Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED Delirium Screening and Detection Program
Phase: NA
Conditions: Delirium
Sponsor: Northwell Health

 
 
Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency 
Department (ED): A Novel ED Delirium Screening and Detection Program 
Research Protocol Document 
 
Principle Investigator: Liron Sinvani, MD 
NCT05606328 
Document Date: 10/28/2022 

Version Date: 10.28.2022   
 
 
RESEARCH PROTOCOL 
 
 
Protocol Title: 
Improving Delirium Screening and Detection for Older Adults 
Presenting to the Emergency Department (ED): A Novel ED 
Delirium Screening and Detection Program 
Principal Investigator: 
Liron Sinvani, M.D. 
Primary Contact Name: 
Alexandra Perrin 
 
Primary Contact Phone: 
646-864-6020 
Primary Contact E-mail: 
aperrin1@northwell.edu 
Date Revised: 
10/28/2022 
IRB Number: 
22-0681 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
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• Do not use this template if: 
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you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
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submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 Continue to next page to begin entering information about this study  
 

Version Date: 10.28.2022   
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
Delirium occurs in up to 20% of older adults presenting to the Emergency 
Department (ED) and is associated with poor outcomes. Failure to identify patients 
with ED delirium not only prevents initiation of mitigation strategies, but is also a 
barrier to advancing the field in terms of evaluating management and clinical 
outcomes. This project studies the potential of an ED Delirium Detection Program 
(ED-DDP), developed to address the need for consistent and accurate ED delirium 
detection.  
 
This research will have two objectives: Aim 1 will conduct a pilot stepped wedge 
cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to 
determine preliminary efficacy of the detection training program and Aim 2 
will use a mixed methods approach to assess RE-AIM implementation 
outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of 
the training program. Aim 1 will consist of a multicomponent 1-day delirium 
champion workshop where the training is delivered, real-time direct 
observation/training of champions via telehealth, and practical training of nurses 
throughout each ED by champions. In Aim 2 we will assess implementation 
outcomes using training logs, tele-observation, interviews with champions and 
nurses, and electronic medical record screening. 
 
The overarching aim of this proposal is to determine the preliminary efficacy of the 
training program for improving ED delirium screening, detection, and management 
in older adults, while also evaluating implementation outcomes of the program for 
champions/nurses. We will use findings from this study to inform a full-scale SW-
CRT to evaluate the impact of the program on patient outcomes at Northwell 
Health. The long-term goal of this study is to implement and disseminate a 

Version Date: 10.28.2022   
comprehensive ED-DDP that will improve screening, detection, and management 
of ED delirium in older adults.   
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
Over 23 million older adults present to the Emergency Department (ED) each year 
in the United States, and up to 20% will experience delirium while in the ED. Yet, 
it is estimated that over 75% of ED delirium cases are missed. Failure to 
systematically screen and detect ED delirium affects clinical management (e.g., use 
of chemical and physical restraints) and outcomes (e.g., increased mortality and 
dementia).  
 
Despite the use of traditional educational programs (online modules, didactics), 
integration of validated delirium screening tools (e.g., brief Confusion Assessment 
Method, bCAM) into the electronic health record (EHR), and screening 
prioritization, existing ED delirium programs have only demonstrated improvement 
in screening rates, while consistently failing to improve delirium detection. These 
repeated failures necessitate a comprehensive training program that can address the 
known barrier of wide-ranging knowledge deficits, and improve consistent and 
accurate delirium screening.  
 
Known barriers to ED delirium detection consist of a lack in screening tool use, 
competing priorities, and wide-ranging knowledge deficits. Even when validated 
screening tools (e.g., brief confusion assessment method, bCAM) are prioritized 
and integrated into nursing workflow, they are rarely used consistently or 
accurately in clinical practice, leading to lack of delirium detection. Our long term 
goal is to implement and disseminate a comprehensive ED Delirium Detection 
Program (ED-DDP) that will improve screening, detection, and management of ED 
delirium in older adults. 
 
Our innovative ED-DDP builds on EHR integration and screening prioritization 
(resulted in delirium detection rates of <3%), with a “train-the-trainer” model, 
consisting of a multicomponent one-day workshop for delirium champions, nurse 
training by champions, and real-time bedside training via telehealth (delirium tele-
training).  Tele-delirium training is used, not only to provide direct 
training/feedback on screening tool use and management strategies, but also to 
assess screening accuracy by nurses (tele-observation). By addressing wide-ranging 
delirium knowledge deficits and lack of real-world bedside delirium screening tool 

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use, the ED-DDP has the potential to change practice and improve ED delirium 
screening, detection, and management. 
 
This study will be the first to evaluate accurate delirium screening. Previous ED 
delirium programs have only been able to demonstrate improvement in delirium 
screening adherence, while consistently failing to improve detection.14,32,33 
Accurate delirium detection is essential, not only to initiate management strategies, 
but also to inform future research on improving patient-centered 
outcomes (e.g., mortality and dementia).4 
 
This study is also one of the first interventions to go beyond traditional education 
programs (online modules, didactics) and EHR integration of a validated delirium 
screening tool (e.g., bCAM), which have both failed to improve ED delirium 
detection in real-world clinical practice.4,25,32 The innovative components of the 
ED-DDP (“train-the-trainer” model, 1-day training workshop for champions, tele-
training using direct observation and feedback), will overcome barriers by: 
explaining the significance of delirium as a disease process; and teaching, 
monitoring, and reinforcing appropriate screening tool use and management 
strategies.  
 
This will be one of the first studies to utilize the RE-AIM framework to evaluate 
implementation outcomes of a training program to improve delirium screening and 
detection, which will enhance future sustainability, generalizability, and the 
potential for broad dissemination.4,19,33 The use of an established Implementation 
science framework, combined with a broad-based mixed-methods approach, 
represents a substantive departure from extant research on ED delirium. 
 
Our group has previously developed and tested the innovative DDP in the intensive 
care unit (ICUDDP) within the Northwell Health system. The ICU-DDP utilizes a 
“train-the-trainer” model, which consists of: 1) a multicomponent one-day delirium 
champion training workshop; 2)  real-time direct observation, training, and 
reinforcement via telehealth (tele-delirium training); and 3) practical training of 
nurses by champions. The ICU-DDP improved delirium detection from 9.1% to 
30.1% (p = 0.005).  
 
Given the success of the ICU-DDP, we refined the ICU-DDP for the ED (ED-
DDP). In order to accomplish this, we obtained informal feedback from ED 
stakeholders who indicated that participation in the ED-DDP was of high priority, 
acceptable, and feasible.  
 
 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  

Version Date: 10.28.2022   
• The goals and the hypothesis to be tested should be stated. 
 
The objectives of this proposal are to: 1) conduct a pilot stepped wedge cluster 
randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine 
preliminary efficacy of the EDDDP to improve ED delirium detection, screening, 
and management; and 2) use a mixed-methods approach to assess RE-AIM 
implementation outcomes of program Reach, Efficacy, Adoption, Implementation, 
and Maintenance. 
 
Aim 1: Conduct a pilot stepped-wedge cluster randomized trial (SW-CRT) 
across 3 ED sites to determine the preliminary efficacy of the training 
program for improving delirium screening, detection, and management in 
older adults presenting to the ED. We will enroll 3 diverse EDs (based on setting 
and patient demographics), and randomize them to receive the intervention at 3-
month intervals over a 15-month period (control—standardized delirium screening 
[bCAM]; intervention—standardized delirium screening [bCAM] + ED-DDP). The 
primary outcome will be delirium detection (proportion of positive bCAM 
documentation among those with delirium via validated chart review). Secondary 
outcomes will be delirium screening (proportion of older adults with bCAM 
documentation among eligible older adults) and management strategies (e.g., use of 
restraints). 
 
Table 1. Stepped Wedge Cluster Randomized Trial (SW-CRT) Design 
ED Site 
Crossover 
Sequence 
Period 
1 
(3 
months) 
Period 2 
(3 months) 
Period 3 
(3 months) 
Period 4  
(3 months) 
Period 5 
(3 months) 
A 
Control 
*Implementation 
Intervention 
Intervention 
Intervention 
B 
Control 
Control 
*Implementation 
Intervention 
Intervention 
C 
Control 
Control 
Control 
*Implementation 
Intervention 
*No chart review will occur during Implementation Periods 
 
The primary objective will be to assess the preliminary efficacy of the ED-DDP 
and to estimate the effect size and intraclass correlation coefficient (ICC) 
information needed for a future full-scale SW-CRT. ICC is critical to capture 
because as ICC increases, the design effect (and hence the sample size 
needed) decreases. Currently no known estimate of the ICC exists, so it is 
important to conduct this preliminary trial to obtain a rough estimate of the ICC. 
 
Aim 2: Use a mixed methods approach to conduct implementation outcome 
assessments of the ED-DDP for champions and nurses. A multimodal approach, 
using training logs, tele-observations, and EHR data, will assess quantitative 
outcomes during implementation/intervention periods: Reach (training 
completion), Efficacy (accurate screening tool use), Adoption (screening rates), 
and Implementation (fidelity/time of program delivery). We will conduct semi-
structured interviews (intervention period) to assess and explain: successes and 
challenges of training completion (Reach) and Adoption of delirium screening; 

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adaptations made to ED-DDP delivery (Implementation); and plan for 
Maintenance. 
 
Table 2. Mixed-Methods Approach to Assess Implementation Outcomes of ED-DDP 
Delivery to Champions and Nurses 
RE-AIM 
Framework 
Measures –  
Implementation Period 
Measures –  
Intervention Period 
Reach 
Training Logs (Quant): Proportion 
of champions who complete training 
at each ED site (workshop + 3 tele-
training sessions); Proportion of 
nurses who complete at least 1 
training session with a champion at 
each ED site (Goal: 80%) 
Interviews of nurses/champions 
(Qual): Program participation 
(why/why not?) 
Efficacy 
(Accurate 
Delirium 
Screening) 
 
Tele-Observations using a validated 
spot check tool (Quant): Proportion 
of nurses (10 at each ED site) who 
score at least 80% accuracy on 
bCAM use in Intervention (Goal: 
80%) 
Adoption 
 
EHR (Quant): Proportion of nurses 
who screen 80% of eligible patients 
(Goal 80%) 
Interviews (Qual): Adoption of 
delirium screening by nurses 
(why/why not?) 
Implementation 
Training Logs (Quant): Proportion 
of training components (e.g. 
workshop, tele-training sessions) 
that adhered to ED-DDP protocol 
(Fidelity; Goal: 80%) 
Training Logs (Quant): Time 
required to train champions and 
nurses (Time; Goal: 80% of 
champions/nurses complete training 
during Implementation Period) 
Interviews (Qual): Adaptations to 
ED-DDP (Adaptations) 
Maintenance 
 
Interviews (Qual): Degree to which 
the ED-DDP and delirium screening 
has become institutionalized; Plans 
to continue/discontinue training by 
champions and delirium screening 
by nurses 
Emergency Department Delirium Detection Program (ED-DDP); Quantitative (Quant); 
Qualitative (Qual); Electronic Health Record (EHR) 
 
We will use a mixed-methods concurrent parallel design, collecting and analyzing 
separately the implementation and intervention data, as well as the quantitative and 
qualitative data. Then, we will analyze and interpret the data together to triangulate 
results. We will use a matrix and data transformation approach to mix the data and 
lead to a final set of findings. 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 

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• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
The study team has prior experience implementing the same program customized 
to, and delivered in, an intensive care unit, and previously demonstrated high 
recruitment/retention rates of champions.  Preliminary data demonstrates high 
levels of “buy-in” among ED stakeholders. Further, we obtained informal feedback 
from  ED stakeholders (nurses, physicians, leadership, patients/caregivers), which 
revealed that participation in the ED-DDP was of high priority, acceptable, and 
feasible. The program was refined to be low burden to staff through tactics such as 
nurse training occurring during work hours, ability to implement training without 
additional resources, and strong hospital leadership support. 
 
The three participating Emergency Departments were chosen based on stakeholder 
commitment to the program as well as setting, patient diversity, and participation in 
national collaboratives (e.g., Geriatric ED Collaborative). The first ED is 
located in the most diverse urban county in the country (Long Island Jewish Forest 
Health) within a 312-bed hospital; the second ED is located in a highly diverse 
region in NY within a 284-bed hospital (South Shore University Hospital); and the 
third ED is located in a suburban area of NY, within a larger 371-bed hospital, and 
serves as the primary site of co-I Dr. Barnaby (Huntington Hospital). These 3 ED 
sites have between 50-60 full-time nurses and 2019 (pre-COVID) annual volumes 
of 14,051, 16,917, and 17,333, respectively. 
 
All individuals on the study team will be required to attend weekly meetings with 
the PI to discuss the study protocol, timelines, and issues as they come up in real-
time. 
 
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
In Aim 1, site champions will be identified by emergency department leadership at 
Long Island Jewish Forest Hills, Huntington Hospital, and South Shore University 
Hospital or they will self-identify by expressing interest to their ED leadership. 
Once identified, the study team will contact the potential participant to confirm 

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their eligibility and interest in volunteering as a site champion. Although leadership 
will identify champions who qualify for participation, there will be no requirement 
by ED leadership to participate.  The voluntariness of participation will be made 
clear during the recruitment process.  
 
For Aim 2, training logs from Aim 1 will be used to contact ED staff trained by 
champions to invite them to participate in semi-structured interviews during the 
intervention period. The study team will also invite trained champions to 
participate in these interviews.   
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
Aim 1 (ED-DDP Champions) 
 
Inclusion Criteria 
• Nurse educators, managers or bedside nurses self-identified or 
recommended by ED leadership to volunteer as a program site champion 
• Primarily working at Long Island Jewish Forest Hills, Huntington Hospital, 
or South Shore University Hospital 
• Commitment to program participation 
 
Exclusion Criteria 
• Unable to meet program requirements, including attending champion 
workshop, agreement to observation and training via telehealth, and 
commitment to train department staff 
• Does not primarily work in the emergency department 
 
Aim 2 (Participant Interviews) 
 
Inclusion Criteria 
• Champion trained through the ED-DDP program or 
• Staff member trained by ED-DDP Champion 
• Currently working at Long Island Jewish Forest Hills, Huntington Hospital, 
or South Shore University Hospital 
 

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Exclusion Criteria 
• Does not primarily work in Emergency Department  
 
Eligibility for Chart Review 
• Aged 65 years or older 
• Presenting to a participating study site ED during control or intervention 
periods 
• Survival to ED discharge or to hospital admission 
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
This study will enroll at least 5 and up to 10 clinical staff Champions at each of 3 
Northwell ED sites (up to N=30 total). During Aim 2, the study team will conduct 
5-10 interviews of a mixed sample of champions and champion-trained nurses until 
saturation is reached at each site (approximately N=15, or until saturation, no more 
than N=30).  
 
For the primary outcome of delirium detection: Every three months, with the 
exception of when a site is in their implementation period, we will randomly select 
250 patients per participating ED for chart review, totaling N=1,000 patients per 
ED ant N=3,000 patients overall. Thus, chart reviews will take place during control 
periods and intervention periods only. No patient data will be collected during 
implementation periods. 
 
For the secondary outcomes of delirium screening and management strategies, we 
will include all charts of all older adults (greater than 65 years of age) presenting to 
the ED to survive to hospital admission or ED discharge (in both control and 
intervention periods) in analysis.  
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
Aim 1 
Retrospective in-depth chart reviews will be conducted during the control period 
which will occur prior to implementation at each site. The implementation period 
will take place in a 3-month period at each ED site. During the implementation 

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period, participant Champions will be asked to attend a one-day workshop and 
participate in two 15-minute tele-training and one 15-minute Champion-nurse 
observation sessions with a study investigator during their normal work hours. 
These activities will take approximately 1 month to complete. Participant 
Champions will also be asked to train all additional unit staff via additional 15-
minute training refreshers on standard of care practice. 
 
Aim 2 
Semi-structured participant interviews will last approximately 30-minutes.   
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
The primary endpoint will be delirium detection, calculated by proportion of 
positive bCAM documentation among those with delirium via validated chart 
review.  
 
Secondary endpoints will be delirium screening (proportion of older adults with 
bCAM documentation among eligible older adults) and ED delirium mitigation and 
management strategies (proportion of eligible patients who receive safety 
precautions [fall, aspiration, or wandering], and proportion of eligible patients who 
receive physical and chemical restraints (benzodiazepines, antipsychotics, 
diphenhydramine) for behavioral symptoms.  
 
 
11.  RESEARCH PROCEDURES 
1. Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
2. Include any screening procedures for eligibility and/or baseline diagnostic tests 
3. Include procedures being performed to monitor subjects for safety or minimize risks 
4. Include information about drug washout periods 
5. If drugs or biologics are being administered provide information on dosing and route 
of administration 
6. Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 
Aim 1: Conduct a pilot stepped-wedge cluster randomized trial (SW-CRT) 
across 3 ED sites to determine the preliminary efficacy of the ED-DDP for 
improving delirium screening, detection, and management in older adults 
presenting to the ED.  
 

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The study has identified 3 sites with strong commitment from emergency 
department leadership at Long Island Jewish Forest Hills, Huntington Hospital, and 
South Shore University Hospital to participate in study activities.  
 
Control Period  
• All nurses working in the emergency department receive a 20-minute ilearn 
training module on an integrated electronic health record (EHR) delirium 
screening tool (bCAM) as part of their standard job preparedness training. 
The study will begin by assessing baseline adherence to standard of care 
screening and associated outcomes for all three sites. During the control 
period, trained study staff members will conduct retrospective in-depth 
chart reviews to assess presence of delirium in eligible patients with visit 
records at each participating site, as well as any corresponding delirium 
documentation, including the bCAM and delirium mitigation and 
management strategies employed during the patient’s ED visit. These chart 
reviews will take place every 3 months a site is in the control period, and 
will assess 250 randomly-selected charts that meet eligibility requirements 
for delirium screening.  Charts will be pulled based on dates the 
participating site is within their control period. Eligible patients are defined 
as those aged 65 years or older, presenting to a participating study site ED 
who survive to ED discharge or to hospital admission. 
 
Eligible patient data will be collected using a HIPAA-compliant REDCap database. 
Data collected include: 
• Total number of adults aged 65 and older presenting to the ED site 
• Total number of eligible older adults presenting to the ED site 
• Eligible patient demographics:  
o Age 
o Gender 
o Race 
o Ethnicity 
• Eligible patient clinical presence:  
o Baseline function 
o Chronic conditions (based on Charlson Comorbidity Index) 
o Severity of acute illness (based on Modified Early Warning System 
(MEWS) 
• Eligible patient dementia-related documentation 
o Presence of dementia 
o All bCAM documentation, and corresponding result (positive, 
negative, unable to assess) 
o ED delirium safety strategies (e.g. orders for fall, aspiration, or 
wandering safety precautions) 
o ED management of behavioral symptoms associated with delirium 
(e.g. orders for benzodiazepines, antipsychotics, diphenhydramine, 
or restraints) 
• Proportion of nurses that screen eligible patients 

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Two delirium experts (Dr. Sinvani and Dr. Makhnevich) will perform chart checks 
and adjudicate any uncertain cases. 
 
In conjunction with the 3-month retrospective chart review (control period), the 
study team will begin implementing the ED-DDP program one site at a time in a 
stepped-wedge cluster randomized trial design (Table 1). Every 3 months, the study 
team will implement the ED-DDP program at one new site until all 3 sites have 
received the intervention. ED sites will remain in the control period and have their 
data retrospectively reviewed until they enter the implementation period.  
 
Table 1. Stepped Wedge Cluster Randomized Trial (SW-CRT) Design 
ED Site 
Crossover 
Sequence 
Period 
1 
(3 
months) 
Period 2 
(3 months) 
Period 3 
(3 months) 
Period 4  
(3 months) 
Period 5 
(3 months) 
A 
Control 
*Implementation 
Intervention 
Intervention 
Intervention 
B 
Control 
Control 
*Implementation 
Intervention 
Intervention 
C 
Control 
Control 
Control 
*Implementation 
Intervention 
*No chart review will occur during Implementation Periods 
 
Implementation Period  
The implementation period will last three months for each site and consist of three 
parts. No chart review will occur during a site’s implementation period.  
 
1. Delirium Champion Workshop: 
ED leadership at each site will identify 5-10 champions, consisting of 
nurse educators, managers, or bedside nurses to participate in a one-day 
train-the-trainer workshop. ED leadership will be instructed to select 
champions based on their interest in delirium and their commitment to 
participate in the program. The workshop will include additional 
education regarding the presence and clinical significance of delirium 
and a review of the appropriate use of the bCAM screening tool, 
delivered via patient testimonials, small group discussions, delirium and 
screening tool use (didactics) and role-playing.  
 
2. Real-time direct observation/training: 
Following workshop participation, all champions will receive 3 tele-
training sessions. The first 2 tele-training sessions will provide direct 
observation and feedback from one of the co-investigators while the 
champion performs a bedside delirium screen. The final tele-training 
session will consist of direct observation and feedback of the champion 
by one of the co-investigators while the champion is providing training 
to a nurse. During each training session, Drs. Sinvani and Makhnevich 
will use a validated Spot Check Form to determine baseline delirium 
screening activities before training takes place. 
 
3. Training of nurses by champions: 

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Upon successful completion of the Delirium Champion Workshop and 3 
tele-training sessions, champions will be asked to provide bedside 
delirium trainings for all ED nurses at their site. Champions will be 
provided with training logs and asked to submit completed logs to the 
study team. 
 
Intervention Period  
During the intervention period, ED nurses will be assessed for their use of the 
bCAM delirium screening tool during their initial assessment of all older adults 
presenting to the ED. At the beginning of the intervention period, Drs. Sinvani and 
Makhnevich will observe a random sample of nurses (N=30, 10 at each ED site) 
performing a delirium screening using validated Spot Check Form to determine 
baseline delirium screening activities post-implementation period.  
 
Trained study staff will conduct retrospective in-depth chart reviews to assess 
presence of delirium in each site and any corresponding delirium documentation, 
including the bCAM and delirium mitigation and management strategies employed.  
These chart reviews will take place every 3 months a site is in the intervention 
period, and will assess 250 randomly-selected charts that meet eligibility 
requirements for delirium screening. Charts will be pulled based on dates the 
participating site is within their intervention period. Eligible patients are defined as 
those aged 65 years or older, presenting to a participating study site ED who 
survive to ED discharge or to hospital admission.  
 
All data will be collected using a HIPAA-compliant REDCap database: 
• Total number of eligible older adults presenting to the ED 
• Eligible patient demographics:  
o Age 
o Gender 
o Race 
o Ethnicity 
• Eligible patient clinical presence:  
o Baseline function 
o Chronic conditions (based on Charlson Comorbidity Index) 
o Severity of acute illness (based on Modified Early Warning System 
(MEWS) 
• Eligible patient dementia-related documentation 
o Presence of dementia 
o All bCAM documentation, and corresponding result (positive, 
negative, unable to assess) 
o ED delirium safety strategies (e.g. orders for fall, aspiration, or 
wandering safety precautions) 
o ED management of behavioral symptoms associated with delirium 
(e.g. orders for benzodiazepines, antipsychotics, diphenhydramine, 
or restraints) 
 

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As in the control period, two delirium experts (Dr. Sinvani and Dr. Makhnevich) 
will perform chart checks and adjudicate any uncertain cases. 
 
Aim 2: Use a mixed methods approach to conduct implementation outcome 
assessments of the ED-DDP for champions and nurses 
 
Aim 2 will gather quantitative and qualitative data collected during implementation 
and intervention periods to assess and explain the reach, efficacy, adoption, 
implementation, and plan for maintenance using the RE-AIM framework. 
 
Data assessed from the implementation period include training logs to determine 
proportion of champions who complete training, proportion of nurses who are 
trained by a champion, proportion of training components adhered, time required to 
train champions and nurses, and proportion of nurses who scored at least 80% 
accuracy on bCAM use during the tele-observation sessions in Aim 1.  
 
Data assessed from the intervention period include all data derived from the 
retrospective chart review, including proportion of nurses who screen eligible 
patients. 
 
In addition to assessing data collected during Aim 1, the study will incorporate 
semi-structured interviews in Aim 2 to provide additional context to reach, 
adoption, and implementation of the ED-DDP program and to help plan for 
program maintenance. The study team will conduct 6-9 interviews of a mixed 
sample of champions and champion-trained nurses until saturation is reached at 
each site (minimum of N=18, up to N=30). Interviews will be 30-minutes in length 
and will be scheduled by a research coordinator at a mutually beneficial time for 
the participant and study team member. All interviews will be recorded and 
transcribed before being analyzed with NVivo software. Interview participants will 
receive $50 compensation for their time via ClinCard mailed to an address they 
provide the study team. 
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
The primary objective will be to assess the preliminary efficacy of the ED-DDP 
and to estimate the effect size and intraclass correlation coefficient (ICC) 
information needed for a future full-scale SW-CRT. ICC is critical to capture 
because as ICC increases, the design effect (and hence the sample size needed) 
decreases. Currently no known estimate of the ICC exists, so it is important to 
conduct this preliminary trial to obtain a rough estimate of the ICC. 

Version Date: 10.28.2022   
 
Primary Outcome: Delirium detection defined as the proportion of positive 
delirium screens (positive bCAM documentation), among those with delirium 
(based on validated chart review). 
 
Secondary outcomes: 
• Delirium screening, defined as proportion of eligible patients (65+, 
presenting to the ED) screened for delirium (EHR bCAM documentation)  
• ED delirium mitigation and management strategies: 
o Proportion of older adults with any order for safety precautions 
(fall, aspiration, or wandering) 
o Proportion of older adults receiving benzodiazepines, 
antipsychotics, diphenhydramine, or restraints for behavioral 
symptoms.  
 
Primary and secondary outcomes will be assessed at study completion. 
 
Analysis of the outcome delirium detection will be conducted solely to calculate 
estimates needed to complete a sample size calculation for a subsequent full-scale 
SW-CRT. Effect size and intraclass correlation coefficient (ICC) estimates 
obtained will be used to compute the sample size needed for a full-scale SW-CRT 
using methodology outlined by Hemming and Taljaard, 2016. ICC is critical to 
capture because as ICC increases, the design effect (and hence the sample size 
needed) decreases (Woertman, 2013). There is currently no known estimate of the 
ICC so it is important to run this preliminary trial to obtain a rough estimate of 
what the ICC will be. 
 
Analysis of delirium detection will be based on the proportion of patients with 
documented delirium in their chart among those with who truly had delirium. True 
cases of delirium will be identified retrospectively by expert chart review using a 
standardized protocol. This is essentially the sensitivity of delirium detection. 
Analysis of delirium detection will be conducted on patients with true delirium 
among a randomly sampled population of 3000 patients (1000 patients per ED or 
250 patients per ED per data collection period), see sample size considerations 
below. 
 
To estimate the intervention effect, we will use a generalized linear mixed effect 
model (GLMM) to account for the hierarchical structure of the data (patients nested 
within EDs) using PROC GLIMMIX in SAS Studio version 3.8. GLMMs are an 
extension of linear mixed models and will be used to allow for the binary primary 
outcome. For GLMM, we define a basic model as: 𝑔𝑔(𝑝𝑝) = 𝑋𝑋𝑘𝑘𝑘𝑘𝜃𝜃 + 𝑎𝑎𝑘𝑘 + 
𝛽𝛽𝑘𝑘 + 𝑒𝑒𝑖𝑖𝑖𝑖𝑖𝑖, where 𝑝𝑝 represents the probability of 𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖 taking on the value 
of 1, and 𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖 is an indicator variable of the response from individual 𝑖𝑖 in 
cluster 𝑘𝑘 at time period 𝑡𝑡 (1=delirium detected, 0=delirium not detected) 
𝑋𝑋𝑘𝑘𝑘𝑘 is an indicator variable of the intervention assignment of cluster 𝑘𝑘 at 
time period 𝑡𝑡 (1=intervention, 0=control). 𝜃𝜃 represents the fixed effect for the 

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intervention, 𝑎𝑎𝑘𝑘 represents the random effect for cluster 𝑘𝑘, 𝛽𝛽𝑡𝑡 represents the 
random effect for time period 𝑡𝑡, and 𝑒𝑒𝑖𝑖𝑖𝑖𝑖𝑖 represents within-cluster error. The 
GLMM will use a logit as the link function, represented by 𝑔𝑔. Estimates obtained 
will be used to compute the sample size needed for a full-scale SW-CRT. 
 
Exploratory moderator and mediator analyses will be conducted. Moderator 
analyses will explore if patient characteristics, specifically age, Modified Early 
Warning System (MEWS) score, and presence of dementia, moderate the 
intervention effect (i.e., there is a differential effect of the intervention on delirium 
detection based on the value of the moderator). In the GLMM model, separate 
interaction terms of the intervention group and age, MEWS score, and presence of 
dementia will be added. Any interaction term that is statistically significant 
(p<0.05) will be included in the final model so that independent effects of the 
intervention and corresponding moderators can be determined. Mediator analyses 
will explore if implementation outcomes (see Aim 2), specifically the proportion of 
nurses who complete at least 1 training session with a champion, the proportion of 
nurses who score at least 80% on bCAM accuracy, and the proportion of nurses 
who screen 80% of eligible patients, mediate the intervention effect (i.e., are on the 
causal pathway between the intervention and delirium detection). Each potential 
mediator will be assessed as a continuous variable at the ED level. Mediator 
analyses will be carried out by assessing the difference between the direct effect of 
the intervention in a model with vs. without the mediator. The significance of the 
mediated effect will be tested via bootstrapping. Mediators will first be tested 
separately, and mediators found to be significant will be included in the final 
model. Exploratory analyses will also adjust for the following covariates: gender, 
race, marital status, baseline function, and chronic conditions (CCI). 
 
Sample size considerations (Aim 1): 
We will randomly select 250 patients per ED per each of the 4 periods of data 
collection per cluster. This equates to 1000 patients per ED or 3000 patients overall 
and is a feasible number of medical charts for the expert chart reviewer to abstract 
and review. Additionally, based on 2019 data, the smallest estimated available 
sample size of eligible subjects (aged 65 years and older presenting to the ED) per 
ED per period is >14,000, indicating that this is an achievable number of patients 
for each ED. If 3000 patients total are included, we conservatively estimate that 
300 true cases of delirium will be detected, assuming that the prevalence of 
delirium is 10%. We expect the sensitivity of delirium detection to be 80%, where 
the precision of the 95% CI will be approximately ± 5% with a sample size of 300. 
Table 2 shows precision of estimation for delirium detection sensitivities of 50%, 
65%, and 80%. 
 
Table 2. Precision of Estimation for Delirium Detection 
Sample Size with True 
Delirium 
Sensitivity of Delirium 
Detection 
Precision of the 95% CI 
300 
50% 
±5.66% 
300 
65% 
±5.40% 

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300 
80% 
±4.53% 
 
 
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
The researchers take the issue of privacy very seriously. Study information will be 
stored in a Northwell-approved database drive to store PHI (e.g. SharePoint and 
REDCap), and it will only be accessible to research staff listed on the approved 
IRB protocol. Names or other identifying information will not be shared with those 
outside the research team, except for the purposes of sending research 
communications. Phone numbers and email will only be used for study-related 
communications. Any phone calls or emails will be sent to participants through the 
respective study site’s secured server and calls made at each study location in a 
secured area.   
 
Along with the organizational administrative, technical and physical safeguards and 
IRB approved measures, data privacy and security procedures will include:  
(1) training staff on data sensitivity and protocols for safeguarding confidentiality; 
(2) scanning any potential hardcopy (e.g. training logs) with PHI into an approved 
electronic database (i.e. SharePoint)  
(3) shredding hardcopies once scanned into the secure electronic database;  

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(4) Destroying all identifiable linkages to data after data accuracy has been verified 
and final analyses have been completed (Disposal Policy for Protected Health and 
Confidential Health System Information – policy no 800.47);  
(5) capturing and storing assessments in REDCap, a secure web-based HIPAA 
compliant application designed to support data capture for research 
studies; and  
(6) using restricted logon identification and password protection computer 
protocols for all computerized entry, retrieval, and analysis. 
 
This research is funded by the NIH, thus a Certificate of Confidentiality has been 
issued for this research. Certificates of Confidentiality (CoCs) protect the privacy 
of research subjects by prohibiting disclosure of identifiable, sensitive research 
information to anyone not connected to the research except when the subject 
consents or in a few other specific situations.   
 
On June 17, 2021 NIA released NOT-AG-21-029: NIA Announces New Policy and 
Procedures for the Reporting of Human Subject Enrollment Data for NIA Clinical 
Research Trials/Studies. The new policy applies to all NIA grants, contracts, and 
cooperative agreements that are active as of July 1, 2021 and support human 
subjects research as defined by the National Institutes of Health (NIH). In addition 
to NIH reporting requirements for study enrollment, NIA investigators will be 
required, on a monthly basis, to electronically submit participant enrollment data 
into the secure NIA Clinical Research Operations & Management System 
(CROMS) for all human subjects enrolled in their trials/studies. This information 
will be provided for Nurse Champions and interview participants ONLY. 
Enrollment information about individuals whose charts are reviewed for this 
research will NOT be transferred to NIA/NIH.  
 
 
 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 

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•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
The Principal Investigator, Co-Investigators, and research team members will be 
responsible for monitoring the scientific integrity and data safety for the 
full duration of the study. They will meet on a weekly basis to discuss the progress 
of the study. 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
 
Oversight Responsibilities:  
The PI will be responsible for ensuring participants’ safety on a daily basis. Study 
procedures involve record reviewing, delirium training, observation of training and 
screening and interviews.  The PI will supervise the research, ensure that each 
individual engaged in research is qualified to do so by virtue of education, training 
and experience to perform the delegated task. She will protect the rights, safety and 
welfare of participants by ensuring that the research is conducted in accordance 
with all federal regulatory requirements, state law, and Northwell Health policies 
(including IRB SOPs), and is conducted in accordance with the IRB-approved plan, 
and ensure the accuracy, security and integrity of the research data and data 
analysis.  
 
Monitoring Responsibilities:  
• Study data are accessible at all times for review by the PI and named co-
investigators. The PI and study team will meet weekly.  Reportable events 
(unanticipated problems, deviations, violations, etc.) will be reviewed by 
the PI in real-time and reported to the IRB in a timely manner and in 
accordance with Northwell IRB Policy. 
Should an unanticipated event related to the research that exposes individuals other 
than the research participants (e.g., investigators, research assistants, students, the 
public, etc.) to potential risk, the event will be reported in a timely manner but not 
more than five (5) working days after discovery by the PI.  

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The PI, as well as the IRB and other oversight committees, have the authority to 
stop or suspend the study or require modifications.  
 
 
 
 
 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Should a participant choose to withdraw from research, they will be instructed to 
email the study team to withdraw. Participants will be contacted by a member of 
the research team confirming their study withdrawal, and to answer any questions 
they may have. All data up until the receipt date of the email will be included in the 
research study. 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
We do not expect any adverse events directly attributable from this study. Delirium 
screening is a standard of care and should be performed on all older adults 
presenting to the ED. The training is meant to improve accurate delirium screening. 
The outcomes (delirium detection, screening rates, and management) of this study 
will be obtained retrospectively through EHR data and a chart review process. The 
research poses no more than minimal risk to subjects. 
 
The primary potential risk of this study is loss of confidentiality. Measures to 
mitigate risks to loss of confidentiality are detailed in Section 14 “Data 
Management and Confidentiality” above.  

Version Date: 10.28.2022   
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
Research-related injuries are not expected for this no greater than minimal risk 
project. . 
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
This research is designed to determine the preliminary efficacy of the proposed 
ED-DDP for improving ED delirium screening, detection, and management in 
older adults, as well as to evaluate outcomes for champions/nurses. Although there 
will be no direct benefit to research participants, their contributions to this study 
will inform a full-scale SW-CRT to evaluate the impact of ED-DDP on patient 
outcomes, and will eventually scale to a comprehensive program to improve 
delirium management and outcomes in the emergency department.  
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
The study will be introduced by a study team member after individuals first self-
identifies as interested in participating as a champion to ED leadership, and/or after 
ED leadership first solicits interest in participation. Participants will be encouraged 
to ask questions at any time during the research. Should questions arise, research 
personnel will ensure that the individual is in a private location for open 
conversation to protect the privacy interests of the individual. All study-related 

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communications will be delivered via a secure, Northwell email or via the 
Northwell approved e-platform.     
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
This research study is funded by the National Institutes for Health (NIH). All study 
related equipment, services will be provided to participants at no cost. Patient 
insurance will not be billed. 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
Those participants who successfully complete 30-minute semi-structured 
interviews in Aim 2 will be provided a $50 ClinCard. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 

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Aim 1 
Participant champions will receive an information sheet describing their 
involvement in research prior to attending the one-day training workshop. The 
information sheet will be delivered electronically via REDCap, a web-based 
platform capable of recording electronic signature. The information sheet will 
contain all of the elements required by applicable federal regulation for the 
protection of human subjects, and will begin with a concise and focused 
presentation of the key information that is most likely to assist participants in 
understanding the reasons why he/she might or might not want to participate in 
the research. Included in the electronic information sheet will be contact 
information to reach a consenting coordinator to answer any questions a 
potential participant may have before continuing with the research. Both the 
research phone and email inbox will be monitored daily by consenting 
coordinators.  
 
This study does not propose to collect information about the patient receiving 
the delirium screen at bedside for any of the tele-training sessions.  As such, we 
do not consider the patient a secondary subject.  Patients will be informed in 
advance that the Champion and trainee will be observed as part of the training 
program; any patient who expresses concern with observation will still have the 
delirium screen administered as part of the program, but their Champion and 
Nurse Trainee will not be observed.   
 
 
 
 
Aim 2 
Participant champions and trained nurses invited to take part in a semi-
structured interviews during the intervention period will also receive an 
information sheet describing their involvement in research. Similar to the 
information sheet given to champions before the training workshop, the 
information sheet will be delivered electronically via REDCap and will contain 
contact information to reach a consenting coordinator to answer any question a 
potential participant may have before continuing with the interview. 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 

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• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
N/A 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
The study is committed to enrolling a racially and ethnically diverse 
population. Given that the study is focusing on recruitment of Northwell 
employees, we anticipate that most employee participants will have the 
competency to comprehend study materials produced in the English 

Version Date: 10.28.2022   
language at a 6th grade level, particularly when explained by trained 
clinical research coordinators.    
 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
We request a waiver of consent under 45 CFR 46.116 for record review to 
establish the control cohort and to assess the training program. Record review 
procedures involve no more than minimal risk to participants and the waiver 
will not adversely affect their rights or welfare. The primary risk of record 
review is loss of confidentiality; we have mitigated this loss by establishing 
sound data protection procedures to maintain privacy and confidentiality. We 
propose to review 3,000 records. As such, it would not be practicable to 
perform the record review, as it has been defined in this study, if consent was 
required for these reviews which use identifiable private information.     
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 

Version Date: 10.28.2022   
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
We are requesting a waiver of documentation of consent. We will provide an 
information sheet to participants that explains the training program and 
procedures, and document verbal agreement to proceed given the research 
presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the 
research context  
 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
 We request a waiver of authorization for record review during both Aims. 
  
The description of the PHI for which use or access is requested is as follows:   
 
• Eligible patient age (if over 89 years of age) 
• Medical record number or encounter number 
• Location of service 
• Elements of date of related admission, encounters, orders, and 
discharge, including, but not limited to: 
 

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Collection of this information is necessary to establish our control cohort and 
assess the training program. The use of this protected health information 
involves no more than a minimal risk to the privacy of individuals, based on 
our adequate plan to protect the identifiers from improper use and disclosure as 
described above.  
  
The health information collected for the described purpose will not be reused or 
disclosed to any other person or entity, except as required by law, for 
authorized oversight of the research study. The research could not practicably 
be conducted without the waiver or alteration. In addition, the research could 
not practicably be conducted without access to and use of the protected health 
information.  
 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 

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If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
This study will recruit eligible employees of the health system to participate in an ED-
DDP program aimed to increase delirium screening and improve patient outcomes. 
 
Individuals with a supervisory relationship over an employee will not enroll any 
individual who reports to them in this study. Employee participation or non-
participation in this study will have no bearing on an individual’s position at Northwell 
Health. The voluntariness of participation will be made prominent during the 
recruitment process.  
 
We are not intentionally targeting minorities, but expect minorities to be part of those 
eligible for participation. 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
N/A 
 
 
 
28.  REFERENCES/BIBLIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful.