Effect of an Advance Care Planning Intervention on Documentation of Advance Directives and Goals of Care in Assisted Living Centers
Phase: NA
Conditions: Dementia
Sponsor: Brown University

Protocol Template, Version 4.0  
Clinical Interventional Study  
Protocol Template 
 
 

Protocol Template, Version 3.0 
 
PREFACE 
The Clinical Intervention Study Protocol Template is a suggested format for clinical trials 
sponsored by the National Institute on Aging (NIA). Investigators are encouraged to use this 
format, as appropriate, when developing protocols for their studies. Large multi-site 
observational studies will also benefit from this protocol template. 
Note that instructions and explanatory text are indicated by italics and should be replaced in 
your protocol with appropriate text.  Section headings and template text formatted in regular 
type should be included in your protocol document as provided in the template. 
The goal of this template is to provide a general format applicable to all single- and multicenter 
clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc.).  
As you can see the version number and date are on the bottom of each page. When making 
changes to an approved and “final” protocol, please provide a summary of the changes, with the 
date, at the front of the protocol. 
 
 

Protocol Template, Version 3.0 
 
 
EFFECT OF AN ADVANCE CARE PLANNING INTERVENTION ON 
DOCUMENTATION OF ADVANCE DIRECTIVE ORDERS 
 
Study Chairman or Principal Investigator: 
Susan Mitchell, MD, Professor of Medicine, Harvard Medical School 
Ellen McCreedy, PhD, Assistant Professor, School of Public Health, Brown University  
Supported by: 
The National Institute on Aging 
Administrative Supplement for the National Institute on Aging (NIA) IMbedded Pragmatic 
Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) 
Collaboratory (U54AG063546) 
Version 2 
September 20, 2021
 
 

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TABLE OF CONTENTS 
Page 
PREFACE ....................................................................................................................................... i 
TABLE OF CONTENTS ............................................................................................................ iii 
PRÉCIS ......................................................................................................................................... vi 
Study Title .................................................................................................................................. vi 
Objectives .................................................................................................................................. vi 
Design and Outcomes ................................................................................................................ vi 
Interventions and Duration ........................................................................................................ vi 
Sample Size and Population...................................................................................................... vii 
STUDY TEAM ROSTER............................................................................................................. 1 
Principal Investigator: ................................................................................................................. 1 
Co-Investigators: ......................................................................................................................... 1 
PARTICIPATING STUDY SITES ............................................................................................. 2 
1 
Study objectives ..................................................................................................................... 4 
1.1 
Primary Objective ........................................................................................................... 4 
1.2 
Secondary Objectives...................................................................................................... 4 
2 
BACKGROUND AND RATIONALE ................................................................................ 4 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 4 
2.2 
Study Rationale ............................................................................................................... 5 
3 
STUDY DESIGN ................................................................................................................... 5 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 6 
4.1 
Inclusion Criteria ............................................................................................................ 6 
4.2 
Exclusion Criteria ........................................................................................................... 6 
4.3 
Study Enrollment Procedures ......................................................................................... 6 
5 
STUDY INTERVENTIONS ................................................................................................ 8 
5.1 
Interventions, Administration, and Duration .................................................................. 8 
5.2 
Handling of Study Interventions ..................................................................................... 8 

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5.3 
Concomitant Interventions .............................................................................................. 8 
5.4 
Adherence Assessment ................................................................................................... 9 
6 
STUDY PROCEDURES ...................................................................................................... 9 
6.1 
Schedule of Evaluations ................................................................................................ 10 
6.2 
Description of Evaluations ............................................................................................ 10 
6.2.1 Screening Evaluation ................................................................................................ 10 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 10 
6.2.3 Follow-up Visits........................................................................................................ 10 
6.2.4 Completion/Final Evaluation .................................................................................... 10 
7 
SAFETY ASSESSMENTS ................................................................................................. 11 
7.1 
Adverse Events and Serious Adverse Events ............................................................... 11 
7.1.1 Reporting Procedures ................................................................................................ 11 
7.1.2 Follow-up for Adverse Events .................................................................................. 12 
7.2 
Safety Monitoring ......................................................................................................... 12 
8 
INTERVENTION DISCONTINUATION........................................................................ 12 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 13 
9.1 
General Design Issues ................................................................................................... 13 
9.2 
Sample Size and Randomization .................................................................................. 13 
9.2.1 Treatment Assignment Procedures ........................................................................... 14 
9.3 
Interim analyses and Stopping Rules ............................................................................ 14 
9.4 
Outcomes ...................................................................................................................... 14 
9.4.1 Primary outcome ....................................................................................................... 14 
9.4.2 Secondary outcomes ................................................................................................. 15 
9.5 
Data Analyses ............................................................................................................... 15 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 15 
10.1 
Data Collection Forms .................................................................................................. 15 
10.2 
Data Management ......................................................................................................... 16 
10.3 
Quality Assurance ......................................................................................................... 17 
10.3.1 
Training ................................................................................................................. 17 
10.3.2 
Monitoring ............................................................................................................ 17 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 18 
11.1 
Institutional Review Board (IRB) Review .................................................................... 18 
11.2 
Informed Consent Forms .............................................................................................. 18 

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11.3 
Participant Confidentiality ............................................................................................ 19 
11.4 
Study Discontinuation ................................................................................................... 20 
12 ETHICAL CONSIDERATIONS ....................................................................................... 20 
13 COMMITTEES................................................................................................................... 20 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 21 
15 REFERENCES .................................................................................................................... 21 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 23 
 
 
 

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PRÉCIS 
Study Title  
Effect of an Advance Care Planning Intervention on Documentation of Advance 
Directive Orders 
Objectives  
The primary objective of this embedded, pragmatic, cluster-randomized trial (ePCT) is to 
test the effects of an advance care planning (ACP) intervention on documentation of do-
not-resuscitate (DNR) orders in a target cohort of assisted living community (ALC) 
residents with dementia from 160 ALCs in FL, MN, and WI.  
 
We will also be conducting semi-structured interviews with Bluestone clinicians and staff 
from 18 ALCs, to describe: (1) the ACP process with ALC patients and their families, 
and how changes in advance directives are communicated to ALC staff; (2) impressions 
of the ACP intervention; and (3) challenges to honoring resident advance directives in the 
ALC setting  
Design and Outcomes   
ALC residents who are “full code” or do not have a documented code status in their 
electronic health record (EHR) at baseline will be randomly assigned to Usual care or  
ACP informational packet and video sent electronically to resident or proxy.  
 
The primary clinical outcome will be the proportion of residents with DNR orders in the 
EHR at the end of four months followup. Secondary clinical outcomes will be: proportion 
of residents with do-not-hospitalize (DNH) orders in the EHR at the end of four months 
followup; proportion of residents with Medicare CPT billing code for ACP during the 
four months followup; and proportion of enrolled residents with any hospitalizations over 
four months (outcome available for FL ALCs only). Implementation outcomes include 
counts of emails sent and video views. 
Interventions and Duration  
ALCs recruited for the study share a common clinician service group, Bluestone 
Physician Services (Bluestone). Bluestone delivers 800-900 physician visits per day, 
including urgent care and COVID-19 testing. Delivery of the intervention leverages a 
component of Bluestone’s EHR infrastructure, an online portal used to share resident 
clinical updates with family members, ALC staff, and other members of the resident’s 
care team (hospice, home health, etc.). This ePCT has two arms: usual care or ACP 
information .  
 
ACP Information:  
Patient centered medical home (PCMH) specialists at Bluestone will determine who is 
the correct person to receive the informational materials. If the patient is the correct 
recipient, Bluestone will deliver the informational materials to the resident at the ALC. If 

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the proxy is the correct recipient, the PCMH specialist will determine whether or not the 
proxy is using the existing online portal. If the proxy is using the portal, the informational 
materials will be sent electronically. If the proxy does not access the portal, the 
informational materials will be sent to their residences.  
 
The informational materials include an email with a link to a video highlighting the goals 
of care and their relationship to common treatment decisions including resuscitation, 
hospitalization, antibiotic use, and feeding tubes. For patients and proxies who are not 
using the online portal, a cover letter and brochure with the same information contained 
in the video will be mailed. Materials will be available in English and Spanish.   
 
 
Usual Care: ALC patients and proxies randomized to the usual care arm have ACP 
discussions with a clinician at admission, annually, and sometimes with a hospitalization 
or other change in condition. There is no standardized decision- or conversation-support 
tools used to have these discussions.  
 
Sample Size and Population  
 
Based on baseline Bluestone data, for the 100 already randomized facilities, we expect 
54% of residents in the control arm will have a DNR order at the end of 4-months 
followup. Based on the same data, we estimated an ICC of 0.012. Assuming a 
conservative ICC of .02, to achieve a power of .80, we need 71 ALCs per arm with 10 
PLWD in each to demonstrate an 8-percentage point increase in DNR orders, such that 
information outreach would result in 62% of these residents having a DNR order at the 
end of 4-month follow-up.  
 
For the additional 60 facilities, we expect only 26% of the residents in the control arm 
will have DNR order at the end of 4-months follow-up based on baseline Bluestone data 
(similar ICC to previously randomized facilities). Assuming a conservative ICC of .02, to 
achieve a power of .80, we need 79 ALCs per arm with 10 PLWD in each to demonstrate 
a 7-percentage point increase in DNR orders, such that information outreach would result 
in 33% of these residents having a DNR order at the end of 4-month follow-up.  
 
We will add 30 ALCs to the existing 50 ALCs per arm, resulting in 80 ALCs per arm. 
We will be able to detect between a 7- and 8-percentage point change in documentation 
of DNR orders in the EMR. Our primary approach will be an intention-to-treat (ITT) 
analysis.  
 

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STUDY TEAM ROSTER  
Collaboratory Principal Investigator:  
Susan L. Mitchell, M.D., M.P.H. 
Professor of Medicine, Harvard Medical School 
Senior Scientist, Hebrew Senior Life Institute for Aging Research  
1200 Centre Street 
Boston, MA 02131-1097 
(617) 971-5326 
smitchell@hsl.harvard.edu 
Supplement Principal Investigator: 
 
Ellen McCreedy, PhD 
Assistant Professor 
Center for Gerontology and Healthcare Research 
Health Services, Policy & Practice 
Brown University, School of Public Health 
121 South Main Street, Suite 6 
Providence, RI 02903 
(401) 863-7345 
ellen_mccreedy@brown.edu 
Co-Investigators: 
 
Roee Gutman, PhD 
Associate Professor of Biostatistics 
Brown University, School of Public Health 
121 South Main Street, Suite 7 
Providence, RI 02912 
(401) 863-2682 
roee_gutman@brown.edu 
role: co-Investigator, statistical design and analysis lead 
 
Rosa Baier, MPH 
Associate Director, Center for Long-Term Care Quality & Innovation 
Associate Professor of Practice, Department of Health Services, Policy & Practice 
Center for Gerontology and Health Care Research 
Brown University, School of Public Health 
Providence, RI 02912 
(401) 863-3818 
rosa_baier@brown.edu 
Role: co-Investigator, process evaluation co-lead 
 
Emily Gadbois, PhD 
Assistant Professor 

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Center for Gerontology and Healthcare Research 
Health Services, Policy & Practice 
Brown University, School of Public Health 
121 South Main Street, Suite 6 
Providence, RI 02903 
(401) 863-3635 
emily_gadbois@brown.edu 
Role: co-Investigator, process evaluation co-lead 
 
 
Kali Thomas, PhD, MA 
Associate Professor of Health Services, Policy and Practice 
Center for Gerontology and Health Care Research 
Brown University, School of Public Health 
Providence, RI 02912 
(401) 863-9036 
kali_thomas@brown.edu 
Role: co-Investigator, assisted living expert, intervention co-lead 
 
Sandra Shi, MD 
Research Fellow 
Beth Israel Deaconess Medical Center and Harvard Medical School 
25 Shattuck Street 
Boston, MA 02115 
(617) 432-1000 
Sandra_shi@hsl.harvard.edu 
Role: co-Investigator, geriatrician, intervention co-lead 
 
PARTICIPATING STUDY SITES  
The study is being conducted at 160 ALCs in which clinician services are provided by Bluestone 
Physician Services (Bluestone). Bluestone contacts for this study are: 
 
Todd Stivland, M.D. 
Chief Executive Officer and Founder 
Bluestone Physician Services 
drstivland@bluestonemd.com 
Role: study champion 
 
Sarah Keenan, R.N. 
Chief Clinical Officer 
Bluestone Physician Services 
sarah.keenan@bluestonemd.com 
Role: clinician training 
 
Nate Hunkins 

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Director of Population Health 
Bluestone Physician Services 
nate.hunkins@bluestonemd.com 
Role: data management, eligibility, and enrollment 
 
 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary objective of this embedded, pragmatic, cluster-randomized trial (ePCT) is to 
test the effects of an advance care planning (ACP) intervention on documentation of do-
not-resuscitate (DNR) orders in a target cohort of assisted living community (ALC) 
residents with dementia from 160 ALCs in FL, MN, and WI.  
 
1.2 Secondary Objectives 
The secondary objective is to use semi-structured interviews with Bluestone clinicians 
and staff from 18 ALCs to describe: 1) the virtual ACP process with ALC residents and 
their families, and how changes in advance directives are communicated to ALC staff; (2) 
impressions of COVID-specific ACP intervention; and (3) challenges to honoring 
resident advance directives during the coronavirus pandemic. 
 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Assisted living communities (ALCs) serve over 800,000 vulnerable older adults at high 
risk of developing complications and dying from COVID-19. Most ALC residents are 85 
years of age or older and require assistance with bathing and dressing. Over 80% of ALC 
residents have three or more chronic conditions, and ALC and long-stay nursing (NH) 
residents have similar rates of diabetes, chronic obstructive pulmonary disease (COPD), 
and heart failure. Up to 70% of ALC residents have Alzheimer's Disease and Related 
Dementias (ADRD). In normal times, 43% of ALC residents are transferred in the last 30 
days of life and 16% die in hospital. However, ALC residents with dementia and other 
comorbid conditions are especially susceptible to the most serious respiratory 
complications of COVID-19, and the least likely to benefit from hospital level care.  
Unlike nursing homes, ALC residents contract separately for most medical services, 
which are delivered by external provider groups. Bluestone Physician Services, an 
existing partner under the National Institute on Aging IMPACT Collaboratory 
(U54AG063546), provides medical services in approximately 1,000 ALCs across three 
states (MN, WI, and FL). In the face of the coronavirus pandemic, Bluestone has rapidly 
transitioned from an on-site population health management model to remote care 
delivery. Bluestone is delivering 800-900 virtual physician visits per day, including 
urgent care and COVID-19 testing. 
Documenting preferences in the form of an advance directive or medical order, reduces 
receipt of unwanted care. In the face of the current pandemic, it is critically important to 
optimize advance care planning (ACP) and documentation of advance directives. ALC 
residents and their proxies must understand the course of COVID-19, treatment options if 
complications develop, and potential outcomes of these treatment options to make 
informed choices about their advance directives, particular as they relate to their 
preferences for hospital transfer and artificial ventilation.    

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2.2 Study Rationale 
A major long-term care priority in response to COVID-19 is increased use of resident 
advance directives. Despite an overwhelming patient and caregiver preference for 
comfort-focused end-of-life care, 43% of ALC residents are transferred in the last 30 
days of life and 16% die in hospital. In the face of COVID-19, Bluestone understands the 
urgent need to increase advance directive ascertainment and documentation in their 
ALCs, particularly for their most vulnerable residents, such as the 69% of their residents 
with dementia. Bluestone is unique among ALF providers in that it has an integrated 
electronic health record (EHR) with a HIPAA-compliant feature that allows its 
physicians to communicate information about residents to family members, ALC staff, 
and other members of the resident’s care team. Bluestone’s EHR data contain detailed 
information on resident physical and cognitive function, chronic conditions (including 
dementia diagnoses), and documentation of advance directives. We will leverage this 
infrastructure to conduct a 1-year trial of an ACP intervention directed toward residents 
and families of ALC residents with dementia. 
 
3 
STUDY DESIGN 
This is a one year, embedded, pragmatic cluster-randomized trial (ePCT). ALCs will be 
randomly assigned to Usual care or ACP informational website and video sent 
electronically to family members. Stratifying by state and balancing on baseline use of 
DNR orders, number of Bluestone residents in the ALC, and resident clinical 
characteristics, a Brown statistician will randomize 160 ALCs to the intervention or 
control study arms (80 ALCs per arm). 
Information materials include an email (Appendix A) with a link to a video describing 
resident goals of care and instructions for documenting treatment preferences in the form 
of advance directives or medical orders (Appendix B). When patients or proxies are not 
using the online portal, a letter and brochure reflecting the same content as the video will 
be sent to their residences. The materials were developed by Susan Hickman, Kathleen 
Unroe and colleagues at Indiana University. Dr. Hickman has agreed to modify their 
materials for the purposes of the study.In addition, all Bluestone clinicians will receive 
training (Appendix C) and a tailored conversation guide to help structure conversations 
with patients or proxies, when appropriate (Appendix D).  
Residents and family members of eligible residents in ALCs randomized to the usual care 
arm have ACP discussions with a clinician at admission, annually, and sometimes with a 
hospitalization or other change in condition. There is no standardized decision- or 
conversation-support tools used to have these discussions. Clinicians will engage PLWD 
in advance care planning discussions as they would in usual care. 
The primary clinical outcome will be the proportion of residents with DNR orders in the 
EHR at the end of four months followup. Secondary clinical outcomes will be: proportion 
of residents with do-not-hospitalize (DNH) orders in the EHR at the end of four months 
followup; proportion of residents with Medicare CPT billing code for ACP during the 
four months followup; and proportion of enrolled residents with any hospitalizations over 

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four months (outcome available for FL ALCs only). Implementation outcomes include 
counts of physician calls with family members and counts of website and video views. 
We plan to enroll approximately 3,000 patients and/or their proxies.  
Our partner health care systems will know which ALCs are randomized to each arm. 
Brown University statistician and data management staff will present aggregated post-
random assignment comparisons of intervention and control facilities’ baseline 
characteristics, but these preliminary analyses will be not generated at the individual 
facility level. Drs. Mitchell and McCreedy will be blinded. ALC assignment will be 
unblinded to the DSMB members at their request. 
We will also be conducting semi-structured interviews with Bluestone clinicians and staff 
from 16 ALCs, to describe: 1) the ACP process with ALC patients and their families, and 
how changes in advance directives are communicated to ALC staff; (2) impressions of 
the ACP intervention; and (3) challenges to honoring resident advance directives in the 
ALC setting  
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
The unit of random assignment will be the ALC and the unit of analysis the resident, 
clustered within the ALC. We will use Bluestone’s EHR data to identify eligible ALCs. 
Eligible ALCs will have at least 10 patients with a dementia diagnosis (ICD-10) who are 
not on hospice and do not have orders for comfort care or DNH at baseline.  
4.2 Exclusion Criteria  
ALCs with less than 10 patients with a dementia diagnosis (ICD-10) who are not on 
hospice and do not have orders for comfort care only or DNH baseline will be excluded 
from the study. Further, Bluestone may exclude ALCs prior to randomization based on 
knowledge of competing ACP initiatives or any other concerns about their relationship 
with the ALC. 
4.3 Study Enrollment Procedures  
This is an ePCT in which Bluestone will be responsible for enrolling participants. We are 
asking for a waiver of informed consent on Bluestone’s behalf. Per 45 CFR §46.116 f 3 
(i-v), we believe that: 
(i) The research involves no more than minimal risk to the subjects; The only risk to the 
broad group of individuals for whom we are requesting the EHR data is the risk of breach 
of confidentiality and we have described our security procedures for minimizing this risk. 
We also believe there is minimal risk to the subset of individuals who will be subjected to 
the intervention itself. The intervention will consist of three arms - a control arm (usual 
care); treatment arm 1 where eligible residents in ALCs randomized to the information 
arm will receive a letter from their Bluestone physician with links to an informational 
website and advanced care planning (ACP) video sent through the online portal; and 
treatment arm 2 where eligible residents will receive the same outreach letter from their 
Bluestone physician with links to the informational website and video in addition to a 
follow-up phone call by their Bluestone physician to have a structured conversation about 

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ACP with families. ACP is something that is routinely discussed between physicians and 
patients and their caregivers. This intervention, which examines the effectiveness of two 
modes of delivery for the discussion compared to usual care, does not increase the level 
of risk beyond what an individual would encounter in usual care. 
(ii) The research could not practicably be carried out without the requested waiver or 
alteration; There is no need for the research team to have contact with study subjects for 
this study. Recruitment and selection can be done passively through the use of EHR and 
the physician offices will be sending the letters and making the clinical phone calls in the 
two treatment arms directly. It would not be practicable to contact individuals for 
informed consent. 
(iii) If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format; The data could not practicably be 
sent to the research team without identifiers because we will be following individuals 
over time and must be able to link their information longitudinally. In addition, we must 
be able to identify EHR records within specific locations in order to recruit facilities as 
well as tell physicians which patients to include in the intervention. 
(iv) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; and We do not believe the waiver or alteration will adversely affect the rights 
and welfare of the subjects. The physicians who will be involved in the intervention 
already have access to the patients' EHR for routine clinical care purposes and will be 
reaching out to them as they would in regular practice. Patients are free to ignore the 
informational letter and not engage with the physician in an ACP discussion. The EHR 
data used will be will be securely stored and kept confidential. Direct identifiers will be 
removed by Brown Center for Gerontology and Health Care Research IT Director and 
replaced with study IDs prior to release to the study team for analysis. All results will be 
presented in aggregate. No individual information will be released. 
(v) Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation. We will provide 
Bluestone with copies of reports and manuscripts that result from this project. they are 
free to share information with their clinicians and facilities. The clinicians and facilities 
are free to share the information with interested families and patients.  
For the process evaluation, will ask Bluestone leadership to nominate eight physicians to 
participate in semi-structured interviews. The research assistant will contact the 
physicians recommended by corporate leadership, explain the study, and provide an opt-
out for participation. We will use the baseline EHR data to identify eight ACLs (one for 
each physician interviewed) with varying baseline AD use. Bluestone leadership and/or 
the physician working in the ALC will approach the director to ask if s/he would 
participate in an interview. The director will nominate a member of the direct care staff 
for interview. 

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5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
Delivery of the intervention leverages a component of Bluestone’s EHR infrastructure, an 
online portal used to share resident clinical updates with family members, ALC staff, and 
other members of the resident’s care team (hospice, home health, etc.). This ePCT has 
two arms: usual care and ACP information.  
Information Only:  
Patient centered medical home specialists at Bluestone will determine who is the correct 
person to receive the informational materials. If the patient is the correct recipient, 
Bluestone will send the informational materials to the resident at the ALC. If the proxy is 
the correct recipient, the clinical assistant will determine whether or not the proxy is 
using the existing online portal. If the proxy is using the portal, the informational 
materials will be sent electronically. If the proxy does not access the portal, the 
informational materials will be sent to their residences.  
 
The informational materials include an email with a link to a video highlighting the goals 
of care and their relationship to common treatment decisions including resuscitation, 
hospitalization, antibiotic use, and feeding tubes. For patients and proxies who are not 
using the online portal, a cover letter and brochure with the same information contained 
in the video will be mailed. Materials will be available in English and Spanish.   
 
 
Usual Care: ALC patients and proxies randomized to the usual care arm have ACP 
discussions with a clinician at admission, annually, and sometimes with a hospitalization 
or other change in condition. There is no standardized decision- or conversation-support 
tools used to have these discussions.  
 
5.2 Handling of Study Interventions  
Our partner, Bluestone, will know which ALCs are randomized to each arm. Brown 
University statistician and data management staff will present aggregated post-random 
assignment comparisons of intervention and control facilities’ baseline characteristics, 
but these preliminary analyses will be not generated at the individual facility level. Drs. 
Mitchell and McCreedy will be blinded. ALC assignment will be unblinded to the DSMB 
members at their request. 
5.3 Concomitant Interventions 
This is a pragmatic study. It is possible that ALCs enrolled in this study may be 
participating in other ACP interventions. We do not expect participation in competing 
interventions will differ between treatments and control arms. When Bluestone is aware 
of such interventions, they may choose to exclude ALCs prior to randomization. It is also 
possible that Bluestone physicians may work in ALFs randomized to different study 
arms. We will work to limit this contamination through the randomization process. We 
expect the effect of this potential contamination to be limited as clinical assistants will 

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only send informational materials to patients randomized to the information only arm and 
physicians will only call patients / proxies whom they are instructed to call. 
5.4 Adherence Assessment  
Adherence outcomes include number of emails sent to patients / proxies and the number 
of clicks to follow links for informational website or video, and number of patients / 
proxies. 
6 
STUDY PROCEDURES 
There will be 80 ALCs in each study arm. The outcome follow-up time for this 
intervention is four months. If the outreach intervention works, we expect orders to 
change shortly after the physician and patients or proxies have a discussion.  
 
 

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6.1 
Schedule of Evaluations 
Table 1. Project Timeline 
 
 
6.2 Description of Evaluations  
6.2.1 Screening Evaluation 
Consenting Procedure 
We are requesting a waiver of informed consent per 45 CFR §46.116 f 3 (i-v). Please 
see section 4.3 for details.  
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
This is a pragmatic trial. Using Bluestone’s EHR, research staff will identify 
potentially eligible ALCs which have at least 10 residents with a dementia diagnosis 
(ICD-10) who  are full code or missing code status at baseline. Bluestone will enroll 
ALCs. Bluestone will have discretion to exclude potentially eligible ALCs prior to 
randomization based on information on competing interventions or other relationship 
characteristics with ALC. 
Randomization 
Stratifying by state and balancing on baseline use of advance directives, number of 
Bluestone residents in the ALC, and resident clinical characteristics, a Brown 
statistician will randomize 160 ALCs to the intervention or control study arms (80 
ALCs per arm). 
6.2.3 Follow-up Visits 
There will be no direct follow-up for residents / proxies in ALCs randomized to usual 
care or information only study arms.  
6.2.4 Completion/Final Evaluation 
There are no completion, final evaluations. Outcomes will be evaluated using EHR 
data 
Workgroup
Task
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Data
Ongoing transfers of EHR data to Brown
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Data
ALC eligibility and randomization
X
X
X
X
Data
Ongoing eligibility list transfer from Brown to Bluestone
X
X
X
X
X
X
X
X
X
X
Aim 1
Finalize intervention materials
X
X
X
Aim 2
Finalize interview guides
X
X
Aim 2
Identification of providers and AL staff for interviews
X
X
Aim 1
Intervention roll-out: rolling study enrollment, 4-month follow-up
X
X
X
X
X
X
X
X
*
*
Aim 1
Intervention roll-out to newly added facilites, 4-month follow-up
X
*
*
*
*
Aim 2
Process evaluation interviews
X
X
X
Aim 2
Transcribe interviews
X
X
X
Aim 2
Analyze interviews
X
X
Aim 1
Unblinding and evaluation of study primary & secondary outcomes
X
X
X
X
Aim 1 & 2
Dissemination of results
X
X
2021
2022

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7 
SAFETY ASSESSMENTS  
7.1 Adverse Events and Serious Adverse Events  
Adverse Event (AE) Definition: AE is any untoward or unfavorable medical occurrence 
in a human study participant, including any abnormal sign (e.g. abnormal physical exam 
or laboratory finding), symptom, or disease, temporally associated with the participants’ 
involvement in the research, whether or not considered related to participation in the 
research.  
AEs for this study include:   
The potential AEs that could occur during this trial are negative emotional reactions 
when patients or family members watch ACP video or talk to a clinician about resident 
care preferences. Negative emotional reactions may include feelings of anxiety, worry or 
sadness. Negative emotional reactions resulting from watching the ACP video or talking 
to a clinician about resident care preferences would be classified as mild because the 
distress is easily tolerated and/or remediated, requires no medical evaluation, and has 
signs and symptoms that are transient. An immediate, negative reaction to watching the 
video or having a conversation with a clinician would fit the study relatedness category 
“Definitely Related.” AEs resulting from negative emotional reactions to the intervention 
are expected but likely rare. Our prior testing of a similar ACP video in a nursing home 
population with dementia demonstrated high user acceptability and few negative 
emotional responses. We believe the intervention does not incur any greater distress than 
usual ACP practices. 
Serious Adverse Events (SAE) Definition: SAEs consist of any adverse event that results 
in death; is life threatening or places the participant at immediate risk of death from the 
event as it occurred; requires or prolongs hospitalization; causes persistent or significant 
disability or incapacity; results in congenital anomalies or birth defects; is another 
condition which investigators judge to represent significant hazards 
SAEs for this pilot study include:   
No serious adverse events (SAEs) are expected, as this intervention does not contain any 
components with the potential to be life threatening, require or prolong hospitalization, 
cause persistent or significant disability or incapacity, or result in congenital anomalies or 
birth defects. 
 
7.1.1 Reporting Procedures 
Process for identifying AEs and SAEs:  
As part of Bluestone clinician training, instructions will be given as to what constitutes an 
AE / UP and how to report potential AEs / UPs to study staff. Bluestone clinicians will be 
instructed to offer to end a conversation, or have a conversation at another time, if a 
resident or proxy seems to be experiencing emotional distress as a result of their 
discussion. The Bluestone staff should report any potential AEs / UPs to the study project 
manager within one day of the event by calling or emailing the study project manager 

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(contact information provided during training). All potential AEs / UPs will be 
investigated and a Event Reporting Form will be completed and submitted to the PI via 
email within 24 hours of the project manager becoming aware of the event. Similarly, 
contact information for the study project manager will be provided at the end of the 
outreach letter. All potential AEs / UPs reported by study participants will be investigated 
and a Event Reporting Form will be completed and submitted to the PI via email within 
24 hours of the project manager becoming aware of the event.  
 
7.1.2 Follow-up for Adverse Events 
Upon receipt of the Event Reporting Form, the PI and Dr. Sandra Shi complete the Event 
Verification Form. Dr. Shi is a co-investigator on the project and a board-certified 
geriatrician with ACP experience. Specifically, the PI and Dr. Shi will review the details 
of the event, confirm that the event meets criteria for a true AE / UP, and classify the 
severity, expectedness, and relatedness of the event.  
During verification, if it is determined that the event does not meet the criteria for a true 
AE / UP, the Event Reporting Form and the Event Verification Form will be retained by 
the study team, and no further action will be taken. During verification, if it is determined 
that the event meets the criteria for a true AE / UP, we will follow the reporting schedule 
detailed below. 
During verification, if it is determined that the event is a true AE, the Event Reporting 
Form and the Event Verification Form will be retained for quarterly reporting of AEs to 
the Safety Officer (SO), the NIA Program Officer, and the IRB. A summary of AEs will 
be included in the annual DSMB report.   
During verification, if it is determined that the event is a true UP, the PI will notify the 
safety officer, the SO, the NIA Program Officer, the Office for Human Research 
Protections, and the IRB within 24 hours of the research team becoming aware of the 
event (within 48 hours of the event occurring). The Event Verification Form will also be 
used to capture the follow-up status of a resident who has experienced a UP. The Event 
Reporting Form and the Event Verification Form will be retained and a summary of UPs 
will be included in the annual DSMB report.   
. 
7.2 Safety Monitoring 
8 
INTERVENTION DISCONTINUATION  
We do not include stopping rules for two reasons.  First, this is a minimal risk study for 
which AEs will be rare. Second, a stopping rule would not be very feasible since the 
implementation period is less than one year– which means that interim data analyses will 
be difficult, if not impossible, to perform until the intervention is nearly complete. 
. 

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9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
The primary objective of this embedded, pragmatic, cluster-randomized trial (ePCT) is to 
test the effects of a COVID-specific, advance care planning (ACP) intervention on 
documentation of do-not-resuscitate (DNR) orders in a target cohort of assisted living 
community (ALC) residents with dementia from 160 ALCs in FL, MN and WI.  
 
ALC residents with dementia who are full code or missing code status at baseline will be 
randomly assigned to usual care  or to receive ACP informational website and video sent 
electronically to patients / proxies .  
 
The primary clinical outcome will be the proportion of residents with DNR orders in the 
EHR at the end of four months followup. Secondary clinical outcomes will be: proportion 
of residents with do-not-hospitalize (DNH) orders in the EHR at the end of four months 
followup; proportion of residents with Medicare CPT billing code for ACP during the 
four months followup; and proportion of enrolled residents with any hospitalizations over 
four months (outcome available for FL ALCs only). Implementation outcomes include 
counts of emails and video views.  
9.2 Sample Size and Randomization 
Table 2 presents the number of ALCs per study arm required to detect varying levels of 
prevalence of DNR orders in the treatment arm for the 100 ALCs already randomized to 
the Information Only or Control study arms, assuming α=.05, β=.20, and several values 
of the intra-class correlation coefficient (ICC). Based on baseline Bluestone data, we 
expect 54% of residents in the control arm will have a DNR order at the end of 4-months 
followup. Based on the same data, we estimated an ICC of 0.012 from the random 
intercept logistic model.4 Assuming a conservative ICC of .02, to achieve a power of .80, 
we need 71 ALCs per arm with 10 PLWD in each to demonstrate an 8-percentage point 
increase in DNR orders, such that information outreach would result in 62% of these 
residents having a DNR order at the end of 4-month follow-up.  
 
Table 1. Number of ALCs required per study arm at varying effect sizes and values of 
the intra-class correlation coefficient (10 residents per cluster, 54% DNR among 
controls) 
Intraclass Correlation Coefficient (ICC) 
Effect in 
Treated 
0.010 
0.015 
0.020 
0.025 
0.030 
0.60 
117 
121 
126 
131 
136 
0.61 
85 
89 
92 
96 
99 
0.62 
65 
68 
71 
73 
76 
0.63 
51 
53 
56 
58 
60 
0.64 
41 
43 
45 
47 
48 
 

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In the additional 60 facilities, we expect only 26% of the residents in the control arm will 
have DNR order at the end of 4-months follow-up based on baseline Bluestone data 
(similar ICC to previously randomized facilities). Assuming a conservative ICC of .02, to 
achieve a power of .80, we need 79 ALCs per arm with 10 PLWD in each to demonstrate 
a 7-percentage point increase in DNR orders, such that information outreach would result 
in 33% of these residents having a DNR order at the end of 4-month follow-up (Table 3).  
 
Table 3. Number of ALCs required per study arm at varying effect sizes and values of 
the intra-class correlation coefficient (10 residents per cluster, 26% DNR among 
controls) 
Intraclass Correlation Coefficient (ICC) 
Effect in 
Treated 
0.010 
0.015 
0.020 
0.025 
0.030 
0.32 
98 
102 
106 
110 
114 
0.33 
73 
76 
79 
82 
85 
0.34 
56 
59 
61 
63 
65 
0.35 
45 
47 
49 
50 
52 
0.36 
37 
38 
40 
41 
43 
 
We will add 30 ALCs to the existing 50 ALCs per arm, resulting in 80 ALCs per arm. 
We will be able to detect between a 7- and 8-percentage point change in documentation 
of DNR orders in the EMR. 
 
9.2.1 Treatment Assignment Procedures 
Stratifying by state and balancing on baseline use of advance directives, number 
of Bluestone residents in the ALC, and resident clinical characteristics, a Brown 
statistician will randomize 160 ALCs to the intervention or control study arms (80 
ALCs per arm).   
9.3 Interim analyses and Stopping Rules 
There will be no interim analysis and we do not include stopping rules for two reasons.  
First, this is a minimal risk study for which AEs will be rare. Second, a stopping rule 
would not be very feasible since the implementation period is less than one year– which 
means that interim data analyses will be difficult, if not impossible, to perform until the 
intervention is nearly complete. 
9.4 Outcomes  
9.4.1 Primary outcome   
The primary clinical outcome will be the proportion of residents with DNR orders in 
the EHR at the end of four months followup.  

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9.4.2 Secondary outcomes   
Secondary clinical outcomes will be: proportion of residents with do-not-hospitalize 
(DNH) orders in the EHR at the end of four months followup; proportion of residents 
with Medicare CPT billing code for ACP during the four months followup; and 
proportion of enrolled residents with any hospitalizations over four months (outcome 
available for FL ALCs only).  
 
Implementation outcomes include counts of emails sent to patients/proxies and counts 
of website and video views. 
9.5 Data Analyses 
Our primary approach will be an intention-to-treat (ITT) analysis. Last observed 
advance directive status will be used for residents who are censored due to death or 
discharge after 2 months followup. Model specifications are based on Donner & Klar 
for cluster randomized controlled trials where 𝑌𝑖𝑗 is the advance directive status for 
resident 𝑖 from ALC 𝑗, and 𝑙𝑜𝑔𝑖𝑡(𝑃(𝑌𝑖𝑗= 1)) = 𝜇𝑖𝑗, where 𝜇𝑖𝑗= 𝜇+ 𝛼𝐼𝑖𝑗+
∑
𝛾𝑖𝑗𝑙𝑋𝑖𝑗𝑙
𝐿
𝑙=1
+ 𝑢𝑗.  We define 𝑢𝑗~𝑁(0, 𝜎𝑢
2) as the conditional effect of ALC 𝑗 on the 
logit scale, 𝑋𝑖𝑗𝑙 are individual-level covariates, 𝛾𝑖𝑗𝑙 are unknown parameters, 𝐼𝑖𝑗 is an 
indicator for intervention arm membership, and α is the conditional treatment effect.  
10 DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
We will be receiving data from three pieces of Bluestone’s integrated health information 
system: the primary EHR; the specialized Bridge interface with families and the care 
team; and the individual level capture of hospitalizations (FL ALCs only). Brown has an 
existing partnership with Bluestone [U54AG063546], for which we developed a Data 
Use Agreement. As we have done in previous trials, Bluestone IT staff will place a new 
copy of the data package in a SharePoint location each month. Brown IT staff will 
download the data into our secure environment, apply study identifiers, and create 
analytic data sets.  
Specific data elements available from the EHR include: 
● 
Resident and ALC identifiers 
● 
Active diagnosis codes (ICD-10) 
● 
Functional and cognitive status assessments 
● 
Physician orders (treatments, diagnostic tests, etc.) 
● 
Medication orders 
● 
Advance directives / code status (full code, DNR, DNH, DNI, preference for 
comfort care) 
● 
COVID testing results 
● 
Hospitalizations (emergency department, ED, and observation stays, inpatient) 
 

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10.2 Data Management  
Brown University’s Center for Gerontology and Health Care Research (CGHCR) will 
serve as the Data Management/Statistical Center for the study. The CGHCR will be 
responsible for: receiving all person-level data from NHs, linking all data sources, 
creating analysis files, and conducting analyses. 
The CGHCR will receive person-level data from Bluestone’s EHR. To protect resident 
confidentiality, the corporation will place their data in a SSH secure server and will 
provide login information to the CGHCR. Data transfer to CGHCR secure servers will be 
via SFTP protocol with password protection. Once the files have been uploaded to the 
CGHCR servers, they will be stored, unmodified, in a secure file location specific to 
these uploads. They will then be read into SAS datasets, one per file type. The CGHCR 
will then notify the ALC system that the data were successfully downloaded and 
extracted, at which point the ALC systems will remove the data from their servers. All 
data files will be accompanied by a manifest detailing the number of distinct persons and 
records expected in them. The CGHCR will connect to the corporation servers on a 
monthly basis. The CGHCR’s information systems manager will be in charge of the data 
transfer, and he will replace the HICs and SSNs fields with a Brown University-generated 
identification number (throughout our different data sources) to allow linkage of data for 
analytic purposes. 
We maintain numerous confidential databases and have a high level of security built into 
our computing system. The computing infrastructure consists of a VMS cluster, which 
houses all substantial data, a group of Windows servers that provide computing services 
and infrastructure support for client systems, and client Windows PCs through which all 
users access our systems. Network security is provided by a combination of firewalls, 
local network access controls, and continuous auditing and monitoring for security 
breaches. All access from systems external to the LAN is limited to encrypted channels 
(e.g., SSL for VMS terminal sessions or VPN connections for LAN file sharing access). 
Unencrypted access is provided only for the CGHCR external Web site and general e-
mail support functions. The VMS cluster acts as a file server for Windows clients, and 
file access controls are consistently applied whether access is from the VMS or Windows 
environment.  
Security within the system is applied via Access Controlled Entries (ACEs) attached to 
all files on all systems. Security is applied uniformly to all files within a subtree of any 
file system, with the general rule that groups of users sharing a common task may read 
each other’s files but, in most cases, not write to each other’s files. VMS provides a 
highly-secure programming environment with ACEs applied to all objects and extremely 
controlled access to the larger system for individual users, as well as a versioning file 
system, secure batch queues and distributed processing, and efficient backup and 
recovery procedures. Windows clients are limited to a subset of these services (e.g., there 
is no way for file version information to be shown to Windows clients), but otherwise 
access is secured as for any other method of accessing data. 
Personally- and partially-de-identified data are housed in files that are restricted to 
systems management or to programmers who have been identified as custodians. No data 
are ever moved to more "public" spaces without identification information being stripped 

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or non-reversibly encoded. Encoding is generally done via fairly large Roman cyphers 
applied iteratively to the original character string. No reverse encoding is ever generated 
nor maintained. Any matching between personally-identified data sources is done within 
a secured area prior to any data being exported. Windows servers that house partially de-
identified data have matching ACEs applied so that access restrictions are applied 
consistently with VMS-based data. 
Since we use demographic covariates for many of our analyses, even the encoded data 
are best considered partially de-identified. ACEs restrict access to all data housed by 
CGHCR, such that access to any data elements on the servers is limited to those staff 
authorized to make such access. Authorizations are, in turn, granted by the core system's 
support staff upon request from a PI or other appropriate data owner. All users authorized 
to access CGHCR systems have access to some storage that is considered "general file 
sharing" but, by convention and policy, all individual or otherwise restricted data is 
prohibited from being stored on such space. Desktop systems are authorized to specific 
users, and it is assumed that they will store data they are authorized to work with on such 
local systems. The LAN is switched, yielding a reasonable amount of security between 
clients and servers within the LAN. Desktop systems are required to run current anti-
virus software and are prohibited from running local file-sharing software. External 
analyses are run periodically to verify the security of systems within the LAN. 
Similarly, the Windows servers which support the LAN are configured as a local, 
isolated, secure, collapsed AD forest local to our LAN. DNS, DHCP, and other critical 
services are secured within the context of the local forest and are not accessible externally 
(with the exception, of course, of VPN or RDP access from authorized client systems). 
Extensive monitoring is done from the VMS cluster to ensure the health and stability of 
the Windows forest structure, and the individual servers within it. 
In summary, CGHCR’s VMS computer system is highly secure and accessible only to 
authorized users. Within the group of authorized users, access to project data is restricted 
to individuals who are authorized to work on that specific research project. Access to 
identifiers is further restricted to the systems manager alone. Furthermore, CGHCR 
employees have signed an oath of confidentiality, and its violation is sufficient grounds 
for immediate termination. 
 
10.3 Quality Assurance  
10.3.1 
Training 
Clinicians will receive training (Appendix C) and a tailored conversation guide to 
help structure conversations with patients or proxies, when appropriate (Appendix D).  
10.3.2 Monitoring 
The NIA IMPACT Collaboratory DSMB will oversee all data and safety monitoring 
activities for this study. The number of DSMB members will be determined by NIA, 
and one will be designated the Chairperson. DSMB members will be appointed by the 
NIA Director. This DSMB will act in an advisory capacity to the NIA Director to 
monitor participant safety, to evaluate the progress of the study, and to review 

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procedures for maintaining the confidentiality of data, the quality of data collection, 
management, and analyses. Advarra IRB will conduct the ethical review required for 
the protection of human subjects or else make an exempt determination.  NIA PO, in 
consultation with DSMB chair, will make a determination regarding the level and 
format of data and safety monitoring this study requires, i.e., full DSMB oversight or 
monitoring by an independent SO. Lynn Mcnicoll, MD, has agreed to serve as the SO 
for this study. 
 
The facility level randomized clinical trial will be operating under the direction of 
Drs. Susan Mitchell and Ellen McCreedy, in conjunction with the trial statistician 
Roee Gutman, Ph.D. Bluestone Physician Services, under the direction of Todd 
Stivland, MD, will be recruiting, introducing the intervention and training local staff. 
Mr. Jeff Hiris (systems manager) and Ms. Laura Dionne (database manger) will be 
responsible for extracting the necessary data from the participating facilities’ EMR in 
order to construct the outcome variable as well as all relevant independent variables 
and to integrate into the analysis data base the implementation monitoring data. Once 
the data files have been properly prepared, Ms. Annie Yang (analyst) will conduct 
outcome analyses according to pre-specified analysis plan. The study PI and the MPIs 
of the IMPACT Collaboratory will remain blind throughout this process.  
 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol any subsequent modifications will be reviewed and approved by the IRB or 
ethics committee responsible for oversight of the study.  
11.2 Informed Consent Forms 
This is an ePCT in which Bluestone will be responsible for enrolling participants. We are 
asking for a waiver of informed consent on Bluestone’s behalf. Per 45 CFR §46.116 f 3 
(i-v), we believe that: 
(i) The research involves no more than minimal risk to the subjects; The only risk to the 
broad group of individuals for whom we are requesting the EHR data is the risk of breach 
of confidentiality and we have described our security procedures for minimizing this risk. 
We also believe there is minimal risk to the subset of individuals who will be subjected to 
the intervention itself. The intervention will consist of three arms - a control arm (usual 
care); treatment arm 1 where eligible residents in ALCs randomized to the information 
arm will receive a letter from their Bluestone physician with links to an informational 
website and advanced care planning (ACP) video sent through the online portal; and 
treatment arm 2 where eligible residents will receive the same outreach letter from their 
Bluestone physician with links to the informational website and video in addition to a 
follow-up phone call by their Bluestone physician to have a structured conversation about 
ACP. ACP is something that is routinely discussed between physicians and patients and 

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their caregivers. This intervention, which examines the effectiveness of two modes of 
delivery for the discussion compared to usual care, does not increase the level of risk 
beyond what an individual would encounter in usual care. 
(ii) The research could not practicably be carried out without the requested waiver or 
alteration; There is no need for the research team to have contact with study subjects for 
this study. Recruitment and selection can be done passively through the use of EHR and 
the physician offices will be sending the letters and making the clinical phone calls in the 
two treatment arms directly. It would not be practicable to contact individuals for 
informed consent. 
(iii) If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format; The data could not practicably be 
sent to the research team without identifiers because we will be following individuals 
over time and must be able to link their information longitudinally. In addition, we must 
be able to identify EHR records within specific locations in order to recruit facilities as 
well as tell physicians which patients to include in the intervention. 
(iv) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; and We do not believe the waiver or alteration will adversely affect the rights 
and welfare of the subjects. The physicians who will be involved in the intervention 
already have access to the patients' EHR for routine clinical care purposes and will be 
reaching out to them as they would in regular practice. Patients are free to ignore the 
informational letter and not engage with the physician in an ACP discussion. The EHR 
data used will be will be securely stored and kept confidential. Direct identifiers will be 
removed by Brown Center for Gerontology and Health Care Research IT Director and 
replaced with study IDs prior to release to the study team for analysis. All results will be 
presented in aggregate. No individual information will be released. 
(v) Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation. We will provide 
Bluestone with copies of reports and manuscripts that result from this project. they are 
free to share information with their clinicians and facilities. The clinicians and facilities 
are free to share the information with interested families and patients. ALCs with less 
than 20 residents with a dementia diagnosis (ICD-10) who are not on hospice and do not 
have orders for comfort care only or DNH baseline will be excluded from the study.  
  
11.3 Participant Confidentiality  
To protect resident confidentiality, the corporation will place their data in a SSH secure 
server and will provide login information to the CGHCR. Data transfer to CGHCR secure 
servers will be via SFTP protocol with password protection. Once the files have been 
uploaded to the CGHCR servers, they will be stored, unmodified, in a secure file location 
specific to these uploads. They will then be read into SAS datasets, one per file type. The 
CGHCR will then notify the ALC system that the data were successfully downloaded and 
extracted, at which point the ALC systems will remove the data from their servers. All 
data files will be accompanied by a manifest detailing the number of distinct persons and 

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records expected in them. The CGHCR will connect to the corporation servers on a 
monthly basis. The CGHCR’s information systems manager will be in charge of the data 
transfer, and he will replace the HICs and SSNs fields with a Brown University-generated 
identification number (throughout our different data sources) to allow linkage of data for 
analytic purposes. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12 
ETHICAL CONSIDERATIONS 
Ethical consideration for the trial will be in accordance with the Federal Policy for the 
Protection of Human Subjects (HHS Human Subjects Research 45 Code of Federal 
Regulations (CFR) 46). 
13 
COMMITTEES 
The study uses a concurrent, embedded mixed methods design in which qualitative data 
is used to capture impressions of implementation and help explain quantitative results. To 
accomplish this, the project team is split in half and Aim 1 and Aim 2 tasks are carried 
out simultaneously. Weekly meetings will be held for Aim1 and Aim 2 teams, with a 
biweekly meeting for the study leadership. We will also hold weekly meetings with 
Bluestone leadership. The PI (EM) has served as co-Investigator on three embedded 
pragmatic trials of institutionalized older adults, one of which she directs. The PI (EM) 
will lead full team meetings, oversee overall project direction, ensure timely submission 
of all requested project materials, ensure project milestones are met, and review and 
approve all publications. She will be assisted by the Project Manager (AR) and Project 
Coordinator (EZ). The Aim 1 team will be led by PI (SM) and Co-I (SS), geriatricians 
with expertise in testing physician support tools for the NH and ALC settings, and Co-I 
(KT), a nationally recognized expert on assisted living. The Aim 2 team will be led by 
Co-I (RB) and Co-I (EG). Co-I (RB) is the Director of the Center for Long-Term Care 
Quality & Innovation, which has conducted several similar process evaluations to the one 
proposed. Co-I (EG) is a qualitative researcher with experience conducting and analyzing 
interviews with clinicians and long-term care staff. The team also includes an 
experienced data manager and an analyst with experience using EHR physician orders to 
establish code status. As a supplement, the study also benefits from the oversight of the 
NIA IMPACT Collaboratory (U54AG063546). Figure 1 describes organizational 
structure and leadership of work teams. 
 

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14 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures 
developed by the Steering Committee.  Any presentation, abstract, or manuscript will be 
made available for review by the sponsor and the NIA prior to submission. 
15 
REFERENCES 
1. 
Thomas KS, Dosa D, Gozalo PL, et al. A Methodology to Identify a Cohort of Medicare 
Beneficiaries Residing in Large Assisted Living Facilities Using Administrative Data. 
Med Care. 2018;56(2):e10-e15. 
2. 
Caffrey C, Sengupta M, Park-Lee E, Moss A, Rosenoff E, Harris-Kojetin L. Residents 
living in residential care facilities: United States, 2010. NCHS Data Brief. 2012(91):1-8. 
3. 
Zimmerman S, Sloane PD, Reed D. Dementia prevalence and care in assisted living. 
Health Aff (Millwood). 2014;33(4):658-666. 
4. 
Rosenblatt A, Samus QM, Steele CD, et al. The Maryland Assisted Living Study: 
prevalence, recognition, and treatment of dementia and other psychiatric disorders in the 
assisted living population of central Maryland. J Am Geriatr Soc. 2004;52(10):1618-
1625. 
5. 
Thomas KS, Belanger E, Zhang W, Carder P. State Variability in Assisted Living 
Residents' End-of-Life Care Trajectories. J Am Med Dir Assoc. 2020;21(3):415-419. 
6. 
Teno JM, Gozalo P, Mitchell SL, Bynum JP, Dosa D, Mor V. Terminal hospitalizations 
of nursing home residents: does facility increasing the rate of do not resuscitate orders 
reduce them? J Pain Symptom Manage. 2011;41(6):1040-1047. 
7. 
Gaster B, Larson EB, Curtis JR. Advance Directives for Dementia: Meeting a Unique 
Challenge. Jama. 2017;318(22):2175-2176. 
8. 
Huang HL, Shyu YL, Weng LC, Chen KH, Hsu WC. Predictors of advance directives 
among nursing home residents with dementia. Int Psychogeriatr. 2018;30(3):341-353. 
9. 
Lynn J. Getting Ahead Of COVID-19 Issues: Dying From Respiratory Failure Out Of 
The Hospital. April 1, 2020; 
https://www.healthaffairs.org/do/10.1377/hblog20200330.141866/full/. Accessed April 
26, 2020. 

Protocol Template, Version 3.0 
22 
10. 
Grabowski DC, Stevenson DG, Cornell PY. Assisted living expansion and the market for 
nursing home care. Health Serv Res. 2012;47(6):2296-2315. 
11. 
Silver BC, Grabowski DC, Gozalo PL, Dosa D, Thomas KS. Increasing Prevalence of 
Assisted Living as a Substitute for Private-Pay Long-Term Nursing Care. Health Serv 
Res. 2018;53(6):4906-4920. 
12. 
Magsi H, Malloy T. Underrecognition of cognitive impairment in assisted living 
facilities. J Am Geriatr Soc. 2005;53(2):295-298. 
13. 
Workgroup AL. Assuring quality in assisted living: Guidelines for federal and state 
policy, state regulation, and operations. Washington DC: US Senate Special Committee 
on Aging. 2003. 
14. 
Kane RL, Mach JR, Jr.,. Improving Health Care for Assisted Living Residents. The 
Gerontologist. 2007;47(suppl_1):100-109. 
15. 
Sloane PD, Zimmerman S, Perez R, et al. Physician perspectives on medical care 
delivery in assisted living. Journal of the American Geriatrics Society. 
2011;59(12):2326-2331. 
16. 
Maxwell CJ, Amuah JE, Hogan DB, et al. Elevated Hospitalization Risk of Assisted 
Living Residents With Dementia in Alberta, Canada. J Am Med Dir Assoc. 
2015;16(7):568-577. 
17. 
Kronhaus A, Fuller S, Zimmerman S, Reed D. Prevalence and Medication Management 
of Dementia by a Medical Practice Providing Onsite Care in Assisted Living. J Am Med 
Dir Assoc. 2016;17(7):673 e679-673 e615. 
18. 
Chidambaram P. State Reporting of Cases and Deaths Due to COVID-19 in Long-Term 
Care Facilities. Apr 23, 2020; https://www.kff.org/medicaid/issue-brief/state-reporting-
of-cases-and-deaths-due-to-covid-19-in-long-term-care-facilities/. Accessed April 26, 
2020. 
19. 
Thomas KC, P. Grabowski, D. https://www.statnews.com/2020/03/25/assisted-living-
covid-19-kirkland-nursing-home/. March 25, 2020; 
https://www.statnews.com/2020/03/25/assisted-living-covid-19-kirkland-nursing-home/. 
Accessed April 26, 2020. 
20. 
Premier Inc. Survey: More Than Two-Thirds of Senior Living Facilities Say They Can’t 
Access Personal Protective Equipment Needed for COVID-19 Containment Plans. March 
16, 2020; https://www.premierinc.com/newsroom/press-releases/premier-inc-survey-
more-than-two-thirds-of-senior-living-facilities-say-they-cant-access-personal-protective-
equipment-needed-for-covid-19-containment-plans. Accessed April 26, 2020, 2020. 
21. 
Van Houtven C, Boucher, N., Dawson, W. Impact of the COVID-19 Outbreak on Long-
Term Care in the United States. International Long-Term Care Policy Network;24 April 
2020. 
22. 
Mitchell SL, Palmer JA, Volandes AE, Hanson LC, Habtemariam D, Shaffer ML. Level 
of Care Preferences Among Nursing Home Residents With Advanced Dementia. J Pain 
Symptom Manage. 2017;54(3):340-345. 
23. 
Vandervoort A, Houttekier D, Vander Stichele R, van der Steen JT, Van den Block L. 
Quality of dying in nursing home residents dying with dementia: does advanced care 
planning matter? A nationwide postmortem study. PLoS One. 2014;9(3):e91130. 
24. 
Namendys-Silva SA. Respiratory support for patients with COVID-19 infection. The 
Lancet Respiratory medicine. 2020;8(4):e18. 

Protocol Template, Version 3.0 
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25. 
White DB, Lo B. A Framework for Rationing Ventilators and Critical Care Beds During 
the COVID-19 Pandemic. Jama. 2020. 
26. 
Cohen SM, Volandes AE, Shaffer ML, Hanson LC, Habtemariam D, Mitchell SL. 
Concordance Between Proxy Level of Care Preference and Advance Directives Among 
Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical 
Trial. J Pain Symptom Manage. 2019;57(1):37-46.e31. 
27. 
Nakashima T, Young Y, Hsu WH. Are Hospital/ED Transfers Less Likely Among 
Nursing Home Residents With Do-Not-Hospitalize Orders? J Am Med Dir Assoc. 
2017;18(5):438-441. 
28. 
Donner A, Klar N. Design and analysis of cluster randomization trials in health research. 
New York. 2010. 
29. 
Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model 
(PRISM) for integrating research findings into practice. Joint Commission journal on 
quality and patient safety. 2008;34(4):228-243. 
30. 
Weston C, Gandell T, Beauchamp J, McAlpine L, Wiseman C, Beauchamp C. Analyzing 
interview data: The development and evolution of a coding system. Qualitative 
sociology. 2001;24(3):381-400. 
31. 
Bazeley P, Jackson K. Qualitative data analysis with NVivo. SAGE publications limited; 
2013. 
32. 
Palinkas LA, Aarons GA, Horwitz S, Chamberlain P, Hurlburt M, Landsverk J. Mixed 
method designs in implementation research. Adm Policy Ment Health. 2011;38(1):44-53. 
33. 
Zimmerman S, Sloane PD, Eckert JK, et al. How good is assisted living? Findings and 
implications from an outcomes study. J Gerontol B Psychol Sci Soc Sci. 
2005;60(4):S195-204. 
34.      Wu, S., Crespi, C. M., & Wong, W. K. Comparison of methods for estimating the 
intraclass correlation coefficient for binary responses in cancer prevention cluster 
randomized trials. Contemporary clinical trials. 2012;33(5), 869-880. 
16 
SUPPLEMENTS/APPENDICES 
Appendix A. Letter to Bluestone Families 
Appendix B. Educational Video for Patients / Proxies 
Appendix C. Provider Training Video 
Appendix D. Provider ACP Discussion Guide 
 
 

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Appendix A. Outreach Email / Letter 
At Bluestone we believe that our patients deserve a customized approach to all aspects of their 
care. As your provider team, we are reaching out to all our patients and families to introduce our 
Advance Care Planning process. Talking with your loved ones and your provider team about 
values, goals, and treatment preferences ahead of time is called Advance Care Planning. 
 
Advance Care Planning is important because it is easier to make decisions when things are stable 
and calm. This gives you time to reflect, talk with family, and get more information. We have 
learned from the COVID-19 pandemic that decision making ahead of time will help ensure 
medical preferences will be honored. 
 
Every year we discuss with our patients their medical preferences. This year we are also sharing 
a booklet and video with our patients and family members. The booklet and video provide more 
information about what Advance Care Planning is, the questions you may be asked, and the 
benefits of Advance Care Planning. Please look through the booklet and access the video here: 
link to the video. 
 
As always, if you have any questions please reach out to your Bluestone provider team through 
the Bridge. 
 
Thank you 
 
 
 

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Appendix B. Educational video for patients / proxies 
 

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Appendix C. Provider Training Video 
 

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2
 

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Appendix D. Provider ACP Discussion Guide 
 
DISCUSSION TOPIC 
KEY QUESTIONS AND 
PROMPTS 
SUPPORTIVE INFORMATION 
AND GUIDANCE 
Introduce the topic and 
frame the conversation 
What is your 
understanding of 
Advance Care Planning? 
 
OR  
 
What have you heard of 
Advance Care Planning? 
 
Provide support: “It can 
be easier to make these 
types of decisions when 
things are stable and 
calm. This gives you 
time to reflect, talk with 
your family, and get 
more information.” 
 
“The goal of Advance 
Care Planning is to make 
sure you receive the care 
you want.” 
 
Describe ACP as discussions 
about goals, values, and 
preferences about what kind 
of medical treatments are 
wanted. 
 
Emphasize that ACP is a part 
of providing residents with 
good care.  
 
Explain that it can be easier to 
think, reflect, and decide in 
advance of a crisis. 
 
Normalize the conversation. 
Explain that we have these 
discussions with all our 
residents.  
 
Reassure patient that 
preferences will be reviewed 
periodically and can be 
revisited anytime. 
Describe the role of 
surrogate and family 
 
 
 
 
 
 
 
 
 
 
Who is the patient’s legal 
health care decision-
maker? 
 
If speaking to the 
patient: 
If you become very sick 
and unable to make your 
own care decisions, 
someone else will need 
to make medical 
decisions for you. This is 
called a surrogate 
decision-maker or health 
care proxy.  
 
 
Who would you like to 
be your health care 
proxy?  
Identify / appoint legal 
surrogate, if appropriate. 
Verify you have the correct 
surrogate decision-maker. 
 
Review any prior 
documentation about the 
patient’s preferences to 
inform the discussion.  
 
Remind patient to have a 
conversation with their 
chosen health care proxy. 
 
 
 
 
Describe the surrogate’s role 
and responsibility to make 

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Direct next steps: “You 
should have a 
conversation with your 
health care proxy about 
the type of care you 
would want if you 
became very sick.” 
 
If speaking to the 
surrogate decision-
maker: 
(Patient name) has 
chosen you to be their 
surrogate/health care 
proxy, which means if 
there comes a time that 
(patient name) cannot tell 
the medical team what 
they would want, you 
would responsible for 
making medical 
decisions for them. How 
do you feel about that? 
 
decisions on the resident’s 
behalf when the resident is 
unable to do so. 
 
A surrogate decision-maker 
should make decisions based 
on the patient’s prior 
preferences and choices, when 
available. If not, the surrogate 
should choose what they think 
the patient would want if they 
could be a voice in the room. 
If surrogate does not know 
what the patient would want, 
they should decide what’s in 
the patient’s best interest. 
 
 
 
 
Discuss the patient’s 
current health status 
What is your 
understanding of your 
(the patient’s) current 
health, medical 
problems, and care 
needs? 
 
What do you expect will 
happen in the future? 
 
Explore understanding, 
identify gaps in knowledge 
and provide information as 
appropriate.  
 
For patients with dementia, 
explore understanding of 
trajectory of dementia and 
common complications. 
 
Explore personal goals 
Tell me a little bit about 
what is important to you 
(the patient) right now.  
 
What makes you (the 
patient)  happy or 
satisfied?  
 
What makes you (the 
patient) unhappy, 
distressed, or fearful? 
 
Discuss past experiences, 
statements, or preferences to 
help identify what is 
important to the patient. 

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What do you hope, or 
fear, will happen in the 
coming months? 
Explore goals of care 
When people have a 
serious illness, like 
dementia, it is important 
to think about the most 
important goal you want 
for your healthcare. This 
helps us choose 
treatments that are best 
for you and fit with your 
values.  
 
 
What questions do you 
have?  
 
What is the main goal of 
care for (patient name) at 
this time? 
 
Do you have any 
concerns about this goal? 
 
Describe the three goals of 
care using the goals of care 
framework. Explain goals 
framework. 
 
The goal of prolonging life is 
to help the patient live longer  
 
The goal of maintaining 
function is to help the person 
stay strong and do as much as 
possible independently  
 
The goal of comfort care is to 
improve the person’s comfort 
level and quality of life.  
Note on hospice: To receive 
hospice care under the 
Medicare benefit, a patient 
must meet certain criteria 
including less than 6 months 
life expectancy. 
Link goals and 
treatment preferences 
(CPR) 
 
{SKIP IF PATIENT IS 
DNR} 
Now we are going to talk 
about specific treatments 
and how they fit with 
your goals of care. 
 
{describe CPR using key 
points} 
 
If patient goal is 
prolonging life: If your 
main goal is to prolong 
life, CPR can be 
attempted if your heart 
and breathing stops. 
Breathing machines may 
be used to increase the 
chance of restarting the 
heart and lungs.   
 
If patient goal is 
maintaining function or 
comfort care: If your 
If the patient’s goal of care is 
clear, suggest what makes 
sense for the patient. 
 
Share CPR outcomes - less 
than 3 out of 100 residents  
will survive CPR.   
 
Describe side effects in 
survivors including  brain 
damage, broken ribs, or organ 
damage.  
 
If applicable in the specific 
assisted living center, educate 
surrogate that CPR may not 
be started in many assisted 
living centers until the EMTs 
arrive. It is extremely unlikely 
the resident will be able to 
return to his/her current 
quality of life.  

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main goal is to improve 
comfort or maintain 
function, CPR should 
not be attempted. 
 
Do you have any more 
questions about CPR? 
 
If you heart and 
breathing stops, would 
you want CPR? 
 
 
Document CPR preference. 
Link goals and 
treatment preferences 
(HOSPITALIZATION) 
 
{SKIP IF PATIENT IS 
DNH} 
Next, we’ll talk about 
going to the hospital 
 
If patient goal is 
prolonging life: If your 
goal is to prolong life, 
the hospital may be the 
right place to get 
treatments that are only 
offered in that setting. 
These include treatments 
that can only be given in 
an intensive care unit 
like mechanical 
ventilators or a breathing 
machine 
 
If patient goal is 
maintaining function: If 
your goal is to maintain 
function, hospitalization 
may be appropriate for 
selective treatments, 
usually does not include 
care in the intensive care 
unit or breathing 
machines.  
 
If patient goal is comfort 
care: If your goal is 
comfort care, 
hospitalization should be 
avoided unless 
treatments needed to 
make you comfortable 
are not available outside 
the hospital. 
If the patient’s goal of care is 
clear, suggest what makes 
sense for the patient. 
 
Explain that hospitalization 
involves evaluation, 
stabilization of medical 
conditions, or treatment 
intended to prolong life.  
 
Describe ICU care using lay 
language including breathing 
tubes (Intubation) and 
breathing machines 
(ventilation).  
 
Comfort-focused can usually 
be provided in the AL facility 
through hospice or palliative 
care services.  
 
Ask if they want to know 
more about hospice or 
palliative care. 
 
Document decisions 
appropriately. 
 
If patient wants to go to the 
hospital, explore further if 
that includes use of a 
breathing machine or not. 

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Do you have any more 
questions about hospital 
care? 
 
What are your thoughts 
about whether you would 
want to go to the hospital 
if you get sick?  
 
Link goals and 
treatment preferences  
 
(ANTIBIOTICS) 
Now we will talk about 
infection management 
and antibiotics. 
 
Antibiotics help treat 
several different 
infections caused by 
bacteria, such as urinary 
tract infections and 
pneumonia. Antibiotics 
do not treat colds or the 
flu, which are caused by 
viruses. 
 
If the patient goal is 
prolonging life or maintaining 
function: If your goal is to 
prolong life or maintain 
function, antibiotics are 
usually used for all infections 
(if medically indicated).  
 
If the patient goal is comfort 
care: If your goal is comfort 
care, antibiotics are usually 
not provided unless needed to 
enhance comfort. 
 
If the patient’s goal of care is 
clear, suggest what makes 
sense for the patient. 
 
Describe antibiotics using lay 
language. 
 
Explain that sometimes even 
the right antibiotic will not 
work if an infection is 
overwhelming. A patient who 
is very frail or has multiple 
medical problems may not be 
able to fight off the infection 
even with antibiotics. 
 
If a patient’s overall care goal is 
focused on comfort care, consider 
whether the antibiotic will make 
them more comfortable or if there 
are other ways to keep him or her 
comfortable.  
Document antibiotic use 
preferences appropriately. 
Link goals and 
treatment preferences 
(TUBE FEEDING) 
 
{SKIP IF PATIENT IS 
NO ARTIFICIAL 
FEEDING OR DOES 
NOT HAVE 
DEMENTIA} 
 
Now we are going to talk 
about eating problems. 
{Describe artificial 
feeding using key 
points} 
 
Eating problems are 
very, very common in 
late stage dementia, and 
often indicate the end-of-
Feeding tube discussion is 
only appropriate for 
patients with dementia. 
If the patient’s goal of care is 
clear, suggest what makes 
sense for the patient.  
 
This discussion should mainly 
focus on eating problems in 
late-stage dementia. Feeding 

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life may be near. The 
choice at this point is to 
eat and drink to extent it 
is still enjoyable and 
comfortable for you, and 
not worry too much 
about how much food 
you get.  
 
The other option is to 
have a feeding tube. 
These tubes go through 
the skin and into your 
stomach and liquid food 
is given through the tube. 
This procedure must be 
done at a hospital. 
 
If patient goal is 
prolonging life: If your 
goal is to prolong life, it 
is important to know that 
there is no evidence 
feeding tubes help 
residents with advanced 
dementia live longer.  
 
If patient goal is 
maintaining function or 
comfort care: If your 
goal is to maintain 
function or comfort 
care, then continuing to 
eat and drink by mouth, 
sometimes with the help 
of another person, makes 
sense.  
 
Do you have any more 
questions about feeding 
problems?  
If you had feeding 
problems in late-stage 
dementia, what would 
you want? 
problems for other specific 
conditions, like Parkinson’s 
or stroke, are very different. 
 
Educate that for patients with 
dementia, 15 years of research 
have shown that feeding tubes 
do not prolong life, prevent 
aspiration or improve pressure 
ulcers.  
 
Educate that many assisted 
living communities do not 
support tube feeding. The 
patient may need to move to a 
different facility to receive 
tube feeding. 
 
Describe complications 
associated with tube-feeding 
in dementia, like diarrhea, risk 
of pulling out tube and 
needing restraints, need to go 
to hospital for blockages or 
dislodgement. 
 
Document tube feeding 
decision. 
Explain next steps 
Let me share the next 
steps with you. 
 
Summarize your 
understanding of patient’s 
wishes. 
 

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Based on our discussion, 
I’m first going to 
summary my 
understanding of your 
wishes (summarize 
here)… Did I get this 
right? 
 
Now we will write down 
your wishes in your 
medical chart / fill out a 
POLST form / complete 
HCP / relevant state-
specific forms. 
 
Describe process for getting 
medical orders signed.  
 
Describe process for 
formalizing health care proxy 
if relevant.  
 
Reassure them that 
preferences will be reviewed 
periodically and can be 
revisited anytime. 
Address any questions 
Do you have any other 
questions? 
Provide additional 
information or record 
questions for the 
Physician/Advanced Practice 
Provider as appropriate.