Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
Phase: NA
Conditions: Dementia
Sponsor: Weill Medical College of Cornell University

Cover page for clinicaltrials.gov 
 
 
Protocol title:   
Improving How People Living with Dementia Are Selected for Care 
Coordination: A Pragmatic Clinical Trial Embedded in an Accountable 
Care Organization 
 
NCT number:  
NCT05651308 
 
Protocol date:   
November 2, 2023 
 
 

Protocol Template, Version 3.0 
i 
 
Clinical Interventional Study  
Protocol Template 
 
 

Protocol Template, Version 3.0 
ii 
 
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. 
List of changes to the protocol 
 
Protocol number 
Date of Protocol 
Revision made, if any 
1 
May 11, 2022 
Original approved protocol 
2 
September 9, 2022 
Adding an exclusion for people enrolled in home 
hospice 
3 
October 26, 2022 
Stratifying randomization by care management team 
4 
November 2, 2023 
Changing 24-hour reporting requirement from all 
deaths to unexpected deaths and updating reporting 
logistics 
 
 
 

Protocol Template, Version 3.0 
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FULL PROTOCOL TITLE 
 
Improving How People Living with Dementia Are Selected for Care Coordination: 
A Pragmatic Clinical Trial Embedded in an Accountable Care Organization 
 
Study Chairman or Principal Investigator: 
 
Lisa M. Kern, MD, MPH, Associate Professor of Medicine, Weill Cornell Medicine 
 
 
Supported by: 
The National Institute on Aging 
 NIA IMPACT Collaboratory  
FY22_Demo2_Kern 
Study Intervention Provided by:  
Not applicable 
Sponsor of IND/IDE:  
Not applicable 
(Any modification to the protocol should be annotated on the coversheet or in an appendix.  The 
annotation should note the exact words that are changed, the location in the protocol, the date 
the modification was approved, and the date it became effective.)  
Version 4  
November 2, 2023

Protocol Template, Version 3.0 
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TABLE OF CONTENTS 
Page 
PREFACE ...................................................................................................................................... ii 
FULL PROTOCOL TITLE ........................................................................................................ iii 
TABLE OF CONTENTS ............................................................................................................ iv 
PRÉCIS ........................................................................................................................................ vii 
Study Title ................................................................................................................................. vii 
Objectives ................................................................................................................................. vii 
Design and Outcomes ............................................................................................................... vii 
Interventions and Duration ...................................................................................................... viii 
Sample Size and Population..................................................................................................... viii 
STUDY TEAM ROSTER............................................................................................................. 1 
Principal Investigator: ........................................................................................................................... 1 
Co-Investigators: .................................................................................................................................... 1 
PARTICIPATING STUDY SITES ............................................................................................. 2 
1 
Study objectives ..................................................................................................................... 3 
1.1 
Primary Objective ........................................................................................................... 3 
1.2 
Secondary Objectives...................................................................................................... 3 
2 
BACKGROUND AND RATIONALE ................................................................................ 3 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 3 
2.2 
Study Rationale ............................................................................................................... 4 
3 
STUDY DESIGN ................................................................................................................... 5 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 6 
4.1 
Inclusion Criteria ............................................................................................................ 6 
4.2 
Exclusion Criteria ........................................................................................................... 7 
4.3 
Study Enrollment Procedures ......................................................................................... 7 
5 
STUDY INTERVENTIONS .............................................................................................. 10 

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5.1 
Interventions, Administration, and Duration ................................................................ 10 
5.2 
Handling of Study Interventions ................................................................................... 10 
5.3 
Concomitant Interventions ............................................................................................ 12 
5.3.1 Allowed Interventions ............................................................................................... 12 
5.3.2 Required Interventions .............................................................................................. 12 
5.3.3 Prohibited Interventions ............................................................................................ 12 
5.4 
Adherence Assessment ................................................................................................. 12 
6 
STUDY PROCEDURES .................................................................................................... 12 
6.1 
Schedule of Evaluations ................................................................................................ 12 
6.2 
Description of Evaluations ............................................................................................ 13 
6.2.1 Screening Evaluation ................................................................................................ 13 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 14 
6.2.3 Follow-up Visits........................................................................................................ 14 
6.2.4 Completion/Final Evaluation .................................................................................... 14 
7 
SAFETY ASSESSMENTS ................................................................................................. 14 
7.1 
Specification of Safety Parameters ............................................................................... 14 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 14 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 14 
7.3.1 Reporting Procedures ................................................................................................ 15 
7.3.2 Follow-up for Adverse Events .................................................................................. 16 
7.4 
Safety Monitoring ......................................................................................................... 17 
8 
INTERVENTION DISCONTINUATION........................................................................ 17 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 17 
9.1 
General Design Issues ................................................................................................... 17 
9.2 
Sample Size and Randomization .................................................................................. 18 
9.2.1 Treatment Assignment Procedures ........................................................................... 18 
9.3 
Interim analyses and Stopping Rules ............................................................................ 19 
9.4 
Outcomes ...................................................................................................................... 19 
9.4.1 Primary outcome ....................................................................................................... 19 
9.4.2 Secondary outcomes ................................................................................................. 19 
9.5 
Data Analyses ............................................................................................................... 19 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 20 
10.1 
Data Collection Forms .................................................................................................. 20 

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10.2 
Data Management ......................................................................................................... 20 
10.3 
Quality Assurance ......................................................................................................... 20 
10.3.1 
Training ................................................................................................................. 20 
10.3.2 
Quality Control Committee................................................................................... 20 
10.3.3 
Metrics .................................................................................................................. 20 
10.3.4 
Protocol Deviations ............................................................................................... 21 
10.3.5 
Monitoring ............................................................................................................ 21 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 21 
11.1 
Institutional Review Board (IRB) Review .................................................................... 21 
11.2 
Informed Consent Forms .............................................................................................. 21 
11.3 
Participant Confidentiality ............................................................................................ 21 
11.4 
Study Discontinuation ................................................................................................... 21 
12 ETHICAL CONSIDERATIONS ....................................................................................... 21 
13 COMMITTEES................................................................................................................... 22 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 22 
15 REFERENCES .................................................................................................................... 22 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 24 
 
 
 
 

Protocol Template, Version 3.0 
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PRÉCIS 
Study Title  
Improving How People Living with Dementia Are Selected for Care Coordination:  
A Pragmatic Clinical Trial Embedded in an Accountable Care Organization 
Objectives  
The primary objective is to determine the comparative effectiveness of two different 
approaches for allocating care coordinators to people living with dementia (PLWD) in the 
context of a Medicare Accountable Care Organization (ACO) (i.e., based on care 
partners’ reported need for care coordination vs. usual care, which is typically after 
hospital discharge) on the combined outcome of emergency department (ED) visit or 
hospital admission over 12 months of follow-up, as measured in claims. 
 
The secondary objective is to measure implementation outcomes for the trial to inform 
future dissemination: acceptability (percent of participants who engage with the care 
coordinators), appropriateness (types and frequencies of different care coordination 
services provided), fidelity (percent of eligible individuals who receive care coordination 
services based on perceived need), and efficiency (total number of care coordinator 
hours), as measured with data from electronic health records. 
Design and Outcomes   
The proposed study is a pragmatic clinical trial embedded in a Medicare ACO with 
prospective randomization to determine the comparative effectiveness of two different 
approaches for allocating care coordinators to PLWD. It will include Medicare 
beneficiaries who have had fragmented ambulatory care (that is, care spread across 
multiple providers without a dominant provider), because individuals with fragmented 
ambulatory care are at risk for gaps in communication across providers, which care 
coordinators can address.  
 
Figure 1. Overview of study design 
 
 
 
 
 
 
 
 
 
 
Participants will be followed for the primary combined outcome of emergency 
department visit or hospitalization over 12 months. 
Community-dwelling Medicare beneficiaries ≥65 years old with 
dementia who are attributed to the NewYork Quality Care ACO 
and had fragmented ambulatory care in the past 12 months 
Intervention approach for 
assigning care coordinators 
Usual approach for assigning 
care coordinators 

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Interventions and Duration  
Overview:  This study will leverage the existing infrastructure of the NewYork Quality 
Care (NYQC) ACO, which already works with care coordinators. Care coordinators are 
members of the medical team (typically with previous training in nursing, social work, or 
another related field) whose job it is to facilitate communication among all the 
participants involved in an individual’s care. ACOs typically have thousands of patients 
assigned, or attributed, to them by Medicare and only a few care coordinators. Thus, care 
coordinators are a scarce resource, and it is not known how best to allocate them. This 
study will not change what care coordinators do; rather, it will test the comparative 
effectiveness of two different strategies for allocating care coordinators to PLWD. 
 
Usual care:  Usual care assigns attributed patients to care coordinators in response to: 1) a 
discharge from an NYQC hospital (approximately 80% of cases), 2) a discharge from a 
non-NYQC hospital (approximately 15% of cases), or 3) a referral from an NYQC 
physician asking for care coordination for a specific patient (approximately 5% of cases).  
 
Intervention:  The intervention group will assign care coordinators to PLWD based on 
perceived need for assistance with care coordination, as follows. The PLWD who are 
randomized to the intervention arm will each receive an initial call from a care 
coordinator, which we will refer to as the “screening” call. If the patient has severe 
dementia and is not able to participate in a phone call (as judged by the care coordinator), 
the care coordinator will reach out to the healthcare proxy documented in the EHR. The 
care coordinator will administer a previously validated 7-minute telephone survey on 
perceptions of care coordination. If the patient or proxy responds to the survey in a way 
that indicates a perceived problem with care coordination in the past 6 months (i.e., a 
“positive” response to ≥1 of 8 questions, as defined previously), then we will consider 
this a “positive screening.” The care coordinator will then ask open-ended questions to 
understand the specific problem with care coordination and proceed to address it. (As in 
the usual care group, referrals from NYQC physicians asking for care coordination for a 
specific patient will also be allowed for the intervention group.) 
 
Timeline:  The first 3 months after randomization will be considered the period of time 
for qualifying events (e.g. a hospitalization in the usual care group or a positive survey in 
the intervention group). PLWD who are assigned to care coordinators (in both groups) 
will receive care coordination services for a minimum of 30 days. After 30 days, the 12-
month follow-up period (for the occurrence of and ED visit or hospitalization) will begin.  
Sample Size and Population  
We will include Medicare beneficiaries ≥65 years old who: 1) are attributed to NYQC by 
Medicare, 2) have dementia (using the previously validated Bynum-Standard 1-year 
definition for ICD-10 codes), 3) reside in the community, and 4) had fragmented 
ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index 
≥50th percentile). At the time of the grant application, 688 individuals met these criteria. 
We will recalculate eligibility at the start of the trial, since attribution changes over time, 
but we expect the total number of eligible individuals to be similar.

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STUDY TEAM ROSTER  
List individuals who play key roles in the development and execution of the study, especially 
those who may need to be contacted by the sites during the course of the study.  Include address, 
telephone, fax and e-mail address of each individual listed and include a brief summary of each 
individual’s main responsibilities.  
Principal Investigator: 
Name:  Lisa M. Kern, MD, MPH 
Weill Cornell Medicine 
420 East 70th Street, Room LH-349 
New York, NY 10021 
T: 646-962-5889 
E: lmk2003@med.cornell.edu 
Role:  PI (As PI, Dr. Kern will oversee all aspects of the 
research, including coordination of the research team 
(including the subcontract to NewYork Quality Care), study 
design, data collection, data analysis, interpretation of 
results, manuscript preparation, dissemination of results, and 
coordination with the IMPACT Collaboratory.)  
Co-Investigators: 
 
Name: Samprit Banerjee, PhD 
Weill Cornell Medicine 
402 East 67th Street, Room LA-233 
New York, NY 10065 
T: 646-962-8014 
E: sab2028@med.cornell.edu 
Role:  Biostatistician (As the Biostatistician, Dr. Banerjee 
will contribute his methodological expertise to this project, 
advising on study design, overseeing randomization, and 
overseeing statistical analysis. He will also assist with 
revising manuscripts for critical scientific content.) 
 
Veerawat Phongtankuel, MD 
Weill Cornell Medicine 
525 East 68th Street, Payson 2 
New York, NY 10065 
T: 212-746-1501 
E: vep9012@med.cornell.edu 
Role:  Geriatrician (Dr. Phongtankuel will contribute to this 
project his expertise in the clinical care of patients with 
dementia, contributing to study design, interpretation of 
results, revisions of manuscripts, and dissemination. He will 
also be available to the PI and the care coordinators as a 
clinical resource.) 

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Catherine Riffin, PhD 
Weill Cornell Medicine 
420 East 70th Street, 3rd Floor 
New York, NY 10021 
T: 646-962-7160 
E: acr2213@med.cornell.edu 
Role:  Social scientist (Dr. Riffin will contribute her 
expertise in family care partners for individuals with 
dementia, contributing to study design, interpretation of 
results, revisions of manuscripts, and dissemination.  She 
will be available to the PI and the care coordinators for any 
questions that may arise with the proxy respondents.) 
 
PARTICIPATING STUDY SITES  
 
List the name and address of each study site investigator, including telephone numbers and e-
mail address. Use the same format as used for the Study Team roster.  
 
Site PI: 
          Name:            Paul Casale, MD, MPH 
NewYork Quality Care (NYQC) 
520 East 70th Street 
New York, NY 10021 
T: 646-962-2735 
E: pnc9003@med.cornell.edu 
Role:  Co-I, Executive Director of NYQC (Dr. Casale will 
contribute to this project his expertise on how advancing care 
coordination aligns with the goals of accountable care 
organizations. He will contribute to interpretation of study 
results. Dr. Casale will also oversee the activities of the 
NewYork Quality Care staff.) 
 
Note on the relationship between Weill Cornell Medicine and NewYork Quality Care:  
NewYork Quality Care is an accountable care organization that brings together NewYork-
Presbyterian Hospital, Weill Cornell Medicine, and ColumbiaDoctors. Weill Cornell Medicine is 
thus a part of NewYork Quality Care. NewYork Quality Care does not have its own IRB and 
instead relies on the IRBs of its component organizations. We are providing a letter from 
NewYork Quality Care, saying that for this project they cede IRB oversight to Weill Cornell 
Medicine and thus cede to the Advarra IRB. 
 
 
 
 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary objective is to determine whether a novel approach to allocating care 
coordinators to PLWD (i.e., based on care partners’ perceived need for care coordination) 
results in fewer ED visits and hospitalizations over 12 months, compared to usual care, 
which allocates care coordinators to PLWD after hospital discharge.  
1.2 Secondary Objectives 
The secondary objective is to determine the acceptability (percent of participants who 
engage with the care coordinators), appropriateness (types and frequencies of different 
care coordination services provided), fidelity (percent of eligible individuals who receive 
care coordination services based on perceived need), and efficiency (total number of care 
coordinator hours) of this novel approach to allocating care coordinators to PLWD based 
on care partners’ perceived need for care coordination. 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
In response to a survey in 2021 about how their organizations approach care for PLWD, 
members of the NEJM Catalyst Insights Council (>500 clinicians, clinical leaders, and 
executives directly involved in care delivery) reported that “fragmentation of care 
delivery” is the #1 barrier to improving dementia care.1 Fragmentation of care delivery 
refers to ambulatory care that is spread across numerous ambulatory providers without a 
dominant provider.2,3 Seeing multiple providers may be clinically appropriate, but it 
increases the risk of gaps in communication across providers caring for the same patient.4 
Fragmented ambulatory care is ubiquitous in the U.S., with 25% percent of Medicare 
beneficiaries ≥65 years old seeing ≥11 ambulatory providers each year.5-7  Although 
PLWD may not be the only people who experience fragmentation of care, they may be 
particularly vulnerable to its adverse effects; that is, they may not have the physiologic 
reserves to withstand the drug-drug interactions, repeat tests, and unnecessary procedures 
that are associated with fragmented care.8 How best to address fragmented ambulatory 
care for PLWD is not known. 
Care coordination is one solution to fragmented ambulatory care, and care coordination 
has been found to be an efficacious intervention for PLWD.9 However, there are not 
enough care coordination resources for all the people who might benefit from their help.10 
“Care coordinators” are members of the medical team whose job it is to facilitate 
communication among all the participants involved in a patient’s care.11,12 They usually 
have previous training in nursing or social work,13,14 and they are already employed by 
providers across the country, including accountable care organizations (ACOs).11 An 
ACO is a formal organization that brings together physicians, hospitals, and other clinical 
entities for the purpose of providing care to a population of patients.15 ACOs contract 
with payers, such as Medicare.15 ACOs typically have thousands of attributed patients 
(including PLWD) and only a small number of care coordinators. For example, an ACO 
with 9,000 attributed patients may only have 3 care coordinators, who can care for 

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approximately 350 patients each, for a total of 1,050 patients (12%).10 Determining how 
best to allocate care coordinators is critical for patient outcomes and the success of the 
ACO. However, there have been no studies of the comparative effectiveness of different 
approaches. 
2.2 Study Rationale 
The usual approach for selecting the patients who will receive assistance from care 
coordinators is to select patients who are the “sickest” (based on type or severity of 
illness) or who experience a transition in care, such as a hospital discharge.16,17 This 
approach is reasonable, but it assumes that all patients meeting those criteria have 
problems with care coordination, which they may not. The usual approach also has the 
disadvantage of often waiting until after a hospitalization, at which point the patient, care 
partner, and care coordinator need to manage not only the illness that prompted the 
hospital admission but also any complications from the admission itself. 
An alternate approach would identify patients and care partners who experience problems 
with care coordination and then assign care coordinators to them. This approach would 
involve identifying patients with highly fragmented care (who are at high risk of having 
poor care coordination) and then asking them or their care partners their perceptions of 
the extent to which care is coordinated. Patients and care partners have a unique vantage 
point from which to detect gaps in care coordination, as they are the first to know if the 
patient seeks care from multiple health systems.18 They are also often the first to know if 
something with care does not seem right, such as being asked to repeat a test.18 In a 
national 2020 survey by AARP, 31% of care partners for PLWD reported difficulty 
coordinating care among their care recipient’s providers, which was up from 23% in 
2015.19 Self-reported concerns with care coordination have recently been validated 
against objective measures of quality of care.20 
This study is based on a conceptual model that has arisen from Dr. Kern’s previous work 
(Figure 2).4 The model describes the relationships among fragmentation, communication, 
and harm and identifies different time points at which interventions could occur. The 
intervention we are proposing in this application would detect and address gaps in 
communication before they cause harm (Box F). By contrast, usual care would intervene 
after a hospital admission (Box G). This is not to say that all hospital admissions are 
preventable or related to fragmented care; they are not. However, our preliminary data 
suggest that more fragmented care for Medicare beneficiaries over 12 months 
independently increases the risk of an incident ED visit(under review) or incident hospital 
admission21 in the subsequent 1-3 months, compared to less fragmented care. The 
magnitude of this association is a 31% increase in the risk of an ED visit (95% 
confidence interval [CI] 29%, 34%) and, separately, an 18% increase in the risk of a 
hospital admission (95% CI 12%, 24%). If this risk can be modified with better 
communication, the potential for averted ED visits and hospital admissions is substantial. 
 
 

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Figure 2. Conceptual model describing the relationships among fragmentation, 
communication, and harm 
 
Of note, in a nationwide survey, Black Medicare beneficiaries were significantly more 
likely than White Medicare beneficiaries to report experiencing an adverse event that 
they thought could have been prevented with better communication among their 
healthcare providers.22 Addressing concerns about care coordination has the potential to 
avert preventable events that may disproportionately affect racial minorities. 
3 
STUDY DESIGN 
We will conduct a pragmatic clinical trial embedded in an ACO (ePCT) with prospective 
randomization. The trial consists of a parallel design with two groups of equal size. 
Masking is not feasible. 
The trial will determine the comparative effectiveness of two different approaches for 
allocating care coordinators to PLWD. The primary outcome is the combined outcome of 
ED visit or hospitalization over 12 months of follow-up. The secondary outcome consists 
of implementation measures (acceptability, appropriateness, fidelity, and efficiency), 
which will be used to inform future dissemination.  
The setting for the study is the NewYork Quality Care (NYQC) ACO, the ACO that 
brings together NewYork-Presbyterian Hospital, Weill Cornell Medicine, and 
ColumbiaDoctors.23,24 Individuals in the study have already been assigned to NYQC by 
Medicare and will be contacted by care coordinators who already work with NYQC. 
Interactions between care coordinators and individuals in the study (PLWD or their 
proxies) will be done by telephone or by video, both of which are part of standard care.  
The study population will consist of Medicare beneficiaries ≥65 years old who: 1) are 
attributed to NYQC by Medicare, 2) have dementia (using the previously validated 
Bynum-Standard 1-year definition for ICD-10 codes),25,26 3) reside in the community, 
and 4) had fragmented ambulatory care in the previous 12 months (defined as a reversed 
Bice-Boxerman Index ≥50th percentile).27,28 At the time of the grant application, 688 
individuals met these criteria. We will recalculate eligibility at the start of the trial, since 
attribution changes over time, but we expect the total number of eligible individuals to be 
similar. This population will be randomized to the two arms of the trial (344 per arm). 
At the start of the study, we will have the list of participants and will randomize them into 
two groups. (We will be requesting a waiver of informed consent and a waiver of HIPAA 
authorization, as described below in section 4.3, so there will be no recruitment per se.) 

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The first 3 months after randomization will serve as the period during which individuals 
will have “qualifying events” for receipt of care coordination services. In the usual care 
group, a qualifying event is discharge from a hospitalization. In the intervention group, a 
qualifying event is a “positive screening call” (indicating a perceived problem with care 
coordination), as described in Section 5.2 below. Direct referrals from physicians to care 
coordinators for assistance with particular patients will be allowed in both groups. 
Individuals with qualifying events in both groups will receive care coordination services, 
which will be consistent with the professional standards of the American Case 
Management Association and the Case Management Society of America.29,30 Usual care 
includes describing care coordination to the patient or proxy and inviting them to engage 
in care coordination; approximately 70-80% of people agree to engage. Each interaction 
with a patient or proxy (including declining care coordination) is documented in the 
electronic health record (EHR). Usual care coordination is broad and encompasses post-
discharge medication reconciliation, inquiries about any symptoms post-discharge, a 
review of upcoming appointments, assistance with obtaining transportation, review of 
paid home care services, and any other needs that may arise, with the primary goal of 
preventing rehospitalization. Patients and proxies are given the care coordinator’s contact 
information and are invited to reach out with any questions or concerns. Care 
coordination in the intervention group will start narrowly, with the care coordinator 
seeking to understand the positive screening result (exactly what the patient or proxy 
thinks is not working well and why). The care coordinator will then seek to address the 
issue, documenting the process in the EHR. The care coordinators will be free to engage 
in broader care coordination activities (e.g., general medication reconciliation, reviewing 
upcoming appointments, arranging transportation, etc.) at their discretion. 
The length and frequency of interactions between the patient or proxy and the care 
coordinator varies depending on the patient’s needs and the care coordinator’s discretion. 
Patients are followed for a minimum of 30 days and a maximum of 1 year, which is a 
typical duration for care coordination.31 Care coordination starts at the time of the 
qualifying event. Follow-up for ED visits and hospitalizations begins after the first 30 
days of care coordination.   
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
Key components of the success of a clinical study are the selection and enrollment of 
participants who are reasonably representative of the populations or characteristics 
under investigation to allow for sufficient generalizability.  This section should define 
and describe the study population. 
4.1 Inclusion Criteria  
Participants must meet all of the inclusion criteria to participate in this study.  
• Medicare beneficiaries ≥65 years old who are attributed to NYQC by Medicare,24  
• Who have dementia, using the previously validated Bynum-Standard 1-year 
definition with ICD-10 codes from Medicare claims for the previous 12 months,25,26 
and 

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• Who had fragmented ambulatory care, based on Medicare claims in the previous 12 
months, defined as a reversed Bice-Boxerman Index (BBI) score ≥50th percentile. 
27,28 
𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟 𝐵𝐵𝐵𝐵𝐵𝐵= 1 −𝐵𝐵𝐵𝐵𝐵𝐵= 1 − ൫∑
𝑛𝑛𝑖𝑖
2
𝑝𝑝
𝑖𝑖=1
൯−𝑛𝑛
𝑛𝑛 (𝑛𝑛−1)
 
where  n = total number of ambulatory visits in the 12-month period 
 
ni = number of ambulatory visits to provider i 
 
p = total number of ambulatory providers 
4.2 Exclusion Criteria  
All candidates meeting any of the exclusion criteria at baseline will be excluded from 
study participation. 
• Those whose addresses are the same as the addresses of nursing homes and other 
long-term care facilities, as those individuals have distinct care coordination 
needs. This is routinely captured by the NYQC ACO. 
• Those who are enrolled in home hospice, as captured in Medicare claims. The 
rationale for excluding these individuals is that they are not at the same risk of 
having an ED visit or hospitalization as other community-dwelling individuals. 
By virtue of being enrolled in home hospice, they have essentially agreed not to 
receive services in those more acute settings. 
4.3 Study Enrollment Procedures  
For this trial, we are collaborating with the NYQC ACO. The Centers for Medicare & 
Medicaid Services (CMS) requires that ACOs inform Medicare beneficiaries if their 
doctor chooses to participate in an ACO.32 This notification can come in the form of a 
letter, written information provided when the patient sees the doctor, a sign posted in the 
doctor’s office, or a verbal conversation between patient and doctor.32 NYQC chooses to 
notify patients by putting up posters in their providers’ practices. Medicare beneficiaries 
do not have to seek care within the ACO; they are free to seek care elsewhere. NYQC 
receives from CMS the names of the patients that have been assigned, or attributed, to 
NYQC. Attribution is done by CMS and is based on prior healthcare utilization. 
We are requesting a waiver of informed consent. We believe that the study meets the 5 
Common Rule criteria for a waiver,33 as follows. 
 
(i) 
Minimal risk: The research involves no more than minimal risk to the subjects, 
because receipt of care coordination services is part of standard clinical care. 
Completing the survey is also minimal risk, as the survey does not inquire about 
sensitive topics. Review of data in the electronic health record and analysis of 
claims data are also minimal risk activities. 
 
(ii) 
Practicability: The research could not practicably be carried out without the 
waiver. This is because, during usual care, patients are not aware of care 
coordinator resources unless they are assigned a care coordinator through a 
physician referral or after a recent discharge. If we were to try to obtain informed 

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consent, we would need to explain care coordination, which may then raise 
concerns about care coordination among the participants and proxies. This would 
be especially problematic in the control group, which by the design of the study 
cannot directly request the assistance of care coordinators. This would then create 
problems for the feasibility and validity of the trial. 
 
(iii) 
Identifiable information: The research could not practicably be carried out without 
the use of identifiable information. The trial relies on identifying community-
dwelling Medicare beneficiaries 65 years and older with dementia who are 
attributed to NewYork Quality Care. We then need to reach out to those 
individuals who qualify for care coordination in each group, provide care 
coordination services, review their electronic health record data for 
implementation outcomes, and follow them over time for the occurrence of 
emergency department visits and hospital admissions as captured in claims. This 
study is not possible without the use of identifiers. 
 
(iv) 
Rights and welfare: The waiver will not adversely affect the participants’ rights. 
There is uncertainty about the optimal way to allocate care coordinators; this 
study is a comparative effectiveness trial of two approaches. Which approach is 
superior is currently unknown. In addition, even if a waiver is granted, eligible 
participants in both groups will have the option to agree to or decline care 
coordination services. 
 
(v) 
Distribution of pertinent information after the trial: NYQC will have the 
opportunity to distribute the results of the trial to its attributed population. This 
may take the form of posters or flyers distributed in doctors’ offices, a form of 
communication which NYQC has used previously. 
We are also requesting a full waiver of HIPAA authorization for this study. We are 
requesting this for use of protected health information from the EHR and for use of 
Medicare claims for research purposes (both recruitment and outcome assessment) in 
compliance with the HIPAA Privacy Law. We believe that the study meets the criteria for 
a full HIPAA waiver, as follows: 
(i) 
Use or disclosure involves no more than minimal risk to the privacy of 
individuals:  We have an adequate plan in place to protect health information 
identifiers from improper use or disclosure. We will destroy identifiers at the 
earliest opportunity, absent a health or research justification or legal requirement 
to retain them. We also have adequate written assurances that the protected health 
information will not be used or disclosed to a third party, except as required by 
law, for authorized oversight of the research study, or for other research uses and 
disclosures permitted by the Privacy Rule. 
(ii) 
Research could not practicably be conducted without the waiver: The research 
could not practicably be carried out without the waiver because, during usual care, 
patients are not aware of care coordinator resources unless they are assigned a 
care coordinator through a physician referral or after a recent discharge. If we 

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were to try to obtain authorization, we would need to explain care coordination, 
which may then raise concerns about care coordination among the participants 
and proxies. This would be especially problematic in the control group, which by 
the design of the study cannot directly request the assistance of care coordinators. 
This would then create problems for the feasibility and validity of the trial. 
(iii) 
Research could not practicably be conducted without access to and use of PHI: 
The research could not practicably be carried out without the use of identifiable 
information. The trial relies on identifying community-dwelling Medicare 
beneficiaries 65 years and older with dementia who are attributed to NewYork 
Quality Care. We then need to reach out to those individuals who qualify for care 
coordination in each group, provide care coordination services, review their 
electronic health record data for implementation outcomes, and follow them over 
time for the occurrence of emergency department visits and hospital admissions 
as captured in claims. This study is not possible without the use of identifiers. 
If this waiver is granted, then there will be no recruitment or enrollment per se, because 
we will include 100% of eligible individuals. Even with a waiver of informed consent, 
participants in both the intervention and control groups will be able to decline care 
coordination services if they do not want them. Currently, with usual care, about 70-80% 
of Medicare beneficiaries who are approached by the NYQC care coordinator agree to 
engage in care coordination. Each interaction with a patient or proxy (including declining 
care coordination) is documented in the EHR.  
 
Of note, under usual care, care coordinators interact with PLWD and informally assess 
their capacity to participate in answering questions related to their healthcare. If care 
coordinators believe that the PLWD cannot accurately answer questions related to their 
healthcare, they contact the healthcare proxy listed in the electronic health record. We 
will apply this approach to the intervention group as well. We considered expanding 
“care partners” to non-healthcare-proxies, but since this is not consistent with usual care, 
we will not. Thus, we will not consider proxies to be separate participants in the trial; 
they will answer questions on behalf of the PLWD. We are not asking any information 
about the proxies themselves. Care coordinators routinely document in the EHR whether 
they spoke to the patient or proxy. 
If a patient has severe dementia and does not have a healthcare proxy documented in the 
EHR, the patient will not be excluded (because they are still the responsibility of the 
ACO); in that case, the care coordinator will review the EHR to assess the extent of care 
coordination and rectify any apparent gaps in communication. 
Randomization will be overseen by Dr. Samprit Banerjee (biostatistician). He will advise 
the data analyst at NYQC on how to employ random number generators to randomly 
allocate the study population into two equal size groups. Masking is not feasible for this 
study, so NYQC will be aware of which patients are allocated to which group. This is 
necessary, because they will need to conduct screening surveys for everyone in the 
intervention group. (See section 5.2 for a more detailed discussion of masking.) 

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5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
The intervention in this trial is the method for allocating PLWD to care coordinators. The 
content of the care coordination services will be essentially the same in both groups, with 
slight differences in the start of care coordination (whether focused on the problem that 
led to a positive survey screen or whether focused on post-discharge management). 
Overall, though, care coordination services will be highly flexible and tailored to meet 
each patient’s needs, as is standard.  See section 5.2 for more information. 
5.2 Handling of Study Interventions  
As above, the intervention consists of a novel method for assigning care coordinators to 
PLWD based on perceived need. Perceived need will be measured with a previously 
validated 7-minute telephone survey. This survey consists of 22 questions, has been 
previously administered to more than 7,000 adults ≥65 years old (with funding from Dr. 
Kern’s R01 HL135199), and is published.34 This published paper, which includes the 
survey instrument as an appendix, is being provided to the IRB with this protocol. The 
survey includes 8 questions regarding perceptions of care coordination; the other 
questions relate to self-reported ambulatory utilization and self-reported preventable 
adverse events. The 8 questions on perceptions of care coordination include 6 questions 
from the previously validated Care Coordination Measure for the Consumer Assessment 
of Healthcare Providers and Systems (CAHPS) Medicare survey, which was previously 
tested on more than 300,000 Medicare beneficiaries35 These 8 questions ask (using 
different wording) whether the respondent has experienced difficulty with care 
coordination over the past 6 months, and the responses are ultimately combined into a 
single indicator for the presence or absence of a self-reported problem with or “gap” in 
care coordination. Of the 7,568 respondents in the original administration (average age 77 
years), 38% reported a gap in care coordination.34 
Care coordinators will administer this survey by telephone to participants (patients or 
proxies) in the intervention group. The care coordinators will document the survey 
responses in customized data entry form in REDCap, a secure web-based data 
management platform.36 If the patient or proxy responds to the survey in a way that 
indicates a perceived problem with care coordination in the past 6 months (i.e., a 
“positive” response to ≥1 of 8 questions, as defined previously),34 then we will consider 
this a “positive screening.” Care coordinators will be trained in advance to recognize 
“positive” responses and respond to them in real time, asking open ended questions to 
understand why the respondent felt that that there was a problem with care coordination. 
For patients and proxies whose screening calls were “negative” (not revealing a perceived 
problem with care coordination), the care coordinators will give them their contact 
information and invite them to reach out with any questions or concerns. NYQC 
considers administration of this survey to be part of clinical care. 
We will have a data analyst review the survey responses to measure (as part of the 
implementation measure for fidelity) whether surveys were correctly categorized as 
positive or negative. 
For the control group, an administrator at NYQC is responsible for querying daily the 

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Epic EHR to identify discharges from NYQC hospitals and for querying daily a New 
York City health information exchange called NYCLIX to identify hospital discharges 
from non-NYQC hospitals. 37,38 (An emergency department visit that results in discharge 
to home without hospital admission does not qualify.) The administrator assigns each 
discharged patient to a care coordinator, who then reaches out to the patient by phone.  
Care coordination services for both groups will be provided consistent with the 
professional standards of the American Case Management Association and the Case 
Management Society of America.29,30 Most components of care coordination are flexible 
and can be varied by staff. For example, the care coordinators will have some discretion 
over what types of care coordination tasks to engage in. Facilitating provider-provider 
communication will be emphasized in the intervention group, but care coordinators can 
also help with other tasks, such as reviewing upcoming appointments or arranging 
transportation. One of our implementation outcomes will consist of measuring the 
frequencies of different types of care coordination activities in the two groups. This is a 
highly pragmatic approach. 
Masking is not feasible for this study, so NYQC will be aware of which patients are 
allocated to which group. This is necessary, because the care coordinators will conduct 
screening surveys for everyone in the intervention group. The care coordinators will 
know that this is part of a research study. The same care coordinators may be assigned to 
individuals in the intervention group and in the control group. However, we do not expect 
contamination to be an issue, because an administrator at NYQC (the same one who 
monitors hospitalizations) will assign intervention patients to the care coordinators for 
administration of the survey. The administrator will supervise the care coordinators to 
ensure that they approach patients as intended (either for post-discharge planning or for 
assessment through the survey). 
Interactions between care coordinators and individuals in the study (PLWD or their 
proxies) will be done by telephone or by video, both of which are part of standard care. 
Note that all participants will be included, regardless of language spoken. For non-
English speaking patients, the care coordinators use a professional interpreter service, 
which they conference in through an 800 number. The current service they use is 
LanguageLine Solutions, which provides on-demand, live interpreters in more than 200 
languages (https://www.languageline.com/s/). Because this is a usual care process, we are 
not planning to have any translations reviewed by Advarra. 
Additional considerations:  The research team carefully considered how to handle several 
complexities that are interrelated. (1) Consistent with standard practice in which patients 
are followed for a maximum of 1 year, patients in the usual care group may continue to 
have events that qualify them for care coordination beyond the 3-month timeframe that 
we have specified for the “qualifying event window.” That is, patients in the usual care 
group will continue to be assigned care coordinators when they are hospitalized and 
discharged. (2) Patients randomized to the intervention group may be hospitalized during 
the first 3-month qualifying-event-window and after that window as well. (3) Patients 
randomized to the intervention group may be referred by their physicians for care 
coordination, just as that occurs for about 5% of the usual care participants. To address 
these complexities, we have developed the following approach. If a physician refers a 

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patient who is assigned to the intervention group to care coordination, we will honor that 
referral and provide care coordination. If a patient in the intervention group has a hospital 
admission at any time (during the first 3-month qualifying window or during follow-up), 
we will administer the perceptions of care coordination survey after discharge and 
provide care coordination if the survey indicates a need. We believe this is more ethical 
than not providing care coordination at all to discharged patients in the intervention 
group; assignment of care coordinators would still be made based on reported problems 
with care coordination and not given automatically. Thus, during the 3-month window for 
qualifying events, all participants in the intervention group will receive the survey; after 
that, the survey will be given to those intervention participants who are discharged from 
the hospital. 
5.3 Concomitant Interventions 
5.3.1 Allowed Interventions 
Not applicable 
5.3.2 Required Interventions  
Not applicable 
5.3.3  Prohibited Interventions 
Not applicable  
5.4 Adherence Assessment  
We will measure different versions of adherence when we collect implementation 
outcomes for the secondary objective of the study. These implementation outcomes will 
be collected by a research assistant, who will review the EHRs for participants in both 
study groups. The research assistant will extract data from the EHRs manually, using a 
structured form in REDCap. The following implementation outcomes will be collected: 
acceptability (percent of participants who engage with the care coordinators in both 
groups), appropriateness (types and frequencies of different care coordination services 
provided in both groups), fidelity (percent of eligible individuals who receive care 
coordination services based on perceived need in the intervention group), and efficiency 
(total number of care coordinator hours in both groups). These implementation outcomes 
are drawn from the Consolidated Framework of Implementation Research (CFIR) and 
related work by Proctor et al.39-41 
6 
STUDY PROCEDURES 
6.1 
Schedule of Evaluations 
This trial does not have a schedule of evaluations per se. Instead, we show a timeline of 
events for all participants in the trial (Figure 3). 
 
 

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Figure 3. Timeline of events for each participant (not to scale) 
 
 
 
 
 
 
*See section 3 for the definition of qualifying event, which varies based on the arm of the trial 
†Care coordination may extend beyond 30 days for participants in either trial arm, at the 
discretion of the care coordinator, but the follow-up period still starts after the initial 30 days of 
care coordination. For those participants who do not have a qualifying event, their follow-up 
period for ED visits or hospitalizations will start 4 months after randomization (simulating the 
3-month qualifying period + 1 month during which they did not receive care coordination). See 
also section 5.1 for more information. 
 
The study will use three data sources: the survey on perceptions of care coordination, 
the EHR, and Medicare claims. The survey data will be used to determine eligibility for 
care coordination in the intervention group. The EHR will be used to collect 
demographic and clinical characteristics of patients (age, race, sex, co-morbidities), as 
well as the implementation outcomes. Medicare claims will be used to measure 
fragmentation as an eligibility criterion and the primary outcome of ED visit or hospital 
admission over 12 months. The survey will be administered by care coordinators, the 
EHR data collection will be done by a research assistant, and the Medicare claims will 
be analyzed by data analysts. 
 
Note that all participants will contribute data to the study whether they are selected for 
care coordination or not. This is because we are comparing two methods for allocating 
care coordinators, and we are interested in ED and hospitalization outcomes for both 
those selected and those not selected. 
 
 
6.2.   Description of Evaluations  
6.2.1 Screening Evaluation 
Consenting Procedure 
We are requesting a waiver of informed consent and a waiver of HIPAA 
authorization (see section 4.3). 
Screening   
This is not applicable, because the study will include all community-dwelling 
Medicare beneficiaries with dementia who have been attributed to NYQC and had 
Randomization 
Qualifying event window (first 3 months) 
Selected for 
coordination if 
and when a 
qualifying event 
occurs* 
Initial 30 days of 
care coordination 
(starting with date 
of qualifying event, 
which may vary 
across participants) 
Follow-up over 12 months for 
the combined outcome of ED 
visit or hospitalization, as 
measured in claims† 

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fragmented care in the past 12 months. All of these criteria will be measured using 
claims, not interactions with patients or proxies. 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
The enrollment date for all participants will be the date of randomization.  
Baseline Assessments 
The research assistant will manually review the EHR for participants’ demographic 
characteristics (age, race, sex, co-morbidities). 
Randomization 
See section 6.1 for a timeline of randomization, intervention, and follow-up. 
6.2.3 Follow-up Visits 
Follow-up visits per se are not applicable to this trial. The length and frequency of 
interactions between the care coordinator and patient or proxy will vary with the 
patient’s needs and care coordinator’s discretion. 
6.2.4 Completion/Final Evaluation 
A completion or final evaluation visit is not applicable to this trial. The length and 
frequency of interactions between the care coordinator and patient or proxy will vary 
with the patient’s needs and care coordinator’s discretion. The ED and hospitalization 
outcomes will be measured in claims. 
7 
SAFETY ASSESSMENTS  
7.1 Specification of Safety Parameters 
This is not a drug trial, so we will not be assessing safety with laboratory values. See 
below for how we will monitor safety in this trial. 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
This is not a drug trial, so we will not be assessing safety with laboratory values. See 
below for how we will monitor safety in this trial. 
7.3 Adverse Events and Serious Adverse Events  
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a clinical 
research study participant, temporally associated with the participants’ involvement in the 
research, whether or not considered related to participation in the research. 
AEs for this study: AEs may include a mild increase in anxiety or stress on the 
part of the patient or patient’s healthcare proxy. This may be expected from a 
discussion about the challenges of navigating healthcare, but is expected to be 
short-lived, due to the provision of resources to address the problem.  
Serious Adverse Event (SAE): Any adverse event that: 
• 
Results in death 

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• 
Is life threatening, or places the participant at immediate risk of death from the event 
as it occurred 
• 
Causes persistent or significant disability or incapacity 
• 
Is another condition which investigators judge to represent significant hazards 
SAEs for this study: Because the study population consists of PLWD, the 
possibility of emergency department visits and hospitalizations may be reasonably 
expected. The occurrence of these events will be measured by the study as 
outcomes, and it is hypothesized that the intervention group will have fewer of 
these events than the control group. Because the study population consists of 
PLWD, the possibility of death is also an expected occurrence, though it is not 
expected to be related to the intervention. We will monitor for this event as well, 
although it is not a study outcome per se.  
7.3.1 Reporting Procedures 
Process for identifying AEs and SAEs:  
If the care coordinators perceive that a patient or healthcare proxy has increased anxiety, 
the care coordinator will report this to the PI, who will consult with the research team’s 
geriatrician.  The geriatrician can discuss the case with the care coordinator and also with 
the patient’s physicians. 
The research team will analyze Medicare claims monthly to monitor for the outcomes of 
emergency department visits and hospitalizations. These are expected events that will be 
tracked and reported to the PI. 
Any deaths that are detected through review of electronic health records by the care 
coordinators or research assistant will be reported to the PI. 
Any unanticipated problems encountered by team members will be reported to the PI. 
Severity of Event 
All AEs will be assessed for severity by the PI using the following scale:  
• 
Mild – Events require minimal or no treatment and do not interfere with the 
participant’s daily activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require 
systemic drug therapy or other treatment. Severe events are usually potentially life-
threatening or incapacitating.  Of note, the term “severe” does not necessarily equate to 
“serious.”  
Relationship To Study Intervention 
All adverse events (AEs) will have their relationship to study intervention assessed by the 
PI who will evaluate the situation based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories 
below. In a clinical trial, the study product must always be suspect.  

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• 
Definitely Related – There is clear evidence to suggest a causal relationship, and 
other possible contributing factors can be ruled out. The clinical event occurs in a 
plausible time relationship to study intervention administration and cannot be explained 
by other factors.  
• 
Possibly Related – There is some evidence to suggest a causal relationship. 
However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” 
soon after discovery, it can be flagged as requiring more information and later be 
upgraded to “probably related” or “definitely related,” as appropriate. 
• 
Not Related – The AE is completely independent of study intervention 
administration, and/or evidence exists that the event is definitely related to another 
etiology. There must be an alternative, definitive etiology documented by a qualified 
medical professional. 
7.3.2 Follow-up for Adverse Events 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to 
the attention of study personnel during interactions between care coordinators and study 
participants and their proxies. The occurrence of an AE or SAE may also come to the 
attention of study personnel upon review of medical records. 
All AEs will be captured on the appropriate case report form (CRF). Information to be 
collected includes event description, time of onset, qualified medical professional’s 
assessment of severity, relationship to study, and time of resolution/stabilization of the 
event. All AEs occurring while on study must be documented appropriately regardless of 
relationship. All AEs will be followed to adequate resolution. 
Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity to be performed.  
Reporting schedule:  
 
• All adverse events that are serious (SAE) and unexpected (i.e., have not been 
previously reported for the study’s intervention) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team  and NIA IMPACT Collaboratory PO 
for dissemination to the IMPACT Collaboratory DSMB Chair (or the project’s 
Safety Officer) within 48 hours of the study’s knowledge of SAE.  
 
o Only those adverse events that are serious (SAE), unexpected, and related 
to the intervention must also be reported to Advarra IRB.  Unexpected 
and unrelated SAEs will be reported to Advarra IRB on a case-by-case 
basis if requested by the IMPACT Collaboratory DSMB Chair (or the 
project’s Safety Officer) or NIA IMPACT Collaboratory PO. 
 
• All unexpected deaths will be reported to IMPACT Collaboratory Regulatory and 
Data Team and NIA IMPACT Collaboratory PO for dissemination to the 
IMPACT Collaboratory DSMB Chair (or the project’s Safety Officer) within 24 
hours of study’s knowledge of death.  

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o Advarra IRB does not require the specific reporting of death outside of the 
SAE reporting requirement above, but they will be notified on a case-by-
case basis if requested by the IMPACT Collaboratory Chair (or the 
project’s Safety Officer) or NIA IMPACT Collaboratory PO. 
 
• All unanticipated problems (UPs) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team and NIA IMPACT Collaboratory PO 
for dissemination to the Advarra IRB and the IMPACT Collaboratory DSMB 
Chair (or the project’s Safety Officer) within 48 hours of the study’s knowledge 
of the event. 
 
• The summaries of all previously reported unexpected and related SAEs, deaths, 
and UPs, as well as all other SAEs and AEs will be reported to IMPACT 
Collaboratory Regulatory and Data Team  for dissemination to Advarra IRB, NIA 
IMPACT Collaboratory PO, and the IMPACT Collaboratory DSMB Chair (or the 
project’s Safety Officer) 6 months after the start of enrollment and at the end of 
enrollment or data collection (whichever comes later), or at a frequency requested 
by the IMPACT Collaboratory DSMB Chair (or the project’s Safety Officer) or 
NIA IMPACT Collaboratory PO. 
7.4 Safety Monitoring 
The NIA Guidelines on Data and Safety Monitoring generally require that a NIA-
appointed Data and Safety Monitoring Board or Safety Officer monitor clinical trials. 
This trial will have oversight from the Data and Safety Monitoring Board appointed by 
the NIA IMPACT Collaboratory. 
8 
INTERVENTION DISCONTINUATION  
No interim analysis is planned, as the planned trial is fairly short, with 12 months of 
follow-up for the combined outcome of an emergency department visit or hospital 
admission. Interim analyses of emergency department visits and hospital admissions will 
not likely be sufficiently powered to be meaningful. 
However, findings that might trigger a safety review are the number of unexpected deaths 
in the trial. Such findings are presented to the study statistician or to the Data and Safety 
Monitoring Board (DSMB) statistician to review the events by group to determine 
whether there are statistical as well as clinical concerns. The statistician reports his 
findings to a closed session of the DSMB or to the Safety Officer and/or NIA. The 
findings are used to determine what steps will be taken.  
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
The trial is based on the hypothesis that assigning care coordinators to PLWD whose care 
partners’ perceive a problem with care coordination will result in fewer ED visits and 
hospitalizations than assigning care coordinators to PLWD at the time of hospital 

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discharge. To avoid circularity, we will separate exposures and outcomes in time. That is, 
we will have a 3-month exposure period, during which a hospitalization that prompts care 
coordination will only be counted for the exposure and not as an outcome. 
 
The 3-month time period was chosen, based on preliminary data suggesting that more 
fragmented care over 12 months independently increases the risk of an incident ED 
visit(under review) or incident hospital admission21 in the subsequent 1-3 months, compared 
to less fragmented care. 
 
A parallel design was chosen because it is a robust design that allows for concurrent 
comparisons. The outcome of ED visit or hospitalization will be measured using 
Medicare claims data, which are the gold standard, because they capture events across 
health systems and are thus broader than EHRs. 
9.2 Sample Size and Randomization 
The primary outcome is the number of events (emergency department visits or 
hospitalizations) / person-time alive. Preliminary data (for the control group) show an 
average event rate per person of 1.99 events over 334 live days (0.92 years). Using 
Poisson regression, with a sample size of 688 PLWD and assuming 20% attrition and α = 
0.05, we have >90% power to find an event rate ratio of 0.74 (i.e., a reduced event rate of 
1.47 or lower in the intervention group vs. 1.99 in the control group), which is a 
meaningful difference. Data will be analyzed using an intention-to-treat approach. We 
will use descriptive statistics to report our secondary implementation outcomes; these are 
designed to inform future iterations and dissemination of this intervention, rather than test 
hypotheses per se. 
9.2.1 Treatment Assignment Procedures 
Randomization will be overseen by Dr. Samprit Banerjee (biostatistician). He will 
work with the data analyst at NYQC to enumerate the study population and 
conduct stratified randomization by care management team. That is, the study 
population will first be stratified into groups based on care management team. 
Within each group the study population will be randomized to the two trial arms, 
so that the trial arms will be of equal size. One rationale for randomizing by care 
management team is that the demographic characteristics of patients vary with 
care management team (for example, dual eligible beneficiaries are currently 
more likely to be assigned to one care management team than another). A second 
rationale for randomizing by care management team is that the clinical styles of 
care management teams may vary. By stratifying randomization by care 
management team, we will minimize any unmeasured confounding that variation 
by care management team might have otherwise introduced. Randomization will 
be done with random number generators. 
Masking is not feasible for this study, so NYQC will be aware of which patients 
are allocated to which group. This is necessary, because they will need to conduct 
screening surveys for everyone in the intervention group. 

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9.3 Interim analyses and Stopping Rules 
No interim analysis is planned, as the planned trial is fairly short, with 12 months of 
follow-up for the combined outcome of an emergency department visit or hospital 
admission. Interim analyses of emergency department visits and hospital admissions will 
not likely be sufficiently powered to be meaningful. 
However, findings that might trigger a safety review are the number of unexpected deaths 
in the trial. Such findings are presented to the study statistician or to the Data and Safety 
Monitoring Board (DSMB) statistician to review the events by group to determine 
whether there are statistical as well as clinical concerns. The statistician reports his 
findings to a closed session of the DSMB or to the Safety Officer and/or NIA. The 
findings are used to determine what steps will be taken.  
9.4 Outcomes  
9.4.1 Primary outcome   
We will measure the occurrence of ED visits and hospital admissions using Medicare 
claims. 
 
9.4.2 Secondary outcomes   
Secondary outcomes will consist of four implementation outcomes drawn from the 
Consolidated Framework of Implementation Research (CFIR) and related work by 
Proctor et al.39-41 Acceptability will be operationalized as the percent of study participants 
who are retained in each group over time (that is, continue to engage with the care 
coordinators when contacted). Appropriateness will be operationalized as: a) the types of 
problems with care coordination uncovered in response to the survey in the intervention 
group, and b) the frequency of different types of care coordinator activities in each group 
(i.e., facilitating provider-provider communication, facilitating transportation, etc.). 
Fidelity will be measured by tracking the percent of eligible individuals who receive care 
coordination services. Implementation Cost (or Efficiency) will be measured as the total 
number of care coordinator hours spent in each group. Implementation outcomes will be 
measured through manual review of the EHR, using a structured abstraction tool.  
 
9.5  Data Analyses 
We will compare the characteristics of the PLWD in each study group, using chi-squared 
tests for dichotomous variables and t-tests for continuous variables, to confirm that the 
study groups are balanced (p > 0.05). We will use Poisson regression to compare study 
groups for the outcome of the number of events (ED visits or hospital admissions) per 
person-time alive, adjusting for care management team (as it was used to stratify 
randomization42) and any co-variates that were imbalanced between the study groups at 
baseline. We will conduct analyses using an intention-to-treat approach, considering all 
individuals as members of the group to which they were randomized. We will use 
descriptive statistics to report implementation outcomes. 
 

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We will take biological sex and race/ethnicity into consideration in both the design and 
valid analysis of the trial. We will employ inclusive eligibility criteria, including 
individuals in the study regardless of sex or race/ethnicity. We will allocate study 
participants of both sexes and all races/ethnicities to the intervention and control groups 
by the unbiased process of randomization. We will conduct unbiased assessment of the 
occurrence of outcomes in all study participants. We will also use unbiased methods of 
statistical analysis and inference for the study population overall. In addition, we will 
conduct analyses to determine if the effect of the intervention varies with subgroups by 
sex and, separately, by race/ethnicity. For Aim 1 (which has the combined outcome of 
emergency department visits or hospital admissions), we will conduct exploratory 
moderator analyses with sex and race as potential moderators of treatment effect by 
introducing moderator x treatment interactions into our regression models. For Aim 2 
(which captures implementation outcomes), we will conduct exploratory analyses 
stratifying implementation outcomes (such as the types and frequencies of care 
coordination activities provided) by sex and, separately by race/ethnicity. 
 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
Care coordinators will collect survey responses, which will be entered into a REDCap 
form. The research assistant will extract data from the EHR, regarding participant 
demographics and clinical characteristics, as well as the data for the implementation 
outcomes. The PI will use separate forms to report data on any AEs and SAEs. 
10.2 Data Management  
A data analyst at Weill Cornell Medicine will be responsible for data management and 
analysis of the survey data on perceptions of care coordination. A data analyst at NYQC 
will be responsible for data management and data analysis of Medicare claims. 
10.3 Quality Assurance  
10.3.1 Training 
The PI will coordinate the activities of the members of the research team. The PI will 
provide any training needed for this study, though the team members are already 
experienced in the roles they will play. 
10.3.2 Quality Control Committee  
Not applicable 
10.3.3 Metrics 
Not applicable 

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10.3.4 Protocol Deviations 
The PI will meet weekly with the care coordinators, research assistant, and 
geriatrician to follow the progress of the study. The PI will be responsible for 
detecting and reporting any protocol deviations.  
10.3.5 Monitoring 
See 10.3.4. above. 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and 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 
We are requesting a waiver of informed consent and a waiver of HIPAA authorization, as 
described in section 4.3. 
11.3 Participant Confidentiality  
To minimize the likelihood of a breach in confidentiality, we will use several methods to 
keep data secure. Care coordinators will enter survey data into customized forms that we 
will build using Research Data Electronic Capture (REDCap), a secure web-based data 
management platform. REDCap was developed by Vanderbilt University, supported in 
part by the National Institutes of Health. Weill Cornell Medicine provides its 
investigators with access to REDCap. All other interactions between care coordinators 
and study participants will be documented in the Epic electronic health record, which has 
its own security features. Identifiable Medicare claims will be maintained by NewYork 
Quality Care. Access to study data will be restricted to authorized staff, the IRB, and the 
Office of Human Research Protections (OHRP). No publications or presentations arising 
from this research will include personally identifiable information. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, or other 
government agencies as part of their duties to ensure that research participants are 
protected.  
12 
ETHICAL CONSIDERATIONS 
This study is guided by the ethical principles of the Belmont Report, which was written 
by the U.S. National Commission for the Protection of Human Subjects of Biomedical 
and Behavioral Research. This study is also guided by the Common Rule (U.S. Protection 
of Human Subjects).  

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13 
COMMITTEES 
Not applicable 
14 
PUBLICATION OF RESEARCH FINDINGS 
Any presentation, abstract, or manuscript will be made available for review by the 
sponsor and the NIA prior to submission. 
15 
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16 
SUPPLEMENTS/APPENDICES 
Article by Kern et al., describing survey instrument to be used in this study (with survey 
instrument included as an Appendix), same as reference #34 above