Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Phase: NA
Conditions: Dementia
Sponsor: NYU Langone Health

POISED IRB Protocol May 10, 2021 
Study Number: 16-01473 
PI: Joshua Chodosh 
NCT: NCT03325608 
 
PURPOSE OF STUDY AND BACKGROUND 
 
Objective 
Dementia is a common problem for older patients presenting to emergency departments (EDs) 
and for their family caregivers who often lack the support, understanding, and skills to manage 
the myriad of problems that may be related to the need for that ED visit. The purpose of the 
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively 
Impaired Patients (POISED-CPCIP, hereon referred to as POISED)  randomized controlled trial 
is to use previously established quality improvement methods of root cause analysis to uncover 
reasons for ED use and to focus on caregiver (CG) activation within a program of dementia care 
management. Study goals are to reduce recurrent ED visits and improve caregiver symptoms of 
depression, anxiety and need for social support. POISED, a 4-year study, will test whether a 
novel care management intervention for family CGs of ED users with cognitive impairment and 
likely Alzheimer’s disease and related dementias will reduce ED use at 3 and 6 months over the 
intervention period. In addition to ED use, we will test whether CGs exposed to the intervention 
will experience greater improvements (compared to controls) in family caregiving confidence in 
managing the healthcare needs of the care recipient (CR), and improved anxiety, depression 
and sense of social support. 
 
Background 
The United States spends more than $100 billion providing care for the millions of individuals 
and their family caregivers (CGs) affected by Alzheimer’s disease and related dementias 
(ADRD).1,2 By 2050, 11–19 million people in the U.S. will have ADRD with the associated 
projected annual Medicare costs exceeding one trillion dollars.3,4 Most patients with ADRD have 
suboptimal management of their cognitive, behavioral and functional disability and this is made 
worse by under-recognition.5 The unmet needs of family CGs challenge chronic disease 
management and necessitate high levels of acute care.6-9 Compared with those without 
dementia, patients with ADRD visit the emergency department (ED) more often, are more likely 
to return within 30 days, and are more likely to die after an ED visit.10 Despite such concerns, 
the role of ADRD as a factor in ED use is likely unrecognized, not typically addressed, and may 
be much larger than anticipated.10,11 
 
An ED visit represents a “sentinel event”—either a failure in managing a chronic condition or the 
occurrence of new symptoms or problems—and is typically prompted by the need for urgent 
attention.12-14 Although the presenting symptom provides a sharp focus for ED care and is 
usually addressed before the patient is sent home, EDs do not deploy strategies to uncover or 
address symptom precipitants or root causes—those key contextual factors that contribute to 
ED use. Among those contextual factors are the presence of unrecognized dementia or 
cognitive impairment in the patient and the caregiving situation at home. In general ED care 
does not address the needs of CGs (used here to mean key family and friends of persons with 
ADRD) in managing the presenting problem and the ED discharge plan at home. Concerns 
about the needs of CGs of persons with ADRD have motivated the development of dementia 
care management programs. However, such programs do not focus specifically on high-risk or 
high-need patients, do not use the need for ED care of patients with comorbid chronic disease 
as an organizing principle to engage and empower CGs in their healthcare management, and 
do not view CGs as care partners.  Moreover, care management programs are not typically 

offered at the crisis-point of an ED visit. Whereas some EDs now use cognitive assessment as 
part of their routine evaluation, the efficacy of dementia care management initiated at the point 
of an ED visit has not been tested.  
 
This proposal benefits from the recent decisions of two large academic institutions to include 
cognitive screening as part of ED care for older patients.  
 
Of note, cognitive screening is not part of the experimental design; thus, patients are not being 
consented to undergo cognitive screening. 
 
We propose to conduct a randomized controlled trial of care management, POISED, for 
caregivers of patients who fail a cognitive screening test at the point of an ED visit and are 
discharged to home. We will randomize dyads—family caregivers and their care-recipient (CR) 
patients—to POISED or to a usual care control group. Within POISED, we will identify root 
causes of ED visits (using root cause analysis, RCA) and apply this to focused care 
management protocols and interventions.  
 
Specific Aims 
The specific aims of this proposal are to: 
 
1) Test whether the POISED intervention will reduce recurrent acute care use over 6 
months when compared with post-ED care for dyads without POISED. We hypothesize 
that recurrent acute care use over 6 months will be less for CRs whose family CGs 
participate in POISED. 
 
2) Test whether the 6-month POISED intervention will improve family caregiver 
“activation” in managing the health care of care recipients compared with post-ED 
care without POISED at 3 and 6 months. We hypothesize that POISED will improve family 
CG activation in managing the health care of CRs. 
 
3) Test whether POISED will improve caregiver psychosocial outcomes compared with 
post-ED care without POISED at 3 and 6 months. We hypothesize that CG depression, 
anxiety, and experience of social support will improve more for CGs who are enrolled in 
POISED than for those referred to other care management programs. 
 
Potential Impact: Studying this approach may lead to low cost strategies to reduce high cost 
acute care use and related improvements in CG ability to assist in chronic disease management 
for CRs with dementia. Related impacts are improved health of CRs and psychosocial well-
being of CGs. 
 
METHODS 
 
Setting: The study will be conducted in two cities, New York and Indianapolis, in the EDs of their 
respective academic institutions—NYU Langone Medical Center and Indiana University Health 
University Hospital. The NYU Ronald O. Perelman Center for Emergency Services sees 
>60,000 patients annually. In 2015 the numbers of ED patients >75 years who were discharged 
to home were >3700 in the NYU ED and 2400 patients in the Indiana University Eskanazi and 
Methodist EDs. 
 

Aim1: Recruit and randomize a sample of  900 patient-caregivers (CGs) dyads 
(1800people total) presenting to the ED and test whether the POISED intervention will 
reduce recurrent acute care use over 6 months when compared with post-ED care for 
patients and CGs without POISED.  
 
Study Design: We will randomize subjects to either usual care or interventional groups where 
we will perform an initial assessment and provide a novel care management intervention for 
family CGs of ED users with cognitive impairment and likely ADRD. 
 
Inclusion/Exclusion Criteria for Care Recipients:  
Inclusion criteria for participation in care management or usual care are as follows: 
1) 
Must be 75 years and older 
2) 
Must be in the emergency department for care at the point of recruitment 
3) 
Must be English- or Spanish-speaking 
4) 
Must have a family member or friend who provides caregiving assistance  
5) 
Must have a plan to be discharged to home  
6) 
Must have scored < 4 on the MiniCogTM15-19 or if using caregiver assessment by 
IQCODE20, 21, must be > 3.4 
7) 
Must have capacity to consent or have a proxy. 
 
Exclusion criteria for participation in care management or usual care are as follows: 
1) 
Care recipient (CR) is a resident of a nursing home or other supportive facility 
2) 
CR scores > 3 on the MiniCogTM or the caregiver assessment by IQCODE was < 3.4 
3) 
Caregiver (CG) declines participation 
4) 
CR is not being discharged to home 
CR does not allow their family member or emergency contact to be contacted 
Note: If the care recipient lacks capacity and we cannot obtain consent from their proxy, we will 
not access those data or include them in any analyses. Please note that a caregiver can still 
participate in the study with the assent of the care recipient, without the use of the health care 
data. 
 
Inclusion/Exclusion Criteria for Care Givers of Affected Patients: 
Inclusion criteria for telephone survey and potential care management are as follows: 
• 
Family or informal caregiver (herein described as “caregiver”) of a person must be 
identified by that patient or self-identified as that individual who provides most of assistance 
among potentially other family members or friends of the care recipient (patient in the ED) 
• 
For a caregiver to be eligible for inclusion the care recipient must be living in the 
community; however, later facility placement will not exclude that caregiver from continued 
participation. 
• 
Caregiver must be English- or Spanish-speaking 
• 
Caregiver must be able to speak on a telephone to be eligible for randomization 
• 
Caregiver must have adequate hearing to communicate by phone 
• 
Caregiver must demonstrate capacity to consent to research participation. 
• 
Caregiver must be at least 21 years old 
 
Exclusion criteria for potential telephone survey are as follows: 
1) 
Caregiver does not have adequate knowledge of identified patient and/or does not 
participate in that member’s healthcare decisions 
2) 
Caregiver is not English or Spanish speaking 

3) 
Caregiver does not have adequate hearing to participate in telephone survey and is 
therefore not eligible for randomization. 
4) 
Caregiver is not able to speak on a telephone 
5) 
Caregiver is less than 21 years old 
 
Recruitment: Potential subjects will be identified from the ED on the basis of the cognitive state 
of the ED patient. Family caregivers will be identified and approached in the ED and if not 
present, will be contacted by phone and offered participation in the study. Potential subjects 
(caregivers) are identified by the treating team who have no direct involvement in the research. 
As is typical for these kind of clinical studies, the treating team, using clear inclusion and 
exclusion criteria will ask potential subjects whether or not a research assistant (RA) (from the 
POISED team) can speak with them to tell them about an opportunity to participate in a study.  
The treating team is never informed as to whether a potential subject agrees to participate or 
refuses after meeting with the RA. Caregivers and/or care recipients who are in the ED will be 
approached only after we (the POISED team) are given permission from the ED staff who will 
alert the research assistant of a potential caregiver-care recipient dyad. Caregivers and their 
care recipients will be informed that declining to participate will in no way impact their care in the 
emergency department or elsewhere and that the treating medical staff will not know about their 
decision as to their agreement or refusal of participation. 
 
After ED staff have completed cognitive assessment using the Mini-CogTM and given us 
permission for to speak to the dyad, we will approach and offer participation to CGs and ED 
patients > 75 years who have scored <=3/5 on the Mini-CogTM and have plans to be discharged 
home. A score of >3.4 on the Short IQ-CODE (a proxy tool used by ED staff) will identify those 
few who cannot complete the Mini-CogTM. We will consent CGs and care-recipients at the time 
of ED visit. (See Recruitment, Consent, and Assent). If the care recipient lacks capacity, we will 
attempt to consent to identify and consent the Care Recipient via a proxy (See Recruitment, 
Consent and Assent) If there is no available or identified CG, we will attempt to identify and 
consent the CG at a later date either by phone (using an IRB approved verbal consent 
telephone script with waiver of written documentation of consent) or in person using an IRB 
approved consent form to obtain written consent. Please note that the study team will maintain a 
deidentified record (using a linking code) of who had been approached (in person or by phone), 
whether they had declined or accepted to participate in the research, and at what time and on 
what date this conversation took place. 
 
Phone Recruitment: In the event that ED recruitment and assessment cannot be done in 
person, a Phone Recruitment Protocol will take effect. Potential subjects will be identified from 
the ED on the basis of a recent admission to a participating ED site location, using the EMR.  
Family caregivers will be identified by the patient, or via the EMR (i.e. Emergency Contact). In 
order to contact a family caregiver, the person who was the ED patient will need to be called by 
telephone first, If the patient gives any indication of not wanting research staff to call their family 
member or emergency contact, research staff will not attempt to call that person and the patent 
and care partner will no longer be eligible to participate. A recruiter will attempt to contact the 
patient within 48 hours of their discharge from the ED to assess willingness to participate and 
our interest in contacting the designated care partner. When a Mini-Cog cannot be administered 
in person, the study team member will contact a Care Partner (if no refusal by the patient to do 
this) and will conduct the IQCODE with that care partner.  After assessment for eligibility, 
informed consent will be obtained over the phone.  

 
Randomization: A web-based randomization scheme will be used to randomize participants to 
intervention or usual care groups in blocks of four or six stratified by: site (NYU or 
IU), English or Spanish speaking, whether the care partner lives with the CR, and Mini-CogTM 
score less than or equal to 3 (or IQCODE of >3.4).  
. We assume a positive IQ-CODE score (>3.4) with an inability to complete a Mini- CogTM is 
equivalent to a Mini-CogTM score of 0. 
 
Initial assessment phase: The POISED care management team consisting of specially-trained 
nurses functioning as care managers (CMs) and para-professionals in the role of care manager 
assistants (CMAs) will conduct a biopsychosocial/environmental needs assessment by phone 
within 48 hours of emergency room discharge if not possible during the ED stay. These team 
members are clinical professionals delivering a clinical service. They are not research staff or 
delivering experimental procedures. This assessment includes a demographic and psychosocial 
interview focused on achieving problem identification. The program uses standardized 
assessment tools including “Managing Your Loved One’s Health” (MYLOHTM) for chronic 
disease management22 and BEHAVE 5+ to identify problem behaviors common in advancing 
dementia that have been associated with caregiver strain, challenges to caregiving at home and 
in long-term care. BEHAVE 5+ also identifies proven behaviors common in prescribing of 
psychotropic medications to people with dementia.23 (See Appendix 3) If the consented CG is 
not available, we will attempt to complete the CG questions at a later date either by phone or in 
person.  
 
Root Cause Analysis: Starting with the ED visit and working backwards in time, the team will 
explore and identify problems or branch-point situations that progressed to the need for ED 
care. Using a logic tree as a cause and effect approach to create a timeline of events leading to 
ED visit24,25 and asking the question, “how could this occur?” or “why” based on the “Five-Whys” 
strategy,26 the CM team will ask “why” for each successive answer, starting with “why did you 
come to the ED.” Answers will be applied to medical record review looking for other possible 
triggers and opportunities for intervention. This brainstorming/investigative process to improve 
quality is also deployed by patient safety teams investigating adverse events. 
 
Usual Care Group: The comparison group, those randomized to usual care (UC), will receive 
referrals to services at the time of enrollment. The usual care group will not receive the POISED 
structured assessment, attention to chronic disease management, or RCA related to the ED 
visit. Similar to intervention group, we will provide UC patients with a laminated card showing 
the Stress ThermometerTM 23 (Appendix 5) for use in follow-up interview assessments.  
 
Specific Aim 1 Measures – Emergency Department (ED) Use: We will obtain consent from 
patients to enable review of their medical records. We will identify all ED visits for the year prior 
to the index ED visit/study enrollment and for one year after enrollment. We will also search all-
payer databases (APD) New York and the Indiana State Network for Patient Care to identify any 
episode of ambulatory or acute care that occurred within the 6 months of enrollment (6-month 
intervention and 6-month follow-up) and the 12 months prior to enrollment. Using the Care 
Recipient medical records, we will determine any prior diagnoses of dementia. We will also use 
the Care Recipient’s medical records to determine comorbidity and root cause for ED use.  
 
A one-item survey question will identify any additional visits that might have occurred outside 
the indicated state regions. For descriptive purposes, ICD discharge diagnoses will be included 
for any ED use. We will structure continuous variables that describe the number of ambulatory 
and/or acute care episodes. 

 
Aim 2: Develop a collaborative care plan with the interventional group and schedule 
follow up testing to assess whether the 6-month POISED intervention will improve family 
caregiver “activation” in managing the health care of care recipients compared with post-
ED care without POISED at 3 and 6 months. 
 
Strategy: The POISED care management team consisting of specially-trained nurses 
functioning as care managers (CMs) and para-professionals in the role of care manager 
assistants (CMAs) will work to create an individualized care plan through the lens of cognitive 
impairment with an emphasis on coordinating care with the patient’s primary care provider 
(PCP) and achieving relevance with the goals and capacity of the family CG and CR. 
 
First Follow up Visit: After review of all findings from prior data and the first encounter, the CM 
and CMA create an initial plan and identify areas needing further assessment at the first home 
visit (within 2 weeks after enrollment). That visit enables the CM team to conduct some 
additional cognitive and functional testing while the RN uses the time to address more sensitive 
issues that the CG may be uncomfortable discussing in the presence of the CR. The results of 
this initial assessment and home visit are forwarded to the CR’s PCP with requested feedback 
and further direction as needed 
 
Collaborative Care Plan Development Phase: After the initial assessment is completed by the 
POISED care management team, any urgent issues are addressed, and consulting with the 
program geriatrician (Dr. Chodosh at NYU and Dr. Boustani at Indiana University) and the PCP 
as needed, the CM rules in or out the diagnosis of dementia and its subtypes. The CM team 
maps out a proposed care plan and schedules a second home visit. 
 
During the second home visit, the CM team reviews the identified problem list and seeks input 
from the CR and CG on this list and prioritizing those problems, issues or topics felt most 
important to be addressed first. From this consensus, the CM discusses a proposed plan of care 
and tailors interventions to the patients, and then explains the diagnosis, natural history, and the 
prognosis of dementia; implements care protocols; reviews, explains, and distributes 
corresponding educational handouts for the dyad; and connects patients and family CGs to in-
home services and community resources as needed. 
 
Specific Aim 2 Measures – CG Activation in Health Care Management of CR: After 
consenting the CG, we will measure caregiver activation, a multi-dimensional construct 
developed by Borson and colleagues that includes CG knowledge, skills, and confidence to 
manage a range of tasks and tackle challenges common to dementia health care 
management.27 Domains include recognizing, anticipating, and managing day-to-day symptoms 
and challenges for CR health; managing CR medications; recognizing and managing sudden 
changes in CR health; accessing health services and advocating for the CR in the health care 
space; and managing CG self-care. Four-level item responses range from “agree completely” to 
“disagree completely” with an additional option, “not my job”. We will use the total score to 
measure activation. 
 
Aim 3: Test whether POISED will improve caregiver psychosocial outcomes compared to 
post-ED care without POISED at 3 and 6 months. 
 
Strategy: Follow-up regularly in a scheduled manner with resources and interventions to 
continue supporting CG and CR 
 

The follow-up phase: During the follow-up phase, the POISED care management team 
(primarily the CMA) will continue to interact with the CG and CR either face-to face at their 
home, through video, telephone, email, fax, or mail. The minimum amount of CMA contact 
during this time will be by telephone and will be weekly for the first month, twice monthly calls 
during the second and third months, and monthly calls for the following 3 months. 
 
Interaction intensity will be dictated by presenting needs and circumstances. During these 
interactions, the CM or CMA will answer any questions generated from previous visits; collect 
CR and family CG feedback; have the family CG complete a brief assessment to identify need 
for specific care protocols; and facilitate family CGs’ participation in an array of community 
services that are already available in either the New York or Indianapolis areas. The CM (nurse) 
will reconcile medications and review medication adherence at the initial and second home visit. 
Medication questions will be referred to the study pharmacist.  
 
Throughout the duration of the follow-up phase, the team will continue to work with the CG/CR 
and the patient’s primary care provider to monitor, implement, and adjust the individualized care 
plan as needed. Both NYU and IU have significant caregiver support resources, such as CG 
support groups, respite care, and individual telephone counseling support. The programs benefit 
from already developed field-tested services from prior work by both Chodosh and Boustani 
(and in clinical application by Borson and Connor). Specific POISED features are highlighted 
here and included in Appendix 4 
 
Specific Aim 3 Measures – Psychosocial States as Important Predisposing and Time-
Varying Enabling and Need Characteristics: These include CG depression, anxiety, 
experience of social support, and stress. We will use the Patient Health Questionnaire–9 (PHQ-
9)28-30 and Generalized Anxiety Disorder Scale (GAD-7)31,32  to determine the impact of the 
POISED intervention on CGs’ mood and anxiety at baseline, 3 months, and 6 months.  
 
Experience of social support will be measured using the Medical Outcomes (MOS) Social 
Support Survey — Abbreviated.33 This is a four-item survey measure that uses a five-point Likert 
scale. Respondents are asked how often each kind of support is available if needed. The Stress 
ThermometerTM23 a visual thermometer with a five-level analogue scale to indicate the level 
stress chosen by the CG, will measure CG stress. Every enrolled CG will be given a laminated 
card with the stress thermometer at the time of ED discharge to use during interviews.  
 
We will use the HABC-monitor to adjust for dementia symptom severity.34 The HABC-Monitor is 
a CG survey tool for monitoring three CR symptom domains (cognitive, functional, and 
behavioral/psychological) and a CG quality of life measure.  
 
PROTECTION OF HUMAN SUBJECTS 
 
Risk to Subjects 
Patients with cognitive impairment / likely dementia and their family / informal caregivers are a 
vulnerable group; however, the procedures employed in this clinical trial are low risk and have 
been successfully employed without incident in a number of other studies by this research team 
as well as by other investigative teams. In some parts of the country, dementia care 
management is a standard of care practice. The procedures are non-experimental but have 
never been tested in an ED-based population as the point of entry. This study poses minimal 
risk to subjects, since the study does not involve tests or treatments beyond that which they 
would normally receive as part of their normal care. 
 

Care management programs are now considered non-experimental. However it is not known 
whether using the ED as the point of initiation will cause any undue stress or burden to the 
families or caregivers. Research coordinators will be trained in order to minimize any 
foreseeable risk. 
 
Recruitment, Consent and Assent 
Cognitive assessment is a usual care procedure for these emergency departments as part of 
the evaluation of patients 75 years and older who present to their emergency department. 
Eligible caregivers provide care for patients to be discharged home who perform poorly on the 
screening assessment defined by specific cut-points as abnormal (MiniCogTM < 3). If the patient 
is unable to be assessed but identified by the caregiver as having impairment consistent with 
likely dementia (IQCODE > 3.4)  the caregiver will be considered eligible (see 
inclusion/exclusion criteria above, see page 3). 
 
The first stage of recruitment and consent is to determine the eligibility of the caregiver. The 
caregivers of the eligible patients are considered for study recruitment and the caregivers will be 
approached in the ED or by phone (if Phone Recruitment in effect) and offered research 
participation. Only caregivers of those patients scheduled to be discharged home will be 
considered eligible for participation. If a caregiver is not present in the ED and a patient provides 
permission to contact that person, we will conduct consent procedures by telephone. 
 
The second stage of recruitment and consent is consent of the Care Recipient for access to 
health records. After it is determined that the Care Recipient has an eligible Caregiver, the Care 
Recipient will be approached regarding allowing the research team access to their medical 
records. Capacity is determined for the CR for consent using a common sense procedure. This 
is possible because the request in question  is easy to understand  procedure (collecting 
information from the health record). We anticipate that most will demonstrate capacity to decide 
regarding use of their medical records. For those who do not, we will use a proxy consent –the 
caregiver if that person is next of kin (defined based on hierarchy: spouse, child, sibling, nephew 
or niece) in the absence of a DPOA for healthcare or by consenting the proxy who is DPOA but 
not present, which again will require discussion of the consent process via telephone using an 
IRB approved script and mailing the original consent for to be signed or returned via mail, fax, or 
SendSafe email procedure for e-consentIf the care recipient does not want us to use his/her 
medical records we will of course not do so and for those subjects, and this will be missing data. 
This is a minimal risk study with a chart review being completed 6 months later; we will not 
require capacity to be reassessed at the end of the 6 months. We request consent at the 
beginning of the study because this is an element of the research protocol and both caregivers 
and care recipients need to be aware and agree with participating given this approach. Loss of 
capacity after giving permission does not negate this consent and require a new consent 
procedure but a caregiver (legal healthcare proxy) under these circumstances, can override the 
consent at any point in the study if in the future, the proxy does not want us to have access to 
the chart at the end of 6 months. The Care Recipient, as the consenting individual, can also 
always rescind their earlier consent. Please note that at the time of capacity assessment, the 
only clinical information that we have on this patient is that they have performed below a pre-
specified cut point on a simple 2 minute cognitive screening test. This result neither indicates a 
definitive diagnosis of dementia, nor any level of severity of cognitive impairment.   
 
The third stage of consent is for participation in care management or usual care and 
randomization into one of two treatment arms – receipt of the Program of Intensive Support in 
Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP) 
or usual care. The Caregiver can be included regardless of CR health record consent. 

Randomization will occur after completion of the baseline interview. Here, the caregiver will 
consent for himself or herself. Capacity will be determined for the Caregiver. For the care 
recipient, we will use an assent procedure, in which the Care Recipient has authority to decline 
participation on behalf of the Caregiver.  
 
Vulnerable Populations 
Care Recipient: The study will involve caregivers of patients with cognitive impairment and the 
healthcare data of those with cognitive impairment. The risk for care recipients are minimal due 
to the nature of their part of the study, which is limited to a chart review. To protect individuals 
with cognitive impairment, the research assistant will require consent from the caregiver and will 
assent the care recipient for the participation of their Caregiver in a care management program, 
and care recipient consent for health record access. If the care recipient refuses participation 
through any form of rejection, then that dyad will not be considered for the study. Care 
recipients subjects in this study insofar as they have given the research team permission to 
access their health records. Because we are working with family caregivers, care recipients may 
or may not be indirectly involved with the clinical support given to caregivers. Although we have 
never been required to involve the care recipients in consent procedures for the purpose of 
involving the caregivers as participants in other similar funded trials, we are offering (out of 
respect to these individuals) the opportunity to have them decline our involvement with their 
caregiver even if the caregiver wants to participate. However, because we are collecting 
information from their chart, a consent procedure will be necessary for this small component. 
The Care Recipient will have the right to decline participation on the part of their family caregiver 
even if they do not have capacity to do so.  Moreover, they can decline participation at any time 
during the study duration and we will no longer include that caregiver in our research 
procedures or use their data. This approach is in keeping with our commitment to ensuring the 
highest level of respect for these individuals. 
If the caregiver does not have the capacity to consent, we will not enroll that dyad. Please see 
the approach to addressing capacity to consent in the evaluation consent form and in additional 
text below (“Subject Capacity”). Protection of vulnerable subjects includes utilizing highly-trained 
RAs who will be available to answer all questions and who will provide written materials that are 
at a 6th grade reading level. Assessment of capacity is a common-sense procedure that does 
not require professional level expertise. This is a minimal-risk study and the approach, as 
articulated in the “evaluation to sign consent” form, is a well-worn procedure used in countless 
studies where some subjects may have some degree of cognitive impairment. Several studies 
of subjects even with early to moderate Alzheimer’s disease have demonstrated the 
appropriateness and validity of this approach and for many, their capacity to decide about 
research participation. We do not anticipate significant levels of cognitive impairment among 
caregivers given their caregiving roles. Capacity determination is conducted by research 
assistants who will be trained in this approach as we have done in several other IRB-approved 
studies.  
 
Protection Against Risk 
 
We will obtain all data by computerized assisted interview instruments (CATI) that enable all 
answers (data) to be stored in electronic files. These files are physically separate from any 
identifiable data. These data will be kept on password-protected encrypted servers stored and 
protected under the supervision of NYU DataCore staff until transferred to the study statistician 
at Indiana University. Data transfer will be done through encrypted password protected discs 
with a unique linking ID kept by the study team in locked files and used later for analytic 
assignment of the randomization status. In the event that NYU has completed its plans for an 

information portal that enables direct data acquisition within a secure encrypted environment, 
we will amend our IRB application accordingly and request that this on-line system be utilized. 
 
Data collected by care managers at both NYU and IU sites and in subjects’ homes is specific to 
the care management and not the research study per se. Nonetheless, care managers (who are 
also research credentialed) will protect these data (clinical information) on encrypted, password 
protected tablet computers using encrypted files. Care management data will be downloaded to 
site servers on a weekly basis. 
 
All electronic data will be entered into and stored on a secure NYU School of Medicine server 
that will be accessible only by IRB approved study personnel. The secure server is maintained 
by NYU Medical Center’s IT department and protected by the Medical Center firewall. Hard 
copy data will be double-locked and accessible only to the PI and research assistants. Only 
group-level information without personal identifiers will be included when presenting results or 
submitting manuscripts for publication. 
 
Potential Benefits to Subjects 
We anticipate that participants will receive some benefit  either from dementia care 
management or usual care.  Subjects in either arm will be offered social services and facilitated 
access to receipt of services. Subjects in either arm will have greater opportunity to receive 
additional evaluation for their care recipient by being provided with clear referral information. 
Caregivers (subjects) are often isolated and suffer from loneliness and partipating in this study 
will mitigate that isolation to greater or lesser degrees. Therefore, we anticipate that all 
participants will receive some potential benefit regardless of the arm into which they are 
randomized. All subjects will be offered referral for diagnostic assessment regardless of 
treatment assignment and the ED assessments will be sent to primary care physicians. 
 
Process of Consent 
Potential subjects will be identified from the ED on the basis of the cognitive state of the ED 
patient. Family caregivers will be identified and approached in the ED and if not present, will be 
contacted by phone and offered participation in the study. Caregivers and/or care recipients who 
are in the ED will only be approached only after giving permission to ED staff who will alert the 
research assistant of a potential caregiver-care recipient. Should phone recruitment be in effect, 
the family caregiver will be identified through the EMR or via patient and will complete the 
IQCODE to determine eligibility. Should the family caregiver screen into the study via IQCODE, 
they will be offered participation in the study. 
 
Trained Research Associates (RAs) will approach caregivers presenting to the Emergency 
Department with eligibility criteria. The RAs will also provide the caregiver and care recipient 
with the consent form that contains all pertinent study and contact information, and will describe 
the nature of the study to the dyad. The care recipient will be asked to explain their 
understanding that we will be accessing their medical records to obtain data through the 
Evaluation to sign consent (ESC) form, and then verbally consented to participate. Because this 
is a simple procedure to understand, we anticipate that most will demonstrate capacity. For 
those who do not, we will use a proxy consent – typically the caregiver if that person is next of 
kin (defined based on hierarchy: spouse, child, sibling, nephew or niece) in the absence of a 
DPOA for healthcare or by consenting the proxy who is DPOA but not present, which will 
require telephone and waiver of written consent. This will require telephone verbal consent with 
waiver of written documentation of consent, as well as written authorization submitted via mail 

or fax. If the care recipient does not want us to use his/her medical records we will of course not 
do so and for those subjects, and this will be missing data.  
The caregiver will be asked to summarize the study, using the Evaluation Signed Consent 
(ESC) form, and consent to participate. The RAs will determine if the caregiver understands the 
study and that participation is voluntary and will not affect the care the Care Recipient receives 
in the Emergency Department. 
This procedure for both the Care Recipient and Care Partner will be completed by phone when 
recruitment is not permitted in person (Phone Recruitment Protocol). 
 
In the case that in-person documentation is limited, (for example, when all contact is made over 
phone) an e-consent process will be in effect. In this process, the research staff will complete 
the same verbal informed consent process with CG and CR. If informed consent is obtained, the 
research staff will e-sign the PDF or Word document to indicate that informed consent was 
obtained. The research staff will offer the CG and CR to receive a copy of their signed consent 
form by mail or via SendSafe email.  
 
Family CGs will receive the care management. CGs are research subjects and will therefore be 
consented. Permission to use healthcare data (See Emergency Department Patient Assent 
Form) will be obtained from care recipients through a consent process. The Caregiver may 
participate regardless of the Care Recipients ability to consent, Therefore the Care Recipient 
will be assented regarding the participation of the Caregiver in the study. The care recipient will 
be assented even if the care recipient does not appear to understand our request. If the care 
recipient refuses through any form of rejection, then that individual does not assent to the study. 
We will thank both individuals for their time and remove them from eligibility as research 
subjects. This process is an approach we have used for over 15 years of dementia caregiver 
human subject research. 
 
Caregiver consent covers participation in four evaluation survey/interviews and agreement to be 
randomly assigned to receive care management (POISED) or continue with care as usual.  
The baseline survey will be either in person or by telephone for both the IU and NYU EDs, 
depending upon the availability of the caregiver. We will conduct subsequent 3 and 6 month 
research interviews by telephone. Only caregiver names, telephone numbers, and addresses 
without other identifying data will be provided to the interviewer in a secure manner using 
encrypted password protected files. 
 
Subject Capacity 
After going through the consent process with the caregiver and care recipient, we will determine  
capacity. The RA will ask the following questions: 
 
 
Capacity Assesment for CG 
“We have just reviewed what it means to participate in this study.  I am going to ask you a few 
questions just to make sure you understand what we will be doing once we begin.  
 
1. What would you be doing if you agree to take part in this study?  (Examples of 
acceptable answers: “Take part in an interview/survey,” or “Answer questions about 
hearing.”)  
 

oPerson is able to answer this   
 
oPersonisnotabletoanswerthis 
 
 
2. What can you do or ask me to do if you are uncomfortable with a particular question in 
the survey? (Examples of acceptable answers: “Ask to skip the question.”  “Ask you to 
read another question.”)    
 
o Person is able to answer this 
 
oPersonisnotabletoanswerthis 
 
 
3. What can you do if you decide after we start that you do not want to participate in the 
study?  (Examples of acceptable answers: “Tell you that I do not want to answer any 
more questions.”)   
 
oPerson is able to answer this 
 
oPersonisnotabletoanswerthis 
 
Capacity Assesment for CR 
“We have just reviewed what it means to take part in this study.  I am going to ask you a few 
questions just to make sure you understand.  
 
1. What will the researchers be doing if you agree to take part in this study?  (Examples of 
acceptable answers: “Taking information from my medical record,” or “Going into my 
records.”)  
 
oPerson is able to answer this   
 
oPersonisnotabletoanswerthis 
 
 
2. What can you do or ask me to do if you are uncomfortable being a subject in the study? 
(Examples of acceptable answers: “Ask to leave the study.”  “Ask to speak to the 
principal investigator”)    
 
o Person is able to answer this 
 
oPersonisnotabletoanswerthis 
 
 
3. What can you do if you decide after we start that you do not want to participate in the 
study?  (Examples of acceptable answers: “Tell you that I do not want to be in the 
study.” Or “Tell you to delete my information from the study.”)   
 
oPerson is able to answer this 
 
oPersonisnotabletoanswerthis 
 
 
Subject/Representative Comprehension 
Caregivers themselves may have cognitive impairment. To determine that the subject/subject’s 
authorized representative understood the information presented, the investigator will ensure the 
representative has a factual understanding of information presented to them assessed through 
the Evaluation to Sign Consent (ESC) described above. If the legally authorized representative 
is determined by the investigator to have the decisional capacity to consent the patient, he/she 

will be able to consent that patient. However, if the representative is not deemed to have the 
capacity to consent the patient the patient will be excluded from enrollment in this study. 
Documentation of Consent 
Documentation of consent will be obtained through the consent form. Otherwise if consent is 
obtained verbally, written documentation of consent will be waived. 
 
Costs to the Subject 
There are no expected costs to subjects related to the study.  
 
Payment for Participation 
Caregivers will receive a $40 gift card by mail as payment for their time and effort in completing 
interviews at 0, 3, and 6 months. 
 
Data Collection and Documentation  
Data will come from three sources. First, the web-based tracking system contains data entered 
by the POISED care management team. The care management team documents the initial and 
follow-up visits using RedCap. The CM team focuses on problem clarification and reviews the 
assessment findings, the medical record, medication lists, ED discharge plans and pharmacist 
consultation. These data will provide us with extensive information on the process and content 
of care for those randomized to POISED. This system is specifically designed to support and 
monitor clinical care and was used in prior clinical trials. We will add fields that support the care 
processes of the POISED intervention, including the results of assessment instruments, the 
content of the tailored intervention, and clinical observations such as dyads’ level of 
participation.  
 
Second, we will obtain data on health services use including all diagnostic testing and 
medication use and use of inpatient and outpatient services from 1 year prior to study 
enrollment to 1 year after enrollment (2-year duration) from NYU’s EPIC system and the Indiana 
Network for Patient Care (INPC). Data are obtained from the electronic medical record by a 
team of data managers employed by NYU (DataCore) and Regenstrief Institute in support of 
clinical research, including demographic information and date of birth..  
 
Third, primary outcome measures will come from telephone interviews and will be entered in 
REDCap.35 A research assistant interviewer will collect complete telephone survey data from 
CGs at baseline, 3 months and 6 months using a 30-minute survey (Appendix 3). Some 
baseline CG interviews will be conducted in person at both sites, depending on CG availability 
prior to CR discharge. The RA will enter de-identified survey data from each survey wave into a 
HIPAA-compliant REDCap electronic database hosted at NYU.  REDCap baseline data will be 
electronically linked to care manager software so that specific relevant data fields can populate 
the POISED RN care manager pre-visit data and limit redundancy in questions and CG 
interview burden. DataCore—a resource launched by the NYU Langone Medical Center 
(NYULMC), housed within the NYULMC IT Department and formed in collaboration with the 
Clinical and Translational Science Institute (CTSI), the Biomedical Informatics and Translational 
Library Programs, and the Department of Population Health—will provide enterprise level 
support to ensure the integrity of electronic data during its capture, storage, management, 
extraction, and sharing. DataCore will merge these three data streams using unique identifiers 
assigned to the study participants and provide regular backups onto a secure server.  
 
Data and Safety Monitoring Plan: 

Our study team will monitor all adverse events and accumulated study data through weekly 
meetings to review enrollment progress and identify any adverse events. We will evaluate any 
adverse effects related to recruitment, enrollment, interview process and the care management 
intervention (including the possible issues of severe caregiver depression and unsafe home 
situations). Adverse events will be reported to the study IRBs and will include any medical event 
regardless of its relationship to the study intervention. All such events will be recorded but 
blinded (where possible) except for the IRB who will be unblinded and notified immediately of 
any serious and unexpected event. In such instances, the IRB will determine appropriate action 
with respect to reporting and additional steps. For more urgent situations, the study interviewer 
or the Care Management team may contact any of the physician investigators on the team for 
urgent medical decisions or contact 911 in the case of an inhome emergency. Any adverse 
event will be reported to the IRB within 72 hours, which includes Caregiver or Care Recipient 
hospital admission, death or Care Recipient Emergency Department revisit. As is required by 
the IRB, the research team will submit an annual report for the data safety monitoring with 
continuing review. 
 
Statistical Plan  
We will compare randomization results to the pre-planned schedule, to ensure randomization 
integrity. To verify the comparability of the randomized groups, we will compare dyads to identify 
differences between their baseline characteristics (age, gender, race, education), CR comorbid 
medical conditions, and the Charlson comorbidity index. We will also look for differences in the 
number of primary care visits and acute care use during the year prior to enrollment between 
POISED and the usual care group by using analysis of covariance (ANCOVA) models for 
continuous variables and the Cochran-Mantel-Hansel statistic for categorical variables. We will 
control for stratification variables: recruitment site (NYU or IU), English vs Spanish (at NYU site), 
living arrangement (CG lives with CR or not), and cognitive status (Mini-CogTM score of a 3 or 
less). A cutoff of 0 or 1 is more strongly associated with functional disability than a cutoff of 3. 
Subjects requiring the IQ-CODE with scores >3.4 will be included with those with MiniCogTM 
scores =0 to reflect greater impairment for those who cannot complete the Mini-CogTM. We will 
examine the distributions of continuous variables and use transformation or nonparametric 
methods in cases of violation to the normal distribution assumption. We will also examine the 
frequency distribution of all categorical variables and use exact inference procedures in cases of 
zero or small cell size. We will use SAS 9.4 (SAS Institute, Carey, North Carolina) for all 
analyses. 
 
Specific Aim 1: We will use logistic regression models to compare the rates of ED admissions 
during the 6-month intervention period following the index (recruitment) ED visit. ED 
readmission within 6 months will be used as a binary outcome in the logistic model and 
randomization group will be the independent variable while adjusting for all stratifying variables 
including site, language, living arrangement and CR cognitive status. Baseline characteristics 
that are shown to be unbalanced in univariate comparisons between the two groups will also be 
adjusted.  
 
Specific Aim 2: We will use mixed effects models with CG activation scores at 3 months and 6 
months as the outcome measure and randomization group as the independent variable while 
controlling for baseline activation score and stratification variables (site, language, living 
arrangement and CRs’ cognitive status). We will conduct post-hoc comparisons of the activation 
scores between the POISED group and the usual care group at 3 and 6 months using linear 
contrast from the mixed effects model following a significant group effect. To explore what 
changes are responsive to the POISED intervention, we will also use the mixed effects model to 
examine differences in activation domain scores between the two groups. The mixed effects 

model will account for potential correlations between repeated measures from the same 
individual and deal with missing data appropriately when the probability of missing data is 
unrelated to the missing observation.  
 
Specific Aim 3: We will use mixed effects models with repeatedly measured PHQ-9, GAD-7 and 
MOS social support scores collected at 3 and 6 months as dependent variables. The 
independent variable for the mixed effects model will be the indicator variable for the 
randomization group while controlling for baseline scores and stratification variables. We will 
use post-hoc analysis to determine group differences in these measures between the two 
groups at the 3- or 6-month evaluations. The modeling approach resembles that for Aim 2. 
 
Sensitivity analysis for missing data: The analysis plan outlined above assumes that outcome 
measures at follow up are missing at random with respect to demographic characteristics and 
baseline results. We will compare baseline characteristics of subjects with missing outcomes 
due to death or withdrawal to detect potential violation of the missing-at-random assumption. 
Further sensitivity analyses will involve various imputation methods or a full parametric 
likelihood approach that assumes various patterns of missing data86.  
 
Sample Size and Power Consideration: Sample size for the proposed study is estimated for 
achieving 80% power in reducing acute care use in the POISED group compared with the usual 
care group in Specific Aim 1. A previous study had reported a 30-day readmission rate of 58% 
in dementia patients as compared to 38% in those without dementia. Given that our patient 
sample may include less severe cognitive impairment with less ED use, we assume, 
conservatively, that the rate of ED visits in the usual care group is 40%. With 320 patients 
enrolled per group, we will have 82% power to detect an odds ratio of 0.62 for repeat ED visits 
in the POISED group compared to the usual care group at the 0.05 significance level. This 
detectable odds ratio is equivalent to reducing the ED visit rate to 29% or lower in the POISED 
group compared with the 40% assumed for the control group. The use of stratified 
randomization ensures that patients in the intervention and control groups are similar on the 
stratification variables, thus reducing the variance of the difference between the two group 
means and resulting in greater power than simple randomization. Therefore, actual power for 
our study will be higher than projected here. Since we will be using EMR for acute care data and 
phone follow-up to supplement out of network use, we anticipate complete data from all study 
participants for this aim.  
  
For Aims 2 and 3, assuming that 205 (64%) dyads will complete the 6-month evaluation (see 
Figure 2), we will have 80% power to detect an effect size of 0.28 or greater on the CG 
activation score, PHS-9, GAD-7 and MOS scores between POISED group and the control group 
using a two-sample t-test at the 0.05 significance level. The detectable effect size of 0.28 used 
in our power estimation is reasonable and justified given that previous studies on collaborative 
care management of dementia patients have shown an effect size of 0.45 SD on a number of 
caregiver psychosocial outcomes. Our previous studies have found a mean PHQ-9 score of 4.4 
(SD=5.6), and a mean GAD-7 score of 3.2 (SD=3.5). Thus our projected effect size will allow us 
to detect a change as small as 1.6 on the PHQ-9 and 1 on the GAD-7. As described above, the 
use of stratified randomization will provide greater power than those projected here. 
 
 
 

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Appendices: 
1) List of variables 
2) Chronic Management Guide Example 
3) Research Survey 
4) Poised Detailed Care Management Strategies 
Appendix 1: Data Variables 
 

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Appendix 2: 
POISED intervention Chronic Disease-Specific Care Management 
Guides: Dementia and Diabetes  
 
CARE MANAGEMENT MATTERS  
 
The basics:  
Following a prescribed diet plan, monitoring blood sugar regularly, using medications correctly, 
keeping a daily log, recognizing when diabetes is getting out of control, and keeping 
communication open with the medical team to respond to problems – all are important for 
successful management of diabetes. Team-based care management can help assure that 
caregivers have the support they need to accomplish these tasks. Care managers can also spot 
trends that indicate that a problem may require caregiver coaching, or more intensive medical 
care.  
 
Know how dementia affects diabetes:  
• 
People with dementia may have problems with eating and drinking properly, and this can 
make diabetes harder to control. Problems can include under-eating, overeating, eating 
too few different foods, eating things that are not foods, and refusing to eat or drink 
fluids.  
• 
Dementia may alter activity (exercise) patterns – higher or lower levels of activity may 
occur and can affect diabetes management.  
• 
People with dementia need help managing medications. When dementia is mild, 
sometimes it’s enough for a family member to watch over a loved one’s self care, or help 
organize a schedule and make sure the log is completed accurately to monitor food, 
fluids, testing, and medications. Caregivers need to look for warning signs that more 
help is needed – since most people with any level of dementia benefit from more active 
help from family caregivers. In many cases caregivers will need to take over all aspects 
of diabetes care, and some will need coaching to assure that the person with dementia 
allows this transition to happen.  
 
Understand how diabetes affects dementia:  
Big fluctuations in blood sugar – either too high or too low – cause people with dementia to have 
more trouble with confusion and erratic behavior, and reduce their ability to function. Long 
periods of poor control of blood sugar can lead to long-term, permanent worsening in brain 
function. Assuring good control of diabetes gives people the best chance to live well with 
dementia and diabetes.  
 
Make and monitor a plan for everyday home care and caregiver coaching:  
MANAGING FOOD AND FLUID INTAKE  
• 
Know the individual’s prescribed diet. Identify and problem solve any specific difficulties 
patients and caregivers have in understanding or following it.  
• 
Record food and fluid intake on a log. This helps avoid blood sugar that is too low 
(hypoglycemia) or too high (hyperglycemia).  
• 
Record weight on a log, and note trends over time.  
 
TESTING BLOOD SUGAR AND GIVING MEDICATIONS  
• 
Know how to use the blood sugar meter and the blood sugar log (‘daily glucose tracker’).  
• 
Know how often to test and record blood sugar levels.  

• 
Know when and how to adjust medication (if home adjustments are prescribed by the 
doctor).  
• 
Take time to prepare the person with dementia before each test and each time 
medication is to be given – don’t assume he remembers why this is important or 
what is happening.  
• 
Identify caregivers who need coaching with any of these steps. Some caregivers 
may have trouble learning what to do, keeping on track, or approaching the person 
with dementia in a way that ensures cooperation.  
 
Red flags:  
• Blood sugar readings below 80 mg/dl  
• Sweating and shakiness (early warnings of hypoglycemia)  
• Weight loss or gain of 5 or more pounds  
 
People with dementia may not notice or tell you about these symptoms.  
 
Tips for smarter caregiving:  
Giving medication:  
• 
People with dementia may forget to take their medication.  
• 
They are also at risk of taking too much medication because they forgot they already did. 
Medication boxes (MediSets) and blister packs help for medications given by mouth.  
• 
Caregivers should use a log or calendar to check off when medications are given 
(caregivers get busy).  
• 
All medications and over-the-counter medications should be kept safely out of reach to 
reduce the chance of mistakes.  
• 
Some people with dementia may resist taking medications or have trouble swallowing. 
Ask the doctor about crushing the oral medication or disguising in food like pudding that 
the person will accept.  
• 
Insulin injections: easiest when the routine is the same as before cognitive impairment 
developed, as long as this is medically recommended.  
 
Exercise:  
• 
Provide a predictable, regular, and pleasurable routine for daily exercise and rest (for the 
caregiver too!).  
 
Eating and food preparation:  
• 
When feeding becomes a problem, break it down:  
• 
Is lighting adequate in the dining area?  
• 
Is it quiet or is light music helpful?  
• 
Is the type and amount of social interaction conducive to eating? Some people 
may prefer to eat alone.  
• 
Is the person distracted by conversation, TV or radio, noise in another room?  
• 
Is there enough time allowed to chew and swallow?  
• 
Are foods the proper size?  
▪ 
Chop foods small enough to grasp, chew and swallow.  
▪ 
Puree foods when whole foods are not possible to eat due to the inability 
to chew or lack of teeth.  
• 
People who put food in their mouths and forget to swallow may be cued by gently 
stroking the sides of their neck.  
 

• 
Caregivers should be taught the Heimlich maneuver to assist a choking person.  
• 
Foam handles on utensils can facilitate grasping.  
• 
For people who cannot use a spoon, a cup may be used to drink soup.  
• 
Rubberized placemats may help to keep the food plate from slipping  
• 
Are the food items distinguishable on a white or lightly colored plain plate. 
(People with dementia may not be able to distinguish food items from 
decorations embedded in the plate). A plain plate with dividers (as in a child’s 
plate) may be helpful by separating foods and providing a “wall” against which 
foods may be pushed.  
• 
Is the food at a reasonable temperature (not too hot or too cold)?  
• 
People with severe dementia may “forget” how to eat. These people may be able 
to be coaxed by “following the leader.”  
• 
Dental disease, gum inflammation or soreness, mal-fitting dentures may interfere 
with eating.  
• 
Visual impairment may impede eating. (Check that eye glasses are clean and in 
place)  
• 
Constipation or bladder fullness may cause diminished eating. 
▪ 
 Offer fluids every 2 hours; offer the bathroom an hour later.  
▪ 
Offer the bathroom ½ hour after eating a meal.  
▪ 
Acute refusal may indicate the need to defecate or void. Clues to this are 
resistance to sitting at the table or tugging at clothes.  
• 
Because of amnesia associated with dementia, people may forget they have just 
eaten and request more food.  
• 
Provide a standard and predictable routine for eating meals.  
• 
Food preparation is a process that may require too many steps for a person with 
dementia living alone. An intermittent caregiver can prepare foods that are easy to open 
and do not require preparation. Consider home-delivered meals that do not require 
refrigeration or heating.  
 
Working with the doctor:  
• Caregivers need to know when to contact the doctor. Schedule a conversation to get those 
questions answered. Provide caregivers with a card they can post in a prominent place, 
with red flags, warning signs, and information about when and whom to call.  
• 
Examples:  
o No bowel movement in 3-5 days signals a potential problem with constipation 
and should be brought to the attention of the doctor. Be sure to provide the food 
and intake log to the doctor.  
o If the person seems apathetic or sleepy, tell the doctor. Toxicity from too many 
medications or certain medications may lead to apathy or sedation. Bring the full 
up-to-date list of medications (including additional herbs and over-the-counter 
medications) to the doctor.  
 
• 
Have a plan that all caregivers know about, including part-time and intermittent 
caregivers.  
• 
Work with the doctor to simplify routines and medication plans.  
• 
For every doctor visit: Bring a written list of caregiver’s concerns, the full up-to-date list of 
medications (prescriptions, over the counter, supplements, and herbal medications) daily 
glucose tracker, and food and fluid intake and weight logs.  
 
 

Appendix 3:  
POISED Research Evaluation Survey 
POISED STUDY 
RESEARCH EVALUATION SURVEY 
SURVEY OVERVIEW 
Notes to IRB: 
The POISED Study research evaluation survey is the baseline evaluation survey that will be 
modified for follow-up surveys.  Text will be adjusted to orient the respondent to the follow-up 
survey time frames (3 months and 6 months). Also, demographic characteristic questions will 
not be repeated.]   
The study research assistant will administer the baseline survey either in person at the 
Emergency Department visit if is practical and feasible without disrupting patient care as 
delivered by ED and hospital staff, or at a time by telephone that is agreeable to the caregiver. 
The research assistant will administer the follow-up surveys by telephone. 
FOR TELEPHONE: 
• 
Hello, my name is [interviewer name] from the POISED study. May I speak with [Insert 
name of caregiver]?   
**Caregiver comes to telephone**  
• 
Hello, my name is [interviewer name]. I am from the POISED research study. You may 
remember that you spoke with me  
o when we did [the consent] or [the other survey about 3 months ago (if this is a 
follow-up survey)].  
• 
I am calling you as part of the evaluation of this research study.   
• 
Is it okay if we talk now? 
 INSTRUCTIONS TO INTERVIEWER:  
 If ‘No’, ask about another time that is more convenient. 
 If the person refuses to participate in the survey interview, thank the person. 
 If ‘Yes’, continue…→ 
• 
The program looks at ways to improve care for people with memory or thinking problems. 
The program is also for those family members or friends who provide help to the person 
with memory problems.  We refer to individuals who provide help as caregivers or care 

partners.  
  
• 
Your participation in the program and interview will help us understand how best to help 
people with memory loss. Your participation will also help us understand how to help 
caregivers or care partners. 
Introduce Survey: 
• 
The interview will take about 30 minutes to complete.  We will keep all of your answers 
confidential.  Participating in this telephone interview is completely voluntary.   
• 
If you feel uncomfortable answering specific questions, you can refuse to answer any or 
all questions.  You may stop the interview at any time and continue it later.  You may 
end the interview at any time and not continue.   
• 
At the end of this interview, we will mail you a $40 gift card for your time.   
• 
Your decision to participate does not in any way affect the health care that either you or 
[name of Care Recipient] receives.  None of the doctors that you or [name of Care 
Recipient] see will know whether or not you have participated in this survey.   
• 
Do you have any questions about the study or about your participation?”  
IF YES: RESPOND TO ALL QUESTIONS BEFORE PROCEEDING.  
Now I’m going to ask you a few questions to make this call as easy as possible. 
1a. Are you in a quiet and comfortable location?  
 Yes 
 No (wait for respondent) 
   1b. Am I speaking loudly and clearly enough for you to understand me? 
 Yes 
 No (go to 1c) 
1c. (INTERVIEWER SPEAKING LOUDER) is this better? 
 Yes 
 No (code Hearing Impaired)  
[If “No,” thank the subject and end the interview explaining that you cannot conduct the 
interview because of difficulty hearing on the telephone. Immediately Contact the 
Program Coordinator. If the interviewer thinks the difficulty hearing is because of a bad 
connection (due to cell phone) offer to call at another time.] 
May I start the interview? 
 No/Refused  
 
End Interview: Thanks very much for listening.  Goodbye. 

[REASON: 
_________________________________________________________________] 
GENERAL QUESTIONS 
 
First, I would like to start this interview by asking you some brief general questions 
about yourself. 
 
1. How old are you today?  _____ years old 
 
2. What is your gender?    
 Male       
 Female 
 
3. What is your race/ethnicity?  You may answer yes to more than one. 
  White         
  Black 
  Asian 
  Hispanic    
  Other 
 
4. What is your highest level of education?   
  Less than high school     
  Completed High school 
  Some college 
 
  College graduate+ 
 
5. What is your relationship to [name of Care Recipient], your Care Recipient? 
  Spouse     
  Child 
  Other relative  
  Friend/other 
 
6. How many years have you been his/her caregiver? _____ years 
 
7. What is your marital status? 
  Single/never married  
  Married 
  Divorced 
 
8. What are your current living arrangements? 
  Live with Care Recipient 
  Live in close proximity    How many miles? _____miles 
  Other (please specify: __________________________) 
 
9. How hard is it for you to pay for the very basics like food, housing, medical care, and heating? 
Would you say it is… 
  Very hard     
  Somewhat hard    
  Not hard at all  
 
Now I am going to ask you some questions about [insert name of Care Recipient], the 
person you care for.  
 
 
1. Where does he/she live? (ex. private home, assisted living, nursing home, other?) 
  Apartment/home/condo 
  Assisted living/ Board and Care 
  Nursing home 
  Other (please specify: __________________________) 
Financial Strain: Study of Women’s Health across the Nation (SWAN) and the 
Coronary Artery Risk Development in Young Adults (CARDIA) studies (see, for 
example, Hall et al. [2009] and Puterman et al. [2013]) 

 
 
 
2. Has [name of Care Recipient] ever received a diagnosis of dementia? 
 Yes      
 No 
 
3. If Yes,  
About what year did he/she receive that diagnosis?  ______   
Or, about how many years ago? ______ 
 
4. Has [insert name of Care Recipient] had a change in his/her primary care provider in the 
last year?   
 Yes      
 No 
 
5. Does [insert name of Care Recipient] have health care insurance?  
 Yes      
 No 
 
6. We have to ask for our study whether [insert name of Care Recipient] has a history of 
substance abuse, including alcohol?   
 Yes      
 No    
 Don’t know/refused 
 
7. Does he/she currently have a substance abuse problem?   
 Yes  
 No   
 Don’t know/refused 
 
8. Has [insert name of Care Recipient] received a diagnosis of any of the following conditions:  
  Depression    
  PTSD     
  Schizophrenia     
  Other  (please specify: ___________________) 
 
Now I will ask you a few questions about traveling. 
9. We have [insert name of Care Recipient] address as [Fill In]. Is this correct? 
 
10. What is the primary mode of transportation you use? 
  Personal car      
  Taxi 
  Train 
 
  Bus 
  Walk              
  Other  ( please specify: ________________________) 
 
11. Where do you go when you have to bring [insert name of Care Recipient] to see the 
doctor, meaning the doctor’s office or clinic (usual source of care – USC) ? Do you have 
the location or address?  ____________________________ 
 
12. Where do you usually go if you need to travel to the hospital or Emergency Department 
(ED)?  ____________________________ 
 
(For Calculating Miles and Difference in distance between ED vs. USC)  
 
 
 
 
 
 
 
 
 
 

 
Next, I want you to think about the last 12 MONTHS and the care you have provided to 
[insert name of Care Recipient].  It might help to get a calendar. 
 
NOTE: FOR FOLLOW-UP SURVEYS, REPLACE “12 MONTHS” WITH THE 
CORRESPONDING TIME FRAME SUCH AS 3 MONTHS, 6 MONTHS 
 
1. How many times did [insert name of Care Recipient], the person you care for, visit his/her 
Primary Care Provider or PCP) in the last year?  #____ times 
 
2. For each time, please indicate the primary reason for going to the PCP” 
 
2a. Was the visit for a new symptom or for a change in a 
       
 Yes    
 No  
symptom that [insert name of Care Recipient]’s had previously? 
 
2b. A fall or other injury?  
                          
 Yes      
 No    
 
2c. A symptom that has been present for more than the past     
 Yes      
 No    
month? 
 
 
2d. A medication refill?  
                          
 Yes      
 No 
 
2e. Other (please specify: ____________________________) 
 
3. Have you had any difficulty getting medication refills for [insert name of Care Recipient] 
 
Yes   
 No 
 
4. Over the past [insert time frame] has [care recipient name] had any new medical 
problems or illness? 
 Yes   
 No 
 
5. Over the past [insert time frame] has [insert name of Care Recipient] had any injuries? 
 
Yes   
 No 
 
6. How many times did he/she use the Emergency Department?  #____ times 
 
7. How many times did he/she stay in the hospital overnight or longer in the last year?   
#____ times 
7a. For each stay in the hospital, I want you to tell me, to the best of your knowledge, 
the month and number of days he/she was in the hospital? 
i. Stay number 1:  Month: _____.      #______days 
ii. Stay number 2:  Month: _____.      #______days 
iii. Stay number 3:  Month: _____.      #______days 
iv. Stay number 4:  Month: _____.      #______days 
v. Stay number 5:  Month: _____.      #______days 
vi. Stay number 6:  Month: _____.      #______days 
 
8. Over the past [insert time frame], has [name of CR] received help from the “In-Home 
Supportive Services” Program?  This program helps pay for services to help keep [name 
of CR] safely in [his/her] home.  Services include personal care and household tasks 
such as housecleaning, meal preparation, laundry, and grocery shopping.  
 Yes   
 No     
8a. If Yes, how many months?  _____   
 Acute use 
 Non-acute use 
 Non-acute use 

8b. How hours per week on average   ______ 
HCAHPS1 COMPONENT 
 
Using any number from 0 to 10, where 0 is the worst health care possible and 10 is the best 
health care possible, what number would you use to rate ___________________’s health care? 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
HABC-M2 COMPONENT 
 
Now I am going to ask you some questions about [insert name of Care recipient]’s memory, mood, 
behaviors, and day-to-day activity.  I will also ask questions about your overall health.  When 
answering these questions please keep in mind the following: 
1. Answer each questions based on your first reaction – evidence of actual change is not as important 
as your gut instinct. 
2. There are no formal definitions for the symptoms you are being asked to rate, although, in some 
cases, examples of the symptom are included. In general, whatever the term means to you in a 
reasonable and acceptable definition. 
3. Rate the frequency of the symptoms over the past two weeks using a scale of: 
a. Not at all (0‐1 day) 
b. Several days (2‐6 days) 
c. More than half the days (7‐11 days) 
d. Nearly every day (12 ‐14 days) 
4. First, how well do you know [insert name of Care Recipient]?  
  Not at all    
  Somewhat well                 
  Well           
  Very well 
 
Over the past two weeks, how often did [insert name of Care 
recipient] have problems with the following items:  
 
Not at all 
(0-1 Day) 
0 Points 
Several 
days 
(2-6 Days) 
1 point 
More than 
half the days 
(7-11 Days) 
2 points 
Almost 
daily 
(12-14 
days) 
 3 points 
Judgment or decision‐making 
 
 
 
 
Repeating the same things over and over such as questions or 
stories 
 
 
 
 

Forgetting the correct month or year 
 
 
 
 
Handling complicated financial affairs such as balancing 
checkbook, income taxes & paying bills 
 
 
 
 
Remembering  appointments 
 
 
 
 
Thinking or memory 
 
 
 
 
Learning how to use a tool, appliance, or gadget 
 
 
 
 
Planning, preparing, or serving meals 
 
 
 
 
Taking medications in the right dose at the right time 
 
 
 
 
Walking or physical ambulation 
 
 
 
 
Bathing 
 
 
 
 
Shopping for personal items like groceries 
 
 
 
 
Housework or household chores 
 
 
 
 
Leaving him/her alone 
 
 
 
 
His/her safety 
 
 
 
 
His/her quality of life 
 
 
 
 
Falling or tripping 
 
 
 
 
Less interest or pleasure in doing things, hobbies or activities 
 
 
 
 
Feeling down, depressed, or hopeless 
 
 
 
 
Being stubborn, agitated, aggressive or resistive to help from 
others 
 
 
 
 
Feeling anxious, nervous, tense, fearful or panic 
 
 
 
 
Believing others are stealing from them or planning to harm 
them 
 
 
 
 
Hearing voices, seeing things or talking to people who are not 
there 
 
 
 
 
Poor appetite or overeating 
 
 
 
 
Falling asleep, staying asleep, or sleeping too much 
 
 
 
 

Acting impulsively, without thinking through the consequences 
of her/his actions 
 
 
 
 
Wandering, pacing, or doing things repeatedly 
 
 
 
 
Over the past two weeks, how often did you have problems 
with: (Use √ to indicate your answer.) 
Not at all 
(0-1 Day) 
0 Points 
Several 
days 
(2-6 Days) 
1 point 
More than 
half the days 
(7-11 Days) 
2 points 
Almost 
daily 
(12-14 
days) 
3 points 
Your quality of life 
 
 
 
 
Your financial future 
 
 
 
 
Your mental health 
 
 
 
 
Your physical health 
 
 
 
 
 
Cognitive subscale: 
Functional subscale: 
Behavioral and mood subscale: 
Caregiver stress subscale: 
Total score: 
 
 
 
 
 

I would like to ask you some questions about how YOU, the care partner/caregiver, are 
managing with your own day-to-day activities.  Do you need assistance with any of the 
following? 
ACTIVITIES OF DAILY LIVING (ADLS)3 
 
Needs no 
help  
Needs 
some help  
Unable to 
do at all  
A. Bathing 
2 
1 
0 
B. Dressing 
2 
1 
0 
C. Toileting 
2 
1 
0 
D. Transferring, (use explanatory text as necessary: “Transferring 
means changing positions such as going from bed to standing, 
standing to sitting, 
2 
1 
0 
E. Continence 
2 
1 
0 
F. 
Feeding 
2 
1 
0 
 
INSTRUMENTAL ACTIVITIES OF DAILY LIVING (IADLS)3 
 
Needs no 
help  
Needs 
some help  
Unable to 
do at all  
G. Using the telephone 
2 
1 
0 
H. Getting to places beyond walking distance 
2 
1 
0 
I. 
Grocery shopping 
2 
1 
0 
J. 
Preparing meals 
2 
1 
0 
K. Doing housework or handyman work 
2 
1 
0 
L. 
Doing laundry 
2 
1 
0 
M. Taking medications 
2 
1 
0 
N. Managing money 
2 
1 
0 

Now I will ask a few questions about how YOU have been feeling over the last 2 weeks.  
Possible answers are: Not at all; Several days; More than half the days; or Nearly every day 
 
GAD-7 COMPONENT4 
 
GAD-Over the last 2 weeks, how often have 
you been bothered by the following 
problems?  
Not at all 
Several 
days 
More than 
half the 
days 
Nearly 
every day 
1. Feeling nervous, anxious, or on-edge 
0 
1 
2 
3 
2. Not being able to stop or control worrying 
0 
1 
2 
3 
3. Worrying too much about different things 
0 
1 
2 
3 
4. Trouble relaxing 
0 
1 
2 
3 
5. Being so restless that it’s hard to sit still 
0 
1 
2 
3 
6. Becoming easily annoyed or irritable 
0 
1 
2 
3 
7. Feeling afraid as if something awful might 
happen 
0 
1 
2 
3 
 
How often is each of the following kinds of support available to you if you need it? 
Possible answers are: None of the time; A little of the time; Some of the time; Most of the 
time; or All of the time. 
SOCIAL SUPPORT “SS-5” 5 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of 
the 
time 
A. Someone to confide in or talk to about 
problems. 
1 
2 
3 
4 
5 
B. Someone to get together with for relaxation. 
1 
2 
3 
4 
5 
C. Someone to help you with daily chores if you 
were sick. 
1 
2 
3 
4 
5 
D. Someone to turn to for suggestions about how 
to deal with a personal problem. 
1 
2 
3 
4 
5 
E. Someone to love and make you feel wanted. 
1 
2 
3 
4 
5 

 
 
 
 
 
Patient Health Questionaire-9 (PHQ-9)6 
 
Over the past 2 weeks how often have you been 
bothered by any of the following problems.  Possible 
answers are: Not at all; Several days; More than 
half the days; or Nearly every day 
Not 
at all 
Several 
Days 
More 
than 
half the 
days 
Nearly 
every 
day 
1.  
Little interest of pleasure in doing things 
0 
1 
2 
3 
2.  
Feeling down depressed or hopeless 
0 
1 
2 
3 
3.  
Trouble falling asleep, staying asleep or 
sleeping too much 
0 
1 
2 
3 
4.  
Feeling tired or having little energy 
0 
1 
2 
3 
5.  
Poor appetite or overeating 
0 
1 
2 
3 
6.  
Feeling bad about yourself – or that you have 
been a failure or let yourself or your family 
down 
0 
1 
2 
3 
7.  
Trouble concentrating on things, such as 
reading the newspaper or watching television 
0 
1 
2 
3 
8.  
Moving or speaking so slowly that other people 
could have noticed. Or the opposite – being so 
fidgety or restless that you have been moving 
around a lot more than usual 
0 
1 
2 
3 

9.  
Thoughts that you would be better off dead or 
of hurting yourself in some way** 
0 
1 
2 
3 
10. 
If you selected any of these problems, how 
difficult have those problems made it for you to 
do your work, take care of things at home, or get 
along with other people 
 Not difficult at all 
 Somewhat difficult 
 Very difficult  
 Extremely difficult 
 
**Refer to local site Suicide Prevention Protocol 
 
 
 
MYLOH© COMPONENT7 
 
Now I am going to ask you some questions about any problems you might have in 
helping [name of Care Recipient]. Many of the questions are very similar to what has 
already been asked. 
Please keep in mind the following definitions when answering these questions: 
• 
The terms “He/She, Him/Her” refer to your care recipient. 
• 
The term “Health Care Providers” refers to doctors, nurse practitioners, physician 
assistants, nurses, social workers, pharmacists, medical specialists (ex. cardiologist, 
psychiatrist), and other healthcare staff. 
• 
The term “Care Partner” refers to YOU. 
o Primary Care Partner: Live with or nearby the person who needs care. Regularly 
provide care and assist with daily and medical decisions and care tasks. 
o Helper Care Partner: Live with or nearby. Help a primary care partner when 
needed. 
o Long-distance Care Partner: Live further away. Visit when they can and assist 
with making decisions. 
What kind of Care Partner are you? Please answer questions below. 

 
The primary person responsible for 
care 
 
A helper who assists with 
care 
 
A person who assists with care 
from a long-distance 
From a score of 1 to 5; “1” being ‘Not difficult’ and “5” being ‘Extremely difficult’, please 
tell me…  
How difficult is it for you to pay for all of the basic needs* for the person with dementia?: 
1                              2                              3                                   4                                5 
NOT DIFFICULT  
 
 
 
 
 
 
 EXTREMELY 
DIFFICULT 
 
*Basic Needs ex. food, medical & other supplies, medications 
 
 
Next I want to understand what his/her problems are.  I will name several possible 
problems your care recipient might have. Possible answers to the questions are: Agree 
completely; Agree; Disagree; Disagree completely; or Not my job. 
 
 
 
 
 
 
 
Agree 
Completely 
Agree 
Disagree 
Disagree 
Completely 
Not 
My Job 
1. I understand WHAT his/her problems are: 
A. With Memory  
(ex. remembering, planning, making 
decisions) 
 
 
 
 
 
B. With Mood/Behaviors  
(ex. anger, sadness, irritation, poor 
sleep) 
 
 
 
 
 
C. With Medical Issues  
(ex. illnesses, pain, headaches) 
 
 
 
 
 
D. With Self-Care 
(ex. eating, dressing, showering, 
using the toilet) 
 
 
 
 
 
2. Right now, I can deal with DAY-TO-DAY problems he/she has: 

A. With Memory  
(ex. remembering, planning, making 
decisions) 
 
 
 
 
 
B. With Mood/Behaviors  
(ex. anger, sadness, irritation, poor 
sleep) 
 
 
 
 
 
C. With Medical Issues  
(ex. illnesses, pain, headaches) 
 
 
 
 
 
D. With Self-Care  
(ex. eating, dressing, showering, 
using the toilet) 
 
 
 
 
 
3. I know, or can get information about: 
A. What medications his/her 
health care provider 
recommends (prescription and 
non-prescription)  
 
 
 
 
 
B. What dose, when and how 
these medications should be 
taken (ex.10 mg tablet twice a 
day) 
 
 
 
 
 
C. What conditions these 
medications are used for (ex. 
blood pressure, blood sugar, 
dementia) 
 
 
 
 
 
4. I watch to be sure that he/she 
takes medications correctly and 
provide help when needed 
 
 
 
 
 
5. If I have concerns about his/her 
medications (ex. I worry about the 
safety or value of what is 
prescribed) I tell the clinician 
about them 
 
 
 
 
 
 
 
Agree 
Completely 
Agree 
Disagree 
Disagree 
Completely 
Not  
My Job 
6. I can tell when there are NEW or RAPIDLY WORSENING changes in his/her: 
A. Memory  
(ex. remembering, planning, 
making decisions) 
 
 
 
 
 

B. Mood/Behaviors  
 (ex. anger, sadness, irritation, 
poor sleep) 
 
 
 
 
 
C. Medical Issues 
(ex. illnesses, pain, headaches) 
 
 
 
 
 
D. Self-Care  
(ex. eating, dressing, showering, 
using the toilet) 
 
 
 
 
 
7. When NEW or RAPIDLY WORSENING changes happen, I know: 
A. What to watch for and what to 
report to his/her healthcare 
provider 
 
 
 
 
 
B. What I can deal with on my 
own  
 
 
 
 
 
C. When to contact his/her 
health care provider 
 
 
 
 
 
D. Which health care provider I 
should contact  
     (ex. doctor, nurse, pharmacist) 
 
 
 
 
 
E. When I need immediate 
assistance and I should call 
911 or other emergency 
medical help 
 
 
 
 
 
 
8. In helping with HEALTH CARE DECISIONS (ex. start new medication, go to a hospital
have surgery), 
    I understand: 
A. What would be important to the 
person I care for  
 
 
 
 
 
B. How to speak up on his/her 
behalf  
 
 
 
 
 
C. The responsibilities of a person 
who has a Power of Attorney 
for Medical Decision Making 
 
 
 
 
 
9. In regards to CAREGIVING RIGHT NOW: 
A. I can do everything needed to 
ensure that his/her care needs 
are met 
 
 
 
 
 
B. I am taking care of myself so 
that I can continue to care for 
 
 
 
 
 

him/her (ex. I take a break 
when needed) 
C. When I need help with 
caregiving, I know how to get it 
 
 
 
 
 
D. I know what to do if I have a 
personal crisis and cannot 
provide care or help with care 
as I usually do. 
 
 
 
 
 
 
Based on all the questions you just answered, please tell me the 3 most important questions 
to discuss with a healthcare provider now:  
INSTRUCTIONS TO PERSON ADMINISTERING SURVEY: (enter descriptor text and the 
question number after rereading the question to be sure you have it right) 
The question you would  like to discuss first:  
 
Question#_____  
The question you would  like to discuss second:  
Question# _____ 
The question you would  like to discuss third: 
 
Question# _____ 
Is there anything else we did not ask about that a healthcare provider could help you with in 
caring for your loved one?  
 
 
 
 
 
 
 
 
BEHAV5+8 
Please check yes for the behaviors that you have observed in your care recipient in the past month. 
1.  AGITATION/AGGRESSION 
Does your care recipient get angry or hostile?  
Resist care from others? 
☐ Yes     ☐ No 
2.  HALLUCINATIONS 
Does your care recipient see and/or hear things that no one else can see or 
hear? 
☐ Yes     ☐ No 
3.  IRRITABILITY/ FREQUENTLY CHANGING MOOD 
☐ Yes     ☐ No 

Does your care recipient act impatient and cranky? Does his or her mood 
frequently change for no apparent reason? 
4.  SUSPICIOUSNESS/PARANOIA 
Does your care recipient act suspicious without good reason (example: 
believes that others are stealing from him or her, or planning to harm him or 
her in some way)? 
☐ Yes     ☐ No 
5.  INDIFFERENCE/SOCIAL WITHDRAWAL 
Does your care recipient seem less interested in his or her usual activities and 
in the activities and plans of others? 
☐ Yes     ☐ No 
6. SLEEP PROBLEMS 
Does your care recipient have trouble sleeping at night? 
☐ Yes     ☐ No 
 
STRESS THERMOMETER COMPONENT8 
 
1. Will you please tell me how stressed you are feeling?*   
  Extremely stressed 
 
  Very stressed 
  Moderately stressed  
  A little stressed 
  Not stressed at all                 
  Don’t know 
 
 

 
*STRESS: Feeling tense, nervous, anxious, restless, or unable to sleep because your 
mind is troubled all the time.  
[End of Interview Questions] 
In about 3 months, I or another Interviewer for this study will call you to request your 
participation in another interview.  At that time, we will go through the same process that 
we went through today.  Your participation in any future surveys is voluntary and you 
can decide at that time if you would like to speak with us.   
1. May we call you in about 3 months from now?” 
 Yes, Go Q. 2 
 No, Skip to “Address Confirmation” 
2. Which are the best days and times to reach you about 3 months from now?  What do you 
prefer? 
During the week:  
 Morning 
       
 Afternoon 
 Evening 
 
Telephone:  ___ ___ ___ -- ___ ___ ___ -- ___ ___ ___ ___ 
 

On Saturdays:  
 Morning 
       
 Afternoon 
 Evening 
 
Telephone:  ___ ___ ___ -- ___ ___ ___ -- ___ ___ ___ ___ 
 
ADDRESS CONFIRMATION 
For the purpose of sending you a $40 gift card that we are giving to you in appreciation of your 
time with this interview, I need to verify your mailing address:  
 
Address: 
_______________________________________________________________ 
 
Please call our Study Coordinator, [insert full name] at [insert hospital name] at [insert telephone 
number] if you should have new your contact information so that we can contact you for the next 
telephone survey.  Again, that number is [insert telephone number]. 
If you have any other questions or concerns about the research, please feel free to 
contact the Principal Investigator, [insert site PI name] at [Insert telephone number] 
 
If you wish to ask questions about your rights as a research participant or if you wish to voice 
any problems or concerns you may have about the study to someone other than the 
researchers, you may contact the [insert head of IRB] at [insert site]. The telephone number is 
[Insert telephone number].         Thank you again!  
 
 

References: 
1. HCAHPS: Hospital consumer assessment of healthcare providers and systems. 
http://www.hcahpsonline.org/home.aspxd. Accessed January 23, 2016.  
2. Monahan PO, Boustani MA, Alder C, et al. Practical clinical tool to monitor dementia 
symptoms: The HABC-monitor. Clin Interv Aging. 2012;7:143-157.  
3. Katz S. Assessing self-maintenance: Activities of daily living, mobility, and instrumental 
activities of daily living. J Am Geriatr Soc. 1983;31(12):721-727.  
4. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized 
anxiety disorder: The GAD-7. Arch Intern Med. 2006;166(10):1092-1097.  
5. Dour HJ, Wiley JF, Roy-Byrne P, et al. Perceived social support mediates anxiety and 
depressive symptom changes following primary care intervention. Depress Anxiety. 
2014;31(5):436-442.  
6. Kroenke K, Spitzer RL. The PHQ-9: A new depression and diagnostic severity measure. 
Psychiatric Annals. 2002;32:509-521.  
7. Sadak, T., Wright, J., & Borson, S. (2016). Managing Your Loved One’s Health Development 
of a New Care Management Measure for Dementia Family Caregivers. Journal of Applied 
Gerontology. 
8. Borson S, Scanlan JM, Sadak T, Lessig M, Vitaliano P. Dementia services mini-screen: A 
simple method to identify patients and caregivers in need of enhanced dementia care services. 
Am J Geriatr Psychiatry. 2014;22(8):746-755.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Appendix 4:  
POISED Detailed Care Management Strategies 
 
 
POISED includes:  
1. Initial Assessment: The POISED care management team is structured to maximize 
the skill sets of specially-trained nurses functioning as care managers (CMs) and 
para-professionals in the role of care manager assistants (CMAs) in a collaborative 
model to maximize effectiveness and decrease cost. The CM and CMA conduct a 
biopsychosocial/environmental needs assessment by phone within 48 hours of 
emergency room discharge if not possible during the ED stay. This initial 
assessment (in person or by phone) includes a briefer demographic and 
psychosocial interview (compared with the home visit) focused on achieving most 
urgent problem identification. The program uses standardized assessment tools 
including “Managing Your Loved Ones Health” (MYLOHTM) for chronic disease 
management1 and BEHAVE 5+4 . If the consented CG is not available, we will 
attempt to complete the CG questions at a later date either by phone or in person. 
The CM’s interview also uses principles of root cause analysis (RCA) (further 
described below) to better understand the events and potential causes leading to the 
ED visit. The CM team then focuses on initial problem clarification and reviews the 
assessment findings, the medical record, medication lists, ED discharge plans and 
pharmacist consultation. The CM also reviews any diagnostic testing, any brain 
imaging results, and functional details of the assessment to determine the presence 
or absence of a likely dementia diagnosis, identifying any reversible and co-morbid 
conditions and, for complex cases, the need for referral for further evaluation at 
either NYU’s or IU’s well-developed dementia assessment centers.  
 
2. First Home Assessment: After review of all findings from prior data and the first 
telephone encounter, the CM and CMA create an initial plan and identify areas 
needing further assessment to be conducted at the first home visit (within 2 weeks 
after enrollment). That visit enables the CM team to conduct some additional 
cognitive and functional testing while the POISED RN uses the time to address more 
sensitive issues that the CG may be uncomfortable discussing in the presence of the 
CR. The results of this initial assessment and home visit are forwarded to the CR’s 
PCP with requested feedback and further direction as needed.  
 
3. Root-Cause Analysis of Emergency Department Visit or Repeat Visit / 
Hospitalization: Both CM and CMA members of the care management team will be 
well versed in the strategies of Root Cause Analysis. Starting with the ED visit and 
working backwards in time, the team will explore and identify problems or branch-
point situations that progressed to the need for ED care. Using a logic tree as a 
cause and effect approach to create a timeline of events leading to ED visit2 and 
asking the question, “how could this occur?” or “why” based on the “Five-Whys” 
strategy3 they will ask “why” for each successive answer starting with “why did you 
come to the Emergency Department.” Answers will be applied to medical record 
review looking for other possible triggers and opportunities for intervention. This 
brainstorming/investigative process is a successfully used quality improvement 
strategy and is also deployed by patient safety teams investigating adverse events.  

 
4. Self-Management/Caregiver Skills Enhancement: Prior to the second home visit, the 
CM prepares the various relevant materials to enhance patient self-management or 
caregiver skills. These materials (the Patient or Caregiver Care Manual) can include: 
chronic disease specific self-management strategies and medical information 
focused on identifying “red-flag” signs or symptoms, medication effects and proper 
use, enhanced information based on RCA investigation relevant to the sentinel ED 
visit, information on legal and financial planning with referrals made to elder law 
specialists and legal services programs in the community; specific behavioral 
interventions techniques to help manage, reduce or avoid care recipient problem 
behaviors; and/or coping strategies to ensure the caregivers’ emotional and physical 
health remain intact. These materials are provided to dyads via various face-to-face 
or home counseling sessions. If the dyad’s needs are particularly complex, the 
counseling can take place over more than one face-to-face and/or telephone 
session.  
 
5. Informal Telephone Support: Dyads will have access to telephone consultation with 
the care team. Any Family members participating in the patient’s care can initiate the 
telephone contact. Offering access to the care team empowers caregivers to more 
readily try different interventions.  
 
6. Problem Solving Process: Using data collected from the structured caregiver 
interview or during face-to-face visits, the care team uses standardized protocols to 
manage behavioral and psychological symptoms related to dementia. The care team 
educates the caregiver on implementing these protocols and monitors the success of 
such implementation via face-to-face or telephone follow-up interactions.  
 
7. Reducing the Anticholinergic Cognitive Burden: Using the Anticholinergic Cognitive 
Burden Scale (ACBS), developed by the Indiana Aging Brain group, the care team 
reviews the over-the-counter and prescribed medications taken by the patient and 
coordinates with the primary care provider (PCP) to identify the presence of any 
anticholinergic medication in efforts to balance their benefits and harms.  
 
8. Prescribing FDA-Approved Medications: The care team, in coordination with the 
PCP, discusses the indications, benefits and expectations of using FDA-approved 
medications for dementia.  
 
9. Managing High Vascular Disease Burden: The care team will review the care 
recipient vascular burden and provide the PCP with data to reduce burden with 
pharmacological and non-pharmacological approaches.  
 
10. Monitoring and Support of the Caregiver’s Emotional and Physical Health: The care 
team will use brief assessments to monitor care recipient cognitive, functional, 
behavioral and psychological symptoms; and caregiver stress using the caregiver 
Stress Thermometer.4  
 

11. Managing Transitional Care: Starting with the ED visit or within 48 hours and after 
any emergency department or hospital discharge the CM will reconcile discharge 
instructions, medications, and counsel and support the dyad to carry out any post-
discharge care plans.  
 
12. Managing Acute Care Problems: There are times when a care recipient or caregiver 
will call the care management team with an acute care problem and seek direction. 
To avoid a potentially unnecessary ED visit, the care team may make a home visit, 
inform the PCP, and address the problem accordingly.  
 
13. Care Prioritization: Under circumstances where patients have significant needs that 
exceed the capacity of the clinical program, the care team will utilize established 
guidelines to prioritize addressing these needs to ensure the most vulnerable 
patients (those who require a hospital or emergency department visit followed by 
those who require post-hospital or emergency department transitional care) receive 
timely care coordination by the care team including a home visit within 72 hours of 
discharge from a hospital or emergency department.  
 
14. Discharge Criteria: The care team will discharge the patient and caregiver if they 
meet any of the following criteria: 1) patient expires; 2) patient and/or 
family/caregiver decline to continue in the program; 3) primary care provider 
requests patient discharge from the program; 4) patient transitions to another health 
care system or move outside Marion County; 5) patient’s living situation/environment 
becomes unsafe for patient and/or staff and therefore requires long-term skilled 
nursing home care; or 6) complete the 6-month study.  
 
 
 
1. Sadak T, Korpak A, Borson S. Measuring caregiver activation for health care: 
Validation of PBH-LCI:D. Geriatr Nurs. 2015;36(4):284-292.  
 
2. Latino RJ. Patient safety: The PROACT root cause analysis approach. Boca Raton, 
FL: Taylor and Francis; 2008.  
 
3. Five Whys Technique. http://www.adb.org/publications/five-whys-technique. Updated 
2009. Accessed January 25, 2016.  
 
4. Borson S, Scanlan JM, Sadak T, Lessig M, Vitaliano P. Dementia services mini-
screen: A simple method to identify patients and caregivers in need of enhanced 
dementia care services. Am J Geriatr Psychiatry. 2014;22(8):746-755. 
 
 
 
 
 
 
 

Appendix 5:  
POISED Laminated Information Card