Best Case/Worst Case Trauma Study: A Communication Tool to Assist Severely Injured Older Adults
Phase: NA
Conditions: Communication
Sponsor: University of Wisconsin, Madison

A Communication Tool to Assist Severely Injured Older Adults  
 
 
Principal Investigator: 
 
Margaret (Gretchen) Schwarze, MD, MPP 
 
UW Co-Investigators: 
Toby Campbell, MD, Department of Medicine, University of Wisconsin, Madison, Madison, WI 
Paul Rathouz, PhD, Department of Biostatistics & Medical Informatics, University of 
Wisconsin, Madison, Madison, WI  
 
Multisites and Co-Investigators:  
Karen Brasel, MD, MPP, Oregon Health and Science University, Portland, Oregon 
Thomas Shoultz, MD, University of Texas Southwestern Medical Center, Dallas, Texas 
 
Communication Skills Instructor: 
Toby Campbell, MD, WeTALK Program, University of Wisconsin School of Medicine and 
Public Health, Madison, Wisconsin 
 
 
Contact Information of Principal Investigator: 
 
Campus Address:  
G5/315 CSC, 600 Highland Avenue 
 
Phone Number: 
(608) 265-4420 
 
Email Address: 
schwarze@surgery.wisc.edu 
 
 
Funding Sponsor: National Institutes of Health (NIH) 
 
 

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Contents 
Project Summary and Timeline ...................................................................................................... 4 
Background and Significance ......................................................................................................... 5 
Preliminary Studies ......................................................................................................................... 7 
Study Aims...................................................................................................................................... 8 
Selection of Participants ................................................................................................................. 8 
Inclusion Criteria ........................................................................................................................ 8 
Exclusion Criteria: ...................................................................................................................... 9 
Research Design and Methods ...................................................................................................... 10 
Research Design ........................................................................................................................ 10 
Training Program .......................................................................................................................... 11 
Study Procedures ...................................................................................................................... 12 
Screening and Recruitment ....................................................................................................... 12 
Consent and HIPAA authorization ............................................................................................... 14 
Instruments ................................................................................................................................ 18 
Data Collection Administration ................................................................................................ 21 
Schedule of Events ........................................................................................................................ 24 
Incentives ...................................................................................................................................... 24 
Statistical Considerations .............................................................................................................. 25 
Sample Size ............................................................................................................................... 25 
Analysis..................................................................................................................................... 25 
Risks and Discomforts to Research Subjects ................................................................................ 26 
Adequacy of Protection against Risks .......................................................................................... 27 
Overall Protection Against Risks .............................................................................................. 27 
Potential Benefits to Human Subjects and Others ........................................................................ 29 
Importance of the Knowledge to be Gained ............................................................................. 29 
Records to be Kept ........................................................................................................................ 29 
Data and Safety Monitoring Plan .................................................................................................. 30 
References ..................................................................................................................................... 31 
 
 

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Investigators Plan 
The Principal Investigator, Dr. Margaret (Gretchen) Schwarze will serve to coordinate and 
organize all data. UW will serve as lead site and coordinating center for this study and monitor 
study progress and methods for other sites. Three sites will participate in this study: University of 
Wisconsin-Madison, Oregon Health & Science University (PI: Karen Brasel), and University of 
Texas Southwestern Medical Center at Parkland Memorial Hospital (PI: Thomas Shoultz). Toby 
Campbell will be involved in development of a training program to be used at OHSU and UT-S.  
 
Dr. Schwarze, Ms. Buffington, Ms. Tucholka and Mr. Fox will be responsible for project 
development, data collection, coding and analyzing the data, and/or writing the manuscript.  Ms. 
Sisavath and Ms. Lape will be responsible for overseeing screening, recruitment, enrollment and 
data collection at their respective sites. Ms. Buffington will be the point of contact and 
coordinator for the study, managing and organizing data and records.  
 
UW Co-Investigator Dr. Rathouz, is a senior advisor to the project and will assist in oversight of 
project development, implementation and data analysis of coded and de-identified data.  
 
Protocol Control 
To ensure that all investigators have the most current version of the UW protocol, UW will send 
each site Co-Investigator a copy of the UW protocol after any major changes and minor 
amendments are made. UW will communicate changes to the protocol to UT-S and OHSU and 
these changes will be reported to each site IRB by the site Research Coordinator as required.   
 
Multisite Plan 
UW will request that UT-S and OHSU’s IRB cede review to the UW Health Sciences IRB.  
Study staff at the UW site will oversee this process and offer assistance to other sites with the 
reliance process. All 3 institutions have a Federalwide Assurance (FWA) on file with the Office 
for Human Research Protections (OHRP). The lead site Principle Investigator (PI), Dr. 
Schwarze, will be responsible for disseminating information between sites. Unanticipated 
problems, adverse events, protocol deviations, new information about the study, and changes of 
protocol will be communicated between the sites within 48 hours of discovery and will be 
reported to the UW and site IRBs within reporting guidelines.  Protocol compliance will be 
monitored by the PI at each site. In addition, the UW site will conduct regular quality checks on 
data collected by each site. Any changes to the protocol will be communicated between sites by 
the UW team and will be reported to each IRB as required.   
 
Dr. Schwarze, Anne Buffington and Jennifer Tucholka will communicate with the Research 
Coordinators at other sites through regular conference calls and contact via phone and email to 
ensure that there is adherence to the protocol and to conduct regular checks on issues relating to 
data quality. Regular webinars with the Co-Investigators at other sites will be scheduled monthly 
and as needed.  
 
 
 

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Project Summary and Timeline 
 
The purpose of this study is test the effect of the “best case/worse case” communication tool on 
the quality of communication with older patients admitted to two trauma units and to collect 
feedback on the tool to help adapt it to the trauma setting. The intervention was developed and 
tested with acute care surgical patients at the University of Wisconsin (UW) and the present 
study seeks to test whether the intervention will work in a different setting.  
 
To adapt the tool to trauma settings, we will conduct focus groups at UW Health Oregon Health 
Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of Texas-
Southwestern (UT-S). Because trauma care is delivered by a multidisciplinary team, we will 
include attending trauma surgeons, surgical residents, ICU nurses, nurse practitioners, consulting 
physicians (e.g. orthopedic surgeons) and others on the trauma care team. Up to 60 trauma care 
providers will participate in focus groups across the three sites. We will test the intervention with 
severely injured older adults at OHSU and UT-S/PMH. In the first year, UT-S/PMH and OHSU 
will recruit and enroll 50 patients total in the control arm and train trauma providers to use the 
best case/worst case tool. Trauma providers trained on the tool will be interviewed after training 
to explore their thoughts on how the tool works in their trauma unit. In the second year, UT-
S/PMH and OHSU will recruit and enroll 50 patients total in the intervention arm. UW will 
compare survey-reported and chart-derived measures before and after clinicians learn to use the 
best case/worst case tool.  
 
UT-S/PMH and OHSU research team members will survey family members of trauma patients 
to compare the quality of communication for severely injured geriatric trauma patients cared for 
by trauma teams. When possible, UT-S/PMH and OHSU will survey patients on their quality of 
life. UT-S/PMH and OHSU will survey the patient’s primary nurse on the quality of 
communication patients and will survey patient’s families about their thoughts on the quality of 
communication as well. UT-S/PMH and OHSU will survey trauma unit staff before and after 
clinicians learn to use the best case/worst case tool, to assess whether the communication 
intervention improves feelings of moral distress. UT-S/PMH and OHSU will use chart review to 
collect downstream clinical outcomes including intensity of treatment and receipt of palliative 
care. UT-S/PMH and OHSU will archive de-identified graphic aids used by trauma surgeons 
with intervention patients to explore how the intervention was enacted.  
 
 
 
 
 
 
 
 

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Background and Significance 
Improvements in medical care that have increased life expectancy have shifted the end-of-life 
trajectory for older adults who are now increasingly vulnerable to traumatic injury.1 Each year, 
half a million older adults will suffer injury from a fall or car crash, making it the fifth leading 
cause of death. Older adults fare far worse than younger patients with similar injuries due to 
presence of chronic comorbid conditions and reduced physiologic reserve.2-4 Traumatic injury is 
often a terminal event that leads to a 20% in-hospital and 40% one-year mortality.5 Severely 
injured older adults undergo a series of invasive surgical interventions furthering a course of 
care—including prolonged life support3 or confinement in a nursing home—that is often 
inconsistent with patients’ preferences and goals. Given the burdens of treatment and poor 
prognosis, severely injured older adults would benefit from decision support interventions to 
facilitate early access to palliative care which can reduce unwanted invasive procedures, address 
symptoms and clarify long-term goals.6,7  
Trauma surgeons are in a unique position to help older patients and their families make 
difficult treatment decisions. Surgeons meet patients in the acute setting often at off-hours, to 
consider invasive treatments with profound implications. They also have access to robust 
prognostic information, specifically the Geriatric Trauma Outcomes Score (GTOS),4 a predictive 
nomogram that is easily understood by clinicians, simple to calculate, and pragmatically based 
on variables that are readily available. Although these decisions might be better led by primary 
care physicians who know the patient, those physicians are frequently not available for inpatient 
care and lack knowledge about traumatic injury. Moreover, patients’ preferences are often not 
clearly articulated in a living will or advance directive—or may shift in the context of acute 
illness, injury or potential invasive treatment.8-13  
Pre (control)
50 patients
• 8 months
Surgeon training
Simulated 
patients
• 3 months
Post 
(intervention)
50 patients
• 8 months
Trauma provider 
training (up to 40 
trained) 
 

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Although surgeons endorse palliative strategies, especially for this population, current 
communication practices make it difficult for patients and families to associate their 
personal values with the likely consequences of complex treatment decisions. Our previous 
studies have shown that surgeons routinely name (e.g. heart attack), but do not describe 
unwanted outcomes and their associated treatments.14 Moreover, much attention is paid in the 
surgical literature to precise risk prediction;15-17 and surgeons rely on the decontextualized 
language of informed consent, which presents the overall hazards of treatment as discrete 
complications for isolated physiologic systems (e.g., a 50% chance of ventilator dependence) to 
explain these risks to patients.18 This language does not provide a narrative about how patients 
might experience surgical interventions, or even expected downstream outcomes, such as 
additional invasive treatments or predictable changes in functional status. Reliance on risk 
disclosure with informed consent makes it difficult for patients to associate their personal values 
with the likely consequences of surgery and other invasive procedures.18-20  
To make decisions consistent with their preferences, older adults and their families need 
information about possible interventions such as life support or surgery contextualized into 
a personal framework.21-23 Shared decision making, in contrast to informed consent, allows 
patients to express values and outcome preferences so physicians can, in turn, recommend 
treatments that best support these values.24  
We have developed a decision support intervention specifically for face-to-face clinical 
interactions that promotes dialogue and patient deliberation, and supports shared decision 
making in the context of life-limiting illness. Building on a conceptual model of shared decision-
making proposed by Elwyn,25,26 and the practice of scenario planning27,28 our intervention is 
designed “to engage patients in a discussion about preferences” and to “assist them with the 
emotional work of considering future prospects.”25   
Scenario planning is a strategy used to facilitate decision making 
in the setting of uncertainty. By appealing to deeply held 
concerns of decision makers, a well-constructed scenario can 
encourage people to comprehend a new, previously 
unimaginable reality and prepare for major shifts in a way 
simple forecasting cannot.27-29 The “best case/worst case” 
communication tool uses short statements and graphics to help 
patients and families visualize options, organize information and 
deliberate. It also uses narrative, rather than statements about 
risk, to describe how patients might experience a range of 
outcomes, helping them consider the value of future health 
states. It results in a handwritten diagram used by the surgeon, 
family and patient as the basis for further dialogue, so patients 
can express preferences and surgeons can recommend treatment 
corresponding to preferences.25 
How the “Best Case/Worst Case” Tool Works: The surgeon 
verbally describes the “best case,” “worst case,” and “most 
likely” outcomes for each treatment option—incorporating 
rich narrative from clinical experience and translation of 
Figure 1: Visual aid of “best case/worst 
case” with written details. 

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probabilistic information—while drawing a diagram of those options (Figure 1). Vertical bars 
represent treatment options; their length shows the range of outcomes and the magnitude of the 
difference between the “best case” (star), the “worst case” (box) and a “most likely case” 
(oval).30 The surgeon also writes details about each option on the diagram. The narrative and 
graphic help family and patients formulate and express preferences.  
 
The conceptual framework of the best case/worst case communication tool and this 
proposal is based on the theories of self-determination31 and relational autonomy32,33  that 
support shared decision making as described by Elwyn.26 The best case/worst case tool uses 
scenario planning to target the structural and interactional barriers that inhibit family members’ 
and patients’ participation in decision making.  By supporting autonomy and relatedness through 
improving family members’ and patients’ capacity to participate, this intervention supports 
shared decision making so that decisions are aligned with personal preferences and based on 
expectations that reflect the patient’s clinical reality. 
We theorize that teaching trauma surgeons to use the best case/worst case tool—in 
conjunction with the Geriatric Trauma Outcomes Score (GTOS)4—will improve 
communication between families, patients and surgeons and ultimately identify the need 
for palliative care sooner in the treatment plan. Because the GTOS4 can help identify patients 
with poor prognosis early in their post-injury course, surgeons can use the best case/worst case 
tool to translate this prognostic information during treatment decisions. When discussions about 
treatment use narrative to interpret evidence about the patient’s overall health state—including 
symptoms, events like ICU care, invasive procedures and prognosis—surgeons, patients and 
their family members can recognize that palliative care can assist with these burdens and limit 
treatments that are not aligned with the patient’s goals.  
Preliminary Studies 
The UW research team performed an NIA (GEMSSTAR) funded study 
to test the feasibility of teaching surgeons to use the best case/worst 
case communication tool with frail older patients with acute general and 
vascular surgical problems at UW. All but one eligible surgeon enrolled 
in this study and 25 of 29 surgeons completed the best case/worst case 
training. Using a consensus checklist of best case/worst case elements, 
surgeons completed a mean of 9.8 of 11 elements with enrolled study 
patients.34 Three months after training, 70% reported actively using the 
tool in clinical practice.  In this pre-post study, observed patient 
engagement as measured by the OPTION 5 score35 improved from a 
mean of 41 (IQR 26-66) before training to 74 (IQR 60-81) after 
surgeons completed the best case/worst case training.36 (Figure 2) Measures of decision quality 
(e.g. decisional conflict)37 had a high ceiling effect at baseline and did not correlate with the 
deliberative process used by patients and families.  Measures of post-treatment distress (e.g. 
impact of event scale)38 depended on patient survival which was highly variable. 
Importantly, the framework promoted dialogue about treatment options: patients and family 
expressed preferences about outcomes, thereby enabling surgeons to recommend preference-
concordant treatments. For example, one surgeon explained to his patient’s family, “This is what 
Figure 2: OPTION 5 scores from 

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I know about her …that she didn’t want a lot of these interventions…and we’re gonna do a 
maximum amount of those things if we decide to go for surgery …so my general thought is that, 
surgery where she ends up in a nursing home, with complications from surgery, is not something 
that she ever wanted.”39 In interviews 30 days after enrollment, patients and/or family members 
reported that Best Case/Worst Case facilitated dialogue about options and allowed them to 
anticipate unwanted outcomes. (Table 1) 
 
 
Study Aims   
This project has two aims:  
1. We will conduct focus groups to assess how the best case/worst case tool may be adapted 
to the trauma setting.  
2. We will test the effect of teaching trauma care providers to use the best case/worst case 
tool on the quality of communication. 
Selection of Participants 
Inclusion Criteria    
Trauma providers 
Focus groups:  There will be two rounds of focus groups. During Round 1 we will invite trauma 
surgeons, trauma fellows (including consulting physicians such as orthopedic surgeons) to 
participate.  
During Round 2: All of those invited to Round 1 will be invited as well as: specialists who work 
in trauma (orthopedics, neurology), mid-level providers, ICU nurses, social workers, chaplains, 
palliative care trained surgeons, PGY-5 senior residents and others whose primary work is 
patient care in the trauma setting.  
For both rounds, participants’ primary job must be in trauma (except for senior residents), they 
must have at least one year of experience in a trauma center setting, they must have more than 2 
years experience at the research site trauma unit (with the exception of trauma fellows).  
Best case/worst case tool training and subsequent follow up interviews: All attending surgeons, 
Table: Patient and family interviews 30 days after 

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trauma fellows and mid-level trauma providers (NP/PA) from the OHSU and UT-S/PMH sites 
will be invited to participate in “best case/worst case” communication tool training. 
Nurse survey: The nurse responsible for care of the enrolled patient at 3 days post-admission will 
be invited to complete a Quality of Communication (QOC) survey assessment.  
Moral distress survey: All trauma unit nurses and physicians will be invited to participate in this 
survey.  
Family members and patients 
Family members: Family members are the primary participants in this study and the primary 
outcome is family-reported quality of communication. We anticipate that few patients will be 
well enough or have decision making capacity (DMC) to participate. Patients will participate 
with a family member who is present and is a formally or informally designated decision maker. 
If a patient has DMC, they will be asked by a UT-S/PMH or OHSU research team member to 
designate a family member to enroll in the study as the “study partner”.  Patients cannot be 
enrolled without a family member study partner as our primary outcome is the family member’s 
perception of the quality of communication. If a patient lacks DMC, their family member or 
surrogate decision maker will be identified and approached. In this circumstance, the surrogate 
decision maker and study partner do not have to be the same person; a surrogate decision maker 
may provide consent for the patient chart review and re-contact at 30 days if they have regained 
DMC whereas another family member serving as study partner may participate in the surveys. In 
this circumstance (where the study partner is the only one to have consented), if the patient is 
alive at 30 days, the study partner will complete 3 surveys (including the Trauma Quality of Life 
survey at 30 days). If they are deceased, the study partner will complete the first two surveys 
only.  
Patients:  
We will include traumatically injured patients 50 and older admitted to the ICU. 
We will include both patients who have or lack DMC, as described in the “Consent and HIPAA 
Authorization” section. Given the nature of traumatic injury in the study patient population we 
anticipate few, if any, patients will have DMC. 
Exclusion Criteria: 
Trauma providers 
Focus groups: Potential participants must not be on call at the time of the focus group. 
Best case/worst case tool training and subsequent follow up interviews: We will exclude 
residents who have not had at least 5 years of postgraduate training. We will also exclude care 
providers who do not directly provide primary trauma care in the ICU. Trauma consultants 
including for example, neurosurgeons, orthopedic surgeons, otolaryngologists will be excluded 
from best case/worst case training. 
Nurse survey: No exclusion criteria.  

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Moral distress survey: No exclusion criteria. 
Patients and family members 
Family members: We will exclude patients whose family members do not speak English, are 
under the age of 18, lack decision making capacity (DMC) or have a severe hearing or vision 
impairment. Family members who will serve as study partners must have been present at bedside 
after admission so that they can report on the quality of care and communication with the treating 
team.  
Patients: Surgeons will have an opportunity to exclude a patient or family who, in the 
physician’s judgment, would not be an appropriate participant. Reasons for exclusion include the 
surgeon’s assessment that there is a legal or risk management concern for serious psychiatric 
illness for example schizophrenia. We will also exclude patients who have a Physician Orders 
for Life-Sustaining Medical Treatment (POLST) or Medical Orders for Life-Sustaining Medical 
Treatment (MOLST) form on file in their medical record that specifies that the patient or their 
decision maker wishes them to receive no intervention. Additionally, we will exclude patients 
with an isolated head injury as defined by a Head Abbreviated Injury Scale (AIS) score of 2 or 
less and an External AIS score of 1 or 0 and a Glasgow Coma Scale (GCS) score of 15. This 
serves to exclude the mildly traumatically brain injured patients with minimal external injuries 
who require ICU-level monitoring for a short period of time only. 
Research Design and Methods 
Research Design 
 
We will conduct two 90-minute focus groups at each of three sites with five to ten participants per 
group, for a total of up to 60 participants. Participants will be trauma providers from UW, UT-
S/PMH and OHSU. The first focus group at each site will include trauma surgeons and trauma 
fellows. The second focus group at each site will include trauma surgeons, trauma fellows, 
specialists who work in the trauma unit (such as orthopedic or neurology specialists), ICU nurses, 
social workers, chaplains, and others engaged in caring for trauma patients. 
We will conduct a pre/post interventional study at the trauma centers within OHSU and UT-
S/PMH. Research team members at UT-S/PMH and OHSU will recruit 50 patients in the control 
arm and 50 patients in the intervention arm, aiming to balance patients who receive usual care 
with those who receive intervention from each participating surgeon. As close as possible to 72 
hours of injury, study staff  at UT-S/PMH and OHSU will administer the Quality of 
Communication (QOC) questionnaire family version40 to the patient’s family member present 
(study partner) for care discussions. At 10 days post-admission, study staff will administer The 
Family Inpatient Communication Survey (FICS)41 and the Goal Concordant Care survey42.  At 
thirty days after admission, if the patient is still living and has DMC, they will be given The 
Trauma Quality of Life (T-QoL)43 survey and their enrolled family member will complete an 
adapted T-QoL. If the patient is alive but lacks DMC at 30 days after admission, their family 
member will complete an adapted T-QoL. If the patient has died by 30 days after admission, the 
Family Member will only complete the first two family member surveys. Study staff at UT-

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S/PMH and OHSU will conduct chart reviews 30 days after admission to record treatments 
received including surgery, intensive care unit days and palliative care. 
 
Using our best case/worst case training program, a trainer at the UT-S/PMH and OHSU sites will 
train all consenting attending trauma surgeons and trauma team members. As part of the training, 
participants (estimated 15 participants per site, no more than 20) will participate in an assessment 
session, demonstrating their use of the tool with a standardized patient and scripted clinical 
scenario. Standardized patients for these teaching sessions will be hired at UT-S and OHSU and 
will not be study subjects (do not need to sign consent). In the second hour of the session, 
surgeons will practice these skills and use the communication tool with two standardized patients 
in audio recorded sessions. Surgeons will then receive immediate feedback and encouragement 
from an expert observer after each interaction with the standardized patient. UW research team 
members will assess the fidelity of participant use of the tool using an 11-item checklist of 
adherence criteria and give feedback until they achieve an acceptable level of competence. 
Training participants will be asked to participate in a one-time brief interview following the 
training to explore their thoughts on how the tool has worked/could work in their trauma unit.  
 
As close as possible to 72 hours after injury, study staff at UT-S/PMH and OHSU will give the 
patient’s primary nurse the clinician version of the QOC  
 
Study staff at UT-S/PMH and OHSU will also archive a copy of the graphic aid that surgeons 
used with study-enrolled family members and patients. Study staff at UT-S/PMH and OHSU will 
give all trauma unit nurses and physicians  the Moral Distress Scale-Revised (MDS-R)44, 
physician and nurse versions at the start and end of the study. 
 
There will be two groups of patient participants at UT-S/PMH and OHSU in this study:  
 
Group A (control): Before the surgeon has been taught to use the best case/worst case tool, we 
will enroll patients and their family member. These patients will have been provided usual care.   
Group B (intervention): After the surgeon has been taught to use the best case/worst case tool, 
patients and family members will be enrolled and will follow the same data collection schedule 
as for control patients. The study team will archive a copy of the “best case/worst case” graphic 
aids created by the surgeon in the intervention arm as well.  
Training Program 
Our current training program, based on David Kolb’s cycle of experiential learning,45 includes a 
10-minute introduction46 explaining use of the tool followed by two hours of practice with 
standardized patients and expert feedback, i.e. coaching.34  During training, surgeons learn how 
to translate clinical knowledge and prognostic data into the best case/worst case format, how to 
use phrases that encourage deliberation47 and how to use the communication tool to elicit 
preferences and support value-concordant decisions.39  Two to three surgeons will participate in 
each training session. Using principles of adult learning theory, these small-group sessions will 
provide skills training, skills practice and expert feedback. In the skills training, surgeons will 
first learn how to translate clinical knowledge and statistical data into the “best case/worst case” 

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format, how to use phrases that encourage deliberation and how to use the communication tool as 
part of a decision-making conversation (first hour).  
In the second hour of the session, surgeons will practice these skills and use the communication 
tool with two standardized patients. This component of the training will be audio-recorded and 
surgeons will receive immediate feedback and encouragement from an expert observer after each 
interaction with the standardized patient. This assessment component of the training will utilize 
an 11-point Tool Completion Checklist to determine whether surgeon trainees have correctly 
used the communication tool. UW research staff will fill out this checklist for each surgeon 
though no identifiers will be recorded on it. In past work, an acceptable level of fidelity was 
achieved with more than 90% of participants within one training session. 
The audiotaped recordings of the surgeon practice with a standardized patient will be used as 
quality control for the training, to judge its effectiveness. The UW study team will review 
audiotape transcriptions of surgeons using the communication tool with standardized patients, in 
addition to archiving the best case/worst case graphic diagrams created. The audiotape, 
transcript, graphic diagrams and checklists will all be de-identified and not linked to any 
particular study surgeon; they will only be labeled with a random number (not their study ID 
number) that cannot be linked back to them.  
The training will be scheduled at a convenient time and surgeons will receive compensation 
(described in the Incentives section) for their time.  
To troubleshoot problems and reinforce essential elements of the tool, coaches may meet with 
surgeons for one-on-one debriefing after they have had an opportunity to use the tool in clinical 
practice. This optional feedback session will be informal and based on the interest and needs of 
any surgeons who request it. After training, while recruitment of individuals to the intervention 
arm is underway, training participants will be invited to participate in a brief, one-time interview 
to discuss their thoughts on the communication tool.  
 
Study Procedures 
Screening and Recruitment 
 
Trauma providers 
Focus groups:  Research team members at each of the three sites will use staff lists from their 
site to invite surgeons and trauma care providers to the study by email. Researchers will send this 
recruitment email up to three times over the course of a month. The email will encourage anyone 
who is interested in attending to call a research coordinator at the site. For ICU nurses 
specifically, their e-mail will contain a link to an electronic survey which will assess how many 
trauma patients the nurse has cared for in the past month as a means of screening out those who 
do not take care of traumatically injured patients very often. No information will be collected 
from this survey, and responses will not be kept. Those who meet a pre-determined cutoff for 
volume of trauma patients cared for (which will be unique at each center) will be given more 
information about the study and the site coordinator’s contact information for participation in the 

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focus group. The research coordinator will then ask a few brief questions to determine eligibility 
and collect demographic information. If interested individuals respond via e-mail, they will be 
contacted via telephone for confirmation and in order to complete a brief phone screen which 
will determine eligibility and collect demographic information. From willing respondents we will 
select participants to capture a broad variety of trauma care perspectives based on professional 
role, years in practice, and gender.   
Best case/worst case tool training: Researchers at UT-S/PMH and OHUS will use staff lists from 
their site trauma divisions to invite surgeons and trauma care providers to the study. After initial 
introduction of the study by email, they will contact eligible physicians (or their administrators) 
in-person or by email again if there is no response (3 total contact attempts). The recruitment 
email will include information about study components and ask if they would be interested in 
meeting in-person with study staff to discuss the study in-depth. This in-person meeting by study 
staff will include explanation of the study, inquiry of whether the surgeon would like to 
participate, and written informed consent.  
Trauma provider interviews following best case/worst case tool training: Those who have 
completed the training will be contacted by phone or emailing them inviting them to participate 
in an optional interview. 
Nurse survey:  Those included in clinic staff lists will be emailed information about the study and 
will then be approached in clinic by a member of the research team if they are the primary nurse 
caring for an enrolled study patient. For the nurse-reported QOC surveys, the primary nurse 
caring for an enrolled study patient will be approached by a UT-S/PMH or OHSU research team 
member during their work shift and asked to participate by filling out a survey that assesses the 
quality of communication the patient and family have received over the prior 72 hours.  
Moral distress survey: All nurses and physicians of the trauma units at UT-S/PMH and OHSU 
will be invited to participate in this survey. Those included in clinic staff lists will be emailed 
information about the study and will then be approached in clinic by a member of the research 
team.  
Family members and patients 
UT-S/PMH and OHSU surgeons and their team will assist authorized site study staff in pre-
screening inpatient trauma-ICU rosters daily for newly admitted patients who are eligible for 
participation. Study staff will confirm with each site’s trauma team that the patient is eligible to 
participate based on their age, ICU status, and presence of a family-member decision maker. If 
the patient has an isolated head injury, its severity will be calculated via the AIS score and the 
GCS scores and confirmed by study staff. Screening will occur through contact with service 
teams as well as through medical chart review. 
 
In order to conduct these pre-screenings, we are requesting a waiver of consent for pre-screening 
as it will be impractical to obtain consent to screen for all eligible patients. A waiver of informed 
consent for pre-screening is justified because:  
1. Pre-screening eligibility review of medical records by clinical research staff does not 
adversely affect the rights or welfare of subjects because medical record information is 

Best Case/Worst Case Trauma | Protocol (version date:  7/22/19) 
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screened to establish preliminary eligibility prior to approaching a potential subject about 
a study, 
2. Pre-screening eligibility review of medical records cannot practicably be done without 
the waiver due to the number of patients. Pre-screening decreases the burden on patients; 
those who are found ineligible via chart review will not be presented with study 
information that does not apply to them,  
3. Pre-screening eligibility review of medical records involves no more than minimal risk 
because the person accessing the information has undergone training in confidentiality of 
medical records and the records are viewed solely to pre-screen for eligibility criteria. 
Further, only minimal information collected in the pre-screening process will be recorded 
for research purposes. Names of patients (and other unique identifiers) that are deemed  
ineligible will not be recorded. 
 
Based on others’ experience,48,49 daily in-person contact with clinical staff is also critical to 
successful recruitment in a busy hospital setting. In addition to medical record review, each day, 
study staff will talk with the clinical staff on the trauma service (such as residents, nurses or 
midlevel providers) to identify patients who are appropriate for this study.  
 
Ineligible patients:  
No data on patients who are deemed ineligible will be collected or recorded.  
 
Patients who decline to participate: No data after patients decline participation will be 
collected by UT-S/PMH and OHSU research team members, except for reason for non-
participation and screening data. Screening data will include gender, race, and ages of 
individuals as well as GTOS score (and Trauma Injury Severity Score (TRISS) score for patients 
aged 50-64) and reason for non-participation. We will not record identifiable information such as 
patient name or medical record number, instead UT-S/PMH and OHSU research team members 
will assign a unique identifier (such as D001) to this information, to assist us in tracking the 
number of declines and maintaining accurate data entry.  These data will be recorded so that we 
may determine whether participants (both in the usual care and intervention group) are 
categorically different than non-participants.   
Consent and HIPAA authorization 
 
Trauma providers 
 
Focus groups: Prior to the start of the focus group, the focus group facilitator will give all 
participants the info sheet. Participants will be provided with ample time to review it and given 
the opportunity to ask questions. 
 
 
Best case/worst case tool training: After a surgeon has expressed interest in learning more about 
the study, UT-S/PMH or OHSU research staff will meet with them in a private meeting space, 
explain study procedures and obtain written informed consent. Surgeons who enroll will consent 
to participating in both the training and to having their patients screened and enrolled in the 

Best Case/Worst Case Trauma | Protocol (version date:  7/22/19) 
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study, including having family members and nurses answer survey questions regarding their 
communication. Given high participation by surgeons in our initial study and endorsement from 
the chief of trauma at both institutions we anticipate the majority of surgeons at each center will 
participate.  Interested physicians will complete written informed consent prior to participating in 
the control arm and the surgeon training session.  
Trauma provider interviews following best case/worst case tool training: A member of the 
research team will give an information sheet to trauma providers who participated in best 
case/worst case communication tool training and are interested in participating in an interview. 
This will be done in person, if the interview is to be conducted face-to-face. Or, if the interview 
will be conducted by phone/Skype, a member of the research team will send the information 
sheet to the trauma provider in advance. In either case, the research team member will answer 
any questions the clinician has before starting the interview. 
Nurse survey: 
UT-S/PMH or OHSU research staff will meet with the provider in a private space at a convenient 
time to explain the study and inquire whether the provider would like to participate. We are 
requesting a waiver of signed consent for this study activity. This is justified because the study 
activity is a brief survey for which completion of the survey would indicate the subject’s 
willingness to participate in the research.  
Moral distress survey: 
UT-S/PMH or OHSU staff members in the trauma unit will be approached by a member of the 
research team and asked to complete a paper survey. If they are interested, the researcher will 
give them an information sheet and answer any questions they have. No identifiable information 
will be collected as part of this survey and no participant identifiers are collected at any point for 
this study activity. Returned paper surveys will be labeled only with a sequential number that is 
used strictly for tallying how many surveys have been returned. We are requesting a waiver of 
signed consent for this study activity. This is justified because the study activity is minimal risk, 
comprised of a brief anonymous survey given at two time points. Completion of the surveys 
would indicate the subject’s willingness to participate in the research and a signed consent form 
would constitute the only link between the data and the participant’s identity. 
 
Family members and patients 
 
Family member study partners are the primary participants in this study and the primary outcome 
is family member-reported quality of communication. We anticipate that few patients will be 
well enough to participate or have decision making capacity (DMC). If a patient meets the 
eligibility criteria, study staff will approach the enrolled provider caring for the patient to 
confirm eligibility. A research team member will check in the patient’s chart or with their care 
team as to whether the patient is intubated. If they are intubated, the research team member will 
proceed as though they do not have DMC. For non-intubated patients, a member of the research 
team will check the patient’s chart or ask a member of the care team to determine whether 
capacity has already been assessed. If there remains a possibility a potential subject has limited 
cognitive abilities, a qualified member of the study team (MD) will determine the patient’s 
decision-making capacity and need for a representative. 

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If the patient is deemed eligible and is found to lack DMC, a member of the patient’s treating 
team will approach or contact an individual who is consenting on behalf of the subject for other 
medical procedures (formal or informally designated decision maker), and ask if they would be 
willing to speak with study staff. A member of the study team may also approach a patient or 
individual who is consenting on behalf of the patient at the OHSU site. The patient’s 
representative will consent for the patient to participate in this study. We anticipate that many 
eligible patients will lack DMC. Adult subjects are commonly sedated and/or intubated upon 
admission and may remain so for much of their initial inpatient course. These subjects are of 
diminished capacity due to alterations in consciousness resulting from injury/illness and/or to 
medications administered for the purposes of treatment.  
 
The UT-S/PMH and OHSU research teams will follow applicable IRB and state law guidance for 
assessment of incapacity and the need for a surrogate decision maker. These sources (along with 
direction from the trauma service) will also be used to determine the appropriate decision maker. 
At the time study staff approaches the subject and obtains consent, the study team will instruct 
the subject's representative that he or she should make a decision about research participation 
based on (1) what the subject would have decided if capable of consenting or (2) what is in the 
best interest of the potential subject. 
 
If the patient is found to be eligible and has DMC, a member of the patient’s treating team will 
approach the patient to ask if they and their family member would be willing to speak with study 
staff. (At OHSU a member of the study team may also approach a patient or family member to 
ask if they are willing to hear about a research study participation opportunity.) Patients will only 
be enrolled if a family member or support person is willing to enroll with them as a study 
partner. Family members cannot participate as a study partner if the patient has DMC and 
declines to participate.  The activities for patient participation include only chart review and a 
survey on quality of life if the patient regains capacity while in the hospital (as documented in 
their medical record). If the patient’s representative does not consent to participate, the patient 
will not be enrolled. 
 
If a family member or a patient with DMC and their family member are willing, a member of the 
research team will meet with them in the patient’s room or another private clinic exam room. 
Family members and patients (if they have DMC) will be approached within 24-48 hours of 
injury. The research team member will explain study procedures and obtain written informed 
consent from the patient and family member (if they have DMC) or family member only (if 
patient does not have DMC).  
 
If a patient lacks DMC their surrogate decision maker will be approached or contacted regarding 
surrogate consent. This consent process will occur either face-to-face (if the family member 
providing surrogate consent is available locally) in which case written consent will be collected 
OR may be provided via phone or web survey (if the family member providing surrogate consent 
is out of the area), in which case verbal consent or consent via clicking a survey answer will be 
collected. In cases where the family member providing surrogate consent is not available locally, 
the first contact with them will always be made via phone, at which time they will be given the 
option of a verbal consent or web-based consent process.  
 

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Table: Consent and enrollment options 
Patient has DMC 
• 
Patient wants to participate 
• 
Family member wants to 
participate as study partner 
Enroll patient and family 
member 
• 
Patient wants to participate 
• 
Family member does not want 
to participate as study partner 
Do not enroll in study 
• 
Patient does not want to 
participate 
• 
Family member wants to 
participate as study partner 
Do not enroll in study 
 
Patient does not have DMC and LAR/surrogate is bedside 
• 
LAR wants to participate as 
both surrogate and study 
partner 
Enroll LAR as surrogate and 
study partner 
• 
LAR does not want to 
participate as surrogate or 
study partner and no other 
family member agrees to be 
study partner 
Do not enroll in study 
• 
LAR does not want to 
participate as surrogate  
• 
Another family member agrees 
to be study partner 
Enroll study partner. Do not 
enroll LAR/patient (no chart 
review or P1 data collected) 
 
Patient does not have DMC and LAR/surrogate is not bedside/is out of area 
• 
LAR wants to participate as 
surrogate    
• 
Bedside family member wants 
to participate as study partner   
Enroll LAR as surrogate and 
family member as study partner 
• 
LAR does not want to 
participate as surrogate 
• 
Bedside family member wants 
to participate as study partner 
Enroll family member as study 
partner. Do not enroll 
LAR/patient (no chart review or 
P1 data collected) 
• 
LAR wants to participate as 
surrogate  
• 
Bedside family member does 
not want to participate as study 
partner 
Do not enroll LAR/patient or 
family member 

Best Case/Worst Case Trauma | Protocol (version date:  7/22/19) 
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• 
LAR does not want to 
participate as surrogate  
• 
Bedside family member does 
not want to participate as study 
partner 
Do not enroll LAR/patient or 
family member 
 
Definitions:  
Patient consent: Patient with DMC consents to chart review and P1 survey 
Study partner consent: A family member or caregiver present at bedside who consents to 
completing F1-F3 surveys. This person may or may not be the same as the surrogate LAR  
Surrogate consent: In case of patient who lacks DMC, the appropriate surrogate decision maker 
or legally authorized representative (LAR) provides consent for patient chart review and for 
researchers to contact patient for P1 if they have regained DMC   
 
Instruments 
 
Instrument 
Definition 
When 
administered 
How 
administered/obtained 
Specific Measures 
Focus group guide  
Used in each focus 
group to guide 
discussion 
During focus groups 
Facilitator will draw on 
questions from the 
guide.  
N/A 
Interview guide 
Used in interviews 
follow trauma 
provider training  
Interviews with 
trauma providers 
following their 
BC/WC training 
Interviewer will pose 
questions from the 
guide  
N/A 
F1: Family Survey 1 
First survey 
administered to 
family member 
study partner 
As close as possible 
to 72 hours after 
admission 
 
In-person (if family 
member available in 
hospital) 
Telephone 
QOC40, family version 
  
Single Item Literacy 
Screener50 
 
Family member 
demographics, 
including relationship 
with patient 
N1: Nurse survey 
Survey given to 
primary nurse for 
patient 
As close as possible 
to 72 hours after 
admission 
 
In-person  
Email/web survey  
QOC40, nurse version 
(During the 
intervention arm, this 
survey will contain 
several addition 
questions on whether 
the surgeon used best 
case/worst case. These 

Best Case/Worst Case Trauma | Protocol (version date:  7/22/19) 
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will be submitted as 
part of a Change of 
Protocol) 
F2: Family Survey 2 
Second survey 
administered to 
family study partner 
10 days post-
admission 
In-person (if family 
member available in 
hospital) 
Telephone  
FICS41 
Goal Concordant 
Care42 
F3: Family Survey 3  
Third survey 
administered to 
family study partner 
30 days post-
admission 
In-person (if family 
member available in 
hospital) 
Telephone 
T-QoL43, if patient is 
alive. If patient is 
deceased, no survey 
given  
P1: Patient Survey  
(Only given to 
patients with DMC) 
Survey given to 
patients with DMC 
30 days post-
admission 
In-person (if patient 
member available in 
hospital) 
Telephone 
T-QoL43 
U1: Unit-wide moral 
distress survey (pre) 
Start of study, prior 
to any patient 
enrollment  
Before best  
case/worst case 
training   
Anonymous paper 
survey 
MDS-R44 Physician 
and nurse versions 
U2: Unit-wide moral 
distress survey (post) 
End of study, after 
all intervention 
patients are enrolled 
After best 
case/worst case 
training 
Anonymous paper 
survey 
MDS-R Physician and 
nurse versions 
Graphic aid photo- 
documentation 
Graphic aid created 
by surgeon  
As close as possible 
to 24-72 hours after 
admission 
De-identified digital 
image 
N/A 
 
 
 

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As shown below, research team members at UT-S/PMH and OHSU will administer 2-3 surveys 
to family member study partners (number dependent upon whether the patient is alive at 30 
days). If the patient has DMC at 30 days, they will be contacted for a single survey.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
F2 survey 
at 10 days 
F1 survey  
at 72 hours 
 At 30 days, do 
they have 
DMC? 
Yes 
P1 TQoL  
F3 TQoL 
at 30 days 
No 
 F3 TQoL 
at 30 days 
At 30 days,  
is the patient 
alive? 
Yes 
No 
 No more family 
member 
surveys 

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Data Collection Administration 
 
Focus groups:  
 
A skilled focus group facilitator familiar with technical constructs relating to the topic area will 
lead the focus group discussions. Focus group discussions will last approximately 90 minutes and 
will include questions on the challenges providers face when talking with family members of older 
patients with serious traumatic injury about treatment and prognosis. The focus group moderator 
will also describe a hypothetical patient and ask focus group participants how they might discuss 
prognosis and treatment options with the patient's family. Participants will then watch a brief video 
depicting a surgeon describing treatment options to a patient using the best case/worst case 
communication technique. After viewing the video, the focus group moderator will ask attendees 
how best case/worst case could be used in their practice. Focus group guide questions are sample 
questions and in some cases the facilitator may ask follow up questions not included on the guide.  
 
We will give focus group participants a brief exit survey to complete at the conclusion of the 
focus group. The exit survey will includes demographic questions, as well as questions about the 
participant’s professional role and training. The exit survey will not include collection of any 
identifiers.  
 
Digital audiotapes of the focus groups will be transferred from UTS/PMH and OHSU to UW for 
transcription. The files will be sent via a secure, password protected UW server file-transfer 
service. Once the audio files are securely transferred to UW, the audiotapes at the collection site 
will be destroyed so that only one digital audiotape recording will exist. Along with all other 
computer files associated with this project, these audio files will be stored on a secure UW server 
which is backed up regularly.  
 
Trauma provider interviews following best case/worst case tool training:  A skilled interviewer 
familiar with technical constructs relating to the topic area and what was covered during best 
case/worst case training will conduct the interviews at both sites. Interviews will last 20-30 
minutes and will be conducted either in-person or by phone. The same procedure will be 
followed for transfer of digital recordings as was used for focus group recordings.  
 
 
F1: Family Survey 1 (for study partners) 
Research team members at UT-S/PMH and OHSU will aim to collect the F1 survey as close as 
possible to 72 hours after the patient’s admission. This survey consists of the family Quality of 
Communication40 (QOC) survey and will be administered in person or by phone. This 19-item 
survey includes questions on how well their family member or friend’s doctor talked with them 
about their care. We will also measure the health literacy of enrolled family members using the 
Single Item Literacy Screener (“How often do you need to have someone help you when you 
read instructions, pamphlets or other written material from your doctor or pharmacy?”)50 and will 
collect basic demographic information. Participants will be reminded at the start of the survey 
that they do not need to answer any questions that may make them feel uncomfortable. Research 
team members will make multiple attempts to collect this data in person, when the family 
member is available at the patient’s bedside. If the family member cannot be reached in person, 

Best Case/Worst Case Trauma | Protocol (version date:  7/22/19) 
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research team members will reach out to them by phone and may administer the survey over the 
phone.   
 
F2: Family Survey 2 (for study partners) 
Research team members at UT-S/PMH and OHSU will aim to collect the F2 survey 10 days after 
the patient’s admission. The Family Inpatient Communication Survey (FICS)41 will be 
administered as part of this survey. This instrument is designed for family members of patients to 
measure communication and care coordination. FICS includes 30 questions, 18 of which assess 
information and 12 of which assess emotional support. Two additional survey questions taken 
from the SUPPORT study42 will also be asked, to assess goal concordant care.  The family 
member surveys are independent; unless a family member withdraws their participation from the 
study, we will contact them to complete all surveys, regardless of whether they have completed 
prior ones.   
 
Research team members will make multiple attempts to collect this data in person at 10 days 
after admission if the patient is still receiving care in the trauma unit and if the family member is 
available at the patient’s bedside. If the family member cannot be reached in person or the 
patient is no longer receiving care in the hospital, research team members will reach out to them 
by phone and may complete the survey by phone.  
 
F3: Family Survey 3 (for study partners) 
Chart review conducted by research team members at UT-S/PMH and OHSU will be used to 
assess whether patients are alive and, if so, have DMC at 30 days.  
 
If the patient is alive, a member of the research team will contact the enrolled family member to 
schedule a good time to conduct this survey over the phone or in person in the hospital setting, if 
the patient is still receiving care there. This F3 survey consists of The Trauma Quality of Life (T-
QoL)43 survey, adapted for reporting by family members. This 43-item survey is designed assess 
posttraumatic quality of life. 
 
If the patient has died in between admission and 30 days post-admission, there is no third family 
survey.  
 
P1: Patient Survey  
A member of the research team will check the patient’s chart and, if needed, check with the care 
team to determine whether the patient is alive at 30 days and, if so, if they have DMC at that 
time. If patients are alive at 30 days and have DMC, they will be contacted by UT-S/PMH or 
OHSU research team members either in-person (if still receiving care in the hospital) or by 
phone (if they have been discharged), to complete the P1 survey. (If patients did not have DMC 
at the time of their family member enrollment but have regained it, as noted in their medical 
chart, they will be mailed a copy of the consent form or be consented in person if they remain 
hospitalized so that they may participate in the P1 survey.) The P1 survey consists of The 
Trauma Quality of Life (T-QoL)43 survey. This 43-item survey is designed assess posttraumatic 
quality of life.  
N1: Nurse survey 

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Research team members at UT-S/PMH and OHSU will give the N1 survey to the patient’s 
primary nurse as close as possible to 72 hours after admission. The nurse-specific Quality of 
Communication (QOC) survey40 is comprised of 18 items asking how well a provider talks with 
his or her patients about their care. Research team members at UT-S/PMH and OHSU will make 
multiple attempts to collect this data in person, 72 hours after admission, if the nurse is still on 
shift and in the clinic. If the nurse cannot be reached in person, research team members will 
reach out to them by email to complete a web version of the QOC.  
 
U1: Unit-wide moral distress survey (pre-intervention) and U2: Unit-wide moral distress 
survey (post-intervention) 
All trauma unit nurses and physicians at UT-S/PMH and OHSU will be invited to participate in 
this anonymous paper survey at two time points: at the start of the study (prior to any patient 
enrollment) and the end (after all study patients are enrolled). Research staff will approach 
trauma unit clinicians in person to invite them to complete a paper copy of this survey. The 
survey consists of the Moral Distress Scale-Revised (MDS-R) 44, physician and nurse versions. 
The survey describes brief descriptions of 21 situations which may occur in clinical practice, 
asking the frequency and level of disturbance that each situation causes. 
 
Chart review  
Chart reviews will be conducted at 10 and 30 days after admission by research team members at 
UT-S/PMH and OHSU. Team members will use the Therapeutic Intervention Scoring System to 
guide chart data abstraction in order to measure treatment intensity for the first 10 days after 
injury.51-55 We will record the number and duration of life supporting treatments received56 
within 30 days of admission using six well described data fields: intubation and mechanical 
ventilation, tracheostomy, feeding tube insertion, hemodialysis, enteral or parenteral nutrition, 
and cardiopulmonary resuscitation. We will also record measures of high quality palliative care 
including initiation and timing of palliative care consultation, documentation of care preferences 
within 48 hours of admission, timing of Do Not Resuscitate orders and discharge to Hospice.57 
We will collect the following patient-level covariates: Injury Severity Score, GTOS, TRISS for 
patients age 50-64, pre-existing comorbid illnesses, age, race and ethnicity, gender, insurance 
status, educational attainment. 
 
Best case/worst case graphic aid retention  
A coded digital image of the graphic aid that accompanies the communication intervention 
(labeled only with study ID number) will be archived by research team members at UT-S/PMH 
and OHSU. This graphic aid is created as part of the intervention and before it is given to the 
patient’s family a member of the research or clinical teams will take a picture of it for archival.  
Primary outcomes:  Primary outcome: The QOC questionnaire40 is a 19-item scale with two 
domains: general communication (8 items) and end-of-life communication (11 items). The 
instrument is available in patient-specific and family member-specific versions and has 
acceptable internal consistency and construct validity.  
 
Data analysis plan:   The intervention effect, QOC, will be tested in the framework of 
generalized linear mixed effects models58,59 comparing the pre-intervention with post-
intervention periods with a treatment dummy variable, surgeon random effect, and site dummy 
variables to control for site-specific effect. UW analysts will adjust for covariates to increase the 

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statistical precision of our treatment effect estimation. Our exploratory analyses will examine 
other patient endpoints such as intensity of treatment and palliative care received. We will use 
linear mixed effects models for continuous responses, logistic random effects models for binary 
responses and log-linear random effect models for count-dependent variables. 
Schedule of Events 
 
     Patient/family will be approached as close as possible to 24-48 hours post-admit (up to 7 days 
post-injury) and F1/N1 surveys will be conducted as close as possible to 72 hours post-admit.   
Incentives 
Trauma providers 
 
Focus groups: To compensate participants for their time during the focus groups, each participant 
will receive $200 at the completion of the focus group. 
 
Best case/worst case tool training: To encourage surgeons to participate as research subjects in 
the “Best Case/Worst Case” training session, incentives will be required as the training will take 
2 hours of their time. Using incentives with physicians as research subjects is well-documented 
in the survey-research literature. Participation is significantly more likely with increased 
remuneration.60,61 Previously, about $250 per physician has proven a successful incentive for our 
research; this is the amount given to participants in our surgeon focus groups. We will be giving 
surgeons $245 for their time so we do not have to collect social security numbers from surgeon 
participants at OHSU ($250 is a common limit for collecting social security numbers from 
research participants).  In addition, we will provide refreshments for surgeons who participate in 
the training sessions at UT-S/PMH and OHSU. Surgeons will receive incentives only for 
participating in the training as the intervention requires modest effort beyond the usual care 
surgeons provide to patients. 
Trauma provider interviews following best case/worst case tool training:  No incentive is 
provided for those participating in the interview. Nurse survey: UT-S/PMH and OHSU research 
team members will give $5 to nurses upon completion of each QOC survey.  

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Moral distress survey: No incentive is provided for those participating in the moral distress 
survey.  
Family members and patients 
Family Member Participant Incentives: OHSU research team members will give family member 
participants $15 for completing the first survey and $10 for the second survey. Family members 
who complete the third survey will receive an additional $10 for a maximum incentive of $35.   
UT-S/PMH research team members will give family member participants $24 for completing the 
first survey. Incentives given to family members at UT-SW are lower than at OHSU because 
UT-SW requires researchers to collect social security numbers and use ClinCards for incentives 
of $25 or more. To avoid burdening family members by asking for social security numbers and 
by including the off-putting Clincard language in their consent form, we have reduced their total 
incentive.  
At both sites, patients will not receive any compensation for participating in this study. If the 
family member providing surrogate consent for a patient who lacks DMC and the study partner 
are not the same person, only the study partner will receive incentives.  
Statistical Considerations 
Sample Size 
 
UT-S/PMH and OHSU research team members will sequentially recruit 50 patients in the control 
and 50 patients in the intervention arms.  Power calculation: Based on current available 
publications, the standard deviation for the QOC measurement is estimated to be around 3.5. 
Assuming the between doctor variance accounts for 10% of the total variance, we computed 
power of 84% to detect a medium-large effect of 2.00 points on the QOC scale, and 96% power 
to detect a large effect of 2.50 QOC points.  If the between doctor variance accounts for 30% of 
the total variance, the power to detect these effects are 92% and 99% respectively.  
 
Analysis 
Analysts at UW will test the intervention effect, QOC, in the framework of generalized linear 
mixed effects models58,59 comparing the pre-intervention with post-intervention periods with a 
treatment dummy variable, surgeon random effect, and site dummy variables to control for site-
specific effect. We will adjust for covariates to increase the statistical precision of our treatment 
effect estimation. Our exploratory analyses will examine other patient endpoints such as intensity 
of treatment and palliative care received. We will use linear mixed effects models for continuous 
responses, logistic random effects models for binary responses and log-linear random effect 
models for count-dependent variables.  
We will audio record and transcribe each focus group and interview transcript. Using qualitative 
content analysis,62 three coders with distinct clinical backgrounds will analyze each transcript 
independently and then convene to adjudicate each coded phrase or idea using the technique of 
constant comparison to develop a taxonomy of consensus codes. A group process of code 

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adjudication will initiate higher level analysis, identifying themes and trends in the data and 
consolidating feedback for tool adaptation.  Using the technique of member checking, tool 
modifications will be presented to trauma team leaders for additional comments and refinement.  
NVivo software, QSR International-Melbourne, will be used to catalogue the data. De-identified 
data from the focus groups may be shared with the Qualitative Research Group (QRG) at UW. 
QRG is an ICTR resource and a UW-Madison initiative. All QRG members are UW-Madison 
faculty or staff and only de-identified data may be shared.  
 
Risks and Discomforts to Research Subjects 
All activities of the study meet the Office of Human Research Protections (OHRP) definition of 
a minimal risk study.  There are known potential risks for participants but the likelihood and 
seriousness of these risks is considered to be low and ample protections are in place to minimize 
the likelihood of their occurrence. 
Trauma providers:  
The main risk for trauma providers who participate in the training is loss of time. Providers who 
participate in “best case/worst case” communication tool training may find that use of the tool 
results in their consultations with patients and family members taking more time than their usual 
care practice did. There is a risk that providers may be stressed by participating in a training 
program and learning to use the communication tool. Providers might be stressed by knowing 
that family members and nurses will be completing surveys regarding the providers quality of 
communication. There is also a potential for psychological stress from the presence of an audio 
recorder during the standardized patient practices. 
For focus group and post-training interview participants, there is the possibility that participants 
may feel anxious knowing that the discussion/interview is being audio-recorded. To address this, 
the information sheet will include clear instruction that participants do not have to answer any 
questions they do not wish to. The focus group moderator/interviewer will remind participants of 
this at the start of the session. 
For nurses who complete the QOC survey, there is a risk that reporting on the quality of care 
communication provided by a trauma provider in their unit may prove stressful.  
For those who complete a moral distress survey, there is a risk that these providers may find 
some of the questions distressing or be reluctant to answer.  
Patients and Family members:   
There is a risk of loss of privacy for patients whose chart is reviewed while in the study. There is 
a risk of family members developing confusion or anxiety about questions related to the patient’s 
care while completing follow up surveys with study staff. There is also a risk of patients or 
family members developing confusion or anxiety during the discussion about treatment decisions 
for both groups, due to the way the surgeon may describe treatment options. There is a risk of 
confusion about options for both the control and intervention groups as we do not know if one 
approach to talking to patients may cause more confusion than the other. However, our previous 

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studies show that patients and families have been remarkably supportive of the communication 
intervention, noting that it improved clarity about options and decision making, promoted better 
understanding of expectations, and helped them prepare for adverse events.63 Answering 
questions about the physician’s communication skills may make family members feel 
uncomfortable. 
Protections against all of the above risks are described below.  
Adequacy of Protection against Risks  
Overall Protection Against Risks 
All investigators, researchers, statisticians and collaborators with access to identifiable study data 
will have completed human subjects training prior to the start of the study. Dr. Schwarze will be 
alert for any potential harm to subjects, including breaches of confidentiality. Research 
coordinators at each site will report any breach of confidentiality to the site IRB and UW lead 
site upon its discovery. The risk of breach of confidentiality is low because only information 
related to the research questions will be collected. However, adequate provisions are in place to 
ensure that breach of confidentiality will not occur including: all hardcopy research files 
(including consent forms, surveys, audiotape transcripts) will be kept in a secure, locked office, 
all computer files will be kept on a secure, password protected computer, only the minimum 
amount of information that is necessary to achieve the aims of the research will be collected, 
excess copies of paper documents will be promptly shredded, and health information collected 
will not be associated with any identifying information. Only a unique participant study number 
will be associated with the data.  
Data will be managed and protected rigorously at each study site. All hardcopy research files 
(including consents and surveys) will be kept in secure, locked offices and all computer research 
files will be kept on secure, password protected computers. Excess copies of paper documents 
will be shredded. Only indirectly identifiable information will be collected on study surveys and 
chart abstraction data collection forms. To protect participant data, electronic study data will be 
kept in two separate databases at each site. One spreadsheet will have a master code that includes 
the subject’s name and an associated number which will serve as the participant identifier (ID) 
for study purposes. This participant ID will be kept on a password protected computer on a 
secure server at each institution (in a place separate from the data collection database).  Only 
approved study personnel will have access to the identifiers. The data collection database (UW 
REDCap server) will have the subject’s ID number only, without any identifying information. 
After data analysis is complete the master list that links the subject’s name and study ID number 
will be destroyed and the data will then be stored in a de-identified state on a secure server for a 
minimum of 7 years post publication. After data analysis is complete and manuscripts have been 
accepted for publication all hard copies of research files will be destroyed. Only the minimum 
amount of information that is necessary to achieve the aims of the research will be collected.  
 
Site investigators will be alert for any potential harm to subjects, including breaches of 
confidentiality. Any breach of confidentiality will be reported to the site IRB and UW lead site 
upon its discovery. The risk of breach of confidentiality is low because only information related 

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to the research question will be collected and adequate provisions are in place to ensure that 
breach of confidentiality will not occur.  
 
For the recorded training session with standardized patients and focus groups, study staff 
members or outside contractors with a business associate agreement who have been approved by 
UW Legal Services/Privacy Officer for HIPPA compliance will perform complete transcription 
of the audio tape recordings from all sites. Sites will send audio recordings (from the focus 
groups and post-training interviews) to UW for central transcription. The audio recordings and 
transcripts will be shared through a secure server that only contractors and study team members 
have access to. Though it is unlikely any identifying information would exist on audio files of 
the standardized patient sessions, transcriptionists will remove any identifiers.  
Plans for addressing specific risks to subject groups are noted below:  
 
Trauma providers 
 
Best case/worst case tool training: Trauma providers participating in training and intervention 
activities at UT-S/PMH and OHSU will be given the opportunity to stop study participation at 
any time, during both the usual care and intervention arms. This will be noted on the consent 
form for this research activity. They may also choose to exclude specific patients to approach for 
study participation.  In addition, the training session will include skills that address length of 
time required to use the tool with patients.  Trainers are available for optional, informal feedback 
sessions following the training, should an enrolled surgeon wish to check in regarding use of the 
tool.  
 
Focus groups and post-training interviews: To address any anxiety felt by being recorded, the 
focus group and interview consent forms will include clear instruction that participants do not 
have to answer any questions they do not wish to. Participants will be reminded of this by the 
focus group moderator/interviewer at the start of the session. To address concerns about 
confidentiality, all participants will be informed that adequate provisions are in place to ensure 
that breach of confidentiality will not occur. We do not believe the study will place participants 
at risk of damage to their reputation or employment status. The purpose of the focus groups is to 
discuss with members of the trauma unit how they currently discuss treatment options and 
prognosis and how they might use the best case/worst case tool to accomplish this.  
 
Nurse survey: Nurses who participate in QOC surveys will be reminded that they do not have to 
answer survey questions they prefer not to and this will be noted on their consent form as well. 
Moral distress survey: Survey instructions will remind participants that they may skip any 
questions they do not wish to answer and that the survey is anonymous.   
Patients and family members 
UT-S/PMH and OHSU Research Coordinators will instruct trauma providers to check in with 
patients and family members from both the control and intervention groups after their treatment 
discussion to ensure that they are not confused about treatment options. During follow up 
surveys family members will be instructed that they do not need to answer any questions that 

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make them feel uncomfortable. Research staff will also remind family member participants that 
their participation is voluntary and they may drop from the study at any time. In cases where 
patients have DMC and have consented to participate in the study, they will be reminded that 
they may withdraw from the study at any time. Research staff at UT-S/PMH and OHSU will be 
trained on adverse event reporting and will encourage patient and family member participants to 
contact the trauma care team if they have any medical questions.  
Potential Benefits to Human Subjects and Others 
 
Trauma providers: It is possible that trauma providers who participate in the communication 
tool training will learn new communication skills which may subsequently improve provider 
satisfaction and communication with patients. Surgeons will also have an opportunity to discuss 
the challenges of helping patients make these difficult decisions with their colleagues and study 
staff during the surgeon training which may make them feel supported psychologically and 
professionally.     
 
Patients and family members: Patients and family members in the control arm are not expected 
to directly benefit from participation in this study but they may indirectly benefit knowing that 
knowledge gained from this study may benefit future patients. Patients and family members in 
the intervention arm could benefit by receiving better communication and care that better aligns 
with their values, benefiting their treatment experience.  
Importance of the Knowledge to be Gained 
Use of the “best case/worst case” communication tool could result in improved communication 
in the context of trauma care delivery, potentially leading to care that is better aligned with the 
values and goals of patients. This patient-centered approach may improve trauma care decision 
making and quality of life for the nearly 500,000 geriatric patients who are admitted to the 
hospital with a traumatic injury annually. The risks in this study are minimal and reasonable in 
relation to the importance of knowledge that will be generated. Study staff will remain alert to 
any changes in the risk/benefit ratio.  
 
Records to be Kept 
To better protect patient information, electronic study data will be kept in two separate databases. 
One spreadsheet will have a master code that includes the subject’s name and medical record 
number and an associated random number which will serve as the participant ID number. This 
participant ID master list will be kept on a secure departmental server at UT-S/PMH and OHSU 
and will never be transferred to UW. Only approved study personnel will have access to this 
document and investigators who will not be interacting with study participants and/or are only 
involved with analysis will only have access to the coded and eventually de-identified study data. 
Coded study survey and chart review data will be stored in a database on the UW ICTR REDCap 
server. The data collection database (UW ICTR REDCap) will bear the subject’s ID number 
only, without the subjects’ (patient, family member, provider) identifying information. No 

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identifiers will be entered into the REDCap database and only the unique participant study 
number will be associated with the data.   
No tissue or other physical specimens will be collected for this study. The following data 
security measures will be taken: all research files (including consents, surveys and transcripts) 
will be kept in secure, locked offices, all computer files will be kept on a secure, password 
protected computer, and excess copies of paper documents will be shredded.  
 
 
Only approved study personnel at UT-S/PMH and OHSU will have access to the identifiers 
(personnel approved for identification and recruitment and interaction with subjects will need 
access to update the master code/spreadsheet). Investigators who will not be interacting with 
study subjects and/or who are only helping with analysis will only have access to the coded study 
data.  
 
After data analysis of the questionnaires is complete and manuscripts have been accepted for 
publication all hard copies of research files (including the audiotapes) will be destroyed. Other 
research materials and data are maintained in on the secure Department of Surgery server for a 
minimum of 7 years post publication. 
Data and Safety Monitoring Plan 
This is a minimal risk study. The lead PI (Dr. Schwarze) will be alert for any potential harm to 
subjects, including breaches of confidentiality. All research team members will be involved in 
safety monitoring. Although not expected, research staff will be prepared to address any negative 
reactions to the conversation with the surgeon or to survey questions. All negative reactions will 
be reviewed to determine whether a change in protocol is necessary.   
 
We will follow an internal Data and Safety Monitoring Plan (DSMP) for this minimal risk study. 
A Data Safety Monitoring Committee (DSMC) will be established with membership made up of 
our study staff. All research team members will be involved in safety monitoring. Although not 
expected, research staff will be prepared to address any negative reactions to the conversation 
with the surgeon or to interview and survey questions. All negative reactions will be reviewed to 
determine whether a change in protocol is necessary.   
 
Prior to enrollment of the first subject, the DSMC will meet to finalize DSMP. We anticipate 
DSMC meetings four times; at enrollment, 3 months, 6 months, 12 months, and 18 months. 
Reports to the DSMC will include data quality, timeliness and participant recruitment, accrual, 
retention, and confidentiality of the research subjects. Notes will be taken to document the 
meetings.  These summaries will be available for inspection when requested by any of the 
regulatory bodies charged with the safety of human subjects and the integrity of data including, 
but not limited to, the UW-Madison Health Sciences IRB.  The PI will report any policy 
violations to the IRB immediately. The PI will also report any adverse events in compliance with 
the IRB policy for reporting. In addition to the DSMP, the PI will review the research study and 
the accrued data on a monthly basis in project meetings so as to ensure the validity and integrity 

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of the data and to evaluate whether changes to the anticipated benefit-to-risk ratio of study 
participation have occurred. 
 
Research team members will also be involved in safety monitoring throughout the study. 
Although not expected, research staff will be prepared to address any negative reactions to study 
procedures such as survey questions. All negative reactions will be reviewed to determine 
whether a change in protocol is necessary.  Site investigators will report any policy violations to 
their respective IRB immediately. Site investigators will also report any adverse events in 
compliance with the IRB policy for reporting. In addition to DMC review, the lead site PI will 
review the research study and the accrued data on a monthly basis in project meetings so as to 
ensure the validity and integrity of the data and to evaluate whether changes to the anticipated 
benefit-to-risk ratio of study participation have occurred. 
 
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