Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
Phase: NA
Conditions: Caregiver Burnout
Sponsor: Weill Medical College of Cornell University

Title: Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
NCT04946942
Approval Date: 02-May-2024

Protocol # 21-04023513 
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Table of Contents 
LIST OF ABBREVIATIONS ......................................................................................................... V 
1. PROTOCOL SUMMARY .......................................................................................................... 1 
1.1 Study Objectives .................................................................................................................... 2 
1.1.1 Objectives 
2 
1.1.2 Hypotheses / Research Questions 
2 
2. BACKGROUND AND SIGNIFICANCE .................................................................................... 3 
3. STUDY DESIGN AND METHODS ........................................................................................... 3 
3.1 Overall Design ....................................................................................................................... 3 
3.2 Interviews, Focus Groups, Surveys, and/or Observations ..................................................... 4 
4. STUDY DESIGN ....................................................................................................................... 6 
4.1 Study Population .................................................................................................................... 6 
4.2 Inclusion Criteria .................................................................................................................... 6 
4.3 Exclusion Criteria ................................................................................................................... 7 
4.4 Strategies for Recruitment and Retention .............................................................................. 7 
5. REGISTRATION PROCEDURES ............................................................................................ 8 
5.1 Subject Registration (WCM only) ........................................................................................... 8 
5.2 Subject Registration (Sub-sites) ............................................................................................ 8 
6. STUDY PROCEDURES ........................................................................................................... 8 
6.1 Schedule of Assessments ..................................................................................................... 8 
7. DATA REPORTING / REGULATORY CONSIDERATIONS .................................................... 9 
7.1 Data Collection ...................................................................................................................... 9 
7.1.1 REDCap 
9 
7.2 Regulatory Considerations .................................................................................................... 9 
7.2.1 Institutional Review Board/Ethics Committee Approval 
9 
7.2.2 Ethical Conduct of the Study 
10 
7.2.3 Informed Consent 
10 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
11 
7.2.5 Record Retention 
11 
8. STATISTICAL CONSIDERATIONS ....................................................................................... 11 
9. ADVERSE EVENT REPORTING REQUIREMENTS ............................................................. 12 
9.1. Adverse Event Definition .................................................................................................... 12 
9.1.1 Adverse Event Characteristics and Related Attributions 
12 
9.1.2 Recording of Adverse Events 
12 
9.1.3 Reporting of AE to WCM IRB 
12 
9.1.4 Reporting Events to Participants 
12 
Not applicable 
12 
9.1.5 Events of Special Interest 
12 
Not applicable 
12 
9.1.6 Reporting of Pregnancy 
12 
Not applicable 
12 

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10. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS ........ 13 
Not applicable 
13 
10.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) . 13 
Not applicable 
13 
10.1.1 Unanticipated Problem Reporting 
13 
Not applicable 
13 
 
 
 
 
 
 
 

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Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or institutional 
review boards. The contents of this document shall not be disclosed to others without written 
authorization from WCM. 
 
 
 
 
 
 
 

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List of Abbreviations 
 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center  
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety Monitoring Plan 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HRBFA 
Human Research Billing Analysis Form 
HUD 
Humanitarian Use Device  
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
UIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
WCM 
Weill Cornell Medicine 

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1. Protocol Summary 
 
Full Title:  
 
 
 
Implementing a Family Caregiver Checklist in Primary Care: A 
Pilot Study 
Short Title: 
 
 
 
CHEC  
Principal Investigator: 
 
Catherine Riffin, PhD  
Study Description:   
The goal of this project is to pilot test CHEC (Collaborative 
Healthcare Encounters with Caregivers) in primary care. CHEC is 
brief intervention with two components: 1) a checklist to identify the 
needs and concerns of unpaid/family caregivers who accompany 
older patients (aged 65+) to their primary care visits and 2) 
accompanying Tip Sheet for clinicians.    
Sample Size: 
 
N = 60 caregivers* 
 
 
N = 60 patients* 
 
 
N = 10 primary care clinicians 
 
 
*Participants will be a part of a patient-caregiver dyad and will be 
recruited together.  
 
 
 
Enrollment: 
 
This study will enroll 60 patient-caregiver dyads and 10 primary 
care clinicians. It will screen up to 200 patients, up to 200 
caregivers, and up to 15 clinicians.  
Study Population: 
 
Patient participants will include individuals who have upcoming 
appointments at the Center on Aging (COA) and are identified by 
COA clinicians as typically attending appointments with a family 
caregiver. 
Patient 
participants 
will 
vary 
in 
age, 
gender, 
race/ethnicity, and health conditions. Family caregiver participants 
will include caregivers of patients receiving care at the COA. They 
will also vary in age, gender, and race/ethnicity. The clinician 
sample will include individuals who provide care at the COA. 
Clinicians will vary in age, be enrolled regardless of gender, and 
include those who have patient visits scheduled for June 2021 – 
August 2022. 
Enrollment Period: 
 
14 months   
Study Design: 
 
Two group single-blind randomized pilot RCT collecting: 1) survey 
data, 2) audio-recordings, and 3) electronic medical record data.    
Description of Sites/  
Facilities Enrolling 
Participants: 
 
Participants will be recruited and enrolled at WCM/NYP offices, 
specifically the Center on Aging.  
 
Study Duration: 
 
August 31, 2024 
Participant Duration: 
Providers – 14 months 
 
 
Caregivers – 6 months 
 
 
Patients – 1 month 
Primary Objective: 
To examine the feasibility and acceptability of implementing 
CHEC in primary care practice.  

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Secondary Objectives: 
To examine the preliminary impact of CHEC on primary care visit 
communication (discussion of family caregivers’ needs).   
Exploratory Objectives: 
Not applicable  
Primary Endpoints:  
Feasibility will be assessed by accrual rates and rate of 
intervention completion. Acceptability will be assessed by surveys 
assessing perceived helpfulness, satisfaction, length, and impact 
on workflows.  Effectiveness will be measured by the number of 
checklists 
that 
result 
in 
a 
conversation 
about 
caregivers’ 
needs/concerns. 
 
Secondary Endpoints: 
Not applicable.  
 
 
 
1.1 Study Objectives 
 
1.1.1 Objectives  
 
Objective 1: To demonstrate the feasibility and acceptability of CHEC in primary care 
practice.  
 
Objective 2: To test the preliminary impact of CHEC on primary care visit 
communication (discussion of family caregivers’ needs). 
 
1.1.2 Hypotheses / Research Questions 
 
 
 
Hypothesis 1: Greater than 70% of caregivers will perceive the checklist to be an 
acceptable length and easy to use. 
 
Hypothesis 2: Greater than 70% of caregivers will report that the checklist is helpful in 
identifying their unmet needs and starting a discussion with providers.  
 
Hypothesis 3: Greater than 70% of caregivers and providers will report that they desire 
to continue using the checklist in the future.  
 
Hypothesis 4: The checklist will not significantly impact primary care workflow or visit 
duration.  
 
Hypothesis 5: Discussion of caregivers’ needs and concerns will occur more often in the 
intervention group than in the usual care group. 
 
Hypothesis 6: Caregiver perceptions of visit communication will be more positive in the 
intervention group than in the usual care group. 
 
 
 
 
 

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2. Background and Significance 
 
In the United States, nearly 8 million older adults rely on family and other unpaid caregivers 
(neighbors; friends) for assistance with their health care. These caregivers collectively provide 
75-80% of the total care hours to community-dwelling older adults and fill multiple roles in the 
health care system: attending doctor’s visits, coordinating care, and assisting with treatment 
regimens. The availability and adequacy of assistance provided by family and unpaid caregivers 
have direct implications for health care costs and quality of care of older adults. Yet, caregivers 
are not systematically identified in care delivery systems, and their abilities and needs are not 
routinely assessed. Caregivers receive inadequate preparation for the tasks they must assume. 
They report high levels of stress and are at risk for physical illness, depression and anxiety, and 
sleep disturbance. If these impairments and unmet needs are not assessed and addressed, they 
can impede the caregiver’s ability to provide effective assistance to the older adult, ultimately 
leading to costly hospitalizations and nursing home placements. These caregiver factors (health 
impairments; unmet needs) are particularly influential in the context of dementia where patients 
require substantial caregiving assistance.  
 
Primary care practices are well positioned to aid in identifying and addressing the needs of at-risk 
family caregivers – in particular, persons who suffer from caregiving-related stress or have unmet 
needs for training or support – through systematic screening and referral. Nearly 40% of patients 
over the age of 65 are accompanied by a caregiver to routine medical visits. Primary care 
providers are often the first point of contact in the health care system for patients and caregivers, 
and thus have the opportunity to detect issues early in the caregiving trajectory. In addition, the 
long-term nature of the patient-caregiver relationship with a primary care provider affords the 
opportunity for periodic reassessment. This aspect is critical as the caregiver’s needs change in 
response to the patient’s physical health and cognitive function.  
 
The objective of this project is to pilot test a novel screening-referral system for family caregivers 
who accompany older adults to their primary care visits, The long-term goal of this research is to 
develop a clinically feasible and scalable caregiver screening system that is acceptable to 
providers and caregivers. This system will set the stage for a sustained line of intervention work 
that connects at-risk caregivers with appropriate resources, services, and supports. From a 
clinical perspective, broad implementation of this system has the potential to reduce demands on 
primary care providers by directing caregivers to services designed to support their well-being 
and caregiving capacity. 
 
 
3. Study Design and Methods 
 
3.1 Overall Design 
 
Clinicians who see patients at the Center on Aging (COA) will be made aware of the study via 
individual meetings with co-investigators. These meetings will be by phone, Zoom, or in-
person if/when feasible. Patients and caregivers will be identified through referrals from 
physicians practicing at the Center on Aging. They will be sent a recruitment letter in the mail 
one month prior to a co-investigator calling them to go over the screening and consent forms. 
Any study data collected for potential participants that do not meet eligibility will be 
immediately deleted. Informed Consent and HIPAA authorization for caregivers and patients, 
and informed consent for clinicians will occur orally over the phone or in-person at the COA 
just prior to in-person health visits when feasible as outlined in the Informed Consent section.  

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Patient-caregiver dyads will be randomized into either the CHEC (n=60; 30 caregivers and 
30 patients) or control (usual care) condition (n=60; 30 caregivers and 30 patients). 
Randomization will occur through block randomization with alternative block sizes of 4 and 6 
for each participating clinician.  
 
Intervention Condition. Participants in the intervention condition will complete the 
Caregiver Checklist portion of CHEC at the beginning of their health visit. The participating 
clinician will then respond to the checklist following the guidelines on the accompanying 
Tip Sheet.  
 
Control Condition. Caregivers in the control condition will receive their usual care from the 
participating clinician during the health visit.  
 
Baseline (pre-visit). Caregivers in both conditions will be asked to complete identical pre-visit 
surveys. The survey will be scheduled to be completed over the phone, digitally on REDCap, 
or in-person depending on the participant’s preference and COVID-19-related guidelines. We 
will ask about the participant’s background, caregiving role, communication with providers, 
and feelings of caregiver preparedness. It will take approximately 20 minutes to complete. 
Medical chart abstraction will be used to collect patient’s background characteristics, 
medications, diseases, and health events (e.g., hospitalization). Clinicians will complete a pre-
intervention survey over the phone or in-person depending on the participant’s preference and 
COVID-19-related guidelines. We will ask for the clinicians’ personal characteristics and 
preparedness to assess and address caregivers’ needs and concerns.  
 
Visit. All participants will have their medical visit audio recorded.  
 
Post-visit. All caregiver participants will complete a post-visit survey within 1 week of the visit. 
They will also complete follow-up surveys 2 months and 6 months after the visit.  
 
Post-intervention. At the completion of the entire intervention period, clinicians will complete 
a post-intervention survey and interview. The clinician surveys and interview will take no more 
than 30 minutes total and will be conducted within 1 month of the conclusion of the intervention 
period.  
 
3.2 Interviews, Focus Groups, Surveys, and/or Observations  
 
A.  Administration 
§ 
Timing and Frequency 
o 
Caregiver baseline (pre-visit) surveys will take no more than 20 minutes 
and will be conducted prior to the visit; caregiver post-visit surveys will take 
no more than 25 minutes and will be conducted within one week of the visit, 
either in-clinic or remotely (via telephone and secure web survey or mail), 
based on the participant’s preference. Separate post-visit, follow-up 
surveys will take no more than 15 minutes and will be conducted at 2 
months and 6 months following the visit.  
o 
Clinician baseline surveys will take no more than 5 minutes and will be 
conducted prior to the entire intervention period. Clinician post-intervention 
surveys and interviews will take no more than 30 total minutes and will be 

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conducted within 1 month of the conclusion of the intervention period. The 
post-intervention interviews will occur in-person or over the phone (based 
on the participant’s preference) and will be audio-recorded.  
o 
Medical chart abstraction will be conducted following enrollment/consent 
but prior to the visit. The medical visit will be audio-recorded. 
 
§ 
Procedures For Audio And Visual Recording  
o 
Medical visits and interviews will be recorded (phone, video, or in-person 
encrypted recording) and stored on secure WCM servers via password 
protected tagged WCM computers.  
o 
Audio-recordings will be transcribed by study co-investigators and will not 
leave the institution. The transcripts will also be stored on secure WCM 
servers via password protected tagged WCM computers.  
 
§ 
Person Identifiers 
o 
Personal identifiers (e.g. names, email address, phone number, and 
address) will be collected for recruitment and compensation purposes. 
Voice and video recordings, as well as compensation identifiers, will be 
made on a voluntary basis. 
o 
Patient data will be abstracted from the medical chart. Information obtained 
will include name, address, phone number, age, gender, race/ethnicity, 
provider, 
MRNs, 
electronic 
mail 
addresses 
and 
health 
diagnosis 
information including primary visit diagnosis code and clinic location (from 
defined time window), and health events (e.g. hospitalization, visit from 
home health aide). A partial HIPAA waiver will be requested for access to 
this information. All participants will be provided with a participant ID and 
their survey responses will be de-identified. Records will be maintained and 
kept in secure locations for a minimum of 3 years; the length of time 
specified according to WCM and HIPAA policies.  
 
 
 
B. Study Instruments 
The primary instruments for this study are validated, widely-used patient- and 
caregiver-reported outcomes (PCRO) assessments that are commonly used in health 
services research and clinical practice. These validated and reliable self-report 
measures include: Preparedness for Caregiving scale (Zwicker, 2010), CAPACITY 
measure (Van Houtven et al., 2019), Perceptions of Visit Communication (Talen et al., 
2011), Caregiver Satisfaction with Primary Care Interactions (Clair et al., 2014; Haley 
et al, 1992), Perceived Self Efficacy in Primary Care Interactions (Maly et al., 1998), 
knowledge and use of resources (Thomas et al., 2017), caregiver anxiety and 
depressive symptoms (Mauer, 2012; Wild et al., 2014), and burden (Zarit, Reever & 
Bach-Peterson, 1980). We will use short forms when possible in order to reduce 
participant burden.  We also developed several specific questions about caregivers’ 
perception of the screening tool and knowledge of resources.  All study instruments are 
attached to the IRB application in the WRG-HS system.  
- 
Caregiver Subjects in CHEC (intervention group)  
§ 
CHEC Caregiver Screening Questions 
§ 
CHEC Caregiver Demographics 
§ 
CHEC Caregiver Pre-Test Questionnaire 

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§ 
CHEC Visit Companion Checklist 
§ 
CHEC Caregiver 1-Week Post-Test Follow-Up Survey – Intervention 
§ 
CHEC Caregiver 2-Month Post-Test Follow-Up Survey – All Caregivers 
§ 
CHEC Caregiver 6-Month Post-Test Follow-Up Survey – All Caregivers  
 
- 
Caregiver Subjects in control group  
§ 
CHEC Caregiver Screening Questions 
§ 
CHEC Caregiver Demographics 
§ 
CHEC Caregiver Pre-Test Questionnaire 
§ 
CHEC Caregiver 1-Week Post-Test Follow-Up Survey – Control 
§ 
CHEC Caregiver 2-Month Post-Test Follow-Up Survey – All Caregivers 
§ 
CHEC Caregiver 6-Month Post-Test Follow-Up Survey – All Caregivers  
 
- 
Clinician Subjects  
§ 
CHEC Clinician Pre-Test Demographics and Eligibility Questionnaire 
§ 
CHEC Visit Companion Checklist + Provider Tip Sheet 
§ 
CHEC Clinician Post-Test Questionnaire 
§ 
CHEC Clinician Post-Test Interview Guide 
4. Study Design 
 
4.1 Study Population 
The patient participant sample includes individuals who have upcoming appointments 
at the Center on Aging (COA) and are identified by COA clinicians as typically 
attending appointments by a family caregiver. Patient participants will vary in age, 
gender, race/ethnicity, and health conditions. The family caregiver sample will include 
caregivers of patients receiving care at the Center on Aging. They will also vary in age, 
gender, and race/ethnicity. Caregivers and patients will be recruited and enrolled as 
dyads. The clinician sample will include individuals who provide care at the Center on 
Aging. Clinicians will vary in age, be enrolled regardless of gender, and include those 
who have patient visits scheduled over the next year. 
 
4.2 Inclusion Criteria 
Patients  
1. Age 65-89 
2. English speaking 
3. Women and men 
4. Of varying race/ethnicity 
5. Accompanied to primary care visits at the Center on Aging by a family caregiver 
5.1. Family caregiver also consents to participating in this study.  
6. Sufficient cognitive capacity to consent themselves or through a legal representative 
 
Caregivers 
1. Age 21+ 
2. English speaking 

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3. Women and men 
4. Of varying race/ethnicity 
5. Accompany an older adult to his or her primary care visits at the Center on Aging 
5.1. Older adult also consents to participating in this study.  
6. Cognitively intact (on basis of a 6-item cognitive screen) 
 
Clinicians 
1. Age 21+ 
2. Women and men 
3. Of varying race/ethnicity 
4. Treat patients at the Center on Aging  
 
4.3 Exclusion Criteria  
 
 
 
1. Patients, caregivers, and clinicians that do not meet the inclusion criteria. 
2. Patients and caregivers who are deaf or have hearing impairments that limit their 
ability to answer telephone queries. 
3. Caregivers who are visually impaired and cannot see well enough to read large print 
and complete paper-based surveys. 
4. Patients and/or caregivers whose dyad counterpart does not consent to take part in 
the study (i.e., Patients gives consent and their caregiver does not).  
 
4.4 Strategies for Recruitment and Retention 
 
Co-investigators will meet with clinicians who see patients at the Center on Aging to make 
them aware of the study protocol, including the request for their participation in the study and 
the plan to send recruitment letters (postal mail or email) to their patients and their family 
caregivers. An IRB-approved, informative study flyer will be sent with the recruitment letters 
(via postal mail or email). These meetings will be by phone, Zoom, or in-person if/when 
feasible. Co-investigators will review the consent form with each clinician, allowing for 
questions and reminding him or her that participation is voluntary. The co-investigator will 
subsequently ask each clinician who agrees to a) complete the pre-intervention survey (which 
will be administered orally by the trained co-investigator) and b) review his or her patient list 
and identify individuals who typically attend appointments with a caregiver (family or friend). 
When meeting with these clinicians, co-investigators will verify that the caregiver lives with the 
patient and/or obtain the caregiver contact information from the providers. A study team 
member will then query EPIC to determine the dates of upcoming appointments for those 
patients. Pre-notification recruitment letters will then be sent by mail, email (when available), 
or Weill/EPIC Connect to the patients and caregivers of the identified patients one month prior 
to his or her next scheduled appointment. Recruitment letters may also be sent to potential 
participants via EPIC Pool of WCM/NYP Consent to be Contacted for Research (CCR) 
patients and chart review to determine potential eligibility. When possible, letters will be sent 
to the emergency contact (i.e., caregiver) if their telephone matches that of the patient, or by 
email. The recruitment letter will describe the study and advise potential participants that they 
may decline participation by emailing or placing a telephone call to the study team. 
Approximately two weeks after the initial letter (postal mail or email) is sent, patients and 
caregivers who have not opted-out will be telephoned or emailed by the trained co-investigator 
to confirm their interest. Participants complete the consent form and pre-visit survey over the 

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phone, for both their convenience and safety during the COVID-19 pandemic. COA waiting 
rooms are presently closed and patients/caregivers are met at the door and brought 
immediately to an exam room. Once these restrictions are lifted, patient/caregiver participants 
will be given the option to complete their informed consent process and study pre-visit survey 
in the waiting room prior to the patient’s next visit. Participants who elect to do so in person 
will be asked to arrive 30 minutes prior to their scheduled visit to ensure sufficient time to 
review the consent form and complete the survey. 
 
Trained co-investigators will use the caregivers’ preferred method of contact to inform them 
about the study (phone or email) after sending the pre-notification letter. If it is safe to do so 
and if time allows, co-investigators may choose to have participants consent in-person at The 
Center on Aging, and in that case, they will also be given the first survey at this time prior to 
their health visit.  
 
Caregivers in both the intervention and control group will be voluntarily compensated $25 via 
AmEx gift cards for their participation in the initial post-visit survey. They will receive an 
additional $10 via ClinCards for their participation in each of the follow up surveys (at 2 months 
and 6 months). In total, caregivers may be compensated up to $45. 
 
5. Registration Procedures 
 
5.1 Subject Registration (WCM only) 
 
Subjects will be registered within the WRG-CT as per the standard operating procedure 
for Subject Registration.  
 
 
 
5.2 Subject Registration (Sub-sites) 
 
N/A 
 
 
6. Study Procedures 
 
6.1 Schedule of Assessments  
 
Table 1. Schedule of events 
    
Pre-Study 
Pre-visit 
(Baseline) 
 
Visit 1 
Post-visit 1 
(within 1 
week of 
Visit)  
Post-visit 2 
(2-month 
follow-up) 
Post-visit 3 
(6-month 
follow-up) 
Post-
intervention 
Cognitive Screen 
X 
 
 
 
 
 
 
Informed Consent  
X 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
Caregiver Surveys  
 
X 
 
X 
X 
X 
 
Clinician Surveys 
 
X 
 
 
 
 
X 

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Audio-Recording of 
Medical Visit 
 
 
X 
 
 
 
 
Medical Chart 
Abstraction 
X 
 
 
 
 
 
 
Medical Events 
Log Six Months 
Post 
 
 
 
 
 
X 
 
 
 
7. Data Reporting / Regulatory Considerations 
 
7.1 Data Collection 
 
The data collection plan for this study is to utilize REDCap to capture all data for all 
enrolled subjects.  
 
7.1.1 REDCap 
 
REDCap (Research Electronic Data Capture) is a free data management software 
system that is fully supported by the Weill-Cornell Medical Center CTSC.  It is a 
tool for the creation of customized, secure data management systems that include 
Web-based data-entry forms, reporting tools, and a full array of security features 
including user and group-based privileges, authentication using institution LDAP 
system, with a full audit trail of data manipulation and export procedures.  REDCap 
is maintained on CTSC-owned servers that are backed up nightly and support 
encrypted (SSL-based) connections.  Nationally, the software is developed, 
enhanced and supported through a multi-institutional consortium led by the 
Vanderbilt University CTSA. 
 
7.2 Regulatory Considerations 
 
7.2.1 Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are 
covered, and approval of the appropriate regulatory bodies obtained, before study 
initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other 
written material given to the patients, and any other relevant study documentation 
will be submitted to the appropriate Ethics Committee. Written approval of the 
study and all relevant study information must be obtained before the study center 
can be initiated or the IP is released to the Investigator. Any necessary extensions 
or renewals of IEC/IRB approval must be obtained for changes to the study, such 
as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study 
files.  
The Investigator will report promptly to the IEC/IRB any new information that may 
adversely affect the safety of the subjects or the conduct of the study. The 

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Investigator will submit written summaries of the study status to the IEC/IRB as 
required. On completion of the study, the IEC/IRB will be notified that the study 
has ended.  
 
All agreed protocol amendments will be clearly recorded on a protocol amendment 
form and will be signed and dated by the original protocol approving signatories. 
All protocol amendments will be submitted to the relevant institutional IEC/IRB for 
approval before implementation, as required by local regulations. The only 
exception will be when the amendment is necessary to eliminate an immediate 
hazard to the trial participants. In this case, the necessary action will be taken first, 
with the relevant protocol amendment following shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the 
lead site, Weill Cornell Medicine, updated documents will be provided to 
participating sites. Weill Cornell Medicine must approve all consent form changes 
prior to local IRB submission.  
Relevant study documentation will be submitted to the regulatory authorities of the 
participating countries, according to local/national requirements, for review and 
approval before the beginning of the study. On completion of the study, the 
regulatory authorities will be notified that the study has ended.  
 
7.2.2 Ethical Conduct of the Study  
The Investigators and all parties involved should conduct this study in adherence 
to the ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines 
and the applicable national and local laws and regulatory requirements.  
 
This study will be conducted under a protocol reviewed and approved by the 
applicable ethics committees and investigations will be undertaken by scientifically 
and medically qualified persons, where the benefits of the study are in proportion 
to the risks. 
 
This study will have been reviewed by the WCM IRB, Protocol Review and 
Monitoring Committee, and the Data Safety and Monitoring Committee (WCM 
DSMC), prior to conducting any human subjects research activities. The WCM 
Data Safety and Monitoring Committee has determined that their oversight & 
monitoring is not required for this low-risk study. Only surveys and chart 
abstraction are involved and it does not involve the evaluation of intervention on 
health outcomes of human subjects. 
 
7.2.3 Informed Consent 
 
The co-investigator or qualified designee must obtain documented consent according to 
ICH-GCP and local regulations, as applicable, from each potential subject or each 
subject’s 
legally 
authorized 
representative 
prior 
to participating 
in 
the 
research 
study.  Subjects who agree to participate will receive an oral consent document prior to 
speaking to a co-investigator. 
 
Informed Consent will occur prior to administration of the pre-visit survey (for caregivers) 
and pre-intervention survey (for clinicians), by oral consent for participants until in-person 

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consent measures are safely feasible.  For oral consent, a member of the study team will 
review the ICF in-full (see Oral Consent Script attachment) by phone, allowing for 
questions and reminding the potential subject that participation is voluntary. Oral 
confirmation of consent to participate will be documented by the study team member.   
 
Older adults – who are the focus of this study – are at higher risk of severe illness from 
COVID-19. To minimize exposure of this vulnerable group, we are requesting a waiver of 
documentation of written consent. We have two points of justification. First, administering 
oral, rather than written consent would reduce the time participants spend in the waiting 
room prior to the study and unnecessary contact (i.e. with study co-investigators). Second, 
given that the Center on Aging is conducting a combination of video and in-person visits, 
oral consent is needed in order to accommodate those participants who cannot leave their 
homes at this time.  
 
The initial ICF, any subsequent revised written ICF and any written information provided 
to the subject must be approved by IRB prior to use. The ICF will adhere to IRB/IEC 
requirements, applicable laws, and regulations. 
 
7.2.4 Compliance with Trial Registration and Results Posting Requirements  
 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) 
and the Food and Drug Administration Amendments Act (FDAAA), the Sponsor-
Investigator of the trial is solely responsible for determining whether the trial and 
its 
results 
are 
subject 
to 
the 
requirements 
for 
submission 
to 
http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation 
by calling a central contact number for further information on appropriate trial 
locations and trial site contact information. 
 
7.2.5 Record Retention 
 
Essential documents are those documents that individually and collectively permit 
evaluation of the study and quality of the data produced.  After completion of the 
study, all documents and data relating to the study will be kept in an orderly manner 
by the Investigator in a secure study file.  Essential documents should be retained 
for 2 years after the final marketing approval in an ICH region or for at least 2 years 
since the discontinuation of clinical development of the IP. In addition, all subject 
medical records and other source documentation will be kept for the maximum 
time permitted by the hospital, institution, or medical practice.   
 
8. Statistical Considerations 
 
Feasibility and acceptability will be examined by conducting frequency and descriptive statistics 
(i.e. mean, median, standard deviation, range) for enrollment rates and Likert-scale items 
assessing satisfaction with CHEC and perceived helpfulness.  
 
Effectiveness will be measured by the number of completed checklists that result in a 
conversation with providers about caregiver needs and the receipt of relevant support. The effect 
of CHEC on the primary outcome variable, discussion of caregivers’ needs, will be examined in a 
general linear mixed model with intervention group and time (pre-posttest) as fixed classification 

Protocol # 21-04023513 
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factors, and individuals as levels of a random classification factor. The model will account for pre-
intervention measures and will include a group x time interaction. Additional covariates (e.g., 
caregiver and care recipient age) and fixed classification factors (e.g., caregiver gender, race) will 
also be examined. Prior to model fitting, the distribution of all study variables will be assessed. 
 
9. Adverse Event Reporting Requirements 
Adverse event (AE) monitoring and reporting is a routine part of clinical research.  Safety is 
monitored by evaluation of adverse events reported by subjects or observed by investigators or 
research staff, as well as by other investigations such as clinical laboratory tests, x-rays, 
electrocardiographs, etc. 
 
9.1. Adverse Event Definition 
An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a drug, and does not imply any judgment about causality. An 
adverse event can arise with any use of the drug (e.g., off-label use, use in combination 
with another drug) and with any route of administration, formulation, or dose, including an 
overdose.  
 
 
9.1.1 Adverse Event Characteristics and Related Attributions 
CTCAE term (AE description) and grade:  The descriptions and grading scales 
found in the revised NCI Common Terminology Criteria for Adverse Events 
(CTCAE) version 4.0 will be utilized for AE reporting.  A copy of the CTCAE version 
4.0 can be downloaded from the CTEP web site (http://ctep.cancer.gov). 
 
• 
Attribution of the AE: 
- 
Definite – The AE is clearly related to the study treatment. 
- 
Probable – The AE is likely related to the study treatment. 
- 
Possible – The AE may be related to the study treatment. 
- 
Unlikely – The AE is doubtfully related to the study treatment. 
- 
Unrelated – The AE is clearly NOT related to the study treatment. 
 
 
 
 
9.1.2 Recording of Adverse Events 
All adverse events will be recorded on a subject specific AE log. The AE log will 
be maintained by the research staff and kept in the subject’s research chart.    
 
 
 
 9.1.3 Reporting of AE to WCM IRB 
All AEs occurring on this study will be reported to the IRB according to the IRB 
policy, which can be accessed via the following link: 
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immedi
ate_Reporting_Policy.pdf.  
 
9.1.4 Reporting Events to Participants 
Not applicable 
 
 
9.1.5 Events of Special Interest 
Not applicable 
 
 
9.1.6 Reporting of Pregnancy  
Not applicable 

Protocol # 21-04023513 
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10.  Unanticipated Problems Involving Risks to Subjects or Others  
 
Not applicable 
 
10.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others 
(UPIRTSO) 
 
Not applicable 
 
 
 
10.1.1 Unanticipated Problem Reporting 
 
 
 
 
 
 
 
Not applicable