Palliative Care Consultations for Persons With Alzheimer's Disease and Related Dementia and Cognitive Impairment in the Medicare Skilled Nursing Facility (SNF) Setting
Phase: NA
Conditions: Advance Care Planning, Palliative Care, Skilled Nursing Facility, Cognitive Impairment
Sponsor: University of Maryland, Baltimore

Version 1.0 
 
1 
 
 
FULL PROTOCOL TITLE: 
Palliative Care Consultations for Persons with Alzheimer's Disease and Related Dementia and 
Cognitive Impairment in the Medicare Skilled Nursing Facility (SNF) Setting 
 
SHORT TITLE:  
Palliative Care for Persons with ADRD in SNF  
 
Principal Investigator: 
Joan G. Carpenter, PhD, CRNP 
Assistant Professor 
University of Maryland, Baltimore 
 
Sponsor/Funding Source:   
National Institutes of Health/National Institute of Nursing Research 
 
Protocol Version Date: 
March 30, 2023 
 
 
 
 
 
 

Version 1.0 
 
2 
 
Table of Contents 
FULL PROTOCOL TITLE: ..................................................................................................................... 1 
STUDY TEAM ROSTER ........................................................................................................................... 4 
Principal Investigator: 
  Joan G. Carpenter, PhD, CRNP ................................................. 4 
Research Project Manager:  Jasmine A. Newman, B.S. .......................................................... 4 
                                                     
1 
STUDY OBJECTIVES ...................................................................................................................... 5 
1.1 
Primary Objectives  (1a and 1b) .................................................. 5 
1.2 
Secondary Objectives (2) ............................................................. 5 
2 
BACKGROUND AND RATIONALE .............................................................................................. 5 
2.1 
Background .................................................................................. 5 
2.2 
Study Rationale............................................................................ 5 
3 
STUDY DESIGN and Duration ........................................................................................................ 6 
3.1 
Design .......................................................................................... 6 
3.2 
Enrollment Numbers.................................................................... 6 
3.3 
Study Duration ............................................................................. 6 
3.4 
Compensation .............................................................................. 6 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................................... 6 
4.1 
Key Inclusion Criteria ................................................................. 6 
4.2 
Key Exclusion Criteria ................................................................ 6 
4.3 
Study Enrollment Procedures ...................................................... 7 
5 
INTERVENTION............................................................................................................................... 7 
5.1 
Palliative Care Encounter Intervention ........................................ 7 
5.2 
Handling of Study Interventions.................................................. 8 
6 
STUDY PROCEDURES .................................................................................................................... 8 
6.1 
Research Procedures .................................................................... 8 
6.2 
Consenting Procedures ................................................................ 9 
6.3 
Data Collection .......................................................................... 10 

Version 1.0 
 
3 
 
6.4 
Measures and Instruments ......................................................... 10 
6.5 
Table 3 Study Measures ............................................................ 10 
7 
SAFETY MONITORING ................................................................................................................ 11 
7.1 
Data Safety Monitoring Plan ..................................................... 11 
7.2 
Adverse Events and Serious Adverse Events ............................ 11 
7.3 
Assessment of External Factors Related to AEs ....................... 12 
8 
PARTICIPANT WITHDRAW/DISCONTINUATION ............................................................... 12 
8.1 
Study Discontinuation ............................................................... 12 
9 
STATISTICAL CONSIDERATIONS ............................................................................................ 13 
9.1 
General Design Issues ............................................................... 13 
9.2 
Sample Size and Randomization ............................................... 13 
9.3 
Interim analyses and Stopping Rules......................................... 13 
9.4 
Data Analyses ............................................................................ 13 
10 
DATA COLLECTION AND QUALITY ASSURANCE .............................................................. 14 
10.1 
Data Collection/Management .................................................... 14 
10.2 
Quality Assurance...................................................................... 14 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................... 14 
11.2 
Participant Confidentiality .......... Error! Bookmark not defined. 
11.3 
Ethical Considerations ............................................................... 15 
12 
PUBLICATION OF RESEARCH FINDINGS/DELIVERABLES . Error! Bookmark not defined. 
13     REFERENCES ................................................................................................................................. 15 
 
 
 
 
 
 
 
 
 
 

Version 1.0 
 
4 
 
STUDY TEAM ROSTER 
Principal Investigator:  
 
Joan G. Carpenter, PhD, CRNP 
655 W. Lombard St., Suite 445 
Baltimore, MD 21201 
 
 
 
 
 
410-706-2585 
Joan.carpenter@umaryland.edu 
Supervise all aspects of this study’s implementation including 
study start up, regulatory approvals, data collection, data 
management, all analyses, lead the drafting of primary 
manuscripts and scientific conference abstracts. 
Research Project Manager: 
 
Jasmine A. Newman, B.S. 
 
 
 
 
 
655 W. Lombard St., Suite 445 
Baltimore, MD 21201 
410-706-7819 
Jasmine.newman@umaryland.edu 
 
Under PI direction, the project manager is responsible for day-to-
day operations (e.g. meeting coordination, meeting minutes) 
including ongoing reports, database development and 
maintenance, budget oversight, regulatory approvals, data 
collection, data management, and analyses. 
 
Graduate Research Assistant:  
Amy Jackson, BSN, RN 
 
 
 
 
 
 
655 W. Lombard St., Suite 445 
Baltimore, MD 21201 
410-706-7819 
aljackson@umaryland.edu 
Under the project manager and PI direction, the research 
assistant is responsible for developing and executing procedures 
and processes of study implementation, recruitment and 
retention, data collection, preparing Data/Safety monitoring 
reports, and regulatory processes. 
 
 
 

Version 1.0 
 
5 
 
1 
STUDY OBJECTIVES 
1.1 
Primary Objectives (1a and 1b) 
This study will examine the feasibility of a SNF-PC intervention in persons with Alzheimer’s and 
related dementias (ADRD) and cognitive impairment (MCI) and address patient/caregiver reported 
outcomes including quality of life, symptom management, and satisfaction. 
1a: Establish the feasibility of the SNF-Palliative Care (PC) intervention, determined by: (1) 
percentage of all post-acute SNF patients with ADRD/CI who meet eligibility criteria; (2) 
percentage of eligible patients with ADRD/CI and legally authorized representatives 
(LAR)/surrogate decision makers (also called a caregiver) who participate in the study; (3) 
percentage of participating patients with ADRD/CI who receive the SNF-PC and from whom all 
data are collected; and (4) clinician fidelity to the SNF-PC protocol (defined as 90% adherence to 
protocol elements). 
1b: Measure patient/caregiver reported quality of life, symptom management, and satisfaction 
with care post SNF-PC in a two-arm non-randomized controlled pilot clinical trial among 50 
patients with ADRD/CI. 
 
 
1.2 
Secondary Objectives (2) 
This study will compare the demographics, clinical characteristics, and palliative (PC) needs of 
people with ADRD/CI versus non ADRD/CI serious illnesses during post-acute SNF care in NHs. 
 
2 
BACKGROUND AND RATIONALE  
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Alzheimer’s disease and related dementias (ADRD) are serious, life limiting illnesses with no known 
cure. ADRD are often underdiagnosed in older adults yet cognitive impairment (CI) is often an 
early/middle stage of the dementia continuum with about one third of older adults with mild cognitive 
impairment developing dementia within 5 years.1 Dementia is the fifth-leading cause of death in older 
adults 2 and the majority of people with advanced dementia die in nursing homes (NHs). 3 Miller et al 
reported that 40% of U.S. NH residents dying with advanced dementia received Skilled Nursing Facility 
(SNF) care in the last 90 days of life, and receipt of this care was associated significantly with poorer end-
of-life outcomes, including a higher risk of dying in a hospital, compared to decedents with no SNF care. 
4 SNF care is a Medicare post-acute rehabilitation service delivered in NHs focused on intense 
rehabilitation and/or aggressive, disease-modifying therapies. Regardless of life expectancy, use of SNF 
care precludes access to Hospice services. 5,6 Palliative care (PC) offers an evidence-based alternative. 7 
2.2 
Study Rationale 
PC offers an approach to improve care for older adults with ADRD in SNFs. 7,8 Key components of 
PC are: 1) open discussion of illness trajectories, and establishment and communication of patient- 
and family- directed goals that guide health care; 2) aggressive prevention, early identification and 
treatment of illness-related symptoms; and 3) identification of psycho-spiritual needs and 
approaches to mitigating suffering. 9,10 PC interventions are associated with improvements in patient 
quality of life and symptom burden. 9-12 There is evidence that PC for persons with ADRD can 
increase advance care planning and improve patient and caregiver satisfaction. 12 

Version 1.0 
 
6 
 
 
The evidence-based SNF-PC encounter is a multi-component non-pharmacologic primary care 
provider delivered intervention designed to meet the PC needs of persons living with dementia 
(PLWD) receiving post-acute care in NHs. Components focus on assessing and managing 
symptoms, conducting and documenting goals of care conversations, communicating needs, 
recommendations, and treatment preferences of the NH team members. 
 
3 
STUDY DESIGN AND DURATION 
3.1 
Design 
The study team will conduct a two-arm non-randomized controlled pilot clinical trial enrolling 50 
persons with ADRD/CI who are in post-acute SNF NH care to meet the study objectives.  
 
3.2 
Enrollment Numbers  
We anticipate screening up to 150 participants. Up to 50 patients with ADRD/CI admitted to 11 
SNF NHs owned and/or operated by Acts Retirement Life Communities (<Acts=) will be 
enrolled. 
 
3.3 
Study Duration  
Participants will be enrolled in the study for up to a total of 21 days. 
3.4 
Compensation 
N/A 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Key Inclusion Criteria  
Patients: 1) admitted for SNF post-acute care at a participating NHs following a recent 
hospitalization, 2) age g 60 years old, 3) speaks English (if verbal), 4) if non-verbal/unable to 
participate in a conversation and/or unable to make decisions, has a legally authorized 
representative (LAR)/surrogate decision maker who can make decisions for the patient as 
determined by Acts staff, 5) documented ADRD or CI (BIMS f 12) diagnosis in the medical 
record, 6) at least one global indicator for PC at SNF admission (provider would not be surprised if 
patient died within 1 year, believes the patient would benefit from advance care planning or 
symptom management; frequent hospital or NH SNF admissions; complex care requirements; 
decline in function; feeding intolerance; unintended decline in weight; or previous hospice 
assessment or enrollment and subsequent discharge). 
 
Surrogate/LAR: 1) > 18 years old; 2) family member or friend of an eligible patient as determined 
by Acts staff; 3) speaks English 
 
4.2 
Key Exclusion Criteria  
Patients: 1) who have previously received or are referred for PC by their primary care team, 2) 
with a discharge plan within 48 hours of screening, 3) currently receiving hospice care, 4) who do 
not have one global indicator of need, 5) not recently hospitalized, 6) not diagnosed with ADRD/CI 
(BIMS f 12), 7) <60 years of age, 8) that are non-English speaking, (if verbal) and 9) if unable to 
make decisions, do not have an LAR/surrogate decision maker.  
 

Version 1.0 
 
7 
 
Surrogate/LAR: 1) < 18 years of age, 2) not a family Member or friend of an eligible patient, 3) 
non-English speaking 
4.3 
Study Enrollment Procedures  
UMB study team members will email designated points of contact at Acts at designated times that 
are predetermined and convenient for Acts staff weekly (this will vary based on their schedules). 
Study team members will then call the designated points of contact at each Acts site to receive new 
SNF unit admissions each week using the Screening Script for Acts. The study team will attempt to 
recruit all residents who meet inclusion criteria. The study team member will then contact 
designated Acts staff to screen and review medical records using the inclusion criteria to determine 
eligibility remotely. The research staff will not be cold calling potential participants. Acts staff will 
not be engaged in the research. 
Global indicator of need: Acts staff will be given a copy of these forms to review medical records 
remotely with research staff. The purpose of this form is to confirm if the resident has at least one 
global indicator of need. If the resident is found to not have a global indicator of need, they will be 
excluded from the study. Those who meet these criteria will be contacted for enrollment into the 
study. 
Once the study team has the list of eligible residents from the facility, they will contact potential 
participants (eligible patients or the LAR/surrogate decision makers of eligible patients) by phone 
and read the broadcast notification with the option to opt out. If they decide they want to enroll, 
study team members will arrange a convenient time to administer the baseline Palliative Care 
Outcome Scale version 2 (POSv2), Satisfaction with Care at the End of Life in Dementia (SWC-
EOLD, and the Symptom Management at the End of Life in Dementia (SM-EOLD) with each 
patient or LAR/surrogate decision maker. 
If patient names are provided by Acts, study staff will ensure they are recorded separate from the 
primary database and are used only for the necessary amount of time to complete enrollment after 
which the record will be erased/destroyed. 
5 
INTERVENTION  
5.1 
Palliative Care Encounter Intervention (STANDARD OF CARE) 
Subjects will receive usual care plus a SNF-PC Encounter (intervention) by existing Acts providers 
who have been provided evidence-based PC focused training that includes ADRD/CI components. 
The goal of the intervention, the SNF-PC Encounter, is to evaluate illness understanding, symptom 
assessment and management, goals of care conversations, documentation, communication, and 
implementation recommendations. While the intervention is not specifically designed for patients 
diagnosed with ADRD/CI, all components are consistent with appropriate care for persons with 
cognitive impairment and their LAR/surrogate decision maker and include some ADRD/CI specific 
components. The intervention will be administered by Acts providers who have been trained to 
conduct the SNF-PC Encounter.  
 

Version 1.0 
 
8 
 
5.2 
Handling of Study Interventions  
A standardized treatment manual will guide the general approach for the Acts providers delivering 
the SNF-PC Encounter.  
 
6 
STUDY PROCEDURES  
6.1 
Research Procedures 
In this pragmatic clinical trial, broadcast notification will be utilized to inform all newly admitted 
patients at each study site of their participation in this trial. During the admission process, 
potential subjects will be provided with a 1-page summary sheet (Broadcast notification) detailing 
their participation in this study that will include contact information for the study team, should the 
subject or their LAR/surrogate decision maker elect to opt-out of participating. Baseline data will 
be collected virtually via telephone by asking each newly admitted patient or their surrogate to 
complete the Patient Outcomes Scale (POSv2), the Satisfaction with Care at the End of Life in 
Dementia (SWC-EOLD), and the Symptom Management at the End of Life in Dementia (SM-
EOLD).  
 
Between 14 days and 21 days after the baseline POSv2, SWC-EOLD, and the SM-EOLD are 
administered, all subjects will be asked to complete the POSv2, SWC-EOLD, and the SM-EOLD 
again virtually via telephone. The POSv2, SWC-EOLD, and the SM-EOLD will be given a total 
of two times to those in the INTERVENTION and CONTROL groups (at baseline and follow up 
(14-21 days later)).  
 
Deidentified subject demographics will be collected on all participants in the following way: 
Study team members will review subject's medical records and enter de-identified data into a 
Research Electronic Data Capture (REDCap) database (Acts staff assists with the study team’s 
access to subject's medical record).  
 
The goal of the intervention is to prevent, identify and treat symptoms early during SNF care, 
establish goal directed treatment decisions, and support the patient and family in decision making. 
We anticipate that many Palliative Care encounters involve a single encounter with the patient 
and/or LAR/surrogate decision maker, but we have made allowances for follow up visits 
depending on individual patient and family needs (e.g., symptom management, continuing goals 
of care discussions). We will use usual care as the control condition. Usual care consists of 
traditional resources focused on skilled nursing care without services to support specialty 
palliative care. A usual care comparison will test whether the Palliative Care Encounter improves 
patient/family reported outcomes compared to traditional services. We have chosen to not use an 
attention control condition because the goal of this pilot clinical trial is to assess feasibility and 
determine the effect size of the intervention on the primary outcome.  

Version 1.0 
 
9 
 
Study team members will collect measures via phone or through a secured online template to 
minimize missing data at two time points (baseline and 14-21 days later) during the study. All 
data will be entered and managed in REDCap by the RA, project manager, or the PI.  
 
Patient/Caregiver Quality of Life: Measured at baseline and follow-up (14-21 days later), the 
Palliative Outcomes Scale version 2 (POSv2) is a 12-item survey that measures quality of life in 
five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision 
of information and support. (RESEARCH PROCEDURE)  
 
Satisfaction With Care at the End of Life in Dementia (SWC-EOLD): Measured at baseline and 
follow-up (14-21 days later), the SWC-EOLD is a validated, 10-item scale that measures 
satisfaction with care for PLWD. Each item is measured on a 4-point Likert scale ranging from 1 
(<strongly disagree=) to 4 (<strongly agree=) and uses a <prior 90 days= timeframe. Specific 
elements include satisfaction with medical and nursing care, decision-making, and their 
understanding of illness. All items are summed, yielding a range of scores of 10-40. Higher 
scores indicate greater satisfaction. (RESEARCH PROCEDURE) 
 
Symptom Management at the End of Life in Dementia (SM-EOLD): Measured at baseline and 
follow-up (14-21 days later), the SM-EOLD is a valid and reliable 9-item scale that measures 
PLWD physical and psychological symptoms over the previous 90 days. Each item is rated on a 
6-point Likert scale ranging from 0 to 5 (0 = <daily=, 1 = <several days a week=, 2 = <once per 
week=, 3 = <2 or 3 days a month=, 4 = <once a month=, 5 = <never=). Scores are summed and 
range from 0 to 45 (higher scores indicate better symptom management). (RESEARCH 
PROCEDURE) 
 
Palliative Care Encounter: Trained provider will discuss illness trajectories, establish, and 
communicate patient-directed goals that guide health care decisions, identify and treat illness-
related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering. 
(STANDARD OF CARE) 
6.2 
Consenting Procedures 
The study team will broadcast the study notification to all new admissions by placing a poster at 
the common areas of the facility as well as a copy of the broadcast study notification within the 
standard admissions paperwork (this provides a way for the patient or their legally authorized 
representative to receive a written statement of the research). The use of the broadcast study 
notification as well as the proposed broadcast study notification statement/flyer (included in this 
submission) has been approved by Acts (the participating nursing home). The broadcast 
notification will serve both as an advertisement and information sheet.  
 

Version 1.0 
 
10 
 
Study team members will consult virtually with Acts staff to determine eligibility and contact 
recently admitted potential participants via telephone. If the potential participant meets eligibility 
criteria, study team members will contact potential participants (eligible patients or the 
LAR/surrogate decision makers of eligible patients) by phone to explain the purpose of the study. 
The study team members will read the broadcast study notification to all subjects with the option 
to opt out.  
 
Study team members can confirm that the individual is the LAR because we have been given the 
contact information by a designated Acts staff member who is involved in the resident’s 
admission and overall care. The study team member asks the designated person at Acts if the 
resident can make their own decisions.  
6.3 
Data Collection 
Baseline data will be collected virtually via telephone by asking each newly admitted patient or 
their LAR/surrogate to complete the Patient Outcomes Scale (POSv2) as well as two ADRD 
specific evaluations: the Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) and 
the Symptom Management at the End of Life in Dementia (SM-EOLD).  
 
Follow-up visit data will be collected virtually via telephone as well. The patient or 
surrogate/LAR will complete the POSv2, SWC-EOLD, and SM-EOLD 14-21 days post baseline 
measures.  
6.4 
Measures and Instruments 
To establish feasibility, benchmarks for success will be measured. To measure quality of life, the 
Palliative Outcomes Scale (POSv2) will be used. To assess care satisfaction and symptom 
management, the Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) and the 
Symptom Management at the End of Life in Dementia (SM-EOLD) surveys will be used.  
 
Table 3 provides an outline of the outcome measures. 
6.5 
Table 3 Study Measures 
 
Construct  
Measure/ Description  
Primary Outcomes: Baseline, 14-21 days  
 
Patient/Caregiver 
Quality of Life  
  
  
Palliative Outcomes Scale version 2 (POSv2): A 12 item survey that measures 
quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) 
spiritual needs, and 5) provision of information and support. Items scored on a 5-
point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in 
the past week. Overall profile score is calculated by summing responses to the 10 
questions (range 0-40).   
Secondary Outcome: Baseline, 14-21 days  

Version 1.0 
 
11 
 
 
Satisfaction with Care  
  
  
  
  
  
 
 
Symptom 
Management  
Satisfaction with Care at the End of Life in Dementia (SWC-EOLD): A 
validated, 10-item scale that measures caregiver satisfaction with care for persons 
with dementia. Each item is measured on a 4-point Likert scale ranging from 1 
(<strongly disagree=) to 4 (<strongly agree=). Specific elements include 
satisfaction with medical and nursing care, decision-making, and their 
understanding of the persons with dementia illness. All items are summed, 
yielding a range of scores of 10-40. Higher scores indicate greater satisfaction. 
 
Symptom Management at the End of Life in Dementia (SM-EOLD): A valid 
and reliable 9 item scale administered to a caregiver that measures persons with 
dementia physical and psychological symptoms. Each item is rated on a 6-point 
Likert scale ranging from 0 to 5 (0 = <daily=, 1 = <several days a week=, 2 = <once 
per week=, 3 = <2 or 3 days a month=, 4 = <once a month=, 5 = <never=). Scores 
are summed and range from 0 to 45. Higher scores indicate better symptom 
management. 
 
7 
SAFETY MONITORING  
7.1 
Data Safety Monitoring Plan 
The investigator will permit all study-related monitoring, audits, and inspections by the IRB and 
regulatory bodies. Participation as an investigator in this study implies acceptance of potential 
inspection by regulatory authorities. The PI will ensure the trial is conducted according to the 
approved protocol and be responsible for carrying out the DSM Plan. The PI will monitor the data 
safety monitoring plan and will submit an annual report to the UMB IRB. 
 
7.2 
Adverse Events and Serious Adverse Events  
The study is low risk because it reflects current best practices for palliative care in the nursing home 
setting. We do not anticipate any adverse reactions to the intervention and therefore minimal risks to 
participants is expected. For Acts staff participating in the palliative care encounter training there is 
no risk. Adverse events (AEs) are defined as <unanticipated problems= involving risks to study 
participants or others (https://grants.nih.gov/grants/guide/notice-files/not99-107.html). AEs will be 
identified by study staff through participant self-report, routine study assessments, or through 
interactions with participants or SNF nursing home staff. Because this proposal involves an evidence-
based palliative care intervention provided by specialty trained Nurse Practitioners, no serious 
adverse events are expected to occur. However, the following may occur and expected in persons 
with serious illness:  
 
• Death, Hospitalization, Change in clinical status 
 
Adverse Event (AE): 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.   
 
Serious Adverse Event (SAE): 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; 

Version 1.0 
 
12 
 
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  
Any SAE will be reported to the IRB as soon as possible but no later than 5 calendar days. If AEs 
or SAEs are identified or reported, the PI will convene an immediate (within 48 hours) ad hoc 
meeting with the study team. During this meeting, we will determine the relevance and significance 
of the AE to the study, including an aggregate analysis of other occurrences of the same (or similar) 
event. Then we will determine if the AE can be determined to be an anticipated or unanticipated 
problem (evaluate whether or not the event would have likely happened regardless of participation 
in the study) involving risk to human subjects or a serious adverse event and determine what, if any, 
follow-up is needed with the participant/family surrogate, participant’s primary care team, and the 
nursing facility leadership and staff. AEs will be monitored on an ongoing basis by the research 
assistant and/or the project manager. A listing of AEs and their attribution (e.g., level of probability 
of being study related, intervention related, or unrelated to study or treatment) will be recorded and 
reviewed with each AE. 
 
Data needing to be reported: 
 
The date the adverse event occurred 
 
The adverse event 
 
Relationship of the adverse event to intervention 
 
If the AE was expected 
 
The severity of the AE 
 
The intervention 
 
Detailed text that includes the following information: 
o An explanation of how the AE was handled 
o A description of the subject's condition 
o Indication if the subject remains on the study 
o If an amendment will need to be made to the protocol and/or consent form 
o If an amendment will need to be made to the protocol and/or consent form 
 
The PI’s signature and the date it was signed are required on the completed report. 
7.3 
Assessment of External Factors Related to AEs 
The study team will track literature reports, developments in palliative care, and results of related 
studies that may have an impact on the safety of participants or on the ethics for this research study. 
8 
PARTICIPANT WITHDRAW/DISCONTINUATION  
Subjects remain free to refuse the Palliative Care encounter (e.g.,= SNF-PC=) and/or any care or 
therapies offered because of said consultation. Subjects may withdraw voluntarily from 
participation in the study at any time and for any reason. Participants should continue to be 
followed for 30 days, with their permission, even if the study intervention is discontinued.  
8.1 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the NINR, the OHRP, or other government 
agencies as part of their duties to ensure that research participants are protected. 

Version 1.0 
 
13 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
N/A 
9.2 
Sample Size and Randomization 
The primary outcome is to establish the feasibility of the post-acute Skilled Nursing Facility (SNF) 
Palliative Care (PC) intervention for patients with Alzheimer’s disease and related dementias 
(ADRD) and cognitive impairment (CI). Following guidelines on sample size selection for pilot 
studies we focused on the corresponding precision (widths of confidence intervals [CIs]) of our 
estimates of feasibility to assess sample size. With 25 participants per group, 90% CIs for 
proportions will be ± 10-16% for within-group proportions between 10-90%, which is sufficient 
precision for a pilot under a wide range of possible outcomes. Another primary outcome of the 
study is to estimate effect sizes for the SNF-PC intervention on patient/family caregiver reported 
satisfaction with care, symptom management, and quality of life. Based on our current experience 
in the parent study, we anticipate up to 10% of participants will not have outcomes available (e.g., 
missing data or dropout).  
 
Based on prior results and a conservative assumption of a modest correlation (r = 0.3) between pre- 
and post-intervention values, we estimate the corresponding standard deviation (SD) of pre-post 
changes of the Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) scale to be 4.9 
units.  With 25 participants enrolled per group (22 with complete data), we will have 80% power to 
detect a change in SWC-EOLD within the intervention group of 2.7 scale units at a two-sided 
significance level of α = 0.1, which corresponds to a clinically significant change. The precision of 
the mean changes in SWC-EOLD within group and between groups (90% CIs) would be ± 1.0 and 
± 2.5 scale units, respectively. Lastly, with this sample size, the upper bound of the one-sided 90% 
CI for the SD of each endpoint will be only 17% higher than the point estimate, so there will be 
limited sample size inflation needed when powering a follow up study based on the SD estimates 
from the proposed study 
 
This is a non-randomized pragmatic clinical trial.  
9.3 
Interim analyses and Stopping Rules 
An interim analysis is not planned. 
9.4 
Data Analyses 
We will establish the feasibility of the SNF-PC intervention in persons with ADRD/CI using 
established benchmarks based on published recommendations for evaluating pilot studies. We will 
track the number of eligible patients, monitor follow-up, document rates of eligibility, enrollment, 
and completion of the intervention, and collect the outcome measures with <5% missing data. We 
will determine clinician fidelity to the SNF-PC protocol  
We also will estimate the effect size of the SNF-PC intervention on pre-post changes in the POSv2, 
SWC-EOLD, and the SM-EOLD relative to the control group. These estimates will be summarized 
with two-sided 90% Confidence Intervals and p-values corresponding to tests against the null 
hypothesis of no (zero) difference.  
We also will examine the demographics, clinical characteristics, and palliative care needs of people 
with ADRD/CI versus non ADRD/CI serious illnesses during post-acute SNF care. As the 

Version 1.0 
 
14 
 
comparisons will be made using baseline/pre-intervention information, all 50 participants enrolled 
in this study are potentially includable in the analysis.  
The primary analysis will be to compare the mean pre-post changes in the POS v2 between the 
intervention and control arms. Linear regression models will be used to compare the two groups. 
The within-arm changes and differences between arms will be summarized with two-sided 90% CIs 
and p- values corresponding to tests against the null hypothesis of no (zero) change or difference. 
We will also explore subgroup effects of the intervention on endpoints by testing for statistical 
interactions between the binary group indicator and covariates of interest such as sex, age, and race.  
 
Other key parameters needed to plan a follow-up study will be estimated as well, including the 
standard deviation (SD) and intraclass correlation coefficient (ICC) of each endpoint. The ICC 
summarizes the degree of correlation of values among patients within a site, which is an important 
parameter when planning a future cluster randomized controlled trial.  
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection/Management  
Study data will be entered and managed using REDCap (http://www.project-redcap.org) which is a 
secure, web-based application. The University of Maryland is a member of the REDCap consortium, 
and this application is freely available to consortium members. REDCap provides: 1) an intuitive 
interface for data entry (with data validation), 2) audit trails for tracking data entry and changes, 3) 
automated export procedures for seamless data downloads to common statistical packages, 4) 
procedures for importing data from external sources, and 5) advanced features, such as branching 
logic and calculated fields.  
 
10.2 
Quality Assurance  
10.2.1 Training 
To maximize quality control, the study team will be trained in all data collection and 
entry procedures. A designated study team member will monitor data collection by 
checking completed data fields.  
10.2.2  Metrics 
The study team will utilize double-data entry methods on a 10% random sample, with 
checks for discordant errors, and as data are entered into the REDCap system. 
10.2.3 Protocol Deviation 
Protocol deviations will be captured, documented, and reviewed by a member of the 
study team during interaction with Acts staff and/or participants/LARs. The PI will 
monitor deviations and the team will review each deviation for its root cause and assess 
whether a modification to the protocol is needed.  
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
Confidentiality will be maintained by adhering to HIPAA guidelines. The study team will keep 
all data confidential in accordance with state and federal laws. Data will not be linked to 

Version 1.0 
 
15 
 
participant identifying name in the study database. Any data, specimens, forms, reports, or audio 
recordings, and other records that leave the site will be identified only by a participant 
identification number (Participant ID, PID) and stored in secure computer files and locked filing 
cabinets to maintain confidentiality. All computer entry and networking programs will be done 
using PIDs only. Information will not be released without written permission of the participant, 
except as necessary for monitoring by IRB, the FDA, the NIA, and the OHRP. The study team 
will destroy the records at the earliest opportunity following data analysis and study completion. 
11.2 Ethical Considerations  
The guiding ethical principles being followed by the study include the NIH Common Rule.  
 
 
 
 
 
 
 
 
 
 
13 
REFERENCES 
1. 
Alzheimer’s Association. 2023. Mild cognitive impairment (MCI). 
https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-
impairment#:~:text=Approximately%2012%25%20to%2018%25%20of,develop%20dementia%
20within%20five%20years. Accessed April 3, 2023.  
2. 
Alzheimer's Association. 2019 Alzheimer's disease facts and figures. 
https://www.alz.org/alzheimers-dementia/facts-figures. Published 2020. Accessed May 20, 2020. 
3. 
Mitchell SL, Teno JM, Miller SC, Mor V. A national study of the location of death for older 
persons with dementia. J Am Geriatr Soc. 2005;53(2):299-305. 
4. 
Miller SC, Lima JC, Looze J, Mitchell SL. Dying in U.S. nursing homes with advanced 
dementia: how does health care use differ for residents with, versus without, end-of-life 
Medicare skilled nursing facility care? J Palliat Med. 2012;15(1):43-50. 
5. 
Givens JL, Mitchell SL, Kuo S, Gozalo P, Mor V, Teno J. Skilled nursing facility admissions of 
nursing home residents with advanced dementia. J Am Geriatr Soc 2013;61:1645-50. 
6. 
Aragon K, Covinsky K, Miao Y, Boscardin WJ, Flint L, Smith AK. Use of the Medicare 
posthospitalization skilled nursing benefit in the last 6 months of life. Arch Intern Med 
2012;172:1573-9. 
7. 
Miller SC, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Specialty Palliative Care 
Consultations for Nursing Home Residents With Dementia. J Pain Symptom Manage 2017;54:9-
16 e5. 

Version 1.0 
 
16 
 
8. 
National Consensus Project for Quality Palliative Care. Clinical Practice Guidelines for Quality 
Palliative Care 2018. 
9. 
Kavalieratos D, Corbelli J, Zhang D, et al. Association Between Palliative Care and Patient and 
Caregiver Outcomes: A Systematic Review and Meta-analysis. JAMA 2016;316:2104-14. 
10. Hanson LC, Carey TS, Caprio AJ, et al. Improving decision-making for feeding options in 
advanced dementia: a randomized, controlled trial. J Am Geriatr Soc 2011;59:2009-16. 
11. Holley AP, Gorawara-Bhat R, Dale W, Hemmerich J, Cox-Hayley D. Palliative Access Through 
Care at Home: experiences with an urban, geriatric home palliative care program. J Am Geriatr 
Soc 2009;57:1925-31. 
12. Ersek M, Sefcik J, Stevenson D. Palliative care in nursing homes. In: Kelley A, Meier D, eds. 
Meeting the Needs of Older Adults with Serious Illness: Clinical, Public Health, and Policy 
Perspectives. New York: Humana Press; 2014:73-90.