Collaborative Care for the Older Injured Patient: A Trauma Medical Home
Phase: NA
Conditions: Injuries
Sponsor: Indiana University

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Elderly Trauma Medical Home 
 
 
Principal Investigator’s name and address 
Ashley Meagher, MD, MPH 
IU Department of Surgery 
 
 
 
 
 
 
 
Sub-Investigators 
Ben Zarzaur, MD, MPH 
 
Malaz Boustani, MD, MPH, Richard M. Fairbanks Professor in Aging Research 
Department of Internal Medicine 
Indiana University School of Medicine 
 
Sujuan Gao, PhD, Professor 
Department of Biostatistics 
Indiana University School of Medicine 
 
Babar Khan, MD, MS, Assistant Professor 
Department of Internal Medicine 
Indiana University School of Medicine 
 
Rita Sue Lasiter, PhD, RN, Associate Professor 
UMKC School of Nursing and Health Studies 
 
Dustin Douglas French, PhD, Assistant Professor 
Department of Ophthalmology  
Northwestern University 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 

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1.0 
Background 
 
Injury from motor vehicle crashes, falls, gunshot wounds, knife stab wounds, and 
natural or manmade disasters lead to over 2.5 million acute care hospitalizations 
every year.  Older injured patients, those 50 and older, are particularly at risk for 
poor outcomes.  Physical injury results in an early reduction in quality of life as 
measured by the Quality of Well Being Scale and the Short Form-36, when 
compared to population norms.  Over the year following injury, quality of life 
improves for some, but, often does not return to the pre-injury baseline.  There is 
a significant link between poor physical function and quality of life and the 
development of psychological symptoms.  We are proposing a collaborative care 
intervention targeting non-neurologically injured survivors as a means of 
improving functional and psychological outcomes.  
 
  
 
2.0 
Rationale and Specific Aims 
 
Every year, 1.4 million Americans over age 50 are hospitalized for severe injuries.1  The 
majority of older injured patients have the potential for full recovery, yet studies have 
shown that the current fragmented American health care system is failing to optimally 
serve these injury survivors leading to residual functional disability and reduced quality 
of life for years after injury.2,3  Disability after injury is expensive, with injuries accounting 
for over $83 billion in direct and indirect costs.4  Timely and integrated rehabilitative 
services have the potential of reducing the personal and societal burden of disability 
after injury. 
   To address the current fragmented care, the Institute of Medicine and the Center for 
Medicare and Medicaid Services recommend implementing the collaborative care 
model within both primary care and specialty care settings.5,6  The goal of such a model 
is to provide continuous, coordinated and personalized care to patients with a wide 
range of healthcare needs and to ensure that patients receive the right care in the right 
place at the right time.  After injury, patients experience a diverse set of physical, 
psychological, and socioeconomic challenges that threaten their full functional recovery.  
Indiana University School of Medicine researchers have over 20 years of experience 
developing innovative and effective collaborative care models.7-10 These models are 
integrated within primary care practices to address the complex biopsychosocial needs 
of frail elders with multiple chronic conditions and survivors of acute critical illnesses.  
Based on these successes, an Interdisciplinary team of clinical investigators at Indiana 
University revised the collaborative care model to meet the needs of older injury 
survivors. This Trauma specific collaborative care model is called the Trauma Medical 
Home (TMH).  This proposal aims to conduct a randomized controlled trial to evaluate 
the efficacy of 6-month duration of TMH in improving the functional and psychological 
recovery of older injury survivors, enhancing their quality of life and reducing their acute 
health care utilization.  The trial has the following specific aims: 
 
Primary Objective:  Evaluate the ability of the TMH intervention to improve the 
physical recovery of older injury survivors. 

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Primary hypothesis: In comparison to the older injury survivors randomized to usual 
care, those randomized to the TMH intervention will have the following at 6 and 12-
month follow-ups: 
• 
Higher physical performance as measured by the short physical performance battery 
(SPPB); 
• 
Higher scores on the Physical Component Summary (PCS) of the Medical Outcomes 
Study 36-time short form (SF-36). 
 
Secondary Objectives: 
 
1: Evaluate the ability of the TMH intervention to improve the psychological 
recovery of older injury survivors. 
Secondary hypothesis 1: In comparison to older injury survivors randomized to usual 
care, those who are randomized to the TMH intervention will have the following at 6 and 
12-month follow-ups:  
• 
Lower mood and anxiety symptoms as measured by the Patient Health 
Questionnaire–9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) scale; 
• 
Higher scores on the Mental Component Summary (MCS) of the SF-36. 
 
2: Evaluate the ability of the TMH intervention to reduce health care cost of older 
injury survivors and evaluate the cost effectiveness of TMH.  
Secondary hypothesis 2:  In comparison to older injury survivors randomized to usual 
care, those who are randomized to the TMH intervention will have the following at 6 and 
12-month follow-ups: 
• 
Lower emergency department and hospital related cost. 
• 
Savings in healthcare utilization in the intervention arm that will offset the intervention 
costs.] 
 
Due to demographic shifts, changes in life expectancy and increased activity of older 
Americans – putting them at risk for injury – there is an urgent need to enhance the 
recovery care for older injury survivors.  Trauma centers across the nation are in an 
extraordinary position to use the information generated from the proposed trial to 
intervene; so older injury survivors may enjoy the maximum level of functional ability and 
quality of life after injury.  
 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria: 
 
[1] English-speaking adult age 50 years and older; 
[2] admitted to Methodist or Eskenazi hospitals; 
[3] able to provide consent or has a legally authorized representative to 
provide consent; 
[4] access to a telephone; 
[5] and an injury severity score (ISS) of 9 or greater. 
 
 

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Exclusion Criteria: 
 
[1] have a self-reported diagnosis of cancer with short life expectancy;  
[2] have a history of dementing illnesses and other neurodegenerative 
disease such as Alzheimer disease, Parkinson disease, or vascular 
dementia;  
[3] have a significant traumatic brain injury (defined as the presence of any 
intracranial blood on Computed Tomography scan of the head or best 
Glasgow Coma Scale Score of less than 13 at the time of study 
enrollment);  
[4] have any spinal cord injury with persistent neurologic deficit at the time 
of study enrollment;  
[5] are pregnant women (assessed by a urine pregnancy test);  
[6] have a primary residence outside the state of Indiana;  
[7] are incarcerated at the time of study enrollment;  
[8] have an acute stroke upon admission or develop a stroke as a new 
event during the course of hospitalization; 
[9] unable to complete study questionnaire due to severe hearing loss; 
[10] recent history of alcohol or substance abuse; 
[11] discharged to a permanent care facility; 
[12] admitted with a burn affecting >10% total body surface area. 
 
 
4.0 
Enrollment/Randomization 
 
Enrollment.  A research coordinator (RC) will screen for eligible subjects each 
day using the trauma service census at each site.  Eligible individuals (those who 
meet inclusion criteria and do not meet any exclusion criteria) will be approached 
prior hospital discharge for enrollment into the study. If an individual is interested 
in participating and discharged before enrollment could be completed, a RC may 
follow up with the individual and complete enrollment at their place of discharge. 
 
The target population is 430 English-speaking adults age 50 years and older, 
admitted to Methodist or Eskenazi Hospitals. 
 
5.0 
Study Procedures 
 
After obtaining approval from the local institutional Review Board (IRB) and the 
leadership of trauma services at each hospital, subjects or their legally 
authorized representative will be approached prior to hospital discharge for 
participation in the study. Patients may be consented after discharge if they 
expressed interest in the study at the hospital but were unable to complete the 
consent process at that time. After obtaining an informed consent, the Research 
Coordinator/Research Assistant (RC/RA) will complete the Initial Case Review 
(see below for description) and will obtain baseline measurements of physical 
function, depression and anxiety, and quality of life.  The RC and RA will be 

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blinded to the treatment assignments, therefore, after consent and baseline 
measurements are made, subjects will be randomized by the Care Coordinator 
via a computer-generated stratified randomization scheme.  This scheme will be 
used to assign consented patients to intervention or control groups within each of 
the three hospitals.  All subjects will receive the interventions described in the 
usual care section below.  Those randomized to the TMH intervention will also 
receive the collaborative care (TMH) intervention.   
 
During the hospital stay, research coordinators/assistants will review the medical 
records and conduct screening to assess the eligibility criteria for potential 
subjects. Furthermore, blinded assessors will complete the baseline, and follow-
up data collection at the subject’s home. The data obtained from subjects will 
include self-report of demographics, health history, current medications, anxiety 
and mood symptoms, and quality of life questionnaire. The assessors will also be 
collecting information on cognitive and physical performance via objective tests.  
Finally, the assessors will conduct a medical record review to assess subject’s 
chronic conditions (Charlson index), physiologic status (blood pressure, height, 
weight, heart rate), and severity of medical illness (APACHE index) as well as 
their injury severity (Injury Severity Score). 
 
 
TMH Intervention:  
The Initial Case Review: Patients randomized to the TMH intervention will 
receive the same intervention as described under Usual Care (See below) 
at the time of the Initial Care Review. A time will also be arranged for the 
First Home Visit – which is the beginning of the TMH intervention. 
 
The First Home Visit: After completing a pre-home visit review, the CC will 
travel to the patient and conduct a face-to-face initial assessment. The 
Care Coordinator (CC) will conduct a physical, cognitive, and 
psychological assessment of the patient.  The CC will also perform a 
social and community needs assessment for the patient and the informal 
caregiver and will reconcile all prescribed and over the counter 
medications.  The CC will make note of all scheduled and recommended 
appointments with specialists, physical therapists and occupational 
therapists.  The CC will use the Healthy Aging Brain Care Monitor (HABC-
M) to monitor the cognitive, functional, and psychological symptoms of 
patient and caregiver stress and to trigger the utilization of specific 
treatment protocols.  The CC will document the initial and the follow-up 
visits using a modified version of population health decision support 
software, called the eMR-TMH.  
 
The Plan of Care Development: This phase is designed to facilitate the 
creation of an individualized care plan with an emphasis on coordinating 
services with the patient’s primary care and specialty providers. This 
phase begins with the TMH CC’s first home visit and concludes with the 

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second home visit. Using the information provided by the patient and the 
informal caregiver, the CC will collaborate with the remainder of the TMH 
team and the primary care provider to finalize the individualized care plan. 
Complex patients and patients with diseases that may benefit from 
specialty care may be recommended for specialty evaluation and co-
management.  If necessary, the patient will be referred for a more 
extensive cognitive and psychological evaluation at local mental health 
practices. The TMH CC, the TMH team members, and the patient’s 
primary care provider would collaborate on this decision. Finally, the CC 
will schedule a second face-to-face home visit with the patient and the 
informal caregiver to occur within 1-2 weeks of the first home visit. 
 
The Second Home Visit: During the second home visit, the CC will 
disclose and review the individualized recovery care plan with the patient 
and the informal caregiver. This process will include a) understanding the 
process of monitoring the patient’s recovery progress; b) implementation 
of the appropriate care recovery protocols; c) distribution and explanation 
of the corresponding educational recovery handouts (patient and informal 
caregiver); and d) connection to in-home services and community 
resources as needed.  
 
The 6-month Interaction Period: Follow-up includes a 6-month interaction 
period with the patients and/or their informal caregivers via face-to-face 
visit, phone contact, email, fax or mail.  At the end of 6 months, the TMH 
team will transition the full care of every patient to his or her primary care 
physician. The minimum amount of contact during the intervention will be 
every two weeks.  During these interactions, the TMH CC, will answer any 
questions generated from previous visits; collect patient and caregiver’s 
feedback; review and reconcile medications and discuss adherence; 
review specialist and therapists appointment and adherence to care plans; 
have the patient and/or the informal caregiver complete the HABC Monitor 
to trigger the use of specific care recovery protocols (described below); 
and facilitate the informal caregiver’s access to appropriate community 
resources.  Throughout the duration of the follow-up phase, the TMH team 
will continue to work with the patients, their informal caregivers, and the 
patient’s primary care providers and specialists to monitor, implement, and 
revise the individualized recovery care plan. 
 
Usual Care:  
The Initial Case Review: The Care Coordinator (CC) will conduct a 
medical record review of each eligible patient after consent is obtained.  
The CC will confirm eligibility criteria, obtain contact information for patient 
and his or her legally authorized representative, review hospital discharge 
and rehabilitation plan, identify the primary care physician responsible for 
the patient care, identify the residential location of the patient, compose 
and send a letter to the primary care provider that summarizes the 

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patient’s injuries, new diagnosis, hospital course and discharge 
medications and dosages, and the plan for rehabilitation and post-injury 
care.  Comorbid medical conditions and current treatments will also be 
determined.  If the patient does not already have a primary care provider, 
the CC will work with the patient to identify a primary care provider.  The 
patients will also receive education on communication skills; caregiver 
coping skills; and legal and financial advice.  Patients randomized to usual 
care will receive no further interventions.  
 
The Support Tools of the TMH 
The TMH Care Protocols: Care protocols have already been developed by members of 
our interdisciplinary team of researchers and successfully utilized in previous studies.  
We have modified these evidence based care protocols to address the specific needs of 
the non-neurologically injured patient.  Specifically, these protocols address: personal 
care, repetitive behavior, mobility, sleep disturbances, depression, agitation or 
aggression, delusions or hallucinations, the caregiver's physical health, driving safety, 
nutrition, and PTSD.  The protocols also address medication adherence and compliance 
with physical therapy and occupational therapy recommendations.  These protocols will 
be utilized as needed by the TMH team to address issues as they arise in the patient’s 
recovery.  
 
The TMH Population Health Decision Support Software: In order to efficiently deliver the 
various components of any collaborative care model, care-coordination decision support 
software must be developed. Using the software that was developed for the Healthy 
Aging Brain Center as a model, we have altered the software to meet the needs of the 
injured patients.  This web-based care-coordination software includes the following 
functions: a) flexible and secure access to the platform from multiple locations and by 
various users; b) manual and web-based solutions to capture patient-centered 
symptoms such as cognitive, functional, and psychological symptoms; c) decision 
support to deliver personalized pharmacological and non-pharmacological care recovery 
protocols; d) tracking process of care coordination delivered by the care coordination 
team; e) monitoring patients’ and informal caregivers’ responses to care recovery 
protocols; f) monitoring population-based outcomes to guide the overall program 
performance;  g) integration capacity with other informatics tools such as the local 
electronic medical record and regional health information exchange; and h) an easy 
interface to move data from the software to analyzable datasets.  Each member of the 
TMH team will have access to this software via an electronic device with wireless 
capability to accommodate the TMH office mobility.   
 
The Healthy Aging Brain Care (HABC) Monitor: The TMH team will use the HABC Monitor 
(HABC-M) to monitor the cognitive, functional, and psychological symptoms of patients 
and caregiver stress.  The HABC-M is a reliable and practical tool to monitor 
biopsychosocial needs of the patient or the informal caregiver. The HABC-M is 32 items 
tapping the previously mentioned four constructs.  While the total HABC-M score is 

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helpful to measure change over time, each question also indicates a specific care area 
where help or coping strategies might be indicated. The HABC-M also includes questions 
on dangerous behaviors such as falls, home safety and automobile driving.  
 
The HABC-M is a process measurement tool that will guide the personalization of the 
TMH collaborative care protocols to the needs of the patient at any point in time during 
recovery.  Our preliminary data indicate that recovery trajectories after non-neurologic 
injury are widely variable.  When cognitive, functional, or psychological symptoms are 
identified, the TMH team can utilize the evidence based care protocols that our team 
has developed as a type of “drop down menu” of interventions that can be customized 
to the patient’s particular needs at any point in time.  Thus, the HABC-M is a part of a 
dynamic feedback loop that allows for adaptation and customization of the intervention 
in real time by the care coordinator.  The TMH team will also work with the primary care 
clinician and other providers to communicate changes in the care plan and to begin 
initial pharmacological and non-pharmacological management if needed.  
 
Data Collection.   
All assessments will be completed in the participant’s hospital room or home by 
trained RC.  Frequency, timing of contacts and the intervention offered in the group 
receiving TMH will be tracked using the HABC Trauma Medical Home software which 
offers quantitative measures of intervention intensity in the TMH group. All of the 
cognitive, physical, psychological, and quality of life outcome measures, with the 
exception of the Katz and Lawton ADL scales, will be assessed at baseline (hospital 
discharge or shortly thereafter, if consented after discharge), and at 6 and 12-month 
follow-up.  If study team is unable to contact the subject by telephone to set up home 
visit at any point in the study, study assessments may be sent by mail with return 
postage-paid envelope. 
 
Outcome Measures.  
 
Short Physical Performance Battery (SPPB)  
Physical recovery effects will be assessed via the SPPB, a validated objective 
assessment. The SPPB yields a performance score of 0-12; 0-4 poor, 5-7 intermediate, 8-
12 is good. Based on previous studies in similar patient populations the expected scores 
on the SPPB are 6.0 (SD 2.5) (at baseline), 7.5 (SD 2.5) at 6-months, and 8 (SD 2.5) at 12 
months.  A difference of more than 1.3 would be considered clinically significant. 
 
Self-reported quality of life outcomes 
Non-neurologically injured patient’s health–related quality of life will be 
assessed using the Medical Outcome Study Short Form (SF-36). This scale has eight 
components (physical functioning, role-physical, bodily pain, general health, vitality, 
social functioning, role-emotional, and mental health) that are aggregated into a 
Physical Component Summary (PCS) and a Mental Component Summary (MCS).  
Expected scores on the PCS of the SF-36 are 40 (SD 5) at baseline, 49 (SD 5) at 6-months, 

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and 51 (SD 5) at 12-months.  A difference of more than 2 would be considered clinically 
significant. Functional status prior to admission and 12 months after enrollment will be 
assessed using the Activities of Daily Living (Katz scale) and Instrumental Activities of 
Daily Living (Lawton Scale). 
 
Self-reported Mood and Anxiety symptoms  
We will use the Patient Health Questionnaire–9 (PHQ-9) and Generalized Anxiety 
Disorder Scale (GAD-7) to determine the impact of the intervention on non-
neurologically injured patient’s mood and anxiety. The PHQ-9 is a nine-item depression 
scale with a total score from 0 to 27 and the GAD-7 is a seven-item anxiety scale with a 
total score from 0 to 21. Both of these scales are derived from the Patient Health 
Questionnaire, have good internal consistency, and test–retest reliability as well as 
convergent, construct, criterion, procedural and factorial validity for the diagnosis of 
major depression and general anxiety disorder.54,57 
 
Acute Health Care Utilization (Secondary Objective). 
In addition to patient reported emergency department and hospital admission 
data, we will use the local data-warehouse of IUH and IUH Physician Group to capture 
all of the data needed to determine utilization.  The IUH and IUH Physicians Group data 
warehouse includes detailed administrative, billing and hospital records of all patients 
seen within the IUH system.  The IUH system has nearly 60% market share in the state of 
Indiana, so, using this database will likely capture the majority of healthcare encounters.  
Furthermore, we will also use the data from the Indiana Network for Patient Care (INPC) 
to compliment any data use outside of IUH system. INPC is the primary health 
information exchange in the state of Indiana and it provides data for acute care services 
from all of the health care systems within the state of Indiana.  We will determine the 
number of emergency department visits and the number of rehospitalizations within 6 
months of discharge as well as the diagnoses associated with each utilization episode.  
Based on previously published data we expect the cumulative readmission proportions 
at 30 days, 3 months, 6 months, and 12 months will be around 6%, 11%, 15%, and 20% 
respectively.  We would expect the emergency department visits to be approximately 3-
5% higher at each time point.   
 
Other data collection.  
At hospital discharge and baseline we will measure the subject’s age, race, 
gender, years of education completed, visual acuity, height, weight, body mass index, 
heart rate, blood pressure, and Charlson Comorbidity Index.  We will also establish a 
linkage to the trauma registries maintained at both Level I trauma centers.  The trauma 
registries contain detailed, demographic, physiologic, injury type, injury location, injury 
severity, treatment and complication information.  These measures will be used to 
describe the non-neurologically injured patient characteristics and as potential 
confounders.  We will also utilize findings from previous studies in similar patient 
populations to act as historical, usual care controls. These data have been gathered as 
part of previous IRB approved studies or are published in the literature already.   

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Sources of Materials: During the hospital stay, RC will review the medical records and 
conduct screening to assess the eligibility criteria for potential subjects. Furthermore, 
assessors will complete the baseline, and follow-up data collection at the subject’s 
home. The data obtained from subjects will include self-report of demographics, health 
history, current medications, anxiety and mood symptoms, and quality of life 
questionnaire. The assessors will also be collecting information on cognitive and physical 
performance via objective tests. Finally, the assessors will also conduct a medical record 
review to assess subject’s chronic conditions (Charlson index), physiologic status (blood 
pressure, height, weight, heart rate), and severity of medical illness (APACHE index) as 
well as their injury severity (Injury Severity Score).  
 
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
 
Potential Risks: 
 
(1) Fatigue, anxiety, stress, or embarrassment from the testing sessions. 
Emotional distress may result from answering health and behavior 
questions. Testing may also create anxiety, stress, or embarrassment at 
perceived performance. Participants may also become fatigued during the 
testing sessions. Screening instruments for the presence of substance 
abuse, depression and significant anxiety will be used during this study.  It 
is possible that subjects could feel embarrassed by these questions.  
 
(2) Falls and/or muscle stiffness and soreness from the physical 
assessment. Based on piloting and published studies, the most likely 
adverse events risk is a fall, and mild muscle stiffness and soreness 
associated with increased exercise. Moderate-intensity physical activities 
are associated with a very low risk of musculoskeletal complications. 
  
(3) Exposure of confidential information. There is the potential for loss of 
privacy or confidentiality due to the data collection efforts of this study.  
 
 
Adequacy of Protection Against Risks.  
 
Recruitment and Informed Consent: Eligible subjects will be identified through 
the intensive care units’ census to which they are admitted. Study personnel will 
consent the patient or their legally authorized representative (if the patient is 
unable to consent for themselves).   
 
Protections Against Risk:  
 

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(1) Fatigue, anxiety, stress, or embarrassment from the testing sessions. 
All questions planned for this study are part of validated standardized 
instruments, and we are not asking any questions that do not directly 
relate to the study purpose. Both Interventionists and Assessors will be 
trained in their proper use and in the importance of privacy and sensitivity 
to the participant’s time. They will be trained to be alert and sensitive to 
signs of fatigue and other symptoms and to take appropriate actions when 
they are present. Breaks from testing will be offered as needed; 
assessment sessions can also be split into two sessions if a participant is 
tired or physically uncomfortable. Screening instruments for the presence 
of substance abuse, depression and significant anxiety will be used during 
this study.  For persons who screen positive for any of these problems, we 
will make appropriate referrals for treatment based on our established 
referral patterns in our institution.  We will follow-up with individuals who 
are referred for treatment to be sure that they have taken necessary steps 
to address their issue. 
 
(2) Falls and/or muscle stiffness and soreness from the physical 
assessment. We have minimized the risk of a fall through and stiffness 
that may occur from the physical testing.  We expect that any soreness 
that may occur during the testing will subside within a few days and be 
unlikely to occur again. Participants with persistent or very severe 
soreness will be encouraged to contact their primary care provider. In the 
~2,000 in-home assessments that we have done in the similar studies 
which have extensive physical exam protocols, we have not had a single 
fall or other adverse event. We attribute this to our very careful training 
and supervision procedures, which we will also be using in the proposed 
trial. We will have an emergency plan in place to handle any emergencies 
that might occur.  
 
(3) Exposure of confidential information. Indiana University requires 
certification of training in protection of human subjects in research. The 
investigators, interventionists, assessors, and all key personnel have or 
will have successfully completed training and certification in these 
courses. All research involving the use of these data must be reviewed 
and approved by the IRB. We will assure the privacy of subjects and 
confidentiality of study data by assigning unique identifiers to track 
participants’ data (rather than using names or hospital or social security 
numbers) and keep all records under lock with access only by study 
personnel. These procedures have been dutifully adhered to in prior 
studies. The final data files for this study will be merged, maintained, and 
analyzed on servers managed by the Division of Biostatistics, Department 
of Medicine, Indiana University School of Medicine. This group has 
extensive experience in the handling and security of PHI. None of the 
individual participant data will be identifiable in published reports or 

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manuscripts and the analyzable datasets will not contain the participant’s 
unique identifier.  
 
Definitions: 
An adverse event (AE) is defined as any unintended or abnormal reaction or 
clinical condition that is not of benefit to the participant.  Either the 
response/condition was not present prior to exposure to the study or 
participation has worsened the intensity or frequency of the 
response/condition. A reportable adverse event is any unintended or 
abnormal reaction or clinical condition in a subject that (1) places the 
subject at increased risk of harm and (2) was unexpected and (3) was 
related to the research procedures.  Any breach of patient confidentiality is 
considered a reportable adverse event.   
 
 
Unanticipated problems involving risks to subjects or others will be 
reported promptly to the IRB if they: 
 
1. were unexpected (in terms of nature, severity, or frequency); 
2. were related or possibly related to participation in the research; and  
3. suggest that the research places subjects or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) 
than was previously known or recognized.  [Note that such events 
routinely warrant consideration of substantive changes in the research 
protocol or informed consent process/document or other corrective 
actions in order to protect the safety, welfare, or rights of subjects or 
others.] 
 
 
The timeline for reporting promptly to the IRB is within 5 working days of 
notification. 
 
 
Submit reports to: 
 
 
Indiana University Institutional Review Board on Prompt Report form via 
the KC-IRB system. 
 
 
Events not meeting requirements for prompt reporting will be recorded in 
the study record and summarized at time of continuing review. 
 
Data and Safety Monitoring Plan.  
This trial will be monitored by the PI and a three-member Data Safety and 
Monitoring Board (DSMB).  
 
a. Qualifications and responsibilities of the Safety Officer: The safety officer for 
this trial will be a physician researcher experienced in running intervention 
studies, and will have an understanding of the types and severity of injuries or 
complications as a result of a collaborative care intervention. The safety officer 

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will review the reports sent by the study manager and will determine whether 
there is any corrective action, trigger of an ad hoc review, or stopping rule 
violation that should be communicated to the study investigator, the DSMB, the 
IU IRB, and the NIH. In addition, the safety officer may comment on whether the 
study investigator needs to report any specific out of range data to the participant 
and/or her physician.  
 
b. Qualifications of the DSMB: The safety officer will be joined by an expert 
trauma surgeon and a biostatistician. These persons will not be otherwise 
affiliated with the project. The three member DSMB panel will meet at 6-month 
intervals.  
 
c. Monitoring and Reporting: The frequency of data review for this study differs 
according to the type of data and can be summarized in the following table: 
 
The study coordinator and biostatistician will generate reports for PI, safety 
officer, and DSMB that will contain: 
a) summary of adverse events and an explanation of how each event was 
handled;  
b) summary of complaints and how each complaint was handled;  
c) subject retention, including the number and reasons of participant 
withdrawals;  
d) intervention compliance (session attendance); and  
e) summary of protocol violations and how each was handled.  
 
All reports will be submitted to IU IRB at time of continuing review.  
 
 
 
d. Measurement and reporting of adverse events: Adverse event rates 
associated with a collaborative care intervention are low. Therefore, adverse 
event rates are expected to vary little between the treatment and control groups. 
We will present blinded adverse event data to the statistician and PI throughout 
the trial. We plan to present unblinded adverse events data to the safety officer 
throughout this trial and to the DSMB panel when requested by the safety officer 
and at bi-annual meetings. If there is evidence of elevated adverse events, the 
safety officer will consult with the statistician and PIs. An adverse event form will 
be used by the study staff to report injuries or other adverse events caused by 
the intervention.  
 

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e. Possible 
Adverse Events: 
Adverse events 
will be 
monitored on an 
ongoing basis 
by the study 
manager. The 
PIs will be 
notified within 24 
hours of any 
adverse events. 
Serious adverse events will be reported within 5 business days to IU IRB, Safety 
Officer, DSMB, and NIH. Non-serious adverse events will be reported at time of 
continuing review to IU IRB. In cases where there is any question regarding the 
level of AE or attributable cause, we will consult with the DSMB and safety 
officer.  
 
Serious adverse events are defined as:  
 
1) death, life threatening event, prolonged inpatient hospitalization, 
permanent disability, clinically significant lab exam or any deemed by 
the reporter to be medically serious. 
 
f. Stopping Rules: It is unlikely that the study would be stopped early due to 
important favorable differences in the intervention group compared to control 
group because of the short term nature of the intervention. However, the study 
could be stopped early due to adverse events. Some events of particular concern 
would be a high number of study withdrawals due to discontent with the study 
procedures. The NIH will make the final decision on whether or not to accept the 
DSMB’s recommendation about discontinuation of any component of the study. 
Interim analysis of the study is planned according to the O’Brien-Fleming alpha 
spending rule. The p-values are constructed to maintain the overall study power 
of 0.05, two-sided. If the test statistic exceeds the boundary, then the study could 
be considered for early termination due to emerging differences. The interim look 
is planned after enrollment and follow-up of 200 patients. The study can also be 
stopped if continuing is considered futile after the interim analysis.  Further, if 
dropout rates remain high after an extreme alert (see below for description) the 
study can be stopped early. 
 
g. Limits of Assumptions: It is possible that baseline differences between the 
groups, excessive study dropouts and/or missing data by the interim 
measurement time point (midway point to targeted enrollment) will limit the value 
of data analysis of measurements at the one year time point. Baseline 
differences will be evaluated after the first measurement time point and effects on 
the power to detect differences in the primary outcome will be evaluated and 
Data Type 
Frequency of Review 
 
Each 
Occurrence 
Q 6-mo 
Annual 
Subject accrual (adherence 
to inclusion/exclusion); drop-
out rates; randomization 
 
X 
 
Adverse event rates 
(injuries) 
X 
X 
 
Subject complaints 
 
X 
 
Compliance to interventions 
 
X 
 
Protocol 
violations/noncompliance 
X 
X 
 
Out of range data 
 
X 
 
Risk-benefit ratio 
assessment 
 
 
X 
Stopping rules report 
 
 
X 

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communicated to the PI, DSMB, and NIH. Given the monitoring plans outlined 
elsewhere in this document, it is exceedingly unlikely that there will be baseline 
differences between groups of any magnitude to threaten the validity of the 
study.  
 
Dropout rates higher than 40% would be of concern, so we propose to monitor 
the dropout rate quarterly. Alert points are set at dropout rates of 20% (low alert), 
35% (mid-alert), 45% (high alert) and 55% (extreme alert). With early alerts to 
problems, action would be taken to avoid higher level alerts; if a higher level alert 
should arise, more drastic remedial action would be invoked.  
The actions taken at each level of alert are given below:  
• Mid-level alert = Conference call between study investigators to 
discuss approaches to minimize further losses to follow-up/dropouts.  
• High-level alert = Conference call between investigators and DSMB to 
determine further alterations of study protocol to complete the study 
with no further losses. 
• Extreme-level alert = In the unlikely event of a 55% dropout rate occurs 
prior to the 1-year measurement time point, study investigators, the 
DSMB members, and the NIH program official would convene on a 
conference call to discuss the usefulness of continuing the study. 
 
 
7.0 
Study Withdrawal/Discontinuation 
 
This study is voluntary and participants have the right to withdraw at anytime.  
Participants must notify the Principal Investigator that they choose to withdraw 
from the study: 
 
Ashley Meagher, MD, MPH 
Indiana University Department of Surgery 
Trauma and Emergency General Surgery 
1730 N. Capitol Avenue, Suite B249 
Indianapolis, IN  46202 
(317) 962-9231 
 
Participants who choose to withdraw will be informed that no new procedures will 
be performed after receiving their notice that they choose to withdraw from the 
study.  Information that has been obtained up to that point will remain as part of 
the study.   
 
8.0 
Statistical Considerations 
 
We will compare randomization results to a pre-planned randomization schedule 
to ensure randomization integrity. To verify the comparability of the randomized groups, 
patients’ baseline characteristics between the intervention and the usual care group will 
be compared using analysis of covariance (ANCOVA) for continuous variables and the 
Cochran-Mantel-Hansel statistic for categorical variables while adjusting for recruitment 

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sites.  We will examine the distributions of continuous variables and use alternative 
approaches such as transformation or nonparametric methods in cases of violation to 
the normal distribution assumption.  We will also examine the frequency distribution of all 
categorical variables and adopt exact inference procedures in cases of zero or small cell 
size.  All analyses will be conducted using SAS 9.4 (SAS Institute, Cary, North Carolina).  
 
Obective 1: Evaluate the ability of the TMH intervention to improve the physical 
recovery of the non-neurologically injured patient. Mixed effects models will be used 
with repeated physical function scores (SPPB and PCS on the SF-36) collected at 
baseline, 6 months and 12 months as the outcome measures, group, time, and a group 
and time interaction as independent variables while adjusting for stratification variables 
(recruitment site, injury severity and injury type) and other potential baseline covariates 
that are found to be different between the two groups. An unstructured variance-
covariance matrix will be used in the mixed effects models to adjust for the potential 
correlations among SPPB and PCS obtained from the same individual over time. A 
significant interaction between group and time would indicate differences in changes of 
physical functions over time between the two groups. Post-hoc comparisons at each 
follow-up time will be conducted following a significant interaction between group and 
time to determine the time when a group difference can be detected. Parameter 
estimation and inference for the mixed-effects models are conducted using the 
maximum likelihood approach which are robust under many missing data mechanisms.72  
We will also include additional covariates to examine whether patients’ characteristics or 
prior medical comorbidities are associated with the changes in physical function scores.  
 
Objective 2: Evaluate the ability of the TMH intervention to improve the 
psychological recovery of the non-neurologically injured patient. Mixed effects 
models will be used with repeated PHQ-9, GAD-7 or MCS on SF-36 scores as the 
outcome variables, group, time and interactions between group and time as independent 
variables while adjusting for stratification variables and other baseline covariates that 
may be different between the two groups, similar to the approach described for Aim 1.  
Post-hoc analyses will also be conducted following significant interactions in the mixed 
effects models to examine differences in psychological outcome measures between 
intervention and usual care groups at 6 and 12 months.   
 
Objective 3: Evaluate the ability of the TMH intervention to reduce health cost and 
the TMH cost effectiveness relative to usual care of the non-neurologically injured 
patient. Economic Value and Costs.  Time from enrollment to emergency department 
visits and hospital readmissions will be used as the outcome variables in Cox’s 
proportional hazard models and group as the independent variable while adjusting for 
sites and other baseline covariates. Patients who are followed to 12 months without 
experiencing any event will have their event time censored at 12 months and patients 
who died or were lost to follow-up will have their observation time censored at time of 
death or date of last contact.  The proportional hazard assumption will be examined by 
including the interaction between the group indicator variable and time.   
We will conduct a cost effectiveness analysis to determine if changes in health 
care utilization offset the intervention costs between treatment arm and usual care. To 
conduct this analysis, we will use established methods to estimate direct costs of the 
interventions and health care spending from a Medicare payment perspective. The 
conceptual proposition begins with our proposed TMH intervention, which requires 
healthcare and non-healthcare resources for delivery (e.g., therapists or transportation) 
and caregiver assistance. The foregone economic opportunities and ability for 

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successful return to activities of daily living and participation can be assessed in 
combination with recovery time in dollar value. Changes in patients’ health status, long-
term mobility, and community participation will be assessed using the SF-36 tools for 
measuring physical functioning and utility.73-76  Changes in health status and community 
participation are captured. The cost effectiveness ratio is practically measured as the 
increment in cost summary to the increment in the effect measure. 
 
Multivariate regression models will be constructed to examine total healthcare 
costs in the 12-month post index period. To address issues of skewness and violations 
of normality assumptions, and medical comorbidities, a generalized linear model with a 
gamma distribution and a log-link function will be used. Estimated parameters will be 
obtained using the maximum likelihood technique,77-81 and adjusted results will be 
presented with 95% confidence interval (CI) estimates. Finally, the incremental cost to 
achieve a clinically meaningful change in SF-36 scores due to the interventions, i.e., the 
cost-effectiveness (CE) ratio, is the difference in intervention costs of the treatment 
arms, divided by the difference in effectiveness between groups; or   
 
Sensitivity analysis of all key assumptions and bootstrapping will be conducted.  All 
analyses were conducted with Statistical Analysis Software (SAS, Version 9.3, Cary, 
NC).46   
 
Missing Data: Two types of missing data are anticipated in this trial: those due to lost to 
follow-up and those due to death. There may be a potential for higher rate of lost to 
follow-up in the usual care group than in the intervention group because of the frequent 
contacts between the research team and study participants in the TMH group. The 
mixed effects model approach we propose to use for data analysis is robust under the 
missing at random assumption, i.e. the probability of missing is unrelated to the missing 
outcomes. We will compare baseline characteristics of patients with missing outcomes to 
completers in order to detect potential violation to the missing at random assumption. 
Sensitivity analyses will be performed if the missing at random assumption is violated 
using various methods of imputation or a full parametric likelihood approach assuming 
various patterns of missing data. Intention to treat analysis will be used in all models. 
 
Sample Size and Power: Based on previous studies,21,82-84  we assume a mean baseline 
SPPB score of 6.0 (SD=2.5) in this patient population. A sample size of 150 patients in 
each group will yield 80% power to detect a change score of 0.81 using a two-sample t-
test at α=0.05. Since we expect balanced outcomes at baseline due to the RCT design, 
projected effect size is also the effect of the interaction in the mixed effects models. To 
be conservative and allowing 30% patients missing the 12-month assessments, we will 
need to enroll and randomize 430 patients (215 per group). Our enrollment sample size 
will allow us to detect significant effect of 0.325 SD or larger with 80% power on the PCS 
of SF-36, PHQ-9, GAD-7, MCS of the SF-36 and log-transformed total healthcare cost.  
We present effect sizes and estimated power in the study and within each stratum in the 
following table. 

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This 
study is not powered to detect significant treatment effect within each randomization 
stratum unless there are large effect sizes in each stratum. Instead, stratified 
randomization was used to control for potential heterogeneity in patient outcomes in 
order to detect a significant treatment effect in the overall sample. Since we will have 
access to the electronic medical records on all enrolled patients, for the analysis on 
acute care utilization, data on all 430 randomized patients will be retrieved to determine 
status and time to ER visits and re-hospitalization. We will have 80% power to detect 
odds ratio of 1.8 or greater for ER visits assuming cumulative event rate of 25% in the 
usual care group and 82% power to detect odds ratio of 1.9 or greater for re-
hospitalization assuming cumulative event rate of 20% in the usual care group using 
Chi-squared test at the 0.05 significance level. 
 
Potential Problems and Alternative Strategies. 
 While recruitment into clinical trials is a challenge, retention of subjects over a 
period of time presents its own difficulty. For clinical trials of the type proposed, the 
control condition faces the greatest challenge to retention. We plan to mitigate 
withdrawals from both groups through several mechanisms. First, the control condition 
offers tangible, concrete, and immediate benefits. Second, our quality control procedures 
allow us to monitor subjects’ perceptions about the risks and benefits of participation. 
Occasionally new and fixable issues arise that, if addressed, can prevent the withdrawal 
of subjects. We also recognize that approximately 10% of our participants will be 
African-American, 40% will be women, many will be socioeconomically disadvantaged, 
some will have cognitive impairment, and many will have other chronic conditions and 
unique vulnerabilities.  We recruit research personnel representative of the target 
population by gender and race and we seek to identify personnel who have life 
experiences in this community. All research staff will complete specific training in 
working with research populations representing vulnerable subjects, including those with 
cognitive impairment.  We will periodically measure retention.  If retention drops below 
80%, we will have the study staff follow-up with the participant to troubleshoot issues 
and provide coaching.  We will also institute gift card incentives and we will use fair 
subject payments contingent on the completion of the baseline, 6 months and 12 months 
follow-up assessments.  Loss of information could occur if subjects are unable to 
complete outcome assessments.  We have a “step-down” battery if a participant is not 
able to tolerate the full outcome assessments, which will allow us to estimate the 
treatment effect in key domains (SPPB and PHQ).  We also can provide assistive 
devices (glasses, headphones or pocket talker) if a participant’s visual or auditory acuity 
declines and interferes with interventions or outcome assessments.  Finally, the 
proposed intervention has multiple components and the study is not designed to test 
which of these components is most important or which represents the active ingredient. 
We do not believe that one component can be singled out as more important than 
another and we fully anticipate that ever more complex interventions will be required to 
Detectable effect sizes and estimated power in the overall sample and each stratum. Projected 
sample size (n=300) is the number completing 12 month of follow-up.  
Overall 
(n=300) 
Randomization Stratum 
Severity ISS 10-15 (n=136) 
Severity ISS ≥ 16 (n=164) 
Combined 
Fall (n=68) 
Other Injuries (n=68) 
Fall (n=82) 
Other Injuries (n=82) 
0.33 (81%) 
0.33 (27%) 
0.33 (27%) 
0.33 (32%) 
0.33 (32%) 
0.34 (84%) 
0.50 (53%) 
0.40 (37%) 
0.30 (27%) 
0.20 (15%) 
0.66 (99%) 
0.69 (80%) 
0.69 (80%) 
0.63 (80%) 
0.63 (80%) 

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deliver excellent care. Our research team’s capacity to design, to deliver, and to 
measure outcomes for a multi-component intervention is one of our key strengths. 
 
9.0 
Privacy/Confidentiality Issues 
 
 
All data gathering is done initially with each subject or their legally authorized 
representative in the hospital and then with each subject in their home by a 
trained assessor. Data will be linked to participants through the use of a unique 
identifying number. Only persons on the research team will have access to the 
data. All data are collected for research purposes only. Case Report Forms 
(CRFs) will be stored in locked filing cabinets in the Department of Surgery and 
all data will be entered into electronic case report forms (eCRFs) in a secured 
password-protected database.  All study data will be entered via a password-
protected, study specific REDCap (Research Electronic Data Capture) database 
website. REDCap was developed specifically around HIPAA-Security guidelines 
and has been disseminated for use locally at other institutions and currently 
supports > 140 academic/non-profit consortium partners and 11,000 research 
end-users (www.project-redcap.org). 
 
10.0 Follow-up and Record Retention 
 
Subjects will be followed for 12 months after injury.  Study records will be 
maintained for a minimum of seven years per state HIPAA guidelines.   
 
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