SPEEKO for Elderspeak: A Self-Monitoring App to Improve Communication and Reduce Behavioral Symptoms in Care for Persons With Alzheimer's Disease and Other Dementias
Phase: NA
Conditions: Dementia, Staff Attitude
Sponsor: University of Kansas Medical Center

 
KUMC – HRPP- 03/12/2015 
 
Page 1 of 21
 
 
 
University of Kansas Medical Center  
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
 
Version date: 3/25/2019 
Principal Investigator: Kristine Williams, RN, PhD, FNP-BC, FGSA, FAAN 
 
Study Title: SPEEKO for Elderspeak: A Self-Monitoring App to Improve Communication and Reduce 
Behavioral Symptoms in Care for Persons with Alzheimer’s Disease and Other Dementias 
Co- Investigator(s): Carissa K. Coleman, PhD, MA, Project Director 
 
I. 
Purpose, Background and Rationale 
A. Aim and Hypotheses  
A new person is diagnosed with Alzheimer’s disease or other dementia every 66 seconds, 
and most persons with dementia (PWD) spend the late stages of dementia in nursing homes 
(NHs) where lack of dementia care skills and staff shortages limit quality of care.1,2 Care of 
PWD in NHs is complicated by behavioral and psychological symptoms of dementia (BPSD) 
such as aggression, vocal outbursts, wandering, and withdrawal that occur as PWD lose 
cognitive and communication abilities and cannot express their unmet physical and 
psychosocial needs.3,4 BPSD present to NH staff as resistiveness to care (RTC) that increases 
staff stress and costly time to complete care, often leading to staff turnover, injury, and 
inappropriate use of psychotropic medications to control BPSD. Although Center for Medicare 
and Medicaid Services (CMS) mandates and penalties have reduced antipsychotic medication 
use slightly, contraindicated use in NH residents remains a pervasive problem, causing 
harmful side effects and reducing the quality of life for PWD.5 
 
The PI and other researchers have empirically verified that RTC occurs when NH staff use 
elderspeak (speech similar to baby talk) that features inappropriately intimate terms of 
endearment (diminutives such as “honey”), belittling pronoun substitutions that imply 
dependence (“we” need a bath), and harsh task-oriented commands (“sit down”).6-9 
Elderspeak conveys a message of disrespect and incompetence to residents who react with 
withdrawal or BPSD. Our R03 study established that residents with dementia are more than 
twice as likely to exhibit BPSD (measured by coding RTC behavior in videos) when staff use 
elderspeak instead of normal adult communication.8 Our subsequent R01 trial verified that 
staff reduced their use of elderspeak after attending the three-session Changing Talk (CHAT) 
communication training program, and that this reduced RTC.9 
 
To facilitate dissemination, we developed interactive online CHAT modules (CHATO) that 
provide the same CHAT classroom content with the advantage of flexible and independent 
internet access for busy NH staff, including those in rural and small NHs.10 Recognizing the 
delay and incomplete adoption and application of evidence-based skills in practice, we 
believe additional strategies to optimize CHATO skills implementation are indicated.11-13 
Performance-based reinforcement of skills is effective in achieving greater immediate 
implementation and long-term maintenance of new skills use in practice.14 However, 
feasibility and costs for individualized expert feedback in NH settings are usually prohibitive 
and thus not widely used in practice. 
 
This study will test feasibility and preliminary effects of an automated and performance-
based feedback app that detects and reports the use of diminutives (terms of endearment 
such as honey, dearie, and sweetie) that are prevalent elderspeak terms linked to BPSD. The 
PI and colleagues developed the SPEEKO for Elderspeak app using our archived NH 
recordings to identify the most commonly used diminutives and then to develop algorithms 

 
KUMC – HRPP- 03/12/2015 
 
Page 2 of 21
 
 
 
to detect them in speech.15 Building on proof of concept established in the laboratory, we 
propose to demonstrate feasibility of app use at the point-of-care and will then conduct a 
clinical trial to test preliminary efficacy of the app for amplifying reductions in diminutives 
use for NH staff completing the CHATO training. 
 
SPECIFIC AIMS: 
1) AIM 1. Demonstrate feasibility, acceptability, and validity of the SPEEKO for 
Elderspeak feedback app use by staff in the NH. Five certified nursing assistants 
(CNAs) will use the app during NH care and provide feedback about any needed 
modifications. Hypothesis: The app will be readily used and acceptable to CNAs. 
Diminutive counts determined by the app will be correlated with psycholinguistic 
analysis, validating accuracy. 
 
2) AIM 2. Test preliminary effects of an innovative self-monitoring feedback app on staff 
elderspeak use and compare accuracy to psycholinguistic analyses of audio-recorded 
staff communication. Hypothesis: Staff who receive immediate app feedback (N= 30 
in three NHs) will have greater elderspeak reduction after completing CHATO training 
compared to delayed feedback controls (N= 30 in three NHs). 
 
3) AIM 3. Evaluate app acceptability and costs. Hypothesis: Staff who use the app will 
find it acceptable and beneficial for their practice. Process-based costing will be used 
to determine costs for app use in NHs and other long-term service and support 
settings. Costs will be compared in relation to each group’s outcomes. 
 
B. Background and Significance 
The population afflicted with Alzheimer’s disease and other dementias will expand from 5 to 
16 million by 2050, increasing dementia care costs from $259 billion to $1.1 trillion.
16 Of 
today’s 1.4 million NH residents, 61% have moderate to severe dementia, and up to 90% 
exhibit BPSD such as physical and verbal aggression, agitation, and wandering.
3,17,18 These 
behaviors are associated with depression, reduced quality of life, and lower survival rates 
among PWD.
18 BPSD increase time to provide NH care; staff, primarily CNAs who provide 
most direct care, find BPSD to be the most stressful aspect of their job.
19-21 Considering staff 
stress, burnout, and turnover, BPSD increase costs of care by up to 35%.
22 With annual 
semi-private room costs of $82,200, reducing BPSD would result in significant dementia care 
savings.
23  
 
As cognitive and communication abilities decline due to dementia, NH residents become 
unable to convey care preferences and needs and staff communication becomes infantilizing, 
impersonal, and task-oriented resulting in BPSD. As verified in our research using behavioral 
coding and sequential analyses of video-recorded care, staff elderspeak (communication that 
sounds like baby talk) is linked to resident RTC, a subset of BPSD that disrupts nursing care. 
In our study, NH residents were more than twice as likely to be resistive to care when staff 
used elderspeak compared to normal communication.
8 Thus, improving communication has 
great potential as a nonpharmacological intervention to reduce BPSD in NH care.
24  
 
The Communication Predicament of Aging theory establishes the link between elderspeak 
and BPSD. Elderspeak derives from stereotypical views of older adults as less competent 
than younger persons.
25 When younger people talk with older adults, they modify their 
speech by simplifying, clarifying, and altering the underlying affective quality of 
messages.
26,27 The resulting implicit message of incompetence begins a negative feedback 
loop for older persons, who react with depression, withdrawal, and dependency.
25 Elderspeak 
is especially threatening to self-concept and personhood, critical to the well-being of PWD 
who are likely to respond with BPSD.
28,29 The Need-driven Dementia-compromised Behavior 

 
KUMC – HRPP- 03/12/2015 
 
Page 3 of 21
 
 
 
model recognizes BPSD as the expression of unmet needs of PWD.
30,31 Communication that 
staff can modify to prevent BPSD is an essential part of the environment connecting PWD to 
others and affirming their self-concept.  
 
Psychotropic medications are often used inappropriately to control BPSD in NH residents with 
dementia.
32,33 Alarmingly high rates persist, despite negative outcomes,
34 an FDA black box 
warning of increased mortality for older adults with dementia,
32 and a recent CMS mandate to 
reduce off-label prescribing of antipsychotics.
35 CMS and the National Partnership to Improve 
Dementia Care target reductions in psychotropic drug use as top priority.
36 Despite reductions 
in antipsychotic rates (one type of psychotropic medication) ranging from 3 to 12% from 
2011 to 2016, up to 20% of NH residents still received inappropriate antipsychotic 
medication in 2017.
37 Research has established that educating direct care providers in 
behavioral interventions can control BPSD and also reduce psychotropic drug use,
38-40 and 
this has been confirmed in our research.
9,41  
 
Our recently completed R01 clinical trial that tested Changing Talk (CHAT) communication 
training provides preliminary data for the proposed research. CHAT increases staff 
awareness of elderspeak’s negative effects and guides practice in more effective 
communication. CHAT includes three 1-hour sessions, with replicated effects on 
communication in three studies among staff (N=89) and residents (N=194) in over 20 
NHs.
9,42,43 Effect sizes ranged from η
2 = .35 to .62 for reducing elderspeak diminutives 
(inappropriately intimate terms of endearment) and collective “we” pronoun substitutions, 
effects that were maintained over 2 months. Person- centered (vs. task-focused) 
communication also increased after CHAT.
9,44 CHAT was highly rated by past participants 
(N=217); mean program ratings ranged from 4.5 to 4.8 on a 1(low) to 5 (high) scale.
45  
 
The CHAT R01 demonstrated that CHAT decreases staff elderspeak and reduces resident 
RTC.
9 On average, elderspeak declined from 34.6% (SD = 18.7) at baseline by 13.6 
percentage points (SD = 20.00) post- intervention and 12.2 percentage points (SD=22.0) 
after 3 months. RTC declined from 35.7% (SD = 23.2) by 15.3 percentage points (SD = 
32.4) post-intervention and 13.4 percentage points (SD=33.7) at follow-up. Linear mixed 
modeling determined that change in elderspeak was predicted by CHAT (b = -12.20, p = 
.028) and baseline elderspeak (b = -0.65, p < .001), while RTC change was predicted by 
elderspeak change (b = 0.43, p < .001), baseline RTC (b = -0.58, p < .001), resident 
communication disability, and comorbid illnesses.  
 
We also extracted CMS NH Quality Measures (NHQM) data for use of antipsychotics for the 
10 CHAT NHs for which data were available. We compared each NH’s rates for two quarters 
before and two quarters after each participated in CHAT. The percentage of residents 
prescribed antipsychotics decreased by an average of 4.9 percentage points, from 20.7% 
(SD=8.5) to 15.8% (SD=9.0) after CHAT. We used state average rates for antipsychotic 
medication use for the same time periods to control for changes that may have occurred due 
to the CMS mandate and other factors.
46 State benchmarks for prescribed antipsychotics 
averaged 25.4% across quarters before and declined to 24.9% for quarters after CHAT, a 
decrease of 0.5%. The average decrease in CHAT NHs (4.9%) compared to the other state 
NHs (0.5%) was significant (p=0.05 for two-tailed t-test).
47  
 
To improve dissemination, we transitioned CHAT content to interactive online modules 
(CHATO) and are currently pilot testing the online version (R61AG061881) and planning a 
pragmatic clinical trial (R34NR017793) testing CHATO effects nationwide. Translating 
evidence-based best practices into practice is slow and inefficient and additional strategies 
are needed to support implementation.
11-13 Performance-based reinforcement of skills is 
effective for achieving greater immediate implementation and long-term maintenance of 

 
KUMC – HRPP- 03/12/2015 
 
Page 4 of 21
 
 
 
staff skill use in practice.
14 However, feasibility and costs for expert individual feedback in the 
clinical setting are prohibitive.  
 
C. Rationale 
Our SPEEKO for elderspeak app provides immediate feedback to staff on elderspeak use at 
the point- of-care with the potential to engage staff in self-monitoring to increase CHATO 
effects. This approach combines CHAT interactive online learning with on-site feedback that 
is established as effective and efficient for training direct care workers and reflects staff 
preferences for education.49-51 NH continuing education research has established that 
supervision of skills use in clinical practice is critical for long-term implementation of new 
practice skills by staff (typically including multiple weeks of observation and feedback).14,52,53 
Although expert on-site feedback is most effective to help staff implement new skills in 
practice, this is costly and usually not feasible.14,54,55 Using available technology, the app 
records staff using a wearable, voice- activated recorder and promptly analyzes speech using 
natural language processing. The app then provides immediate and private graphic feedback 
and encouragement to individual staff on their use of elderspeak diminutives (terms of 
endearment).56  
 
Hypothesized increased efficacy of CHATO training based on use of the automated feedback 
app will further improve training effectiveness and reduce costs. The average cost for CHAT 
training was $79.69 per staff attendee. We determined that an average 1% decrease in 
resident RTC cost $4.31 per resident, assuming average staff baseline elderspeak and each 
staff member caring for two residents with average RTC.57 The new online version of CHAT 
(CHATO) eliminates costs for interventionist preparation, coordination, travel, and time to 
provide CHAT on-site on multiple days and times. Adding point-of-care reinforcement for 
CHAT skills use in practice has potential to increase effects of the training that may reduce 
RTC further. Costs for the app use will be determined in this study as a basis for estimating 
likelihood of adoption in long-term care settings. Repeated use of the app over time will be 
tested in future research to provide periodic tune-up reinforcement for NH staff. If effective, 
the app will be integrated into our ongoing pragmatic clinical trial testing to increase CHATO 
effects on behavioral symptoms in dementia care.  
 
CHATO and the feedback app are readily scalable. Online CHATO modules and the portable 
feedback app are accessible for rural and small independent NHs and across other long-term 
services and support settings that frequently have unmet needs for staff education, fewer 
resources, less access to programs, and greater costs for training. Using technology-based 
resources is efficient as NHs experience more residents with dementia and needs for 
dementia-specific training increase.58 This technology is suitable for other care settings 
(assisted living, adult day care, and home care) and may be adapted for the service sector in 
the future. Empowering staff to reduce BPSD may also reduce stress, job dissatisfaction, and 
turnover, further reducing costs and improving care continuity.59  
 
II. 
Research Plan and Design 
A. Study Objectives: This study will demonstrate feasibility (Aim 1) and preliminary efficacy 
(Aim 2) of the point-of-care SPEEKO for Elderspeak feedback app in the NH setting as well as 
evaluate acceptability and cost (Aim 3). The goal is to increase and extend CHATO effects to 
further reduce BPSD and inappropriate psychotropic medication use to improve NH dementia 
care.  
 
B. Study Type and Design:  
 
Feasibility Testing (Aim 1): We will demonstrate feasibility, acceptability, and validity of 
the SPEEKO for Elderspeak feedback app use by staff in the NH and identify needed 
modifications prior to testing in Aim 2. The PI worked with the Speeko Company (see 
resources and letter) to develop the elderspeak feedback app. App proof of concept has been 

 
KUMC – HRPP- 03/12/2015 
 
Page 5 of 21
 
 
 
demonstrated in the lab setting. With a preliminarily trained natural language processing 
detection model, diminutive accuracy testing resulted in a sensitivity (true positive rate) of 
87.7% and a specificity (true negative rate) of 99.9%. The app provides immediate feedback 
with potential to increase CHATO effects. Recordings are analyzed by a natural language 
processing app that provides immediate and private feedback and encouragement to 
individual staff. The app detects common elderspeak terms of endearment (diminutives), 
identified through reanalysis of the PI’s archived NH recordings.56 Detection algorithms were 
also developed using the recordings to establish proof of concept. App modifications were 
completed to enhance recording quality and transcription accuracy and to filter noise.  
 
Further feasibility and detection model algorithm optimization will be tested at Garden 
Terrace of Overland Park, a NH dedicated to dementia care. A detailed protocol and user 
manual will be developed, and pilot tested. Feasibility will be tested with five CNA volunteers 
(n=5) who will each record a 2-hour care session. These staff will record their speech during 
a 2-hour work session to demonstrate use of the feedback app and complete a 10-item 
usability scale. Potential issues (e.g., background noise, Internet and bandwidth adequacy, 
acceptability to residents) will be assessed. App outputs will be compared to data from 
transcription and psycholinguistic coding, using our established protocols, to validate app 
reliability for diminutive detection. The CNAs will be interviewed about use of the app, 
providing additional data to improve the system for Aim 2 testing. If validated, app functions 
may be expanded to monitor additional aspects of elderspeak (i.e., “we” pronoun 
substitutions).  
 
Recording equipment: To create high fidelity recordings for optimal natural language 
processing, each CNA volunteer will wear a hypercardioid condenser headset microphone 
with unidirectional sound sensitivity. This microphone assembly is designed to pick up sound 
directly in front of the microphone and to reject off-axis background sounds such as from 
residents and staff. In addition to using microphone hardware to isolate the user's voice, the 
app uses digital noise gating and frequency level stabilization to limit extraneous content and 
to support audio quality. An iPod Touch with password encryption will be carried in the 
pocket of the CNA volunteer. The iPod Touch will be connected to the microphone by a 
standard 3.5 mm headphone jack. The battery life of the iPod Touch enables continuous use 
during the 2-hour recording window for each CNA.  
 
iOS App: The iPod Touch will run an iOS app that records and processes audio in real time 
and utilizes voice activation frequency technology to isolate and record when a user is 
speaking and discard periods of silence from the recording analysis. Original back-up 
recordings are saved locally on the secured iPod Touch for the Project Director to access 
through a master password within the app to all user accounts. Together, the iPod Touch and 
low profile, lightweight headset microphone will provide high quality audio for maximal 
analytic accuracy and minimal workflow interruption or reaction by residents and staff. The 
initial 15 minutes of each recording session will be discarded to allow CNAs time to adjust to 
being recorded. Recordings will be analyzed in real time using a transcription detection 
model powered by Amazon Transcribe. All speech-related data are communicated using 
Transport Layer Security protocols to ensure end-to-end security and HIPAA compliance. 
Transcripts will be downloaded to the iPod Touch app that identifies and tabulates 
diminutives, displaying a feedback infographic at the end of the session.  
 
Audio recording supports precise measurement of verbal communication including 
duration, intensity, and patterns and is less invasive than videotaping, encouraging natural 
communication and maintaining privacy. Recordings can be reviewed repeatedly to verify 
accuracy and reliability. Limitations are (1) alteration of natural speech and behavior due to 
the awareness of recording and (2) inability to control for environmental factors such as 
noise. Research has established that NH staff do not significantly modify communication if 
recording is presented in a nonjudgmental manner 60,61 and this was confirmed in the PI’s 

 
KUMC – HRPP- 03/12/2015 
 
Page 6 of 21
 
 
 
research.43 The audio recording protocol is designed to measure communication in NHs 62 and 
health care settings;63 it was effective in the PIs research, uses measures to limit the 
Hawthorne effect (i.e., minimally obtrusive recording equipment), and will record each CNA 
during the same time periods from day to day to assure consistency.8,27,42-44,64,65  
 
Preliminary Effects Testing (Aims 2): We will test preliminary effects of app feedback on 
elderspeak use in audio-recorded staff communication. A cluster randomized trial will be 
conducted in six NHs that participate in CHATO training. We will compare the immediate and 
delayed-feedback control groups on elderspeak (diminutive) changes after participation in 
CHATO. We hypothesize that staff who receive immediate feedback will demonstrate greater 
reductions in use of diminutives, the most common and recognizable marker of elderspeak, 
compared to control group staff before they receive delayed feedback. We will validate app 
accuracy by comparing app results to psycholinguistic coding using our established protocols 
for data reduction, transcription, and coding.8,44,66  
 
Six NHs will participate in audio recording of CNA communication before and after CHATO 
(see letters of support). These NHs will be randomly assigned to immediate feedback (n=3; 
recording with app feedback on elderspeak use) or control (n=3; recording with end of study 
feedback) groups. In each NH, 12 CNAs will be recruited using strategies successful in our 
past research such as announcing the research opportunity at staff meetings. Enrollment of 
12 CNAs per NH allows for levels of attrition experienced in our prior studies. If fewer than 
30 CNAs per group complete recordings, more NHs will be added. CNA volunteers (at least 
30 per group) will record their communication in 2-hour care sessions on 1 day before and 
on 3 days after completing CHATO.  
 
In both NH groups, 12 CNAs will be recorded for a 2-hour shift prior to participating in 
CHATO training (baseline). The URL link to complete the CHATO modules will be provided for 
the CNAs as well as other NH staff. Staff will be expected to complete the training over a 2-
week period. After completion, the 12 CNAs from each NH who are participating in the app 
testing will be recorded again within a week of completing training (post-CHATO time 1), 
then approximately 1 week later (post-CHATO time 2), and finally another week later (post-
CHATO time 3). Immediate feedback NH CNAs will receive the app feedback at the end of 
each post- CHATO recording session, while control group NH CNAs will not receive app 
feedback until the end of their post-CHATO time 3 recording sessions.  
 
Each NH will provide a letter of interest, acknowledging random assignment, committing to 
engage staff in CHATO training, and agreeing to provide descriptive and cost data including 
number and types of staff and average wages. Each NH will be approved prior to 
participation by the KUMC IRB. NH size and census, profit status, proportion of residents 
with dementia, presence of a special care unit, staffing and turnover ratios, Medicare star 
rating, antipsychotic prescription rate, and Medicaid case mix will be collected from Nursing 
Home Compare and NH reports. Medicaid case mix is a measure of resident acuity or care 
needs that is used to determine Medicaid reimbursement rates and has been used in 
research to control differences in care needs across NHs.67,68 Participating NHs will be 
encouraged to engage all direct care staff, including housekeeping, dietary, and 
administrative staff in the training.  
 
CHATO Training. CHATO is a direct Internet module adaptation of the CHAT program, 
developed by the PI and an instructional design team to include all CHAT content and 
interactivity. Standards for online education were used to transition to the module format. 
CHAT (and CHATO) have interchangeable content and are conceptually based on the 
Communication Predicament of Aging Theory27 that describes how stereotypes of older adults 
as incompetent prompt younger persons (NH staff) to alter their communication with older 
adults (NH residents). The exaggerated simplification and clarification strategies of 
elderspeak result in speech that sounds like baby talk and is perceived as demeaning, 

 
KUMC – HRPP- 03/12/2015 
 
Page 7 of 21
 
 
 
contributing to isolation, depression, assumption of dependency, and BPSD.27,69 CHATO alerts 
NH staff to elderspeak and its negative effects, involves them in taking the older adult’s 
perspective, and guides self-evaluation and practice in effective communication.70 Improved 
communication, based on individual assessment of resident abilities, supports positive self-
concept and meets socialization needs, reducing need-driven dementia-compromised 
behavior or BPSD.  
 
Session Content. CHATO includes review of actual NH video examples and practice in 
improved communication strategies that staff readily apply and monitor in practice, 
significantly reducing elderspeak in just three modules. CHATO targets adult learners using 
applied strategies tailored to improve specific aspects of elderspeak that are described in the 
literature and are modifiable. Limiting content and complexity minimizes burden to staff and 
their NH employers and increases the likelihood of skill enactment.71 CHAT was developed 
step-wise and iteratively through the NIH Stage Model for Behavioral Intervention 
Development.72 Early Stage 1 development led to Stage III testing of CHAT in controlled NH 
(community) settings to establish efficacy. After additional Stage I modification of the 
original CHAT content to online module format, CHATO is now positioned for effectiveness 
testing (Stage IV) with NH (community) providers to maximize external validity in 
preparation for future implementation and dissemination research (Stage V).73  
 
CHATO is presented in three modules.10,70 Session 1 introduces effective versus ineffective 
communication. Participants identify communication issues in video vignettes. Session 2 
focuses on identification and negative effects of elderspeak, using video-recorded examples. 
Session 3 includes strategies for improved communication based on assessment of each 
resident’s abilities. Participants critique communication in videos and correct transcripts to 
eliminate elderspeak. Training is limited to three 1-hour sessions to assure feasibility in busy 
NHs. The modules include moderated discussion and interactive exercises that must be 
completed to advance through the program. This assures content fidelity and dose of the 
intervention. CHATO is provided to as many staff as possible to achieve facility-wide effects 
of reduced elderspeak.74 The modules contain pre- and post-tests (scenario-based questions 
and rating of staff communication in video clips) to evaluate knowledge gain. The Modified 
Duke Diffusion of Innovation75 survey provides information about CHATO participant 
intentions to use learned skills in practice and the likelihood for translation.  
 
Audio Recordings. CNAs will be recorded for 2 hours on 1 day in the week before and 3 
days in the 2 weeks after CHATO training. To ensure consistency, every attempt will be 
made to make post-CHATO recordings at the same time of day. CNAs will be permitted to 
turn the recording unit off when they do not wish to be recorded. Although this may limit 
validity of the recordings, it assures privacy and participation. Recordings will be time coded 
and take place during morning care when elderspeak and BPSD are most frequent.44,76,77 To 
minimize attrition, CNAs will be recruited just prior to their NH’s participation in CHATO 
training. A priori randomized order for NH participation will control for historical effects. 
Intention-to-treat analyses will be used. The feedback group CNAs will receive automated 
feedback on elderspeak use after each post-CHATO recording session. The control group will 
receive feedback for all recording sessions after their final (third post-CHATO recording 
session). The Project Director will download recordings for both groups and delete them from 
the iPod Touch.  
 
Data Archiving. After each recording session, the Project Director will screen and edit 
recordings to delete any resident or other staff communication or other identifiers (names) 
so that the archived recording contains only the desired CNA participant’s voice. Recordings 
and data will be archived in a dedicated research computer labeled with unique identifier 
codes. To reduce the Hawthorne effect, the initial 15 minutes of each recording session will 
be discarded. An estimated hour of recorded speech will be collected four times for each of 

 
KUMC – HRPP- 03/12/2015 
 
Page 8 of 21
 
 
 
60 CNAs, providing approximately 240 hours of recordings for transcription, coding, analysis, 
and additional app algorithm training.  
 
Psycholinguistic Coding. RAs will transcribe all recordings (for both groups) and will use 
brackets to code diminutives using our established operational definitions and 
protocols.10,43,45,56,78 To assure reliability, as used in our past studies, RAs will be trained on a 
practice sample until achieving 90% agreement for utterance segmentation and coding. A 
second trained coder will independently code 10% of the actual study transcripts. Additional 
training will be provided if agreement falls below 85%. Systematic Analysis of Language 
Transcripts (SALT)79 will be used to tabulate frequencies for each code. Data will be entered 
in an electronic spreadsheet using unique identifier codes and stored on a secure computer. 
RAs will not have access to the key connecting codes with identifying information and will be 
blind to group assignment and assessment time points.  
 
Acceptability and Cost Testing (Aim 3): CNAs testing the app will complete the System 
Usability Scale (SUS), a validated 10-item industry standard survey to rate (1) use of the 
microphone, recorder, and app; (2) acceptability and work compatibility; (3) feedback 
infographic; and (4) interest in self-monitoring. We hypothesize that staff who use the app 
will find it acceptable and beneficial for their practice. As in our prior studies, we will use 
process-based costing to determine average costs for using the SPEEKO for Elderspeak 
feedback app, comparing costs relative to any difference determined for reductions in 
diminutive use in the immediate and delayed feedback groups.80,81 Evaluation of acceptability 
and costs are key factors in consideration of ongoing plans for app dissemination in NHs and 
across other long-term services and support settings.  
 
C. Sample size, statistical methods, and power calculation 
Aim 1: We will demonstrate feasibility, acceptability, and validity of the SPEEKO for 
Elderspeak feedback app with detection model algorithm optimization with a diminutive 
accuracy testing benchmark of 80% or higher. App outputs will be compared to data from 
transcription and psycholinguistic coding, using our established protocols, to validate app 
reliability for diminutive detection. Also, an analysis of a CNA-completed, 10-item usability 
scale (The System Usability Scale) with an acceptability benchmark of 50% or higher. 
 
Aim 2: Linear Mixed Models (LMMs) or Generalized LMMs, depending on the distribution of 
each outcome, will be developed to determine the impact of group assignment (feedback or 
no feedback) on use of elderspeak diminutives. Baseline diminutive use, group (feedback vs. 
no feedback), recording session (pre- and post CHATO sessions 1, 2, and 3), and interaction 
between intervention and session will be fitted as fixed effects. To account for clustering, 
each NH will be fitted as a random effect. To account for correlation due to repeated 
measurements, an appropriate covariance pattern will be determined from data. CNA and 
resident sex and CNA knowledge gain will be tested as covariates. Aim 2 will estimate 
variability, effect sizes, and intracluster correlation for a future larger-scale study. Sample 
sizes of as few as 30 in each group, or 10 CNAs on average in each NH, will achieve 80% 
power to detect a difference between the group means of 0.74 to 0.76 standard deviations, 
assuming the intracluster correlation coefficient ranging from 0.001 to 0.01 and coefficient of 
covariation among cluster sizes of 0.25. A two-tailed t-test was used with a significant level 
of 0.05 and the degrees of freedom based on the number of subjects.  
 
Aim 3: We will use process-based costing to determine average costs for using the SPEEKO 
for Elderspeak feedback app, comparing costs relative to any difference determined for 
reductions in diminutive use in the immediate and delayed feedback groups.80,81  
 
D. Subject Criteria (See Vulnerable Populations appendix, if applicable):  
1. Inclusion criteria: We will recruit CNAs who are age 18 or older, permanent employees, 
and fluent in English to participate. Descriptive information (age, sex, race, ethnicity, 
role, experience) will be used to identify CNA covariate factors predicting communication 

 
KUMC – HRPP- 03/12/2015 
 
Page 9 of 21
 
 
 
change. CNAs will be compensated a $25 gift card after each recording session and $50 
to complete the CHATO training (all three modules and pass the posttest). CNA staff who 
have the least preparation but provide most direct care may benefit the most from 
feedback on their communication provided in a private and nonthreatening manner. 
Volunteers who self-select may not be representative of all CNA staff. However, CNAs 
who are willing to make recordings and receive feedback will provide information about 
app feasibility, acceptability, and preliminary effects.  
2. Exclusion criteria: CNAs younger than 18 or CNAs who are not fluent in English. 
3. Withdrawal/Termination criteria: The volunteer CNAs may withdraw at any time.  
 
E.  Specific methods and techniques used throughout the study  
 
1. Laboratory tests: N/A 
2. Study Procedures: Staff Training, CNA audio recordings (prior to training and 3 times 
post training), and surveys post training and post recording.  
3. Timeline: 
 
 
F. Risk/benefit assessment:  
1. Social/Economic risk: The primary risk is accidental disclosure of audio recordings or 
other data outside the research team. Accordingly, all audio and other data will be 
handled as confidential by assigning codes, not including names, from the point of 
archiving through data analyses. The original audio and other data files and file linking 
data identification codes to participants will be stored in locked secure files. Data access 
will be strictly controlled by the research protocol. To protect staff from use of study data 
in performance evaluations, NH administrators will not have access to recordings or other 
data that may be connected to individual staff or neighborhoods. 
2. Psychological risk: CNA staff risks of participation include anxiety at being recorded, 
but this is minimal. An additional risk is disclosure of recordings of their communication 
revealing performance, and survey responses to supervisory staff and administrators who 
may use this information for performance evaluations. Thus, NH administrators will not 
have access to recorded or other data that identifies individual staff or neighborhoods. 
Staff will be assured that recordings, descriptive data, and survey responses will not be 
shared with administrators, supervisory staff, or other staff. In addition, recordings that 
may be used for future training materials or presentations will not identify the CNA or 
their NH employer. No appreciable risk of physical, psychological, social, legal or other 
harm to staff participants is expected. No information about past, present, or future 
physical or mental health or payment of health care benefits (HIPAA protected 
information) will be collected. Any recordings or other data suggesting physical or mental 
harm or illegal behaviors will be reported to the NH administration and state authorities 
following mandated reporting guidelines. 
3. Potential benefit of participating in the study  
a. Participation in this study may benefit NH staff participants who may gain 
knowledge about communication with older adults with dementia from the CHATO 
training program that may improve their job performance and secondarily, 
increase their job efficacy and satisfaction.  
b. Residents in the NH may benefit from improved and more respectful nursing staff 
communication (resulting from the CHATO training) that could improve the NH 
environment and their mood and reactions to care. The potential benefit of the 

 
KUMC – HRPP- 03/12/2015 
 
Page 10 of 21
 
 
 
knowledge gain to improve future care for persons with dementia and staff, 
outweighs the minimal risks.    
c. The CHAT intervention has been established as effective in reducing NH staff 
elderspeak use, that is linked to increased BPSD and inappropriate antipsychotic 
medication use. NHs that participated in the CHAT communication training 
program demonstrated reductions in elderspeak use and in BPSD and 
antipsychotic medication use. To increase access to training, CHAT has been 
transformed from a traditional classroom format into interactive online modules 
(CHATO) and an automated app has been developed to provide individual staff 
feedback to staff at the point of care on their use of elderspeak diminutives.  Use 
of the app has potential to increase the effects of the CHAT training through 
reinforcement. The goal is to further improve and sustain effects of 
communication training in nursing staff that will reduce BPSD and inappropriate 
use of psychoactive medications. This nonpharmacological approach uses 
available technology to improve dementia care and aligns with the top priority 
goal of the National Partnership to Improve Dementia Care. As the number of 
persons diagnosed with dementia triples in the next 30 years, empowering care 
providers to provide high quality care for individuals with dementia is of critical 
importance.   
G. Location where study will be performed: The study will be coordinated and managed 
from the KU School of Nursing. All study records will be kept on secure computers and 
servers managed by KUMC. Garden Terrace of Overland Park, a nursing home that has 
participated in our past studies, will be the site for initial clinical demonstration of the app. 
Dr. Coleman will then work with six nursing homes in rural Colorado, where she resides, to 
test the app effects with six volunteer nursing home communities. The communities are on 
the Western Slope in the cities of Delta, Olathe, Montrose, Paonia, and Grand Junction, CO.  
 
H. Collaboration (with another institution, if applicable): N/A 
 
I. Single IRB Review for a Multi-site study (if applicable):  N/A 
 
J. Community-Based Participatory Research (if applicable): N/A 
 
K. Personnel who will conduct the study, including: 
1. Indicate, by title, who will be present during study procedure(s): Project Director 
2. Primary responsibility for the following activities, for example:  
a. Determining eligibility: Project Director 
b. Obtaining informed consent: Project Director 
c. Providing on-going information to the study sponsor and the IRB: PI & Project 
Director 
d. Maintaining participant's research records: Project Director 
e. Completing physical examination: N/A 
f. Taking vital signs, height, weight: N/A 
g. Drawing / collecting laboratory specimens: N/A 
h. Performing / conducting tests, procedures, interventions, questionnaires: PI & 
Project Director 
i. Completing study data forms: Project Director 
j. Managing study database: Project Director 
 
L. Assessment of Subject Safety and Development of a Data and Safety Monitoring 
Plan 
1. Responsible parties: The Principal Investigator (PI) will be responsible for overall 
assurance and monitoring of safety of participants and integrity of data in conduct of 
both phases of the proposed study. This includes continuous active review of research 
activities that will be completed with assistance of the Project Director. The PI will be 

 
KUMC – HRPP- 03/12/2015 
 
Page 11 of 21
 
 
 
responsible for submitting necessary reports (including minutes of annual and any 
additional SMC meetings) to the National Institute on Aging (NIA). The PI will provide 
timely reporting to NIA of a) any unanticipated problems or unexpected serious adverse 
events that are determined to be related to the study protocol, b) IRB-approved revisions 
to the study protocol that indicate a change in risk for participants, c) a summary of 
recommendations made by the SMC and if applicable the action plan for response, and) 
notice of any actions taken by the IRB or regulatory bodies regarding the research and 
any responses to those actions.  
 
In addition, an expert Safety Monitoring Committee (SMC) will provide oversight to 
assure the safety of participants and integrity of the data. The members of the SMC 
include a team of interdisciplinary professionals who are not a part of the research team.  
Per direction of the NIA program officer responsible for this FOA, members of the 
committee will be identified upon funding of the study. It is anticipated that the SMC 
members include clinical and research experts on NH dementia care and NH staff 
education as well as a statistician.   
2. Data/events/frequency of review: The SMC will initially review and approve the 
written study protocol, data collection and storage protocols, intervention materials, 
informed consent procedures, and this plan for data and safety monitoring.  Any outside 
agreements with vendors and subcontractors will be reviewed. The SMC will also review 
the general reporting guidelines based on the study procedures approved by IRB.  
Reporting rules will be established taking into consideration the population under study 
and anticipated adverse outcomes (reflected in the human subjects consent documents).  
Prior to study implementation, the SMC will identify pre-specified stopping rules that will 
be employed if significant benefits or risks have developed, if trial management issues 
prevent successful completion, or if compelling ethical concerns arise. The PI and other 
research team members as delegated will conduct an audit at least annually including 
review of a random sample of at least 3 CNAs who participate in CHATO training and 
participate in audio recording for compliance with study protocols including informed 
consent documents, data storage documentation and deidentification of data. The SMC 
will meet annually and additionally if needed at the request of the PI (due to issues 
arising in study conduct or major changes in study protocols). The SMC will review 
reports of the research team concerning data quality and timeliness, adherence to study 
protocols, participant recruitment and accrual, and consenting procedures. The research 
team (under the direction of the PI) will report accrual, retention figures, and all adverse 
and other events and outcomes.   
3. Types of analyses to be performed: At the end of the first year, the research team 
will generate summary analyses of results for primary outcomes. The annual SMC 
meeting will include evaluation of these interim data analyses to evaluate the need for 
revising or stopping the study.   
4. Safety-related triggers that would cause the PI to stop or alter the study: 
a.  Adverse occurrences (untoward or unfavorable medical occurrences in a 
human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research study, whether or not 
considered related to the subject’s participation in the research) will be identified 
by all research team members and promptly reported to the PI (and recorded on 
an adverse occurrence report sheet).  The PI will review all reports to determine 
whether the event is 1) unexpected, 2) is related or potentially related to the 
research study participation and 3) suggests that the research places subjects or 
others at a greater risk of harm related to the research than was previously 
known or recognized88.  If these three conditions exist, the occurrence will be 
considered an adverse event and will be immediately reported to the IRB on the 
appropriate form and to the SMC for review89. The SMC will review all adverse 
occurrence reports (including those that do not meet criteria for adverse events) 
at annual meetings.  Because the NH staff participants are participating in a 

 
KUMC – HRPP- 03/12/2015 
 
Page 12 of 21
 
 
 
behavioral intervention and some staff will passively record care sessions, there 
is minimal risk of adverse events in this study.  NH residents who staff interact 
with are not likely to be adversely affected by changes in staff communication 
after the CHATO training. Through these reviews of adverse events and 
occurrences, the SMC will consider whether cumulative data indicates the need to 
change the research design, to modify information presented to participants, or 
to terminate the project.  It is anticipated that the committee may decide that 
due to minimal risk in this behavioral intervention study, there is not a risk for 
severe adverse events that would require a-priori stopping rules (this decision 
will be reviewed at least annually by the SMC)2. Any action taken to suspend or 
terminate the project will be reported to the respective IRB, the NIH Office of 
Sponsored Projects, and the program director at NIA. New, scientific 
developments outside the study that may impact participant safety, or the ethics 
of the study are considered in making these determinations.  
b.  New Developments: The PI and SMC will monitor media, professional 
presentations, and scientific literature for breaking scientific developments 
regarding new developments, safety, and ethics that could impact the study.  
These will be reviewed at each annual SMC meeting. The SMC will evaluate the 
final study manuscripts and final reports to assure results are fairly presented 
and conclusions are appropriate. 
 
III. 
Subject Participation 
 
A. Recruitment: 
1. Recruitment will be conducted at the 7 nursing homes involved in the study. The 
feasibility nursing home is in Kansas City, KS and the 6 nursing homes in the clinical trial 
are on the Western Slope of Colorado. All the staff at the nursing homes will be invited to 
participate in the CHATO training and 12 CNAs at each nursing home will be recruited to 
evaluate the feedback app effects. 
2. The PI and Project Director will work directly with the leadership and staff at the nursing 
homes to recruit voluntary participants. Presentations at staff meetings will be conducted 
to inform direct care staff at the nursing homes of the training, app, and research. An 
information sheet about the project will be provide to staff. The project director will meet 
with interested CNAs to further explain research, answer questions, and gain consent.  
 
B. Screening Interview/questionnaire: CNAs who participate in audio recording will be at 
least 18 years old (have legal right to provide consent), speak fluent English, and be 
permanently employed in the NH. The Project Director will meet with interested CNAs and 
confirm they meet the eligibility criteria.   
 
C. Informed consent process and timing of obtaining of consent 
1. Only trained research team members who have completed the NIH-approved Human 
Subjects’ protection certification will obtain informed consents. The research team will 
give subjects detailed and comprehensive information about the study and obtain their 
written consent. The consenting process will be a private conversation between the 
research team member and the interested CNAs in the nursing home. Written 
information will be provided to the CNAs and time will be allowed for thoughtful decision-
making prior to consent. Consent includes the standard elements: a study description, 
the potential risks, benefits and options for non-participation. Permission will be obtained 
to use data (including audio recordings) for secondary data analysis, use in scholarly 
presentations, and for training caregivers. Signed consent for administrators and CNAs 
participating in recording will be obtained and kept in a locked file in the study office.  
2. The consent process will be CNA-driven to avoid coercion and the voluntary nature of 
participation will be stated upfront. Due to the time commitment and extra effort of CNAs 
participating in the audio recordings, they will be paid a $50 incentive to acknowledge 
their efforts and to encourage ongoing participation in each recording session. This small 

 
KUMC – HRPP- 03/12/2015 
 
Page 13 of 21
 
 
 
financial token will be awarded after completing the recording sessions before and after 
CHATO completion to acknowledge participation and is not large enough to be construed 
as coercive 7,8. Use of small financial incentive is reasonable to convey respect to 
research participants in exchange for their time and associated burden and has been 
found to enhance participation 9. 
3. To guarantee confidentiality, a unique code number that has no connection to 
identification of subjects will be assigned to all staff and resident data. A list that links 
the assigned code number to the subjects’ identifying information will be kept by the PI 
in a secure file and not disclosed to research assistants or others. Descriptive information 
for CNA participants recording participants will include age, gender, race and ethnicity, 
years of education, and experience working in long term care. No protected health 
information (PHI) will be collected from NH staff.  
 
D. Alternatives to Participation: All staff at the nursing homes will have access to the CHATO 
training and participation in the audio recording is voluntary.   
 
E. Costs to Subjects: N/A 
 
F. How new information will be conveyed to the study subject and how it will be 
documented: Any new information will be conveyed to participants or nursing home 
leadership by direct conversation (in-person or via Zoom Conferencing) or by email.  
 
G. Payment, including a prorated plan for payment: CNAs who participate in audio 
recordings will receive a $50 incentive after completing the study (1 recording session before 
CHATO training and 3 recording sessions after CHATO). 
 
H. Payment for a research-related injury: N/A – Participants will consent to being audio 
recorded while providing regular care to nursing home residents, no research-related injury 
is anticipated.   
 
IV. 
Data Collection and Protection 
A. Data Management and Security: The PI and research team will review all data to assure 
that any of the following demographic information has been removed (participant name, 
age, address, long term care facility name and location, dates, phone and fax numbers, 
social security numbers, medical record numbers, health plan beneficiary numbers, account 
numbers, and certificate or license numbers). It is not anticipated that the following 
identifiers will be present, but if present, these identifiers will also be removed (vehicle 
identifiers and serial numbers, device identifiers and serial numbers, web universal resource 
locators, internet protocol address numbers, and finger prints). A unique code number that 
has no connection to the identifying information will be assigned to each recording and 
demographic and survey data. The list that links the assigned code number to the subjects’ 
identifying information will be kept by the PI and only disclosed as needed. 
 
The research team will maintain one copy of the deidentified staff data archived in a 
computer solely dedicated to the study with information protections procedures in place 
specific to the data/communications internet computer environment. One backup copy of the 
data will be made in case of computer malfunction. This backup copy on CD, DVD, or 
external hard drive, will be kept in a double locked storage area. Other staff data will also be 
securely maintained in deidentified, secured files. Only selected research personnel will have 
access to this data. All research team members will be informed that study materials are not 
to be discussed or placed on the internet, so that incidental disclosure does not occur. Data 
will be maintained in a double locked file for seven years after this study is completed and 
then destroyed (at least 3 years after the final expenditure report submission). No 
identifiable data will be sent outside of KUMC. 
 

 
KUMC – HRPP- 03/12/2015 
 
Page 14 of 21
 
 
 
1. 
SPEEKO App: The iPod Touch will run an iOS app that records and processes audio 
in real time and utilizes voice activation frequency technology to isolate and record 
when a user is speaking and discard periods of silence from the recording analysis. 
Original back-up recordings are saved locally on the secured iPod Touch for the 
Project Director to access through a master password within the app to all user 
accounts. All speech-related data are communicated using Transport Layer Security 
protocols to ensure end-to-end security and HIPAA compliance. The Project Director 
will download recordings for both groups and delete them from the iPod Touch.  
2. 
Audio Data: All audio will be handled as confidential by assigning codes, not 
including names, from the point of archiving through data analyses. The original 
audio and file linking data identification codes to participants will be stored in locked 
secure files. Data access will be strictly controlled by the research protocol. 
 
B. Sample / Specimen Collection: N/A 
C. Tissue Banking Considerations: N/A 
 
D. Procedures to protect subject confidentiality: The primary risk to participant 
confidentiality is accidental disclosure of audio recordings or other data outside the research 
team. Accordingly, all audio and other data will be handled as confidential by assigning 
codes, not including names, from the point of archiving through data analyses. The original 
audio and other data files and file linking data identification codes to participants will be 
stored in locked secure files. Data access will be strictly controlled by the research protocol. 
Any recordings or other data suggesting physical or mental harm or illegal behaviors will be 
reported to the NH administration and state authorities following mandated reporting 
guidelines. CNA staff risks of participation include anxiety at being recorded, but this is 
minimal. An additional risk is disclosure of recordings of their communication revealing 
performance, and survey responses to supervisory staff and administrators who may use 
this information for performance evaluations. Thus, NH administrators will not have access 
to recorded or other data that identifies individual staff or neighborhoods. Staff will be 
assured that recordings, descriptive data, and survey responses will not be shared with 
administrators, supervisory staff, or other staff. In addition, recordings that may be used for 
future training materials or presentations will not identify the CNA or their NH employer. No 
appreciable risk of physical, psychological, social, legal or other harm to staff participants is 
expected. No information about past, present, or future physical or mental health or 
payment of health care benefits (HIPAA protected information) will be collected. These 
procedures were utilized in the PI’s R03 and R01 studies that analyzed video recordings from 
dementia care.  
E. Quality Assurance / Monitoring 
1. 
The PI and other research team members as delegated will conduct an audit at least 
annually including review of a random sample of at least 3 CNAs who participate in 
CHATO training and participate in audio recording for compliance with study protocols 
including informed consent documents, data storage documentation and 
deidentification of data. The PI will conduct an annual review of research team 
member compliance with IRB required training and certification. The PI or delegate 
will train and supervise research team members in recruitment and consenting 
procedures, data collection, provision of intervention, and data analysis and coding on 
a quarterly basis.  Specific procedures to assure fidelity and compliance with the 
protocol are included in the research plan. 
 
2. 
The SMC will initially review and approve the written study protocol, data collection 
and storage protocols, intervention materials, informed consent procedures, and this 
plan for data and safety monitoring. Any outside agreements with vendors and 
subcontractors will be reviewed. The SMC will also review the general reporting 
guidelines based on the study procedures approved by IRB.  Reporting rules will be 
established taking into consideration the population under study and anticipated 

 
KUMC – HRPP- 03/12/2015 
 
Page 15 of 21
 
 
 
adverse outcomes (reflected in the human subjects consent documents).  Prior to 
study implementation, the SMC will identify pre-specified stopping rules that will be 
employed if significant benefits or risks have developed, if trial management issues 
prevent successful completion, or if compelling ethical concerns arise.   
 
V. 
Data Analysis and Reporting 
A. Statistical and Data Analysis:   
1. AIM 1. Demonstrate feasibility, acceptability, and validity of the SPEEKO for 
Elderspeak feedback app use by staff in the NH. Five certified nursing assistants (CNAs) 
will use the app during NH care and provide feedback about any needed modifications. 
Analysis: A 10-item usability scale. Success will be determined by a cumulative score 
of 80% or more.  
 
2. AIM 2. Test preliminary effects of an innovative self-monitoring feedback app on staff 
elderspeak use and compare accuracy to psycholinguistic analyses of audio-recorded 
staff communication. Statistical Analysis: Linear Mixed Models (LMMs) or Generalized 
LMMs, depending on the distribution of each outcome, will be developed to determine 
the impact of group assignment (feedback or no feedback) on use of elderspeak 
diminutives. 
 
3. AIM 3. Evaluate app acceptability and costs. Analysis: Process-based costing to 
determine average costs for using the SPEEKO for Elderspeak feedback app, comparing 
costs relative to any difference determined for reductions in diminutive use in the 
immediate and delayed feedback groups. 
 
B. Outcome:  
1. AIM 1 Expected Outcome: The app will be readily used and acceptable to CNAs. 
Diminutive counts determined by the app will be correlated with psycholinguistic 
analysis, validating accuracy.  
 
2. AIM 2 Expected Outcome: Staff who receive immediate app feedback (N= 30 in 
three NHs) will have greater elderspeak reduction after completing CHATO training 
compared to delayed feedback controls (N= 30 in three NHs). 
 
3. AIM 3 Expected Outcome: Staff who use the app will find it acceptable and beneficial 
for their practice. Process-based costing will be used to determine costs for app use in 
NHs and other long-term service and support settings. Costs will be compared in 
relation to each group’s outcomes.  
 
C. Study results to participants: Audio recording feedback via the app will be provided either 
immediately after recording (treatment group) or at the end of the study (control group). 
Nursing homes will receive CHATO participation rate feedback.  
D. Publication Plan: The PI will develop an appropriate plan for publication of research results 
based on the study aims and results.   
VI. 
Bibliography / References / Literature Cited 
1. Department of Health and Human Services. National plan to address Alzheimer’s disease: 2015 
Update. 2015.  
2. Alzheimer's Association (2017). Alzheimer's Disease Facts and Figures.  
3. Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and 
psychological symptoms of dementia. BMJ: British Medical Journal. 2015;350  

 
KUMC – HRPP- 03/12/2015 
 
Page 16 of 21
 
 
 
4. Kovach CR, Noonan PE, Schlidt AM, Wells T. A model of consequences of need-driven, 
dementia-compromised behavior. Journal of Nursing Scholarship. 2005;37(2):134-140  
5. Pulsford D, Duxbury J. Aggressive behavior by people with dementia in residential care settings: 
a review. Journal of Psychiatric and Mental Health Nursing. 2006;13(5):611-618  
6. Gilmore-Bykovskyi AL, Roberts TJ, Bowers BJ, Brown RL. Caregiver Person-Centeredness and 
Behavioral Symptoms in Nursing Home Residents with Dementia: A Timed-Event Sequential 
Analysis. The Gerontologist. 2015;55(Suppl_1): S61-S66  
7. Williams K, Herman R. Linking resident behavior to dementia care communication: Effects of 
emotional tone. Behavior therapy. 2011;42(1):42-46. PMC3485306.  
8. Williams K, Herman R, Gajewski B, Wilson K. Elderspeak communication: Impact on dementia 
care. American Journal of Alzheimer’s Disease and Other Dementias. 2009; 24:11-20. 
PMC2823803.  
9. Williams K, Perkhounkova Y, Herman R, Bossen A. A Communication Intervention to Reduce 
Resistiveness in Dementia Care: A Cluster Randomized Controlled Trial. The Gerontologist. 
2017;57(4):707-718.PMID: 27048705, PMC5881770.  
10. Williams K, Abd-Hamid NH, Perkhounkova Y. Transitioning Communication Education to an 
Interactive Online Module Format. Journal of Continuing Education in Nursing. 2017;48(7):320-
328.PMC5492957.  
11. Baldwin CD, Chandran L, Gusic ME. Building Sustainable Professional Development Programs: 
Applying Strategies from Implementation Science to Translate Evidence into Practice. Journal of 
Continuing Education in the Health Professions. 2017;37(2):106-115  
12. Goldstein H, Olswang L. Is there a science to facilitate implementation of evidence-based 
practices and programs? Evidence-Based Communication Assessment and Intervention. 
2017;11(3-4):55-60  
13. Nilsen P. Making sense of implementation theories, models and frameworks. Implementation 
Science: IS. 2015; 10:53  
14. Burgio L, Stevens A, Burgio K, Roth D, Paul P, Gerstle J. Teaching and Maintaining Behavior 
Management Skills in the Nursing Home. The Gerontologist. 2002;42(4):487-496  
15. Williams K, Shaw C, Lee A, Kim S, Dinneen E, Turk M, Jao YL, Liu W. Voicing Ageism in 
Nursing Home Dementia Care. J Gerontol Nurs. 2017;43(9):16-20. PMC5572481.  
16. Alzheimer's Association (2016). Alzheimer's Disease Facts and Figures. 
http://www.alz.org/documents_custom/2016-facts-and-figures.pdf. Accessed July 26, 2016.  
17. Family Caregiver Alliance. Selected Long-Term Care Statistics. National Center on Caregiving; 
2015.  
18. Cerejeira J, Lagarto L, Mukaetova-Ladinska E. Behavioral and Psychological Symptoms of 
Dementia. Frontiers in Neurology. 2012;3(73). 
19. Brodaty H, Draper B, Low L. Nursing home staff attitudes towards residents with dementia: 
Strain and satisfaction with work. Journal of advanced nursing. 2003;44(6):583-590  
20. Grant L, Pothoff S, Ryden M, Kane R. Assignment, Staff Ratios, and Training in Alzheimer's 
Special Care Units. Journal of Gerontological Nursing. 1998; 24:9-16  

 
KUMC – HRPP- 03/12/2015 
 
Page 17 of 21
 
 
 
21. Maas M, Buckwalter KC. Providing quality care in Assisted Living Facilities: Recommendations 
for enhanced staffing and staff training. Journal of Gerontological Nursing. 2006; 32:14-20  
22. Beeri MS, Werner P, Davidson M, Noy S. The cost of behavioral and pshychological symptoms 
of dementia (BPSD) in community dwelling AD patients. International Journal of Geriatric 
Psychiatry.2002;17:403-408  
23. Genworth Financial. Cost of Care Survey. 2016. 
http://www.genworth.com/content/etc/medialib/genworth/us/en/Long_Term_Care.Par.14291.File.
dat/37522%20CoC%20Brochure.pdf. Accessed November 19, 2008.  
24. Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. Targeting and Managing Behavioral 
Symptoms in Individuals with Dementia: A Randomized Trial of a Nonpharmacological 
Intervention. Journal of the American Geriatrics Society. 2010;58(8):1465-1474  
25. Ryan EB, Giles H, Bartolucci RY, Henwood K. Psycholinguistic and social psychological 
components of communication by and with the elderly. Language and Communication. 
1986;6(1/2):1-24  
26. Kemper S, Ferrell P, Harden T, Finter-Urczyk A, Billington C. Use of elderspeak by young and 
older adults to impaired and unimpaired listeners. Aging, Neuropsychology, and Cognition. 
1998;5(1):43-55  
27. Ryan EB, Hummert ML, Boich LH. Communication predicaments of aging; Patronizing behavior 
toward older adults. Journal of Language and Social Psychology. 1995;14(1-2):144-166  
28. Kitwood T, Bredin K. Towards a theory of dementia care: Personhood and wellbeing. Ageing and 
Society. 1992; 12:269-287  
29. Kitwood T. The experience of dementia. Aging and Mental Health. 1997; 7:15-22  
30. Kolanowshi A, Hurwitz S, Taylor L, Evans L, Strumpf N. Contextual factors associated with 
disturbing behaviors in institutionalized elders. Nursing Research. 1994; 43:73-79  
31. Talicero K, Evans L, Strumpf N. Mental health correlates of aggression in nursing home 
reisdents with dementia. The Gerontologist. 2002; 42:169-177  
32. Maher A, Maglione M, Bagley S, Suttorp M, Hu JH, Ewing B, Wang Z, Timmer M, Sultzer D, 
Shekelle PG. Efficacy and comparative effectiveness of atypical antipsychotic medications for 
off-label uses in adults: A systematic review and meta-analysis. JAMA. 2011;306(12):1359-1369  
33. Stevenson DG, Decker SL, Dwyer LL, Huskamp HA, Grabowski DC, Metzger ED, Mitchell SL. 
Antipsychotic and benzodiazepine use among nursing home residents: findings from the 2004 
National Nursing Home Survey. The American journal of geriatric psychiatry: official journal of 
the American Association for Geriatric Psychiatry. 2010;18(12):1078-1092.PMC3009456.  
34. Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos 
CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA. Effectiveness of Atypical 
Antipsychotic Drugs in Patients with Alzheimer's Disease. New England Journal of Medicine. 
2006;355(15):1525-1538  
35. Center for Medicare and Medicaid Services. National Partnership to Improve Dementia Care in 
Nursing Homes, June 2016 update,.  
36. Borson S, Boustani MA, Buckwalter KC, Burgio LD, Chodosh J, Fortinsky RH, Gifford DR, 
Gwyther LP, Koren MJ, Lynn J, Phillips C, Roherty M, Ronch J, Stahl C, Rodgers L, Kim H, 

 
KUMC – HRPP- 03/12/2015 
 
Page 18 of 21
 
 
 
Baumgart M, Geiger A. Report on milestones for care and support under the U.S. National Plan 
to Address Alzheimer's Disease. Alzheimer's & Dementia: The Journal of the Alzheimer's 
Association. 2016;12(3):334-369  
37. Human Rights Watch. "They Want Docile:" How Nursing Homes in the United States 
Overmedicate People with Dementia. United States, 2018.  
38. Thompson Coon J, Abbott R, Rogers M, Whear R, Pearson S, Lang I, Cartmell N, Stein K. 
Interventions to Reduce Inappropriate Prescribing of Antipsychotic Medications in People With 
Dementia Resident in Care Homes: A Systematic Review. Journal of the American Medical 
Directors Association. 2014;15(10):706-718  
39. Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, Howard R. Effect of enhanced 
psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster 
randomised trial. BMJ. 2006;332(7544):756-761  
40. Tawaih P, Black M, Scott-Walkder M, Johnson E, Vaughan, C., Reducing antipsychotic use 
through culture change: An interdisciplinary effort. Annals of Long-Term Care. 2016  
41. Shaw C, Williams K, Perhounkova Y. Educating Nursing Home Staff in Dementia Sensitive 
Communication: Impact on Antipsychotic Medication Use. Journal of the American Medical 
Directors Assoication (JAMDA). 2018, in press. PMCID in Process.  
42. Williams K. Improving outcomes of nursing home interactions. Research in Nursing and Health. 
2006; 29:121-133  
43. Williams K, Kemper S, Hummert ML. Improving nursing home communication: An intervention to 
reduce elderspeak. The Gerontologist. 2003;43(2):242-247.PMID 12677081. No PMCID.  
44. Williams K, Ilten T, Bower H. Meeting communication needs: Topics of talk in the nursing home. 
Journal of psychosocial nursing and mental health services. 2005; 43:38-45. PMID 14116925. 
No PMCID.  
45. Williams K, Bossen A, Perkhounkova Y, Hein M. Knowledge to Practice: Nursing Home Staff 
Perceptions and Intentions for Learned Communication Skills. Journal of Gerontological Nursing. 
2016;42(3):26-34. PMC4841447.  
46. Mollot RJ, Butler D. Federal Requirements & Regulatory Provisions Relevant to Dementia Care 
& the Use of Antipsychotic Drugs. New York, NY: Long Term Care Community Coalition; 2013.  
47. Wiliams K, Shaw C, Perkhounkova Y. Improved Communication: Effects on Inappropriate 
Psychotropic Medication Use. Paper presented at Midwest Nursing Research Society 42nd 
Annual Research Conference; April 13, 2018; Cleveland, Ohio.  
48. Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010–2050) 
estimated using the 2010 census. Neurology. 2013;80(19):1778-1783  
49. McCutcheon K, Lohan M, Traynor M, Martin D. A systematic review evaluating the impact of 
online or blended learning vs. face-to-face learning of clinical skills in undergraduate nurse 
education. Journal of advanced nursing. 2015;71(2):255-270  
50. Ochylski DP, Luz CC, Shen X. Direct Care Workforce Training: Internet Accessibility and 
Acceptance. J Gerontol Nurs. 2017:1-7  
51. Rowe M, Frantz J, Bozalek V. The role of blended learning in the clinical education of healthcare 
students: a systematic review. Medical teacher. 2012;34(4):e216-221  

 
KUMC – HRPP- 03/12/2015 
 
Page 19 of 21
 
 
 
52. Cohen-Mansfield J. Stress in nursing home staff: A theoretical model. Journal of Applied 
Gerontology. 1995; 14:444-466  
53. Sloane PD, Hoeffer BC, Mitchell M, McKenzie DA, Barrick AL, Rader J, Stewart. B.J., Talerico 
KA, Rasin JH, Zink RC, Koch GC. Effect of Person-Centered Showering and the Towel Bath on 
Bathing- Associated Aggression, Agitation, and Discomfort in Nursing Home Residents with 
Dementia: A Randomized, Controlled Trial. Journal of the American Geriatrics Society. 
2004;52(11):1795-1804  
54. Beeber AS, Zimmerman S, Fletcher S, Mitchell CM, Gould E. Challenges and strategies for 
implementing and evaluating dementia care staff training in long-term care settings. Alzheimer's 
Care Today. 2010;11(1):17-39  
55. McCallion P, Toseland R, Lacey D, Banks S. Educating nursing assistants to communicate more 
effectively with nursing home residents. The Gerontologist. 1999;39(5):546-558  
56. Williams K, Shaw C, Lee A, Kim S, Dinneen E, Turk M, Jao Y-L, Liu W. Voicing Ageism in 
Nursing Home Dementia Care. Journal of Gerontological Nursing. 2017:1-5.PMID 28556867. 
PMC5572481.  
57. Williams K, Ayyagari P, Perkhounkova Y, Bott M, Herman R, Bossen A. Costs of a Staff 
Communication Intervention to Reduce Dementia Behaviors in Nursing Home Care. Journal of 
Nursing Home Research Sciences. 2017; 3:22-27. PMC5425099.  
58. Harris-Kojetin L, Sengupta M., Park-Lee E., Valverde R. H, MD: Long-term care services in the 
United States: 2013 overview. Hyattsville, MD2013.  
59. Berridge C, Tyler DA, Miller SC. Staff Empowerment Practices and CNA Retention. Journal of 
Applied Gerontology.0(0):0733464816665204. 
60. Caris-Verhallen W, Kerkstra A, Bensing J. Non-verbal behavior in nurse-elderly patient 
communication. Journal of advanced nursing. 1999;29(4):808-818. 
61. Caris-Verhallen W, Timmermans L, van Dulmen S. Observation of nurse-patient interaction in 
oncology: review of assessment instruments. Patient education and counseling. 2004;54(3):307-
320. 
62. Carpiac-Claver ML, Levy-Storms L. In a Manner of Speaking: Communication Between Nurse 
Aides and Older Adults in Long-Term Care Settings. Health Communication. 2007;22(1):59 – 67. 
63. Happ MB, Sereika S, Garrett K, Tate J. Use of the quasi-experimental sequential cohort design 
in the Study of Patient–Nurse Effectiveness with Assisted Communication Strategies (SPEACS) 
Contemporary Clinical Trials. 2008;29(5):801-808. 
64. Caporael L. The paralanguage of caregiving: Baby talk to the institutionalized aged. Journal of 
Personality and Social Psychology. 1981;40(5):876-884. 
65. Herman R, Williams K. Elderspeak’s influence on resistiveness to care: Focus on specific 
behavioral events in dementia care. American Journal of Alzheimer’s Disease and Other 
Dementias. 2009; 24:417-423.PMC2836897.  
66. Williams K, Perkhounkova Y, Jao YL, Hein M, Bossen A, Chung SJ, Starykowicz A, Turk M. 
Person-Centered Communication for Nursing Home Residents with Dementia: Four 
Communication Analysis Methods Western Journal of Nursing Research. 
2017:193945917697226. PMID 28335698. PMC5581294.  

 
KUMC – HRPP- 03/12/2015 
 
Page 20 of 21
 
 
 
67. Harrington C, Swan J. Nursing home staffing, turnover, and case mix. Medical Care Research 
and Review. 2003;60(3):366-392  
68. Zimmerman S, Williams CS, Reed PS, Boustani M, Preisser JS, Heck E, Sloane PD. Attitudes, 
stress, and satisfaction of staff who care for residents with dementia. The Gerontologist. 
2005;45(Special Issue 1):96-105  
69. Kemper S. Elderspeak: Speech accommodations to older adults. Aging and Cognition. 
1994;1(1):17-28  
70. Williams K, Kemper S, Hummert ML. Enhancing communication with older adults: Overcoming 
elderspeak. The Journal of Gerontological Nursing. 2004;30:1-10  
71. Banazak DA, Mickus M, Averill M, Colenda CC. Herding cats: Barriers to implementing a nurse 
aide educational program. Annals of Long-Term Care. 2000;8(10):68-71  
72. National Institue of Aging. Stage Model for Behavioral Intervention Development. 2016; 
https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development. 
Accessed September 9, 2016.  
73. Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning Clinical Science: 
Unifying the Discipline to Improve the Public Health. Clinical Psychological Science. 
2014;2(1):22-34  
74. Stolee P, Esbaugh J, Aylward S, Cathers T, Harvey D, Hillier L, Keat N, Feightner J. Factors 
associated with the effectiveness of continuing education in long-term care. The Gerontologist. 
2005;45(3):399-405  
75. McConnell ES, Corazzini K.N., Lekan D., Bailey D.E., Sloane R., Landerman LR, Champagne 
MT. Diffusion of innovations in long-term care measurement battery. Research in Gerontological 
Nursing. 2012;5(1):54-76  
76. Hoeffer B, Rader J, McKenzie D, Lavelle M, Stewart B. Reducing aggression during bathin 
cognitively impaired nursing home residents. Journal of Gerontological Nursing. 1997;23(16-23)  
77. Ryden MB, Bossenmaier M, McLachlan C. Agressive behavior in cognitivly impaired nursing 
home residents. Research in Nursing and Health. 1991;14:87-95  
78. Williams KN. Improving nursing home communication. Dissertation Abstracts International. Vol 
62 (06A). Lawrence: University of Kansas; 2001.  
79. Miller JF, Chapman RS. SALT: Systematic Analysis of Language Transcripts. Madison, 
Wisconsin: University of Wisconsin; 1984 1984.  
80. Williams KN, Ayyagari P, Perkhounkova Y, Bott MJ, Herman R, Bossen A. Costs of a Staff 
Communication Intervention to Reduce Dementia Behaviors in Nursing Home Care. The journal 
of nursing home research sciences. 2017; 3:22-27.PMC5425099.  
81. Lee RH, Bott MJ, Forbes S, Redford L, Swagerty DL, Taunton RL. Process-based cosing. 
Journal of Nursing Care Quality. 2003;18(4):259-266  
82. Polit DF, Beck CT. Nursing Research Principles and Methods. 7th edition ed: Lippincott, 
Williams, and Wilkins; 2007.  
83. Munro CL, Savel RH. Rigor and Reproducibility in Critical Care Research. American Journal of 
Critical Care. 2017;26(4):265-267  

 
KUMC – HRPP- 03/12/2015 
 
Page 21 of 21
 
 
 
84. Coleman CK, Fanning K, Williams KN. Comparing person centered communication education in 
long term care using onsite and online formats. Journal of Gerontological Nursing 2015;41(11):1-
6. PMC 5025030.  
85. Nelson RM, Merz JF. Voluntariness of consent for research: An empirical and conceptual review. 
Medical Care. 2002;40(supplement):69-80  
86. Motzer S, Moseley JR, Lewis FM. Recruitment and retention of families in clinical trials with 
longitudinal designs. Western Journal of Nursing Research. 1997; 19:314-333. 
87. Ulrich C, Grady C. Financial incentives and response rates in nursing research. Nursing 
Research. 2004; 53:73-74. 
88. Office for Human Research Protections. Guidance on Reviewin gand Reporting Unanticipated 
Problems Involving Risks to Sujects or Others and Adverse Events,. OHRP Guidance. 2007. 
http://www.hhs.gov/ohrp/policy/advevntguid.html#Q2.  
89. Czaja SJ, Schulz R, Belle SH, Burgio LD, Armstrong N, Gitlin LN, Coon DW, Martindale-Adams 
J, Klinger J, Stahl SM. Data and safety monitoring in social behavioral intervention trials: the 
REACH II experience. Clinical Trials. 2006;3(2):107-118.  
 
APPENDIX I: VULNERABLE POPULATIONS 
 
I.     Cognitively or decisionally impaired individuals: This study will include NH staff who 
work with a vulnerable population of older adults including persons with dementia. Of 
importance to these populations is the protection of privacy and confidentiality of materials that 
might be used for performance evaluations or released to unauthorized parties. This is a 
minimal risk study because protections and protocols limit the probability and magnitude of 
harm or discomfort from participation. Harm and discomfort is not greater than that ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.  
 
II.     Children: N/A 
 
III.     Pregnant women: N/A 
 
IV.     Prisoners: N/A 
 
V.     Students and/or Employees: N/A