HearCARE: Hearing for Communication and Resident Engagement
Phase: NA
Conditions: Hearing Loss, Age-Related
Sponsor: University of Pittsburgh

HearCARE 
 
V.4 
STUDY19120233  23 May 2021;updated 06 October 2021; 30 December 2021 
 
Based on NIH Protocol Template for Behavioral and Social Sciences Research Involving humans 
 
HearCARE: Hearing for Communication and Resident 
Engagement 
Protocol Number: STUDY19120233 
National Clinical Trial (NCT) Identified Number:  NCT04575051 
Principal Investigator: Catherine Palmer 
Sponsor: University of Pittsburgh 
 
Study Title: HearCARE 
Contract Number: HL-2019C1-16067 
Funded by: PCORI 
Version Number:  v.4 
30.December.2021 
 
 

HearCARE 
 
V.4 
STUDY19120233  23 May 2021;updated 06 October 2021; 30 December 2021 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
PCORI terms of award.  
 

HearCARE 
 
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23 May 2021; updated 06 October 2021; 30 Dec 2021 
 
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 4 
1.3 
Schedule of Activities .......................................................................................................................... 6 
2 
INTRODUCTION ............................................................................................................................................ 7 
2.1 
Study Rationale .................................................................................................................................... 8 
2.2 
Background........................................................................................................................................... 8 
2.3 
fit Assessment ...................................................................................................................................... 9 
2.3.1 
Known Potential Risks ..................................................................................................... 9 
2.3.2 
Known Potential Benefits .............................................................................................. 10 
2.3.3 
Assessment of Potential Risks and Benefits .............................................................. 11 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 11 
4 
STUDY DESIGN ........................................................................................................................................... 12 
4.1 
Overall Design .................................................................................................................................... 12 
4.2 
Scientific Rationale for Study Design.............................................................................................. 15 
4.3 
Justification for Intervention ............................................................................................................. 15 
4.4 
End-of-Study Definition ..................................................................................................................... 16 
5 
STUDY POPULATION ................................................................................................................................ 16 
5.1 
Inclusion Criteria ................................................................................................................................ 17 
5.2 
Exclusion Criteria ............................................................................................................................... 17 
5.3 
Lifestyle Considerations .................................................................................................................... 17 
5.4 
Screen Failures .................................................................................................................................. 17 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 18 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 22 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 22 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 22 
6.1.2 
Administration and/or Dosing ....................................................................................... 23 
6.2 
Fidelity ................................................................................................................................................. 25 
6.2.1 
Interventionist Training and Tracking .......................................................................... 26 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 27 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 28 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 28 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 28 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 28 
7.3 
Lost to Follow-Up ............................................................................................................................... 30 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 30 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 30 
8.2 
Safety Assessments .......................................................................................................................... 36 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 36 
8.3.1 
Definition of Adverse Events ........................................................................................ 36 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 37 
8.3.3 
Classification of an Adverse Event .............................................................................. 37 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 39 

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8.3.5 
Adverse Event Reporting .............................................................................................. 39 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 39 
8.3.7 
Reporting Events to Participants ................................................................................. 39 
8.3.8 
Events of Special Interest ............................................................................................. 40 
8.3.9 
Reporting of Pregnancy ................................................................................................ 40 
8.4 
Unanticipated Problems .................................................................................................................... 40 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 40 
8.4.2 
Reporting Unanticipated Problems to Participants ................................................... 40 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 41 
9.1 
Statistical Hypotheses ....................................................................................................................... 41 
9.2 
Sample Size Determination .............................................................................................................. 41 
9.3 
Statistical Analyses............................................................................................................................ 43 
9.3.1 
General Approach .......................................................................................................... 43 
9.3.2 
Analysis of the Primary Endpoint(s) ............................................................................ 43 
9.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 43 
9.3.4 
Safety Analyses .............................................................................................................. 44 
9.3.5 
Baseline Descriptive Statistics ..................................................................................... 44 
9.3.6 
Planned Interim Analyses ............................................................................................. 44 
9.3.7 
Sub-Group Analyses ..................................................................................................... 44 
9.3.8 
Tabulation of Individual Participant Data .................................................................... 45 
9.3.9 
Exploratory Analyses ..................................................................................................... 46 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 46 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 46 
10.1.1 
Informed Consent Process ........................................................................................... 46 
10.1.2 
Study Discontinuation and Closure ............................................................................. 47 
10.1.3 
Confidentiality and Privacy ........................................................................................... 47 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 47 
10.1.5 
Key Roles and Study Governance .............................................................................. 48 
10.1.6 
Safety Oversight ............................................................................................................. 48 
10.1.7 
Clinical Monitoring .......................................................................................................... 50 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 50 
10.1.9 
Data Handling and Record Keeping ............................................................................ 51 
10.1.10 
Protocol Deviations ........................................................................................................ 52 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 52 
10.1.12 
Conflict of Interest Policy .............................................................................................. 53 
10.2 
Additional Considerations ................................................................................................................. 53 
10.3 
Abbreviations and Special Terms ................................................................................................... 53 
10.4 
Protocol Amendment History ........................................................................................................... 55 
11 
REFERENCES ............................................................................................................................................. 57 
 

HearCARE 
 
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1 
STATEMENT OF COMPLIANCE 
 
 
(1) The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the PCORI Terms and Conditions of Award. The Principal Investigator will assure that no deviation 
from, or changes to the protocol will take place without prior agreement from the funding agency 
and documented approval from the University of Pittsburgh Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard(s) to the trial participants. All 
personnel involved in the conduct of this study have completed Human Subjects Protection 
Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials have 
been submitted to the IRB for review and approval. The study has been approved by the University 
of Pittsburgh as an Exempt study. Any changes to the consent form(s) will be IRB approved. 
 
 

HearCARE 
 
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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
09/29/2020 
 
Name*:  Catherine V. Palmer 
 
Title*: Professor, PI 
 
Investigator Contact Information 
Affiliation*: University of Pittsburgh 
Address: 5026 Forbes Tower, Pittsburgh, PA 15260 
Telephone: 412-647-6089 
Email: palmercv@upmc.edu 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
HearCARE: Hearing for Communication and Resident Engagement
Contract Number: 
HL-2019C1-16067
Study Description: 
An open cluster cohort stepped-wedge randomized design with a phased, 
randomized roll out will be employed to compare the Consult Model and the 
Engage Model of hearing and communication care for residents in Assisted 
Living Facilities. The Consult Model is present in every facility and baseline 
data (primary outcomes: Satisfaction with Social Participation and a Hearing-
Specific HRQoL measure) will be collected in each facility.  Every 5 months, 
two new facilities will be provided with the Engage Model which will continue 
in the facilities until the end of the study.  The primary outcomes will be 
measured over the course of the study.  Secondary outcomes will be addressed 
relative to family burden and staff satisfaction. Linear mixed models will be 
used to test the hypothesis of improving satisfaction with social participation 
and hearing-specific HRQoL.
Objectives: 
 
Amplification is a well-established, evidence-based front-line treatment for 
those with impaired communication secondary to Age Related Hearing Loss 
(ARHL) . The challenge in treating ARHL is identifying a care model that 
effectively promotes adherence to individualized-treatment recommendations 
allowing the end-user to self-manage hearing loss with appropriate support. 
This proposal compares the two most common models of care for ARHL 
(defined below) provided to adults in assisted living/personal care communities. 
Aim 1: Compare the effectiveness of a Consult Model versus an Engage Model 
in improving satisfaction with participation in social activities for all residents.  
Aim 2: Compare the effectiveness of a Consult Model versus an Engage Model 
of care in increasing hearing-specific health-related quality of life (HRQoL) in 
residents with measured hearing loss.  
Secondary Aims will explore the impact of interventions on staff satisfaction 
and family burden as well as other stakeholder prioritized outcomes.  
Endpoints: 
The end point for participants is the end of the study or if they are no longer 
residing in the facility. 
Study Population: 
Phase or Stage: 
Residents in Assisted Living/Personal Care Senior Living Facilities 
Phase 3 
Description of 
Sites/Facilities Enrolling 
Participants: 
Ten Assisted Living/Personal Care Facilities will be the sites involved in the 
study.    
Description of Study 
Intervention/Experimental 
Manipulation: 
The Consult Model (i.e., usual care) is an acute care strategy, relying on a 
monthly Audiologist visit to the facility.  
The Engage Model is a chronic care approach to supportive hearing loss self-
management of ARHL. Engage includes hearing screening for all residents, an 
individualized-communication plan for those with an identified hearing loss, 
provision of non-custom amplifiers, referral to audiology if needed, and 
ongoing support provided by trained personnel under the supervision of the 
audiologist.  
The Consult Model is ongoing in the 10 facilities. Two facilities at a time 
(randomized) will cross over to The Engage Model. 
Study Duration: 
The study duration is 28 months from start of enrollment to end of data 
collection. 

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Participant Duration: 
Participants will be enrolled for 28 months or the number of months 
from entering the facility with the study in progress to the end of the 
study. 
 
1.2 
SCHEMA  
The chart below provides the timeline of events for data collection and introduction of the intervention 
(Engage Model).  
 
 
 
 
 
 
 
 
 
 
 

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1.3 
SCHEDULE OF ACTIVITIES  
Please see the separate spreadsheet entitled “Schedule of Enrollment and Data Collection” for the 
Schedule of Events over 28 months for Residents, Family, and Staff in all facilities.  Below is the schedule 
of activities illustrated for one block of facilities (two facilities). Blocks of facilities cross over to the 
Engage Intervention at different times throughout the study.  
 

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2 
 
INTRODUCTION 

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2.1 
STUDY RATIONALE  
Amplification is a well-established, evidence-based front-line treatment for those with impaired 
communication secondary to Age Related Hearing Loss (ARHL) .1 ARHL is the most prevalent cause of 
communication impairment among older adults.2 The challenge in treating ARHL is identifying a care 
model that effectively promotes adherence to individualized-treatment recommendations allowing the 
end-user to self-manage hearing loss with appropriate support. This proposal compares the two most 
common models of care (defined below) for ARHL provided to adults in assisted living/personal care 
communities.  
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to 
the facility.3–6 
The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL.7–13 
Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for 
those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid 
trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) 
referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication 
Facilitator) under the supervision of the audiologist.  
Aim 1: Compare the effectiveness of a Consult Model versus an Engage Model in improving satisfaction 
with participation in social activities for all residents.  
Aim 2: Compare the effectiveness of a Consult Model versus an Engage Model in increasing hearing-
specific health-related quality of life (HRQoL) in residents with measured hearing loss.  
Secondary Aims will explore the impact of interventions on staff satisfaction and family burden as well 
as other stakeholder prioritized outcomes.    
 
 
2.2 
BACKGROUND  
 
Untreated ARHL is associated with a variety of poor health outcomes including increased frailty,14,15 
falls,16,17 cognitive decline,18–20 depression,20 anxiety,21 and social isolation.22,23 The multiple health and 
social outcomes impacted by untreated hearing loss contribute to decreased quality of life (QoL).24  
Importantly, treating hearing loss in older adults is associated with positive health and social outcomes 
including reduced risk of falling,25  hospitalization,26,27  incidence of depression,13,28,29 and anxiety30. 
Conversely, treatment also fosters increased social participation.31  Social participation is “a person’s 
involvement in activities that provide interaction with others in society or the community”32. Social 
participation is a critical determinant of healthy aging.33–36 
The  audiology consult (i.e., acute-care) model is the most common approach to hearing care in Senior 
Living Facilities.3–6  This Consult Model increases physical accessibility by bringing the clinic to the facility 
on a monthly basis.  Yet, this approach does not address the chronic nature of ARHL or the need for 

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ongoing support to manage technology and the communication environment. An alternative strategy 
(Engage Model) that has shown promise in Senior Living Communities7–10,12 consists of this same access 
to an audiologist but is supplemented by a trained Communication Facilitator (CF) who is available  
weekly to assist the residents and staff. Assistance provided by the CF may include supporting hearing 
aids use, troubleshooting technology, dispensing non-custom amplifiers, fostering group 
communication, and addressing environmental manipulations (RQ-5). The Baltimore HEARS study 
provided a prospective randomized-controlled trial (RCT) designed to assess the feasibility, acceptability, 
and preliminary efficacy of a hearing intervention including simple amplifiers and ongoing support by 
CFs in a community-based environment.  Although the study included a small number of participants, 
results indicated that the program was acceptable, 93% benefited, and 100% would recommend the 
program to others.13  An RCT evaluating the Active Communication Education (ACE) program, a chronic 
care approach, for ARHL  found  improved hearing-specific HRQoL and increased social participation.12 
Researchers also have focused on other health conditions in RCTs examining the use of support 
personnel in order to promote ongoing management of chronic conditions and have found reduced 
disability and improved HRQoL related to the implementation of care assistants.37,38 Although 
encouraging, these results leave a gap in the evidence base that would resolve the dilemma that persists 
in designing hearing care for ARHL. An intervention study comparing the Consult and Engage Model of 
hearing health care would assist the resident, family, staff, and organization in decision making related 
to desired hearing care (RQ-3).  
Ferguson et al’s Cochrane Database Systematic Review confirmed that amplification is the evidence-
based treatment for those seeking hearing help.1 The dilemma lies in which model of care will identify 
those individuals in need of help and provide the needed support to promote successful adherence to 
individualized-treatment recommendations allowing the end-user to participate in self-management of 
the chronic condition of   ARHL. The American Speech-Language-Hearing Association’s Ad Hoc 
Committee on Audiology Service Delivery in Home Care and Institutional Settings provides guidance for 
hearing care supplemented by ongoing support in residential settings and the American Academy of 
Audiology provides guidelines related to audiology support personnel who might provide this ongoing 
care.  The Assisted Living Guidelines in the State of Pennsylvania (consistent with other states) indicate 
that hearing status should be documented (section 2800.252, 2800.224) as part of resident intake, that 
the need for communication support services should be identified (section 2800.4, 2800.130), and that 
self-management of communication issues should be promoted (section 2800.201). Currently, there are 
no data available to inform an individual managing an Assisted Living Facility as to what intervention 
would be effective and bring them into compliance with these guidelines. (Criterion 1. Potential for the 
Study to fill critical gaps in evidence) 
2.3 
FIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 

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The University of Pittsburgh IRB has deemed this a minimal risk study. The research procedures include a 
Pure Tone Hearing Survey, a Hearing Specific Health Related Quality of Life Survey (Hearing Handicap 
Inventory for the Elderly, HHIE), and the Satisfaction with Participation in Discretionary Social Activities- 
Short Form 7a) for residents. Family members are completing the Zarit Burden Interview modified 4 
question v.1 via mail or weblink and Facility Staff are completing the Michigan Organizational Assessment 
Questionnaire (MOAQ).   
 
The research measures do not carry inherent risks. The researchers will be sensitive to the possibility of 
individuals being embarrassed by hearing loss or communication challenges throughout the study. We 
will attempt to minimize any sense of intrusion given that we are entering the residents’ home (facility) 
to conduct this research. We also will be sensitive to staff burden related to a research study being 
performed in their place of work. In addition, we will try to minimize burden on families who we will ask 
to respond to surveys as well.  
The Consult and Engage Interventions are standard of care at UPMC and are not included in the IRB 
research activities. These activities also provide minimal risk.  Any risk would be managed by UPMC as the 
provider of this care.  
There are several mechanisms to inform residents, families and staff about the research and related 
services which we hope will alleviate confusion and stress related to introducing the intervention under 
investigation. We will work with the managing staff at the 10 facilities throughout the project to minimize 
disruption.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
In 2019, older adults account for 17% of the US population and this is expected to grow to 24% by 
2060.45 Over half of these individuals are expected to have hearing loss46 and few use the treatment 
shown to mitigate ARHL.47 With over 800,000 older individuals residing in assisted living/personal care 
facilities and an estimated 8 million living in some type of long-term care facility,48 senior living 
communities are an important population in terms of hearing loss intervention. Increasingly, older 
adults are finding senior communities an appropriate living arrangement as they may need increased 
care and desire increased social participation.  However, the overwhelming presence of untreated 
hearing loss compromises social participation22,49–51 as well as contributing to poor health outcomes.31,52–
56  Healthy People 201057 and Healthy People 202057,58 included “increase the proportion of adults with 
disabilities who participate in social activities as a goal.” Increased social participation is a common goal 
in senior living facilities. Untreated hearing loss presents a barrier to achieving this goal for the 
individuals with hearing loss and the individuals with whom they interact. Health and social 
interventions should focus on prevention, delay, and reversal of risk factors associated with reduced 
social participation.59 Hearing loss is a modifiable risk factor for social isolation.31 Senior Living Facilities 
provide an ideal environment in which to test interventions targeted at improving hearing and 
communication to enhance QoL and increase residents’ satisfaction with social participation (RQ-3). This 
is a group with a high incidence of hearing loss, a location where interventions can be controlled and are 
easily accessible, and an environment where social participation opportunities are consistently offered 
(PC-1). 

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2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The research measures do not carry inherent risks. The researchers will be sensitive to the possibility of 
individuals being embarrassed by hearing loss or communication challenges throughout the study. We 
will attempt to minimize any sense of intrusion given that we are entering the residents’ home (facility) 
to conduct this research. We also will be sensitive to staff burden related to a research study being 
performed in their place of work. In addition, we will try to minimize burden on families who we will ask 
to respond to surveys as well.  
 
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS 
Primary
Compare the effectiveness of 
a Consult Model versus an 
Engage Model in improving 
satisfaction with participation 
in social activities for all 
residents.  
 
 
Compare the effectiveness of 
a Consult Model versus an 
Engage Model in increasing 
hearing-specific health-
related quality of life (HRQoL) 
in residents with measured 
hearing loss.
Satisfaction with 
Participation in 
Discretionary 
Social Activities – 
Short Form 7a V1.0
 
 
 
 
Hearing Handicap 
Inventory for the 
Elderly (HHIE) – 
Screening V1.0  
This is a measure with 
adequate psychometric data 
to support its use in 
identifying change in 
satisfaction with participation 
which is of primary interest 
when improving 
communication through 
hearing.  
The HHIE is a reliable, valid 
measure of self-perceived 
hearing handicap. This is a 
direct measure of the 
intervention for individuals 
with hearing loss.  
Secondary
Compare the effectiveness of 
a Consult Model versus an 
Engage Model in increasing 
Staff Satisfaction.  
 
 
 
 
 
Compare the effectiveness of 
a Consult Model versus an 
Engage Model in decreasing 
Family Burden.  
Michigan
Organizational 
Assessment 
Questionnaire 
(MOAQ) 
 
 
 
 
Zarit Burden 
Interview -
Modified 4 
question V1.0 
This is a standardized 
measure of perceived stress 
by staff. Our previous 
stakeholders indicated that 
the staff questionnaire should 
be brief (3 questions).  
 
 
 
Reduction of burden is of 
interest in this study and the 
Zarit Burden Interview 
provides a standardized way 
to probe this outcome.  

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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS 
Tertiary/Exploratory 
Define a threshold of 
improvement with exposure 
to the intervention 
The HHIE and 
Satisfaction with 
Participation in 
Discretionary 
Social Activities 
will be used to 
assess threshold of 
improvement as a 
function of 
exposure to the 
Engage Model. 
 
The two primary resident 
measures are of interest 
when defining a threshold or 
improvement over time.  
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
The Engage Intervention is a complex intervention and as such we have followed the Medical Research 
Council Framework39,40 to develop, pilot, and now propose evaluation and subsequent dissemination of 
this intervention.  The complexity of the intervention is not only in its multiple aspects but also in the 
complex interactions with other stakeholders indirectly impacted by the intervention. When hearing and 
communication are supported for residents there is potential to impact other non-treated residents 
improving their QoL as well (SCI-1). Changes in these groups potentially impact interactions with staff 
and family and improved family interactions may impact relationships with staff. It is not the goal of this 
project to tease out which components of this complex intervention produce the desired outcomes, but 
it is critical to understand and acknowledge the complexity of the intervention being delivered.  The 
underlying mechanism of change when hearing loss is managed in an aging individual is critical to 
understanding this complex intervention.  Emerging evidence suggests that the underlying mechanism 
related to positive outcomes subsequent to treating age-related hearing loss is the reduction in 
cognitive energy required to communicate and participate67–71 (SCI-2). Diminished hearing produces 
increased cognitive load required to decode the incomplete or distorted signal which the older adult 
may ill afford given their need for cognitive resources for other activities (e.g., navigating the 
environment, interpreting the conversation, etc.) (SCI-5). The cascade hypothesis suggests that the 
untreated hearing loss increases need for cognitive resources that cannot be allocated for other, 
important activities whereas treating hearing loss releases these cognitive resources allowing for social 
engagement which in turn improves quality of life for the individual and communication partners72 (CI-
1).  

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Comparators:  The typical pathway to hearing health care includes a self-selected subset of individuals 
working with an audiologist to obtain hearing aids.47  We label this the Consult Model and it represents 
usual care provided in senior living facilities3–6.  Age-related hearing loss, however, is a chronic condition 
and may be better served with an ongoing self-management support model (Engage Model)8–10,74 
supported by a CF who is available to the resident, family, and staff on a weekly basis (two days per 
week) along with oversight and support from an audiologist who is available virtually to the CF and 
available to the facility monthly (RQ-5).  
Expected Outcomes: We hypothesize that Engage Model participants will have significantly greater 
satisfaction with participation in social activities across residents regardless of hearing status and an 
increase in hearing-specific HRQoL in residents with hearing loss compared to those receiving the 
Consult Model.  Additionally, we expect to find higher staff satisfaction and lower perceived family 
burden after stakeholders have experienced the Engage Model as compared to the Consult Model.  
Study Deign: We propose an open cohort stepped-wedge cluster randomized design (see Table below, 
CI-3) with a phased, randomized roll out (RQ-2). The stepped wedge design is a useful design for the 
evaluation of complex health care interventions75 particularly when the intervention is believed to be 
beneficial with minimal risk.76 This design is increasingly being used to evaluate interventions involving 
health care delivery and has several advantages: (1) allowing the research team and clinical teams to roll 
out the intervention in a small number of facilities in a timely, systematic manner77; (2) possibly 
increasing participation and buy-in since all facilities will eventually implement the intervention during 
the study,75,78,79 (3) possible increase in statistical power compared to a cluster randomized trial due to 
increase in data collection and within cluster comparisons.75 Our intervention is applied at the facility 
level (cluster) but the primary outcomes are obtained at the resident level (RC-1). In this open cohort 
design, all residents in a facility are identified to participate but some may leave the facility and others 
will move into the facility over the course of the study.80  (Criterion 3. Scientific merit) 
Five pairs of 10 facilities will be assigned the intervention (Engage Model, gray cells) randomly over the 
course of 28 months with the first 4 months used as a baseline period (total data collection period is 28 
months).81  Residents enrolled in the study during any time period will be followed until the end of the 
study or until they are no longer a resident of the facility, whichever comes first. This implies that 
crossover to the intervention is not only at the facility level but also the resident level.75 Once the 
intervention is available at a facility, residents will be exposed to the intervention continuously. The 
resident level outcomes of satisfaction with social participation and hearing-specific HRQoL will be 
measured every 5 months for the duration of the study.  
 

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Randomization and Allocation: The stepped wedge design implies a baseline period, in which no clusters 
are exposed to the intervention.79  Then, at the chosen time interval, two facilities will be randomized to 
cross from the control to intervention.  This process continues until all ten facilities have crossed over to 
the intervention.   
 
 
 
 
The order of this cross over process will be randomized.  We will  randomize 2 facilities to switch from 
the control to intervention at each step using SAS version 9.4 (RC-5). The statistician will communicate 
the sequence to the Study Team for intervention implementation preparation (IR-2).  If the expected 
number of individuals across the 10 facilities are not recruited in a timely manner we will expand to 
other Assisted Living/Personal Care Facilities at UPMC.  Triggers for expanded recruitment will include 1) 
lower census in the building than targeted (10% lower than expected) and/or 2) inability to meet 
enrollment milestones over two check points as outlined on the Milestone chart.  
 
Baseline      
(4 months)
Time 1       
(5 months)
Time 2       
(5 months)
Time 3       
(5 months)
Time 4       
(5 months)
Time 5       
(5 months)
Facility 1-2
60
60
Facility 3-4
60
60
Facility 5-6
60
60
Facility 7-8
60
60
Facility 9-10
60
60
Percent of Total Data Collected by this Date
0% 4 months 17% 5 months 34% 5 months 51% 5 months 68% 5 months 85% 5 months 100%
6/1/2021
Baseline 
9/1/2021
Time 1
2/1/2022
Time 2
7/1/2022
Time 3
12/1/2022
Time 4
5/1/2023
Time 5
10/1/2023
Facilities 1-2
Facilities 3-4
Facilities 5-6
Facilities 7-8
Facilities 9-10
Consult Model
Engage Model

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4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
We considered several other designs including individual randomized parallel arm, cluster randomized 
parallel arm, and cluster randomized cross-over. We believe the individual randomized design would not 
be feasible to implement in a facility due to the high likelihood of intervention contamination between 
residents randomized to the intervention arm and those randomized to control (RC-2). The cluster 
randomized parallel arm trial did not fit with our assumption and observations that the intervention will 
benefit all residents. Therefore, randomizing facilities to control did not seem appropriate and would 
not bode well with our facility collaborators. The standard cluster randomized trial also had much lower 
power given the number of clusters available. Due to the type of intervention, a cluster randomized 
crossover trial would not be feasible since we would have to take away the facilitator from facilities that 
were randomized to have it first and there may be large carryover effects of having the facilitator in 
place previously.   
An open cohort stepped-wedge cluster randomized design with a phased, randomized roll out was used 
by Leontjevas et al (2013)82 successfully in a skilled nursing facility with interventions related to 
depression. Our design is consistent with that study.  
 
4.3 
JUSTIFICATION FOR INTERVENTION 
 
A systematic review of interventions to improve hearing aid use found that ongoing communication 
support improves participation and communication (SR-1).7  Yet, the authors also concluded that data in 
this area are limited and that well-controlled studies directly comparing usual care (audiology visit) 
versus a model of care that includes ongoing communication support are needed (RQ-1). Given the 
paucity of data to guide informed choices between the Consult and Engage Model, we conducted two 
pilot studies that focused on the Development and Feasibility & Piloting stages of the Medical Research 
Council framework for complex interventions.39,40 In the first pilot study, we created the support 
personnel training program, engaged stakeholders to identify outcomes of importance, and tested the 
feasibility of providing interventions and measuring these outcomes.41 Residents and family 
stakeholders identified increased social participation and perceived decrease in limitations due to 
hearing loss as critical outcomes (PC-1). Participants were able to respond to questionnaires focused on 
these two areas (85% of residents completed the study). Significant change was measured on both 
primary outcomes within 4 months when an Engage Model was implemented as compared to a control 
group with the Consult Model (CI-3). The second study revealed that 84% of residents in Assisted 
Living/Personal Care had significant hearing loss with less than 5% using personal amplification.  Only 
56% of individuals with significant hearing loss accurately self-identified that they had hearing loss and 
less than 50% of health care providers accurately identified significant hearing loss in individuals with 
hearing loss. Interestingly, 63% of residents with measured hearing loss whether they had self-identified 
hearing loss or not accepted a non-custom amplifier.    

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These preliminary data support the need for hearing loss identification to be part of a broad 
intervention program. Figure 1 illustrates that hearing screening in aging adults is rare,42 yet the 
Welcome to Medicare guidelines include hearing screening for all individuals turning 65. It is not 
possible to promote and support 
individualized hearing solutions if 
the underlying problem is not 
identified. Our pilot data reveal 
that simply asking someone if they 
have hearing loss is neither 
sensitive nor specific in identifying 
individuals with significant hearing 
loss.43  Hearing screening with 
response to calibrated sounds 
identifies the target population. As 
part of the feasibility study, noise 
survey data were collected to 
determine if accurate hearing screening and testing could be conducted in senior living facilities.  
Background noise ranged from 25-67.5 dB SPL (with peaks as high as 78.4 dB SPL) which is consistent 
with previously reported data.44 Importantly, the frequency response of the background noise was 
measured and found to be below the range of frequencies most critical for valid hearing screening 
procedures.  Hearing testing is conducted with insert earphones that sufficiently reduce the background 
noise to allow for accurate testing.  
 
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed the baseline 
assessments and 5 more assessment time points (at 5-month intervals) as shown in the Schedule of 
Activities (SoA, Section 1.3) for the duration of the 28 month study.  Alternatively, a participant will have 
completed the study if they are no longer a resident in the facility regardless of what time point coincides 
with that change in living arrangement. Staff and Family members have completed the study at the end 
of the 28-month period or at which point a Staff member is no longer working in the facility or the Family 
member no longer has a relative in the facility.  
 
5 
STUDY POPULATION 
 
All residents in the 10 Assisted Living Facilities will be eligible to participate in the study. Every resident 
will be approached to participate.  Residents who agree to be enrolled will participate in the Pure Tone 
Hearing Survey and the two questionnaires.  All residents, regardless of enrollment in the study will be 
exposed to the intervention (Engage Model) because this intervention happens at both the individual and 
facility level.  

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One Family member for each resident will be invited to participate in the study. They will receive a link to 
an electronic version of the survey or will be mailed a paper version of the study with a self-addressed 
stamped envelope for return depending on their preference.  
 
All Staff working in the facility will receive a paper version of the Job Satisfaction Survey so they can 
participate in the study.  
 
5.1 
INCLUSION CRITERIA 
 
Resident Inclusion Criteria: 
The participant must be a current resident in one of 10 Assisted Living Facilities. 
Staff Inclusion Criteria: 
The participant must be currently employed in some capacity at one of the 10 Assisted Living Facilities.  
Family Inclusion Criteria:  
The Family member must be the primary contact for the resident in one of the 10 Assisted Living 
Facilities.  
 
5.2 
EXCLUSION CRITERIA 
 
Resident Exclusion Criteria: 
The participant is not a current resident in one of 10 Assisted Living Facilities. 
They are not able to communicate in English. 
They are identified through interactions as having a cognitive challenge that does not allow them to 
respond to the hearing survey or the questionnaires.  
Staff Exclusion Criteria: 
The participant is not currently employed in some capacity at one of the 10 Assisted Living Facilities.  
Family Exclusion Criteria:  
The individual does not have a family member in one of the 10 Assisted Living Facilities.  
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 
5.4 
SCREEN FAILURES 
 
Residents unable to communicate in English or unable to respond to the hearing survey or the 
questionnaires because of cognitive challenges will be considered ineligible.  All family members and staff 
are included.  
 

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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
a. Facility Recruitment 
The UPMC Senior Living Communities provide an opportunity to conduct intervention research.  
Within the 12 Assisted Living Facilities, we were able to collaborate with 7 facilities that have 
not experienced the Engage Model and currently have the Consult Model active. We included 3 
non-UPMC facilities as well. These facilities were identified by the President of Senior Living as 
being appropriate to include in this study. We have existing relationships with all 10 facilities 
because two UPMC audiologists already provide the Consult Model of care in these facilities. 
These facilities have similar demographics of residents (age range, education, family caregivers, 
etc.), similar staff positions, years of experience, and responsibilities, similar physical layout, and 
similar week-to-week programming. This allows us to achieve the number of participants we 
need to complete the proposed intervention study. This coordinated system at UPMC also 
ensures that if there are any changes implemented in Senior Living during the investigation, they 
will be implemented across all facilities. For the three non-UPMC facilities, we will monitor any 
changes that might occur in these locations. The facilities also are geographically close to the 
University of Pittsburgh making intensive data collection (resident survey completion) practical. 
 
b. Facility Retention 
Sites that start the study are anticipated to complete the entire study and continue to 
participate for the full duration of the study. Throughout the study PI Dr. Palmer will continue to 
maintain relationships with the Directors at each facility and be in communication with them 
regarding recruitment/research activities and to answer any questions/concerns the site may 
have. The Data Survey Coordinator, Jon Rivera, will be in monthly contact with the facilities as 
well.  
c. Resident, Family, and Staff Recruitment 
Flyers and advertising on the Facility televisions will be used to introduce the study to residents, 
staff, and families.  Residents will be individually introduced to Data Collectors by current facility 
staff. This method was recommended by our Stakeholder Advisory Panel and was deemed 
appropriate by the facility leadership with whom we interact on an ongoing basis.  In each 
facility, we will work with directors to provide surveys to staff through the mechanism deemed 
most appropriate (paper left in an area where staff receive notifications, direct interaction with 
Data Survey Coordinator, and/or email).  This approach was recommended by our Stakeholder 
Advisory Panel given that staff in different facilities receive information through different 
mechanisms.  We will work with the facility directors to contact family members through this 
individual to introduce them to the study and to determine if they would like to be contacted via 
mail or email for survey completion.  
In addition, the mechanisms for providing information described above as well as 
resident/family meetings will be used to introduce the Engage Model (intervention) into the 
facility. Families also will receive descriptions of the study and later the Engage Model by mail in 
case they are not in the facilities. The Engage Model is an intervention at the Facility and 
Individual Level so all residents, staff, and families are exposed whether they have enrolled in 
the study or not. This care is provided as part of UPMC Senior Living care and is extended to the 
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of the study.  This is an ongoing intervention that was started 5 years ago. At the time of 
introduction, the same techniques as listed above were used to inform residents, families, and 
staff about the program.  The Consult Model continues to be promoted through flyers and 
electronic media (TV screens) in facilities.  In addition, all new residents are provided about the 
access to an Audiologist that the Consult Model provides.  
 
d. Resident, Family, and Staff Retention 
We will work with the staff at each facility to recruit as many residents as possible into the 
study. Because this is being conducted in the facility where they live, it is easy to participate and 
the interventions will be woven into everyday life in addition to individual hearing solutions. Just 
prior to enrollment of each group, we will conduct informational sessions introducing the 
Engage Model for residents, families, and staff to ensure understanding of the program, how to 
access resources, and who to contact with questions. Our preliminary data in three facilities 
indicate that approximately 85% of residents will participate in completing the outcome 
measures. The intervention includes support from the CF (two days per week) which will help 
keep residents engaged in this study. Adequate personnel are budgeted to ensure that residents 
who need assistance will have someone to help them complete surveys (PC-2).  
Based on suggestions from our Stakeholder Advisory Panel (SAP), residents will be provided with 
a small gift (e.g., water bottle and other useful items) after each data collection session (every 5 
months). The item will be labeled with the study name to encourage the resident’s friends to ask 
about the study and perhaps increase interest in participating.  The Data Collector will leave a 
University of Pittsburgh folder with each resident after the first data collection interaction that 
provides the Data Collectors name and picture and a log with the date of the visit along with a 
note about what they talked about (e.g., resident told the Data Collector about grandchildren, 
family, facility activities).  The date of the next visit will be recorded as well. This serves the 
purpose of reminding the resident of the study and the date the Data Collector will return. This 
also provides information for a family member who may be interested in their loved one’s 
interactions.  In the 5-month period between data collection visits, the Data Collector will send 3 
notes to say “hello” to the resident and remind them of the study. The SAP thought that this 
was important given the 5-month period between visits.  
 
e. Total target sample size for primary analysis 
Target sample size is 304 residents for the primary analysis. This has changed from the original 
proposal due to decrease in census and higher decline rate than predicted from the pilot study. 
This represents 60% of the total census (approximately 30 individual per site is the minimum 
goal).  
Target sample size for families is 178.  This has changed from the original proposal because 
census and resident enrollment targets have changed. The percent of families enrolled in 
relation to residents enrolled has not changed; this remains at 58%.  

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Target sample size for staff is 279. This has not changed from the original proposal. We were not 
able to meet this goal at baseline but have received stakeholder input that should assist us in 
reaching this target in the future.  
 
f. 
Historical resident volume and estimated eligible N across study sites (numbers as of 
05.01.2021). 
Residents:  The estimated eligible N across study sites is 440 residents.  
Family Members: The estimated eligible N across study sites is 440 family members.  
Staff Members: The estimated eligible N across study sites is 358 staff members. 
Location 
UPMC or Non-UPMC Facility 
Assisted Living or Personal Care 
Total Census*
Location 1 
UPMC 
Personal Care 
60 
Location 2 
UPMC 
Personal Care 
25 
Location 3 
UPMC 
Personal Care 
22 
Location 4 
non-UPMC 
Personal Care 
74 
Location 5 
non-UPMC 
Personal Care 
47 
Location 6 
UPMC 
Assisted Living 
67 
Location 7 
UPMC 
Personal Care 
34 
Location 8 
non-UPMC 
Assisted Living 
55 
Location 9 
UPMC 
Assisted Living 
69 
Location 10 
UPMC 
Assisted Living 
54 
Total 
 
 
507 
*Census as of 05/01/2021. Census shifts as people leave and enter the facilities. 
 

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g. Estimated yield/consent 
 
Residents: 
Our pilot data suggest that we should expect that 85% of residents will agree to or be available 
to participate in the study measures (Pure Tone Hearing Survey, Hearing Specific Health Related 
Quality of Life Questionnaire and Satisfaction with Participation Questionnaire).  After starting 
baseline data collection, it became evident that both the Census and the rate of decline has 
changed from when we completed the pilot study. We adjusted the study to accommodate 
these changes by adding two locations and adding a data collection time point. Census across 
the 10 facilities suggests that there are 452 residents and we have planned the study around 
collecting data from 304.  
 
Families: 
Our pilot data suggest that we should expect 58% of family members (compared to enrolled 
residents) to participate in the survey that will be sent to them.  
 
Staff:  
Our pilot data suggest that we should expect 90% of the staff in each facility to participate in the 
survey that will be sent to them.  
 
h. Estimated lost to follow-up/attrition 
 
Residents: 
The updated 60% yield accounts for individuals who decline to participate and individuals who 
may move or otherwise no longer be in one of the facilities. In our pilot work, no residents 
dropped out of the study unless they were no longer in the facility. Individuals will move into 
the facilities over the three years and the study design accounts for including these individuals 
regardless of the timing of their entry into the study.  
 
Family Members: In our pilot study 58% of families participated and 0 dropped out (this was 
58% of the resident enrollment).  With this study extending over 3 years there will be families 
who no longer have a family member in a facility who will stop participating.  New families will 
be included as new residents move into the facilities.  
 
Staff Members:  In our pilot study, 2% of staff dropped out over time because they changed 
positions and moved to different facilities. We will collect surveys on any new staff who join the 
facility over the time period of the study.  
 

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i. 
Gender and Race 
The Table below provides the current Race/Ethnicity and Gender distribution in the 10 facilities 
that are participating in this study (data from enrollment time point as of September 1, 2021). 
This represents the individuals who were enrolled at baseline.  These representations may 
change slightly over the course of the study.  
 
Race/Ethnicity and Gender Enrollment Table 
Race 
Male
Female
Missing Gender 
Total
American Indian/Alaska Native 
0 
0 
0 
0 
Asian 
0 
0 
0 
0 
Black/African American 
1 
5 
0 
6 
Hawaiian/Pacific Islander 
0 
0 
0 
0 
White 
66 
235 
0 
301 
Multi-race 
0 
1 
0 
1 
Other 
1 
0 
0 
1 
Prefer not to say 
2 
3 
0 
5 
Missing Race 
0 
0 
12 
12 
Ethnicity 
  
  
  
  
Hispanic(Latino/Latina) 
0 
0 
0 
0 
Non-Hispanic 
69 
238 
0 
307 
Missing Ethnicity 
0 
0 
12 
12 
Prefer not to say 
1 
6 
0 
7 
 
 
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION   
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
The typical pathway to hearing health care includes a self-selected subset of individuals working with an 
audiologist to obtain hearing aids.47  We label this the Consult Model and it represents usual care 
provided in senior living facilities3–6.  Age-related hearing loss, however, is a chronic condition and may 
be better served with an ongoing self-management support model (Engage Model)8–10,74 supported by a 

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CF who is available to the resident, family, and staff on a weekly basis (two days per week) along with 
oversight and support from an audiologist who is available virtually to the CF and available to the facility 
monthly (RQ-5).  
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to 
the facility.3–6 
The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL.7–13 
Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for 
those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid 
trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) 
referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication 
Facilitator) under the supervision of the audiologist.  
The Communication Facilitators are provided with standardized training at UPMC to provide consistent 
hearing care to residents in Senior Living Facilities. The training manual is uploaded as a separate 
document.  
 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
The Consult Model of care consists of an Audiologist visiting the facility once per month.  This is considered 
usual care and is in place in all of UPMC Senior Living Communities.  
 
The Engage Model is the intervention under study. The following description provides support for the 
dose of two visits per week per facility when in the Engage Model.  
The Communication Facilitator was present 5 days per week in the original pilot study (1 year).  During 
that time, Hearing Specific Health Related Quality of Life as measured by the Hearing Handicap for the 
Elderly- short version (HHIE-S) was assessed pre- and post-treatment (after 4 months of the Model in 
place in each of two facilities).  There were two arms in the study, one facility with the Engage Model 
and one facility with the Consult Model. Data were analyzed for those residents completing the HHIE 
with a resulting baseline score of >8 which indicates perceived handicap. The same group of residents in 
each facility was assessed 4 months later with their respective models of care in place.  In the pilot 
study, identifying information was not collected so individual participant changes cannot be assessed; 
only mean data can be evaluated (the same individuals completed the pre- and post-test).  Planned t-
tests were used to test significant differences between groups and between time points within groups.  
A Bonferroni correction was applied given the multiple comparisons (p<0.05/4 = 0.0125 was considered 
significant). The first two rows of data in Figure 1 indicate that there was a significant reduction in 
perceived handicap between pre- and post-treatment (4 months) for the group in the Engage Model (p 
<0.0125) whereas there was no difference for the group in the Consult Model (p > 0.0125). In addition, 
the Engage group had significantly lower self-perceived hearing handicap 4 months into treatment than 
the Consult group (p< 0.0125). The 95% confidence interval for the HHIE-S is 10%1 meaning an individual 
would experience clinically significant benefit in the psychosocial domain of function given this change. 
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changes could not be evaluated due to a lack of identifying information collected during the pilot 
investigation. 
At the end of the 1-year pilot study, our plan was to discontinue the CF model until we received funding 
to further investigate this model. The impact of the CF on resident quality of life and satisfaction with 
participation, reduction of perceived family burden, and staff satisfaction compelled us to maintain the 
Engage Model in this targeted facility. We were able to do this with a CF two days per week as opposed 
to 5-days per week which was a change in the model.  Given this change, we decided to re-survey the 
residents who had completed the HHIE-S. We re-administered the questionnaire six months after 
changing to a 2x per week dose of CF support.  The goal was to establish whether the positive outcome 
of increased Hearing Specific Health Related Qualify of Life was maintained when the CF support was 
reduced to 2x per week. The 
last row in the Figure below 
reveals that the reduction in 
handicap (increase in Hearing 
Specific HR QoL) was 
maintained six months after 
the reduction in CF support (no 
significant difference between 
the 4-month treatment data 
with CF 5x per week versus 6 
months of treatment with the 
CF 2x per week, p>0.0125). 
This allowed us to continue the 
Engage Model with the CF 
present 2X per week which is 
what we are proposing in the 
current study.  
Figure.  Hearing Specific Health Related Quality of Life (Hearing Handicap Inventory for the Elderly-Short 
Version). Means (standard deviations) for each Model of care at baseline (pre-treatment), treatment (4 
months of Model in place), and six months into the Engage Model where the CF support was reduced to 
two visits per week.  Higher scores indicate greater perceived hearing handicap. Significant differences 
are indicated by *.  
 
Satisfaction with participation in discretionary social activities as measured by the PROMIS Form7a also 
was assessed pre- and post-treatment (after 4 months of the Model in place in each of two facilities).  
Data were assessed for all willing participants in these two facilities. The same group of individuals were 
assessed at baseline and at 4 months but identifying data were not collected so individual changes 
cannot be assessed; only group differences can be analyzed and discussed. The first two rows of data in 
Figure 2 provide the mean and standard deviations for each group across time points. Planned t-tests 
were completed to compare the groups at each time point and to compare time points within each 
group. There was a statistically significant difference after initiation of treatment for the Engage Model 
(p< 0.0125) but no difference for the Consult Model at the 4-month time point (p>0.0125).  In addition, 
the Engage Group was more satisfied after 4 months than the Consult Group (higher scores indicate 

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greater satisfaction, p<0.0125). The PROMIS scales provide data on “minimally important differences” 
(MID) which are interpreted as “the smallest difference in score in the domain of interest which patients 
perceive as beneficial and which would mandate a change in the patient’s management”.2,3 A change of 
4.5 is considered a minimally important difference on this measure and although we cannot provide 
individual changes because identifying information was not collected, as a group the individuals 
experiencing the Engage Model did achieve this difference in Satisfaction in Participation (higher scores 
indicating greater satisfaction).  
 
After moving to the 2x per week CF dose, we resurveyed Satisfaction in Participation at the 6-month 
time point (same timing as the HHIE-S data collection) and found that the increase in Satisfaction with 
Participation was maintained. The last row in the Figure below reveals that the increase in satisfaction 
was maintained six 
months after the 
reduction in CF 
support (no significant 
difference between 
the 4-month 
treatment data with 
CF 5x per week versus 
6 months of treatment 
with the CF 2x per 
week, p>0.0125). This 
provided further 
evidence to support 
continuation of the 
Engage Model with the 
CF present 2X per 
week.  
 
 
Figure. PROMIS Satisfaction with Participation in Discretionary Social Activities – Short Form 7a. Means 
(standard deviations) for each Model of care at baseline (pre-treatment), treatment (4 months of Model 
in place), and six months into the Engage Model where the CF support was reduced to two visits per 
week. Higher scores indicate greater satisfaction with participation. Raw scores are transformed to 
standardized scores (T-scores) for analysis. Significant differences are indicated by *.  
 
6.2 
FIDELITY 
 

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6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
The Engage Model is dependent on the Communication Facilitator. Communication Facilitators have 
standard training at UPMC prior to moving into their positions.  The Training Manual for Communication 
Facilitators has been uploaded separately.  
 
The Fidelity measures in the Table below will be tracked throughout the duration of the study to ensure 
that Communication Facilitators are able to provide appropriate hearing care and to verify that there are 
different levels and amounts of care being provided in different facilities.  
Timing
Item
Plan for 
Measurement
Secondary 
Measurement
Baseline  
  
  
  
  
HHIE (Scale) 
% completed 
  
  
Satisfaction with 
Participation (Scale) 
% completed 
  
  
Family - Zarit Burden 
% completed 
  
  
Staff - MOAQ 
% completed 
  
  
Hearing Test 
% completed 
  
5-month intervals 
for research 
measures 
HHIE (Scale) 
% completed 
compared to baseline 
  
  
Satisfaction with 
Participation (Scale) 
% completed 
compared to baseline 
  
  
Family - Zarit Burden 
% completed 
compared to baseline 
  
  
Staff - MOAQ 
% completed 
compared to baseline 
  
  
Hearing Test 
% completed on any 
residents newly 
enrolled 
  
During Engage 
Model Only 
  
  
  
  
Hearing Screening 
% screened 
  
  
Residents who failed 
hearing screening offered 
a hearing test by 
audiologist 
% offered 
time from offer to test by 
audiologist 
  
  
  
  

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Individuals with 
documented hearing loss 
provided with a 
Communication Plan 
% Communication 
Plans completed 
  
  
Action items on 
Communication Plan 
Completed 
% of action itmes 
implemented within 3 
months 
% residence adherance 
with plan 
  
  
  
  
  
  
  
  
  
Non-custom amplifiers 
# dispensed 
% use of non-custom 
amplifiers for all residents 
provide with a non-
custom amplifier 
  
  
  
  
  
Ongoing support of 
individuals using 
technology (custom, non-
custom, group) 
% seen over 1 week 
period 
  
  
Staff Educational 
Sessions conducted 
within a facility 
# of sessions 
% of staff attending 
educational session 
  
  
  
  
  
Resident educational 
sessions conducted 
within a facility 
# of sessions 
% of residents attending 
educational sessions 
  
  
  
  
  
Presence of CF 
% of weeks 
  
  
Presence of Audiologist 
% of months 
  
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
The study is randomized at the facility level with pairs of facilities randomized to cross over to the 
intervention. Pairing is not random, rather pairing will be conducted to have comparable N across pairs.  
The Data Entry System (REDCap) and Database will be constructed in a manner that will not allow the 
DCs to determine what intervention is currently present in the building (Consult Model or Engage 
Model). The DCs will be blinded in this manner but may be unintentionally unblinded by resident 
comments when they are interacting. The research team does not anticipate needing to unblind data 
collectors at any point however if necessary, to unblind will be the decision of the PI in consultation with 
the leadership team. The research team is not blinded due to the need to work with the Data 
Coordinating Center to implement the Engage Model across the study. 
The University of Pittsburgh Physical Therapy Data Center will serve as the Data Coordinating Center 
(DCC) under the direction of Dr. Patterson (IR-7). We will use an electronic data capture (EDC) system 
which will be built around standardized case report forms. The system will have additional applications 

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including participant tracking, file uploads, and reporting. The electronic data management system will 
allow the trial to be paperless, as all data will be input directly by the research staff into a secure web-
based system. Data will be collected on facilities, staff, residents and family members with linkage 
through unique, study specific identifiers. For residents, the data collected are minimal: demographics, 
hearing test results, use of hearing devices, satisfaction with social participation, hearing- specific 
HRQoL, hospitalizations, and change in status such as moving or death. The data core analysts will be 
blinded to condition (IR-6). 
 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
The Fidelity measures outlined in 6.2.1 will confirm that participants are accessing the intervention at the 
individual level. Participants also are impacted at the Facility level and the DSC will collect monthly data 
from the facility about the use of group amplification systems.  
 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
The Engage Intervention is both at the Facility and Individual level.  It is care that is provided through 
UPMC Assisted Living and therefore the resident will be exposed whether enrolled in the study (research 
measures) or not. The most common reason for a resident to discontinue any level of intervention will be 
that the resident no longer lives in the building. This also would be the reason for a family member to stop 
participating. The most common reason for staff to stop participating in the intervention would be 
relocation of his/her job. All data collected to this point will be used in the analysis.  
 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Residents 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
DCDemographicsBaseline1 (Time1, Time 2, Time 3, Time 4, Time 5) Case Report Form (CRF). All new 
residents entering the facility during the study will be invited to enroll.  
 
Reasons for discontinuation or withdrawal: 
Moved to higher level of care 
Moved to hospice care 
Deceased 
Moved to family 

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Family Members 
Typically, family members discontinue or withdraw based on the status of the resident.  
 
Staff Members 
Staff members withdraw or discontinue if their job placement moves to another location.  
 
The sample CONSORT diagram below illustrates the tracking of enrollment, loss to follow up, and new 
individuals entering the study (i.e., people who move into the facility during the study).  Individuals lost 
to follow up will be further characterized related to why they were lost to follow up.  
 
 
 
 
 

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7.3 
LOST TO FOLLOW-UP 
 
Missing data prevention and analysis plan: To minimize missing data, we will create a tracking system 
with reminders in the electronic data capture system that will prompt research staff as to which 
residents are due for follow-up (MD-1). If the resident is temporarily unavailable, e.g., hospitalized, 
visiting family, the research staff member will document the reason for the missing survey and make 
multiple attempts to follow up with the individual (IR-7). We will continue to attempt to collect data 
throughout the 7-8 week time frame where the Data Collector is in the building every 5-months. We 
expect to have at least 1 follow-up assessment for at least 85% of the participating residents, based on 
our pilot data. We will compare baseline characteristics (e.g., age, hearing loss, original responses to 
surveys of hearing and satisfaction in participation, sex, race, ethnicity, date entered facility) between 
residents with any missing follow-up to those without to assess potential biases. We will try to obtain 
reasons for missed assessments so that we can assess the missing data mechanism (MD-3). Missed 
assessments are captured in the REDCap survey when a staff member or resident can tell us why data 
was not collected (e.g., the resident is out of the facility due to hospitalization or due to family visit, 
resident does not want to participate on this day, etc.). The linear mixed models proposed for the 
analyses assume missing data at random (MD-2) and perform as well as multiple imputation given the 
same assumption of the missing data mechanism. We will conduct sensitivity analyses (MD-4) assuming 
non-ignorable missingness with differential imputation of poor scores and pattern mixture models (MD-
2). We will compare the results from the sensitivity analyses to our primary analyses to assess the 
robustness of findings. 
  
As a way to explore the issue of attrition and inclusion of residents after baseline, we propose a 
sensitivity analysis as was done in a similarly designed open cohort stepped wedge trial for depression 
management in nursing homes (82). We will use two dummy variables for newcomers and non-
completers (lost to follow up, died, relocated) and interactions between these variables and the 
intervention to see if the intervention effect is different for these subgroups of residents. 
 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
The set of research measures will be conducted at Baseline 1, , Time 1, Time 2, Time 3, Time 4, and Time 
5 (see the Schedule of Activities in section 3.1) for residents, families, and staff.  The MOP has all of the 
CRFs in the appendices.   
 
Residents:  
Data will be collected by trained data collectors. Training will include: 
 

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DCs will consist of audiology students from the University of Pittsburgh, and the DSC Jonathan 
Rivera. These students have experience in hearing testing and interviewing in their clinical training 
which makes them ideal data collectors in this study.  In addition, they have experience with 
geriatric populations and managing communication with individuals with communication 
challenges. Since June 2020, they also have experience using appropriate PPE and following strict 
sanitation guidelines related to clinical interactions. These same guidelines will be followed in 
resident interactions to ensure safety. Training of the DC’s will include:  
 
Virtual audiometer simulation to ensure accuracy in completing Pure Tone Hearing 
Surveys.  Adequate accuracy is defined as establishing thresholds within +/- 5 dB from 
the target air conduction threshold across four frequencies (500, 1000, 2000, 4000 Hz) 
in 10 simulation cases. The cases are set to have a variety of patient response types to 
mimic what the DC’s will experience on site.  
 
Pure tone hearing surveys on 5 classmates will allow for practice with equipment 
placement and testing in a real environment (rather than simulated). 
 
The DSC will train the DC’s in the use of the iPad interface with the REDCap data 
collection system. The DC’s will collect practice data on two individuals using the 
interface.  Data includes consent, demographics, and two surveys (Hearing Specific 
Health Related Quality of Life and Satisfaction with Social Participation).  
 
Practice interviewing will be completed through role playing with Dr. Mormer to ensure 
that DC’s are ready to handle a variety of situations that may present themselves while 
interacting with older adults in Assisted Living environments. Interviewers will be 
instructed on methods for determining if a participant becomes distressed during an 
interview.  If this situation occurs, the interviewer will be trained to temporarily 
discontinue the interview and ask the participant if they wish to terminate the interview 
and/or to resume at a later time. 
 
The DSC will coordinate all site-specific training for the DC’s.  
Measures include: 
Demographic Information 
 
Facility 
 
Date entered facility 
 
Ethnicity 
 
Race 
 
Sex 
Hearing Handicap for the Inventory – Short Version 
Satisfaction with Participation in Discretionary Social Activities – Short Form 7a 
Pure Tone Hearing Survey (quietest sound that can be heard at 500, 1000, 2000, 4000 Hz in each 
ear.  

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CRFs for these forms are found in the Appendix of the MOP.  
 
Family: 
The DSC will send surveys to family members via email or mail depending on what they prefer.  
Measure includes: 
Zarit Burden Interview -modified 4 question v. 1.0 
CRFs for this form is found in the Appendix of the MOP.  
 
Staff:  
The DSC will provide paper surveys to the Staff based on the lack of use of email accounts at these 
locations. 
Measure includes: 
Michigan Organizational Assessment Questionnaire (MOAQ) 
CRFs for these forms are found in the Appendix of the MOP.  
 
No results from the Pure Tone Hearing Survey or the questionnaires for any group will be shared 
with participants. If a resident is concerned about their hearing, they will be encouraged to see the 
Audiologist who comes to the facility once per month.  This service is always available to them.  
Intervention Data 
The CF and Audiologist routinely track data for QA and QI as part of their work at UPMC. These data 
will be used to track the intervention at the individual and facility level. The activities of the CF 
(described in detail in the MOP) will be recorded in the REDCap database which will allow the Data 
Survey Coordinator (DSC) to view reports of missing data for each visit. The DSC will follow up with 
Elizabeth Dervin (UPMC Communication Facilitator on the Stakeholder Advisory Panel) if there are 
missing data on a consistent basis so she can provide re-training to the CF. The Audiologist sees 
scheduled patients during the monthly audiology visits. We will collect number of visits per facility 
to track consistency and again, will follow up with the audiologist if there are discrepancies between 
facilities.  
CRFs for the Engage and Consult Model are found in the Appendix of the MOP.  
Data related to the complex intervention core functions and forms will be collected and are outlined 
in the table below.  
  

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Problem/Need  
Core Functions  
Forms (dependent on context, 
individualized)  
Intermediate 
Outcomes  
  
  
  
  
1.Lack of awareness 
of hearing loss (HL)  
A. Provide accessible 
hearing screening  
I. Promote HL awareness and 
availability of hearing 
screenings through: a. facility 
media (digital boards, flyers, 
etc.)  
Within 3 weeks of 
screening ask resident 
to describe the results 
and recommendations 
(i.e., teach back)  
  
  
a. facility media (digital boards, 
flyers, etc.  
   
  
  
b. Letters to residents  
   
  
  
c. Letters to families  
   
  
  
II. Provide screening in central 
areas and apartments  
   
  
B.Provide recommendation 
to see the Audiologist for a 
full hearing test  
III. Tracking and follow-up to 
ensure patients receive 
screening and follow-up 
hearing tests  
Adherence to 
recommended follow-
up audiological exam 
  
  
V. Recommend hearing test 
following a "fail" on hearing 
screening  
Within 3 weeks of 
testing ask resident to 
describe the 
recommendations that 
were provided at the 
time of the test (i.e., 
teach back)  
  
  
VI. Schedule hearing test at 
time of completion of the 
hearing screening  
   

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2.Lack of knowledge 
and devices to 
independently 
manage hearing loss 
A.Creation of Individual 
Communication Plan  
I. Use of personal amplification 
device (custom or non-custom) 
if appropriate  
Ask resident to 
demonstrate battery 
removal and re-
insertion (this 
is an direct way to 
determine that the 
device has been used 
given that the battery 
would need to be 
changed) three weeks 
after receiving the 
amplification. CF 
records self-reported 
and staff-reported use 
biweekly.  
  
  
II. TV device if appropriate  
Ask resident to 
demonstrate use (turn 
it on, off, put headset 
on, etc.) 2 weeks after 
delivery. CF records 
self-reported and staff-
reported use biweekly. 
  
  
III. Amplified Phone Device  
Call resident in order to
test ability to use the 
device successfully. CF 
records self-reported 
and staff-reported use 
biweekly.  CF will 
interact with each 
resident with a 
Communication Plan 
once per week to 
ensure there is 
adequate and 
consistent observation. 
Staff are assigned to a 
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can provide these 
observations weekly. 
  
  
IV. Communication Strategies  
Observation of specific 
communication 
strategy use by 
resident when engaged 
with the CF (e.g., 
muting TV when room 
is entered, looking at 
speaker, etc.). CF 
records self-reported 
and staff-reported use 
biweekly. CF will 
interact with each 
resident with a 
Communication Plan 
once per week to 
ensure there is 
adequate and 
consistent observation. 
Staff are assigned to a 
specific number of 
residents and therefore 
can provide these 
observations weekly.  
3.Lack of 
Communication 
Accessibility in the 
Facility related to 
group activities  
A. Use of sound field 
equalization (amplification) 
systems  
I. Hands on staff training.  
Once per month, CF 
plans timing of 
facility visit to coincide 
with planned group 
activity (e.g., crafts, 
discussion group, 
bingo) and record if 
staff are using room 
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different speakers 
(reinstruct as 
necessary).  
  
B. Use of group TV 
amplifying headsets  
II. Hands on staff training with 
system  
Once per month, the 
CF plans timing of 
facility visit to coincide 
with group TV activity 
(movie time, sports 
event, etc.) and record 
if staff are offering to 
assist residents with 
group TV amplifiers.  
  
 
 
 
8.2 
SAFETY ASSESSMENTS 
 
There are no known risks related to the study measures (Pure Tone Hearing Survey and questionnaires).  
The Intervention is being provided by UPMC Audiology and is provided elsewhere in the UPMC system. 
There have been no reported risks or adverse events related to the Consult or Engage Model of 
intervention.  The Study Team will monitor all procedures and the DSMB will monitor the study as well. 
The DSC will visit each facility at each Test Time point to make sure all DCs are following the standard 
protocol for interacting with residents, enrolling residents, and collecting data.  
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 

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For this study, the following standard AE definitions are used:  
Adverse event: Any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless 
of whether it is considered related to the medical treatment or procedure. 
Serious Adverse Event: Any AE that results in any of the following outcomes: 
 • Death 
 • Life-threatening 
 • Event requiring inpatient hospitalization or prolongation of existing hospitalization 
 • Persistent or significant disability/incapacity  
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
There is no expectation of serious adverse events related to the research study. The research measures 
include a Pure Tone Hearing Survey and questionnaires.  There is no expectation of a serious adverse 
event related to the intervention which includes typical hearing care.  
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
AEs will be collected and entered into the electronic data capture system.  
AEs are graded using the Common Terminology Criteria for Adverse Events (CTCAE) according to the 
following scale: 
Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated. An experience that is transient and requires no special treatment or 
intervention. The experience does not generally interfere with usual daily activities. This 
includes transient laboratory test alterations.  
Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. An experience that is alleviated with simple therapeutic treatments. The 
experience impacts usual daily activities. Includes laboratory test alterations indicating injury, 
but without long-term risk.  

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Severe: Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care Activities of Daily 
Living (ADL). An experience that requires therapeutic intervention. The experience interrupts 
usual daily activities. If hospitalization (or prolongation of hospitalization) is required for 
treatment it becomes a SAE.  
Life-threatening: Urgent intervention indicated 
Fatal/Death: Death related to AE.  
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
The study uses the following AE attribution scale:  
Unrelated: The AE is clearly not related to the study procedures (i.e., another cause of the 
event is most plausible, and/or a clinically plausible temporal sequence is inconsistent with 
the onset of the event).   
Unlikely: The AE is likely not related to the study procedures (i.e., another cause of the event 
is plausible and/or a clinically plausible temporal sequence is inconsistent with the onset of 
the event) but causality cannot be clearly ruled out.   
Reasonable Possibility: An event that follows a reasonable temporal sequence from the 
initiation of study procedures, but that could readily have been produced by a number of 
other factors.   
Definite: The AE is clearly related to the study procedures.   
AEs are identified through the Data Collectors who will be interacting with residents in the 
facilities.  For Staff and Families, there is no direct interaction because they will be responding to 
surveys through mail or web link.  
All SAEs and AEs will be recorded in the electronic data capture system immediately upon 
notification of the occurrence of the SAE or AE. If the event is deemed reportable (serious, 
unanticipated, and related), the AE will be reported per the IRB AE reporting.  
SAEs and AEs related to study measures (considered very unlikely) will be reviewed by the Study 
Team to determine appropriate resolution. SAEs and AEs related to the intervention (considered 
very unlikely) will be reviewed by a licensed audiologist and UPMC risk manager for resolution.  
 
8.3.3.3 EXPECTEDNESS  
 

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An Audiologist with appropriate expertise in hearing care will be responsible for determining whether an 
adverse event (AE) is expected or unexpected related to the intervention. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study procedures. This is a minimal risk study with no expected risks to 
participants.  
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
All SAEs and AEs will be recorded in the electronic data capture system immediately upon notification of 
the occurrence of the SAE or AE. DCs will be responsible for recording this information. In addition, the 
DC will alert the DSC who will notify the PI. If the event is deemed reportable (serious, unanticipated, and 
related), the AE will be reported per the IRB AE reporting.  
 
8.3.5 ADVERSE EVENT REPORTING  
 
The study team does not anticipate any AEs due to the nature of the research activities. All AEs will be 
recorded in the electronic data capture system immediately upon notification of the occurrence of the 
SAE or AE. If the event is deemed reportable (serious, unanticipated, and related), the AE will be reported 
per the IRB AE reporting guidelines.  
The Consult and Engage Interventions are care provided by UPMC staff and are not included in the IRB 
research activities. If there are Adverse Events related to these models of care, this would be reported in 
UPMC Risk Master and handled through UPMC protocols for adverse events related to clinical care.  
Management of any AEs will be managed on a case-by-case basis and will be coordinated with the care 
team at the resident’s facility if needed.  AEs will be reported to the University of Pittsburgh IRB and PCORI 
within 10 days of the investigator first learning about the event. AEs will be included in DSMB reports.  
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event and shall report the results of such evaluation to the University of 
Pittsburgh IRB, PCORI, and the DSMB no later than 10 working days after the investigator first learns of 
the event. 
 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 

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N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
 
N/A 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
Given the low risk of this project, unanticipated problems should be at a minimum. An unanticipated 
problem is any incident, experience, or outcome that is unexpected in terms of nature, severity, or 
frequency, given the intervention protocol and characteristics of the residents or staff. 
The study team does not anticipate any UPs due to the nature of the research activities. The study 
procedures for residents consist of a Pure Tone Hearing Survey and two questionnaires completed in 
interview format. For staff and families, they will complete a short survey through the mail or internet.  
Note: The Consult and Engage Interventions are standard of care at UPMC and are not included in the IRB 
research activities. If there are UPs related to these models of care, this would be reported in UPMC Risk 
Master and handled through UPMC protocols for adverse events related to clinical care. 
Management of any UPs will be managed on a case-by-case basis and will be coordinated by the PI with 
the care team at the resident’s facility if needed. 
 
 
 
 
8.4.2 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
If any unanticipated problems occur, the Director of the facility will be notified and the PI and Data 
Survey Coordinator will work with the Director to determine the best way to disseminate information to 
residents.  Depending on the unanticipated problem we may need to communicate with all residents, 
residents enrolled in the study, or only the resident directly impacted.  These decisions will be made in 
consultation with the facility Director and the University of Pittsburgh IRB. Communication also may be 
directed at the family of the resident(s) depending on the issue.  

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Staff member who observes or is involved in the unanticipated problem will immediately notify PI 
Catherine Palmer of a problem that involves a risk to residents or others (e.g. staff, residents, family).   
PI Catherine Palmer will report these unanticipated problems to the IRBs and PCORI within 48 hours.   
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
 
 
Primary Endpoint(s):  
H1 
We hypothesize that Engage Model participants will have significantly greater satisfaction with 
participation in social activities across residents regardless of hearing status compared to those 
receiving the Consult Model. 
Ho 
There will be no difference in satisfaction with participation between participants in the Engage and 
Consult Model.  
H1 
We hypothesize that Engage Model participants with hearing loss will have an increase in Hearing-
Specific HRQoL compared to those receiving the Consult Model.  
Ho 
There will be no difference in Hearing-Specific HRQoL between participants with hearing loss in the 
Engage and Consult Model.  
 
 
 
Secondary Endpoint(s): 
H1 
We hypothesize that Engage Model staff will have higher job satisfaction compared to staff in the 
Consult Model.  
Ho 
There will be no difference in job satisfaction between staff in the Engage and Consult Model.  
H1 
We hypothesize that Engage Model family members will have reduced burden compared to staff in 
the Consult Model.  
Ho 
There will be no difference in family burden between staff in the Engage and Consult Model.  
 
9.2 
SAMPLE SIZE DETERMINATION 
 
We used a method to estimate sample size that takes into account the cluster  
randomization, the stepped wedge design, and the longitudinal data on residents84 (RC-3). Our study 
design originally included 8 clusters (facilities) with 5 time periods (including the baseline), 4 steps, 2 
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being continuously followed (CI-2). We expect some residents to leave the facility for different reasons 
and our design will allow new residents to contribute data from the time of moving into the facility until 
the end of the study period. We conducted sample size analyses accounting for intracluster correlation 
(=0.20) (RC-3), individual autocorrelation (=0.5), and cluster autocorrelation (=0.9)84. The intracluster 
correlation is a measure of correlation among residents measured at the same facility within the same 
time frame. Cluster randomized trials typically assume values between 0.01-0.10 with higher values 
indicating more similarity in outcomes within clusters such as schools, primary care clinics, or providers. 
We assumed a higher correlation given that residents are living within the same quarters and sharing 
the same residential experience. The individual autocorrelation is the correlation between any two 
measures within the same resident over time. We conservatively assumed this to be 0.5 as a lower 
bound because repeated measures within person are often highly correlated. The cluster 
autocorrelation is the correlation between two population means from the same cluster at different 
times. We assumed this would be very high (0.9) given the stability of the population in the facilities 
over time. This design achieves 80% power to detect the hypothesized effect size of 0.3 for either 
primary outcome (satisfaction with participation or hearing-specific health-related quality of life) 
between control and intervention periods (two-sided, =0.025 for each outcome). An effect size of 0.3 
translates to a difference between groups of 3 points on the satisfaction with communication scale 
assuming a standard deviation between 9 and 10 based on our preliminary data from local facilities. An 
effect size of 0.3 translates to a difference between groups of 3.6 points on the hearing-specific health-
related quality of life measure assuming a standard deviation of 12 based on our preliminary data from 
local facilities. These differences are considered clinically meaningful. We believe this hypothesized 
effect exists because of previous literature using these measures in clinical populations and from our 
pilot data.62,64   
 
The original sample size analysis for the study used a closed solution formula for a closed cohort design, 
fixed sample size per cluster, and an underlying model with assumptions valid for a large number of 
clusters. The study is an open cohort design allowing participants to drop out of the study (move out of 
the facility) and new residents to come into the study as they move into the facilities. In addition, the 
number of clusters is small (only 8) and the number of residents per facility is variable. We conducted 
simulations to assess the power and Type I error rate of our study given the open cohort design, 
variability in sample size across facilities, and statistical analysis model that accounts for the small 
number of clusters. We found the estimated power to be 77-79% with α=0.025 and 85-87% with α=0.05 
with minimal to no inflation in the Type I error rates (observed 0.025 to 0.033 for α=0.025 and 0.045 to 
0.058 for α=0.05) assuming a drop out (churn rate) of 7.5% per period. These simulations were sent to 
the DSMB and approved prior to study start. Once the study began, the targeted sample size per facility 
(~65) was deemed not to be achievable due to lower than expected census and higher than expected 
resident decline to participate.  Additional simulations showed that with 10 facilities, 5 steps (2 facilities 
per step), and 30 residents per facility, we achieved 85% power for the same hypothesized effect size 
and correlation parameters. 
 

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9.3 
POPULATIONS FOR ANALYSES 
 
All enrolled residents will be included in the analyses. The Engage Model is a Facility and Individual Level 
intervention so all residents are potentially impacted by the intervention.  
All staff and family members willing to participate will be included in the analysis.  
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Descriptive statistics will be used to characterize the overall cohort and each facility cohort for the 
variables of interest. Summary statistics will include means with standard deviations for normally 
distributed data and medians with interquartile ranges for skewed data. Categorical data will be 
summarized with frequencies and percentages. All tests will be two-sided and conducted at α=0.05 and 
all confidence intervals calculated at 95% unless otherwise stated. All variables for the primary analyses 
are stated below. Although we will assess normality assumptions for the primary and secondary 
outcomes, we do not plan to use transformations for these scale outcomes due to lack of interpretability 
and the large sample size of the trial providing robustness to normality deviations in estimating and testing 
intervention effects.  A full Statistical Analysis Plan is available as a separate document (HearCARE 
Statistical Analysis Plan, October 6, 2021).  
 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
We will use linear mixed models to test the hypothesis of improving satisfaction with participation and 
hearing-specific HRQoL specifying the fixed effects of intervention and time and random effects for facility, 
facility*time, and resident (RC-4). These random effects are based on the statistical model referenced in 
Hooper (2016)81 that account for the correlation among individuals in the same cluster at the same time 
point, correlation between observations for the same individual at two time points, and the correlation 
between two means of the same cluster at two time points. Time will be treated as a categorical variable. 
We will estimate the mean difference and corresponding 95% confidence interval for the intervention 
effect (IR-1) and test that the difference between intervention and control conditions is significant. A two-
sided test =0.025 for each outcome using a Wald t-test with Kenward Roger correction for small sample 
bias and Satterthwaite degrees of freedom will be employed. Primary analysis will be unadjusted for 
covariates.  
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
We will use linear mixed models to explore the impact of the intervention on staff satisfaction and 
family burden. The models will be specified with fixed effects for the intervention and time and 
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the staff member. For each staff member we will measure satisfaction at baseline and at least one 
measurement per time-period. For family burden, the participant is the family member/caregiver. We 
will measure family burden at baseline and at least one measurement per time-period the resident is 
enrolled in the study. These random effects account for correlation among individuals in the same 
cluster at the same time point, correlation between observations for the same individual at two time 
points, and the correlation between two means of the same cluster at two time points. We will 
estimate the mean difference and corresponding 95% confidence interval for the intervention effect.  
 
9.4.4 SAFETY ANALYSES 
 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
We will compare facilities at baseline and the last time period on several characteristics including: number 
of residents with measured hearing loss, gender composition, age range, race and ethnicity of residents, 
total occupancy, and annual staff turnover.  We will also compare them on the following measures from 
the previous 5 months: number of unexpected hospitalizations, number of falls, number of residents 
moving to a higher level of care, and number of deceased residents. 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
N/A 
9.4.7 SUB-GROUP ANALYSES 
 
In an effort to ascertain whether the intervention is more or less effective for certain resident 
subgroups (RQ-4, HT-1), we will explore the following groups (HT-2):  
(a) those who have different degrees of hearing loss at baseline (~84% expected to have some level of 
hearing loss) and those who do not;  
H1The intervention provided by the Engage Model and measured by the HHIE and Satisfaction with 
Participation will have more impact on residents with hearing loss at baseline as compared to residents 
with no measured hearing loss.  
H0 The intervention provided by the Engage Model and measured by the HHIE and Satisfaction with 
Participation will not have a different impact on residents with hearing loss at baseline as compared to 
residents with no measured hearing loss.  
 

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(b) those who have different degrees of hearing loss and use a device (~18-32% of 84%; note these are 
estimates and the actual percent of device use will be used) compared to those who do not use a 
device but have different degrees of hearing loss;  
H1The intervention provided by the Engage Model and measured by the HHIE and Satisfaction with 
Participation will have more impact on residents with hearing loss who do not use a hearing device at 
baseline as compared to residents with hearing loss who do use a hearing device.  
H0 The intervention provided by the Engage Model and measured by the HHIE and Satisfaction with 
Participation will not have a different impact on residents with hearing loss who do not use a hearing 
device at baseline compared to residents with hearing loss who do use a hearing device.  
 
(c) those with high social participation at baseline (~50%) and those with lower social participation;  
H1The intervention provided by the Engage Model and measured by Social Participation will have more 
impact for residents with low social participation at baseline compared to residents with normal or high 
social participation.  
H0 The intervention provided by the Engage Model and measured by Social Participation will not have a 
different impact for residents with low social participation at baseline compared to residents with 
normal or high social participation.  
 
(d) those with high hearing-specific HRQoL (~50%) and those with lower hearing-specific HRQoL. 
Scores of 0-8 on the HHIE are “low” and 10-40 are “high” with 10% indicating a significant change.83  
H1The intervention provided by the Engage Model and measured by HHIE will have more impact for 
residents with high hearing-specific HRQoL at baseline as compared to residents with hearing-specific 
HRQoL within normal limits.  
H0 The intervention provided by the Engage Model and measured by HHIE will not have a different 
impact for residents with high hearing-specific HRQoL at baseline as compared to residents with 
hearing-specific HRQoL within normal limits.  
 
The individual hearing threshold data will allow us to stratify according to hearing levels. We will use 
the ASHA classification of degrees of hearing loss (normal -10 to 15; slight 16 to 25; mild 26 to 40; 
moderate 41 to 55; moderately severe 56 to 70; severe 71 to 90; profound >91 dB).84 The number of 
individuals in the HHIE subgroups and hearing level subgroups cannot be adequately estimated and 
will be known when data collection are complete. We will explore the heterogeneity using interaction 
terms (HT-3) between the factor of interest and the intervention fixed effect. Regardless of the 
significance, we will estimate the treatment effect for each subgroup with corresponding 95% 
confidence intervals (HT-2).  
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 

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N/A  
 
9.4.9 EXPLORATORY ANALYSES 
 
With respect to the effectiveness of the intervention, we believe there is a threshold of improvement 
with exposure to the intervention. In other words, there will be a change (i.e., improved hearing specific 
HR QoL and satisfaction with participation) and then that change will be maintained, it will not 
increase.  However, with the data we will obtain, we will be able to explore if the change over 20 
months relative to baseline is the same as the change at 5 months relative to baseline (dose effect 
within facilities), and the same incrementally for 15 or 10 months of exposure (pooling across facilities). 
These comparisons are exploratory as they are either completely or partially confounded with 
time.   We also can conduct an analysis used in the depression trial82 to explore linear and quadratic 
terms for the number of periods in the intervention condition both at the facility and resident levels and 
the number of periods the resident was in the study.  
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
The University of Pittsburgh IRB has deemed this an Exempt Protocol.  All participants will be informed 
that they are being asked to participate in a research study and the research measures and timing will be 
explained. In addition, every potential participant will be informed that their participation is voluntary and 
they can stop participating at any time without impacting their relationship with their Senior Living 
Community, the University of Pittsburgh, or UPMC.  For residents, this description will be read to them 
and they can take as much time as they like to ask questions.  The DC will record either Yes or No related 
to their willingness to participate. For Staff and Families, they will receive this description either in writing 
or electronically and will have contact information if they have questions.  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
As described in section 10.1.1.1, this is an Exempt protocol and consent will be administered verbally for 
residents and in writing (paper or electronic) for Families and Staff. All participants will be competent in 
communicating in English based on self-report.  
 

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10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
Given the current status of the Global Pandemic, this study could be suspended if the Assisted Living 
Facilities limit non-essential personnel (DCs) from entering the building due to safety concerns for 
residents. If this happens, the Study Team will notify the University of Pittsburgh IRB and PCORI.  This 
disruption (implementing study questionnaires) will not have an adverse effect on residents, staff, and 
family.  The Intervention (Consult and/or Engage) may not be disrupted depending on the Senior Living 
Community decision about continuing what may be viewed as essential care, but it could be limited in this 
same situation.  The providers of the hearing care would work directly with the facility and the residents 
virtually in this case which would be independent of the research project. 
 
The study would resume once concerns about safety of residents due to possible virus exposure were 
addressed.  
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
Participants’ identify will be protected by providing everyone with a code consisting of first and last initial, 
a unique 4 digit identifier and a two letter facility identifier.  The key to this code will be kept in secure file 
that is only accessed by the Study leadership team. An identifier is needed to link data over time and to 
link resident data to family member data and staff to specific facilities.  
 
All research activities will be conducted in as private a setting as possible. 
 
There is no plan to share data while the study is active. This study is registered with clinicaltrials.gov and 
results submitted in accordance with PCORI requirements for public release of research findings (IR-5). 
Prior to submission of the Draft Final Research Report, we will enter into an agreement with a PCORI 
designated data repository (IR-7). Prior to the acceptance of the Final Research Report, we will provide a 
full data package to the PCORI designated repository including an analyzable data set, the full protocol 
for the study, metadata, a data dictionary, full statistical analysis plan, and analytic code for the Final 
Research Report. We will maintain the full data package for at least seven years.   
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 

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Data collected for this study will be analyzed and stored at the University of Pittsburgh Data Coordinating 
Center. After the study is completed, the de-identified, archived data will be transmitted to and stored at 
a PCORI designated repository, for use by other researchers including those outside of the study.  
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
 
Project Directors/Leadership Team  (Names REMOVED) 
Supporting Research Team (Names REMOVED) 
Stakeholder Advisory Panel (Names REMOVED) 
This panel will consist of 19 individuals who have either personal or professional experience related to 
older adults and hearing loss. The panel will initially meet for a series of three kickoff orientation 
meetings, held virtually. Thereafter, one-hour meetings will occur virtually on a monthly basis. 
The Stakeholder Advisory Panel will provide input and feedback on the study protocol, review and advise 
the research team on data collection and recruitment as needed, and address issues that arise during the 
study.  Additionally, the SAP will provide input and assistance with recommendations that emanate from 
the study, and with dissemination of study findings. 
 
10.1.6 SAFETY OVERSIGHT 
It has been determined under the advisement of the project’s coordinating center Institutional Review 
Board at the University of Pittsburgh, that this study has minimal Risk.  
The investigators conducting the trial at the University of Pittsburgh along with the Data Coordinating 
Center are primarily responsible for trial monitoring. In addition, the Data and Safety Monitoring Board 
(DSMB) will act in an advisory capacity to monitor study implementation and resident safety. Further 
details are provided below. 
The Data and Safety Monitoring Board Charter and the Data and Safety Monitoring Plan can be found as 
separate documents.  
The Data Coordinating Center at the University of Pittsburgh will produce administrative reports that 
describe study progress including:  
• 
Accrual by facility  
• 
Demographics in aggregate and by facility  
• 
Study subject status including retention in aggregate and by facility 
• 
Form and visit completeness 
• 
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These reports will be reviewed internally by the study leadership (monthly). Similar reports will also 
be presented to the Data and Safety Monitoring Board (DSMB) and the representative of the 
Patient Centered Outcomes Research Institute (see below).  
The study statistician is Dr. Charity Patterson who will be responsible for overseeing report 
generation.  
 
Interim reports will be generated by the DCC and distributed to the DSMB at least ten days prior to 
a scheduled meeting. The contents of the report will be determined by the DSMB. Additions and 
other modifications to these reports may be directed by the DSMB on a one-time or continuing basis.  
Interim data reports generally consist of two parts. 
(Open Session Report) provides information on study aspects such as participant accrual and 
demographics, retention, withdrawals, data completeness, adverse events, other study 
performance measures, any new information on the intervention or disease/disorder that may 
affect the outcome of the trial, and a list of publications or presentations.  
(Closed Session Report) will divide study participants per coded treatment assignment (e.g., 
Treatments A vs. B), comparing subject demographics and baseline characteristics, rates of and 
reasons for treatment discontinuation and loss to follow-up, and rates of serious adverse events 
(SAEs). The Closed Session Report is considered confidential.  
Dr. Patterson will work with PI Dr. Palmer to prepare an Executive Summary and response addressing 
prior concerns regarding the conduct of the study. This will be distributed to DSMB members along with 
the Open Session report. DSMB meeting data reports will generally include the following types of 
information, although only the Closed Session data reports will include comparisons by intervention 
group: 
• 
Monthly and cumulative accrual, compared with targets 
• 
Baseline characteristics overall 
• 
Completeness and quality of data collection forms 
• 
Status of enrolled participants overall 
• 
Compliance with eligibility criteria and other protocol requirements 
• 
Subject adherence to the visits  
• 
Individual adverse events (AEs) and serious adverse events (SAEs) by subject ID number and 
a table of event-specific cumulative rates 
 
Copies distributed prior to and during a meeting will be requested to be destroyed after the meeting. Data 
files to be used for interim reporting will have undergone established editing procedures to the greatest 
extent possible. Interim analyses of efficacy data will be performed only if they are specified and approved 
in advance and criteria for possible stopping are clearly defined.  
Reports from the DSMB 
Minutes of the DSMB meeting and recommendations of the DSMB will be summarized by the CCC and 
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continue or to terminate the study. This recommendation will be made by formal majority vote. A 
recommendation to terminate the study will be transmitted to the Primary Investigator and relevant 
Institutional Officials as rapidly as possible. In the event of a split vote in favor of continuation, a minority 
report should be contained within the regular DSMB report. The report will not include unblinded data, 
discussion of the unblinded data, etc. The DSMB chair will also create a separate set of minutes 
summarizing the unblinded session. Copies of the blinded DSMB report will be sent to the central and 
local IRB of each site involved in the study.  
 
10.1.7 CLINICAL MONITORING 
The clinical care, Consult Model and Engage Model currently exist in the UPMC Health System and are 
monitored as part of clinical care in the Senior Living Facilities.  The study will not interrupt or impact 
this process. Data collection and research activities will be monitored by the DSMB described in Section 
10.1.6. 
 
 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The consent process will be monitored with every participant required to provide consent that is tracked 
in the REDCap data system. Electronic data capture will be monitored by the DSC (described in more detail 
below). We maintain all source documents to ensure that the electronic data capture mirrors the planned 
data capture. Data Collection and Intervention Fidelity are monitored on an ongoing basis by the DSC. 
Protocol deviations will be monitored on a regular basis and dealt with immediately with re-training.   
 
Data Collectors will be trained prior to starting the protocol (see Section 8.1). The DSC will observe each 
DC in each facility at each data collection time point (Baseline 1, Baseline 2, Time 1, Time 2, Time 3, Time 
4). The CRFs related to residents and staff will be captured electronically and directly entered into the 
REDCap data base built for this study. The Family data will either be electronic (REDCap) survey or 
returned via paper questionnaire to the DSC who will enter the data. The data from the Audiologist will 
be provided to the DSC for electronic entry.  All routine tracking provided by the CF will be captured 
directly into the REDCap system.  These processes reduce the change of inaccuracies due to manual data 
entry from paper records. In addition, this methodology protects participant privacy by reducing paper 
data sheets. The CFs have standard training through the UPMC Audiology Division. The CF Training 
Handbook is uploaded as a separate document.  
 

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For quality monitoring, the DCC will produce reports for the study team to review that will provide 
information on 1) consent process, 2) completion of data elements, 3) compliance with intervention, 
fidelity measures (see section 6.2.1) and 4) protocol deviations.  
 
In addition to reporting, the real-time validation and regular data quality monitoring by the SHRS Data 
Center are intended to detect and correct errors continuously during the study. Real time validation will 
be implemented by building data entry fields with restricted options or restricted ranges and data quality 
prompts upon entry of outlying values. The Data Manager will develop data quality checks, monitor 
incoming data, and generate queries with specific focus on screening, inclusion/exclusion criteria, 
randomization, intervention data, outcomes, and adverse events. We will monitor for missing items, 
missing forms, and range of values entered. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
The University of Pittsburgh Physical Therapy Data Center will serve as the Data Coordinating Center 
(DCC) under the direction of Dr. Patterson (IR-7). We will use an electronic data capture (EDC) system 
which will be built around standardized case report forms. The system will have additional applications 
including participant tracking, file uploads, and reporting. The electronic data management system will 
allow the trial to be paperless, as all data will be input directly by the DCs into a secure web-based 
system. Data will be collected on facilities, staff, residents and family members with linkage through 
unique, study specific identifiers. For residents, the data collected are minimal: demographics, hearing 
test results, use of hearing devices, satisfaction with social participation, hearing- specific HRQoL, 
hospitalizations, and change in status such as moving or death. The data core analysts will be blinded to 
condition (IR-6). 
REDCap is a secure, web-based application designed with the flexibility to support data capture for a 
variety of research projects. REDCap provide management of user-access to the data, a mechanism for 
validated data uploads from external sources, an intuitive user interface for validated data capture 
through the execution of real-time validation rules, an audit trail for tracking transactions within the 
system, such as study system setup and modifications, data imports, data entry and edits, and data 
exports, and a mechanism for seamless data downloads to common data formats (SAS datasets will be 
the format of choice for this study). 
The web-based data submission software is REDCap version 10.3.7 and all data will be stored on the 
University of Pittsburgh’s servers which are housed at the Network Operations Center (NOC) and 
managed by the University’s Computing Services and Systems Development (CSSD).  The NOC is a 
state-of-the-art technical facility that houses servers and network equipment to ensure stable and 
reliable service for University enterprise systems. It is a centralized management center that is capable 
of identifying, notifying, and repairing problems when they occur and projecting when and where they 
might occur. Data are encrypted and protected behind enterprise network firewalls.  CSSD conducts 
web vulnerability scans to analyze web applications from development through production for 
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Each aspect of REDCap project will be tested in three phases before actual study data is collected. 
Phase I entails testing each form for accuracy on elements, fields, and options. Phase II entails testing 
skip patterns and functionality across forms. Phase III entails DC staff and study personnel entering 
mock data including screen failures, randomized cases, and data for cases fully enrolled and followed.  
He/she will enter the mock data in the CRFs into each field of each data collection instrument and 
document the success or failure of a) the user interface for data entry, b) the on-line univariate and 
range data validation checks, and c) custom functions.  
  
All DCC statisticians use SAS version 9.4 for report and statistical analyses. SAS runs off individual 
computers. The SAS data files will only contain de-identified data. Data files and programs used for 
monitoring, reporting, and analysis will be stored on the Office 365 University of Pittsburgh Group for 
the PTDC. Data will be stored indefinitely.  
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Study documents will be retained for a minimum of 7 years after publication of study results but can be 
maintained indefinitely by the Data Management Center. No records will be destroyed without the 
written consent of the sponsor and funding agency.  
 
10.1.10 
PROTOCOL DEVIATIONS   
A protocol deviation occurs when, without significant consequences, the activities on a study diverge 
from the IRB-approved protocol (e.g., staff not completing training within timeframe).  
Deviations from protocol will be monitored and documented throughout the study. The protocol 
deviations will be reported to the University of Pittsburgh IRB as Reportable New Information (RNI). A 
list will be kept and sent to PCORI with quarterly reports if issues do not meet immediate reporting 
requirements by PCORI standards.   
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
All dissemination of information will follow PCORI guidelines: 
https://www.pcori.org/sites/default/files/PCORI-Peer-Review-and-Release-of-Findings-Process.pdf 
All proposed publications must be reviewed by the study team prior to manuscript development. The 
lead author will be required to draft a manuscript proposal, which will detail the authors of the paper (in 
proposed order), target journal, objective of the manuscript, data needs, and resource needs. The lead 
author is responsible for collaborating with and including advisory committee members in dissemination 
efforts to ensure that stakeholder perspectives are represented.  

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The manuscript proposal will be reviewed by the study team for approval. At least one member of the 
leadership team should be included as a contributing author on the manuscript. The lead author will not 
move forward with the manuscript development until they have received written approval from the 
study team. 
After an article has been accepted for publication, it is the lead author’s responsibility to communicate 
the acceptance along with a full reference of the article to the PI.  The PI will be responsible for tracking 
all publications originating from this study. 
 
This study is registered with clinicaltrials.gov and results submitted in accordance with PCORI 
requirements for public release of research findings (IR-5). Prior to submission of the Draft Final 
Research Report, we will enter into an agreement with a PCORI designated data repository (IR-7). Prior 
to the acceptance of the Final Research Report, we will provide a full data package to the PCORI 
designated repository including an analyzable data set, the full protocol for the study, metadata, a data 
dictionary, full statistical analysis plan, and analytic code for the Final Research Report. We will maintain 
the full data package for at least seven years.   
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by hearing device 
manufacturers, is critical. Therefore, any actual conflict of interest of persons who have a role in the 
design, conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. 
Furthermore, persons who have a perceived conflict of interest will be required to have such conflicts 
managed in a way that is appropriate to their participation in the design and conduct of this trial. The 
study leadership in conjunction with the University of Pittsburgh IRB and the PCORI team have established 
policies and procedures for all study group members to disclose all conflicts of interest and will establish 
a mechanism for the management of all reported dualities of interest. At the time of IRB submission, no 
conflicts of interest had been disclosed.  
 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE
Adverse Event
AL
Assisted Living
ACE
Active Communication Education [program]
ARHL
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CF
Communication Facilitator 
CFR
Code of Federal Regulations
COC
Certificate of Confidentiality
Co-I
Co-Investigator
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
DC
Data Collectors
DCC
Data Coordinating Center
DHSS
Department of Health and Human Services
DSC
Data Survey Coordinator
DSMB
Data and Safety Monitoring Board
DSMP
Data and Safety Monitoring Plan
DRE
Disease-Related Event
EC
Ethics Committee
GCP
Good Clinical Practice
HearCARE 
Hearing for Communication and Resident 
Engagement 
HHIE
Hearing Handicap for the Elderly
HIPAA
Health Insurance Portability and Accountability Act
HRQoL
Heath Related Quality of Life
IB
Investigator’s Brochure
ICH
International Council on Harmonisation
ICMJE
International Committee of Medical Journal Editors
IRB
Institutional Review Board
OHRP
Office of Human Research Protection
QA
Quality Assurance
QoL
Quality of Life
MOAQ
Michigan Organizational Assessment Questionnaire
MOP
Manual of Procedures
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
RCT
Randomized Controlled Trial
SAE
Serious Adverse Event
SAP
Stakeholder Advisory Panel
SOA
Schedule of Activities
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version
Date
Description of Change 
Brief Rationale
V1
9/24/2020
Original IRB approved
Original approval
V2
5/26/2021
Added one location
One original location closed and 
we replaced this site. 
V3
7/27/2021
Added two locations
Based on lower census and 
increased declines, we added 
two locations for a total of 10  
facilities. We extended the study 
by 5 months (5th time point). 
V4
12/30/2021
Editorial changes throughout
Guidance from PCORI

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11 REFERENCES  
 
 
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