Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)
Phase: NA
Conditions: Dementia, Depression, Behavior
Sponsor: Miami University

Protocol Version 2.0  
Clinical Interventional Study  
Protocol 
 
 
 

Protocol Version 2.0 
 
TESTING THE FEASIBILITY OF THE INDIVIDUALIZED POSITIVE 
PSYCHOSOCIAL INTERVENTION (IPPI): 
Pilot testing of an evidence-based program engaging 108 to 135 persons living with 
dementia in brief one-to-one preference-based activities 
 
Katy M. Abbott, Ph.D., MGS 
Executive Director, Scripps Gerontology Center 
Professor of Gerontology  
Miami University 
Oxford, OH  45056 
Supported by: 
The National Institute on Aging 
 FY22_Pilot5_Abbott  
Version 2 
Sept.  13, 2023 
Document uploaded into ClinicalTrials.gov on 7/18/25 
 
 

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Summary of Changes 
 
 
 
Page/Section 
Description of Change 
Rationale  
6, 12, 13, 14, 16, 
21, 32, & 33 
Update to the number of residents sites will 
enroll (from 15 to 20), length of time they will 
enroll will be extended by 1 month (from 3 to 4 
months), and number of residents enrolled per 
month updated to 3-8 residents/month. Lastly, 
we have increased the number of staff 
participating in the emotion-focused 
communication training from 30 to up to 75 as 
we already have 50 staff and anticipate more 
being trained. The number of staff completing 
exit interviews remains unchanged.  
One of our recruiting sites was sold to 
another company and will not be 
participating. Another site decided not 
to participate. Due to being down two 
recruitment locations we have asked 
the remaining 7 sites to enroll a few 
more residents to meet our enrollment 
targets and are giving them an 
additional month to complete 
enrollment.  
 
There has been great interest in the 
emotion-focused communication 
training and more staff than we 
anticipated have gone through the 
course. 
9-10 
Updating participating study sites 
Two recruitment locations are not 
participating.  
38 
Information will not be released without 
written permission of the participant, 
except as necessary for monitoring by IRB, 
the sponsor or persons working on behalf 
of the sponsor (i.e. IMPACT research 
study staff, the DSMB and/or Safety 
Officer), the FDA, the NIA and its 
authorized representatives, and the OHRP. 
New policy since my protocol was 
approved. 

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TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS ............................................................................................................. 2 
PRÉCIS ........................................................................................................................................ 6v 
Study Title ................................................................................................................................... 6 
Objectives ................................................................................................................................... 6 
Design and Outcomes ................................................................................................................. 6 
Interventions and Duration ......................................................................................................... 6 
Sample Size and Population........................................................................................................ 6 
STUDY TEAM ROSTER............................................................................................................. 6 
Principal Investigator: Name .................................................................................................... 7 
Co-Investigators: Name......................................................... Error! Bookmark not defined.7 
PARTICIPATING STUDY SITES ............................................................................................. 8 
1 
Study objectives ................................................................................................................... 11 
1.1 
Primary Objective ......................................................................................................... 11 
1.2 
Secondary Objectives.................................................................................................... 11 
2 
BACKGROUND AND RATIONALE .............................................................................. 11 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 11 
2.2 
Study Rationale ............................................................................................................. 11 
3 
STUDY DESIGN ................................................................................................................. 13 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 15 
4.1 
Inclusion Criteria .......................................................................................................... 15 
4.2 
Exclusion Criteria ......................................................................................................... 15 
4.3 
Study Enrollment Procedures ....................................................................................... 16 
5 
STUDY INTERVENTIONS .............................................................................................. 16 
5.1 
Interventions, Administration, and Duration ................................................................ 16 
5.2 
Handling of Study Interventions ................................................................................... 17 
5.3 
Concomitant Interventions ............................................................................................ 17 
5.3.1 Allowed Interventions ............................................................................................... 17 
5.3.2 Required Interventions .............................................................................................. 17 

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5.3.3 Prohibited Interventions ............................................................................................ 17 
5.4 
Adherence Assessment ................................................................................................. 17 
6 
STUDY PROCEDURES .................................................................................................... 17 
6.1 
Schedule of Evaluations ................................................................................................ 18 
6.2 
Description of Evaluations ............................................................................................ 21 
6.2.1 Screening Evaluation ............................................. Error! Bookmark not defined.21 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 22 
6.2.3 Follow-up Visits........................................................................................................ 23 
6.2.4 Completion/Final Evaluation .................................................................................... 24 
7 
SAFETY ASSESSMENTS ................................................................................................. 24 
7.1 
Specification of Safety Parameters ............................................................................... 25 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 25 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 25 
7.3.1 Reporting Procedures ................................................................................................ 26 
7.3.2 Follow-up for Adverse Events .................................................................................. 28 
7.4 
Safety Monitoring ......................................................................................................... 29 
8 
INTERVENTION DISCONTINUATION........................................................................ 29 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 30 
9.1 
General Design Issues ................................................................................................... 30 
9.2 
Sample Size and Randomization .................................................................................. 32 
9.2.1 Treatment Assignment Procedures ........................................................................... 32 
9.3 
Interim analyses and Stopping Rules ............................................................................ 32 
9.4 
Outcomes ...................................................................................................................... 32 
9.4.1 Primary outcome ....................................................................................................... 32 
9.4.2 Secondary outcomes ................................................................................................. 33 
9.5 
Data Analyses ............................................................................................................... 33 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 34 
10.1 
Data Collection Forms .................................................................................................. 34 
10.2 
Data Management ......................................................................................................... 34 
10.3 
Quality Assurance ......................................................................................................... 35 
10.3.1 
Training ................................................................................................................. 35 
10.3.2 
Quality Control Committee................................................................................... 36 
10.3.3 
Metrics .................................................................................................................. 36 
10.3.4 
Protocol Deviations ............................................................................................... 36 
10.3.5 
Monitoring ............................................................................................................ 36 

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11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 36 
11.1 
Institutional Review Board (IRB) Review .................................................................... 36 
11.2 
Informed Consent Forms .............................................................................................. 36 
11.3 
Participant Confidentiality ............................................................................................ 38 
11.4 
Study Discontinuation ................................................................................................... 38 
12 ETHICAL CONSIDERATIONS ....................................................................................... 38 
13 COMMITTEES................................................................................................................... 38 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 39 
15 REFERENCES .................................................................................................................... 39 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 41 
 
I. Procedures Schedule 
  
II. Informed Consent Form Template 
  
III. Other (add as many appendices as necessary) 
 
 

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PRÉCIS 
Study Title  
Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI) 
Objectives  
The primary objective is to effectively deploy the IPPI program so that care providers can 
use the program as a part of their routine care delivery. Implementation will result in 
decreased expressions of behavioral distress and/or depressive symptoms for residents 
engaged in the program at 3-month and 6-month intervention follow-up and increased 
knowledge of emotion-focused communication and self-efficacy for using emotion-
focused communication for care providers. Our secondary objective is to demonstrate 
program feasibility and fidelity as well as document barriers and facilitators in 
implementation. 
Design and Outcomes   
This study will examine the non-randomized trial of a pragmatic delivery of the IPPI 
program with n=108 nursing home (NH) residents to test program feasibility and impact 
on clinical outcomes for residents (symptoms of behavioral distress and/or depression) 
and up to n=75 staff (knowledge of emotion-focused communication and self-efficacy for 
using emotion-focused communication strategies).  
Interventions and Duration  
The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based 
program that engages PLWD in brief (i.e.,10 minute) one-to-one preference-based 
activities 2 times a week. To provide IPPI, care partners first complete an online course 
on emotion-focused communication (EFCT). This course improves care partners’ 
emotional communication skills to be able to build stronger relationships and provide 
more positive care experiences for PLWD and care partners, alike. The care partners are 
then trained to deliver IPPI activities via short protocols to guide brief one-on-one 
interactions with PLWD.  
 
Care partners will initiate implementation of the preferred IPPI activity with 3-8 residents 
per month upon completion of their quarterly or annual MDS 3.0 assessment (this will 
serve as baseline data). Initiation of engagement will be rolling, adding an estimated 3-8 
residents per month for up to 4 consecutive months. The care partners will implement a 
minimum of 2 IPPI protocols per week with each enrolled resident for 6 months, to 
ensure continuous completion of the intervention through to the date of the resident’s 
next two quarterly or annual MDS 3.0 assessments (3-month and 6-month follow-up 
data). 
Sample Size and Population  
We will partner with United Church Homes (UCH), a 106-year-old nonprofit national 
senior living provider to train care partners to use the IPPI program in 7 NHs in Ohio. 
The volunteer implementation team (e.g., approximately 3-4 staff per community, 
working any shift and from any department) will complete an online training and then 

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identify residents who have cognitive impairment and who have experienced symptoms 
of distress or depressive symptoms within the past 2 weeks, regardless of resident age, 
race, gender, or ethnicity. This study will include 105 to 110 nursing home residents (e.g., 
approximately 15-20 per community), and up to 30 staff will provide exit interviews 
about the program. 
  
STUDY TEAM ROSTER  
Principal Investigator: 
Katy M. Abbott, Ph.D., MGS 
 
Scripps Gerontology Center 
 
Miami University 
 
367-C Upham Hall 
 
Oxford, OH  45056 
 
513-529-0869 
 
abbotttkm@miamioh.edu 
Main responsibilities/Key roles: Dr. Abbott will lead the 
project and work with leadership at the nine NH communities 
that UCH both owns and manages in the State of Ohio to 
implement the IPPI. Dr. Abbott will be responsible for the 
overall project including IRB approval, DSMB 
communications, Data Use Agreements, and oversee both 
qualitative and quantitative data analysis. She will be 
responsible for writing all final reports. 
Project Manager: Molly Noble 
 
Scripps Gerontology Center  
 
Miami University 
 
369B Upham Hall 
 
Oxford, OH  45056 
 
513-529-3605 
 
nobleme2@miamioh.edu 
Main responsibilities/Key roles: The Project Manager will 
assist with the virtual coaching to the NH communities who are 
working on the IPPI QIP. This individual will conduct the 
virtual orientation to the IPPI, be the point person that 
champions can reach out to for assistance, retrieve data from 
the EFCT LMS, and assist with conducting the semi-structured 
exit interviews with staff. These interviews will be audio 
recorded and the individual will transcribe the sessions, code, 
and analyze the qualitative data with Dr. Abbott. 
Website Supervisor: Dennis Cheatham, MFA 
 
Miami University 
 
College of Creative Arts, Department of Art 
 
Hiestand Hall 223 
 
Oxford, OH 45056 
 
513-529-7424 

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cheathdm@miamioh.edu 
Main responsibilities/Key roles: Mr. Cheatham will ensure that 
all documents and training materials are usable and accessible 
to providers through the preferencebasedliving.com website, 
update security patches, and support hosting needs for the 
website. 
Biostatistician:  
Alexandra Hanlon, Ph.D. 
 
Virginia Tech 
 
Department of Statistics 
 
Four Riverside Circle MC-0801 
 
Roanoke, VA  24016 
 
540-526-2264 
 
alhanlon@vt.edu 
Main responsibilities/Key roles: Provide guidance and support 
on all quantitative analyses to be conducted for the project. 
Statistical Consultant: 
Allison R. Heid, Ph.D. 
 
2949 Oakford Road 
 
Ardmore, PA 19003 
 
703-727-6570 
 
allisonrheid@gmail.com 
Main responsibilities/Key roles: Dr. Heid will support data 
management and complete analysis for all quantitative data 
collected under the supervision of our biostatistician, Dr. 
Hanlon. 
 
Co-Investigator: Kimberly Van Haitsma, PhD 
The Pennsylvania State University, 
Professor, Ross and Carol Nese College of Nursing 
Director, Program for Person Centered Living Systems of Care 
Adjunct Senior Research Scientist, The Polisher Research 
Institute at Abramson Senior Care 
201 Nursing Sciences Building, University Park, PA  16802 
ksv110@psu.edu 
Main responsibilities/Key roles: Dr. Van Haitsma was the PI 
on the original IPPI RCT and will provide consultative support 
on the implementation of the project as well as analysis, and 
interpretation of study findings. 
PARTICIPATING STUDY SITES  
Dr. Abbott will be responsible for all of the research activities that are carried out at each site. 
There are no site-specific PIs. Dr. Abbott and/or the project manager Molly Noble will touch 
base with each site on a monthly basis as well as on an as needed basis. These meetings will 
serve as brief progress updates as well as trouble shooting sessions.  

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United Church Homes Administrative Support: 
Amy Kotterman 
 
United Church Homes 
 
170 East Center Street 
 
Marion, OH  43302 
 
O: 740.382.4885 | M: 614.496.7675  
 
Email: AKotterman@uchinc.org  
Main responsibilities/Key roles: Ms. Kotterman will assist with 
interfacing with the nine NH communities throughout the state 
of Ohio. Ms. Kotterman will also assist with identification of 
implementation co-champions, communication between their 
IT services and Dr. Abbott and assisting with scheduling the 
in-person semi-structured exit interviews. 
 
Study Site Administrator 1: TBD 
 
SEM Haven 
 
225 Cleveland Ave. 
 
Milford, OH  45150 
 
Main responsibilities/Key roles: Oversee IPPI 
implementation in SEM Haven NH community. 
Study Site Administrator 2: TBD 
 
The Trinity Community at Beavercreek 
 
3218 Indian Ripple Road 
 
Beavercreek, OH  45440 
 
Main responsibilities/Key roles: Oversee IPPI 
implementation in The Trinity Community at Beavercreek NH 
community. 
Study Site Administrator 3: TBD 
 
The Trinity Community at Fairborn 
 
769 Stoneybrook Trail 
 
Fairborn, OH  45324 
 
Main responsibilities/Key roles: Oversee IPPI 
implementation in The Trinity Community at Fairborn NH 
community. 
Study Site Administrator 46: TBD 
 
The Parkvue Community 
 
3800 Boardwalk Blvd. 
 
Sandusky, OH 44870 
 
Main responsibilities/Key roles: Oversee IPPI 
implementation in The Parkvue Community NH community. 

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Study Site Administrator 67: TBD 
 
The Chapel Hill Community 
 
12200 Strausser St NW. 
 
Canal Fulton, OH 44614 
Main responsibilities/Key roles: Oversee IPPI implementation 
in The Chapel Hill Community NH community. 
Study Site Administrator 78: TBD 
 
The Four Winds Community 
 
215 Seth Avenue 
 
Jackson, OH 45640 
Main responsibilities/Key roles: Oversee IPPI implementation 
in The Four Winds Community NH community. 
Study Site Administrator 89: TBD 
 
The Harmar Place Community 
 
401 Harmar Street 
 
Marietta, OH 45750 
Main responsibilities/Key roles: Oversee IPPI implementation 
in The Harmar Place Community NH community. 
 
 
 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The primary objective is to effectively deploy the IPPI program so that care providers can 
use the program as a part of their routine care delivery. We hypothesize that 
implementation of IPPI will result in decreased expressions of behavioral distress and/or 
depressive symptoms for residents engaged in the program at 3-months and 6-months 
following intervention initiation and increased knowledge of emotion-focused 
communication and self-efficacy for using emotion-focused communication for care 
providers delivering the intervention. 
1.2 Secondary Objectives 
Our secondary objective is to demonstrate program feasibility and fidelity, as well as 
document barriers and facilitators in implementation. 
2 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Over 75% of people living with dementia (PLWD) experience psychological and 
behavioral symptoms of distress. Expressions of distress can be both upsetting to the 
individual and care providers. Symptoms of distress can include wandering, persistent 
vocalizations, and resistance or refusal of care. In addition, depressive symptoms are 
common among NH residents living with dementia.  
 
In the US, 59% of the long-stay NH population has dementia (National Academies of 
Sciences, Engineering, and Medicine, 2022). To support PLWD in the NH, Kitwood 
(1997) recommended person-centered care to affirm the personhood of the individual 
receiving care. The foundation for this care is rooted in trusted interpersonal relationships 
between the resident and their care team members with the goal of focusing on how a 
care task is completed in a way that enhances dignity. One crucial component to 
completing a care task with dignity is to individualize care. This means that the 
individual’s preferences are assessed and honored throughout the care delivery process. 
However, easy to use processes are not in place in most NHs to support systematic 
delivery of preference-based, person-centered care for PLWD. 
2.2 Study Rationale 
The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based 
program designed to support care partners in engaging PLWD in positive person-centered 
ways that enhance well-being and reduce negative emotional and behavioral responses 
using non-pharmacological approaches (Van Haitsma et al., 2015). The IPPI program 
targets communications of distress of PLWD. IPPI provides guidance for care partners to 
initiate short 10-minute positive interactions with PLWD based on a resident’s stated 
preferences. The IPPI program is built on the premise of the importance of recreational 
congruence. By matching recreational activities to preferences expressed by the resident, 
the resident’s needs can be met in a way that maximizes well-being. Tailored recreational 
activities have been shown to improve the following outcomes among NH residents: 
improved depressive symptoms (Bailey et al., 2016), positive affect (Cohen-Mansfield et 
al., 2011), increased pleasure (Cohen-Mansfield et al., 2007), alertness (Kolanowski et 

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al., 2011), engagement (Van Haitsma et al., 2015), as well as reduced anxiety (Cohen-
Mansfield et al., 2007) and agitation (Feliciano et al., 2009). In addition, studies have 
shown that a Tailored Activity Program has benefited staff and family caregivers by 
improving caregiver well-being (Gitlin et al., 2021), reducing upset with behavioral 
symptoms (Gitlin et al., 2009), and enhancing both resident and carer engagement (Gitlin 
et al., 2021; O’Connor et al., 2017), as well as skills such as communication and 
simplification (O’Connor et al., 2017). 
A previous Hybrid III randomized-controlled trial of the IPPI program funded by the 
Alzheimer’s Association with 180 PLWD in NHs found that PLWD had fewer negative 
emotional and behavioral responses when receiving IPPI compared to those receiving 
usual care interventions. They also experienced higher well-being as evidenced by more 
pleasure, alertness, engagement, and positive verbal behavior compared with the usual 
care group (Van Haitsma et al., 2015). 
The goal of this project is to assess the pragmatic application of the IPPI program by 
UCH. A non-randomized feasibility trial will be conducted to determine if providers can 
independently and effectively implement the IPPI program/protocol. The IPPI program 
targets PLWD who are communicating distress (either behavioral distress or depressive 
symptoms). We will ask for staff volunteers to be a part of the site’s implementation 
team. We anticipate the team being comprised of two co-champions (e.g., director of 
nursing and activities director or memory care coordinator) in addition to 2-3 care 
partners (e.g., CNA, activities assistants). These individuals will first complete the 
emotion-focused communication online training. 
Next, champions will be trained to identify eligible residents following a resident’s 
quarterly or annual MDS 3.0 assessment. If the resident triggers for cognitive 
impairment, as indicated by a Brief Inventory for Mental Status (BIMS; Saliba et al., 
2012) score of 0-12 (a screening to identify individuals with cognitive impairment) and 
distress as reported in Section D (non-zero response on PHQ-9 items of anhedonia, sad 
mood, poor self-esteem, poor appetite, or restlessness) or Section E (non-zero response 
on a behavior) the resident will be enrolled in the IPPI program.  
Champions will train the care partners to deliver IPPIs to each identified eligible resident. 
Care partners will be asked to conduct 2 IPPIs per week with each resident for 6 months. 
Selected residents will be engaged with the IPPI program for 6-months. IPPI enrollment 
will be rolling for the first 3 to 4 months of project initiation. Each time a 
quarterly/annual MDS 3.0 assessment is completed for a resident, if the resident triggers 
for both cognitive impairment and distress, the resident will be considered for IPPI 
enrollment. We estimate enrollment of 3-8 residents per community per month during the 
first 3-4 months of project initiation. The IPPI intervention will then continue to be 
delivered for 6-months for each enrolled resident. Intervention dosage is based on 
findings from our preliminary study (Van Haitsma et al., 2015). 
No known risks of the intervention are anticipated. Potential risks of engaging in an IPPI 
activity are that the resident may become frustrated if the activity is not appropriately 
matched to their remaining strengths. We will work with the implementation team to 
understand how to use a strengths-based approach to adapt a preferred activity. For 
example, if a resident enjoys gardening but is not able to kneel down to the ground, a 
flower box placed on a table to allow the resident to plant flowers may be recommended. 
In addition, the staff will be trained in emotion-focused communication to identify body 

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language cues when a resident is in distress and unable to communicate. For example, if 
the resident enjoys sitting outside, but then becomes hot in the sun. The staff can 
recognize the change in emotion and alter the activity. 
3 
STUDY DESIGN 
The IPPI program targets communications of distress of PLWD. IPPI provides guidance 
for care partners to initiate short 10-minute positive interactions with PLWD based on a 
resident’s stated preferences. The IPPI intervention first teaches care partners strategies to 
better identify and manage their own feelings and those of the PLWD using an on-line, 
self-paced, emotion-focused communication course (EFCT). Strategies taught in the 
course are designed to build care partners’ emotional communication skills, forge 
stronger relationships and provide more positive care experiences for care partners and 
PLWD alike. The IPPI program, designed with flexibility and feasibility in mind, is 
delivered in a series of simple steps including: 1) utilizing mandatory preference 
assessments (16 preferences collected in Section F of the MDS 3.0; e.g., being around 
animals such as pets, choose what clothes to wear, going outside), 2) using the care 
planning meeting to match a resident’s important preferences with 1-2 appropriate IPPI 
protocols, 3) care partner delivery of one of the matched IPPI protocols with the resident, 
4) real time feedback for the care partner provided by a site champion on how to follow 
the IPPI protocol, and 5) conducting IPPIs with a resident for approximately 10 minutes 2 
days per week, at a time convenient for both the care partner and resident. 
More specifically, a team of staff members who volunteer to carry out the project, 
making up the implementation team, will be solicited at each of the 7 sites. We expect the 
team to be comprised of one or two champions as well as 2-3 care partners who will be 
provided information about the IPPI program. Pulling from the Expert Recommendations 
for Implementing Change (ERIC) Project (Powell et al., 2015), we will start by 
documenting the organization’s level of readiness for implementation and preparing the 
implementation team. This will include ensuring that each NH has staff members (such as 
director of nursing and activities professional) who can serve as champions (e.g., director 
of nursing and activities professional) as well as care partners (e.g., CNAs, activities 
professionals) who can deliver IPPI activities to residents. The implementation team will 
be invited to be trained for the program. Our project manager, Molly Nobel, will provide 
the following support: (1) guidance for the champion(s) to coach care partners in 
identifying an eligible resident upon completion of an annual or quarterly MDS 3.0 
assessment who triggers for cognitive impairment and distress; (2) access to interactive 
online education materials; and (3) ongoing on-demand/as needed and scheduled (i.e., 
monthly) virtual consultation/facilitation for troubleshooting purposes. The 
implementation team will also be provided with developed informational resources that 
can be shared with local opinion leaders and stakeholders, such as family members. 
Eligible residents will be identified by the implementation team (e.g., champion(s) upon 
completion of an annual or quarterly MDS 3.0 assessment. IPPI eligible residents must 
have a BIMS score of 0-12 and communicate distress (as reported in Section D (non-zero 
response on PHQ-9 items of anhedonia, sad mood, poor self-esteem, poor appetite, or 
restlessness) or Section E (non-zero response on a behavior)) on the MDS 3.0 
assessment.  
The implementation team will be trained with the online emotion-focused communication 
training (approximately 2 hours – broken up into six 15-20 min modules), complete 

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provided IPPI activity training videos (each 10-15 min), and be provided the IPPI manual 
with a checklist of steps, 60+ different IPPI protocols that address all 16 MDS 3.0 
preferences in Section F, sample letters/scripts introducing the IPPI to family and staff, 
and communication tips sheets. Any member of the implementation team can deliver an 
IPPI activity. We will ask champion(s) to demonstrate an IPPI for care partners (e.g., 
CNAs) to watch, and then observe each care partner’s initial IPPI implementation. 
The champion(s) will be provided with a pragmatic data collection binder of paper forms 
(See Appendix A) to record these initial observations (in the form of a checklist). In 
addition, this binder will include a form to document staff training completion, resident 
preferences, and the behavior or mood item to target with the IPPI program that is most 
distressing to each identified eligible resident. Forms for champion(s) to document 
adverse events and withdraws will also be included in the binder.  
Implementation team members will align stated preferences of each eligible resident with 
specific IPPI protocols (i.e., important preference for reading will be matched with a 
reading activity IPPI protocol). While any implementation team member can deliver an 
IPPI activity, we will encourage care partners to take the lead in implementation of the 
preferred IPPI activity with each enrolled resident on a regular basis. Initiation of 
engagement will be rolling, adding 3-7 residents per month for 3-4 consecutive months. 
The care partners will implement a minimum of 2 IPPI protocols per week with each 
resident for 6 months, to ensure continuous completion of the intervention through to the 
date of the resident’s next two quarterly or annual MDS 3.0 assessment (3-month and 6-
month follow-up data). The project manager will provide virtual coaching to 
communities throughout implementation as needed. Table 1 below outlines the 
intervention structure and implementation strategy. In addition, we identify the 
implementation measure/metric we will track during the course of implementation. 
Table 1. IPPI Intervention Structure, Implementation Strategy, and Implementation Measures 
Intervention Structure 
Implementation Strategy 
Implementation Measure 
Establish Co-champions 
Assess Organizational Readiness 
Organizational Readiness for 
Implementing Change 
(ORIC)30 
Subject Identification 
Identify residents who score 0-12 on the BIMS with either a non-
zero score on one of 5 Section D Mood items or a non-zero score 
on Section E Behaviors from MDS 3.0 upon completion of a 
scheduled annual or quarterly MDS 3.0 assessment. 
That 15-20 residents with 
both of these criteria are 
engaged during the pilot 
timeframe per NH 
community - approximately 
3-8 residents per month 
Implementation team 
identified 
Recommended Activity Director and DON, and CNAs or activity 
personnel who care for residents identified 
That 3-5 staff volunteer from 
each community to lead and 
deliver IPPI activities 
Orientation to IPPI 
Virtual Coaching session 
Does champion/team attend 
orientation Yes/No 
measured by Project 
Director 
Emotion-Focused 
Communication Training 
Recommended champion(s) and care partners (e.g., 
CNAs/Activity personnel) complete on-line, self-paced, interactive 
education session prior to initiating implementation 
That all of the identified 
implementation team 
completes training as 
identified in the learning 
management system 
Learn how to conduct an IPPI 
protocol 
Watch IPPI training videos, review tip sheets on considerations 
before, during, and ending an IPPI 
Binder for champion to 
record if activity was 
completed or not 
Match Resident Preferences 
with IPPI protocols 
Review Section F of MDS 3.0 to identify resident important 
preferences and review IPPI Protocols on website Identify 1-2 
protocols for use with resident 
Completion of the Resident 
Preference Worksheet and 
EMR 

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Intervention Structure 
Implementation Strategy 
Implementation Measure 
Care Conference Discussion 
Identify targeted behavior to be addressed with IPPI and who will 
be the primary IPPI delivery care partner 
Obtain a deidentified print 
out of the care plan and look 
for documentation of 
targeted behavior and care 
partner 
Identify and procure IPPI 
supplies needed 
Managing supplies – what is needed, where will they be stored, 
identified 
Exit interview and Resident 
Preferences Worksheet 
Assess Fidelity to IPPI 
protocol 
Champion does one IPPI with each resident while care partner 
watches, then champion watches while care partner conducts one 
and documents if IPPI steps followed 
Observation by champion is 
documented with the 
Pragmatic Checklist  
Assess Adherence to IPPI 
protocol and participant 
responsiveness 
Conduct two 10 min IPPIs per week over the course of 6 months 
(e.g., 48 sessions total) 
Documentation of each of 48 
IPPIs completed for each 
resident in EMR 
Troubleshooting 
Virtual Coach (Project Manager) available throughout 
Number of times contacted 
Project Director 
Communicating initiative to 
staff, families 
Town hall meeting, letter to families 
Ask in Exit interview if done 
yes/no 
Acceptability, feasibility, and 
appropriateness of IPPI 
Complete the Exit Interview  (See Draft Appendix B) 
Acceptability of Intervention 
(AIM), Intervention 
Appropriateness Measure 
(IAM), and Feasibility of 
Intervention Measure (FIM) 
in Exit interview 
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
The IPPI intervention targets distress of PLWD. As a result, champion(s) will be trained 
to identify residents in each of the participating nine communities that have both 
cognitive impairment (Brief Inventory for Mental Status (BIMS) score of 0-12) and who 
have recently triggered for distress as reported in Section D (non-zero response on PHQ-
9 items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness) or 
Section E (non-zero response on a behavior) in the MDS 3.0.  
Inclusion Criteria  
Participants of any age, race, gender, or ethnicity will be eligible for enrollment if the 
following criteria are met:  
• The individual is a long-stay resident in one of the nine participating UCH NH 
locations partnering with the PI for this project.  
• The most recent MDS 3.0 assessment indicates a BIMS score of 0-12 and a 
non-zero response on PHQ-9 items of anhedonia, sad mood, poor self-esteem, 
poor appetite, or restlessness or Section E behavior item(s). 
4.1 Exclusion Criteria  
Individuals will be excluded if: 
• Individual does not reside as a long-stay resident in one of the nine 
participating UCH NH locations partnering with the PI for this project. 
• Resident does not have both a BIMS score of 0-12 and a non-zero response on 
PHQ-9 items of anhedonia, sad mood, poor self-esteem, poor appetite, or 
restlessness or Section E behavior item(s). 

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4.2 Study Enrollment Procedures  
Seven UCH NH communities in Ohio will be invited to participate in the IPPI program. 
Dr. Abbott will visit in person to talk with the leadership team of each community and 
secure participation. The 7 sites have an average of 100 beds with approximately 50% of 
residents living with dementia. 
 
Leadership Staff: The UCH staff implementation team at each site may include the 
Director of Nursing, Life Enrichment Director, and direct care providers (State Tested 
Nursing Assistants; STNAs) also known as Care Partners. These individuals will be 
asked to complete an exit interview for which we will seek informed verbal consent.  
 
We will seek staff volunteers to be a part of the UCH implementation team. Dr. Abbott 
will meet with staff in each community, explain the IPPI project, the time commitment, 
and work with leadership to develop an implementation team that includes one or two 
champions(s) and 2-3 care partners.  
 
Residents: UCH implementation team champion(s) will be trained to use MDS data to 
identify residents who are optimal for the IPPI program. Eligible residents will be 
indicated by a Brief Inventory for Mental Status (BIMS) score of 0-12 (a screening to 
identify individuals with cognitive impairment) and who have recently communicated 
distress as reported in Section D (non-zero response on PHQ-9 items of anhedonia, sad 
mood, poor self-esteem, poor appetite, or restlessness) or Section E (non-zero response 
on a behavior) within each community.  
 
Implementation Team: The UCH implementation team will be invited to be trained to 
deliver the IPPI program. They will have choice in the activity that they will do with the 
resident, and will be offered coaching and feedback. Trained care partners will be asked 
to conduct 2 IPPI activities per week with each identified resident. Selected residents will 
be engaged with the IPPI program on a rolling basis immediately after their quarterly 
MDS assessment (pre-test) over 6 months. The provider UCH utilizes a consistent 
staffing approach, and the idea is that the IPPI activities are integrated into routine care 
practices with selected residents. 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
IPPIs will be conducted by trained care partners for each identified eligible resident. 
Enrollment will occur on a rolling basis, upon completion of an initial MDS 3.0 
assessment (i.e., annual or quarterly assessment, whichever is completed at that time). 
Upon determination of eligibility, site champion(s) will 1) assess resident important 
preferences with the 16 preferences required to be collected in Section F of the MDS 
(e.g., being around animals such as pets, choose what clothes to wear, going outside), 2) 
match a resident’s important preferences with 1-2 appropriate IPPI protocols, 3) invite 
one or more of the implementation team care partners to select one of the IPPI protocols 
to conduct with the resident, 4) coach the care partner(s) on how to lead the activity, 5) 
have the care partner(s) lead the one-to-one activity with the champion watching to give 
feedback, 6) have care partners conduct IPPIs with a resident for approximately 10 
minutes 2 days per week, at a time convenient for both the care partner and resident. 

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IPPIs will continue to be offered for 6-months from date of study initiation. IPPIs will be 
conducted within the NH in the resident’s room or a common area, or outside the NH as 
appropriate for meeting the preference targeted. Care partners will select from 60+ pre-
created IPPI protocols and complete the interventions accordingly. 
The IPPI involves minimal risk since the resident can decline and is based on his or her 
preference. Further, IPPI will not adversely impact the rights and welfare of residents 
because it will involve a meaningful and enjoyable use of time with a care partner.  
Handling of Study Interventions  
All participating NH communities will be provided a body of IPPI activity manuals; each 
IPPI activity has a corresponding toolkit with instructions and supportive conversation 
prompts that consist of an introduction, middle, and conclusion section. The IPPI 
program has been explicitly designed for PLWD who are experiencing symptoms of 
distress. We will assess both fidelity and adherence to the IPPI protocols during 
implementation. 
5.2 Concomitant Interventions 
5.3.1 Allowed Interventions 
IPPI intervention activities will be allowed for all eligible residents. 
5.3.2 Required Interventions  
IPPI intervention activities will be offered to all eligible residents, but residents have the 
right to refuse participation prior to starting each IPPI or anytime during an IPPI 
activity. 
5.3.3 Prohibited Interventions 
No prohibited interventions are noted. All other usual care interventions for residents 
can continue as needed during the course of the IPPI pilot implementation process. 
5.3 Adherence Assessment  
Adherence to the study regimen is defined as completion of at least 80% of designated 
IPPI sessions per eligible/enrolled resident. Adherence to completion of two 10-minute 
IPPIs per week over the course of 6-months (e.g., 48 sessions total) will be tracked in the 
UCH EMR upon completion of each IPPI activity with each resident (see evaluations 
section below). 
6 
STUDY PROCEDURES 
The Schedule of Evaluations in section 6.1 includes all study evaluations. 

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6.1 
Schedule of Evaluations 

Protocol Version 2.0 
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Assessment 
Pre-
enrollment 
Baseline, 
Enrollment 
(Day 0) 
Each 
IPPI 
(2x a 
week 
for 
180 
days) 
3-month 
Assessment 
(~Day 90) 
6-month 
Assessment 
 (~Day 180) 
Post 
Intervention 
Trial 
Organizational 
Readiness for 
Implementing 
Change (ORIC) 
X 
 
 
 
 
 
MDS 3.0 data of 
residents BIMS 
scores and Section 
D and E Responses 
(rolling; each 
resident assessed 
for enrollment to 
serve as baseline 
assessment, 3-mon, 
and 6-mon) 
X 
X 
 
X 
X 
 
Identify 
Implementation 
team (Y/N) 
X 
 
 
 
 
 
Virtual Coaching 
session attendance 
(Y/N)  
X 
 
 
X 
X 
 
Emotion-Focused 
Communication 
Training (EFCT) 
completion (Y/N) 
X 
 
 
 
 
 
Emotion-Focused 
Communication 
Training (EFCT) pre 
and post-test 
(knowledge, 
efficacy) 
X 
 
 
 
 
 
IPPI Training 
(watching 2 videos) 
completed (Y/N) 
X 
 
 
 
 
 
Resident Preferences 
Worksheet (rolling) 
 
X 
X 
X 
X 
 
Care Plan 
Documentation 
(Y/N) 
 
X 
X 
X 
X 
 

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Fidelity Assessment 
with Pragmatic 
Checklist 
(observation of 1st 
IPPI between each 
resident and 
implementation team 
member delivering 
IPPI) 
 
 
X 
(1st 
IPPI 
only) 
 
 
 
Exit Interview 
(communication, 
acceptability, 
feasibility, 
appropriateness, 
facilitators, and 
barriers) 
 
 
 
 
 
X 
Troubleshooting 
(count of contacts) 
X 
X 
X 
X 
X 
 
Intervention 
Withdrawal form 
 
 
X 
 
 
 
Adverse Events form 
 
 
X 
 
 
 

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6.2 Description of Evaluations  
6.2.1 Pre-enrollment 
These evaluations occur prior to enrollment of NH residents to the intervention. 
Organizational Readiness 
To understand each NH’s organizational readiness for the intervention, each 
implementation team member will be asked to complete the ORIC assessment.  
Identifying subjects (Screening) 
UCH site champions will be trained to identify eligible residents in each community 
using MDS 3.0 BIMS data (score of 0 to 12) and documentation of distress as 
indicated by a non-zero response in Section D on PHQ-9 items of anhedonia, sad 
mood, poor self-esteem, poor appetite, or restlessness or a non-zero response on a 
Section E behavior.  
Identification of eligible residents will occur on a rolling basis, following completion 
of a given resident’s quarterly or annual MDS 3.0. Upon review of MDS 3.0 
assessments at the care planning meeting, if a resident triggers for cognitive 
impairment and distress, the person will be identified as eligible for the IPPI program. 
As a rolling process, site champion(s) and care partners will identify any newly 
eligible residents who have completed their quarterly or annual MDS 3.0 assessments 
and trigger for cognitive impairment and distress. This process will likely result in 
adding 3-8 residents per month for 3-4 consecutive months.  
Baseline MDS 3.0 assessments (includes BIMS and Distress data) and two 
subsequent MDS 3.0 assessments (at approximately 3 and 6 months), along with 
EMR data that document the IPPIs will be provided to PI approximately half-way and 
at the completion of the project by the UCH corporate IT officer via a secure file 
transfer service. The half-way point will be when all enrolled residents are past their 
3-month post IPPI initiation. The completion of the project will occur 6 months post 
IPPI initiation. Data for all residents will be provided and the PI will link the MDS 
and EMR data, extract residents engaged in the IPPI project, deidentify, and add a 
unique ID number for each participant prior to providing data to the Statistical 
Consultant, Allison Heid via a secure file transfer service. 
Implementation team training 
To track implementation efforts, each NH site champion(s) will be asked to record on 
paper forms located in a binder (see Appendix A) that assess the following yes/no 
questions prior to starting to implement the IPPI with residents: Did the site identify 
an implementation team (Y/N); Did the implementation team attend the virtual 
coaching session (Y/N); did the members of the implementation team complete the 
EFCT (Y/N); and did the implementation team complete the IPPI training (Y/N). 
In addition, all implementation team members (i.e., site champion, care partners) at 
each NH will be asked to complete the EFCT. As a part of the online EFCT course, 
they will be asked to complete a pre- and post-assessment on knowledge and self-
efficacy. The post-assessment will also contain questions assessing acceptability. To 

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assess knowledge gained from the content of the intervention, participants will 
respond to 16 intervention specific multiple-choice or multiple-response items prior 
to training (pre-assessment) and upon completion of the training (post-assessment). 
Items were created to specifically check learning on all key course elements. Items 
assess knowledge regarding ways to recognize and respond to emotions (e.g., anger, 
pleasure). A total count of correct answers is computed (possible range: 0 to 27; note, 
total exceeds 16 as some questions required more than one correct response to be 
selected). For self-efficacy, consistent with Bandura’s (1997) initial conception of 
self-efficacy that it is behavior-specific, we created items modeled after Fortinsky and 
colleagues’ (2002) and Steffen and colleagues’ (2002) work with caregivers, that 
were tailored to the specific intervention content presented in the EFCT. By using a 
tailored set of items created specifically for this course, the impact of the specific 
intervention activities can be assessed. The scale includes 9-items asking participants 
how confident on a scale of 0 (not at all confident) to 10 (certain you can do it) they 
are completing the proposed activity. Items assess confidence in identifying one’s 
own feelings, ability to respond effectively to those emotions, identifying emotions in 
others, and responding effectively to their emotions. A mean-item total score is 
computed (possible range: 0 to 90; α = .90). Third, post-training program 
acceptability will be assessed with three metrics. Drawing upon the Implementation 
Research Measure for program acceptability, appropriateness and feasibility of 
Proctor et al. (2011) and Weiner et al. (2017), we assess Acceptability of the 
Intervention Measure (AIM) and Intervention Appropriateness (IAM) with two 4-
item scales. Items are rated from 1 (completely disagree) to 5 (completely agree). 
AIM includes items such as “The Emotion-Focused Communication Training is 
appealing to me” (α = .92; range 4 to 20). IAM includes items such as “The Emotion-
Focused Communication Training seems applicable” (α = .94; range 4 to 20). In 
addition, we assess general ratings of program satisfaction with 5-items, such as 
“Overall, I was satisfied with this training” (α = .92; range 5 to 25). 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
There will be a waiver of consent for all residents enrolled in the program. Upon 
identification of eligibility, the implementation team uses the Resident Preferences 
Worksheet to identify next steps. This will be a rolling process as individuals are 
identified as eligible to participate. Each enrolled individual will have a Worksheet 
completed at their specific time of enrollment. In this Worksheet, members of the 
implementation team will identify the resident’s important preferences and identify 
matching IPPI protocols that can be used. They will also identify the behavior they 
hope to target with the IPPI intervention. A copy of the care plan will be obtained to 
ensure that the targeted behavior is addressed. The PI will collect this Worksheet 
from champions to determine whether or not the IPPI protocols were appropriately 
matched to important resident preferences as a measure of implementation fidelity 
every three months. 
Baseline Assessments 
The baseline assessment for residents will be their most recent MDS 3.0 (either 

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annual or quarterly). The BIMS and Section D/Section E responses will be provided 
to the PI for each enrolled resident by the UCH IT professionals. These data will 
include the targeted mood or behavior selected by care partners at enrollment. The 
type of mood or behavior item being targeted will be different for each resident (e.g., 
wandering for one, verbal behavior for another). 
6.2.3 Follow-up Visits 
▪ IPPI completions 2x weekly: 
o The Fidelity Assessment with Pragmatic Checklist will be completed the 
first time a member of the intervention team completes an IPPI with a 
resident. This will be completed by the site champion when shadowing 
the care partner in implementation. 
o IPPIs will be documented in the UCH EMR through Point-Click-Care. 
o During implementation, troubleshooting (count of contacts of the 
implementation teams with the PI/Project team) will be recorded.  
o If an eligible resident is withdrawn from participation, the withdrawal 
date, and the reason will be documented on an Intervention Withdrawal 
form and provided to the project PI. This form is part of the binder that 
will be provided to each site champion(s). 
o Adverse Events will be reported directly to the PI if they occur as per 
section 7.3 below. 
▪ 3-months (~90 days): 
o Distress data (Section E and Section D) from the next completed MDS 
3.0 assessment (annual or quarterly) will be provided to the PI by the 
UCH IT Corporate office. The Centers for Medicare and Medicaid 
Services require completion of an assessment every 3-months; however, 
experience indicates that there is individual variability in actual 
completion times and therefore we will not enforce a strict allowable 
time window for these data. Change in each Section E/Section D item 
will be scored as 0 = stayed the same as baseline (e.g., score on MDS 3.0 
baseline assessment equals score on MDS 3.0 follow-up assessment), 1 = 
got better (e.g., score on MDS 3.0 baseline assessment is better (lower) 
than the score on the MDS 3.0 follow-up assessment), or 2 = got worse 
(e.g., score on MDS 3.0 baseline assessment is worse (higher) than the 
score on MDS 3.0 follow-up assessment) for our primary, person-
centered clinical outcome. 
▪ 6-months (~180 days): 
o Distress data (Section E and Section D) from the next completed MDS 
3.0 assessment (annual or quarterly ~6-months post baseline assessment) 
will be provided to the PI by the UCH IT Corporate office. The Centers 
for Medicare and Medicaid Services require completion of an assessment 
every 3-months; however, experience indicates that there is individual 
variability in actual completion times and therefore will not enforce a 

Protocol Version 2.0 
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strict allowable time window for these data. Change in Section E/Section 
D items will be scored as 0 = stayed the same as baseline (e.g., score on 
MDS 3.0 baseline assessment equals score on MDS 3.0 follow-up 
assessment), 1 = got better (e.g., score on MDS 3.0 baseline assessment 
is better (lower) than the score on the MDS 3.0 follow-up assessment), or 
2 = got worse (e.g., score on MDS 3.0 baseline assessment is worse 
(higher) than the score on MDS 3.0 follow-up assessment) for our 
primary, person-centered clinical outcome. 
6.2.4 Completion/Final Evaluation 
Each enrolled resident will receive 6-months of the IPPI intervention. Upon 
completion of the intervention an Exit Interview will be completed with 
implementation team members at each NH site. Members of the implementation team 
will be invited to participate in a semi-structured intervies with researchers at the end 
of the project. The Exit interview (see Appendix B) will contain open-ended 
questions about communication and facilitators and barriers. It will also include 
close-ended questions on acceptability, feasibility, and appropriateness using the 
Implementation Research Measure for program acceptability, appropriateness, and 
feasibility of Proctor et al. (2011) and Weiner et al. (2017). 
 
7 
SAFETY ASSESSMENTS  
Once an individual is enrolled in the study, participant safety will be monitored. 
Enrollment is defined as a resident identified as eligible based on most recent MDS 3.0 
assessments and then having a completed Resident Preferences Worksheet.  
No known risks of the intervention are anticipated. The potential risks or discomfort are 
minimal to the organization, residents, and care partners. This intervention is focused on 
a positive interaction around the preference of the resident and their care partners, such as 
a sing-a-long activity, or going outside when the weather is good. The activities can be 
stopped if the resident or care partners experience distress, however that is unlikely to 
occur as the intervention found that residents had increased positive affect during and 
after the intervention. Residents can refuse to participate any time a care partner seeks to 
engage with them. 
However, a person could become agitated during an IPPI if it is not explained well by a 
care partner, as with routine care. In these instances, behaviors such as wandering or 
becoming aggressive could occur at the same rate with which they occur during typical 
clinical care. Further, the population served by this intervention is by definition a 
vulnerable medical population experiencing dementia and often multiple other chronic 
illnesses. We would expect that due to the age and illness severity of the PLWD that the 
occurrence of falls, emergency room/hospitalizations, and death can reasonably be 
expected. Implementation team care partners are already trained by their specific facility 
in managing safety concerns and health events that may occur during typical care and 
they will behave the same during enrollment in the IPPI program. The care partners 
would act according to their facility's rules and expectations.  
In the case of an adverse event occurring during study participation, an Adverse Event 

Protocol Version 2.0 
25 
form would be submitted to the PI within 3-days of the event (see procedural 
expectations below in 7.3). In the case of death of a resident, the site champion will be 
advised to call the PI to notify her of the passing. 
7.1 Specification of Safety Parameters 
Dr. Abbott will create a data use agreement with UCH in order to receive the MDS 3.0 
and electronic health records data. Dr. Abbott will merge these data sets, add a unique 
identifier to the data set, and remove face identifiers such as name, SSN, HIC prior to 
providing it to the statistical consultant via a secure file transfer. These efforts will 
protect participant privacy. The Biostatistician will direct the statistical consultant on 
conducting the analysis, but will not have access directly to the data. 
 
We will also provide a help line for the implementation team to contact the project 
manager or PI at any time if they need assistance in problem solving to modify an IPPI 
for a resident to their remaining strengths during the course of implementation.  
 
We will plan for monthly check-in calls with the implementation team to see if they have 
any concerns and check-in on implementation progress. Residents have the ability to 
decline to participate in any offered IPPI activity. 
 
All other safety parameters will be in line with safety and health regulations as set forth 
by the NHs themselves. Each NH is regulated by the Centers for Medicare and Medicaid 
Services and will be expected to follow all clinical safety and reporting guidelines during 
the duration of this study. 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
Safety concerns for the IPPI intervention are no more than those experienced in usual care 
for NH residents. NH Residents: The IPPI program will be implemented by staff as part of 
the nursing home resident’s clinical care needs. The IPPI activities involve no more than 
minimal risk to the NH resident as these activities are typically done by care partners as part 
of standard of care. The care partner will be taught to use the good communication practices 
taught in the emotion-focused communication training to deliver activities that are preferred 
by residents. Each NH has a responsibility, as regulated by the Centers for Medicare and 
Medicaid Services to follow specific safety protocols and reporting guidelines. Each NH 
will continue to follow these protocols while delivering the IPPI intervention. The IPPI 
involves minimal risk since the resident can decline and is based on his or her preference, would 
not adversely impact the rights and welfare of residents because it would involve a meaningful 
and enjoyable use of time with a care partner, the legally authorized representative would be 
informed about the new clinical activity being tried with their loved one/client as is the case with 
any new clinical activity being implemented with individuals, and deidentified data will be 
provided from the provider organization. 
7.3 Adverse Events and Serious Adverse Events  
Adverse and serious adverse events for this study are defined as follows: 
Adverse Event (AE): Any unfavorable medical or behavioral outcome in a clinical 
research study participant, including but not limited to expression of extreme distress 
(defined as a person specific change in behavior that is uncharacteristic of the individual 

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whereby the individual is visibly upset and/or inconsolable), an illness event (i.e., a heart 
attack, stroke), or a fall temporally associated with the participants’ involvement in the 
research, whether or not considered related to participation in the research. 
Serious Adverse Event (SAE): Any adverse event that: 
• 
Results in death 
• 
Is life threatening, or places the participant at immediate risk of death from the event 
as it occurred 
• 
Requires or prolongs hospitalization 
• 
Causes persistent or significant disability or incapacity 
• 
Is another condition which investigators judge to represent significant hazards 
 
Unanticipated Problem (UP) Definition: Any incident, experience, or outcome that 
meets all of the following criteria: 
• Unexpected, in terms of nature, severity, or frequency, given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the study population; 
• Related or possibly related to participation in the research; 
• Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
Adverse events are not anticipated to occur in response to the intervention beyond the 
routine experience of events in clinical care. We expect no SAEs to occur as a result of an 
IPPI activity because they are meant to be short, enjoyable activities. We would expect 
that due to the age and illness severity of the people living with dementia that the 
possibility of falls, emergency room/hospitalizations, and death can reasonably be 
expected.  During our monthly check-in calls with the implementation team, we will ask 
if any adverse events have occurred, “Have there been any unexpected changes in 
resident behaviors or health while participating in the study?”  
NHs will otherwise follow their regulated health and safety protocols and responses. 
 
7.3.1 Reporting Procedures 
In the occurrence of an AE or SAE, during an IPPI, the implementation team will be 
instructed to complete the column in the provided binder on the final column of the 
resident preferences worksheet, providing a description of the event, the timing of the 
event, and the anticipated clinical response.  If warranted, the team will be instructed to 
complete the IMPACT Serious Adverse Event (SAE) Report Form.  
If an AE or SAE becomes apparent during a monthly call, the PI will request a 
completion of an Adverse Events or IMPACT Serious Adverse Event (SAE) Report 
Form, as applicable.  
In the case of death, the site champion will also be instructed to call the PI to relay this 
information. 

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Following typical clinical safety protocols of the specific NH, a determination of 
continuation in the IPPI program will be determined by the NH clinical implementation 
team based on severity of event and relationship to the study. The decision for care 
alteration or necessary withdrawal from the study will be communicated with the PI 
through the Adverse Events form and/or if necessary, the second to last column of the 
Resident Preferences Worksheet. That column asks if the resident completed the IPPI 
program and if no, why not. For reporting, the decision of relatedness, expectedness. and 
severity of events will be defined as follows: 
Severity of Event 
All AEs will be assessed by a qualified medical professional on the NH implementation 
team using a protocol defined grading system to describe severity.  
• Mild – Awareness of signs or symptoms, but easily tolerated and are of minor irritant 
type causing no loss of time from normal activities. Symptoms do not require therapy or a 
medical evaluation; signs and symptoms are transient. 
• Moderate – Events introduce a low level of inconvenience or concern to the participant 
and may interfere with daily activities but are usually improved by simple therapeutic 
measures; moderate experiences may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
treatment. Severe events are usually potentially life-threatening or incapacitating. Of 
note, the term “severe” does not necessarily equate to “serious”. 
Expectedness  
• Unexpected - Nature or severity of the event is not consistent with information about 
the condition under study or intervention in the protocol, consent form, product brochure, 
or investigator brochure. 
• Expected - Event is known to be associated with the intervention or condition under 
study. 
Relationship To Study Intervention 
In the case of an AE, a qualified clinical professional on the implementation team at the 
resident’s NH will help judge the relationship of the AE to the study intervention. In light 
of the medical status of the resident participating in the study, the qualified clinical 
professional, will evaluate the degree to which the event was related to underlying 
disease/concurrent illness or study-related procedures, accidents, and other external 
factors. The clinician will indicate “Yes” in the final column of the Resident Preferences 
Worksheet and complete the Serious Adverse Even Report Form Template: 
• Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event occurs in a plausible 
time relationship to the IPPI intervention, follows a known or expected response pattern 
to the suspected intervention, that is confirmed by improvement on stopping and 
reappearance of the event on repeated exposure, and that could not be reasonably 
explained by the known characteristics of the subject’s clinical state. Depending upon 
severity of AE, the clinician may judge the event to warrant withdrawal from the study. 

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• Possibly Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after an IPPI happened or follows a known or 
expected response pattern to the suspected intervention). However, other factors may 
have contributed to the event (e.g., the participant’s clinical condition, other concomitant 
events). An AE rated as “possibly related” soon after discovery, can be flagged as 
requiring more information and later be upgraded to definitely related”, as appropriate. 
• Not Related – The AE is clearly not related and completely independent of study 
intervention administration, and/or evidence exists that the event is definitely related to 
another etiology. For example, another cause of the event is most plausible and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the event and the 
study intervention and/or a causal relationship is considered biologically implausible 
All adverse events that are serious (SAE) and unexpected (i.e., have not been previously 
reported for the study’s intervention) will be reported to the IMPACT Collaboratory 
Regulatory and Data Team Leader (Dr. Julie Lima), NIA IMPACT Collaboratory PO 
(Dr. Partha Bhattacharyya), and the IMPACT Collaboratory Safety Officer within 48 
hours of the study’s knowledge of SAE.  
• Only those adverse events that are serious (SAE), unexpected, and related to the 
intervention must also be reported to Advarra IRB. Unexpected and unrelated 
SAEs will be reported to Advarra IRB on a case-by-case basis if requested by the 
IMPACT Collaboratory Safety Officer or NIA IMPACT Collaboratory PO. 
All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team Leader 
(Dr. Julie Lima), NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharyya), and the 
IMPACT Collaboratory Safety Officer within 24 hours of study’s knowledge of death.  
• Advarra IRB does not require the specific reporting of death outside of the SAE 
reporting requirement above, but they will be notified on a case-by-case basis if 
requested by the IMPACT Collaboratory Safety Officer or NIA IMPACT 
Collaboratory PO. 
All unanticipated problems (UPs) will be reported to the IMPACT Collaboratory 
Regulatory and Data Team Leader (Dr. Julie Lima), Advarra IRB, NIA IMPACT 
Collaboratory PO (Dr. Partha Bhattacharyya), and the IMPACT Collaboratory Safety 
Officer within 48 hours of the study’s knowledge of the event. 
The summaries of all previously reported unexpected and related SAEs, deaths, and UPs, 
as well as all other SAEs and AEs will be reported to IMPACT Collaboratory Regulatory 
and Data Team Lead (Dr. Julie Lima), Advarra IRB, NIA IMPACT Collaboratory PO 
(Dr. Partha Bhattacharyya), and the IMPACT Collaboratory DSMB Chair (or the 
project’s Safety Officer) at a minimum every 6 months, or at a frequency requested by 
the IMPACT Collaboratory Safety Officer or NIA IMPACT Collaboratory PO. 
 
7.3.2 Follow-up for Adverse Events 
NH implementation teams will follow all existing health and safety protocols in their 
NHs for procedures following a safety-related or health-related event until the AE or 
SAE is resolved or the person is considered stable. 

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Upon resolution of the event, the site champion will provide additional information to the 
PI to indicate the timing of resolution/stabilization of the event. All AEs occurring while 
in the study will be documented appropriately regardless of relationship to the 
intervention. All AEs will be followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s 
condition significantly deteriorates at any time during the study, it will be recorded as an 
AE.  
The site champions will record all reportable events with start dates occurring any time 
after participant enrollment for 7 (for non-serious AEs) or 30 days (for SAEs) after the 
last day of study participation.  
During each monthly check-in the PI will inquire about the occurrence of AE/SAEs since 
the last call. Events will be followed for outcome information until resolution or 
stabilization. 
7.4 Safety Monitoring 
The IPPI program does not entail risks to the NH resident or staff member. Each involved 
individual can refuse to participate at any time. The IPPI program is based on a preferred 
activity leading to a meaningful and enjoyable use of time between the resident and care 
partner. 
 
The NIA IMPACT Collaboratory Safety Officer will oversee all data and safety 
monitoring activities for this study to evaluate the progress of the study, and to review 
procedures for maintaining the confidentiality of data, the quality of data collection, 
management, and analyses. Advarra IRB will conduct the ethical review required for the 
protection of human subjects.  
 
In addition, all activities for this intervention will abide by expected Centers for Medicare 
and Medicaid Services Health and Safety care requirements within the NHs. 
8 
INTERVENTION DISCONTINUATION  
Participating in the IPPI intervention is optional for residents. Residents can refuse 
participation at any time. The staff can choose to discontinue the IPPI with any 
participant based upon their clinical judgement and the individual may be withdrawn 
from the study. 
Withdrawal can also follow a significant health change or hospitalization that makes the 
participant unable to continue to participate in the IPPI intervention activities. 
Implementation team clinical staff will make a judgement call. 
Participants may also be withdrawn due to death. Residents living with dementia in a NH 
are a vulnerable population, health events are common and anticipated (i.e. falls).  
Participants may also be withdrawn from the study if the individual leaves the NH to 
move to another NH. The resident must continue to reside in the same NH for the 6-
months of the study period to be engaged in the intervention. 

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For all reasons of withdrawal, the implementation team for a given resident will 
communicate the withdrawal to the PI with the second to last column on the Resident 
Preferences Worksheet stating the date and the reason. 
While there is no formal plan for replacement of subjects, due the rolling nature of 
enrollment, additional eligible residents may be added to the study to accommodate a 
withdrawal if it occurs within the first 3 consecutive months of the study. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
The primary objective is to effectively deploy the IPPI program so that care providers can 
use the program as a part of their routine care delivery. We hypothesize that 
implementation will result in decreased expressions of behavioral distress and/or 
depressive symptoms for residents engaged in the program at 3-month and 6-month 
intervention follow-up and increased knowledge of emotion-focused communication and 
self-efficacy for using emotion-focused communication for care providers.  
Our secondary objective is to demonstrate program feasibility and fidelity as well as 
document barriers and facilitators in implementation. 
For this pilot study, we will have a non-randomized, within-person design, examining 
how individual levels of distress change from baseline to 3-months to 6-months. We will 
report rates of overall sample change versus stability. No randomization will occur for 
this trial, as the primary purpose is to establish pragmatic feasibility of the intervention. 
The primary clinical outcome will be reports of distress as rated in the residents’ MDS 
3.0 annual or quarterly assessments in Section E and Section D (Saliba & Buchanan, 
2009). These items will also be rated by the implementation team care partner delivering 
the intervention. These data will be collected at baseline (to determine eligibility) and at 
3-months and 6-months post-intervention enrollment. The items in Section D and Section 
E are validated standardized items used to assess all NH residents in the United States 
receiving funding from the Centers for Medicare and Medicaid Services. Section D 
depression item responses are drawn from the widely used and validated PHQ-9 
(Kroenke et al., 2001; anhedonia, sad mood, poor self-esteem, poor appetite, or 
restlessness). The items ask “Over the past 2 weeks, have you been bothered by any of the 
following problems?” and then if the resident responds “yes” they are asked “About how 
often have you been bothered by this?”. Item level scores are 0 (did not occur), 1 (2-6 
days), 2 (7-11 days), or 3 (12-14 days). The Section E behavior items have been used as a 
valid indicator of behavioral distress (Saliba & Buchanan, 2009). Items include the 
presence of verbal, physical or other behavior symptoms directed toward others, rejection 
of care, and wandering. For section E, each behavior is rated with a 0 (did not occur in 
the past week), 1 (occurred 1-3 days in the past week), 2 (occurred 4-6 days) or 3 
(occurred daily). For each resident care partners will have designated a targeted mood or 
behavior item selected for improvement and assessed via MDS data. The targeted mood 
or behavior selected by the care partner at baseline will be reassessed at 3-months and 6-
months and recorded as 0 = stayed the same as baseline (e.g., score on MDS 3.0 baseline 
assessment equals score on MDS 3.0 follow-up assessment), 1 = got better (e.g., score on 

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MDS 3.0 baseline assessment is better (lower) than the score on the MDS 3.0 follow-up 
assessment), or 2 = got worse (e.g., score on MDS 3.0 baseline assessment is worse 
(higher) than the score on MDS 3.0 follow-up assessment) for our primary, person-
centered clinical outcome. The type of mood or behavior item being tracked will be 
different for each resident (e.g., wandering for one, verbal behavior for another) 
The secondary clinical outcomes will be knowledge and self-efficacy pre-and post-EFCT 
data for all implementation team members. To assess knowledge gained from the content 
of the intervention, participants will respond to 16 intervention specific multiple-choice 
or multiple-response items prior to training (pre-test) and upon completion of the training 
(post-test). Items were created to specifically check learning on all key course elements. 
Items assess knowledge regarding ways to recognize and respond to emotions (e.g., 
anger, pleasure). A total count of correct answers is computed (possible range: 0 to 27; 
note, total exceeds 16 as some questions required more than one correct response to be 
selected). For self-efficacy, consistent with Bandura’s (1997) initial conception of self-
efficacy that it is behavior-specific, we created items modeled after Fortinsky and 
colleagues’ (2002) and Steffen and colleagues’ (2002) work with caregivers, that were 
tailored to the specific intervention content presented in the EFCT. By using a tailored set 
of items created specifically for this course, the impact of the specific intervention 
activities can be tested. The scale includes 9-items asking participants how confident on a 
scale of 0 (not at all confident) to 10 (certain you can do it) they are completing the 
proposed activity. Items assess confidence in identifying one’s own feelings, ability to 
respond effectively to those emotions, identifying emotions in others, and responding 
effectively to their emotions. A mean-item total score is computed (possible range: 0 to 
90) and internal consistency ratings are high (α = .90). 
To assess feasibility and fidelity as a component of our second objective, we will track 
the number of residents each NH is able to engage in the program via data collected from 
the Resident Preferences Worksheet. This worksheet also tracks alignment of important 
preferences with activities; we will review for appropriateness. We will track how many 
implementation team members complete the EFCT based on data from the EFCT LMS. 
We will also provide a standardized Pragmatic Checklist that site champion(s) will use to 
observe an IPPI session by each care partner to establish implementation fidelity. This 
short checklist incorporates learning from the online trainings into a Yes/No format to 
ensure that good communication practices are utilized. Each checklist item is equal to one 
point and a total number of points will be calculated to assess the fidelity to the 
intervention process. Each care partner delivering the IPPI will be observed once with 
each resident by an implementation team member. Care partners will record the date and 
how long the IPPI session lasted in the EMR. This documentation will be used to report 
on the amount, frequency, and duration of IPPI delivery to determine if the recommended 
2 sessions per week over the course of 6 months were implemented. Further, participant 
responsiveness to the IPPI protocol will be measured through the question “Would you 
like to do this activity again?” posed to residents upon completion of an IPPI activity and 
recorded in the EMR. Finally, acceptability, feasibility, and appropriateness will be 
calculated by staff in both the EFCT post-test and the exit interview (Weiner et al., 2017; 
AIM, IAM, and FIM measures). Qualitative data will be collected to determine 
facilitators and barriers in the Exit interview with participating implementation team 
members. 

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9.2 Sample Size and Randomization 
Nine NHs will be invited to participate in this pragmatic implementation feasibility study. 
Care partners will initiate implementation of the preferred IPPI activity with 3-7 residents 
per month upon completion of their quarterly or annual MDS 3.0 assessment (this will 
serve as baseline data) in each NH. Initiation of engagement will be rolling, adding an 
estimated 3-8 residents per month for 3-4 consecutive months. This study will include 
between 105-1110 residents and between 30-75 staff members from the implementation 
teams. Findings from this study will guide any needed adaptions to the implementation, 
approach, and power needed for a full-scale Stage IV effectiveness ePCT study.  
9.2.1 Treatment Assignment Procedures 
For this pragmatic implementation feasibility study, subjects will not be randomized. 
Individuals will be enrolled in any of the 7 NHs per the proposed 
eligibility/enrollment plan. 
9.3 Interim analyses and Stopping Rules 
No interim analyses are planned since the study is mostly focused on the feasibility of 
implementing the IPPI program. However, the study PI will monitor indicators of project 
feasibility and fidelity and offer virtual coaching as required to ensure implementation is 
being completed (i.e., ensure an implementation team is set up, ensure training with the 
EFCT and the IPPI are completed). 
While not anticipated, in the event of repeat SAE/AEs linked with the study protocols, a 
safety review will be conducted by the PI in concert with the assigned Safety Officer to 
do determine whether study efforts should be discontinued. We will submit an interim 
and final Data Safety Monitoring (DSM) submitted for review by the IMPACT NIA 
Safety Officer. 
9.4 Outcomes  
Outcomes data will be analyzed descriptively.  
9.4.1 Primary outcome   
The primary clinical outcome will be reports of distress as rated in the residents’ 
MDS 3.0 annual or quarterly assessments in Section E and Section D (Saliba & 
Buchanan, 2009). These items will also be rated by the implementation team care 
partner delivering the intervention. These data will be collected at baseline (to 
determine eligibility) and at 3-months and 6-months post-intervention enrollment. For 
each resident, a targeted mood or behavior item selected for improvement and 
assessed via MDS data will be used as the primary outcome. The targeted mood or 
behavior will be recorded as 0 = stayed the same as baseline (e.g., score on MDS 3.0 
baseline assessment equals score on MDS 3.0 follow-up assessment), 1 = got better 
(e.g., score on MDS 3.0 baseline assessment is better (lower) than the score on the 
MDS 3.0 follow-up assessment), or 2 = got worse (e.g., score on MDS 3.0 baseline 
assessment is worse (higher) than the score on MDS 3.0 follow-up assessment) for 
our primary, person-centered clinical outcome at 3-months and 6-months post 

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intervention enrollment. The type of mood or behavior item being tracked will be 
different for each resident (e.g., wandering for one, verbal behavior for another). 
9.4.2 Secondary outcomes   
The secondary clinical outcomes will be knowledge and self-efficacy pre-and post-
EFCT data for all implementation team members. Items will be completed prior to the 
start of the EFCT for each team member and after the completion of the EFCT. 
 
To assess feasibility and fidelity as a component of our second objective, we will 
track the following: 
− Number of residents each NH is able to engage in the program via data 
collected from the Resident Preferences Worksheet.  
− Alignment of important preferences with activities on the Resident 
Preferences Worksheet; we will review for appropriateness.  
− How many implementation team members complete the EFCT based on 
data from the EFCT LMS.  
− Implementation fidelity with a standardized Pragmatic Checklist that a site 
champion will use to observe an IPPI session by each care partner 
− Response to the intervention by the resident for each IPPI, care partners 
will record when an IPPI was conducted in the EMR.  
− Amount, frequency, and duration of IPPI delivery to determine if the 
recommended 2 sessions per week over the course of 6 months were 
implemented with the EMR. 
− Acceptability, feasibility, and appropriateness of the intervention will be 
calculated for staff in both the EFCT post-test and the exit interview 
(Weiner et al., 2017; AIM, IAM, and FIM measures). 
− Facilitators and barriers to implementation in the Exit interview with 
participating implementation team members. 
9.5 Data Analyses 
Analysis of data will be descriptive. To address our first objective of clinical impact for 
residents, we will code a change score for each enrolled resident’s targeted behaviors 
(e.g., improved, stayed same, worsened) in two ways. We will use the MDS 3.0 data 
between baseline and 6 months. We will report aggregate percentages of improved, 
stayed same, and worsened from the MDS 3.0 data. For implementation team members, 
the outcomes of knowledge and self-efficacy will be analyzed through paired samples t-
tests of pre- and post-EFCT test measures. 
For our second objective of feasibility and fidelity, we will calculate the number of 
residents each NH is able to engage as a percentage of the goal (e.g., 15 residents 
minimum) via data collected from the Resident Preferences Worksheet. We will also 
calculate the percentage of the implementation team that completed the EFCT based on 
data from the EFCT LMS. Finally, we will calculate the average number of IPPIs 
completed (via the EMR). Acceptability, feasibility, and appropriateness will be 
calculated according to responses from the exit interview (Weiner et al., 2017; AIM, 
IAM, and FIM measures). Qualitative data collected by the semi-structured exit interview 

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will be audio recorded, transcribed verbatim, and coded for facilitators and barriers in 
Dedoose. 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
The primary clinical outcome for residents is found in the nursing home’s routinely 
collected MDS assessments in their electronic medical record (EMR). Data will be 
extracted from the EMR by UCH IT and provided to Dr. Abbott for merging, extracting 
participating residents and deidentifying the data. 
 
The secondary clinical outcome (for implementation team members) will be completed 
within the EFCT LMS system that directly transmits the data to the PI. 
 
Feasibility and fidelity measures will be documented as follows: 
− The Resident Preferences Worksheet will be completed by the implementation 
team care partner delivering the IPPIs to a given resident. 
− The standardized Pragmatic Checklist will be completed by the site champion 
for each care partner when they are conducting their first IPPI. 
− Documentation of IPPIs will be completed by the implementation team care 
partner delivering the IPPIs to a given resident in the EMR. 
− Measures of acceptability, feasibility, and appropriateness of the intervention 
will be collected from the implementation team members in both the EFCT 
LMS post-test and at the exit interview. A questionnaire will be distributed to 
participating implementation team members at the time of the exit interview. 
− Open-ended qualitative interviews will be audio-recorded by the PI to 
document facilitators and barriers to implementation during the exit interview. 
 
Each enrolled participant and implementation team member will be assigned a unique ID 
number to protect resident privacy. All data analysis will be with deidentified data and 
not include any participant’s name or identifying information. 
10.2 Data Management  
MDS 3.0 data for all residents will be provided to the PI by UCH IT Professionals. Dr. 
Abbott will identify participating/enrolled residents and extract distress (Section D and 
Section E) MDS 3.0 data at 3-months and 6-months post enrollment date and transmit 
data with face identifiers such as name, SSN, and HIC removed prior to statistical 
consultant via a secure file transfer. 
Data collection forms will be provided to the site champion(s) for completion in a binder 
including the a) Implementation team training documentation, b) Resident Preferences 
Worksheet, and the c) Pragmatic Observation Checklist. For the resident preferences 
worksheet, site champion(s) will maintain a password protected list of the name of each 
resident that is enrolled into the IPPI program along with a unique ID# that is determined 
by the champion(s). This password protected file will be shared with the PI who will then 

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link the data from this worksheet to the electronic medical record data prior to 
deidentifying. 
The statistical consultant on the project will receive de-identified data from the PI via a 
secure file electronic transfer. 
Staff completing the EFCT will be prompted to answer questions within the EFCT LMS 
before and after completion of the training. These data will be extracted from Qualtrics, 
de-identified by the PI, and provided to the statistical consultant. 
At the Exit Interviews, the PI and Project Manager will conduct a primarily qualitative 
interview that will help to answer secondary objectives.  
Qualitative interviews will be audio-recorded, transcribed in otter.ai, and then uploaded 
into Dedoose, a qualitative data analysis software, and provided to the statistical 
consultant for coding. 
10.3 Quality Assurance  
10.3.1 
Training 
None of the NH staff serving on the implementation teams will receive human 
subjects research training. However, all NH staff serving on the implementation team 
at each of the 9 NHs will receive a series of trainings in the IPPI program before 
conducting the IPPI intervention. First, implementation team members will be 
provided information about the IPPI program. The implementation team will first 
complete an online training with the EFCT course. The EFCT (Emotion-focused 
communication training) course is a self-paced course set up through a Learning 
Management Service (LMS) to teach individuals strategies to better identify and 
manage their own feelings and those of PLWDs. Strategies taught in the course are 
designed to build individuals’ emotional communication skills, forge stronger 
relationships and provide more positive care experiences for care partners and PLWD 
alike. Second, the implementation team will complete the provided IPPI activity 
training videos. These training videos demonstrate less effective and more effective 
dementia communication skills and staff to the use of simple, “plug and play” 
resources to deliver the IPPI activities during their normal daily workflow. Care 
partners will also be provided a body of IPPI activity manuals with checklist of steps, 
60+ different IPPI protocols that address all 16 MDS preferences in Section F, sample 
letters/scripts introducing the IPPI to family and staff, and communication tips sheets. 
Each IPPI activity has a corresponding toolkit with instructions and supportive 
conversation prompts that consist of an introduction, middle, and conclusion section. 
The IPPI program has been explicitly designed for PLWD who are experiencing 
symptoms of distress.   
Each care partner that is trained will first observe the site champion completing an 
IPPI with a resident and then will be shadowed by the site champion upon 
implementation of their first IPPI. Feedback will be provided to ensure protocols are 
being followed. 
In addition, the project manager will provide virtual coaching throughout the pilot 
grant period through monthly calls and as needed. 

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10.3.2 Quality Control Committee  
A formal quality control committee will not be assembled, however monthly check-in 
calls with the site champions with the participating NHs will serve as an opportunity 
to monitor quality and address concerns in implementation. The  
Project Manager will lead these meetings and ask participants to provide an update on 
implementation at each meeting to ensure the project is moving forward as 
anticipated. 
10.3.3 Metrics 
The MDS 3.0 data will serve as our primary outcome measure. NH providers have 
dedicated MDS nurses who have been trained how to correctly input the MDS data as 
it also provides the algorithm for reimbursement. Data from our secondary outcome 
will be provided by the implementation team before and after they engage with the 
emotion-focused communication training. The Qualtrics questionnaire has been set so 
individuals cannot skip any question. There is a “prefer not to answer” option offered 
for every question to ensure all questions are reviewed and that participants can skip 
any question.  
10.3.4 Protocol Deviations 
During the monthly calls the PI will take notes of any ongoing project barriers or 
facilitators which will be explored in the Exit Interviews as well, with this any 
deviations from the protocol for a given NH will be documented. These documented 
deviations will be shared with the project data manager/statistical consultant to 
determine impact on analyses and inclusion of data. All deviations will also be 
compiled to report as lessons learned from the pilot project to inform submission of a 
future full-scale Stage IV effectiveness ePCT study. 
10.3.5 Monitoring 
Monthly check-in calls with the nine participating NH site champions will serve as a 
monitoring function for this pilot grant. The Project Manager will check-in with each 
site during these calls to ensure each is following the agreed upon protocol for 
enrollment, training, shadowing, and implementation. Data collection forms will also 
be reviewed every 3 months by the Project Manager, to support project 
implementation. 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and waiver for consent and any subsequent modifications will be reviewed 
and approved by Advarra, Inc.   
11.2 Informed Consent Forms 
Consent:  

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Nursing Home Residents: There will be no randomization process for this feasibility 
trial.   
We are requesting a waiver of consent for resident participation in the study.  This 
includes not only those that are exposed to the IPPI program itself, but for the release of 
EHR data for all NH residents in the study sites, regardless of participation/eligibility.  
The latter is because would be challenging for the UCH IT staff to create a cohort-
specific data extract for the project. We believe the waiver of informed consent is 
justified for the follow reasons. 
First, the research involves no more than minimal risk to subjects. Prior research has 
indicated there is minimal risk because this is a preference-based activity for the resident 
and should be a positive experience. The types of activities we are asking staff to engage 
residents in are usually done as part of standard care, but in a group setting.  
Second, the research could not be practicably carried out without the requested waiver. It 
would not be practicable for care partners to seek informed consent from either the NH 
resident living with dementia or their legally authorized representative because the IPPI is 
a clinical process implemented to address a clinical need. For example, the moment a 
resident starts to be physically or verbally abusive to a staff member during care they 
need to have the ability to immediately start an IPPI activity. The IPPI activities would be 
integrated into the care process to address a clinical need. We do not think that residents 
or their legally authorized representative would object if they knew of the waiver and its 
intent in facilitating the research. We believe that most people would prefer to engage in 
activities they find meaningful and enjoyable on a one-to-one basis. 
Third, we need to use identifiable private information and the research could not 
practicably be carried out without using such information in an indefinable format. 
Because we will need to link individual level data from multiple data sources (e.g., MDS 
and EMR) we will work with UCH IT to send the PI a crude dump of their system and 
the PI will link, deidentify the data and send to the statistical consultant. 
Fourth, we do not think the waiver has the potential to cause adverse consequences as it 
involves engagement with a care partner in a preferred important activity. We are not 
allowing for the opportunity to obtain clinical consent but relying upon the staff clinical 
judgement to identify when the resident would benefit from an IPPI activity.  
Fifth, the resident’s legally authorized representative will be provided with information 
about the IPPI program upon enrollment via phone call or email and told that their loved 
one/client is involved in the IPPI program to remediate the communication of distress. 
We can and plan to share information about the findings of the study with each UCH site.  
Implementation Team as Study Subjects: 
We will explain the IPPI program to staff at each UCH location and seek volunteers to be 
a part of the implementation team who will roll out the program (they will not be 
consented as study subjects). We will invite them to be trained in delivering the IPPI and 
support them as needed during the duration of the project.  

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We will seek to consent staff to complete a semi-structed group exit interview at the end 
of the study.  We request a waiver of documentation of consent for this activity.  This 
will be sought by either the project manager or PI conducting the interview because we 
will be conducting the interviews via telephone or Zoom. There is minimal risk as we 
will be asking implementation team members to tell us about the implementation 
facilitators and barriers they experienced. 
  
11.3 Participant Confidentiality  
We are requesting a full HIPAA waiver in order to utilize PHI for both recruitment and 
outcome data. Staff need to access the MDS data to identify eligible residents and the PI 
plans to receive an identifiable data dump from UCH. The use of identifiable data 
involves no more than minimal risk to the privacy of individuals for the following 
reasons. First, UCH IT will send the PI the data through a secure file transfer that is 
password protected. Second, once the PI is able to link the data sets, identifiers will be 
destroyed prior to sending to the statistical consultant via a secure file transfer that is 
password protected. Third, PHI will not be used or disclosed to a third parted except as 
required by law. Fourth, the research could not be practicably conducted without the full 
HIPAA waiver because UCH staff could not be able to identify eligible residents without 
the waiver. Fifth, the research could not be practicable conducted without the ability to 
link individual data from multiple data sets (e.g., MDS 3.0 and EMR).  
 
We will plan for an individualized report to each NH community with results based on 
their staff and residents. In addition, we will offer to present aggregated findings at town 
hall sessions, resident council, and family council meetings. Information will not be 
released without written permission of the participant, except as necessary for monitoring 
by IRB, the sponsor or persons working on behalf of the sponsor (i.e. IMPACT research 
study staff, the DSMB and/or Safety Officer), the FDA, the NIA and its authorized 
representatives, and the OHRP. 
 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the IMPACT 
Collaboratory, the OHRP, or other government agencies as part of their duties to ensure 
that research participants are protected.  
12 
ETHICAL CONSIDERATIONS 
All study procedures and protocols will be pre-approved by the Advarra, Inc. and will 
meet all ethical requirements for Human Subjects Research.   
13 
COMMITTEES 
N/A 

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14 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures 
developed by the Steering Committee. Any presentation, abstract, or manuscript will be 
made available for review by the IMPACT Collaboratory prior to submission. Publication 
of the results of this pilot study will be governed by the policies and procedures 
developed by the IMPACT Collaboratory.   
15 
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depression severity measure. Journal of General Internal Medicine, 16(9), 606–
613. doi:10.1046/j.1525-1497.2001.016009606.x 
National Academies of Sciences, Engineering, and Medicine 2022. The National 

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Imperative to Improve Nursing Home Quality: Honoring Our Commitment to 
Residents, Families, and Staff. Washington, DC: The National Academies Press. 
doi:10.17226/26526. 
O’Connor, C. M., Clemson, L., Brodaty, H., Low, L.-F., Jeon, Y.-H., Gitlin, L. N., 
Piguet, O., & Mioshi, E. (2017). The Tailored Activity Program (TAP) to address 
behavioral disturbances in frontotemporal dementia: A feasibility and pilot study. 
Disability and Rehabilitation, 41(3), 299–310. 
doi:10.1080/09638288.2017.1387614  
Powell, B.J., Waltz, T.J., Chinman, M.J. et al. (2015). A refined compilation of 
implementation strategies: results from the Expert Recommendations for 
Implementing Change (ERIC) project. Implementation Science, 10, 21. 
doi:10.1186/s13012-015-0209-1 
Proctor, E., Silmere, H., Raghavan, R., Hovmand, P., Aarons, G., Bunger, A., Griffey, R., 
& Hensley, M. (2011). Outcomes for implementation research: Conceptual 
distinctions, measurement challenges, and research agenda. Administration and 
Policy in Mental Health and Mental Health Services Research, 38, 65-76. doi: 
10.1007/s10488-010-0319-7 
Saliba, D., & Buchanan, J. (2009). Development and validation of a revised nursing 
home assessment tool: MDS 3.0. Report for Centers for Medicare and Medicaid 
Services. HHS.  Retrieved April 10, 2017 from 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/downloads/MDS30FinalReport.pdf 
Saliba, D., Buchanan, J., Edelen, M. O., Streim, J., Ouslander, J., …Chodosh, J. (2012). 
MDS 3.0: Brief Interview for Mental Status. JAMDA, 13, 611-617. 
doi:10.1016/j.jamda.2012.06.00 
Steffen, A.M., McKibbin, C., Zeiss, A.M., Gallagher- Thompson, D., & Bandura, A. 
(2002). The revised scale for caregiving self-efficacy: Reliability and validity 
studies. The Journals of Gerontology. Series B, Psychological Sciences and 
Social Sciences, 57, P74–P86. 
Van Haitsma, K., Curyto, K., Abbott, K.M., Towsley, G., Spector, A., & Kleban, M.  
(2015). A randomized controlled trial for an individualized positive psychosocial 
intervention for the affective and behavioral symptoms of dementia in nursing 
home residents.  Journal of Gerontology: Psychological Sciences, 70(1), 35-45. 
doi:10.1093/geronb/gbt102. 
Weiner, B. J., Lewis, C. C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., 
Boynton, M. H., & Halko, H. (2017). Psychometric assessment of three newly 
developed implementation outcome measures. Implementation Science, 12(108), 
1-12. doi: 10.1186/s13012-017-0635-3 
 
 

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16 
SUPPLEMENTS/APPENDICES 
While any member of the implementation team can complete these forms, we anticipate the 
champion(s) being primarily responsible. We will ask that the champion(s) submit data to the 
research team in batches with the 3 month and 6 month electronic data. These forms can be 
scanned and emailed or faxed to the project manager, Molly Noble via encrypted email at 
nobleme2@miamioh.edu or private fax at 513-529-3605. 
 
Appendix A. Binder Forms 
Site:__________  
 
 
Implementation Team Details 
 
*email address will be used to identify if individual completed the Emotion 
Focused Communication Training  
 
IPPI Program – Resident Preferences Worksheet 
Site champion(s) will maintain a password protected list of the name of each resident 
that is enrolled into the IPPI program along with a unique ID# that is determined by the 
champion(s). This password protected file will be shared with the PI who will then link 
the data from this worksheet to the electronic medical record data prior to deidentifying. 
After completing a resident’s preference assessment, identify and record their most 
important preferences in the column “Important Preferences.” Next, review the list of 
IPPI protocols then record the protocols that match the resident’s important preferences 
in the “Matching IPPIs” column. Review the list of matching IPPIs with the 
implementation team member(s) that will be facilitating the activity with the resident and 
let them chose which IPPI activities (1-2) they are most comfortable doing. After they’ve 
chosen the IPPI activities, record their selection in the “IPPIs Selected” column. Identify 
one or more resident behaviors that are the target outcome for the intervention as 
indicated on the MDS Section E. Finally, note if the resident completed the project and if 
there were any adverse events. 
Staff 
Name 
Position Did 
individual 
complete 
EFCT? 
Email 
address* 
Did 
individual 
watch both 
IPPI training 
videos? 
Did individual review 
3 tip sheets 
(Considerations 
before, during and 
ending the IPPI)? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Resident 
Unique 
ID# 
 
Important 
Preferences 
Matching 
IPPIs 
IPPIs Selected 
by 
implementation 
team 
Supplies 
Needed 
Location 
Which targeted 
behavior(s) do 
you hope the 
IPPI will 
remediate? 
Check all that 
apply 
Did the 
resident 
complete 
the IPPI 
Project? 
 
Yes
 
No 
If no, why 
did the 
individual 
not 
complete 
the 
project? 
 
Did the 
resident 
have any 
adverse 
events? 
 
Yes    
 
No 
If Yes, 
complete 
Serious 
Adverse 
Event 
Report 
Form 
 
• 
 
• 
 
• 
 
o 
 
o 
Physical 
behavioral 
symptom 
o 
Verbal 
behavioral 
symptom 
o 
Other 
behavioral 
symptom 
o 
Rejection of 
Care 
o 
Wandering 
o 
Depressive 
Mood 
Symptoms 
o 
 
o 
 
 
 
 

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Observation Checklist of Fidelity to IPPI Protocol conducted by Champion 
 
Did the person delivering the IPPI do any of the following? 
1. Yes No N/A Introduce self to resident 
2. Yes No N/A Introduce IPPI activity to resident 
3. Yes No N/A Consider possible distractions (background noise, visual/tactile) 
4. Yes No N/A Check that individual could hear or was wearing hearing aids if applicable 
5. Yes No N/A Interrupt resident in the middle of a visit (reverse coded) 
6. Yes No N/A Give the resident a choice of two items/topics 
7. Yes No N/A Ask open-ended questions 
8. Yes No N/A Allow the resident time to respond to a question or complete a task 
9. Yes No N/A Notice responsive behaviors (eye contact, facial expressions, gestures) 
10. Yes No N/A Validate the resident’s thoughts and feelings (echo words or gestures) 
11. Yes No N/A Encourage the resident to do as much as possible independently 
12. Yes No N/A Is the activity a positive emotional experience for the resident? 
13. Yes No N/A Adapt to situation – if resident does not want to continue – change subject 
14. Yes No N/A If resident becomes agitated, tries to calm them down 
15. Yes No N/A Communicate that the session is over 
16. Yes No N/A Thank the resident for participating 
17. Yes No N/A Explain what is happening next  
 
 
 
Serious Adverse Event Report Form Template 
 
 
Protocol Title: Click or tap here to enter text. 
 
Project ID: Click or tap here to enter text. 
 
PI Name: Click or tap here to enter text. 
 
Encrypted Site ID (e.g., site01, site02):  Click or tap here to enter text. 
 
Encrypted Subject ID (e.g., ptID001, ptID002): Click or tap here to enter text. 
 
1. SAE Onset Timeframe (Two-month timeframe anytime within which the event occurred): 
 Click or tap to enter a date. To Click or tap to enter a date. 
 
2. Duration of SAE (Number of days): 
Click or tap here to enter text. 
 
3. Location of adverse event: 
  ☐ Emergency Department 
  ☐ Hospital 
  ☐ Outpatient visit 

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  ☐ Nursing Home/Skilled Nursing Facility 
  ☐ Home 
  ☐ Other, Specify: Click or tap here to enter text. 
  ☐ Unknown 
 
4. Was this an unexpected adverse event?        ☐ Yes      ☐ No  
 
5. Brief description of participant: 
Sex: Choose an item.    
Age:   Choose an item.     
 
6. Adverse Event Term:  Click or tap here to enter text. 
 
7. Brief description of the nature of the serious adverse event (attach additional page if more 
space is needed.):   Click or tap here to enter text.  
 
8. Category of the serious adverse event: 
 
☐  death  
      ☐  life-threatening 
☐  hospitalization - initial or prolonged  
      ☐  disability / incapacity 
      ☐  required intervention to prevent permanent impairment (Devices Only)  
      ☐  important medical event 
 
9. Intervention type: 
 
☐ Behavioral/Life Style, Specify: Click or tap here to enter text. 
 
☐ Device, Specify:  Click or tap here to enter text. 
☐ Education, Specify: Click or tap here to enter text.   
☐ Medication Deprescribing, Specify: Click or tap here to enter text. 
☐ Other, Specify: Click or tap here to enter text. 
 
10. Intervention target: 
 
  ☐ Clinicians/staff 
  ☒ Person living with dementia 
  ☐ Care partner 
  ☐ Other, Specify: Click or tap here to enter text. 
 

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11. Relationship of event to intervention: 
 
  ☐ Not related (clearly not related to the intervention) 
  ☐ Possible (may be related to the intervention) 
  ☐ Definite (clearly related to the intervention) 
 
12. Was study intervention discontinued due to event?    ☐   Yes        ☐  No 
 
13. What steps were taken to treat serious adverse event?  If none, state so. 
Click or tap here to enter text. 
 
14. List any relevant tests, laboratory data, history, including preexisting medical 
conditions (do not include dates or identifiable locations): 
Click or tap here to enter text. 
 
 
15. Type of report:    ☐     Initial        ☐  Follow-up       ☐  Final  
 
 
 
 
Signature of Principal Investigator _______________________    Date: _________________