guide intervention development. Table 3 lists the Taxonomy domains with pre-

selected components for our intervention (based on our prior/ongoing research). It is important to note that, to 
date, clinical guidelines and research (such as that of the NICE guidelines53 and Transition of Care 
Taxonomy12) address system structural components and processes but does little to explore behavioral 
mechanisms that empower families and patients to follow-through with training and treatment plans. Drawing 
on Dr. Strauman’s (co-investigator) expertise in behavioral modifications, the intervention we develop will 
incorporate behavioral change mechanisms to increase the likelihood that patients and families follow-through 
with training and treatment plans. The intervention’s key processes will aim to improve patient functional 
status, caregiver strain, and to direct patients and families to appropriate resources and care that is concordant 
with their health-related goals. We will create a manualized, intervention protocol, which will take 3 months. 
 
 Refining the Intervention (Aim 1). The manualized intervention protocol will undergo iterative user-
testing to determine acceptability.85 
The 6 focus groups (6-10 participants 
each) will use a stratified, purposive 
sample to obtain informational 
representation.86 Focus groups will 
be organized concordantly based on 
insurance status and group 
membership (patient, family, or 
healthcare provider). We will have 
one group with patients with TBI and 
family members with insurance and 
one group without; one group with 
only patients with TBI and one group with only family members; one group with healthcare providers who care 
for patients in hospital and one group with healthcare providers who care for patients with TBI after discharge. 
Individual interviews will be used if availability for a focus group becomes challenging. At each focus group, we 
will talk through the protocol and describe and show what the intervention could entail.87 We will ask 
participants to discuss if intervention components address their transition needs and goals (discharge process 
and first months at home) and components that are missing or need revision.87 We will also explore individual, 
cultural, and social factors that may influence transition needs such as individual experiences in the clinical 
encounter; cultural beliefs about healthcare, interaction with providers, and communication preferences; and 
social determinants such as economic stability after TBI, neighborhood environment, community resources, 
and access to post-TBI education, training, and providers. We will also establish, from the perspectives of the 
patients and families, additional secondary outcomes that matter the most to them. At the completion of the 
focus group, participants will complete a demographic questionnaire (Appendix B), including questions about 
age, sex, race/ethnicity, and education and employment; patients and families will also answer questions about 
the patient’s injury cause and date, health insurance status, self-identified social economic status, pre- and 
post-injury living arrangements, and post-discharge support. Each focus group will be 90 minutes long. 
Dr. Oyesanya (PI of R03) is a qualitative expert with over 10 years’ of experience in qualitative research 
methodologies and data collection, including conducting focus groups and analyzing focus group data. She will 
conduct all focus groups and analyze all qualitative data with assistance of a trained research assistant. The 
focus groups will be audio recorded and transcribed verbatim. Qualitative data from the focus groups will be 
analyzed using directed content analysis. Directed content analysis is defined as using existing research to 
confirm, validate, or extend knowledge in an area where more research is needed.88 With directed content 
analysis, prior research on the needs and goals of persons with TBI discharged home from acute hospital care 
and their family caregivers7,8,89–91 will be used as a starting point to provide our team with a structure of key 
concepts to use as initial categories of focus during data analysis, which will be our pre-determined codes.88 
Dr. Oyesanya and the research assistant will begin coding, highlighting data relevant to our pre-determined 
codes,88 which will be our categories. Any data that does not fit with our pre-determined codes will be identified 
and analyzed to determine if it represents a new category, or a subcategory of an existing code, called a newly 
identified code.88 Dr. Oyesanya and the research assistant will first code independently and then will meet 
weekly to compare coding and discuss any discrepancies in codes until agreement is met.88 Dr. Oyesanya and 
the research assistant will keep all codes, their definitions, and corresponding quotation exemplars in a 
codebook.88 The analysis will integrate all participants’ perspectives, including analyzing patient and family 
member data together (where available) and incorporating healthcare providers’ perspectives.92 Findings from 
the focus group will be used to refine the intervention. Intervention refinement will take 6 months. 
Table 3. Transition of Care Taxonomy (TCT) Domains and Intervention Components 
TCT Domain 
Pre-selected Components 
Transition Type Acute hospital to home 
Model Type 
Hospital-initiated 
Recipient(s) 
Patient and family caregiver 
Key Transitional 
Care Processes 
Assessment of needs, patient/family education, goal setting, care 
coordination, referral to resources, and individualized care plan 
Intervention 
Facilitators 
Multi-disciplinary team (e.g., nurse, case manager/social w orker, 
therapists, mental health counselor) 
Contact Method In-person home visit, clinic visit, and phone calls 
Intensity and 
Complexity 
In-person home visit 7 days post-discharge, w eekly calls, and 
comprehensive clinic visit at 2 w eeks post-discharge 
Outcomes 
Patient, proxy-, and family-reported outcomes (see Aim 1 and 2) 

Aim 2 Study Overview. A research assistant will recruit, consent, and enroll 15 dyads of patients with 
TBI set to be discharged home from Duke University Hospital and their families to determine feasibility, 
acceptability, and preliminary efficacy of the TBI transitional care intervention. The intervention will be delivered 
by a multi-disciplinary team. Data will be collected at baseline (discharge), intervention midpoint (4 weeks post-
discharge) and intervention endpoint (8 weeks post-discharge). The research assistant will assist with 
recruitment, consent, enrollment, and data collection. Assessing the feasibility, acceptability, and preliminary 
efficacy of the intervention will take 15 months. 
 
 
Aim 2 Data Collection for Feasibility, Acceptability, and Preliminary Efficacy. Recruitment, 
enrollment, and data collection feasibility and intervention fidelity will be used to assess feasibility of 
implementation of the TBI transitional care intervention. For recruitment feasibility, the research assistant will 
record the number of patients and family caregivers eligible vs. number of patients and families consented to 
participate. For enrollment feasibility, the research assistant will record the number of patients and family 
caregivers eligible, consented, and enrolled into the intervention. For data collection feasibility, the research 
assistant will obtain in-person baseline data from patients with TBI up to 48 hours before discharge and will 
also obtain baseline data from family caregivers in person or by phone depending on availability. At 4- and 8-
weeks post-discharge, the research assistant will call patients and families to obtain follow-up data. The 
research assistant will record for each follow up time point: 1) number of patients and family members called 
and reached; 2) number of call attempts per patient and family member; 3) number of patients and family 
members reached but unable to provide information; 4) completeness of data collected; 5) length of phone call; 
and 6) day of week and time of day patients and family members participated. Fidelity will be assessed by 
recording all components of the intervention delivered to each patient and family caregiver. Our team will 
review recruitment and follow-up rates weekly and identify strategies to improve recruitment, enrollment, and 
data collection. We will assess acceptability of the intervention using a survey we develop. The outcome data 
we collect will be used to assess preliminary efficacy. To assess the preliminary efficacy of the intervention, we 
will collect data on our primary outcome [patient functional status (Functional Status Examination)25]. 
Secondary outcomes for family caregivers will include caregiver strain (Modified Caregiver Strain Index26) and 
preparedness for the caregiver role (Preparedness for Caregiving Scale27); secondary outcomes for patients 
and family caregivers will include self-efficacy (Self-Efficacy for Management of Chronic Conditions28) and 
health service utilization (Health Service Utilization Inventory29).  
 
Aim 2 Analysis Plan. All statistical analyses will be conducted by Dr. Yang who is co-investigator on 
this award and a statistician. We will use descriptive statistics to assess all feasibility data. Preliminary efficacy 
will be evaluated based on changes from baseline to intervention endpoint for primary and secondary 
outcomes. We will estimate the variance of the change in all outcomes and estimate the effect size of the 
intervention using Cohen’s D.93 We will estimate missing data and dropout rate at each time point based on 
these preliminary data. Combined with our clinical judgements, this information will provide important insights 
in proposing a clinical meaningful effect size to guide sample size calculation for our future R01 where we will 
conduct a full scale intervention RCT to formally establish the intervention effectiveness.  
 
Potential Problems and Solutions. We recognize some patients with TBI may not have sufficient 
cognitive functioning at the time of discharge or within 8 weeks post-discharge. Thus, we have built in multiple 
opportunities to collect data from family caregivers of patients with TBI in Aim 1 and 2 to ensure we have 
collected, at the very least, family members’ perspectives to inform intervention development and refinement 
(Aim 1) and assessment of the feasibility, acceptability, and preliminary efficacy of the intervention (Aim 2).  
 
Timeline and Milestones (Table 4). Prior to beginning this award, we will obtain IRB approval and hire 
and train study staff. We will 
complete Aim 1 by third-
quarter year 1 and Aim 2 by 
end-year 2. 
 
Significance and Future 
Research. Findings from the 
proposed research will 
provide us with new knowledge useful for informing intervention research on transitional support of patients 
with moderate-to-severe TBI discharged home from acute hospital care and families.94 Our 5-year goal is to 
have developed and tested the feasibility, acceptability, and preliminary efficacy (with this R03) and the 
implementation-effectiveness (with a future R01) of an intervention that will ultimately shift the standard of care 
for patients with moderate-to-severe TBI and their families during the transition home from acute hospital care. 
Table 4. Timeline of Proposed Tw o-Year R03 Aw ard 
 
Pre 
Year 1 
Year 2 
Study Activities 
Pre 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Start up (e.g., IRB, hire & train study staff) 
 
 
 
 
 
 
 
 
 
Develop intervention protocol (Aim 1) 
 
 
 
 
 
 
 
 
 
Refine intervention (Aim 1) 
 
 
 
 
 
 
 
 
 
Test intervention (Aim 2) 
 
 
 
 
 
 
 
 
 

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