An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
Phase: NA
Conditions: Congestive Heart Failure, Metastatic Cancer, Chronic Kidney Disease Requiring Chronic Dialysis, Chronic Obstructive Pulmonary Disease
Sponsor: Brigham and Women's Hospital

 
Version 2021.10.26 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Kei Ouchi, MD, MPH  
 
Project Title: 
An advance care planning intervention in the emergency department: a 
pilot randomized controlled trial  
 
Version Date: 
2021.12.07 
 
 
For Intervention/Interaction studies, submit a Detailed Protocol that includes the following sections.  If 
information in a particular section is not applicable, omit and include the other relevant information.   
 
 
1. 
 Background and Significance 
 
• 
Summarize relevant literature, data, and historical background 
Advance care planning (ACP) conversations can lead to well-informed shared decision making 
and improved quality of life at the end of life.1 For seriously ill older adults, ACP conversations are 
associated with lower rates of in-hospital death, less aggressive medical care at the end of life, earlier 
hospice referrals, increased peacefulness, and a 56% greater likelihood to have end-of-life wishes 
known and followed.1-8 Furthermore, patients with documented ACP conversations experience a 36% 
reduction in the cost of end-of-life care, with an average cost savings of $1,041 per patient in the last 
week of life.9 Experts recognize that earlier ACP conversations are the key to “bend the cost curve” for 
health care.10 Yet only 37% of seriously ill older adults have ACP conversations with their physicians,1 
on average 33 days before death.11  
Emergency departments serve as an ideal setting to engage seriously ill yet clinically stable older 
adults who may benefit from ACP conversations. During the last six months of life, 75% of older 
adults visit the emergency department (ED).12 ED visits are inflection points in these patients’ illness 
trajectories, signaling a more rapid rate of decline.13-15 More than 70% of these patients express 
priorities focused on comfort and quality of life rather than life extension,16 yet a systematic review 
revealed that 56% to 99% do not possess advance directives in the ED,17 and many are at risk of 
receiving care that does not align with their goals.18 We propose to seize the opportunity of the ED visit 
to engage seriously ill older adults to initiate/reintroduce ACP conversations. 
ED clinicians lack practical methods to engage seriously ill older adults to engage in ACP 
conversations. ED clinicians recognize that an ED visit provides a time and location for seriously ill 
older adults to discuss ACP;19 however, the time-pressured ED environment discourages clinicians 
from conducting in-depth conversations.20 Practical methods to overcome these ED-specific barriers 
are needed to engage patients who may benefit from ACP conversations. 
 
• 
Describe previous pre-clinical or clinical studies leading up to and supporting the proposed 
research 
In our prior research, we developed and piloted a ED clinician-led, behavioral intervention (ED GOAL) 
designed to engage seriously ill yet clinically stable older adults in the ED to address ACP with their 
outpatient clinicians.21,22 In an acceptability study, 82% (19/23 patients) found it acceptable and stated 
that it helped them engage in talking about their goals for future care with their outpatient clinicians.21 
In a feasibility study (N=50), average patient-reported ACP self-efficacy increased from 3.8 to 4.3 on 

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a 5-point scale, new electronic medical record (EMR) documentation of ACP (new/change in health 
care proxy or advance directive forms) was found in 26% (13/50 patients), and new EMR 
documentation of ACP conversation (discussion of code status, health care proxy, or advance directive 
forms) was found in 40% (20/50 patients) of seriously ill older adults who underwent ED GOAL (under 
peer review). When COVID restrictions prevented us from conducting ED GOAL physically in the ED, 
we have demonstrated the feasibility of conducting our study virtually using phone/zoom (IRB Protocol 
2020P002934, in preparation for publication).  
 
• 
Describe rationale behind the proposed research and significance to patients, society, and/or 
science 
Since the improvements in ACP engagement were seen in a one-arm, pre-/post-intervention feasibility 
study, we propose to test this in a pilot randomized clinical trial (RCT) as a next step. ED GOAL will 
facilitate ACP conversations for seriously ill older adults in or after leaving the ED. These findings will 
be used for a future R01 proposal to definitively test the efficacy of ED GOAL in a large multi-site 
pragmatic trial. We aim to establish ED GOAL as a national standard of care to help seriously ill older 
adults to receive care concordant with their goals. 
 
2. 
Specific Aims and Objectives  
 
• 
Specify objectives and hypotheses to be tested in the research project 
 
Aim 1: Pilot test, in a randomized controlled design (N=120, 60 in each group), the effect of ED GOAL 
administered by trained nurses on patient and caregiver ACP engagement one month after leaving the 
ED.  
 
Hypotheses: ACP engagement (a composite outcome combining patient-reported and EMR outcomes) 
will significantly increase in those who received ED GOAL compared to usual care.  
 
Aim 2: Identify the patient-perceived benefits and obstacles of ACP conversations after ED GOAL 
using semi-structured interviews (N~30). 
 
Rationale: Most patients who underwent our intervention in prior studies expressed their gratitude and 
reported how helpful the intervention was in their lives. Yet, these perceived benefits (“opened my eyes 
about what I need to focus in my life”) may be difficult to capture using validated, quantitative 
instruments. Furthermore, we will also elicit patient-perceived barriers to completing the ACP 
conversations. 
 
3. 
General Description of Study Design 
 
• 
Explain the basic study design, e.g., parallel group, randomized controlled trial, open-label 
single arm study, cross over, adaptive, etc.   
 
This is a two-armed, parallel-design, pre-/post-intervention assessment study. We will conduct a 
randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect 
patient-centered outcomes and determine preliminary efficacy on increasing ACP engagement (self-
reported and/or in the electronic medical record) one month after leaving the ED. We will also conduct 
qualitative interviews with participants of ED GOAL. 
 
• 
Provide study schema as applicable (a schema is required for greater than minimal risk 
studies, and optional for minimal risk studies 

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4. 
Subject Selection 
Describe sources of subjects and procedures for subject selection, including the following: 
• 
Inclusion/Exclusion Criteria  
Participants will only consist of patients who meet the inclusion/exclusion criteria in Table 1. For 
eligible patients who have mild cognitive impairment (MCI) or mild dementia (as shown by cognitive 
impairment assessment), both the patient and the patient’s caregiver will be enrolled as subjects in the 
study. For patients with moderate to severe dementia, the caregivers will be the study participants, and 
no involvement of the patients will occur. We will determine the potential subject’s cognitive status by 
review of medical records and screening described in the “Subject Enrollment” section below. 
 
The caregivers are defined as health care proxy or next of kin (when health care proxy has not been 
appointed). Patients without competency who has court-appointed legal guardians are excluded from 
this study given the nature of ACP conversations for this group is largely different from ordinary 
patient/caregivers. Given that this is a minimal risk study (i.e., patients and caregivers are routinely 
experiencing ACP conversations in their clinical encounters), we will obtain verbal consent/assent 
using the study information sheet.  
 
Table 1 Patient eligibility criteria  
Inclusion 
Exclusion 
1. 
≥50 years of age AND ≥1 Serious illness* 
OR 
ED clinician would not be surprised if patient died in 
the next 12 months (a validated prognostic sign)23,24 
2. 
English-speaking 
3. 
Capacity to consent  
a. 
Patient with mild cognitive impairment or mild 
dementia with capacity to consent (requires a 
caregiver/study partner to enroll) 
b. 
Caregiver of patient with moderate/severe 
dementia with capacity to consent 
1. 
Acute physical or emotional distress 
2. 
Determined by treating or study clinician not to be 
appropriate 
3. 
Clearly documented goals for medical care** 
(Unless the treating or study clinician recommends that the 
intervention is clinically indicated) 
4. 
Delirium (assessed using 3D-CAM) 
5. 
Already enrolled in this study 
6. 
Unable/unwilling to schedule the follow-ups on the 
calendar 
Screened, enrolled, & baseline questionnaire 
Randomization 
ED GOAL(n=60) 
Usual care(n=60) 
1-, 3-, 6-month outcomes assessment using patient surveys and chart abstraction 
with care navigation interviews 
Post-intervention questionnaire 
Figure 1 Study Schema 
In-person or 
virtually in the ED, 
hospital floor, or 
after recent 
discharge 
Virtually at home 

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7. 
Receive both the outpatient care for serious illness and 
primary care outside of the MGB system 
*NYHA Stage III/IV congestive heart failure, chronic 
obstructive lung disease on home oxygen, chronic kidney 
disease on dialysis, or metastatic solid tumor cancer. In 
addition, patients with NYHA Stage I/II congestive heart 
failure, chronic obstructive lung disease not on home 
oxygen, chronic kidney disease not on dialysis will be 
included if recent hospitalization in the last 12 months 
exists. 
**e.g., MOLST, medical order for life-sustaining treatment, 
documented serious illness conversations in clinician notes 
within the last 3 months, etc. 
 
• 
Local Recruitment Procedures: 
Explain in detail the methods and procedures you will use to recruit participants. Describe in 
a step-by-step procedure below: 
 
o How individuals are identified for recruitment including description of use of 
recruitment materials such as flyers, brochures, advertisements, letters, etc. 
Our research team will review the medical records in Epic to identify the potential subjects 
to approach in this study. To identify potential subjects in the ED, we will review the ED 
patient lists Monday to Friday between 8am to 6pm. To capture potential subjects we 
missed during this screening period, we will also review medical records of patients who 
visited the ED in the last 10 days so that we can enroll them virtually after leaving the 
ED/hospital (if admitted). 
 
o Who is responsible (role on research team) for identifying and recruiting individuals 
Trained RAs will search through the medical records to find potential subjects meeting our 
inclusion and exclusion criteria. The study clinician consenting the subjects will double 
check the eligibility criteria prior to consent.  
 
o When individuals are recruited  
Subjects will be approached for recruitment at the time of ED visit, during their 
hospitalization after the ED visit, or within 10 days of leaving the ED. 
 
o Where individuals are recruited 
We will recruit subjects in the ED, ED observation unit, or hospital floor at Brigham and 
Women’s Hospital, Massachusetts General Hospital, and Brigham and Women’s Faulkner 
Hospital.  
We will make every attempt to enroll/approach the patient in the ED. We will follow the 
following steps:  
1. When potential subjects are identified in the ED, clinical appropriateness is 
assessed with the treating clinicians; 
2. The treating clinicians will introduce the study and obtain permission for our 
research team to approach the subject in the ED; and  
3. The study team will contact the patient for eligibility assessment and consent (if 
eligible).  
When in-person enrollment is not feasible due to COVID restrictions or logistical reasons 
(e.g., potential subjects are identified overnight when research team is not present), we will 
use the Patient Gateway recruitment strategy recommended by the IRB.  
 
o How recruitment goals match the prevalence rates of the condition/disease being 
studied and the populations most impacted by the condition/disease being studied 

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Our recruitment goals match the target populations of clinicians who routinely conduct 
ACP conversations in their clinical practice. 
 
o Methods to enhance enrollment of diverse individuals and under-represented 
populations 
To comply with the NIH recommendations for clinical trials, once we approach 50% of 
enrollment target goals for each arm, we will begin to preferentially recruit minority and 
under-represented populations if they are <20% of the enrolled subjects to ensure that our 
study adequately represent the study population. 
 
 
5. 
Subject Enrollment 
 
• 
Describe any pre-screening procedures as applicable. Indicate whether subjects will be 
prescreened over the phone and/or will be asked to provide separate informed consent 
specific to screening procedures. 
 
No pre-screening procedures are planned. 
 
• 
Describe in a step-by-step procedure the consent process including: 
o When and where informed consent will be obtained (including description of any 
electronic consenting procedures) 
Timing of consent: 
The informed consent will be obtained at the time of ED visit, during the hospitalization, 
or after the potential subjects leave the ED in-person or over the phone/zoom. All study 
procedures including the consent process may occur in-person or over the phone/zoom 
depending on logistical restrictions (e.g., COVID surge restrictions) and patient/clinician 
preference. 
 
Sound amplification device (if feasible): 
Prior to the screening assessments, the study staff will offer a personal sound amplifier as 
a hearing-assistive device to subjects who may benefit from its use (e.g., subjects with 
hearing impairment issue). From our experience, given that the setting may be in the noisy 
ED, the subjects can experience difficulties answering our questions. Therefore, the 
hearing aids will help them respond to our prompts/instructions more appropriately. 
 
Subject identification: 
Trained RAs will use Epic to identify patients in the ED or the hospital 8am to 6pm Monday 
through Friday. To capture potential subjects that we may have missed, we will also review 
recent discharge list who might be eligible based on inclusion/exclusion criteria. Once a 
potential subject is identified, the trained RA will approach the treating clinician to see if 
the patient is eligible and have capacity to consent (if the potential subject is in the ED or 
in the hospital). The study procedure will pause whenever the study team is interrupted by 
clinical activities of the participants and resume when it is determined to be feasible again 
by the clinical team.  
 
Enrollment procedures and cognitive impairment screening: 
Our trained study clinician will review the eligibility criteria with the RA prior to engaging 
with the potential subject. If the potential subject is agreeable to learn more about our study 
verbally, the study clinician will administer a validated, delirium screening (3D-CAM).25 

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If the patient is found to have no delirium, the study clinician will classify the patients 
based on known diagnosis of cognitive impairment or by administering a validated, 
cognitive impairment screening (MiniCog and/or Quick Dementia Rating System, 
QDRS).26,27 Depending on the cognitive impairment status, the patients and/or caregivers 
will be enrolled in the study (Table 2). 
 
Table 2 Intervention target and outcome assessment 
Cognition status 
Study participants 
Outcome assessment 
Normal (MiniCog >2 and/or 
QDRS 0-1) 
Patient only 
ACP engagement for patient + EMR 
Mild cognitive impairment and 
mild dementia (MiniCog<3 and 
QDRS 2-12) 
Patient and 
caregiver  
ACP engagement for patient + ACP 
engagement for caregiver + EMR 
Moderate and advanced 
dementia (MiniCog<3 and 
QDRS 13-30) 
Caregiver only 
ACP engagement for caregiver + EMR 
 
Upon classification of patients by their cognitive status, informed consent will be obtained 
using a 4-item consent capacity checklist (see attached 4-item consent capacity checklist). 
For patients with known/documented moderate/severe dementia per medical record or self-
report, we will approach the caregiver for enrollment and perform the 4-point consent 
capacity checklist. If the caregiver states that the patient can assent (e.g., verbal, able to 
comprehend, etc.), we will obtain an assent from the patient. Patients are not the subjects 
of this study. 
 
At this time, the study clinician will announce to the subject that the research procedure 
will begin. 
 
o A separate description for adults and children if applicable  
Not applicable. 
 
o The process for obtaining consent from non-English speakers if applicable 
Not applicable. 
 
o The process to determine capacity to consent and use surrogate decision makers if 
applicable 
We will conduct the following procedures to determine the capacity to consent: 
 
For subjects with no known diagnosis of mild cognitive impairment or dementia on medical 
record, we will ask the treating clinicians (if subjects are in the ED or in the hospital) 
regarding their assessment of capacity to consent and clinical stability to approach the 
subject. Then, the study clinician will follow the procedures described above to classify the 
patients based on cognitive impairment status and use the 4-item capacity checklist for 
consent. 
 
For subjects with a known diagnosis of mild cognitive impairment or mild dementia, we 
will ask the treating clinicians (if subjects are in the ED or in the hospital) regarding their 
assessment of capacity to consent and clinical stability to approach the subject. At the same 
time, we will confirm the availability of a caregiver to serve as a study partner. If caregiver 
is unavailable, the subject will be excluded. Then, the study clinician will follow the 
procedures described above to classify the patients based on cognitive impairment status 
and use the 4-item capacity checklist for consent. 

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For subjects with a known diagnosis of moderate to advanced dementia, the caregivers will 
be consented for the study (patients will not be the subjects of our study). We will use the 
4-item consent capacity checklist.  
 
o Procedures to minimize undue influence to enroll, particularly if recruiting the 
investigators’ own patients 
The study team will have no patient/clinician relationship with the potential subjects being 
approached in this study. 
 
• 
Describe post-consent intervention assignment and randomization method if applicable 
We will have three groups of participants based on cognitive ability for this study: 
1) Patients with normal cognition 
2) Patients with MCI or mild dementia + their caregivers (both are participants) 
3) Caregivers of patients with moderate and advanced dementia (only the caregivers are the 
participants) 
 
Upon classification of eligible participants into the correct group above, we will randomly assign them 
into one of two arms of the study using block randomization of four using a computer-generated 
algorithm: 
 
1) Intervention (ED GOAL) 
2) Control (usual care) 
 
6. 
STUDY PROCEDURES 
 
Provide detailed description of all study visits, procedures, and data collections, including: 
• 
Description of each study visit and procedures at each visit (include a schedule/table of study 
procedures) 
 
Initial enrollment (~30 to 60 minutes total): 
After the consent, our trained study clinician will administer the intervention to the participant in-
person, on the phone, or over zoom depending on participant preference. After the intervention is 
completed, the RA will obtain post-enrollment questionnaires and also schedule dates/times for the 
follow-up appointments. With participants’ permission, the study clinician will document the 
clinically important findings elicited from the participant (e.g., preferences for end-of-life care goals) 
in Epic’s ACP module and also send an email regarding the findings to patient’s outpatient clinicians 
within Mass General Brigham health system via secure email. The study team will also provide the 
post-enrollment patient handout (see attachment) to the participants. All participants in the 
intervention arm will receive the same intervention and follow-up procedures.  
 
Follow-up appointments (~30 to 45 minutes each): 
During the scheduled follow-up appointments on the phone/zoom, our RA will administer surveys to 
assess for the outcomes. In addition, if the participants report that they have not had conversations 
with their outpatient clinicians about ACP, our study clinician will conduct brief coaching to 
overcome the obstacles participants might be facing in this process and also document clinically 
relevant information in Epic to notify to the outpatient clinician. 
 
Table 3 Study visits 
Study visit 
Intervention 
Outcome assessment 
Initial enrollment 
ED GOAL  
Post-enrollment survey 

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1-month follow-up 
ACP navigation coaching (as needed) 
Follow-up patient-reported outcomes surveys 
3-month follow-up 
ACP navigation coaching (as needed) 
Follow-up patient-reported outcomes surveys 
6-month follow-up 
ACP navigation coaching (as needed) 
Follow-up patient-reported outcomes surveys 
 
• 
Description of study drugs, devices, or other interventions/exposures administered, 
including:   
o Dose, method of administration, schedule of administration, dose modifications 
Our intervention is followed by scheduled, follow-up visits at one, three, and six months 
afterwards. The follow-up visits will be performed to assess the outcomes as well as to 
serve as the ACP care navigation/coaching by our study clinician. 
 
Study clinician training: 
We will train the study clinicians to administer these tools by 3-hour didactic on the 
concepts of delirium, cognitive impairment, and dementia, as well as bedside practice 
administration with the PI until competency is demonstrated (PI will self-record the 
responses next to the study clinician administering the instrument and compare the results. 
We will repeat this process with new patient volunteers until there is no discrepancy). In 
the case of equivocal findings on these assessments administered by study clinician, the PI 
backup will be available. 
 
Intervention fidelity: 
To ensure that all study clinicians deliver our intervention consistently, we will check the 
intervention fidelity. The percent adherence to the intervention fidelity checklist will be 
measured for every participant encounter (see attached fidelity checklist). High fidelity will 
be defined as mean adherence of >70% to the components on the fidelity checklist, which 
is consistent with expert consensus for behavioral intervention studies.28 
 
o Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications (“off-label”):  How are doses, routes of 
administration, or participant populations different from FDA approved indicated 
use? 
Not applicable. 
 
• 
Description of specific data variables to be collected, including data collection methods, 
assessments, data collection sheets, and/or schedule of assessments (A schedule/table of study 
assessments is preferred)  
 
Table 4 Outcomes 
Measures 
Descriptions 
Timing 
ACP engagement 
survey for patients 
(primary outcome) 
Used for patients, this validated instrument will measure the self-
reported processes for ACP (knowledge, contemplation, self-
efficacy, and readiness), and ACP behavior.29 
Baseline & at 1, 3, and 
6 months 
ACP engagement 
survey for caregivers 
(primary outcome) 
Used for surrogate decision-makers, this ACP engagement survey is 
validated to measure the same ACP processes and behaviors.30 
Baseline & at 1, 3, and 
6 months 
EMR documentation 
(primary outcome) 
Review EMR to see if new documentation of ACP conversation, 
change in code status, or advance directive forms documented by 
physicians or mid-level providers exist. 
Baseline & at 1, 6, and 
12 months 
Self-reported ACP 
conversation survey 
(primary outcome) 
Quantitative and qualitative questionnaires to assess the self-reported 
completion of ACP conversations with outpatient clinicians and 
families as well as barriers/facilitators of this process. 
At 1, 3, and 6 months 

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Heard and 
understood survey 
(secondary outcome) 
A validated instrument for seriously ill patients to report how well 
they feel heard and understood about their wishes for end-of-life 
care.31  
Baseline & 1, 3, and 6 
months 
Quality of 
communication 
survey (secondary 
outcome) 
A validated instrument to measure the quality of communication 
about end-of-life care.32 
Baseline & at 1, 3, and 
6 months 
Healthcare utilization 
(secondary 
outcomes)  
Review EMR to see # of urgent care visits, ED visits, 
hospitalizations, hospice visits, and outpatient visits.  
At 6 and 12 months 
before and 1, 6, 12 
months after enrollment  
Mortality 
Review EMR to determine patient’s vital status. 
At 1, 3, and 6 months 
Qualitative benefits 
and obstacles of ACP 
conversations after 
ED GOAL 
(secondary outcome) 
Semi-structured interviews to assess the benefits of ED GOAL and 
obstacles participants faced in completing more ACP conversations 
with their outpatient clinicians and loved ones after ED GOAL (see 
interview guide). 
At 1, 3, and/or 6 months 
 
• 
Description of planned genetic research as applicable (e.g., specific description of whole 
genome sequencing, creation of immortalized cell lines or induced pluripotent stems cells, 
and sharing of genetic material with collaborators and central repositories as applicable, etc.) 
Not applicable. 
 
• 
Description of plans for return of research results as applicable (e.g., specific description of, 
rationale for, and process by which research results will be returned, including to whom, by 
whom, and when, etc.).  Include plans for managing incidental findings as applicable.    
Not applicable. 
 
• 
Definition of primary and secondary outcomes/endpoints.  Note that outcome measures 
should be quantifiable and measurable.  
Please see Table 4 above. 
 
• 
Definition of study termination criteria, e.g., objective criteria for clinical worsening, lack of 
improvement, and/or unacceptable adverse events 
o We do not anticipate any adverse events (AE) for this study other than loss of confidentiality. 
Any AE will be reported to our institutional review board at the time of annual continuing 
review by the principal investigator using an Adverse Event Form in accordance with the MGB 
Human Research Committee guidelines for AE reporting.  
 
• 
Local site restrictions or site-specific procedures as applicable, including: 
o Description of how study procedures (e.g. intervention or diagnosis) compare to 
standard of care, including description of alternative treatments, procedures, or 
methods of diagnosis 
There will be no study procedures. 
 
o Description of what happens to participants receiving therapy when study ends or if 
a participant’s participation in the study ends prematurely. 
Not applicable.  
 
o For studies that are conducted entirely internationally, describe the nature of the 
involvement of investigators at each site in the study, i.e., indicate which personnel 
will be present at the international site(s) and describe the nature of their 
involvement, including which staff will have direct contact with subjects and/or 

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perform any study related procedures and which staff will have access to study data 
and perform data analysis 
There will be no transfer of data to an outside institution for this study. 
 
• 
Remuneration as applicable. Indicate if payments to subjects are made upon completion of 
study visits/certain procedures and how remuneration is pro-rated, particularly for non-
completers 
We will provide renumeration of $48 (gift card purchased through MGB approved mechanisms or 
check, depending on participant preference). 
 
• 
Description of plans for sending and/or receiving specimens or data with research 
collaborators outside Mass General Brigham or with NIH (e.g., dbGaP) or other tissue/data 
repositories (include details of identified versus de-identified sharing, how data or specimens 
are labeled/coded, secure transfer method, external IRB approval as applicable, storage for 
future use, secure transfer method, etc.) 
No transfer of data to an outside institution will be for this study. 
 
7. 
Risks and Discomforts 
Provide detailed description of potential risks of each study-related procedure/intervention, 
including: 
• 
Complications of surgical and non-surgical procedures 
Not applicable. 
 
• 
Drug side effects and toxicities  
Not applicable. 
 
• 
Device complications/malfunctions 
Not applicable. 
 
• 
Psychosocial risks 
The participants will be introduced or re-initiated on the topic of ACP. Some patients with serious 
illness do not wish to discuss ACP because they feel uncomfortable with the topic. This potential 
discomfort, however, is a part of the routine practice in the ED. Many ED clinicians discuss ACP 
with patients routinely, and the study does not add additional discomfort that is different from the 
routine clinical practice. Further, the PI is trained in serious illness communication and will be 
available to manage patients’ anxiety and other emotions as needed.  
 
• 
Privacy/confidentiality risks 
Loss of confidentiality is a minor risk. The protection of data for this study includes the following:  
 
1) Study data will be collected and managed using Dropbox Business, which is fully encrypted and 
is compliant with Partners’ policies and procedures. Data pertinent to this study will only be given 
access to only the members of our study team approved by the IRB.   
  
2) REDCap electronic data capture tools, which are hosted at BWH1. REDCap (Research 
Electronic Data Capture) is a secure, web-based application designed to support data capture for 
research studies, thereby providing an intuitive interface for validated data entry, audit trails for 
tracking data manipulation and export procedures, automated export procedures for seamless data 
downloads to common statistical packages, and procedures for importing data from external 
sources.  

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3) Study participants will be identified by a unique numeric identification, and their protected health 
information (PHI) will be de-identified.  
  
4) Study participant PHI will be collected and stored on a secure REDCap survey, which will be 
created on a secure, password protected desktop computer located at BWH where only the study 
staff will have access.  
  
5) At study completion, contact information and the link between the identifying information and 
their data will be destroyed.  
  
6) Finally, to ensure that all staff is compliant with confidentiality training, all study staff has 
completed the CITI course for the protection of human subjects training in research ethics and good 
clinical practice.  
 
• 
Genetic research risks 
Not applicable. 
 
• 
Radiation risks 
Not applicable. 
 
• 
Include description of steps taken to decrease relevant risks, including the following:  
o How procedures used are consistent with sound research design and do not expose 
unnecessary risks  
Verbal consent will be obtained from the patient / caregiver participants. After learning 
about the general background of the study and reading the study information sheet 
(electronic or hardcopy), the potential participants will be able to decline to participate. 
Further, if the participant expressed anxiety or distress from the intervention (determined 
by the treating clinician), he/she is offered to discontinue the study and the PI will be 
responsible to care for the participant’s emotional needs. The PI will also contact the 
patient’s primary outpatient clinician to ensure adequate follow up of the patient after 
leaving the ED.  
 
o When appropriate, researchers use procedures already being performed on subjects 
for diagnostic or treatment purposes 
Not applicable. 
 
8. 
Benefits 
 
Provide detailed description of potential benefits of study participation, including: 
• Either describe potential benefits to participating individuals or clearly state that there is no 
direct benefit to individuals 
No definitive benefit has been demonstrated. However, our prior pre/post-intervention studies 
indicated that the intervention may lead to increased ACP engagement in patients with serious illness 
(see Previous Studies section above).  
 
• If multiple subject populations are to be enrolled, describe any differences between groups 
with regard to potential benefit (e.g. potential for benefit to an affected subject population versus 
no potential benefit for healthy controls, etc.) 

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Based on the demographic data that we have thusfar, we do not anticipate differences between groups 
with regard to the potential benefit. 
 
• Potential benefits to society (e.g., increased understanding of disease process, etc.) 
For our patients, we hope that our intervention will lead patients to have more ACP conversations with 
their outpatient clinicians and loved ones. ACP conversations can lead to well-informed shared 
decision making and improved quality of life at the end of life.1 For the society, ACP conversations 
are associated with lower rates of in-hospital death, less aggressive medical care at the end of life, 
earlier hospice referrals, increased peacefulness, and a 56% greater likelihood to have end-of-life 
wishes known and followed.1-8 Furthermore, patients with documented ACP conversations experience 
a 36% reduction in the cost of end-of-life care, with an average cost savings of $1,041 per patient in 
the last week of life.9 
 
9. 
Statistical Analysis 
 
Describe plans for statistical analysis, including: 
• 
Statistical methods/data analysis plan 
Aim 1 quantitative data analysis: 
We will conduct an intention-to-treat analysis. Since the primary outcome is mean change in self-
reported ACP engagement, we do not expect differences among patients who are admitted vs. 
discharged. For our secondary outcome, we suspect that there is a propensity of more ACP 
documentation in patients who are hospitalized and missingness in patients who are primarily cared for 
at outside institutions. We will plan to use regression in subgroup analysis for ACP documentation to 
account for hospitalization status. In addition, we will perform sensitivity analyses to account for 
clustering by individual outpatient clinicians, palliative care consultations, and cognitive impairment 
status. We will also perform sensitivity analyses for survey respondents (e.g., patients vs. caregivers). 
We will compare patient demographics by study arm to assess randomization using bivariable analyses 
(t-test for continuous variables and chi-square for categorical variables). The mean changes in ACP 
engagement (primary outcome) at one month will be compared by study arms to estimate effect sizes. 
Within arms, we will use a one-sample binomial exact test of proportions for categorical outcomes 
(e.g., EMR documentation), and Wilcoxon signed ranks test for ordinal outcomes (e.g., ACP 
Engagement Survey) at baseline, after the intervention at one month. A p-value of 0.05 will be the 
significance threshold. To address missing data, I will conduct a secondary analysis using linear mixed 
models at baseline and one month. For qualitative outcomes,  
 
Aim 2 qualitative data analysis:  
We will conduct in-depth, semi-structured interviews with participants. We will explore the perceived 
benefits of the intervention as well as barriers to completing ACP conversations after leaving the ED. 
The interviews will be recorded and professionally transcribed. The transcripts will be analyzed to 
identify recurring themes that illustrate the qualiative benefits (e.g., how the intervention changed their 
lives) and barriers to completing ACP conversations (e.g., how attempted ACP conversations were 
unsuccessful). Transcripts will be analyzed by two trained researchers to ensure interpretive integrity 
and consistency per standard comprehensive qualitative analysis methods. We will use framework 
analysis as the analytic approach,33 which allows the flexibility of incorporating a priori considerations 
as well as more emergent themes in the data. The coding structure will be collaboratively and iteratively 
developed by the research team and include both prefigured and emergent codes.34 We will use an 
ethnographic data management software program, NVivo 10 (QSR International). If there are 
disagreements, the mentors/advisors and we will review the quotes and themes to discuss their meaning 
and to achieve consensus. We will follow the consolidated criteria for reporting qualitative research.35 
 

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• 
Power analysis (e.g., sample size, evaluable subjects, etc.) 
For Aim 1 (quantitative data): 
While this pilot RCT study is not powered to detect statistically significant differences in the ACP 
outcomes, we will compare 1-, 3-, 6-month ACP outcomes in the intervention arm to the control arm 
to estimate the preliminary effect sizes. Our prior study demonstrated a mean patient-reported ACP 
engagement increased from 3.8 to 4.3 on a 5-point scale, corresponding to a moderate effect size of 
0.50.36 A conservative estimate of effect size is 0.25. we also expect that 10% of enrolled patients will 
die before completing all follow-ups. With a sample size of 60 patients per group, we would have 90% 
power to detect the difference using a 2-sided Fisher’s exact test (alpha=0.05). We plan to exclude 
patients who die before 6-month in the analysis. 
 
For Aim 2 (qualitative data): 
Based on my previously successful study, in which I explored patients’ attitudes about ED GOAL,37 
interviewing ~10 dyads of patients and caregivers (N~20 total) with a diverse representation of 
perspectives will yield thematic saturation for tailoring ED GOAL. However, I will continue to enroll 
more participants if thematic saturation is not achieved. 
 
10. 
  Monitoring and Quality Assurance 
 
Describe the plans that will be followed by study staff for monitoring and quality assurance, 
including: 
• 
Adverse event criteria and reporting procedures 
Any AE will be reported to our institutional review board at the time of annual continuing review 
by the principal investigator using an Adverse Event Form in accordance with the Partners Human 
Research Committee guidelines for AE reporting.  
 
• 
Planned safety monitoring, e.g., data monitoring committee (DMC)/data and safety 
monitoring board (DSMB), independent monitor, PI-monitored, etc., including planned 
frequency of review. If DMC/DSMB monitored, include either charter as separate 
attachment or complete DMC/DSMB APPENDIX 
The proposed research is a minimal risk study and does not meet the criteria for an NIH-defined 
Phase III trial given no patient outcomes will be collected. Therefore, a data and safety monitoring 
board will not be required, and PI will be solely responsible for data and safety monitoring of the 
proposed research. In the event of an adverse event, the research team will report immediately to 
the PI, who will be responsible for management and reporting to the IRB, and to the NIH institute.   
 
• 
Outcomes monitoring, including planned frequency of review. 
Not applicable. 
 
• 
Study stopping rules as applicable 
Unanticipated Problems (UP): As with any AE above, the PI will report any UP within 5 working 
days / 7 calendar days of the date. The investigator first becomes aware of the problem using an 
Adverse Event Form in accordance with the Partners Human Research Committee guidelines for 
AE reporting Please see attached institutional policy.  
 
• 
Internal monitoring of source data, protocol adherence, and recordkeeping, including which 
staff will be responsible and planned frequency of review 
The PI is responsible for monitoring and recordkeeping on REDCap and qualitative interview 
findings. 
 

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• 
Independent monitoring of source data as applicable 
All personal health information will be removed from the research data from the participants and 
clinicians at the earliest possible time. All data will be stored in a secured Partners approved shared 
drive accessible only to the study staff. Recordings will be stored on an encrypted recording device 
and saved to the secure Partners-approved shared drive.  
 
 
11. 
  Privacy and Confidentiality 
 
• 
Select the Privacy and Confidentiality measures that apply to this research by checking the 
box next to each statement (Check all that apply) 
• 
Note that not all of the measures outlined below may apply to your study 
• 
Do not delete statements that do not apply to your study; leave the boxes unchecked 
• 
Describe any additional privacy and/or confidentiality measures that are not captured by the 
check box items in free text following the check boxes 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked files/areas) 
☐ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to another 
will be transported only in a secure manner (e.g. encrypted files, password protection, using chain-
of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers with 
coded data or specimens will be limited to the minimal necessary members of the research team 
required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☒ Additional privacy and/or confidentiality protections 
 
 
 

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12. 
References 
 
1. 
Wright AA, Zhang B, Ray A, et al. Associations between end-of-life discussions, patient mental 
health, medical care near death, and caregiver bereavement adjustment. JAMA. 
2008;300(14):1665-1673. 
2. 
Ray A, Block SD, Friedlander RJ, Zhang B, Maciejewski PK, Prigerson HG. Peaceful awareness in 
patients with advanced cancer. J Palliat Med. 2006;9(6):1359-1368. 
3. 
Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of 
life care in elderly patients: randomised controlled trial. BMJ. 2010;340:c1345. 
4. 
Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of 
palliative care interventions and advance care planning on ICU utilization: a systematic review. 
Crit Care Med. 2015;43(5):1102-1111. 
5. 
Lakin JR, Block SD, Billings JA, et al. Improving Communication About Serious Illness in Primary 
Care: A Review. JAMA Intern Med. 2016;176(9):1380-1387. 
6. 
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review of evidence. Palliat Med. 2015;29(10):869-884. 
7. 
Khandelwal N, Benkeser DC, Coe NB, Curtis JR. Potential Influence of Advance Care Planning and 
Palliative Care Consultation on ICU Costs for Patients With Chronic and Serious Illness. Crit Care 
Med. 2016;44(8):1474-1481. 
8. 
Shen MJ, Prigerson HG, Paulk E, et al. Impact of end-of-life discussions on the reduction of 
Latino/non-Latino disparities in do-not-resuscitate order completion. Cancer. 2016;122(11):1749-
1756. 
9. 
Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with 
end-of-life conversations. Arch Intern Med. 2009;169(5):480-488. 
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Smith TJ, Coyne P, Cassel B, Penberthy L, Hopson A, Hager MA. A high-volume specialist palliative 
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11. 
Mack JW, Cronin A, Keating NL, et al. Associations between end-of-life discussion characteristics 
and care received near death: a prospective cohort study. J Clin Oncol. 2012;30(35):4387-4395. 
12. 
Smith AK, McCarthy E, Weber E, et al. Half of older Americans seen in emergency department in 
last month of life; most admitted to hospital, and many die there. Health Aff (Millwood). 
2012;31(6):1277-1285. 
13. 
Wilber ST, Blanda M, Gerson LW, Allen KR. Short-term functional decline and service use in older 
emergency department patients with blunt injuries. Acad Emerg Med. 2010;17(7):679-686. 
14. 
Deschodt M, Devriendt E, Sabbe M, et al. Characteristics of older adults admitted to the 
emergency department (ED) and their risk factors for ED readmission based on comprehensive 
geriatric assessment: a prospective cohort study. BMC Geriatr. 2015;15:54. 
15. 
Nagurney JM, Fleischman W, Han L, Leo-Summers L, Allore HG, Gill TM. Emergency Department 
Visits Without Hospitalization Are Associated With Functional Decline in Older Persons. Ann 
Emerg Med. 2017;69(4):426-433. 
16. 
Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, McIntyre L, Tulsky JA. Factors considered 
important at the end of life by patients, family, physicians, and other care providers. JAMA. 
2000;284(19):2476-2482. 
17. 
Oulton J, Rhodes SM, Howe C, Fain MJ, Mohler MJ. Advance directives for older adults in the 
emergency department: a systematic review. J Palliat Med. 2015;18(6):500-505. 
18. 
O'Connor AE, Winch S, Lukin W, Parker M. Emergency medicine and futile care: Taking the road 
less travelled. Emerg Med Australas. 2011;23(5):640-643. 

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19. 
Stone SC, Mohanty S, Grudzen CR, et al. Emergency medicine physicians' perspectives of providing 
palliative care in an emergency department. J Palliat Med. 2011;14(12):1333-1338. 
20. 
Smith AK, Fisher J, Schonberg MA, et al. Am I doing the right thing? Provider perspectives on 
improving palliative care in the emergency department. Ann Emerg Med. 2009;54(1):86-93, 93 
e81. 
21. 
Ouchi K, George N, Revette AC, et al. Empower seriously ill older adults to formulate their goals 
for medical care in the emergency department. J Palliat Med. 2018;In Press. 
22. 
Leiter R, Yusufov, M, Hasdianda, MA, Fellion, L, Reust A, Tulsky, JA, Block, SD, Ouchi, K. . Fidelity 
and feasibility of a brief emergency department intervention to empower adults with serious 
illness to initiate advance care planning conversations. J Pain Symptom Manage. 2018;In Press. 
23. 
Ouchi K, Strout T, Haydar S, et al. Association of Emergency Clinicians' Assessment of Mortality 
Risk With Actual 1-Month Mortality Among Older Adults Admitted to the Hospital. JAMA Netw 
Open. 2019;2(9):e1911139. 
24. 
Ouchi K, Jambaulikar G, George NR, et al. The "Surprise Question" Asked of Emergency Physicians 
May Predict 12-Month Mortality among Older Emergency Department Patients. J Palliat Med. 
2018;21(2):236-240. 
25. 
Marcantonio ER, Ngo LH, O'Connor M, et al. 3D-CAM: derivation and validation of a 3-minute 
diagnostic interview for CAM-defined delirium: a cross-sectional diagnostic test study. Ann Intern 
Med. 2014;161(8):554-561. 
26. 
Galvin JE. The Quick Dementia Rating System (Qdrs): A Rapid Dementia Staging Tool. Alzheimers 
Dement (Amst). 2015;1(2):249-259. 
27. 
Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a 
population-based sample. J Am Geriatr Soc. 2003;51(10):1451-1454. 
28. 
Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health 
clinical trials. J Public Health Dent. 2011;71 Suppl 1:S52-63. 
29. 
Sudore RL, Stewart AL, Knight SJ, et al. Development and validation of a questionnaire to detect 
behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465. 
30. 
Van Scoy LJ, Day AG, Howard M, Sudore R, Heyland DK. Adaptation and Preliminary Validation of 
the Advance Care Planning Engagement Survey for Surrogate Decision Makers. J Pain Symptom 
Manage. 2019;57(5):980-988 e989. 
31. 
Gramling R, Stanek S, Ladwig S, et al. Feeling Heard and Understood: A Patient-Reported Quality 
Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016;51(2):150-154. 
32. 
Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication 
questionnaire assessing communication about end-of-life care. J Palliat Med. 2006;9(5):1086-
1098. 
33. 
Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 
2000;320(7227):114-116. 
34. 
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Sage Publications; 2013. 
35. 
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 
32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349-357. 
36. 
Shi Y, Barnes DE, Boscardin J, et al. Brief English and Spanish Survey Detects Change in Response 
to Advance Care Planning Interventions. J Pain Symptom Manage. 2019. 
37. 
Ouchi K, George N, Revette AC, et al. Empower Seriously Ill Older Adults to Formulate Their Goals 
for Medical Care in the Emergency Department. J Palliat Med. 2019;22(3):267-273. 
 
 
 

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APPENDIX A 
 
Data Monitoring Committee / Data and Safety Monitoring Board 
Appendix 
 
 
 
• 
To be completed for studies monitored by Data Monitoring Committee (DMC) or Data and Safety 
Monitoring Board (DSMB) if a full DMC/DSMB charter is not available at the time of initial IRB 
review. 
• 
DMC/DSMB Charter and/or Roster can be submitted to the IRB later via Amendment, though these are 
not required.  
 
A Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB) will be convened for 
safety monitoring of this research study.  The following characteristics describe the DMC/DSMB convened 
for this study (Check all that apply): 
 
☐ The DMC/DSMB is independent from the study team and study sponsor. 
 
☐ A process has been implemented to ensure absence of conflicts of interest by DMC/DSMB 
members. 
 
☐ The DMC/DSMB has the authority to intervene on study progress in the event of safety concerns, 
e.g., to suspend or terminate a study if new safety concerns have been identified or need to be 
investigated.   
 
☐ Describe number and types of (i.e., qualifications of) members: 
Click or tap here to enter text. 
 
☐  Describe planned frequency of meetings: 
Click or tap here to enter text. 
 
☐ DMC/DSMB reports with no findings (i.e., “continue without modifications”) will be submitted to 
the IRB at the time of Continuing Review. 
 
☐ DMC/DSMB reports with findings/modifications required will be submitted promptly (within 5 
business days/7 calendar days of becoming aware) to the IRB as an Other Event.