Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
Phase: NA
Conditions: Other Cancer
Sponsor: Dana-Farber Cancer Institute

PROTOCOL TITLE: Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly 
  
 
 
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PROTOCOL TITLE: 
 
Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly 
  
PRINCIPAL INVESTIGATORS: 
James A. Tulsky 
Angelo E. Volandes 
 
NCT#: 03609177 
 
08/05/2019 

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Table of Contents 
1.0 
Objectives* .............................................................................................................. 3 
2.0 
Background* ............................................................................................................ 5 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 7 
4.0 
Study-Wide Number of Subjects* ........................................................................... 8 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 8 
6.0 
Multi-Site Research* ............................................................................................. 10 
7.0 
Study Timelines* ................................................................................................... 12 
8.0 
Study Endpoints* ................................................................................................... 13 
9.0 
Procedures Involved*............................................................................................. 13 
10.0 Data and Specimen Banking* ................................................................................ 17 
11.0 Data Management* and Confidentiality ................................................................ 17 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 21 
13.0 Withdrawal of Subjects* ........................................................................................ 22 
14.0 Risks to Subjects* .................................................................................................. 22 
15.0 Potential Benefits to Subjects* .............................................................................. 23 
16.0 Vulnerable Populations* ........................................................................................ 23 
17.0 Community-Based Participatory Research* .......................................................... 23 
18.0 Sharing of Results with Subjects* ......................................................................... 23 
19.0 Setting .................................................................................................................... 24 
20.0 Resources Available............................................................................................... 25 
21.0 Prior Approvals ...................................................................................................... 26 
22.0 Recruitment Methods ............................................................................................. 26 
23.0 Local Number of Subjects ..................................................................................... 26 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 26 
25.0 Compensation for Research-Related Injury ........................................................... 27 
26.0 Economic Burden to Subjects ................................................................................ 27 
27.0 Consent Process ..................................................................................................... 27 
28.0 Subject Registration Procedures………………………………………………….32 
29.0 Process to Document Consent in Writing .............................................................. 29 
30.0 Drugs or Devices.................................................................................................... 29 
 
REFERENCES 
 
APPENDIX A: Implementation Plan 
APPENDIX B: Data Safety Monitoring Plan 
 

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1.0 
Objectives 
 
The overall objective of this application is to reduce the burden of cancer and its 
consequences for an aging U.S. cancer population. To accomplish this, we propose to 
plan and conduct a pragmatic stepped wedge cluster randomized trial (SW-CRT) of a 
Comprehensive ACP (Advance Care Planning) Program among older oncology patients. 
The Comprehensive ACP Program combines two widely disseminated interventions to 
assess their impact when used concurrently. One is VitalTalk clinician communication 
skills training (www.vitaltalk.org) during which the oncology clinicians will practice 
discussing goals of care with simulated patient actors under the guidance of a trained 
VitalTalk facilitator. The second is the ACP Decisions video decision aids 
(www.acpdecisions.org) which are directed to patients and provide education about ACP. 
The hope is that one intervention activates patients and increases their knowledge and 
interest in ACP, whereas the other intervention ensures that the clinician who hears these 
questions has the skills and a cognitive roadmap to manage this conversation in a more 
expert fashion. The training is five hours, most of which is spent in communication skills 
work, and the remainder learning how to introduce the videos into one’s practice. No 
patients participate in the training. At the conclusion of each of these trainings, each 
clinician will be asked to complete a training evaluation. The results of these evaluations 
will be used to: 
• Measure participant reaction 
• Measure learning and knowledge acquired 
• Measure training effectiveness 
 
This evaluation is comprised of survey questions, it will be anonymous, and poses 
minimal risk. Therefore, we have requested that consent be waived for clinicians. 
 
Following each training, the newly trained oncology clinic will gain access to the ACP 
Decisions decision aids which can be introduced to patients at the discretion of their 
oncology team. Twelve organ-based oncology clinics (e.g., breast oncology, thoracic 
oncology) from each site will be randomly assigned to an intervention time period – two 
at a time, twice a year. For example, in Year 1, breast and thoracic oncology will receive 
the intervention in September and GI and Neuro-oncology will receive the intervention in 
March. The randomization schedule for all 36 clinics (twelve from each site) will be 
determined at the beginning of the study and will be created by the study statistician, Dr. 
Yuchiao Chang at MGH. As a SW-CRT, each clinic will serve as its own control, with 
the six-month period prior to the intervention serving as the control phase and the six 
month period after as the intervention phase. 
 
We will recruit patients from organ-based oncology clinics served by three major health 
care systems: Duke Health (North Carolina), the Mayo Clinic (Minnesota), and 
Northwell Health (New York). We hypothesize that a Comprehensive ACP Program of 
clinician serious illness communication skills training combined with video ACP 
interventions for patients will improve and sustain rates of ACP. We will test our 
hypothesis and achieve our objective through the following:  

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Specific Aims: 
 
Aim 1: To establish the organization, processes, and infrastructure necessary to 
develop all aspects of a pragmatic SW-CRT of the intervention for 4,500 patients 65 and 
older with advanced cancer in three health care systems, and to pilot test the intervention 
study protocol in one oncology clinic in each system. This pilot will include 
administering the VitalTalk and ACP Decisions training to all oncology clinicians, 
identifying 10 patients that meet study eligibility criteria and conducting the in-person 
surveys and video declarations, and extracting the outcome measure data from that health 
system’s electronic health record for all eligible patients in the clinic. The pilot clinics are 
Head and Neck Oncology at the Mayo Clinic, Sarcoma Clinic at Duke Cancer Institute, 
and GI Oncology at Northwell Health. Feasibility will be assessed as the ability to 
successfully complete all aspects of the study protocol, meaning training clinicians at 
each pilot clinic, documenting usage of videos by clinic patients based on clinic staff 
report and usage of video access codes, and extracting EHR outcome data by the NLP 
program and research assistant on 10 patients from each clinic. Advanced cancer is 
defined as metastatic disease for solid tumors and recurrent or refractory disease for 
hematological malignancies. If the research team determines that aspects of the protocol 
need modification to meet the study aims, then such changes will be incorporated into the 
protocol. However, the interventions themselves (VitalTalk and ACP Decisions) are “off 
the shelf” products that will not, themselves, be changed. (For a detailed description of 
the intervention see Appendix A.) 
 
Aim 2: To test the combined effects of a Comprehensive ACP Program on rates of 
ascertainable quality measures of end-of-life care. We will conduct a SW-CRT across 12 
oncology practices in each of the three systems and evaluate the effectiveness of the 
intervention by comparing the following outcomes among 4,500 patients 65 and older 
with advanced cancer: Advance care plans completion; Medical orders for resuscitation 
preferences in the electronic health record; Palliative care consultations; and Hospice use. 
Hypothesis: A higher proportion of patients in the intervention phase (vs. control) will: 
complete advance care plans (primary trial outcome), have documented electronic 
health record orders for resuscitation preferences, be seen in palliative care 
consultation, and enroll in hospice. 
 
Aim 3: To characterize detailed patient-centered outcomes, including confidence in 
future care, communication and decisional satisfaction, and decisional regret in a 
subgroup of 450 patients  65 and older with advanced cancer, as well as analyses of video 
declarations from 240 of these patients about their wishes. Hypothesis: Patients in the 
intervention phase (vs. control) will have improved outcomes.  
 
IMPACT: Clinician communication training along with video decision support is a 
practical, evidence-based, and innovative approach to uniformly provide robust ACP. 
This work has the potential to improve the quality of care provided to millions of older 
Americans with cancer. Helping oncologists better serve the most frail and vulnerable 

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older patients by delivering more patient-centered, goal-concordant care could 
dramatically improve the care of older patients with cancer in health systems. 
 
 
2.0  
Background 
 
SIGNIFICANCE 
  
Epidemiology: Cancer is a common, morbid, and costly condition, especially in patients 
over the age of 65. Persons over 65 account for 60% of newly diagnosed malignancies 
and 70% of all cancer deaths. (24) Of the approximately 600,000 adult cancer deaths in 
2016 in the United States, 420,000 were patients older than 65. (25) The net Medicare 
costs of delivering cancer care for older patients are estimated at $21.1 billion per 
year.(26) The surge in caring for older patients with cancer poses a significant challenge 
to clinicians and health care institutions. 
  
Advance care planning (ACP) in older patients with cancer needs improvement: ACP 
seeks to ensure that patients receive medical care consistent with their values, goals and 
preferences during serious and chronic illness.(10, 11) ACP is the most consistent factor 
associated with better palliative care outcomes in patients with advanced cancer.(16, 17) 
The lack of ACP is associated with greater use of aggressive interventions, more terminal 
hospitalizations, lower hospice use, higher health care costs, and worse family 
bereavement outcomes.(7, 27-31) Unfortunately, ACP completion in older patients with 
cancer remains inadequate.(32) Despite passage of the Patient Self-Determination Act in 
1991, ACP documentation amongst patients with serious illness has remained 
consistently low.(33) Furthermore, marked racial and regional disparities persist in ACP 
documentation for seriously ill patients.(34-39) For the ACP process to lead to optimal 
decisions, patients require accurate and comprehensible information about their options, 
and a care setting where communication needs are addressed early in their illness.(12, 13, 
27, 40) However, studies show that traditional written and verbal ACP does not 
effectively inform many patients, and often occurs late in the disease process.(41-46) 
Patient understanding may be clouded due to pain, medication, or their psychological 
reactions.(30, 44, 47) Patients’ heightened emotional state in response to hearing bad 
news interferes with cognitive processing and this reaction may be exacerbated when 
clinicians insufficiently attend to affect.(41, 48-51) Other common barriers to ACP 
include variable quality of clinician communication, complex relationships between 
patients, family, and clinicians regarding decision making, and the inability for patients 
and caregivers to realistically envision future health states.(30, 44, 45, 52-62) Multiple 
barriers, particularly related to the quality of clinician communication and the ability of 
patients and families to fully understand possible future scenarios, raise serious concerns 
regarding the effectiveness of ACP. 
  
Lack of effective ACP leads to burdensome, costly, and often avoidable interventions: 
Medical technology enables an extraordinary array of possible interventions for older 
people living with cancer. However, particularly in the setting of advanced disease, the 
burdens of treatment may outweigh its beneficial effects. Expected clinical complications 

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at the terminal stages of advanced cancer include respiratory failure, inability to eat, and 
serious infections. (63) Patients' individual values and goals determine whether to initiate 
mechanical ventilation, insert a feeding tube, or attempt cardio-pulmonary resuscitation 
(CPR). Without the presence of an ACP discussion, the default approach is to perform all 
invasive interventions. Research suggests that these “rescue” interventions are 
inappropriately used even when not desired.(1, 38, 64) Despite the mounting evidence 
suggesting that patients with serious illness prefer palliation in the advanced stages of 
cancer, they often receive burdensome interventions and sub-optimal control of pain and 
other distressing symptoms, particularly in the absence of high-quality ACP.(1-4) The 
converse is true for patients who have had documented decisions about their end-of-life 
care.(16-18, 34, 65-67) ACP is necessary to avoid unwanted and potentially unnecessary 
interventions at the end of life; high-quality ACP increases patient safety by ensuring that 
patients receive effective medical care that meets their goals at the end of life. 
  
Clinician communication training and video decision support improves ACP: The 
traditional approach to ACP, which primarily relies on ad hoc verbal descriptions of 
hypothetical clinical situations and treatment choices, is limited because complex 
scenarios are difficult to envision, provider information is inconsistent, and verbal 
explanations are hampered by literacy, emotional and language barriers.(42, 68, 69) 
Patients often do not fully understand the choices presented in advance directive legal 
documents, and the quality of communication about these choices is suboptimal.(70) 
Over the past few years, investigators have recognized the shortcomings of prior efforts 
and have developed new interventions to better facilitate ACP.(10) The Comprehensive 
ACP Program proposed for this study focuses on training patients and clinicians on 
communication. For patients, video decision aids to better educate and inform decision 
making are commonly used, and the ACP Decisions video based tools are the best 
example of these. These videos attempt to overcome literacy barriers and to present 
potential scenarios with a sense of reality lacking in verbal descriptions. ACP Decisions 
has also introduced the ability of patients to record themselves on video stating what is 
most important to them when they have a serious illness and their choices for medical 
care. For clinicians, the VitalTalk program is the most widely disseminated teaching 
method that focuses on patient-centered communication skills training. Prior work, 
including several RCTs, supports the efficacy of the ACP Decisions videos and the 
VitalTalk program in patients with advanced cancer. (19, 20, 22, 23, 71-83) This 
application represents the first Comprehensive ACP Program combining two well-tested, 
evidence-based, and complementary interventions, that treat patients and clinicians as 
equal stakeholders by providing both with the communication skills and tools needed to 
optimally engage with ACP.  
  
A pragmatic, stepped wedge, cluster randomized trial (SW-CRT) is well-suited to 
evaluate a Comprehensive ACP Program intervention in older patients with cancer: SW-
CRTs are increasingly used in health services research, and there are several notable 
advantages of this design for testing communication interventions in patients with 
cancer.(84) With the oncology clinic as the unit of randomization, the contamination that 
can occur when randomizing individuals within clinics is avoided. The stepped wedge 

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design is also practical and considered the design of choice when it's logistically 
impractical to simultaneously roll out the intervention to half the clusters (as in a parallel 
cluster RCT). In addition, the interventions being tested will be implemented at the clinic 
level and individual consent procedures may be unnecessary for low risk studies. To date, 
most randomized trials conducted with older patients with serious illness involved few 
facilities and evaluated the effects of interventions under ideal circumstances (i.e., 
explanatory trials).(85-88) Pragmatic trials, which intend to determine the effects of 
interventions under usual conditions, are a next critical step in research involving older 
patients with cancer.(89, 90)   
 
Summary of significance: The significance of this study rests on five premises: 1. Cancer 
is a common, morbid, and costly condition for patients over 65; 2. Older patients with 
advanced cancer often receive aggressive and costly interventions that may be of little 
clinical benefit and inconsistent with their goals; 3. An opportunity exists to promote 
preference-based, higher quality, and more informed ACP with patients with cancer 
through a Comprehensive ACP Program earlier in their disease trajectory; 4. An 
intervention comprised of clinician communication training and a suite of ACP video 
tools presents a promising, scalable, and efficacious approach that can be implemented on 
a system-wide level in a flexible manner; and, 5. Oncology clinics offer an ideal setting 
for a pragmatic trial. Taken together, this work has the potential to improve the quality of 
care provided to millions of older Americans with cancer and enable future pragmatic 
trials in this increasingly important patient population. 
 
3.0 
Inclusion and Exclusion Criteria 
 
Physician, Staff Eligibility: Any staff member identified by the site-PI (Drs. 
Zafar, Pollak, Tilburt, Loprinzi, Martins-Welch, and Carney) who is affiliated 
with the clinic. 
Clinic Eligibility: Three health care systems are participating in the study, each 
contributing 13 oncology clinics (1 for UG3 year; 12 for UH3 years): Duke 
Health, Mayo Clinic, and Northwell. Clinic eligibility criteria include:  
• 
More than one oncologist 
• 
Serve a patient population that is at least 30% aged 65 or older 
• 
Disease-based oncology clinic 
Subject Eligibility (for the in-person surveys): Any patient affiliated with one of the 
study clinics who speaks English and is aged 65 or older with advanced cancer is eligible 
for participation. Advanced cancer is defined as metastatic disease for solid tumors and 
recurrent or refractory disease for hematological malignancies. There are no exclusions 
based on gender, race, or ethnicity. 
Patients will be identified as having advanced cancer by identification from clinical ICD 
codes. Use of ICD codes has been studied extensively at Dana-Farber Cancer Institute 
(DFCI), and it captures enough patients with advanced cancer with high specificity for 

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outcome assessment without systematic bias towards intervention or control periods. 
During the UG3 year, our site-PIs will identify patients aged 65 or older with advanced 
cancer using the EHR and ICD codes and assess their outcomes using the EHR dataset. 
They will then de-identify (10 patients at each site; 10 patients * 3 sites = 30 patients’ 
EHR records) actual medical record information about these individuals to validate their 
diagnoses and outcomes. For disease types where the ICD identification has not been 
validated or tested, such as liquid tumor clinics, we will identify alternative means for 
selecting advanced cancer patients, such as age and disease related variables in the EMR. 
• We will not be including adults unable to consent 
• We will not be including individuals who are not yet adults (infants, 
children, teenagers) 
• We will not be including pregnant women 
• We will not be including prisoners 
4.0 
Study-Wide Number of Subjects 
 
Over the four years of the UH3 phase of the trial, we will study data from 4,500 patients 
with advanced cancer aged 65 or older for our primary (completed advance care plans) 
and secondary (resuscitation preferences, palliative care consultations, hospice use) 
outcomes. These data will be obtained from the EHR. In addition, we will also recruit 
450 eligible patients (150 patients from each of our three sites broken down into 75 
patients during the control phase and 75 patients during the intervention phase) to 
conduct an in-person survey for our secondary patient-centered outcomes (confidence, 
satisfaction with physician communication, patient decisional satisfaction and regret). 
From among this sub-group we will engage 240 participants (80 from each of our three 
sites broken down into 40 patients during the control phase and 40 patients during the 
intervention phase) in an activity to film video declarations of their preferences. 
 
5.0 
Study-Wide Recruitment Methods 
 
Recruitment of patients for in-person survey:  
 
 
Methods:  
The recruitment methods will only apply to those patients that we will individually 
survey, 450 patients over the course of 3.5 years. Patients with advanced cancer (N=450) 
will have an in-person survey over the course of 42 months of recruitment as indicated 
above (each step = 6 months). Surveys will be evenly distributed among the three health 
care systems (i.e., 150 patients from each system), and will include an even number of 
surveys of patients randomly chosen to clinics in the control phase (i.e., 75 patients 
surveyed in control phase) and in the intervention phase (i.e., 75 patients surveyed in 
intervention phase). For each clinic, control patients will be randomly chosen and 
surveyed during the 6 months prior to the intervention, and intervention patients will be 
randomly chosen and surveyed during the 6 months after the intervention.  
 

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Patients will not be surveyed more than once. Each clinic will have their control surveys 
conducted six-months prior to the intervention, and their intervention surveys in the step 
thereafter. Research staff will exclude any participant that was surveyed during the 
control period to ensure that the participant is not surveyed during the intervention 
period. 
 
From among this group of 450 participants, we aim to conduct the video declaration of 
preferences activity with 240 patients. The 240 patients will be evenly recruited among 
our three health care systems (80 patients per system). Half of patients will be recruited 
during the control period (N=40) and half of patients (N=40) will be recruited during the 
intervention period as indicated below. 
 
 
 
Video Declarations 
Total by Step 
6 Months 
Prior 
Step 1 
Step 2 
Step 3 
Step 4 
Step 5 
Step 6 
Duke Health - Target 
7 
12 
14 
14 
12 
14 
7 
Duke Health - Actual 
  
  
  
  
  
  
  
Mayo Clinic - Target 
7 
14 
12 
14 
14 
12 
7 
Mayo Clinic - Actual 
  
  
  
  
  
  
  
Northwell Health - 
Target 
6 
14 
14 
12 
14 
14 
6 
Northwell Health - 
Actual 
  
  
  
  
  
  
  
Target Total by Step 
20 
40 
40 
40 
40 
40 
20 
Actual by Step 
0 
0 
0 
0 
0 
0 
0 
Target - Cumulative 
20 
60 
100 
140 
180 
220 
240 
Actual - Cumulative 
0 
0 
0 
0 
0 
0 
0 
 
In-person Surveys 
Total by Step 
6 Months 
Prior 
Step 1 
Step 2 
Step 3 
Step 4 
Step 5 
Step 6 
Duke Health - Target 
12 
25 
25 
25 
25 
25 
13 
Duke Health - Actual 
  
  
  
  
  
  
  
Mayo Clinic - Target 
12 
25 
25 
25 
25 
25 
13 
Mayo Clinic - Actual 
  
  
  
  
  
  
  
Northwell Health - Target 
12 
25 
25 
25 
25 
25 
13 
Northwell Health - Actual 
  
  
  
  
  
  
  
Target Total by Step 
36 
75 
75 
75 
75 
75 
39 
Actual by Step 
0 
0 
0 
0 
0 
0 
0 
Target - Cumulative 
36 
111 
186 
261 
336 
411 
450 
Actual - Cumulative 
0 
0 
0 
0 
0 
0 
0 

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During the control and intervention phases of the trial respectively, an RA will use the 
EHR to identify potential participants with advanced cancer being seen in the clinic. The 
RA will review a list of scheduled patients two weeks prior to their clinic visit. Only 
returning patients (i.e., not new consults) who speak English and are known to the 
clinicians will be considered. Using the EHR and the International Classification of 
Diseases and Related Health Problems (ICD-10) code system, the RA will initially 
identify potential participants aged 65 or older with advanced cancer. The RA will use a 
broad selection of ICD-10 codes for advanced cancer, to be as inclusive as possible in the 
screening process. The RA will then review the EHR to verify that the patient meets 
eligibility criteria. To conduct this screening procedure, a waiver of individual 
authorization for disclosure of personal health information (HIPAA) will be obtained 
from each site. For those patients meeting all the criteria for advanced cancer, the RA 
will randomize the order of scheduled patients and then start at the top of this list and go 
down until fulfilling the enrollment target. The RA will then contact the patient's primary 
oncologist by email to solicit his/her opinion as to whether the patient is appropriate to 
approach for participation. Once a potential participant is identified, a letter outlining the 
project will be mailed to the patient prior to the clinic visit. 
 
On the day of his/her clinic visit, the patient will be approached after the scheduled clinic 
appointment to further explain the study and obtain verbal informed consent for the in-
person, anonymous survey.  
 
After completion of the in-person survey, the RA will explain the video declaration 
portion of the trial and obtain written informed consent. Only those participants who can 
understand the aims of the project, what their involvement entails, that participation is 
voluntary, and the risks and benefits of participation will be eligible for the study. 
 
 
“Broadcast notifications”: 
 
We will be providing any potential patients (participants) with the opportunity to opt out 
of this project entirely (i.e., to have their deidentified data from the EHR not included in 
our main analysis). We have created “broadcast notifications” in the form of a poster in 
the clinic/patient areas giving brief commentary about the trial and their choice to 
participate or not to participate in having their data included in our analysis. One of our 
health care systems routinely does this for all patients at registration (Mayo Clinic), and 
we have extended these “broadcast notifications” to our other two sites. 
 
 
6.0 
Multi-Site Research 
 
COMMUNICATION 
 
Communication for the trial is multi-tiered. The committees and working groups maintain 
regular meeting calendars and have representatives who function as liaisons for other 

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groups within the study. Meeting agendas and minutes are prepared and posted on the 
trial UG3/UH3 internet site, which functions as an ongoing venue for document sharing 
and communication. The majority of meetings are held via teleconference through 
WebEx or Zoom, as well as periodic in-person meetings. 
 
Working Groups: 
 
Topic-specific groups (e.g., Executive Committee, Regulatory and Ethics Working 
Group) meet monthly or as needed for the duration of the study. Working group leaders 
communicate relevant actions/information resulting from working group meetings at the 
monthly Steering Committee meetings.  
 
Each “working group" is tasked with reporting, any issues to the larger group. The 
Executive committee will report about any regulatory concerns. The specific designated 
“Working Groups” will oversee dissemination of interim results and information about 
the closing of the study. 
 
DATA STORAGE AND SECURITY 
 
Data Management:  
We are working with the DFCI-based "Survey & Data Management Core." Data will be 
managed by the Data Standards and Quality Working Group led by Dr. Lakin. The RA 
and local champion at each site, where data is being collected, will extract data every six 
months (i.e., the length of each step) from the EHR and surveys. Each site will maintain 
and adhere to the process and procedures for the protection of human subjects and 
protected health information (PHI) for their covered entities. All data collected by the 
RAs will be stored in password protected servers. Participant identifiers will be kept in 
separate password protected files and a third linking file will be maintained. The linking 
file will also be password protected, access will be minimized, and a logging feature will 
be used to identify each user and instance of use. Only the minimum amount of PHI 
necessary will be collected from study participants. Data from each of the clinical sites 
will be transmitted via secure, institutionally approved methods to DFCI for data 
management and to Boston Medical Center for qualitative analyses and MGH as well.  
 
All information in the REDCAP database will be indexed by subject identifier only, so 
that even if the database server is compromised subjects cannot be identified, thus 
maintaining the privacy of their information. Also, assurance of confidentiality of 
information will be made to all subjects. Data will be handled with the same 
confidentiality accorded to patients’ medical records. Specific procedures protecting 
subject confidentiality will be as follows: 
1. ID number only will be placed on electronic (or paper) study forms or records on 
which data are collected and/or stored. 
2. Access to data files will be secured with a password-filing system (that logs entry) and 
is restricted to authorized staff only. 
3. Necessary hard-copy records containing study data of any type will be kept in locked 

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files. 
4. Master lists linking subject information with ID number will be numbered 
consecutively and prepared before data collection (to ensure accurate accounting). These 
lists will be kept locked, in duplicate, with access only by the PIs and the other 
investigators. 
5. All project staff will sign an oath of confidentiality to ensure their understanding of the 
terms of confidentiality required. They will be trained in specific procedures to ensure 
confidentiality. 
6. Sign-out procedures for all access to data files will be strictly enforced. 
7. All reports and publications will preserve participants’ anonymity. 
 
Long-term storage of Data:  
Data stored on the DFCI server will reside there only for the periods they are required to 
be there for study usage. Data will be securely removed from these servers on a per-item 
basis. Removed data will be securely transferred to DFCI long-term servers for storage.   
 
 
7.0 
Study Timelines: 
 
Study Timeline: 
 
During the UG3 year beginning on July 1, 2018, we will finalize the list of all 39 
oncology clinics and recruit 3 pilot clinics (one from each health care system) by month 2 
(August 2018). The remaining clinics (i.e., 36) will be randomized in pairs for the 
remaining six steps of implementing the intervention. By month 3 (September 2018), we 
will begin baseline data collection for the three pilot clinics using their EHRs. We will 
refine and finalize the intervention during months 3-4 and begin trainings (October-
November 2018) in the three pilot clinics. By month 5-6 (November-December 2018) 
implementation of the intervention at the three pilot clinics will begin and intervention-
period data will be collected at the three pilot clinics. By month 10 (April 2019), data 
extraction and cleaning, and measurement validation will be performed from the first set 
of intervention data from the three pilot clinics. During month 10, a UG3 report and UH3 
proposal will be submitted to the NIA. Exit interviews of staff will be conducted during 
months 11-12 (May-June 2019). We will create video declarations for 10 patients at each 
clinic, for a total of 30 during the first year. 
 
During months 1-3 of the UH3 year 
beginning on July 1, 2019 and 
continuing every six months (for a total 
of 6 steps), we will randomize 2 
oncology clinics in each of our three 
health care systems to receiving the 
intervention (Figure 1). 
 
Figure 1 
UG3  
UH3  
Cluster 
Baseline 
1m 
7m 
13m 
19m 
25m 
31m 
1, 2 
 
 
 
 
 
 
 
3, 4 
 
 
 
 
 
 
 
5, 6 
 
 
 
 
 
 
 
7, 8 
 
 
 
 
 
 
 
9, 10 
 
 
 
 
 
 
 
11, 12 
 
 
 
 
 
 
 

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The implementation period covers at least 6 months in each clinic. Data extraction and 
merged database creation will start during the UG3 year and extend through 
approximately 6 months past the end of the implementation phase of the last step; 
ensuring full follow-up of outcomes. The final dataset will be complete and analyses will 
begin in the last six months of the trial. Manuscript preparation and dissemination of the 
trial results will occur during the final three months.  
 
8.0 
Study Endpoints 
 
Primary & Secondary Endpoints: 
 
We will conduct a SW-CRT of the effect of a Comprehensive ACP Program on rates of 
ascertainable quality measures of end-of-life care. Our primary outcome is 
documentation of ACP activity as determined through natural language processing (NLP) 
of EHR records confirmed by human coders. Discussions of goals of care, completion of 
advance plans, and changes of resuscitation orders will all count in this composite 
measure. Secondary outcomes are resuscitation preferences, palliative care consultations, 
and hospice utilization. These outcomes will be ascertained from the records of 4,500 
patients across oncology practices in the three enrolled health systems. 
 
Secondary safety endpoints. 
 
There is a risk of patients becoming uncomfortable with discussing these topics. 
  
To minimize the risks of patients becoming uncomfortable, study staff will emphasize 
that they can take a break if they need to, or can quit the study all together if they decide 
they no longer want to participate. If patients become distraught and they wish to stop, 
we will notify their nurse and attending physician. We will then follow any 
recommendations they have for obtaining support as needed. If patients become 
distraught during the second video declaration and we are in their home, we will contact 
their attending physician to explain the situation and follow their recommendations for 
obtaining support as needed. 
 
 
9.0 
Procedures Involved 
 
Data Collection Protocol:  
 
Patients: Baseline data collection of the 36 randomized clinics will begin by month 10 of 
the UG3 phase. Data Collection will continue and occur throughout the UH3 phase of the 
trial. Our primary (advance care plans) and secondary (preferences for resuscitation, 
palliative care consults, hospice use) outcomes will be abstracted from the EHR and the 
local tumor registry.  
 

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A group of older patients with advanced cancer (N=450) will have an in-person survey 
over the course of the 3.5 years of recruitment. From among this group of 450 
participants, we aim to conduct the video declaration of preferences activity with 240 
patients. 
 
Based on our prior studies, data collection is estimated to take no longer than 30 minutes 
per patient (15 minutes for survey questions, 15 minutes for video declaration) and will 
be conducted after the scheduled clinic visit. The relatively brief interviewing time (30 
minutes) in which the survey is conducted should assure completion of the interview 
without burdening participants who have advanced cancer. We do not foresee the 
additional time to complete the survey to be a barrier to successful recruitment and 
completion of the protocol. 
 
Participants will be provided written copies of the questions to follow along during the 
in-person interviews. For the subgroup of patients who complete the surveys, the RA will 
also ask participants to complete a video declaration. For those participants that agree to 
the video declaration, they will proceed with recording of their video declarations. 
 
To assist participants in creating a video of themselves describing their ACP preferences, 
the RA will begin by reading a standardized introduction to the subject: “Imagine you 
weren’t able to talk to your doctors or family because you were very sick. We would like 
you to make a video about your preferences for medical care so your doctors and family 
can understand what’s most important for you. Please try to be specific. For example, if 
you could not eat by mouth would you want doctors to insert a feeding tube? Or if you 
could no longer breathe on your own, would you want the doctors to place you on a 
breathing machine – a mechanical respirator? I’ll show your video to you when you are 
done. If you aren’t happy with it, you can record it again. Do you have any questions for 
me before we get started?” The introduction will be pilot tested during the UG3 phase 
and modified as needed. The RA then uses the camera on the tablet (e.g., iPad) as a video 
device to record the subject. The tablet will be situated so that the subject is not viewing 
themselves on screen while they are talking, to lessen feelings of self-consciousness 
while recording. The RA will provide prompts as needed, such as if the person is 
exhibiting extreme hesitation in not knowing what to say, or if the person does not 
address their wishes regarding CPR or intubation. In these cases, the RA will ask some 
questions to facilitate the video process. When the recording is complete, the RA will 
play the video for the subject to see if they feel it accurately represents their preferences 
and if they would like to re-film their video declaration. (In our preliminary study, one 
out of 15 patients wished to re-record their video. However, we feel it is important to 
allow participants this flexibility when needed. Patients are able to re-film as many times 
as they want.) 
 
We will discuss the option of sharing the video with the patient. If they are interested, we 
will ask the participant how they would like to share their video. There are four choices: 
1. We can put the declaration video on an encrypted flash drive which is password 
protected and provide the flash drive to the participant; 2. We can post the declaration 

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video on a website called Dropbox for Business. The participant would be provided a 
web link to view the video online. Dana-Farber has more privacy control over this site 
and can remove the video at any time; 3. We can put the declaration video on an 
unencrypted flash drive which is not password protected and provide the flash drive to 
them; or, 4. We can post the declaration video on a YouTube unlisted video setting under 
the study's YouTube account and provide the web link to the participant. An unlisted 
video can only be seen and shared by a web link. The unlisted video should not be 
available on YouTube's search results or for people who do not have access to the web 
link.  
 
<https://support.google.com/youtube/answer/157177?co=GENIE.Platform%3DDesktop
&hl=en<https://support.google.com/youtube/answer/157177?co=GENIE.Platform%3DD
esktop&hl=en>>>  
 
There are times when the research team would like to share participants’ videos with their 
colleagues, in scientific presentations or to train study staff. We will ask participants if 
they would be comfortable in sharing their video publicly for purposes like this. The risk 
is that the video could be widely shared, depending on the venue. If a participant begins 
to feel any distress and changes their mind about sharing the video publicly, they can let 
us know and we will stop sharing it publicly.   
 
We will discuss sharing the video with the patient. We will ask the participant how they 
would like to have their video (e.g., uploaded to YouTube, DropBox, USB drive), and 
with whom they would like to share it with (e.g., oncologist, primary care provider, 
family). 
 
Data collected for long-term follow-up:  
 
Performance of NLP 
 
Dr. Lindvall’s lab at DFCI has published several studies on the use of Natural Language 
Processing (NLP) to capture documentation of ACP in clinical notes.(91 – 93)  Compared 
to standard medical record review her team has achieved a sensitivity 97% - 99% and 
specificity 85% - 100% at the note level. At the patient level, both sensitivity and 
specificity are close to 100%. Patients accrue hundreds to thousands of notes which 
makes standard medical review not feasible, and this method dramatically increases 
efficiency and sensitivity. 
 
 
Advances in computer science techniques such as NLP allow for efficient and accurate 
analysis of the free-text from clinical notes in order to detect our primary outcomes. The 
increasing use of EHR combined with computational advances in NLP can accurately 
quantify our primary and secondary outcomes.  
 

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Over the course of the study, we will  use NLP to analyze outcomes documented in the 
clinical notes  for all of the patients aged 65 or older (4,500)  
 
 
The below procedures will be completed at each health care system by their respective 
site-Investigators. No patient identifiable information will leave the HIPPA-secure 
firewall of each health care system. 
 
Each site-Investigator will use NLP to  identify the following  primary and secondary 
outcomes. 
 
Primary 
outcome 
Domain 
Definition 
 
 
 
 
 
 
 
Advance 
Care 
Planning 
Goals of 
care 
Conversations with patients or family members about the patient’s 
goals, values, or priorities for treatment and outcomes. Includes 
statements that conversation occurred as well as listing specific 
goals. 
 
OR  
 
Documentation advance care planning was discussed, reviewed, 
recommended, or completed. 
Code 
status 
limitations 
Conversations with patients or family members about preferences 
for limitations to cardiopulmonary resuscitation and intubation.  
Palliative 
Care 
Documentation that specialist palliative care was discussed, patient 
preferences regarding seeing palliative care clinician. 
Hospice 
Documentation that hospice was discussed, prior enrollment in 
hospice, patient preferences regarding hospice, or assessments the 
patient did not meet hospice criteria. 
 
 
Secondary outcomes 
Definition 
Surrogate Decision 
Maker 
Documentation of a surrogate decision maker. 
Video 
Video support tool was recommended or viewed. 
 
 

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Data will be abstracted from the EHR data repository (see above tables) at each health 
care system. Demographic information and baseline characteristics relevant to general 
oncology will be collected. Analysis of free text regarding patient preferences and goal-
of-care conversations will be extrapolated using computational methods.  
Individual variables have been selected as they are basic demographic and baseline 
characteristics of study participants that are relevant to general oncology patients (disease 
location, stage, performance status). The primary and secondary outcomes are widely 
used as measures of end-of-life care in the cancer population.  
 
The Investigators at each health care system will use computational methods (NLP) to 
identify our outcomes such as documentation of goals of care and patient preferences. 
 
Once these variables have been abstracted from the health care system's EHR, the data 
will be collected for each patient and the patient will be given a random unique identifier. 
A cross-walk of the unique identifier and the identifiable information of the patient will 
be securely stored at the health care system and not transferred to DFCI. 
 
The deidentified data for each patient will then be sent to DFCI and MGH for further 
analysis. 
 
Only researchers listed on this IRB will be able to access the data at each health care 
system. The risks will be minimal as the data will be stored and analyzed on the HIPAA 
secure cluster at each health care system. None of the data will be stored in paper form. 
The data and identifiers will be kept for three years on the HIPPA secure cluster 
computer at each health care system. After the three years, the data will be permanently 
destroyed.  
 
 
10.0 
Data and Specimen Banking 
 
N/A 
 
11.0 
Data Management and Confidentiality 
DATA ANALYSES  
Aim 2 (UH3): To test the combined effects of a Comprehensive ACP Program on rates of 
ascertainable quality measures of end-of-life care. We will conduct a SW-CRT across 36 
oncology practices in the three systems and evaluate the effectiveness of the intervention 
by comparing the following outcomes among 4,500 patients aged 65 or over with 
advanced cancer: ACP documentation; Medical orders for resuscitation preferences in 
the EHR; Palliative care consultations; and Hospice use. Hypothesis: A higher proportion 
of patients in the intervention phase (vs. control) will: complete ACP documentation 

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(primary trial outcome), have documented EHR orders for limitations on resuscitation, 
be seen in palliative care consultation, and enroll in hospice. 
 
With the stepped wedge design, the outcomes during the intervention (exposed) periods 
will be compared to outcomes during the control (unexposed) periods. We will 
summarize both clusters and patients' characteristics by exposure status to examine 
potential selection biases and lack of balance. We will use a generalized linear mixed 
model with a logit link to compare the rate of advance care plans between intervention 
and control periods. Our basic model is as follows:  
𝑙𝑜𝑔𝑖𝑡(𝑌𝑖𝑗𝑘) =  𝜇+ 𝛼𝑖+ 𝛽𝑗+ 𝛾𝑘+ 𝑋𝑖𝑗𝜃 
where 𝑌𝑖𝑗𝑘 denotes the response from individual k at time j from cluster i;  𝛼𝑖 is a random 
effect for cluster i; 𝑋𝑖𝑗 is the treatment indicator for cluster i at time j; and 𝜃 is the 
treatment effect. Since intervention occurs over time, the proportion of clusters exposed 
to the intervention gradually increases. We will include step as a fixed effect (𝛽𝑗) in the 
model to adjust for the potential confounding factor from calendar time. We added a 
random effect for individuals (𝛾𝑘) to account for the repeated measures since patients are 
likely to be present in multiple periods. 
  
We will entertain several extensions to the basic model. (1) In the case that time effect 
might not be the same for all clusters, we will change the term for time effect from a 
fixed effect 𝛽𝑗 to a random effect 𝛽𝑖𝑗; (2) In the case of treatment effect heterogeneity, we 
will either change the fixed effect 𝜃 to a random effect 𝜃𝑖 or change the fixed effect 𝜃 to 
𝜃(𝑠) which allows different treatment effects for different strata; (3) As the intervention 
might not become effective immediately after it is introduced, we will consider either 
allowing 𝑋𝑖𝑗 (treatment indicator in cluster i at time j) to be a fractional number between 
0 and 1, or changing 𝑋𝑖𝑗𝜃 to 𝑋𝑖𝑗𝑙𝜃𝑙 to account for the number of steps since the 
intervention was introduced; (4) If necessary, we will add additional terms γ1Zijk and γ2Wij 
to the model, where Z and W represent vectors of patient and cluster characteristics that 
could be predictors of outcomes, to adjust for any imbalance from clusters and patients' 
characteristics. Note that the index j in these matrixes allows us to include time-varying 
covariates. In addition, we will include one of the Zijk  to be defined as “time since 
recruitment/enrollment” to account for the (possible) increase in likelihood of completing 
an ACP as disease progresses, independent of any intervention effect. 
 
In a secondary analysis, we will explore the heterogeneity of intervention effect for 
different subgroups such as health care system, sex as a biological variable, race/ethnicity 
(white vs. non-white), or different types of cancer diagnoses (see model extension [2] 
above). We will also take advantage of the stepped wedge design to compare outcomes 
from the exposed and unexposed periods within each cluster. We will use the same 
approach for our secondary outcomes (e.g., resuscitation preference) with the exception 
that the number of palliative care consults will be considered as a Poisson variable and 
modeled with a log link.   
 
Sample Size Estimates are based on the primary study outcome: ACP documentation 
among patients aged 65 or over with advanced cancer. We will recruit 36 oncology 
practices from the three health care systems with a total of 4,500 patients (an average of 
125 patients per cluster; 36 clusters x 125 patients/cluster) with advanced cancer over the 

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age of 65. Our preliminary estimate indicates the ACP documentation rate is around 15% 
for the control periods. As shown in Table 3, the study will have sufficient power for our 
primary outcome with different assumptions on effect size and intra-class correlation 
coefficient (ICC). 
 
 
 
The three health care 
systems offer a broad 
array of patients as well 
as sufficient numbers 
for us to reach our 
recruitment goals for 
the UH3 phase (36 
clinics total) (Table 4). 
 
Aim 3 (UH3): To 
characterize detailed 
patient-centered outcomes, 
including confidence in 
future care, communication 
and decisional satisfaction, 
and decisional regret in a 
group of 450 patients aged 
65 and over with advanced 
cancer, as well as analyses of video declarations from 240 of these patients about their 
wishes. Hypothesis: Patients in the intervention phase (vs. control) will have improved 
outcomes (communication, decisional satisfaction, decisional regret) and will have better 
concordance between the content of their video declarations and their documented 
wishes. 
 
(The 450 participants that complete the in-person surveys will not be included in the 
4,500 patients considered for Aim 2 since surveying patients may in and of itself 
influence the primary and secondary outcomes.)  
 
The patient-centered outcomes will be assessed in a group of 450 patients through 
surveys. We do not anticipate issues with missing data since these surveys will be 
conducted in person. With each clinic contributing survey data only one period before 
and after intervention, we will use linear mixed models to compare survey responses 
from intervention and control periods, with clinic as a random effect to take into account 
of the clustering within clinic. We will include calendar time and any imbalance from 
patient characteristics in the model to adjust for the potential confounding factors.   
 
The patient surveys allow us to richly characterize the experience of patients and enhance 
the analysis of the Comprehensive ACP Program. Comprised of multiple previously 
validated measures as well as two single Likert-scale questions, this survey measures our 
patient-centered secondary outcomes such as patient confidence that their future medical 
care will match their values, satisfaction with their clinician’s communication, 
satisfaction with their medical decision, and regret about their medical decision. The first 
Table 3. Sample size needed for 80% or 90% power in 
different effect size and different assumptions on ICC. 
power control intervention 
N 
(ICC=0) 
N 
(ICC=0.01) 
N 
(ICC=0.05) 
80% 
15% 
25% 
500 
1449 
1473 
30% 
242 
701 
713 
90% 
25% 
670 
1941 
1974 
30% 
322 
933 
948 
Table 4. Number of eligible clinics and eligible patients 
 
# of eligible 
clinics 
# of patients 
65+ with 
Cancer 
# of patients 
65+ with 
Advanced 
Cancer 
Duke 
12 
2890 
1341 
Mayo 
12 
3018 
701 
Northwell 
12 
4235 
2243 
Total 
36 
10143 
4285 

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of the single questions, asking patients how confident they are that they will get the type 
of medical care they want if they become seriously ill, is currently being used in another 
ACP study by the research team. Although it has not been psychometrically tested, it 
carries enormous face validity and is the closest approximation we can obtain of goal-
concordant care prospectively. The next section is comprised of the 10-item 
communication subscale from the Consumer Assessment of Health Plans (CAHPS) and 
asks patients to focus on recent ACP communication with their clinicians and their 
satisfaction with that communication. This is a well-validated and commonly used 
measure of clinician communication. The third section of the survey uses the Satisfaction 
with Decision Scale, a six-item scale that has excellent reliability (Cronbach’s alpha = 
0.86) and good discriminant validity, to derive patients’ satisfaction with their medical 
decisions in relation to their personal values and goals. This leads directly into the five-
item Decision Regret Scale, which measures patients’ regret after a decision has been 
made. This instrument has a Cronbach’s alpha of 0.81-0.92 and correlates well with other 
measures of regret. Finally, the survey asks one question from the End-of-Life Planning 
survey in the National Health and Aging Trends Study (www.nhats.org) exploring 
patients’ discussions about end-of-life medical treatment with non-clinicians in their 
lives. The original question asks “have you talked to anyone about the types of medical 
treatment you want or don’t want if you become seriously ill in the future?” and has been 
amended to say “have you talked with a family member or caregiver about the types of 
medical treatment you want or don’t want if you become seriously ill in the future?” 
before proceeding to ask with whom that conversation occurred and listing about 20 
options. As a single question, we do not believe this has been psychometrically tested and 
we will have it as an exploratory outcome in this study.  
 
Power Analysis. For our Aim 3 survey outcomes, we will select a group of 450 patients. 
Assuming an ICC of 0.05, the effective sample size is ~286. The study will have 90% 
power to detect an effect size of 0.39 and 99% power to detect an effect size of 0.5, 
which is usually considered as a moderate effect size. 
 
Video declaration. We will conduct a content analysis of the video declarations 
(N=240). This sample size represents an approach that favors obtaining a wide breadth of 
data about specific experiences in contrast to more in-depth data that would be obtained 
by interviewing people at length over several sessions. Our guiding principle will be 
thematic saturation, such that if we determine that new themes are emerging, we will 
retain the flexibility to increase the number of people who create video declarations. We 
will use NVIVO version 11 qualitative software to assist in data management across 
health systems. To begin, we will remove any inadvertent references to study group, so 
that Dr. Quintiliani and the RAs will be blinded to. We will transcribe the patient-
recorded videos verbatim and add to the transcript any relevant non-verbal information 
from the video itself, such as expressions of sadness. We will draw from an existing 
conceptual framework of palliative cancer care to create a preliminary coding framework. 
The starting coding categories come from our preliminary study of video declarations: 1) 
ACP; 2) acute issues; 3) psychosocial issues; 4) after death wishes; and, 5) existential and 
spiritual issues. Dr. Quintiliani will then independently code a subset of 15 videos (5 
from each site) adding additional codes as needed to cover emerging topics. Dr. 
Quintiliani will then show the preliminary coding structure to the entire research team. 
Codes will be added, refined, and deleted during this process. Once a final coding 
framework is developed, Dr. Quintiliani and the RAs from each site will each 

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independently code the remaining transcripts, meeting by phone monthly to review 
progress and resolve any coding discrepancies. To enhance the trustworthiness of the 
analysis, we will hold at least two peer debriefing meetings with the entire research team 
to show them the transcripts and the codes applied and ask for their feedback, which will 
then be incorporated into the coding process. Codes will then be summarized into themes 
and presented descriptively; illustrative quotations will accompany each category to 
highlight the content.  
 
In further exploratory analyses, we will evaluate the clarity and comprehensiveness with 
which the video declaration communicates preferences. Similarly, we will compare the 
participant’s ACP preferences documented in the video declaration with the ACP 
preferences documented in the EHR to determine the level of agreement. In this 
exploratory analysis, we would hypothesize that participants who created their video 
declaration of preferences after initiation of the intervention would have videos that, (a) 
have more clarity, and (b) are more consistent with their documented wishes than 
participants who created their video declaration prior to the initiation of the intervention.  
 
Goal-concordant care. Using a chart abstraction tool we will extract data from the 
medical record for the last three months of life for each of the 450 survey participants 
who die during the study period regarding: (a) ACP preferences, and (b) care received.  
Study staff will blind these documents to intervention/control status; this will include the 
‘shift and truncate’ method for obscuring dates while maintaining temporal 
relationships.(109) We will then independently judge if the care delivered was 
concordant with a person’s wishes as documented at that time. While it is not common in 
the literature for patients’ wishes to change over a short period of time,(110) we will 
conduct this analysis in a manner that allows for such changes.  
 
For both the clarity and comprehensiveness evaluation and the goal-concordant care 
assessment we will calculate the extent of agreement using the average P(e) between all 
coder pairs to compute a kappa-like statistic for multiple coders as described by Davies 
and Fleiss.(111) Coders will meet to review their determinations and discuss each case 
for which there was disagreement; final judgements will be determined by consensus. 
 
 
 
SECURING THE DATA 
 
EHR Data Transfer Procedures 
1. Representatives from all three health care systems will make semi-annual “dumps”, 
using appropriately secure tools, of EHR data onto selected servers.  
2. Scheduled job run by DFCI will initiate the ingestion of new data as made available. 
3. DFCI's system manager replaces person identifiers, including all HIPAA face 
identifiers, with an alphanumeric ID. 
 
12.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 

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N/A 
 
13. 
Withdrawal of Subjects 
 
We do not anticipate any circumstances where the patient will withdraw from 
participation in the study. Study staff will make clear to the patient that participation is 
entirely voluntary and may be withdrawn at any time and that the decision not to 
participate will not affect their care, now or in the future. 
 
If a participant chooses to withdraw from the study, or if we terminate a subject’s 
participation in such a research study without regard to the participant’s consent, we will 
retain and analyze already collected data relating to that participant, even if those data 
include identifiable private information about the participant. We will honor a 
participant’s request to destroy the participant’s data or exclude the data from any 
analysis.   
 
14.0 
Risks to Subjects 
 
Potential risks 
 
The interventions are low risk and are the standard of care in many health care systems. 
The interventions will be available to all patients in the clinic not only patients who are  
aged 65 or older with advanced cancer. The clinic is the unit of randomization to a 
minimal risk intervention.  
 
We anticipate little risk to the participants in this study. To be sure, such interactions may 
make some patients uncomfortable, sad, or even distressed as they contemplate death and 
dying with their provider. However, such interactions are explicitly part of the standard 
of care. Patients receiving the intervention will be asked to listen to and watch videos that 
contain verbal narratives and visual images related to ACP by clinicians in their clinics 
trained in this practice. The videos describe three levels of care (life-prolonging care, 
limited care, and comfort care), and/or specific treatments (i.e., CPR, feeding tubes), and 
therefore may be distressing. Using similar video decision support tools in our prior 
studies that have included more than three thousand participants, including patients with 
advanced cancer, over 90% of patients rated the videos as highly acceptable, helpful or 
extremely helpful, and would recommend or highly recommend them to others. In these 
prior studies, we have never had to stop an interview because of participant distress. 
However, as part of clinician training in this trial, clinicians will be instructed that should 
a patient or family member become distressed while watching a video and prefer not to 
continue, the video should be stopped.  
 
In addition, there is a risk for loss of privacy in regards to the video declaration, but we 
will have a series of mutually reinforcing measures to mitigate this risk. 
 
Protections against risk 

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We will emphasize that participation in this research is voluntary.  
 
Qualitative interviews with providers, staff, and management will be conducted by 
personnel who have no affiliation to these subjects' employer. It is quite important that 
providers, staff, and management are able to share openly, even if their feedback may be 
critical.  
 
We will transmit no identifiable data back to the clinic sites to avoid any risk of 
retribution, retaliation, or adverse consequence to disclosures which may come about 
through this process.  
 
15.0 
Potential Benefits to Subjects 
 
Potential Benefits of the Proposed Research to Human Subjects and Others 
 
There is the potential for patients and clinicians in the clinics to benefit from the study by 
having their treatments better aligned with their preferences. The minor risks for the 
participants in this study may be considered counterbalanced by the potential direct 
benefits and knowledge gained. The results gleaned from the study are intended to 
improve the ACP of the overall outpatient clinic population, and particularly those with 
advanced cancer. Thus, the risk/benefit balance for this study appears favorable. 
 
Importance of the Knowledge to be Gained 
 
There is the potential to validate an intervention that could ensure that treatments are 
better aligned with patients’ preferences. The minor risks for the participants in this study 
may be considered counterbalanced by the potential direct benefits and knowledge 
gained. The results gleaned from the study are intended to improve the ACP of the 
overall outpatient clinic population, and particularly those with advanced cancer. Thus, 
the risk/benefit balance for this study appears favorable. 
 
16.0 
Vulnerable Populations 
 
Our project does not involve any individuals from vulnerable populations. 
 
17.0 
Community-Based Participatory Research 
N/A 
18.0 
Sharing of Results with Patients 
 
The results will be shared via a patient friendly pamphlet that explains the results of the 
study and is disseminated in participating clinics. An e-version will also be available on 
any websites affiliated with the practice. 

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19.0 
Setting 
 
Locations: 
We will recruit patients from 39 oncology clinics served by three major health care 
systems: Duke Health (North Carolina), the Mayo Clinic (Minnesota), and Northwell 
Health (New York). 
 
Health Care System Partners: 
Three health care systems are participating in the study, each contributing 13 oncology 
clinics: Duke Health, Mayo Clinic, and Northwell.  
Clinic Eligibility:  
Clinic eligibility criteria include:  
• More than one oncologist 
• Serve a patient population that is at least 30% age of 65 or older 
Eligibility Estimates  
We anticipated that a total of 13 clinic sites per health care system would be eligible for 
the trial. For the UG3 year, the pilot was selected, leaving 12 clinics for random 
assignment during the UH3 year. 
Identification of Eligible Clinics 
Candidate clinics were identified by the research team at each health care system 
site using EHR data to establish patient mix (i.e., >30% age of 65 or older). 
 
The research team at each site along with leaders at the health care system partners 
reviewed these lists for:  
• Recent turnover in Administrator or Director of the Clinic 
• Current new initiatives/competing demands 
Each site then returned the list of clinics to the study statistician who will then randomize 
the sites. 
Clinic Randomization  
• The randomization scheme for the 36 participating clinics at the three health care 
systems will be finalized during the UG3 year.  
• During the first year of the UH3 phase and continuing every six months (a total of 
six steps), we will randomize 2 oncology clinics in each of our three health care 
systems to receiving the intervention. Prior to randomization, the size of 

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Page 25 of 43 
 
participant clinics will be determined based on the number of oncologists on staff 
(≤ 3 vs. >3).  To balance the size of clinics between intervention and control 
phases of the trial, we will pair clinics of different sizes (one with ≤ 3 and one 
with >3) to receive intervention at the same time.  
Masking/Blinding 
Various levels of blinding will be used in this trial. 
• Research site-PIs (Drs. Pollak, Zafar, Tilburt, Loprinzi, Martins-Welch and 
Carney) at each of our sites will know the randomization order and which 
clinics have received the intervention and when. 
• Selected members of the data management (Drs. Lakin and Lindvall, and Dan 
Gundersen) and implementation teams (Drs. Paasche-Orlow, Barry and 
Volandes) are unblinded to all clinic assignments and outcomes as a function 
of their roles in working with the data and generating monthly video 
adherence reports for the clinics using the intervention. 
• Drs. Tulsky will be aware of the identity of the intervention clinics, but will 
remain blinded to all outcomes.  
• All other project staff not involved with data management and implementation 
will be blinded to clinic assignments and outcomes.  
 
Each clinic has an advisory board, who will be involved in the project throughout the 
study. 
 
Each health care system has a regulatory board, which will use DFCI’s OHRS approval 
as their main regulatory agent. Each of the 3 sites, Duke, Mayo Clinic and Northwell 
Health, have conceded to allow that the DFCI IRB will be the IRB of record. The sites 
will be following rules and regulations set forth by DFCI OHRS. 
 
20.0 
Resources Available 
 
James A. Tulsky, MD, Co-Principal Investigator (2.4 CM, Years 1-5): Dr. Tulsky is 
Professor of Medicine at Harvard Medical School and Chair, Department of Psychosocial 
Oncology and Palliative Care at DFCI. He has led multiple federally funded studies 
examining patient-provider communication, and is a Founding Director of VitalTalk, a 
non-profit organization devoted to teaching physicians communication skills 
(www.VitalTalk.org). Dr. Tulsky will provide scientific leadership over all aspects of the 
study. He will oversee the conduct of the study including protocol development, training 
of research staff, codebook development, data analysis and manuscript writing. 
 
Angelo Volandes, MD, MPH, Co-Principal Investigator. Dr. Volandes is a general 
internist and clinical researcher with past training in medicine, decision-making, 
bioethics, and film-making. His research career has been dedicated to developing and 
evaluating video decision support tools for life-limiting conditions. He currently leads an 

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Page 26 of 43 
 
innovative team of video decision scientists at the Massachusetts General Hospital. He 
has successfully led many studies funded by the NIH evaluating the efficacy of these 
tools, the results of which have been published in top-tier journals.  
 
Feasibility: 
 
• All investigators, research assistants, and study staff will be oriented to the 
protocol during an in-person meeting. During this meeting, the PIs and PM will 
provide a detailed orientation to all study procedures and all study staff members’ 
duties and functions. Each site will also have electronic and hard copies of the 
project manual and protocol which will be made available to study staff. Regular 
check-in conference calls with study staff will be used to provide updates on the 
protocol if changes have been made, discuss issues at the individual sites with 
regard to recruitment, administration of the intervention, assessment, or any other 
issue that may arise. All persons assisting with the research will undergo training 
on the protocol including training on informed consent. 
 
• The study will leverage the state-of-the-art EHRs of three large health care 
systems: We will establish a unique, rigorous data infrastructure to identify target 
patient groups (older patients with advanced cancer) in a timely manner. The co-
PIs have a long history of prior work with the three health care systems, and have 
published with their co-Investigators. The proposed work will leverage this 
exceptional field experience and infrastructure, and supports the feasibility of 
the study. 
 
21.0 
Prior Approvals 
 
N/A 
 
22.0 
Recruitment Methods  
 
There will be no local subjects recruited for this project. 
 
23.0 Local Number of Subjects 
 
There will be no local subjects recruited for this project. 
 
24.0 
Provisions to Protect the Privacy Interests of Subjects 
The risks in this study are minimal and non-medical in nature. The primary risk is loss of 
confidentiality. To minimize the likelihood of a breach, we will collect only electronic 
data and anonymous data when possible. Only the minimum amount of PHI necessary 
will be collected from study participants, including oncologists and patients, and all data 

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Page 27 of 43 
 
will be transmitted via secure, institutionally approved methods. We will emphasize that 
participation in this research is voluntary.  
Qualitative interviews with providers, staff, and management will be conducted by 
personnel who have no affiliation to these subjects' employer. It is quite important that 
providers, staff, and management will be able to share openly, even if their feedback may 
be critical.  
 
We will transmit no identifiable data back to the clinic sites to avoid any risk of 
retribution, retaliation, or adverse consequence to disclosures which may come about 
through this process.  
 
Oversight and Protocol Compliance: All research personnel will participate in human 
subjects training, an annual booster training, one-time data integrity and security training, 
and training on the protocol, which will include simulation and practice for all protocol 
procedures including obtaining informed consent and confirming comprehension. We 
will have regular team meetings and regular surveying reliability checks to ensure 
protocol compliance. Patient surveyors will be supervised through monthly conference 
calls and one-on-one communication, as needed. The procedures described here address 
our efforts to minimize the risk of breach of confidentiality and to ensure that procedures 
remain in place for the protection of human subjects. All data management will be 
conducted at DFCI. The Center’s researchers and staff have many years of experience 
working with similar data files.  
 
Adverse Event Reporting: This study presents minimal risk to participants, and there 
are no adverse events given that ACP is part of the standard of care. Nonetheless, the PIs 
will monitor and report unforeseen adverse events to the DFCI IRB. If there are any 
concerns about privacy, will be refer the patient to the DFCI Privacy Officer, and we will 
refer any significant complaints to the DFCI Office of Research Studies.  
  
25.0 
Compensation for Research-Related Injury 
 
N/A 
 
26.0 
Economic Burden to Subjects 
 
Subjects will not be responsible for any costs relating to participation in this research. 
 
27.0 
Consent Process  
 
Non-English Speaking Subjects = N/A 
Subjects who are not yet adults (infants, children, teenagers) = N/A 
Cognitively Impaired Adults = N/A 
Adults Unable to Consent = N/A 

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1. There are special informed consent considerations in this pragmatic SW-CRT: the 
oncology clinic is the unit of randomization, the intervention is of low risk and will be 
implemented facility-wide, and data for our primary outcome is ascertained from existing 
sources.  
 
Thus, we will seek a waiver of individual informed consent after careful review of the 
criteria to do so.  
 
2. To obtain personal health information from the EHRs, a waiver of HIPAA 
authorization will be sought.  
 
For our group of patients (N=450) being surveyed for patient-centered secondary 
outcomes, verbal informed consent will be obtained for the verbal survey, and for those 
individuals who proceed with the video declaration individual written informed consent 
will be obtained.  
 
For those patients meeting all the criteria for advanced cancer, the RA will randomize the 
order of scheduled patients and then start at the top of this list and go down until fulfilling 
the enrollment target for the in-person survey. The RA will then contact the patient's 
primary oncologist by email to solicit his/her opinion as to whether the patient is 
otherwise appropriate to approach for participation based on the clinician's more intimate 
knowledge of the patient's clinical status, psychological disposition, and decision-making 
capacity. Once a potential participant is identified, a letter outlining the project will be 
mailed to the patient prior to the clinic visit.  
 
On the day of his/her clinic visit, the patient will be approached at the conclusion of the 
scheduled clinic appointment to further explain the study and obtain verbal informed 
consent for the verbal survey. The RA will verify the ability of the participant to provide 
consent by explaining the nature of the study and having the participant repeat (teach-
back) the aims and risks of the study. Only those participants who can understand the 
aims of the project, what their involvement entails, that participation is voluntary, and the 
risks and benefits of participation will be eligible for the study. For those participants that 
choose to create a video declaration, written informed consent will be obtained. 
 
28. Subject Registration Procedures 
 
1. Institutions will register eligible participants in the Clinical Trials Management System 
(CTMS) OnCore as required by DF/HCC Policy REGIST-101. Summary accrual 
reporting will be utilized, and accrual data will be entered into OnCore at least monthly 
while the protocol is open to accrual. 
 
2.  The coordinating center will produce site specific accrual reports and update the 
summary accrual report immediately after data transfer occurrence.  Data from each site 
are transmitted to Daniel Gundersen (DanielA_Gundersen@dfci.harvard.edu) who will 
produce the site accrual data and update the summary accrual report. 

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Page 29 of 43 
 
 
 
 
29. Process to Document Consent in Writing 
 
We will be following DF/HCC Policy CON-100: Informed Consent Process. 
The submitted DFCI consent will serve as a master template consent, and 
the subjects will be consented locally, with consents approved by their 
local IRBs. 
 
 30. Drugs or Devices 
N/A 
 
 

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APPENDIX A 
 
In order to maximize the learning of this study and to make sure that the 
intervention is replicable as much as possible, we have described in this 
Appendix our implementation strategy. 
1) Name it. The overall intervention is called the Comprehensive Advance Care 
Planning (ACP) Program. The Comprehensive ACP Program has two 
components: 
a) A clinician-facing component, VitalTalk Training to improve communication 
skills about advance care planning for key clinic personnel 
b) A patient-facing component, Viewing of ACP Videos as an adjunct to ACP 
discussions between clinic staff and eligible patients in the practice. 
2) Define it.  For the clinician intervention, the VitalTalk program is the most 
widely disseminated teaching method that focuses on patient-centered 
communication skills training. Thus, this part of the intervention is best 
considered a clinician training intervention. For patients, video decision aids to 
better educate and inform decision making are commonly used, and the ACP 
Decisions video-based tools are the best example of these. These videos attempt 
to overcome literacy barriers and to present potential scenarios with a sense of 
reality lacking in verbal descriptions. This part of the intervention is best 
considered a patient decision support intervention aimed at insuring patients are 
informed and involved in their ACP planning decisions. Prior work, including 
several RCTs, supports the efficacy of the ACP Decisions videos and the 
VitalTalk program in patients with advanced cancer. To improve the intensity of 
the patient-facing component, there will also be an audit and feedback 
component focused on the intensity of viewing if the ACP videos by eligible 
patients. 
3) Operationalize It.  
a) The actors 
For the VitalTalk Training the actors are the project’s research staff who will 
visit each participating site to train the clinicians. For the Viewing ACP 
Decisions Videos, research staff will also play a role training clinic personnel in 
the use of the ACP Videos to support ACP conversations.  However, the main 
actors will be clinic personnel who will provide access and encouragement for 
ACP video viewing, and then “close the loop” by arranging ACP conversations 
between clinicians and patients. The audit and feedback component will be 
performed by the project’s research staff. 
b) The action 

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For VitalTalk, the action is the in-person training for clinicians in each 
intervention practice. For Viewing of ACP Videos, the action begins with 
training the practice’s clinic team in the use of ACP Videos in conjunction with 
each site’s VitalTalk training. The ultimate action is clinic personnel prescribing 
ACP Videos ahead of eligible patient visits to the practice, and face-to-face 
viewing of the ACP Videos on tablets in the practice in conjunction with ACP 
Conversations. The audit and feedback component will be provision of reports 
on intensity of use of the ACP Videos among eligible patients in the practice at 
the end of each intervention cycle as well as ACP completion. 
c) Action target 
Training in the skills of having ACP conversations and prescribing ACP 
planning videos should help reduce the barriers to initiating ACP discussions in 
these oncology practices. As most patients welcome such discussions and 
respond very positively to the ACP Videos, these patient reactions should 
provide an ongoing feedback loop to reinforce the implementation of the 
intervention over time. Providing regular feedback on the intensity of use of the 
ACP Videos will provide another reinforcement to their use. 
d) Temporality 
ACP conversations with eligible patients should begin immediately after the 
training, as eligible patients are seen in the practice. Similarly, ACP Videos 
should be viewed with practice personnel in the office immediately after the 
training. If desired, clinic staff can send patients links to the relevant videos with 
a recommendation to review them prior to an upcoming visit. However, the loop 
should be closed with an ACP discussion at the upcoming visit. Feedback on 
ACP Video use will be provided to each practice at the end of each 6-month 
cycle after implementation. 
e) Dose 
The dose of VitalTalk training is uniform across the participating practices, with 
one daylong training session conducted at the beginning of each site’s 
implementation period. However, the dose of ACP Video viewing will vary by 
practice. The intensity of use of the videos will be monitored by making a ratio 
of the number of videos viewed overall and separately inside or outside of office 
visits (which the ACP Decisions sire tracks separately) to the number of eligible 
patients in the practice during each 6-month intervention cycle. 
f) The implementation outcome affected 

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The primary outcome of the study is the documentation of ACP conversations in 
the electronic medical record. The main intermediate implementation outcome 
will be the intensity of ACP Video viewing, as measured above.  
g) The justification 
This strategy represents the first Comprehensive ACP Program combining two 
well-tested, evidence-based, and complementary interventions, that treat patients 
and clinicians as equal stakeholders by providing both with the communication 
skills and tools needed to optimally engage with ACP. A modified conceptual 
model integrating patient-professional communication such as ACP 
conversations has been developed by Feldman-Stewart and colleagues. The 
potential for a Comprehensive ACP Program to improve outcomes based on this 
model provides the theoretical framework for the trial. The 4 elements of the 
model are: 1. interventions for patients (ACP Videos) and clinicians (VitalTalk); 
2. moderators for patients (demographics, cancer type/stage, functional status) 
and clinicians (demographics, experience); 3. mediators for patients (self-
efficacy, knowledge) and clinicians (inclination toward social and emotional 
aspects of patient care); and, 4. ACP outcomes. 
 

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