Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living
Phase: NA
Conditions: Assisted Living, Resident to Resident Elder Mistreatment
Sponsor: Hebrew Home at Riverdale

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NCT03383289 
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living 
Protocol and statistical plan 
File date: 8/12/20 
 
 

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Background and rationale  
Researchers have recently begun to address negative and aggressive interactions among 
residents in long-term care. However, scientific attention is increasing1,2,3,4,5,6,7 because such 
aggression has been found to be extensive, and has the potential to impact physically, and/ or 
cause psychological distress to both residents and staff.8,9  A few studies discussing elder abuse in 
the residential care sector address resident-to-resident elder mistreatment (R-REM) in assisted 
living residences (ALRs).10,11, 12 Benson13 examined “relational aggression”, defined as a 
manipulative, non-physical form of aggression using rumour or gossip.  An extensive study on 
elder abuse in residential care facilities14 highlights the need for staff training and behaviour 
management strategies to counter serious outcomes such as physical injury and emotional 
distress. Similarly, Caspi,15 examining R-REM in two special care units of an ALR identified staff 
prevention strategies and suggested incorporating those into care staff training programs. Castle16 
reported the perceptions about elder abuse among administrators and direct care workers in 1,500 
randomly selected ALRs nationwide, documenting that R-REM was reported to be more common 
than staff-to-resident abuse. A recent study17 reported the 30-day prevalence of physical (7.6%), 
verbal (9.5%), and sexual (2.0%) aggression by ALR residents towards other residents or staff 
based on data from the 2010 National Survey of Residential Care Facilities. They found a five, 
four, and two-fold increase, respectively in the likelihood of engaging in these behaviours for 
residents with Alzheimer’s disease and related disorders. These authors call for training and 
prevention in ALR. Thus, R-REM in residential care in general, and specifically in AL settings, 
although prevalent, has received little attention. 
The authors conducted the first systematic, prospective study of resident-to-resident elder 
mistreatment (R-REM) in nursing homes and have developed novel methodology to identify the 
phenomenon.  Data demonstrated that (1) R-REM is highly prevalent, (2) case finding 
methodology is greatly enhanced by meaningful participation of front line staff, and (3) 
paradoxically, higher functioning residents may be at greatest risk for involvement in R-REM (e.g., 
residents who are ambulatory and capable of wandering as opposed to those who are in the last 
stages of dementing illness). Additionally, funded by the New York State Department of Health 

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dementia grants program we developed a three module-program targeting front line staff to 
implement best practices related to R-REM in long-term services and support (LTSS) settings.  
Using an experimental design, we tested the intervention in nursing homes. Evaluation of 
longitudinal outcomes showed significant increases in staff knowledge post training, controlling for 
pre-training levels for the intervention group and of increased recognition of R-REM, and 
longitudinal reporting in the intervention as contrasted with the usual care group.18 Additionally, 
falls, accidents and injuries were reduced.19 These findings have important implications for 
assisted living residences (ALRs) where residents typically have cognitive impairment with better 
mobility and less staff to intervene in R-REM.  The state survey process is also less uniform in 
ALRs (in comparison to nursing homes) and has not addressed R-REM. 
 
Objectives  
The goal of the project is to evaluate a training program for staff that enhances identification and 
intervention with respect to episodes of resident-to-resident elder mistreatment (R-REM). The 
hypotheses corresponding to the specific process outcome aims (1 & 2) and primary distal 
outcome (aim 3) for which the study was powered are: 
Aim 1 (A1).  Enhance staff knowledge of R-REM  
Hypothesis 1: Staff knowledge related to R-REM and R-REM treatment will increase after 
training. 
Aim 2 (A2).  Enhance staff recognition, reporting and care planning related to R-REM  
Hypothesis 2: Due to the heightened awareness as a result of training, the frequency of 
reported R-REM in the intervention group will increase, relative to the comparison group 
after training. 
Aim 3 (A3). Evaluate the impact of the staff intervention on resident falls, accidents and injuries 
and on quality of life using a prospective experimental design that derives information from 
five sources:  (1) resident interviews (2) staff informants (3) observational data (4) chart and 
(5) incident/accident report data. 
Primary Hypothesis: The frequency of falls, accidents and injuries will decrease in the 

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intervention group, relative to the comparison group after implementation of the training 
intervention. 
Secondary Hypotheses:   1.  Resident quality-of-life as measured by affective state will 
improve in the intervention group, relative to the comparison group after implementation of 
the training intervention. 
2.  Resident behavior problems will decline in the intervention group, relative to the 
comparison group after implementation of the training intervention. Resident behaviors will 
mediate the relationship between the intervention and the falls/accidents/injuries outcome. 
Trial design  
This is a pragmatic, prospective, cluster randomized trial (facility level) design with three waves of 
data collection (baseline, 6- and 12-months) at 12 assisted living facilities in two New York regions. 
There will be three levels of clustering:  facilities within regions, units within facilities and repeated 
measures on residents within units, with the regions fixed. On a rolling basis, six facilities will be 
selected at random and recruited in New York City and the nearby suburban counties (downstate 
region). Six facilities in the upstate New York region of Rochester will also be randomly selected. 
Three facilities in each region will be randomized to usual care or to the intervention on a 1:1 ratio. 
Facilities allocated to the usual care group will receive the intervention after completion of their 12 
month data collection.  
 
Methods: Participants, interventions and outcomes 
Study setting  
Because an aim of the study was to examine resident-to-resident elder mistreatment (R-REM) in 
all residents, including those with Alzheimer’s disease, to maximize resources, we restricted our 
sample to larger licensed ALRs with special needs (including memory care) units in the two 
selected New York regions.  The sample includes facilities with special needs units because the 
likelihood of R-REM is greater there.20  Upstate we selected from the population of 33 facilities with 
bed sizes of 50 and over with special units for individuals with cognitive impairment. Downstate, 
there are 50 larger (80+ bed) facilities with special needs units for cognitive impairment in the 

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selected area.   
 
Eligibility criteria  
Because of the longitudinal nature of the study, it was desirable to screen out short-stay residents. 
All residents on long-term care units, except residents receiving hospice care in the sampled 
facilities will be invited to participate.  
Facilities will have the option to exclude individuals for selected reasons. For residents unable to 
complete the consent process (due to e.g., cognitive impairment, language barrier, health 
impairment), consent will be sought by designated proxies (families or legal guardians).  Residents 
unable to respond (due to language other than English or Spanish, or impairment) will be excluded 
from resident level measures; chart review, staff informant, and observational measures will be 
performed on those whose families provide proxy consent.  
 
Who will take informed consent?  
A formal “Informed consent and HIPAA Authorization” document was approved by the Weill 
Cornell Medicine Institutional Review Board (IRB). A brief screen is used to determine capacity to 
provide informed consent. This procedure has been used in several large studies of nursing homes 
and assisted living residents and has been approved by several IRBs. (Family members of 
individuals who are unable to provide informed consent will be contacted to obtain consent.) 
Additionally, family members of all residents will be sent letters informing them of the study with an 
opt-out option. 
The actual informed consent is obtained after the resident either a) reads the Informed Consent 
Form, or b) the interviewer reads the Informed Consent Form to the resident. 
There are several cases where a verbal informed consent is used in place of a written informed 
consent: 
    1) If the resident has a perceptual impairment that makes it difficult for her/him to read/sign the 
Informed Consent Form (e.g., visual impairment) 
    2) If the resident is illiterate, the interviewer reads the Informed Consent Form to the resident  

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    3) If the resident has a physical impairment that prevents her/him from writing (e.g., contractures 
in both arms, paralysis, etc.) 
    4) If the resident does not wish to sign the Informed Consent Form, but verbally indicates that 
s/he is willing to participate in the interview 
Per the IRB, in these cases, an observer not associated with the research (e.g., facility staff) must 
witness the verbal consent process.  
 
Interventions 
Explanation for the choice of comparators  
After successful implementation of the R-REM research protocol in nursing homes, the authors 
wanted to further test the intervention in another LTSS setting with a similar population but with 
less staffing and state oversight. Assisted living was selected because it is an area of LTSS that is 
growing rapidly both in numbers of facilities and in terms of the populations served. 
 
Intervention description  
The intervention, i.e., the training of nursing, social work, administrative and other staff on R-REM 
is conducted in three separate sessions: 1) Recognition and Risk Factors, 2) Management, and 3) 
Implementation of Guidelines. The trainer who administers the three modules is an experienced 
doctoral level, adult education professional who participated in the development and modification 
of the modules; she has extensive experience in staff training. Modules are provided to facilities 
randomized to the intervention after the completion of baseline data collection, and to those 
randomized to usual care after completion of 12-month follow up data collection. 
Description of Module 1: Recognizing R-REM:  Module 1 covers the extent of R-REM which 
includes: evidence; risk factors associated with the victims, perpetrators, and environment; and the 
role of cognitive impairment. Different forms of mistreatment are covered, including physical, 
psychological, sexual, and theft.  This module is delivered in the form of an experiential half-hour 
in-service training, plus pre- and post-tests designed to be conducted at the ALRs.   
Description of Module 2: Management of R-REM  

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A. 
Introduction and review of previous session and pretest 
B. 
Film on management of elder mistreatment  
C. 
A presentation of the SEARCH (Support, Evaluate, Act, Report, Care Plan, Help to Avoid) 
approach to R-REM management;  review, lessons learned; post-test.  
 
The 25- minute film for this module was designed by the research team and directed and produced 
by the New York University Department of Media Production. It was narrated by distinguished 
journalist, Charles Osgood, and includes a discussion of what constitutes putative evidence of 
serious abuse, such as bruises, cuts, or more serious injuries (broken bones or cracked ribs). 
Mistreatment such as verbal aggression and threats, sexual harassment and missing belongings 
are discussed. Three skits by professional actors are presented. 
Skit 1: Most obvious form of elder mistreatment: physical assault; Skit 2:  Less obvious form of 
elder mistreatment: verbal insult; Skit 3: Subtle form of elder mistreatment: psychological abuse, 
e.g. wandering uninvited into another’s room and rummaging through another resident’s property. 
Each skit is followed by an example of a poor staff response to the event as well as a better 
practice, and by commentaries by leading multidisciplinary experts in elder abuse, representing 
different perspectives: psycho-social, medical, nursing, administrator/legal.  
The final component of the video is a review of nine steps to manage and curb R-REM.    
 
Description of Module 3: Implementation of best practices related to R-REM  
1.  Introduction and review of previous session;  
2.  Presentation of implementation methods and forms (The R-REM Behavior Recognition and 
Documentation Sheet -- BRDS); discussion of methods for completion; 
3. Presentation of filmed vignettes for practice in the completion of the BRDS; 
4. Review practice sheets and lessons learned; 
5. Review of implementation guidelines. 
The focus of this session is on the intervention fidelity and implementation measures, including 
implementation of reporting guidelines. The training includes video vignettes that are rated and 
reviewed to confirm skills.  Ways to enhance positive group relationships and the use of 

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community to counteract individual acts of mistreatment are discussed, addressing the question, 
How can staff work together to structure the social and physical environment to mitigate R-REM?  
The importance and rules for reporting R-REM are reviewed.   
 
Criteria for discontinuing or modifying allocated interventions  
There are no predetermined criteria for discontinuing or modifying the intervention. 
 
Strategies to improve adherence to interventions  
Each session is scheduled twice for all shifts, including the night staff.  Additional makeup sessions 
are available for those staff unable to attend the original training sessions. Facility administrators 
alert the staff of the mandatory training sessions using several methods including flyers posted in 
the staff room and notices in pay stubs. 
 
Relevant concomitant care permitted or prohibited during the trial  
None 
Provisions for post-trial care  
There are no such provisions for this non-invasive minimal risk intervention for ALR staff. 
 
Outcomes  
Aim 1: Process level 2 evaluation of staff knowledge outcomes: Knowledge tests: Ten 
question pre-post knowledge tests were developed for each of the first two R-REM training 
modules, i.e., Recognition and Risk Factors, and Management (the SEARCH approach) based on 
its respective content.  An additional knowledge test was developed for the third module: 
Implementation Guidelines, in order to assess use of the BRDS to document R-REM events.  The 
latter test compares staff answers to the gold standard ratings. Hypothesis 1, regarding enhanced 
staff knowledge will be examined for individual knowledge items using paired t-tests, comparing 
pre–post knowledge scores between groups, adjusting standard errors for clustered data within 

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facilities. Group differences in total scores will be examined using a linear mixed (fixed and random 
effects) model for effect estimation. 
Aim 2: Process level 3 evaluation of implementation outcomes: Recognition and reporting 
using the R-REM Measures:  R-REM behavior recognition and documentation sheet (BRDS): 
This measure was based on the Shift Coupon, a form originally designed by nursing staff to 
provide a “quick, easy, anonymous, and non-threatening method to report adverse events,”21 and 
is in the form of a small note pad. BRDSs are intended to measure recognition and capture real 
time R-REM events. Hypothesis 2, regarding enhanced R-REM recognition will be examined with a 
Chi-square analysis comparing counts of BRDS reports from experimental and comparison 
facilities captured over time, and treated as binary incidents. Reporting implementation will be 
examined by evaluating the differences between experimental and comparison group staff reports 
of R-REM, collected over three waves. Individual R-REM reporting will be determined by counting 
whether any of the staff-reported R-REM indicators are positive. The object of this analysis is not 
to identify individuals and perpetrators, but to examine the reported events. In modeling R-REM 
events, a Poisson regression of count data will be performed.  
Aim 3: Primary level-4 evaluation of distal outcomes: Summary of the sources of data for 
determining falls/accidents/injuries and incidents of R-REM: The data used for evaluation of 
the primary distal outcome and for R-REM reports include (a) self-report among those residents 
who are capable, (b) Accident and Incident Reports, (c) resident record review, (d) observational 
data, including the BRDS, and (e) reports from staff. In addition, an environmental evaluation will 
occur. Data for falls and injuries will be collected via chart review, staff report and residents who 
can self-report, and from Incident/Accident Reports on an ongoing basis. Resident and staff 
informant information will be collected at baseline, 6- and 12-month follow-up. Falls will be 
considered as binomial (any fall) and Poisson distributed (fall counts). 
 
Sample size {14} 
Power calculations are provided for the primary distal outcome: falls, including accidents and 
injuries, also the outcome requiring the largest sample size. Upstate it is expected that an average 

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of 50 residents per site will be selected for a total of 300.  Downstate, the facilities are larger, and it 
is expected that the average size will be 125 residents or 750 total. The proposed sample size is 6 
facilities and 525 residents per arm. 
Using the canonical link (Logit), the generalized linear model (GLIMMIX):
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inflation factor (Vif) and reliability(Rel):  m=Vifm* / Rel and  
Vif = (1+ (ne – 1)ρe)(1+ (ns -1) ρsnepe/(1+(ne-1) ρe)) 
 where ns=5 is the average number of units in the facility, ρs=0.015 is the ICC for facility, ne =17 is 
the average number of residents in the unit, ρe =0.03 is the ICC for unit, and the reliability: 
Rel=0.95.   
The following table assumes α=0.05, power (1-β) =80%, R=0.95 and Vif=2.5 (With ne=17, 
ICCUnit=0.03, Ns =5, ICCFacility=0.015, the fall rate at follow-up: p0=33% and p1=20.75%). Two 
scenarios for ρ (the average correlation of the outcomes over waves) were posited: 
As shown, with 525 per group, power is adequate for intent-to-treat (ITT) analyses, including all 
respondents.  Because randomization is at the facility rather than individual level, there is the 
potential for imbalance on baseline variables and missing covariate data.  Assuming attrition of 
Group 
Fall rate P(y=1) 
Diggle Method 
GEE Method 
Baseline 
Rate 
6  
Month 
12 
Month 
Combined 
6M & 12M 
M 
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404 
431 
399 
425 

Page 11 of 34 
15% at wave 1, it is estimated that 445 per group will have at least baseline and one additional 
wave of data included, using the EM missing data algorithm; thus, power is adequate to detect the 
posited difference in fall reduction of about 12% even with attrition.  
 
Recruitment  
All residents are approached and invited to participate. For those who do not wish to be 
interviewed, a different or the same interviewer approaches again at another time that may be 
more amenable to the resident. All resident questions are addressed and interviews occur at a 
time and place preferred by the resident.  
 
Assignment of interventions: allocation 
Sequence generation  
Algorithms for conducting randomization that take into account clustering such as exists with 
geographical regions and rolling enrollment have been developed by the author.  This method has 
yielded balanced groups for many studies.  This randomization procedure will be carried out using 
a SAS macro after a facility completes the baseline interview.  A random number from 0 to 1 will be 
used to determine the assignment group.  The standard cut score will be set at 0.5 for the first n 
facilities from the same region.  Facilities which receive a random number between 0 and 0.5 will 
be assigned to the usual care group and those with a random number greater than 0.5 will be 
assigned to the intervention group. The balance between the groups within each group will be 
carefully weighted after the total number of facilities from a group reaches a number greater than 
n.  Before the randomization procedure, the number of facilities randomized to each arm for each 
region will be estimated using SAS macro programs.  If more than the n facilities are randomized 
initially, the cut score for the next facility is equal to the ratio of the intervention group (n1) to the 
facilities already randomized (m) for that group (n1/m).  For example, group A region provides 
eight facilities for randomization and the n is set to 5, the first five facilities (n) will be randomized to 
the standard cut score 0.5 (about half will go to the intervention and half to the usual care group).  
The sixth facility’s randomization cut score is equal to the number of facilities in the intervention 

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group (n1) divided by the total number of facilities randomized within that group (in this case, the 
denominator m is 5.) The seventh facility's cut score will be adjusted according to the previous six 
facilities, and so forth.    
 
Concealment mechanism  
The biostatistician who runs the randomization procedure passes the information directly to the 
intervention trainer who alerts the ALRs of their assignment. The principal investigator who 
oversees the data coordinating centre (DCC) at the Research Division, Hebrew Home at Riverdale 
(RD-HHAR) is the only other person made aware of the assignment.  
 
Implementation  
A biostatistician at the coordinating centre developed and runs the randomization procedure. 
Randomization occurs at the facility level. Research interviewers who enrol participants are blinded 
to randomization group. 
 
Assignment of interventions: Blinding 
Who will be blinded  
Research staff who interact with facilities are blinded to the extent possible; project managers, field 
managers and research interviewers are not made aware of the site assignment. ALR residents 
are not made aware of group assignment. It is possible that ALR staff in facilities assigned to the 
intervention may mention the training to research staff at either the 6- or 12-month follow-up data 
collection. 
 
Procedure for unblinding if needed  
Not applicable, there are no circumstances where unblinding would be needed. 
 
Data collection and management 
Plans for assessment and collection of outcomes  

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Data for aim 1: Ten question pre-post knowledge tests were developed for each of the first two R-
REM training modules. Data for aims 2 and 3 are derived from five sources:  (1) Resident 
interviews (2) Staff informants (3) Observational data (4) Chart and (5) Incident/accident report 
data. Research interviewers attend a 5-day training session that includes how to administer 
questionnaires. Training continues in the field.  
1.  Resident interview 
Determination of capacity to provide informed consent and participate:  A brief screen will be used 
to determine capacity to provide informed consent (see Protection of Human Subjects). 
Institutional Comprehensive Assessment and Referral Evaluation (INCARE).22,23,24  Individuals who 
are able to provide informed consent (or whose family members consent on their behalf) will be 
assessed with the INCARE, a multilevel-multi source instrument that contains quality of life 
outcomes and case-mix covariates and allows at least some assessment to be completed across 
all levels of residents. It includes: (a) arousal and cognitive functioning, (orientation, memory, 
calculation / attention), (b) range of motion and ambulation, (c) affect and (d) behavior.  It includes 
the Care Dementia Diagnostic Scale (CAREDIAG) which has been studied using several 
advanced psychometric models, including analyses of its relationship to dementia diagnosis.25,26 
Scales for each construct have evidenced moderate to high (Cronbach’s alpha) reliability 
coefficients.  Estimates for the ADL scales range from 0.59 for standing disability to 0.95 for Total 
ADL/Ambulation disorder; from 0.86 to 0.94 for the cognitive scales; and 0.90’s for the behavior 
scales.27 The McDonald’s omega was estimated at 0.95 for the CAREDIAG. 
The Feeling Tone Questionnaire (FTQ): The FTQ measure of affect contains 16 questions asked 
of the resident. Typical items are:  "Are you feeling well?"; "Are you feeling happy today?"; "Do you 
feel lonely?".  Each item is coded “yes”, “no” or "equivocal (sometimes, it depends)", and the 
response rated for affect using a 5-point continuum from  1 -- "laughs, praises, enthusiastic, 
emphatically positive" to 5 -- "extreme negative -- cries, groans, curses, is emphatically negative".  
Three scales are scored: Response, Affect and Total.  The FTQ has been used among numerous 
samples of nursing home residents, in which reliabilities were in the 0.90's. In an AL sample alphas 

Page 14 of 34 
ranged from 0.73 to 0.90 at baseline and from .77 to 0.93 at follow-up. The measure has recently 
been evaluated and shortened28 using a large sample of 6000 LTSS residents, including AL. 
Performance Activities of Daily Living (PADL): The PADL29 (alpha typically in the 0.90’s)30 is a 27-
item scale that measures an individual’s lack of ability to perform various upper and lower body 
movement tasks associated with eating, dressing and grooming, such as putting on a sweater, 
buttoning and unbuttoning a sweater, guiding a spoon to the mouth, combing hair independently. 
Performance times are recorded, and items are rated as to whether the task was performed with or 
without cueing, or could not be performed at all. 
Extended Interview: An extended Interview will be administered to participants with sufficient 
cognitive abilities to respond.  Research has demonstrated that many residents can reliably self-
report yes/no questions about daily care,31 life satisfaction,32 pain,33 and quality of life.34,35,36 It is 
anticipated that about 70% to 80% of residents will be included at this stage. This interview 
includes scales of fear of falling/ falls history, depression/ affect, and ADLs.37 The number of falls 
experienced in the past year and the Fear of Falling scale, comprised of eight items tapping 
feelings regarding fear of falling and the reasons for fear, will be administered.  The alpha 
coefficient for this scale for a prior NY State Assisted Living sample was .84 at baseline and 0.85 
at follow-up. Depression scales: The Short Care 38,39,40,41,42  (alpha of 0.83 for an assisted living 
sample at baseline and 0.81 at follow-up) typical items are “feeling sad or depressed during the 
past month,” “cried during the past month”, and “lie awake at night with depressed thoughts.” 
Included is an anchored four-point global rating of happiness level. We will also include the Patient 
Reported Outcomes Measurement Information System (PROMIS) Depression scale.43 
Resident to Resident Elder Mistreatment- Resident Version (R-REM-R):  For residents who are 
capable, the R-REM-R will be used to determine whether an incident of R-REM has been directed 
at the respondent. This measure was created by the applicant team by combining desirable 
aspects of the most commonly used instrument in violence research44 with a measure used to rate 
behavioral disturbance in LTSS.45 The measure contains 22 items related to verbal, physical, 
sexual and other behaviors along with their frequency during the two weeks and the past year. 

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After focus groups with LTSS staff, more R-REM items were added and a follow-up distress 
question was added to all endorsed items. The Cronbach’s alpha estimate for the scale was 0.90.   
2. Staff Informant Interview 
A brief Informant interview will be administered to the staff member most familiar with the 
participant. 
Nurse Informant Rating of Behaviors:  The Nurse/Primary Care Worker Informant Interview46 will 
be used. Typical items include: “Wanders during the day;” “Repetitive questioning”; 
“Argumentative”; “Demanding”; and “Disrupts other’s activities”.  Items are rated for frequency: 
“Not at all”; “Sometimes (1-4 times per week)”; and “Often (5+ times per week)”. The Cronbach’s 
alpha estimate was in the 0.80s, and the 0.60s in an urban and rural LTSS sample.47 
The R-REM Staff Version was developed along with the resident version (see above). R-REM is 
operationalized as staff endorsing (or incident reports of) any items on the R-REM Interview.  The 
following instructions are given to staff:  “We are trying to find out about things residents have done 
to other residents.  I’d like you to think about incidents involving (resident) and one or more people 
living here.  We’ll focus on different forms of resident-to-resident mistreatment.  This can include 
verbal incidents like: residents saying mean things to each other, insulting each other’s race or 
ethnic group, and/or screaming at each other.  Physical incidents can include: hitting, pushing, 
and/or grabbing. Sexual incidents may include touching, or saying or doing sexual things that 
made other residents feel uncomfortable. We are also interested in incidents involving other 
residents going into rooms without being asked, touching personal things, or throwing things.  We 
are referring to both serious reportable and minor incidents that would not necessarily be formally 
reported.  Remember we are talking about incidents in the past two weeks that involved 
(resident).” A list of R-REM behaviors is provided. Location, time, the identity of the person who 
started the incident and a description of other participant(s) (sex and relationship) are recorded. 
The staff member reports what s/he did about this (e.g., separated or redirected residents). The 
Cronbach’s alpha estimate for the R-REM scale was 0.90. The Schmid-Leiman bi-factor model 
identified three group factors: verbal, physical and a less differentiated factor including items on 
room invasion, throwing and threatening gestures. An additional item related to sexual encounters 

Page 16 of 34 
was also included.48,49  The alpha estimate from the “psych” R package50,51  was 0.94, omega 
hierarchical 0.76, omega total 0.97 and explained common variance (ECV) 52 was 0.59.  
3. Observational Data  
A. For each participant, ten five-minute observations are performed by trained interviewers at 
different times of the day and in different locations in order to obtain additional information about 
incidents of R-REM and other disturbed behaviours. While episodes of R-REM are likely to be brief 
and intermittent, based on our experience in the nursing home study, interviewers did observe 
many incidents of R-REM. The Total Observation Checklist includes 14 affect and 37 behaviour 
items (Observed Behavior Checklist).53  Frequencies of affective and behavioural states are coded 
as: “Not at all”, “Very little (1 or 2xs during observation period)”, “With some frequency (several 
times)”, “With moderate frequency (many times but not continuous)”, or “With great frequency 
(continuous)”.  Typical affect items include: “Crying”; “Agitated”; “Emotionally labile”. Typical 
behavioural items include: “Disruptive of others”; “Wandering”; and “Argumentative”. In an urban 
LTSS sample, the Cronbach’s alphas ranged from .74 to 0.85 and from 0.85 to 0.87 in a rural 
LTSS sample.54   
B. R-REM behavior recognition and documentation sheet (BRDS): This measure was based on the 
Shift Coupon, a form originally designed by nursing staff to provide a “quick, easy, anonymous, 
and non-threatening method to report adverse events,”55 and was in the form of a small note pad. 
BRDSs are intended to measure recognition and capture real time R-REM events. These forms 
are designed as prescription pads to be carried in the pockets of staff.  They are distributed at the 
training sessions (module 3 for intervention facilities and during the opening of the unit for usual 
care staff); additional pads are available at a central location. Sheets are torn off after documenting 
R-REM. Items include: residents involved, identity of the perpetrator, actions involved, location, 
potential cause, and what did you (staff) do about it. Boxes for completed forms are placed in a 
designated location on each unit. 
C. Event logs: When an event is reported from a) resident interview b) staff interview c) interviewer 
observation, or d) BRDS, the research interviewer will complete an Event Log worksheet in order 
to better understand the circumstances of the R-REM event. This form contains descriptive 

Page 17 of 34 
information about the event, its time and place, the reporting source, the participants, and 
environmental factors at the time of the event.   
4. Chart data 
Demographic variables of interest include age, race, educational attainment, and length of stay in 
the facility. Medical diagnoses, medications, activities of daily living, cognitive impairment and 
mental health data will be extracted from the Assisted Living Residence Medical Evaluation form. 
Diagnosis information will be integrated into a comorbidity index, in order to adjust for burden of 
chronic illnesses. Interrater reliability will be examined on a random subset of charts. In addition, 
physical function, including history of falls in the past 3 months, frequency of falls, resulting injuries 
and open-ended comments and behavioral issues data will be extracted from the Assisted Living 
Resident Evaluation Form that is completed at admission. The resident Individual Service Plan will 
be reviewed for reports of occurrences of R-REM, falls, incidents and injuries and other covariate 
information that develop from three months prior to baseline through the study end. 
5. Accident/ Incident Reports 
The New York State Department of Health mandates electronic transfer of accident and incident 
reports to regional offices as part of licensing standards for ALRs statewide. Federal regulations 
require the reporting of alleged violations of abuse, mistreatment and neglect, including injuries of 
unknown origin to the facility administrator and in accordance with state law. The reports will be 
reviewed for potential incidents of R-REM and falls. Data will be collected from three months prior 
to the study through the end of data collection.  Each incident report reviewed for resident falls/ 
accidents/ injuries may also contain evidence of R-REM.  
6. Environmental Assessment 
In addition, physical environment is assessed (direct assessment at local site): The modified 
Therapeutic Environment Screening Scale (TESS)56 will be used by research staff to measure the 
physical environment. The TESS includes 12 domains: unit autonomy, exit control, maintenance, 
cleanliness, safety, lighting, space/seating, physical appearance/homelikeness, access to 
outdoors, orientation and cuing, privacy, and noise, and a scale measuring quality.  These data will 

Page 18 of 34 
be collected for descriptive purposes, and for possible inclusion in hierarchical linear models.  
Facility and unit characteristics will also be collected. 
 
Plans to promote participant retention and complete follow-up  
Based on our experience in the conduct of many studies with residents in long term care facilities, 
we expect 15% attrition at 6 months and up to 40% at 12 months follow up, mainly related to 
discharge, hospitalizations and death.   These percentages have been considered in the power 
calculations. All enrolled individuals who still reside at the facility at the follow-up visits will be 
invited to participate at follow-up at a convenient time for the respondent. Multiple attempts will be 
made to interview these residents. 
 
Data management  
Data entry and quality: All screening and evaluation data will be collected using a computer 
assisted personal interview (CAPI) system. This method provides accuracy in data collection, 
because the system does not accept out-of-range values, and does not allow for deviation from 
prescribed skip patterns.  The DCC will create scoring and cleaning programs for scales within 
instruments. Although the CAPI and data entry systems should not allow these types of errors, the 
cleaning programs serve to double check the accuracy of the data. Periodically, the data manager 
will review all data for duplicate records, illogical collection dates or times of interview, outlier and 
out of range values, and illogical contingencies using program syntax created for each data file. 
After any corrections are made, items distributions will be reviewed to make sure no anomalies 
remain. In addition, the project coordinator periodically reviews entire files as a quality assurance 
measure. 
Data storage, data safety and security: All laptops used for data collection and office based 
desktop computers are password protected and Bitlocker encrypted. Laptops will not leave the 
facility. Laptops with encrypted data are stored in a locked cabinet at the facility and not removed 
until study end. They are dedicated to the project and not connected to the internet. Log sheets will 
also be kept in a locked onsite storage area.  

Page 19 of 34 
At the DCC, electronic data are backed up daily or weekly to a backup server depending 
upon the receipt of data. Additional backup external hard drives are stored in a fireproof safe. 
Protected Health Information (PHI) is confined to a secure device that is not connected to the 
internet. All computers are password protected and the whole drive is encrypted with Bitlocker 
encryption. They are on a non-routable LAN network. No file and database servers are accessible 
to the public through the Internet. A hardware-based firewall device protects the network system 
against hackers and any unauthorized internet access. Spam and email filtering is built-in within 
the firewall device. The anti-virus software (McAffee Anti Virus) protects the network from threats 
of viruses, worms and Trojan horses and other malwares contained in email attachments and also 
from files downloaded through the internet. Through "push-technology" this anti-virus software is 
automatically updated for all virus definitions and other updates.  
 
Confidentiality  
The field coordinator will oversee the onsite assignment of individual IDs. These ID numbers will 
not contain PHI (e.g., social security number, medical records number, etc.) The list of assigned 
IDs with minimal PHI (name, date of birth and date of admission) is maintained in a locked cabinet 
at an on-site location during the course of data collection and later transferred to a secure cabinet 
at the DCC. Data-collection files will be identified only with coded IDs. In compliance with HIPAA, 
individual participant confidentiality will be assured using ID codes throughout data processing and 
analyses. Additionally, none of the analyses will permit identification of any individual by name. 
The interviewers will be aware of the linkage between individual and ID numbers. At the DCC, 
individual participants will be known only by their ID numbers, which will be used as the basis for 
communication with the interviewers in the event of data anomalies. The clinical/research barrier 
will remained intact, in that it is not necessary for any of the data-processing staff to be familiar 
with the identity of the participants.  No PHI will be stored in devices linked to the internet. 
 
Statistical methods 
Statistical methods for primary and secondary outcomes  

Page 20 of 34 
Analyses for the primary hypothesis for the distal outcome:  The primary analyses will 
examine, on an ITT basis, the differences between the usual care and intervention groups in the 
reduction of falls/accidents/injuries over time.  Other approaches, e.g., the analysis of the “as 
treated” sample can result in biased estimates of the causal treatment effect due to compromised 
random assignment. Our primary approach to analyses is guided by our own experience,57 and 
reviews.58,59  Depending on the level of missing data, analytic strategies (see below) can be used 
to address non-compliance, e.g.60   Based on prior trials that we have coordinated, sampled from 
this population, 1 year attrition is between 30% and 40%; thus for 6-month data (projected attrition 
of 15%), the ITT analyses of all subjects will be feasible.  Longitudinal analyses will include those 
with at least baseline and one follow-up.  Sensitivity analysis will be performed using multiple 
imputation under different assumptions for missing data. 
Because randomization is at the facility rather than individual level, imbalance may be 
observed on baseline variables.  Preliminary analyses will be performed to determine whether the 
groups are balanced. Two-tailed tests of significance will be performed. Binomial tests are to be 
conducted on dichotomous variables, Poisson tests on nonbinomial (e.g., count) data, and t tests 
on ordinal data, adjusting standard errors for clustered data within facilities; p values are reported 
because the design does not permit randomization at the level of the individual.  
Effect on likelihood of falls/injuries/accident reduction:    
Statistical methods appropriate for clustered data will be used in the primary analysis to compare 
the groups with respect to the binary outcome. Generalized mixed effects models (MEMs) will be 
used to test the hypothesis that those assigned to the intervention will experience a significantly 
higher rate of fall/accident/injury reduction as contrasted with usual care. The outcome will be 
modeled as a function of intervention, time and their interaction and controlling for the baseline 
falls.  To account for the clustered nature of the outcomes, the models will include random effects 
for facilities, units and subjects. The models will be fit using mixed effects logistic-regression as 
implemented in SAS Proc Glimmix. The appropriate covariance structure will be determined. The 
primary analysis will be supplemented with an exploration of the effect of baseline subject, facility 
and unit characteristics on the intervention effect. These results will inform generalizability of 

Page 21 of 34 
intervention effects.  
 
Analyses for secondary outcomes:  The proposed secondary outcomes are affect, measured by 
the FTQ and the NIH PROMIS depression measure,61,62 ,63    and behavior.  The reliability estimates 
of the outcomes are typically at least 0.90.  Methods for analyses of treatment effects in pre-post 
clinical trials, in the context of missing data, have been compared.64,65,66,67,68,69   The primary 
proposed analyses will use MEMs, and a full information likelihood approach, with sensitivity 
analyses using generalized estimating equations (GEE). 
Statistical models: The primary endpoint analysis for comparison between the two groups with 
respect to various outcomes will be based on models for the outcome at 6 and 12 months as a 
function of the intervention condition, adjusting for the baseline value of the outcome, i.e. an 
ANCOVA-type MEM analysis with intervention as a factor with two levels and baseline value as a 
covariate.  For multiple outcomes (e.g. NIH PROMIS and FTQ) MANCOVA-type MEMs will be 
used to simultaneously model the multiple outcome variables.  An additional factor (domain) 
denoting the individual outcome variables will be included in the model together with interactions 
between domain (depression/affect measures) and intervention.  A significant interaction term 
would indicate that the effect of the treatment is different for affect and depression; in that case two 
treatment effects will be estimated for each outcome. If the interaction is not significant a model 
with only main effects for depression/affect and treatment will be fit and the (common) treatment 
effect will be estimated from this model. In addition to significance testing, we will estimate the 
treatment effects with 95% CI.  The MEMs allow modeling the correlation between the variables 
assessed on the same subject and that between subjects from the same units and facilities.  
Group differences in total scores will be examined using a linear mixed (fixed and random effects) 
model for effect estimation. 
The use of SAS Proc MIXED will allow for the possible group heterogeneity in residual variances 
that may require modeling to satisfy model assumptions and improve model fit, and the modeling 
of the covariance structure.  In secondary analyses, we will examine within subjects change over 
time. We did not perform power calculations for the secondary outcomes because the most 

Page 22 of 34 
stringent power requirements are for the primary outcome.  However, we will be able to detect 
relatively small effect sizes, given the sample size. 
Examination of the exploratory potential mediating effects of behavior on the relationship 
between the R-REM intervention and the falls/injuries/accident outcome will be examined using 
mediation analyses. Although recent evidence from Monte Carlo studies support simple joint 
significance tests of the mediating path coefficients,70,71,72  also examined will be other formal tests 
of mediation effects.73,74 
Based on prior experience with the outcomes, it is not expected that transformations will be 
necessary.  Baseline variables will be examined by study arm; however, no p values will be 
provided, and covariates (other than baseline values) are not proposed for inclusion in the main 
analyses of treatment effects.  
Examination of potential region differences: Data from regions (upstate and downstate) will be 
combined and each outcome (e.g., depression, affect) modeled as a function of two factors (i) 
intervention, a factor with 2 levels and (ii) region, a factor with 2 levels, and the interaction between 
(i) and (ii). MEMs will be used for each outcome, e.g., depression, and likelihood ratio tests (χ2) 
used to test for significance of the interaction term.  The study is not powered to detect meaningful 
regional differences in treatment effect; therefore we will use =0.15 as a criterion, and explore if 
regional differences are related to differences in intervention effects.  
 
Interim analyses  
There are no plans for interim analysis or predetermined stopping guidelines. 
 
Methods for additional analyses (e.g. subgroup analyses)  
Heterogeneity of Treatment Effects (HTE): Because there is interest in examining subgroups to 
determine for which individuals interventions may be effective, we will perform descriptive HTE 
with potential effect modifiers as interaction terms. HTE will be examined for subgroups, e.g., those 
with and without cognitive impairment.   
 

Page 23 of 34 
Methods in analysis to handle protocol non-adherence and any statistical methods to 
handle missing data  
Examination of baseline differences on key variables between completers and those lost-to-follow-
up will be conducted to inform about the nature of the missing data. The ITT analyses performed 
using MEMs will permit all individuals with at least one post-baseline observation to be included.  
Depending on the level of missing data, analytic strategies can be used to address non-
compliance, e.g.75   For the sustainability analyses, analyses will be of those with at least baseline 
and one follow-up.  Sensitivity analysis will be performed using multiple imputation under different 
assumptions for missing data.  Examination of baseline differences on key variables between 
completers and those lost-to-follow-up will be conducted in order to inform about the nature of any 
missing longitudinal data.  Methods of examining missing data, e.g., propensity scores, inverse 
probability, EM algorithm and multiple imputation sensitivity analyses will be considered.  If 
substantial missing outcome data are observed, we will use a specific imputation approach, e.g., 
Markov Chain Monte Carlo procedures76 depending on the amount and pattern of missing data.  
SAS Proc Multiple Imputation and MIAnalyze will be used. We will perform joint simultaneous 
imputation; at least 50 multiple imputations will be generated and PROC MIAnalyze will be used to 
combine the results and estimate the log-odds, adjusted standard errors, and significance.  
 
Plans to give access to the full protocol, participant level-data and statistical code  
There are no such plans at this time. 
 
Oversight and monitoring 
Composition of the coordinating centre and trial steering committee  
The DCC at the RD-HHAR is responsible for oversight of data collection and analyses.  
 
Composition of the data monitoring committee, its role and reporting structure {21a} 
The Data Safety and Monitoring Board (DSMB) or data monitoring committee (DMC) is composed 
of five members including a chair, clinician/ safety officer, and a biostatistician.  The NIA project 

Page 24 of 34 
officer will also attend DSMB meetings.  The DSMB responsibilities include: review the research 
protocol, informed consent documents and plans for data safety and monitoring; evaluate the 
progress of the trial, including periodic assessments of recruitment, accrual and retention, 
participant risk versus benefit, performance of the trial sites, and other factors that can affect study 
outcome; review study performance, make recommendations and assist in the resolution of 
problems reported by the principal Investigator; protect the safety of the study participants; report 
to NIA on the safety and  progress of the trial; and ensure the confidentiality of the study data and 
the results of monitoring. The Board acts independently from the study sponsor.  
 
Adverse event reporting and harms  
All adverse events (AEs) and severe adverse events (SAEs) will be reported by the interviewers to 
the Project Manager who will update the Adverse Events Reporting Form and alert the PI. 
Given that the study intervention is staff training, and there are no physical components to 
the participant evaluation (e.g., no blood draws or physical examinations), it is expected that no AE 
or SAEs will be related to study participation. Given that this is an older study population, SAEs 
(e.g., hospitalizations, death) are expected to occur, with no relationship to study participation. 
Thus, per the NIA sample SAE/AE Process flow diagram, these events are not unexpected and will 
be reported to the DSMB at annual teleconferences. However, in the unlikely event that an AE or 
SAE is determined to be definitely, probably, or possibly related to the study it will be reported as 
follows: SAEs will be reported by the PI to the DSMB, NIA, and IRB within 24 hours of the event 
being reported to the Investigator; AEs will be similarly reported within two weeks of the event. 
Although there will be multiple assisted living facilities enrolled, it is unlikely that these participating 
sites will have their own IRBs; thus, there will not be site specific IRB notification beyond that to the 
Weill Cornell Medical Center and the Hebrew Home at Riverdale IRBs. 
 
Plans for communicating important protocol amendments to relevant parties (e.g. trial 
participants, ethical committees)  
Any protocol amendments will be presented first to the DSMB for approval. If approved, plans will 

Page 25 of 34 
be presented to the IRB. 
 
Dissemination plans  
Study outcomes will be presented in manuscripts in relevant peer-reviewed journals and at 
scientific meetings. Depending on the wishes of the facility administrators, there may be a meeting 
for participating facilities staff to present study findings. 
 
Abbreviations 
AEs: adverse events  
ALRs: assisted living residences 
BRDS: Behavior Recognition and Documentation Sheet 
CAPI: computer assisted personal interview 
CAREDIAG: Care Dementia Diagnostic Scale  
DCC: data coordinating centre 
DSMB: Data Safety and Monitoring Board 
FTQ: Feeling Tone Questionnaire  
HTE: heterogeneity of treatment effects 
INCARE:  Institutional Comprehensive Assessment and Referral Evaluation  
IRB: Institutional Review Board 
ITT: intent-to-treat 
LTSS: long-term services and support 
MEMs: mixed effects models 
NIA: National Institute on Aging  
PADL: Performance Activities of Daily Living 
PHI: Protected Health Information 
PROMIS: Patient Reported Outcomes Measurement Information System 
RD-HHAR: Research Division, Hebrew Home at Riverdale 
R-REM: resident-to-resident elder mistreatment 

Page 26 of 34 
SAEs: severe adverse events  
TESS: Therapeutic Environment Screening Scale 
 
Ethics approval and consent to participate  
This protocol has been approved by the Weill Cornell Medicine IRB (protocol 1710018676) and by 
the Hebrew Home at Riverdale IRB (protocol 0214I/P095/06).  Informed consent will be obtained 
from all study participants.  
 
 

Page 27 of 34 
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