Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive Advance Care Planning With Videos for the Elderly and All Patients With Dementia
Phase: NA
Conditions: Advance Care Planning, Palliative Care, Alzheimer's Disease and Related Dementias, Doctor-patient Communication, Video Decision Aids
Sponsor: Tufts Medical Center

Version 1.2 October 7, 2022 
 
 
 ________________________________________________________________________________________________________  
1 
 
 
Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive 
Advance Care Planning with Videos for the Elderly and all Patients with Dementia 
 
 
ClinicalTrials.gov number: NCT04857060 
BMC Protocol Number: H-41482 
Protocol Version Number: 1.2 
Protocol Version Date: October 7. 2022 
Funding Mechanism: NIH/NIA 1 R01 AG072911 
Principal Investigator: Michael Paasche-Orlow, MD, MPH 
 
Phone: 617-414-6936 
 
E-mail: mpo@tuftsmedicine.org 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston Medical Center. No part of it 
may be transmitted, reproduced, published, or used by other persons without prior 
written authorization from the study sponsor. 
 
 
 
 
 

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TABLE OF CONTENTS 
1 List of Abbreviations ........................................................................................................... 3 
2 Protocol Summary .............................................................................................................. 3 
3 Background/Rationale & Purpose ..................................................................................... 4 
3.1 Background Information ............................................................................................ 4 
3.2 Rationale and Purpose ............................................................................................. 5 
4 Objectives ............................................................................................................................ 6 
4.1 Study Objectives ........................................................................................................ 6 
4.2 Study Outcome Measures ........................................................................................ 7 
4.2.1 
Primary Outcome Measures ....................................................................... 7 
4.2.2 
Secondary Outcome Measures .................................................................. 7 
5 Study Design ....................................................................................................................... 8 
6 Potential Risks and Benefits .............................................................................................. 9 
6.1 Risks ........................................................................................................................... 8 
6.2 Potential Benefits....................................................................................................... 9 
6.3 Analysis of Risks in Relation to Benefits ................................................................. 9 
7 Study Subject Selection ..................................................................................................... 9 
7.1 Subject Inclusion Criteria .......................................................................................... 9 
7.2 Subject Exclusion Criteria ....................................................................................... 10 
8 Study Intervention ............................................................................................................. 11 
9 Study Procedures ............................................................................................................. 11 
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) ............................... 17 
10.1 Definitions ................................................................................................................ 17 
10.2 Safety Review .......................................................................................................... 18 
10.3 Reporting Plans ....................................................................................................... 19 
10.4 Stopping Rules ........................................................................................................ 19 
11 Data Handling and Record Keeping ............................................................................... 17 
11.1 Confidentiality .......................................................................................................... 17 
11.2 Case Report Forms ................................................................................................. 20 
11.3 Study Records Retention ........................................................................................ 19 
 
11.4 Data Management ...................................................................................................... 21 
12 Statistical Plan .................................................................................................................. 22 
12.1 Study Hypotheses ................................................................................................... 22 
12.2 Sample Size Determination .................................................................................... 23 
12.3 Statistical Methods .................................................................................................. 23 
13 Ethics/Protection of Human Subjects ............................................................................. 27 
14 Literature References ....................................................................................................... 28 
 
 
 
 

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1 
List of Abbreviations 
 
Abbreviation 
Abbreviation definition 
ACP 
Advance Care Planning 
ADRD 
Alzheimer’s Disease and Related Dementias 
CPR 
Cardio-Pulmonary Resuscitation 
PCE 
Palliative Care Educator 
SW-CRT 
Stepped Wedge Cluster Randomized Trial 
BMC 
Boston Medical Center 
NLP 
Natural Language Processing 
EHR 
Electronic Health Record 
RA 
Research Assistant 
 
2 
Protocol Summary 
 
Title: 
Meeting the Challenges of COVID-19 by Expanding the Reach 
of Palliative Care: Proactive Advance Care Planning with 
Videos for the Elderly and all Patients with Dementia 
Short Title: 
Video Images about Decisions to Improve Ethical Outcomes 
with Palliative Care Educators (VIDEO-PCE) 
Population: 
Aim 1: Patients ≥65 years admitted to one of the study 
inpatient units 
Aim 2a: Any patient ≥18 years admitted to one of the study 
inpatient units with ADRD/delirium  
Aim 2b: Adult Caregiver of any patient in aim 2a 
Intervention: 
Palliative Care Educator using video decision aid shown at 
time of admission to patients/caregivers in wards/units 
randomized to the intervention phase 
Objectives: 
The overall objective of the present proposal is to reduce the 
burden of COVID-19 and advanced illness and its 
consequences for an aging U.S. population. 
Design/Methodology: 
This project is a multi-center stepped wedge cluster 
randomized trial of an advance care planning (ACP) video 
intervention (vs. standard of care) using a Palliative Care 
Educator among patients ≥65 years OR any patient ≥18 years 
old with ADRD regardless of age admitted to one of the study 
inpatient units 
Total Study Duration: 
2 years 
Subject Participation 
Duration: 
EHR data collection during the 16 months of enrollment (2 
months baseline plus 14 months intervention steps). EHR data 
abstracted for one year after the end of the 16 months of 
enrollment. 
 

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3 
Background/Rationale & Purpose 
 
3.1 
Background Information 
 
COVID-19 disproportionately affects the elderly and those with Alzheimer’s Disease and Related 
Dementias (ADRD/Delirium).1, 2 The COVID-19 pandemic has killed over 500,000 Americans and 
is a common and morbid condition, especially in people over the age of 65 and those with 
functional impairment and ADRD/Delirium.2 When COVID-19 strikes, these patients die at higher 
rates.2, 3 The surge in patients with COVID-19 poses a significant public health challenge and has 
the potential to compromise the orderly function of health institutions.4 
 
The palliative care needs of inpatients with ADRD/Delirium and those over 65 is rapidly 
increasing, and access to palliative care clinicians is limited. The majority of hospitals in the U.S. 
have palliative care programs; indeed, over the past decade access to palliative care services 
has increased dramatically.5-9 However, staffing capacity to meet the clinical needs continues to 
be a significant challenge.10-13 Many hospitals provide palliative care services only to a small 
portion of the patients that would be appropriately served by palliative care14, 15 and the scope of 
this problem has increased with COVID-19. New models are needed for palliative care services 
to meet the need.16 Older patients and those with ADRD/Delirium face the prospect of receiving 
burdensome and unwanted end-of-life care due to lack of palliative care services.  
 
Decision making in patients with ADRD/Delirium and their caregivers during COVID-19 is urgent. 
Patients with ADRD/Delirium have a small window of opportunity to state their preferences for 
the advanced stages of the disease before their disease makes them incapable of decision 
making. Without an Advance Care Planning (ACP) discussion, caregivers are often left to make 
treatment decisions for their loved ones with the advanced stages of the disease.17 Numerous 
studies have shown that caregiver decision making is no better than chance and often lacks 
stability over time.18 Caregivers often suffer a great deal of burden and distress attempting to 
develop a comprehensive care plan for the advanced stages of the disease.17 Caregiver stress 
and communication challenges are exacerbated by their exclusion from the hospital.19-21 COVID-
19 poses significant ACP challenges for patients with ADRD/Delirium and their caregivers. 
 
This study will be conducted in compliance with the protocol, applicable regulatory requirements, 
and BMC/BU Medical Campus Human Research Protection policies and procedures. 
 
3.2 
Rationale and Purpose  
 
Advance care planning (ACP) in older patients or patients with ADRD/Delirium needs 
improvement: ACP seeks to ensure that patients receive medical care consistent with their 
values, goals and preferences during serious and chronic illness.22 The lack of ACP 
documentation is associated with greater use of aggressive interventions, more terminal 
hospitalizations, lower hospice use, higher health care costs, and worse family bereavement 

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outcomes.17, 22 Unfortunately, ACP documentation in older patients and patients with 
ADRD/Delirium remains inadequate.23, 24 Furthermore, marked racial and regional disparities 
persist in ACP documentation for seriously ill patients.25 For the ACP process to lead to optimal 
decisions, patients and their caregivers require accurate, impartial and comprehensible 
information about their treatment options, and a care setting where communication needs are 
addressed early in their illness by a dedicated clinician.26-28 However, studies show that 
traditional written and verbal ACP does not effectively inform many patients and caregivers, and 
often occurs late in the disease process.22 High-quality ACP increases patient safety by ensuring 
that patients receive effective care that meets their goals. 
 
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.22, 29-31 Over the 
past few years, investigators have recognized the shortcomings of prior efforts and have 
developed new interventions to better facilitate ACP.22, 32-37 The video intervention proposed for 
this study focuses on patient, caregiver and clinician communication about treatments for 
medical care facilitated by a Palliative Care Educator (PCE).  
 
The COVID-19 PCE video intervention proposed for this study focuses on patient/caregiver and 
clinician communication about goals of care. Video aids to better educate and inform decision 
making are commonly used. These videos attempt to overcome language and literacy barriers 
and to present potential scenarios with a sense of reality lacking in verbal descriptions.54-56 These 
videos are available in 25 different languages, and attempt to overcome literacy barriers and to 
present potential scenarios with a sense of reality lacking in verbal descriptions. In addition to 
using videos, our PCEs will be trained in the Vital Talk program, the most widely disseminated 
teaching method that focuses on patient-centered serious illness communication skills training. 
To our knowledge, this is the first trial of PCEs trained in communication skills to engage patients 
with palliative care services with videos. If effective, this model can be rapidly disseminated to 
improve care for millions of Americans. 
 
Hospitalized patients often receive burdensome interventions as the default option, without a 
shared decision-making conversation or awareness of more comfort-oriented care.57, 58 Thus, 
patients are at high risk of receiving poor-quality care at the end of life given the burden of such 
care on patients. Poor ACP and communication about patients’ preferences for end-of-life care 
contribute substantially to the receipt of aggressive, costly, and unwanted medical care for 
patients with serious illness.31, 46, 48, 59-62 Therefore, improving palliative care services may prove 
to be an effective strategy to enhance the delivery and quality of medical care for hospitalized 
patients. ACP video tools have shown promising efficacy in educating patients about their 
options and informing their preferences for care.55, 63-66 Given the intensity of health care 
utilization for hospitalized patients, patients may greatly benefit from a PCE-led video 
intervention to expand the reach and impact of palliative care to inform and empower patients 
and their caregivers in the decision-making process and to improve the delivery of care that is 
concordant with their wishes during COVID-19.  

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4 
Objectives 
 
4.1 
Study Objectives 
 
The overall objective of this study is to reduce the burden of COVID-19 by expanding the reach 
of inpatient palliative care services, especially for patients with ADRD/Delirium. We propose to 
conduct a stepped wedge cluster randomized trial (SW-CRT) of a PCE video intervention among 
hospitalized patients aged 65 and over, or any patient ≥18 years with ADRD/Delirium and their 
caregivers in the ward and ICU settings of two major hospitals: Boston Medical Center (BMC) 
and North Shore University Hospital. Patient outcomes will be abstracted from electronic health 
records with Natural Language Processing (NLP).  
 
We will test our hypotheses via the following Specific Aims: 
 
Aim 1: To test the effects of a PCE video intervention leveraging video decision aids on the 
quality of end-of-life care. We will conduct a SW-CRT to evaluate intervention effectiveness by 
comparing the following outcomes among 9,000 hospitalized patients: ACP documentation; 
preferences for resuscitation; palliative care consults; and, hospice use. Hypotheses: A higher 
proportion of patients in the intervention phase (vs. control) will: (1) complete advance care plans 
(primary outcome), (2) have documented resuscitation preferences, (3) have palliative care 
consults, (4) enroll in hospice over the course of one year of follow-up, and (5) have documented 
health care proxies. 
 
Aim 2a: The manual chart review activity is intended only for the patients whose caregiver 
participated in the survey activity. It is distinctive from the NLP activities described in our protocol 
which identify ACP documentation from the free-text of clinical notes. The chart review will 
involve a thorough human review of structured ACP elements such as DNR/DNI order, 
MOLST/POLST and Health Care Proxy form completion in each patient’s chart.  
Aim 2b: To characterize caregiver-centered outcomes of patients with ADRD/Delirium, including: 
(1) knowledge, (2) confidence in future care, (3) communication satisfaction, (4) decisional 
satisfaction, and (5) decisional conflict in 600 caregivers of patients with ADRD/Delirium admitted 
to the hospital. Hypothesis: Intervention phase caregivers of patients with ADRD/Delirium (vs. 
control) will have higher knowledge, confidence, communication satisfaction, decisional 
satisfaction, and lower decisional conflict. 
 
 
 
IMPACT: COVID-19 poses a unique dilemma for older Americans and patients with 
ADRD/Delirium and their caregivers, who must balance their desire to live against the risk of a 
lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-
based, and innovative approach to assist patients facing such choices. We have a highly 
experienced team and infrastructure at BMC and North Shore to execute this proposal. If proven 

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effective, this innovative care model can be immediately deployed across the country to improve 
the quality of care for millions of Americans. Given the urgency of the need for scalable 
interventions, this study will provide the evidence quickly and efficiently to improve care rapidly 
across the country. 
 
4.2 
Study Outcome Measures 
 
4.2.1 Primary Outcome Measures 
 
The primary outcome of this trial is ACP documentation any time during the index hospitalization 
as ascertained by NLP-assisted EHR review for any qualifying documentation of ACP in the EHR 
note (goals of care, advance directive, MOLST/POLST, code status, palliative care or hospice) 
(yes versus no). 
 
4.2.2 Secondary Outcome Measures 
 
Secondary outcomes include: 
• 
Code status preferences (Aim 1) 
• 
Use of palliative care consult/services (Aim 1) 
• 
Hospice use (Aim 1) 
• 
Health Care Proxy (Aim 1) 
 
Secondary outcomes related to Aim 2a (patients 18+ years admitted to one of the study inpatient 
units with ADRD/delirium) include: 
• 
Documentation of ACP Preferences in Electronic Health Record 
 
Secondary outcomes related to Aim 2b (caregivers of patients with ADRD/Delirium) include: 
• 
ACP knowledge (Aim 2) 
• 
Confidence in future care (Aim 2) 
• 
Communication satisfaction (Aim 2) 
• 
Decisional satisfaction (Aim 2) 
• 
Decisional conflict (Aim 2) 
 
5 
Study Design 
 
This is pragmatic SW-CRT of a PCE-led, video-assisted COVID-19 ACP intervention in inpatient-
based units (3 medical-surgical wards, Medical ICU, Cardiac ICU, Neurology ICU, step-down 
unit) at two hospitals: BMC and North Shore University Hospital (Northwell Health). All inpatients 
≥65 and all patients with ADRD/Delirium ≥18who are hospitalized on a unit during the 
intervention phase will receive the intervention.  
 
This 2-year study (2 month data collection and tool preparation, staff training and site 
standardization (we are already embedded in both health systems doing similar work; thus this 

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short timeframe is feasible); 16 months rolling recruitment and surveying; 2 months data cleaning 
and analysis, and 4 months manuscript preparation and dissemination of findings) will roll out the 
intervention to 14 randomized inpatient units at 2 sites. Every two months, an additional inpatient 
unit will be added to our intervention at each hospital, i.e., there will be seven waves or "steps"; 
for a total of 7 units at each hospital.  
 
Consistent with a SW-CRT with two hospital units per step (cluster), prior to the collection of any 
data in the pre-intervention period, we will generate a set of uniform random numbers for each of 
the seven clusters to be assigned to a starting period for the study intervention. There will be 
eight study periods in total with a usual care period at the start of the study for all clusters. The 
first randomized intervention period will then begin in period two.  
 
 
Baseline 
14 Months of Clustered Intervention Expansion  
Cluster 
M0 
M2 
M4 
M6 
M8 
M10 
M12 
M14 
1 
 
 
 
 
 
 
 
 
2 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
5 
 
 
 
 
 
 
 
 
6 
 
 
 
 
 
 
 
 
7 
 
 
 
 
 
 
 
 
 
The data needed to assess the outcomes for all patients will be derived from each hospital's 
EHR (Aim 1).  
 
For Aim 2b, 600 caregivers of patients with ADRD/Delirium (300 control phase; 300 intervention 
phase) will be surveyed by telephone during (or within one week of) the index hospitalization to 
assess caregiver-centered outcomes.  
 
Each day PCEs, who will be nurses or social workers on the palliative care team, will approach 
patients who are currently hospitalized under Aim 1 or Aim 2a. The PCE will then proactively use 
the goals-of-care video decision aid (or any of the additional videos regarding CPR, hospice, 
dementia, etc., as relevant and in the appropriate language) to provide educational support and 
assist in delivering primary palliative care services relating to goals-of-care conversations and 
ACP documentation. The videos range from 4-6 minutes in length and the PCE will watch the 
videos together with the patient and caregiver on an iPad (or remotely via telehealth with the 
caregiver).(130)  
 
The PCE will arrange all video showings to include patient and caregiver (when possible and 
acceptable to the patient); when patients are unable to view a video (e.g., loss of capacity, 
delirium), the caregiver will view the video. The videos do not replace clinician counseling; 
indeed, they are designed to allow the PCE to confirm comprehension and to stimulate 

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conversation with a shared vocabulary. The PCE will then communicate the patient’s or 
caregiver’s wishes to the treating primary medical team to coordinate care.  
 
In cases when the PCE deems that engagement with the full palliative care team is warranted, 
they will approach the treating primary medical team to place the consult. If/when the PCE 
exhausts the automated list for patients, they will coordinate with the palliative care consult team 
to select patients from the list of requested consultations. The PCE role will be fully integrated 
into existing hospital practices at our sites consistent with the pragmatic nature of this study 
design. 
 
For Aim 1, the study population will consist of patients 65 years or older who are admitted to one 
of the study inpatient units in the hospital. For Aim 2a, the study population will consist of any 
patient ≥18 years admitted to one of the study inpatient units in the hospital with a diagnosis of 
ADRD/Delirium. For Aim 2b, the study population will consist of adult (≥18) caregivers of patients 
identified in Aim 2a. These caregivers will be recruited to complete a phone survey for our 
secondary caregiver outcomes  
 
The data needed to assess the outcomes for all patients aged 65 or over will be derived from 
each hospital's EHR (Aim 1). For Aim 2, 600 caregivers (300 control phase; 300 intervention 
phase) will be surveyed in-person (or remotely) during the index hospitalization to assess 
caregiver-centered outcomes.  
 
6 
Potential Risks and Benefits 
 
6.1 
Risks 
The potential risks are minimal given the fact that the intervention promotes learning about 
medical care for patients, improves communication for patients and their families regarding 
advance care planning and self-determination, and the concordance between patient’s wishes 
and the care they receive.  
The major potential risk for subjects is loss of confidentiality. Loss of confidentiality is very 
unlikely because specific procedures have been implemented by the research team to prevent 
such disclosure and these measures will be maintained during the proposed study. Another risk 
in Aim 1 is being upset by the intervention videos/questions. Probability of this occurrence is 
minimal. We have conducted a series of clinical trials for patients with advanced illnesses and 
have rarely had patients get upset due to the topic. In each of these cases, the participant was 
interested in continuing after a short break. 
For subjects enrolled in Aim 2, there is a risk that they could become upset or saddened by some 
of the survey questions. 
 
6.2 
Potential Benefits 
 

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This study provides no direct benefit to subjects, however 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.  
 
6.3 
Analysis of Risks in Relation to Benefits 
 
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 inpatient population, and particularly those with 
ADRD/Delirium. Thus, the risk/benefit balance for this study appears favorable. 
 
 
7 
Study Subject Selection 
 
7.1 
Subject Inclusion Criteria 
 
Over the two years of the trial, we will examine data on approximately 15,000 patients ≥65 
admitted to these 23* units for our primary and secondary outcomes (Aim 1). Given the 
pragmatic nature of this trial, our inclusion criteria are quite broad and consistent with the goal of 
pragmatic trials. 
 
We will also survey caregivers of 600 patients with ADRD/Delirium to conduct a telephone 
administered survey for caregiver-centered outcomes (knowledge, confidence, communication 
satisfaction, decisional satisfaction, and decisional conflict) during the index hospitalization. 
Caregivers may or may not be designated as ADRD/Delirium legal surrogate decision maker for 
the patient (i.e., most patients with ADRD/Delirium do not have a legally designated 
representative.) Any adult identified in the EHR as the contact family member or friend will be 
eligible to partake in the caregiver survey. Half of surveys will be conducted during the control 
period; half during the intervention period. Caregivers will be either English- or Spanish-speaking 
adults, which are the languages in which our surveys are validated. For patients in the control 
group, surveys will be completed during the hospital stay or within 1 week of discharge. For 
patients in the intervention group, the survey will be completed AFTER the PCE intervention, and 
up to 1 week after discharge. 
 
*14 units (7 per hospital) will be included in the stepped wedge trial, an additional 9 units (3 at 
BMC and 6 at NorthShore) will be used to recruit additional control participants only.  These 
additional units were added due to low recruitment at the start of the study and the decreasing 
number of control units as the stepped wedge design progresses. The target enrollment of 600 
caregivers is still accurate. 
 
Adding delirium to the list of eligible diagnoses will also increase the potential number of eligible 
subjects.  The surveys are applicable to the caregiver of any patient who is not capable of 
making their own health decisions; this includes patients who are experiencing any sort of 
memory or cognitive decline. 

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7.2 
Subject Exclusion Criteria 
 
For Aim 1, there are no exclusion criteria. 
 
For Aim 2a, there are no exclusion criteria. 
 
For Aim 2b, not speaking English or Spanish, which are the languages in which our surveys are 
validated. 
 
• 
We will not be including individuals who are not yet adults (infants, children, teenagers) 
• 
 
• 
We will not be including prisoners 
 
8 
Study Intervention 
 
A palliative care trained provider (a nurse or social worker on the palliative care team) will serve 
as the PCE. Using the ACP videos on a tablet via a Video App, the PCE will provide educational 
support and assist in delivering primary palliative care services relating to in-the-moment goals-
of-care conversations and ACP documentation for patients that are hospitalized. PCEs will be 
members of the Palliative Care team, coordinate daily activities with the team, and report to the 
head of the Palliative Care service. PCEs will serve in a triage function to manage cases that can 
be handled with educational support for goals-of-care conversations and ACP documentation or 
to stimulate full palliative care consultation. PCEs will directly coordinate communication of the 
patient’s preferences with the treating primary medical team. A key aspect of this trial design is 
the fully integrated role into existing hospital practices of the PCE position. 
 
PCEs will receive Vital Talk intensive communication skills training via a highly structured series 
of Zoom conferences. The PCEs will also be trained on use of the ACP certified videos using the 
ACP App. Training will instruct clinicians on how to: 1. Introduce the videos to patients and 
caregivers; 2. Use the videos as adjuncts to ACP counseling by clinicians; 3. Select the 
appropriate video(s) from the entire suite according to patients’ needs; and, 4. Prescribe videos 
for patients and caregivers using the electronic platform. The suite of ACP videos is designed to 
address common ACP decisions confronting patients at risk or with COVID-19 and their 
caregivers. The videos also cover all of the decision points surrounding ADRD/Delirium (e.g., 
feeding tubes, resuscitation, etc.). The videos are intended to be an adjunct to clinician 
counseling, not to replace it. Suggested videos for clinicians to use with patients will include 
goals-of-care videos, general ACP videos, intervention-specific videos such as ventilatory 
support or CPR, and hospice videos. PCEs will also have an array of videos to support 
caregivers, including videos regarding compassionate extubation if this is relevant. 
 
The PCE will encourage the patient to make their wishes known to their family or other caregiver 
(and will offer to facilitate a call/video-call) and the attending, and that with the patient's 

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permission, will relay their wishes to the treating team in addition to completing ACP 
documentation in the EHR. As an integrated part of existing hospital practice, PCE will 
communicate with the primary treating team and the palliative care team. When there are 
palliative care needs beyond ACP (e.g., symptom control) or if the PCE determines that the 
support of the full palliative care team is warranted, the PCE will recommend to the treating team 
to place the consult request. The PCE will not be collecting any data for research purposes only. 
For QI purposes, the Palliative care consult team will keep tracking documents of the PCE 
activities (number of patients seen per day, amount of time spent with each patient, etc). This is 
needed for supervisory purposes. These may be reviewed retrospectively by the research team 
and compared to research data. In this case, an amendment will be submitted to the IRB to 
cover these activities. 
 
 
9 
Study Procedures 
 
Eligibility 
Aim 1 and Aim 2a: Each day, PCEs will review a list of inpatients who are ≥65 or have a 
diagnosis of ADRD/Delirium  
 
Aim 2b: Study staff will contact identified adult caregivers by phone to describe the survey 
activity 
 
Recruitment 
For Aim 1, all patients over the age of 65 will be included in the trial. For those patients admitted 
to wards/units in the intervention phase, the PCE will proceed with primary palliative care and 
view the ACP videos with the patients and family. For patients over the age of 65 admitted to 
wards/units that are in the control phase, usual care will proceed without the use of the PCE. 
 
For Aim 2a, we will identify 600 inpatients to the study units with ADRD/Delirium who are 18+ 
years old. 
For Aim 2b, 300 caregivers of the patients identified in Aim 2a will be surveyed during the control 
phase, and 300 caregivers will be surveyed during the intervention phase. For the group of 
caregivers (N=600) being surveyed for caregiver-centered outcomes, individual verbal informed 
consent will be obtained. The RA will survey caregivers using a validated survey tool. For 
patients with ADRD/Delirium and their caregivers that are admitted to a ward/unit that has been 
randomized to the intervention, the PCE will proceed with the video intervention. 
 
 
Recruitment efforts for the caregiver survey (Aim 2) will be limited to English- and Spanish-
speaking caregivers who are able to independently consent to participate in a research study. 
Research staff will work with the care team on the inpatient units where identified patients 
are currently hospitalized.  The health care team will locate (either in person or by phone) 
designated caregivers for identified patients and invite them to participate. A member of the care 

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team will approach the caregiver and ask if they would be interested in getting a phone call from 
the research team to get more information about the study.  If the caregiver says yes, the RA will 
call them, read the recruitment script (attached), and, if the subject is willing, review the consent 
form and complete the survey. If the designated caregiver cannot be located to invite to 
participate, an invitation letter with opt-out postcard will be mailed to them. 
 
Informed Consent 
 
For Aim 1, there are special informed consent considerations in this pragmatic SW-CRT: the 
hospital clinical unit is the level of randomization, the intervention is of low risk and will be 
implemented as the standard of care for the whole clinical unit, and data for our primary outcome 
and related outcomes derived from the EHR are ascertained from existing sources. Thus for this 
aspect of our proposal, we will seek a waiver of individual informed consent and HIPAA 
authorization after careful review of the criteria to do so as we have previously done successfully 
in prior studies. The research involves no more than minimal risk to the subjects as described 
above. We do not believe the waiver will adversely affect the rights and welfare of the subjects. 
As a pragmatic trial of thousands of hospitalized patients and clinicians, this research could not 
practicably be carried out without the waiver nor without access to and use of PHI of patients.  
 
For Aim 2a, we will seek a waiver of individual informed consent and HIPAA authorization due to 
the fact that this is a low risk activity (chart review), and the target population is incapable of 
consent due to a diagnosis of ADRD/Delirium. 
 
For Aim 2b, verbal informed consent will be obtained for the phone survey. The caregiver survey 
should take less than fifteen minutes.  
 
Natural Language Processing (NLP) Data Collection 
Over the course of the study, we will review the charts for all enrolled participants. For Aim 1 and 
Aim 2a, the inpatient EHR records (including those with ADRD/Delirium) will be analyzed 
(approximately 15,000 patients across both sites).  
 
 
Initial NLP analyses will be done locally at each data collection site (BMC and Northwell) using 
software that was developed at DFCI for this purpose. The results of that initial analysis will be 
coded and sent as a HIPAA LDS via HIPAA approved cloud folders such as Box.com to our NLP 
partners at DFCI. Each site will retain a local mastercode file that will not be shared with anyone 
outside the institution. Patients will be assigned a unique identifier that will be used on datasets 
shared with DFCI. 
 
DFCI will have a reliance agreement in place with BUMC and Data Transfer Agreements in place 
with both BMC and Northwell.  
 

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Every 2 months (the size of each step; 1 baseline + 7 steps = 8 data transfers) the outcomes of 
interest using NLP will be transferred to our data collection site (DFCI). Data on the following 
outcomes will be collected until the end of the study period.     
 
• 
ACP discussion (e.g., goals-of-care discussion, advance directive, 
MOLST/POLST, code status, etc.) 
• 
Resuscitation preferences 
• 
Palliative care consults 
• 
Hospice Use 
• 
Health care proxy discussion 
 
 
As stated above, direct identifiers will be held at each respective site (BMC researchers can see 
BMC identifiers but not North Shore University Hospital’s identifiers, and vice versa.) The risks 
will be minimal as the data will be stored and analyzed on a HIPAA secure cluster at each site. 
None of the data will be stored in paper form. The data and identifiers will be kept for seven 
years after the end of the study period on the HIPAA secure cluster computer at each site. After 
the seven years, all HIPAA identifiers and all linking codes will be permanently destroyed in 
accordance with regulation. 
 
NLP Validation 
Prior to the use of NLP for outcome assessment in this trial, we will entrain and validate the NLP 
process for each of our two study sites.  Specifically, we will use historic note data from a sample 
of 20 patients from each site who meet enrollment criteria. We will then measure the validity of 
this process by comparing results from human assisted NLP to a human chart review. The goal 
of the keyword library validation process is to ensure that the keyword library and abstraction 
guidelines accurately represent the language used to communicate information associated study 
outcomes. The semi-automated note annotation process will be cross-validated across both 
sites. Clinical notes will be the substrate of this process and must be requested from each site’s 
clinical data warehouse. 
 
Each site will ensure that the appropriate IRB and Data Sharing protocols are in place before this 
activity begins. 
 
Chart Review  
EHR data will be extracted by manual chart review on all Aim 2a patients whose caregiver 
completes a survey (2b). This survey will be limited to the inpatient stay that generated the 
survey, and include the following elements for collection of secondary outcomes: 
• 
DNR/DNI order 
• 
MOLST/POLST filed 
• 
Resuscitation/Intubation preferences 
• 
Health Care Proxy specified 
• 
Palliative Care Consult during hospitalization 

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• 
Discharge Disposition 
 
A detailed chart review instrument is attached to the protocol. 
 
Withdrawal 
We do not anticipate any circumstances where the caregiver will withdraw from participation in 
the study. Study staff will make clear to the caregiver that participation is entirely voluntary and 
may be withdrawn at any time. 
 
Masking 
Due to the nature of the intervention, participants and staff will not be blinded to the intervention. 
 
The NLP outcomes adjudication process is not fully automated in this study. We are doing a 
human-assisted NLP process in which a staff member validates the text presented in the 
software as a possible outcome. For NLP analysis, the following steps will be taken to ensure 
blinding to study step assignment by the staff member doing the NLP outcome attribution: 
 
• Prior to adjudication activities, names will be coded 
• Annotation will be performed in large batches with all patients enrolled who have clinical 
notes to that point.  
• NLP notes for adjudication will not be grouped by Study ID when presented to annotators. 
Each note will be annotated individually, without reference to concepts contained in other 
notes annotated before or after. 
• When possible, a staff member who did not enroll the participants will perform the 
annotation. 
 
Caregiver Surveys 
Caregivers will be surveyed using a REDcap survey. The REDCap project will be hosted by 
BUMC, both sites will enter data into the same project. All subjects will be assigned a unique 
identifier that will be entered into REDCap.  All other PHI will be retained in a linking file that is 
not shared outside the institution.  
 
Caregiver data will be linked with the associated patient EHR data, but this linking file will be kept 
locally, and only HIPAA LDS will be shared with other sites included on this protocol.  
 
Costs/Payment 
There are no costs to subjects for participating in this study. 
 
Caregivers will be compensated $50 for completing the survey. 
 
 
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
 
10.1 Definitions 

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The following definitions will be used in the assessment of safety: 
 
ACP is a standard part of clinical care for patients. The caregiver survey, however, is purely a 
research activity. We have had excellent experiences with prior caregiver surveys. At the same 
time, it is possible that this survey could make these subjects upset as they consider advance 
care planning issues for their family member. In the context of this study, an expected adverse 
event would be if the participant became distraught during the survey administration, to the point 
of not being able to complete the survey, or asking to end the survey prematurely. In this unlikely 
event, the event will be documented on an AE Reporting Form and reported per the guidelines 
outlined below.  We do not anticipate any Serious Adverse Events. 
 
Unanticipated Problem is defined as an event, experience or outcome that meets all three of the 
following criteria:  
• 
is unexpected; AND 
• 
is related or possibly related to participation in the research; AND 
• 
suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized.  
 
Possibly related means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research 
 
Unexpected means the nature, severity, or frequency of the event is not consistent with either: 
• 
the known or foreseeable risk of adverse events associated with the procedures involved in 
the research that are described in (a) the protocol–related documents, such as the IRB-
approved research protocol, any applicable investigator brochure, and the current IRB-
approved informed consent document, and (b) other relevant sources of information, such 
as product labeling and package inserts; or 
• 
the expected natural progression of any underlying disease, disorder, or condition of the 
subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile 
for the adverse event. 
 
 
10.2 Safety Review 
 
Both the risks listed in Section 6.1 and unknown risks will be monitored as follows: 
Participants will be informed that they may decline to answer any question that makes them 
feel uncomfortable. If any adverse events occur, the Principal Investigator will be notified as 
soon as possible and a corrective plan will be developed and put to use. All AEs will be 
reported to the IRB at each continuing review. 
 
 
10.3 Reporting Plans 

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The Principal Investigator at the site where the event occurred will report Unanticipated 
Problems, safety monitors’ reports, and Adverse Events to the local IRB in accordance with IRB 
policies: 
• 
Unanticipated Problems involving a fatal or life-threatening event will be reported to the 
local IRB and to the IRB of record (BMC/BUMC IRB) within 2 days of the site Principal 
Investigator learning of the event. 
• 
Unanticipated Problems not involving a fatal or life-threatening event will be reported to the 
local IRB within 7 days of the site Principal Investigator learning of the event. 
• 
Reports from safety monitors with recommended changes will be reported to the IRB within 
7 days of the investigator receiving the report.  
• 
Adverse Events (including Serious Adverse Events) will be reported in summary at the time 
of continuing review, along with a statement that the pattern of adverse events, in total, 
does not suggest that the research places subjects or others at a greater risk of harm than 
was previously known. 
• 
Reports from safety monitors with no recommended changes will be reported to the IRB at 
the time of continuing review.  
• 
When reporting to the local IRB the site Principal Investigator will also report to the 
administrative study Principal Investigator Dr. Rao. Such reporting will also include all 
findings and determinations made by local IRBs.  
 
The Principal Investigator will report Unanticipated Problems and Adverse Events to the Data 
Safety Monitoring Board at each bi-monthly Board meeting or as established in the DSMB 
charter. 
 
The Data Safety Monitoring Board will communicate its reports and recommendations per IRB 
policies, the DSMB charter, and the study Sponsor. 
 
Per the DSMB charter, the Board will meet every six months to review safety issues and study 
progress. 
 
10.4 Stopping Rules 
 
The study has no preset stopping rules.  
 
11 Data Handling and Record Keeping 
 
11.1 Confidentiality 
 
Aim 1 Data: Each site (BMC and North Shore Hospital) will collect identifiable EHR data for all 
eligible patients as described above. All patients will be assigned a unique identifier, and each 
site will retain a linking file that will not be shared outside of the institution, and will only be 
accessible to authorized study personnel.  At BMC, all data will be stored in password-protected 

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files on a network server located inside the BMC firewall, which is in compliance with data 
storage requirements for PHI as defined by BMC.  At North Shore, all data will be stored on an 
excel spreadsheet that is password protected on Microsoft OneDrive. OneDrive is a HIPAA 
compliant platform for data storage and sharing and has been vetted by Northwell Health’s 
Research IT and Research Compliance teams.  
 
At both sites, any paper records containing study data will be stored in a locked cabinet that is 
only accessible by the study team. Research participants will be given unique study IDs upon 
enrollment. The links between participants and their identities will be kept on password protected 
excel sheets on that are also restricted to authorized study personnel. Data that is shared with 
external collaborators will be de-identified prior to sending and at least two members of the study 
team will review the data to confirm that no PHI is present.  
 
All data transfers will be via secure cloud link such as Box.com. 
 
Aim 2 Data: All survey data collected at both sites will be entered into a REDCap project housed 
at BUMC.  Patients will be identified by unique identifier only, but a separate linking file (not in 
REDCap) will be kept at each site and not shared outside the institution. This linking file will be 
used to link survey data to the associated patient EHR data. When this data is shared with BMC 
for data analysis, only a HIPAA LDS will be transferred via secure cloud link such as Box.com. 
 
The study monitor or other authorized representatives of the sponsor may inspect all documents 
and records required to be maintained by the investigator. 
 
 
11.2 Source Documents 
 
Source documents for this study will consist of electronic health record (EHR) data from each 
data collection site (Boston Medical Center and Northshore Medical Center). Data generated by 
the methods described in the protocol will NOT be recorded in the subjects' medical records 
and/or study progress notes. Data may be transcribed legibly on CRFs supplied for each subject 
or directly inputted into an electronic system or any combination thereof. 
 
 
11.3 Case Report Forms 
 
The study CRF will be the primary data collection instrument for the study. All data requested on 
the CRF will be recorded. All missing data will be explained. Questions will have a response 
option for “Subject chose not to answer” or “Not applicable”.  
 
CRF List: 
Sociodemographics 
ACP Knowledge 
ACP Engagement 

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Confidence in future care 
Communication satisfaction 
Decisional satisfaction 
Decisional conflict 
 
  
 
11.4 Study Records Retention 
 
Study records, both paper and electronic versions, will be retained, per BMC policy, for at least 
seven years after completion of the study.  
 
11.5 Data Management 
 
Boston Medical Center will serve as the study data repository. A dedicated REDCap database 
housed at BMC will be used to manage randomization and survey data entry across all sites. 
Data will be regularly checked for errors and completeness. 
 
Survey Data 
Survey data from each of the clinical sites will be transmitted via secure, institutionally approved 
methods to Boston Medical Center. Identifying information in REDCap will be limited to only what 
is necessary for study procedures, and these will only be accessed to conduct study activities 
(contact information for study interviews). According to standard REDCap protocols, all access 
will be subject to monitoring and reporting. Assurance of confidentiality of information will be 
made to all subjects. Data will be handled with the same confidentiality accorded to patients’ 
medical records.  
 
Natural Language Processing (NLP) Data 
The RA and site-PI at each of our two sites, where data is being collected, will extract data every 
two months 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. NLP data from each of the sites will be 
processed locally and then a HIPAA LDS of these data will be transferred via secure 
institutionally approved methods to Dana Farber Cancer Institute (DFCI) for data management 
and then to BMC to be merged with the rest of the study data repository. Data stored on the 
Dana Farber 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 BMC long-term servers for storage.   
 

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Specific procedures protecting subject confidentiality will be as follows: 
1. Access to data files will be secured with a password-filing system (that logs entry) and is 
restricted to authorized staff only. 
2. Necessary hard-copy records containing study data of any type will be kept in locked 
files. 
3. 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 at the 
site. 
4. 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. 
5. Sign-out procedures for all access to data files will be strictly enforced. 
6. All reports and publications will preserve participants’ anonymity. 
 
 
12 Statistical Plan 
 
12.1 Study Hypotheses 
 
Aim 1: To test the effects of a PCE video intervention leveraging video decision aids on the 
quality of end-of-life care. We will conduct a SW-CRT to evaluate intervention effectiveness by 
comparing the following outcomes among 15,000 hospitalized patients: ACP documentation; 
preferences for resuscitation; palliative care consults; and, hospice use. Hypotheses: A higher 
proportion of patients in the intervention phase (vs. control) will: (1) complete advance care plans 
(primary outcome), (2) have documented resuscitation preferences, (3) have palliative care 
consults, (4) enroll in hospice over the course of one year of follow-up, and (5) have documented 
health care proxies. 
 
Aim 2: To characterize caregiver-centered outcomes of patients with ADRD/Delirium, including: 
(1) knowledge, (2) confidence in future care, (3) communication satisfaction, (4) decisional 
satisfaction, and (5) decisional conflict in 600 caregivers of patients with ADRD/Delirium admitted 
to the hospital. Hypothesis: Intervention phase caregivers of patients with ADRD/Delirium (vs. 
control) will have higher knowledge, confidence, communication satisfaction, decisional 
satisfaction, and lower decisional conflict. 
 
 
12.2 Sample Size Determination 
 
Statistical power and sample size: All sample size estimates here assume a minimum of 80% 
power and a two-sided alpha of 0.05. We employ the method for the computation of sample size 
for cross-sectional stepped wedge studies comparing intervention to usual care in two-group 
statistical analyses. This method incorporates information on the number of steps used in the 

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stepped wedge/cluster randomized design, the number of subjects per time period, and the 
degree of clustering via the intraclass correlation coefficient (ICC) to compute the design effect, 
the factor by which the sample size found to provide sufficient statistical power for a meaningful 
intervention difference in outcome assuming independent data is multiplied. For the primary 
outcome of the documentation of ACP in the medical record, a sample size of 440 records per 
group in a chi-squared test for independent data will provide 80% power at a two-sided alpha of 
0.05 to detect a difference in the proportion of subjects with notation of 35% in the intervention 
group compared to 25% in the usual care group, values consistent with prior research and 
expectation based on clinical data from the two health systems estimated from recent data. 
Based on our planned number of steps (7 with one uniformly applied usual care period across all 
hospital units), enrollment per study period, and a reasonable ICC of 0.01, the design effect is 
2.72. Thus, we will need to obtain outcome data from the records of at least 2394 subjects 
overall (1197 per health system) to provide 80% power for our analysis of intervention 
effectiveness. We anticipate, however, that as many as 15,000 records will be available for 
analysis with respect to the documentation of ACP. Thus, our planned sample size for our 
primary records-based analysis on 15,000 records will therefore provide more than adequate 
power to test for differences in our primary outcome. 
 
Data for Aim 1 is derived from the EHR and as is typical for trials that integrate new initiatives 
within the workflow of large institutions in a SW-CRT that does not involve consent. Indeed, we 
have been previously approved by multiple IRBs for such activities. Along with our exceedingly 
efficient NLP-assisted and human-confirmed software method for EHR data extraction, we can 
have a very large study sample with for this activity.  
 
Please note: We anticipate the population under study in Aim 1 to exceed that required by a 
simple application of the power calculation presented above. However, this is warranted for eight 
reasons. First, the size of this observed population gives us the opportunity to examine 
intervention effects for less common outcomes. Second, this sample size will allow us to 
evaluate potential heterogeneity in treatment effects for subpopulations as small as 20% of the 
population. Third, this sample size provides an experimental context in which we will be able to 
recruit a population of 600 patients with ADRD/Delirium and their associate caregivers for 
surveying. Indeed, to sustain the activities of Aim 2, we need a large population to draw from, as 
many of the people under study for Aim 1 would not be eligible for participation in Aim 2. Fourth, 
the size of the population for Aim 1 also protects this trial from the potential that we will have 
significantly varying sizes of study clusters, a factor that is often neglected in sample size 
assessments for SW-CRTs.(145) Indeed, this is a likely phenomenon as hospital units vary 
significantly in their population of patients. Fifth, there is minimal risk to human subjects 
presented by the expanded sample size for Aim 1. Indeed, this educational intervention is being 
spread across the clinical units of our two hospitals in a pragmatic manner as part of the 
standard of care. The research activities of Aim 1 involve no direct burden to patients as there is 
no consent process and data for this activity will be derived from the EHR. The chief risk is the 
loss of confidentiality and robust protections are in place to protect patients from this potential 
risk. Sixth, we plan to extend this intervention as a new clinical initiative in our two health 
systems in a manner (time per cluster) that has been endorsed by leadership as a reasonable 
rate for dissemination (i.e., we are not adding more time). Seventh, we have devised an 
exceedingly efficient and accurate method for outcome assessment (i.e., we are not adding more 

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cost). Eighth, we will protect against inappropriate conclusions. We understand that treatment 
effect sizes will be more relevant than p-values and that clinical significance is the goal (not 
simply statistical significance).(146, 147) We have set an absolute increase of 10%, i.e., an 
increase of ACP documentation during the index hospitalization from 25% to 35%, as the 
benchmark for clinical significance. In summary, the size of Aim 1 is needed to be able to do 
Aim 2b and we have taken appropriate measures to ensure that the research design for 
Aim 1 does not yield consequences for being overpowered. 
 
For the interview survey derived outcomes (knowledge, confidence in future care, 
communication satisfaction, decisional satisfaction, and decisional conflict) with approximately 
600 subjects available across the 7 “clusters”/steps, the resulting design effect is 2.03 (again, 
assuming an ICC of 0.01). For this analysis sample size, the minimum effect size that can be 
detected for the uncertainty and knowledge scores separately with 90% power and alpha=0.05 
would be 0.53 after applying the design effect. In sum, our anticipated sample sizes for both 
our primary and secondary aims will provide adequate statistical power to detect 
moderately sized and clinically important effects of the intervention and account for the 
cluster-randomized nature of our stepped wedge study design. 
 
 
12.3 Statistical Methods 
 
Statistical Analysis: For the primary analyses of the primary and secondary outcomes, there 
will be no crossover of data for subjects from usual care to the intervention during the study; that 
is, subjects will only contribute data once during the course of the study, from their index 
hospitalization. Similarly, patients who move units during the course of their index hospitalization 
will be assigned to contribute intervention time data if they spend at least eight daytime weekday 
hours after being identified as meeting the inclusion criterion on a clinical unit where the 
intervention is being conducted. Accordingly, data being contributed by patients at each site 
during the pre-intervention period and data being contributed by patients after the initiation of the 
intervention will be kept separate for initial analyses. However, because we expect some patients 
to have multiple hospitalizations during different steps or to different units (i.e., crossover 
design), we will perform secondary analyses on all outcomes including data from the index 
hospitalization. This will include stratified sensitivity analyses of patients who contribute data (a) 
only to control period; (b) only to intervention period; or, (c) to both control and intervention 
periods. 
 
Given the randomized nature of the stepped wedge design, we will report our results 
according to CONSORT guidelines. For the aims of the study that require patient/caregiver 
enrollment (Aim 2), we will record the number of people approached, screened, ineligible, and 
refusing participation. We will record subject attrition and note all adverse events. We will employ 
the intent-to-treat principle in our comparative analyses between the intervention and usual care 
groups. All hypothesis tests will employ a two-sided alpha level of 0.05. Given that the primary 
aim will be addressed by the analysis of data obtained from available patient records for the 
study period, we will examine the distributions of relevant variables focusing on the data relating 
to the documentation of ACP, the outcome of this aim. For the secondary aims of the study that 
will require enrollment of a caregiver sample for interview (Aim 2), we will examine the 

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distributions of the uncertainty and knowledge scale scores, the outcomes of interest between 
intervention and usual care subjects, as well as the distributional characteristics of all other 
salient study variables. We will generate descriptive statistics (means, standard deviations, 
quantiles for continuous variables; counts and percentages for categorical variables) and 
schematic plots (box-and-whisker, quantile-quantile plots). Given the nature of the cluster 
randomization that we will employ, we will utilize statistical analytic methods that take the 
correlated nature of the data into account as well as the influence of time to account for secular 
trends. In this study, we will examine both the health system and hospital unit as clustering 
variables, with the hospital unit as the primary clustering variable. We will compare the 
intervention and usual care groups on salient variables in order to assess balance in the 
distributions of these variables. Variables found to differ between the study groups will be further 
evaluated to assess their confounding effects of intervention vs. usual care differences on 
outcomes in multivariable analyses for correlated (clustered) data. 
 
Aim 1. To test the combined effects of a COVID-19 ACP Educator-led, video-assisted palliative 
care intervention on rates of: ACP documentation; Medical orders for resuscitation preferences in 
the EHR; Palliative Care Consults; and, Hospice use. Hypothesis: A higher proportion of 
patients in the intervention phase (vs. control) will: complete ACP documentation (primary trial 
outcome), have documented orders for resuscitation preferences, have palliative care consults, 
and enroll in hospice. 
 
Primary outcome: ACP documentation. In order to formally estimate and test differences in the 
proportion of patients with documentation of ACP between the intervention and usual care 
groups, we will employ logistic regression models for correlated binary outcome data. These 
models will either involve the use of robust variance methods to account for the clustering of 
these data by hospital site and/or health system via generalized estimating equations (GEE) or 
the inclusion of a random effects terms (in which case, the results will be interpreted as cluster-
specific). Other potential modifiers of the effect of intervention, confounding variables, or 
covariates can be added to this model as fixed effects. Although we do not expect effect 
modification in the study data, we will examine the potential for such effects (interaction) through 
the use of stratified analyses and the inclusion of interaction terms with study group in our 
statistical models. Candidate effect modifiers will be specified a priori and will include age, 
gender, race/ethnicity, religion, and language. We will also examine and incorporate secular 
trend effects, i.e., the effect of time over the course of the study. Statistically significant 
interactions with the intervention will be retained and the nature of heterogeneous intervention 
effects will be estimated using the interaction model.  
 
Based on our prior work in which we exhibited the fact that African-American and Hispanic 
patients are at particularly high risk for lower level of knowledge related to ACP, not discussing 
ACP with family, not having a health care proxy, and not having ACP documentation, we 
anticipate that this intervention may be particularly beneficial for African-American and Hispanic 
patients.(115, 131, 132) Accordingly, we will evaluate heterogeneous treatment effects by race 
and ethnicity and anticipate having adequate diversity in our study population to make such 
assessments. All data regarding Aim 1 will come from the EHR. Our institutions maintain 
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We will conduct analyses related to potential effect modification as a step in our model 
validation process and to identify relationships that can be examined more fully in future 
research. Should interactions not be found to be statistically significant, we will fit a main effects-
only model and use it to formally evaluate confounding by applying a change-in-estimates 
approach, with a 10% change in estimates being an initial screening criterion. Secondary 
outcomes: Similar procedures will be undertaken to assess intervention effects for the other EHR 
derived outcomes (documented orders for resuscitation preferences, palliative care consults, 
hospice enrollment, and documented health care proxies). 
 
For our primary analysis, we will consider our primary outcome (ACP documentation) and our 
secondary outcomes (resuscitation preferences, palliative care, hospice use, and health care 
proxies) only for the patient’s index hospitalization. However, because we expect some patients 
to have multiple rehospitalizations during the same step and may also include intervention time 
(i.e., crossover design), we will perform secondary analyses on all of our primary and secondary 
outcomes for each patient reviewing all EHR records from the index hospitalization of the patient 
until their death (or through study period). We will also perform stratified sensitivity analyses of 
patients who contribute only to control period vs. patients who contribute only to intervention 
period vs. those that contribute to both control and intervention periods. 
 
We will conduct the above analyses on all Aim 1 and Aim 2a patients for the study primary and 
secondary outcomes.  
 
Aim 2b. To characterize detailed caregiver-centered outcomes, including knowledge, confidence 
in future care, communication and decisional satisfaction, and decisional certainty in a group of 
caregivers of patients with ADRD/Delirium admitted to the hospital. Hypothesis: Caregivers in 
the intervention phase (vs. control) will have higher knowledge, confidence in future care, 
improved communication and decisional satisfaction, and less decisional conflict. For Aim 2b, we 
will compare survey responses from intervention and control periods to take into account 
clustering within clinical unit and hospital. We will include calendar time and any imbalance from 
caregiver characteristics in the model to adjust for the potential confounding factors. We will 
account for clustering using methods as described above but will employ linear models for 
correlated data fitted via GEE or in mixed models. 
 
Missing data: We will impute data when missing using multiple imputation techniques. This 
approach is one of the statistically principled methods noted in a recent NEJM editorial on the 
need for such approaches in the analysis of data from RCTs with missing values.(141) This 
approach assumes that data are missing either completely at random (MCAR) or at random 
(MAR) as a function of non-missing data on available variables in the dataset. We will implement 
this process using PROC MI in SAS. We will generate 20 imputed datasets and will conduct our 
intent-to-treat analyses per our analysis plan, saving results across datasets so they can be 
combined using PROC MIANALYZE in SAS. We will also consider the possibility that data are 
missing in a non-ignorable fashion. For example, should more or less symptomatic subjects be 
lost to follow-up as a result of treatment – and thus produce results that are biased in a manner 
not addressable by the above methods that assume MCAR or MAR data – we will randomly 

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impute data in sensitivity analyses under various alternative scenarios employing multiple 
imputation with the combination of analytic results noted above. 
 
Reporting dropout and missing data. Whenever a participant in the caregiver interview sample 
drops out of the study, we will document the specific reason for dropout, who decided that the 
participant would drop out, and whether the dropout involved intervention participation, data 
collection, or both. If a participant withdraws from the intervention only, we will continue to collect 
data on all outcome measures. All participants included will be accounted for in a CONSORT 
diagram.  
 
 
13 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable U.S. federal regulations and institutional 
policies (which are based in federal regulations, guidance, and ICH Good Clinical Practice 
guidelines). 
 
This protocol and any amendments will be submitted to the BMC IRB, for formal approval of the 
study conduct. The decision of the IRB concerning the conduct of the study will be made in 
writing to the investigator. A copy of the initial IRB approval letter will be provided to the sponsor 
before commencement of this study.  
 
All subjects enrolled for Aim 2 (caregiver survey) will provide verbal informed consent by phone 
prior to answering any survey questions.  Subjects will be provided with sufficient information and 
time to make an informed decision about their participation in this study. These subjects will be 
offered to have a copy of the consent form mailed to them (Email or US Mail) to keep for their 
records. The consent form will be submitted with the protocol for review and approval by the IRB. 
The consent of a subject, using the IRB-approved consent form, must be obtained before that 
subject is submitted to any study procedure. Consent will be documented as required by the IRB.   
 

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