A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
Phase: NA
Conditions: End Stage Liver Disease
Sponsor: Massachusetts General Hospital

A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for 
Patients with End-Stage Liver Disease 
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PARTNERS HUMAN RESEARCH COMMITTEE 
DETAILED PROTOCOL 
 
PRICIPAL/OVERALL INVESTIGATOR 
 
Raymond Chung, M.D.  
 
PROTOCOL TITLE 
 
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for 
Patients with End-Stage Liver Disease (Clinicaltrials.gov Identifier NCT03557086) 
FUNDING 
 
NIH-NIDDK National Institute of Diabetes and Digestive and Kidney Diseases 
4K24DK078772-10 
 
VERSION DATE 
 
Version 9: February 6, 2020 
 
 
 

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SPECIFIC AIMS  
 
The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an 
advanced care planning (ACP) video decision support tool for improving patients’ knowledge 
regarding their goals of care options and end of life (EOL) decision-making in patients with end-
stage liver disease (ESLD). 
 
Aim 1: To assess the feasibility and acceptability of an ACP video decision support tool for 
patients with ESLD 
• Hypothesis 1: The intervention will be deemed feasible and acceptable if at least 60% of 
eligible patients are enrolled in the study and if at least 60% of patients randomly assigned 
to the video intervention report that the video is acceptable  
 
Aim 2: To assess the impact of an ACP video decision support tool on patients’ knowledge about 
their EOL care options 
• Hypothesis 2: Patients randomly assigned to the video intervention will report improved 
knowledge of their EOL care options compared to those randomized to the verbal narrative 
control   
 
Aim 3: To assess the impact of an ACP video decision support tool on patients’ preferences for 
EOL care 
• Hypothesis 3: Patients randomly assigned to the ACP video will be more likely to prefer 
comfort care compared to those randomized to the verbal narrative control arm   
 
 
• Hypothesis 4: Patients randomly assigned to the video intervention will be more likely to 
forgo cardiopulmonary resuscitation (CPR) and intubation compared to those randomized 
to the verbal narrative control arm   
 
Aim 4: To assess the impact of an ACP video decision support tool on patients’ documented EOL 
care preferences  
• Hypothesis 5: Patients randomly assigned to the video intervention will be more likely to 
have their code status documented in the electronic healthcare record compared to those 
randomized to the verbal narrative control arm 
 
BACKGROUND AND SIGNIFICANCE   
 
End-stage liver disease (ESLD) is a terminal condition for which liver transplantation is the only 
cure. Heralded by the development of debilitating symptoms such as ascites, variceal bleeding, 
hepatic encephalopathy, or jaundice in patients with cirrhosis, ESLD is a state of limited life 
expectancy, with a median transplant-free survival of two years. Unfortunately, the diagnosis of 
ESLD is a terminal one for thousands of patients annually who are deemed ineligible for liver 
transplantation due to significant comorbid disease, substance use disorder, inadequate social 
support, or advanced age. However, despite their poor prognosis, patients with ESLD who are non-
transplant candidates still receive aggressive medical care at the end of life (EOL). While most 
patients prefer to die at home, these patients are frequently hospitalized during the last month of 

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life and have high rates of in-hospital mortality.1-5 Furthermore, these patients often receive 
aggressive 
life-sustaining 
therapies 
during 
their 
terminal 
hospitalizations, 
such 
as 
cardiopulmonary resuscitation (CPR) and intubation.6,7 The Institute of Medicine report, Dying in 
America, highlighted substantial deficiencies in EOL care for patients with serious illness and 
identified intensive and costly care at the EOL as poor-quality care given its burden on patients, 
families, and the health care system.8 Thus, there is a critical need to optimize the quality of EOL 
care for patients with ESLD who are not transplant candidates given their terminal diagnosis, poor 
prognosis, and the frequency with which they receive intensive and costly medical care at EOL.  
 
Advance care planning (ACP) is the process by which patients discuss their goals and preferences 
for medical care at the EOL with their clinicians.9-11  Patients who engage in advance care planning 
are better informed about their EOL care options, which improves their EOL decision-making.12-
18 Decisions about CPR and intubation are an integral part of advance care planning, and studies 
have shown that patients with life-limiting illnesses who discuss their EOL care preferences with 
their clinicians are less likely to opt for aggressive medical interventions.18-23 Unfortunately, one 
retrospective analysis showed that only a minority (28%) of patients with ESLD ineligible for liver 
transplantation had documented advanced directives.7 Another series revealed that the majority of 
hospitalized patients with cirrhosis were designated full code on admission24, despite multiple 
studies showing dismal outcomes after cardiac arrest for this population, with rates of survival 
ranging from 0% to 16%.25-29 Thus, interventions are needed to educate transplant-ineligible 
patients with ESLD of their care options at EOL in order enhance the frequency and quality of 
advance care planning for this vulnerable patient population.  
 
Patients must receive accurate and understandable information about their medical options to make 
informed decisions about the care they would prefer to receive at the EOL.9,10 However, verbal 
communication strategies do not effectively inform patients of their EOL care options as they are 
often too complex for patients to comprehend.9-11,30-34 Patients frequently find it difficult to 
realistically envision care in the intensive care unit (ICU) or medical procedures such as CPR and 
intubation, especially given the variability in the quality of communication between patients and 
their clinicians.9-11,30-37 Videos can enhance patients’ comprehension of complex health 
information by providing realistic visual images that can facilitate education about medical 
procedures, such as CPR and intubation.38,39 A video decision support tool offers an innovative 
strategy to educate transplant-ineligible patients with ESLD about CPR and intubation in order to 
empower them to make informed decisions regarding their EOL care.  
 
RESEARCH DESIGN AND METHODS 
 
Study Design and Schema:  
 
Our proposed project is a single-center randomized controlled trial to assess the feasibility, 
acceptability and preliminary efficacy of an ACP video decision support tool versus a verbal 
narrative alone on EOL care preferences in transplant ineligible patients with ESLD in the 
outpatient setting. We will recruit up to 70 consecutive patients with ESLD who receive 
ambulatory care at the MGH Liver Center for this study. Patients will be randomized in a 1:1 
fashion (Figure 1). To ensure that patients in this sample received longitudinal care (ruling out 

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those being seen for second-opinion consultation), we will only include those patients who have 
had two or more visits to the MGH Liver Center. 
 
Eligibility Criteria 
 
Our proposed project is a single-center randomized controlled trial to assess the feasibility, 
acceptability and preliminary efficacy of an ACP video decision support tool versus a verbal 
narrative alone on EOL care preferences in transplant ineligible patients with ESLD. We will 
recruit up to 70 consecutive adult patients with ESLD who receive care at MGH for this study. 
Patients will be randomized in a 1:1 fashion (see Schema for further details).  
 
Eligibility Criteria 
 
All patients with ESLD who are ≥ 18 years of age seen at the Massachusetts General Hospital will 
be screened for study participation. Our study population is defined as patients with cirrhosis 
complicated by at least one of the following clinically-evident decompensating events: 1) ascites; 
2) hepatic encephalopathy; or 3) history of gastroesophageal variceal hemorrhage - which portends 
a poor prognosis.40 Only patients who are deemed ineligible for liver transplantation by either their 
primary hepatologist or the inpatient hepatology consult service attending will be eligible for this 
study as this is a patient population for whom the diagnosis of ESLD is a terminal one. 
 
Patients Inclusion Criteria:   
1. ≥ 18 years of age with an established diagnosis of ESLD  
2. Patient must have either 1) primary hepatologist at the MGH Liver Center or an MGH-
affiliated primary care physician, or 2) a previous inpatient admission at MGH 
3. Deemed ineligible for liver transplantation as determined by the primary hepatologist or 
the inpatient hepatology consult service attending  
4. Ability to communicate in English and provide informed consent  
5. A score ≥ 7 on the Short Portable Mental Status Questionnaire41 (Appendix A) 
 
Patients Exclusion Criteria:  
1. Severe hepatic encephalopathy which the primary hepatologist or the inpatient hepatology 
consult service attending believes prohibits informed consent or participation in the study  
2. Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major 
depression) or other co-morbid disease (dementia, cognitive impairment), which the 
primary hepatologist believes prohibits informed consent or participation in the study 
3. Prior history of liver transplantation  
4. Patient has been referred to or enrolled in hospice care  
5. Patient has been referred to palliative care 
 
We have limited enrollment to patients able to comprehend English, as the video is only available 
in English at this time. If the intervention is effective in improving advance care planning and the 
delivery of EOL care for patients with ESLD, we will develop videos in additional languages for 
future trials.  
 

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Figure 1 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Screening, Recruitment, and Enrollment Procedures  
 
The research assistant (RA) will recruit patients with ESLD from the inpatient units at MGH or 
outpatient clinics at the MGH Liver Center. The RA will be trained by the principal investigator 
(PI, a gastroenterologist) to screen patients based on the eligibility criteria. The RA will be 
responsible for reviewing the inpatient hepatology consultation list, general medicine floors, and 
the outpatient MGH Liver Unit clinic schedule on a daily basis to ensure that we capture all 
potentially eligible patients for study participation. The PI will always be available on a daily basis 
to answer any screening questions regarding patients’ eligibility. We have utilized these 
procedures in prior trials of patients with ESLD to identify all potentially eligible subjects.42,43  
 
Once a potentially eligible patient is identified, the RA will send an email to the primary 
hepatologist in the outpatient setting, or the medicine attending and responding clinician in the 
inpatient setting (as well as the hepatology consult service if available) to notify them that their 
patient is eligible for study participation and inquire about any concerns regarding their 
particpiation. If the clinicians have objections to their patients’ participation in the study, we will 
document the reason and not approach those individuals. If the clinicians do not have objections 
to their patients’ participation in the study, we will ask the attendings to introduce the study to the 
eligible patient to obtain permission for the study staff to approach the patient. After obtaining 
permission from the primary hepatologist, inpatient hepatology consult attending and/or medicine 
attending, the RA will review the consent form with potential participants which will detail the 
nature of the study procedures. When obtaining informed consent, the RA will describe the goal 
Screening 
• Patients with ESLD who have received care at 
MGH and are transplant ineligible 
Enrollment  
Obtain informed consent, complete baseline data 
collection, and perform randomization 
Verbal (Control) Group 
• Patient listens to a verbal narrative describing 3 
levels of goals of care (life-prolonging care, limited 
medical care, and comfort care) and CPR/intubation 
immediately after randomization  
Video (Intervention) Group 
• Patient views an advance care planning video 
depicting 3 levels of goals of care (life-prolonging 
care, limited medical care, and comfort care) and 
CPR/intubation immediately after randomization 
Outcomes assessment 
• Feasibility 
• Acceptability 
• Goals of care preferences 
• Knowledge assessment  
• Clinician documentation of patients’ EOL care preferences in the medical record 

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of the study: to better understand how much patients with ESLD know about ACP and EOL care 
preferences. The RA will also explain that the study requires completing a 15-minute baseline 
questionnaire asking participants about their CPR and intubation preferences, eliciting prior 
advance care planning discussions, and assessing their knowledge regarding CPR and intubation. 
The RA will undergo standardized training in all aspects of the research protocol, including the 
use of structured scripts to administer the questionnaires (Appendix A). For patients agreeing to 
participate in the study, the RA will obtain written informed consent from the participants and 
provide them with a copy of the signed consent form. 
 
After obtaining informed consent, the RA will administer the Short Portal Mental Status 
Questionnaire (Appendix B) to participants to confirm final eligibility. Immediately following 
enrollment, the RA will administer a 15-minute baseline questionnaire (see “Study Measures” 
below) that will include the following: demographics, self-reported health status, baseline EOL 
care preferences, CPR and intubation preferences, and a questionnaire assessing patients’ 
knowledge of EOL care options.  
 
Randomization 
 
After enrollment and completion of the baseline questionnaires, participants will be randomized 
in 1:1 fashion without any stratification to either the control group (verbal narrative alone) or the 
intervention group (video decision support tool) using a random computed generated list, with 
assignments concealed in numbered envelops.  
 
The Intervention Arm 
 
Our group, the VIDEO Consortium (Video Images of Disease for Ethical Outcomes), has 
developed several video decision support tools to assist patients with advance care planning.38,39,44 
We have previously developed a five-minute advance care planning video for patients with 
advanced cancer45, which has been adapted for this study.  
 
We convened a panel of clinicians with expertise in hepatology, critical care, palliative care, 
medical ethics, and decision-making at our institution to develop a verbal narrative introducing the 
patient to advance care planning, a 3-part goals of care framework (life-prolonging care, limited 
medical care, and comfort care), and a description of medical procedures such as CPR and 
intubation that will outline the process, risks, and likelihood of successful resuscitation in patients 
with ESLD. This panel drafted and edit this narrative in an iterative process, which serves as the 
verbal script for our video decision support tool and the verbal narrative for our control group 
(Appendix C). These experts also offered feedback about the representation of medical 
interventions, such as what care in the ICU is like and what CPR and intubation look like.  
 
We designed the video to provide non-medical trained individuals a general understanding of the 
types of medical care patients may receive at the EOL and a description of medical interventions 
such as hospitalizations, ICU admission, CPR, and intubation. The video begins by addressing the 
importance of the patient’s personal goals and perspectives by asking the viewer to reflect on their 
concerns about getting sick and their overall goals for their EOL care. The physician narrator then 

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introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 
2) limited medical care; and 3) comfort care. The visual images illustrating life-prolonging care 
include interventions that are available in a modern-day hospital such as CPR, mechanical 
ventilation, and treatment in the ICU. Scenes include an ICU with a ventilated patient being tended 
to by respiratory therapists, a simulated code conducted with clinicians illustrating chest 
compressions, CPR and intubation, and the administration of medications through a central venous 
catheter. For the second option, limited medical care, the narrator explains the goal of care is to 
pursue treatment for medical conditions, but avoid intensive medical interventions at the EOL. 
This type of care would include hospital care, intravenous medications, and antibiotics, but not 
CPR or ICU care. Visual images include a patient getting medicine via a peripheral venous 
catheter, scenes from a typical medical ward, and a patient wearing a nasal cannula to receive 
oxygen and breathing treatments. For the third option, comfort care, the narrator describes the goal 
of care as relieving symptoms and utilizing medical care that would only be used to provide 
comfort. Visual images include a patient on hospice care at home receiving pain medications, a 
patient with a respiratory face mask receiving oxygen at home, and an attendant assisting a patient 
with self-care. All three sequences of video images accompanying the narration attempt to help 
the viewer imagine the experience and likely outcomes of receiving these medical interventions at 
the EOL. The video was filmed and edited by the research team without the use of prompts or 
stage directions to convey a candid realism in the style known as cinema verité. All patients 
included in the video (or their proxies) gave consent to be filmed.  
 
Immediately after completing the baseline assessment and randomization, patients assigned to the 
video intervention arm will view the 3-minute advance care planning video for patients with ESLD 
on an iPAD in the presence of the RA. We will use standardized procedures to minimize the 
interaction between the RA and patient while the patient is viewing the video. The RA will not be 
permitted to comment or answer questions while the patient views the video. Patients will be 
instructed to watch the video once without any interruption and will have no further exposure to 
the video. If patients have questions about the video or their EOL care options, the RA will instruct 
them to discuss their questions with their medical team. 
 
The finalized video can be viewed by the IRB at the following link:  
https://vimeo.com/269740750 
Access Code: mghirb 
 
The Control Arm 
 
Immediately after completing the baseline assessment and randomization, patients assigned to the 
verbal narrative control arm will listen to the same description of the 3 goals of care used in the 
video arm read out loud by the RA (Appendix C). We will use standardized procedures to 
minimize interaction between the RA and patients during the interview. Specifically, the RA will 
not be permitted to comment or answer questions while the patients listen to the verbal narrative. 
Patients will be instructed to ask their physicians any questions they may have about goals of care.  
 
Study Measures 
 

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We will administer the following study measures at baseline prior to randomization, and 
immediately after the video or verbal narrative in the intervention and control group, respectively 
according to the timeline displayed in Table 1:  
• 
Demographics: Patients will complete a demographic questionnaire at baseline detailing 
their age, sex, race/ethnicity, religion, relationship status, educational level, living 
situation, employment status, and self-reported health status (“Relatively healthy”, 
“Relatively healthy and terminally ill”, “Seriously ill and not terminally ill”, “Seriously 
ill and terminally ill”)46 (Appendix D) 
• EOL Care Preferences: Patients will report their EOL care preferences as follows: life-
prolonging care, limited medical care, comfort care, or unsure. (Appendix E) 
• CPR Preferences: Patients will report their CPR preferences as follows: “Yes, attempt 
CPR”, “No, do not attempt CPR”, or “Not sure.” (Appendix E) 
• Intubation Preferences: Patients will report their intubation preferences as follows: “Yes, 
attempt intubation”, “No, do not attempt intubation”, or “Not sure.” (Appendix E) 
• Knowledge Questionnaire: We will assess patients’ knowledge of goals of care as in 
previous studies using 5 true/false questions and 1 multiple choice question, each worth 1 
point, for a summary score of 0 to 6 (higher score reflects greater knowledge)45,47,48 
(Appendix F) 
• Acceptability of the Video: For the video intervention arm alone, we will administer 3-
items assessing patients’ comfort with watching the video, whether they find the video 
helpful in their understanding of the EOL care options, and whether they would 
recommend it to others.49 (Appendix G) 
 
We will also obtain the following important covariates and outcomes:  
• Disease-related variables: We will collect variables from the EHR at the time of 
enrollment, including the etiology of ESLD, presence of clinically-evident 
decompensating events (ascites, esophageal variceal bleed, hepatic encephalopathy, or 
multiple), Model of End-Stage Liver Disease Sodium (MELD-Na) score, reason for 
transplant ineligibility, and clinical comorbidities using the modified Charlson 
Comorbidity Index.50   
• Code Status Documentation in the EMR: The RA will review the EHR to collect whether 
clinicians’ documented patients’ code status in the EMR (yes: documented, no: not 
documented) 3 months after study enrollment.  
 
Table 1: Data Collection Timeline 
 
Baseline 
Post-
intervention 
3 months post-
enrollment 
Demographics 
X 
 
 
Self-Reported Health Status 
X 
 
 
EOL Care Preferences 
X 
X 
 
CPR Preferences 
X 
X 
 
Intubation Preferences 
X 
X 
 

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Knowledge Questionnaire 
X 
X 
 
Comfort/Satisfaction with Video  
(Intervention group only) 
 
X 
 
Disease-related variables 
X 
 
 
Code status documentation  
 
 
X 
 
We will collect and enter all patient data electronically using Research Electronic Data Capture 
(REDCap). The REDCap Survey is a tool for building and managing online surveys. Vanderbilt 
University, in collaboration with a consortium of institutional partners, has developed this software 
and workflow methodology for electronic collection and management of research and clinical trial 
data. Our research team has extensive experience using REDCap and will create and design the 
surveys in a web browser, with institutional information technology support. The REDCap Survey 
system offers secure, HIPAA compliant, web-based applications that provide an intuitive interface 
for participants to enter data, with real-time validation rules at the time of entry. 
 
Participants will use tablet computers to complete questionnaires in clinic. If any participants 
refuse or are unable to complete the questionnaires on the computer, they will be permitted to use 
hard-copy paper versions. In addition, the patient data collected from the electronic health record 
will be abstracted throughout the study and directly inputted into REDCap. 
 
Study Outcomes 
• Primary Outcome: The primary outcome is feasibility. The proposed video intervention 
will be deemed feasible if at least 60% of eligible patients are enrolled in the study. The 
60% feasibility cut-off is commonly used in behavioral intervention studies.51-53 
• Secondary Outcomes: The secondary outcomes will include patients’ comfort/satisfaction 
with the video, patients’ stated post-intervention EOL care preferences categorized as four 
options: Life-prolonging care, limited medical care, comfort care, or unsure; individual 
preferences for CPR and intubation before and after intervention in the verbal narrative and 
video groups; and change in knowledge scores after receiving the verbal narrative or video 
 
Sample Size Calculation 
 
We will randomize up to 70  patients with ESLD for this project. The primary endpoint of the 
study is feasibility. We chose the sample size of 70 patients based on the feasibility of completing 
the project during the proposed timeframe and the ability to assess the preliminary efficacy of the 
intervention. Consistent with the behavioral intervention literature, at least 20 patients are needed 
in each group in a pilot study to estimate a parameter.54,55 Therefore, the proposed sample size will 
provide us with preliminary data that can be utilized to determine the effect size and adequately 
power future randomized trials. This is a commonly utilized study design for pilot testing of 
behavioral interventions and is consistent with the National Institute of Health Stage Model for 
Intervention Development. While the feasibility of the intervention can be assessed using a single-
arm design, preliminary efficacy is better assessed utilizing a control group as we are proposing in 
this trial.  

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Analysis Plan  
 
We will report baseline demographic and clinical characteristics of all study participants using 
means and proportions to describe continuous and categorical variables, respectively. Because 
this is a pilot study, we will use conservative (alpha = 0.05) and liberal (alpha = 0.20) critical 
values to assess statistical significance between the two arms in this pilot study.   
 
Aim 1: The primary endpoint of the proposed study is feasibility. The proposed video intervention 
will be deemed feasible if at least 60% (95% CI +/- 13.6%) of eligible patients are enrolled in the 
study and complete at least 60% of the intervention sessions. The proposed video intervention will 
be deemed acceptable if at least 75% of patients randomized to the intervention arm report 
satisfaction and comfort with the video.  
 
Aim 2: Changes in knowledge scores from before and after the intervention will be compared 
between the two groups using two-sample t-tests. 
 
Aim 3: Post-intervention EOL care preferences (life-prolonging care, limited medical care, and 
comfort care), CPR preferences, and intubation preferences will be compared between the two 
groups using Fisher’s exact tests. The change in CPR and intubation preferences before and after 
the intervention within each group will be compared using McNemar tests.  
 
Aim 4: Code status documentation will be compared between the two groups using Fisher’s exact 
tests.  
Project Timeline 
Table 1: Study Timeline and Study Procedures 
Months 0-2 
❖ Finalize protocol development and submit to Institutional Review Board 
for approval 
Months 3-24 
Months 3-15 
Months 16-24 
Data Collection 
❖ Enroll up to 70 patients to participate in the prospective study 
❖ Collect follow-up data on ACP documentation and prepare 
manuscript(s) for publication 
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APPENDIX A: Script for Administering the Educational Methods 
 
Introduction 
 
Research staff member: My name is (state name) and I am a working on a project about what 
people prefer when receiving medical care at the end of life. The goal of this project is to 
understand what people think and what they like better when getting medical care for advanced 
liver disease. You are being asked to take part in this study because you have advanced liver 
disease. Taking part in the project is strictly up to you. You can decide to not answer any of the 
questions if you wish, and can stop the interview at any time. You may also see an educational 
video during this survey, and you can stop the video at any time. Taking part in this project will 
have no bearing on your current care. This interview will last about a half hour. Does this sound 
like a project you would like to participate in? 
 
If YES: Research staff member will obtain written consent and administer the Short Portable 
Mental Status Questionnaire 
If NO: Research staff member thank the patient and end the interview  
 
Screening: Short Portable Mental Status Questionnaire (Appendix B) 
 
Research staff member: First, I will ask you some general questions.  
 
Administer Appendix B 
If score is ≤ 6: Research staff member thank the patient and end the interview 
If score is 7 or higher: Research staff member will continue to baseline questionnaires  
 
Baseline Questionnaires (Appendices D, E, and F) 
 
Here are some questionnaires to fill out on your own, which will help us to learn more about how 
people with advanced liver disease feel and what they like better when getting medical treatment. 
Please ask the interviewer if you need help at any time 
 
 
Study Randomization - If randomized to VIDEO 
 
Research staff member: I will now play an educational video tool about the different medical 
care options for patients with advanced liver disease. I will not be able to answer any questions 
about the content of the video. However, you should feel free to bring up any questions that you 
have about choices for medical care for patients with advanced liver disease to your care team. 
Do you have any questions about the study procedures before we begin? 
 
If YES: Research staff member will address questions 
If NO: Research staff member will play the educational video tool 
 

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Research staff member: You just watched an educational video tool about the different medical 
care options for patients with advanced liver disease. As a reminder, I will not be able to answer 
questions about the content of the video but again, you should feel free to bring up any questions 
that you have about choices for medical care for patients with advanced liver disease to your care 
team. You will now answer questions about choices for medical care for patients with advanced 
liver disease like those you answered before watching the video, as well as a few which 
specifically ask about the video itself. 
 
Research staff member will administer post-assessment 
 
Study Randomization - If randomized to NARRATIVE 
 
Research staff member: I will now read to you a verbal narrative about the different medical care 
options for patients with advanced liver disease. I will not be able to answer any questions about 
the content of the narrative. However, you should feel free to bring up any questions that you 
have about choices for medical care for patients with advanced liver disease to your care team. 
Do you have any questions about the study procedures before we begin? 
 
If YES: Research staff member will address questions 
If NO: Research staff member will read the verbal narrative (Appendix C) 
 
Research staff member: You just listened to a verbal narrative about the different medical care 
options for patients with advanced liver disease. As a reminder, I will not be able to answer 
questions about the content of the narrative but again, you should feel free to bring up any 
questions that you have about choices for medical care for patients with advanced liver disease to 
your care team. You will now answer questions about choices for medical care for patients with 
advanced liver disease like those you answered before listening to the narrative. 
 
Research staff member will administer post-assessment 
 
 

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APPENDIX B: Short Portable Mental Status Questionnaire  
 
 
Question 
Response 
Incorrect Responses 
1. What are the date, month, and year? 
 
 
 
2. What is the day of the week? 
 
 
 
3. What is the name of this place? 
 
 
 
4. What is your phone number? 
 
 
 
5. How old are you? 
 
 
 
6. When were you born? 
 
 
 
7. Who is the current president? 
 
 
 
8. Who was the president before him? 
 
 
 
9. What was your mother’s maiden 
name? 
 
 
 
10. Can you count backward from 20 
by 3’s?  
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX C: Verbal Narrative Transcript 
I'd like to talk about choices for medical care when patients are very sick and in the hospital. I will 
explain 3 basic types of medical care. This is a way for you to start thinking now about the type of 
care you would want should you get very sick or not able to speak up for yourself. The reason that 
this is important is that people have very different ideas about what they want. 
There are three basic types of medical care for people who are very sick. These are life prolonging 
care, limited medical care, and comfort care. Here is more to know: 
Life prolonging care.  
The first option is life prolonging care. 
The goal of this type of care is to “prolong life,” meaning that doctors will do everything they can 
to keep you alive. This can include trying cardiopulmonary resuscitation (or CPR) to restart your 
heart after it stopped beating. To do this, the doctor presses hard on your chest and uses a device 
to give your heart an electric shock.  
If you want the doctor to try CPR, you must also agree to be on a ventilator (or breathing machine) 
if needed. When getting a ventilator, the doctor puts a tube down your throat. One end of the tube 
goes into your lungs and the other connects to a machine that pushes air into them. You cannot eat 
or talk while on a ventilator. You likely will also need such strong medicines that you must stay in 
the hospital’s Intensive Care Unit (or ICU).  
With life prolonging care, you agree to CPR and a ventilator in hopes for a longer life. But for 
most patients with advanced liver disease, CPR does not work. CPR also will not cure your liver 
disease or get you back to the level of health you had before your heart stopped. 
Limited medical care.  
The second option is limited medical care. 
This is when people agree to just certain kinds of medical care. For instance, with limited medical 
care you might get medicine for treatable problems like fluid in the abdomen or infections around 
the stomach area. You might be admitted into the hospital and get fluids or medications through 
an IV tube that goes into your vein. But with limited medical care, you do not want doctors to try 
CPR or put you on a breathing machine--even if that means that without those treatments, you 
might die.  
Comfort care.  
The third option is comfort care. 

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The goal of this type of care is to increase comfort and reduce symptoms, but not to prolong life. 
People who choose this type of care might be at home, or in a hospice or nursing home. With 
comfort care the healthcare team can treat symptoms like breathing problems, nausea, and pain. 
But comfort care does not include CPR and breathing machines. It also does not include going to 
the hospital, unless the doctor thinks you will be more comfortable there. The goal of this type of 
care is to increase comfort and relieve pain.  
I hope this helped you learn more about choices of medical care when people are very sick. Think 
about what matters to you. Discuss this with your family. Make sure to also talk with your doctor 
who may suggest a certain type of medical care for you. Once you decide what you want, tell your 
doctor and family. It is okay to later change your mind so long as you discuss that with your doctor 
and family. They can help protect your rights and wishes about medical care.   
 
 
 

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APPENDIX D: Demographics and Self-Reported Health Status  
 
Please check the appropriate box or boxes. 
 
1. 
Gender 
 Man  
 Woman 
 Other 
 
2. 
Ethnicity 
 Hispanic or Latino 
 Not Hispanic or Latino 
 
3. 
Race (please check all that apply) 
 American Indian or Alaskan native 
 Asian 
 African American or Black 
 Native Hawaiian or other Pacific Islander 
 White 
 Other (please specify) _____________ 
 
4. 
Religion 
 Catholic Christian 
 Other Christian (such as Protestant, Orthodox, etc.) 
 Jewish 
 Muslim 
 Atheist 
 None 
 Other (please specify)_______________ 
 
5. 
Current relationship status 
 Married or living with someone as if married 
 Non-cohabiting relationship 
 Single, never married 
 Divorced/Separated 
 Loss of long term partner/ Widowed 
 
6. 
Please indicate your highest or current education level 
 11th grade or less 
 High school graduate or GED 
 2 years of college/AA degree/Technical    school training 
 College graduate (BA or BS) 
 Masters degree 
 Doctorate/Medical degree/Law degree 
 

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7. 
What is your annual combined household income? 
 Less than $25,000 
 $25,000 – 50,000 
 $50,000 -100,000 
 $100,000 – 150,000 
 Greater than $150,000 
 
8. 
Please indicate who you live with (you may check more than one box) 
 By myself 
 Partner/Spouse 
 Roommate/Friend 
 Children under 18 
 Children over 18 
 Group home/assisted living/nursing home 
 Parent 
 Other (please specify) _____________ 
 
9. 
Current employment status 
(please check all that apply):  
 Employed (full-time or part-time) 
 Caring for home or family (not currently working and not looking for paid work) 
 Unemployed and looking for work 
 Unable to work due to illness or disability 
 Retired 
 Student 
 Other (please specify) _____________ 
 
10. How would you describe your current medical status? 
 Relatively healthy 
 Relatively healthy and terminally ill 
 Seriously ill and not terminally ill 
 Seriously ill and terminally ill 
 
 
Please enter your email address  
(will only be used if necessary):  
 
_________________________________ 
 
What is the best phone number to use if we needed to reach you?  
 
________________________________ 
 
 
 
 

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APPENDIX E: End of Life Care, Cardiopulmonary Resuscitation, and Intubation 
Preferences  
 
 
1. Imagine that your liver disease became very advanced and that you became very ill and in 
need of medical treatment, which general approach would you want provided?  
 Life-prolonging care 
 Limited medical care  
 Comfort care  
 Unsure  
 
2. If your liver disease were very advanced and you were to get so sick that your heart stopped 
beating, would you want doctors to do chest compressions and CPR to try to make your heart 
start again?  
 Yes, attempt CPR 
 No, do not attempt CPR  
 Not sure  
 
3. If your liver disease were very advanced and you were to get so sick that you could not 
breathe on your own, would you want doctors to place you on a breathing machine to help 
you breathe? 
 Yes, attempt intubation  
 No, do not attempt intubation  
 Not sure  
 
 
 
 
 
 
 
 

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Appendix F: Knowledge Assessment Questionnaire  
 
1. True or False: Cardiopulmonary resuscitation or CPR is a medical procedure 
that is done on patients whose heart stops beating in an attempt to restart 
their heart. (True) 
 
2. True or False: Most patients with advanced liver disease that get CPR in the hospital survive 
and get to leave the hospital. (False) 
 
3. True or False: Most patients with advanced liver disease who survive CPR and being placed 
on a breathing machine have very few complications from these procedures. (False) 
 
4. True or False: Comfort care is a type of medical care that can only be provided 
for patients with advanced liver disease living in hospice. (False) 
 
5. True or False: Once you tell your doctor what kind of medical care you want if 
your liver disease becomes very advanced, you cannot change your wishes in 
the future. (False) 
 
6. Multiple Choice: How many patients with advanced liver disease that get CPR in the hospital 
survive and get to leave the hospital? 
a. almost all (more than 90%) 
b. about half (about 50%) 
c. very few (less than 10%) (correct answer is c) 
 
 
 
 

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Appendix G: Impression and acceptability of the video (intervention arm only) 
 
1)  Was the video helpful in improving your understanding about your choices for medical 
care? 
__ 0  Very helpful 
__ 1  Somewhat helpful 
__ 2  A little helpful 
__ 3  Not helpful  
 
2)  Did you feel comfortable seeing the video in order to help you answer the questions 
regarding medical care? 
__ 0  Very comfortable 
__ 1  Somewhat comfortable 
__ 2  Not comfortable 
__ 3  Don’t know 
 
3)  Would you recommend the video to other patients with advanced liver disease who are 
facing a similar decision?   
__ 0  I would definitely recommend it. 
__ 1  I would probably recommend it. 
__ 2  I would probably not recommend it. 
__ 3  I would definitely not recommend it.