Statewide Implementation of CAPABLE-Community Aging in Place, Advancing Better Living for Elders in the Michigan Medicaid Home and Community Based Waiver Program
Phase: NA
Conditions: Independent Living
Sponsor: Grand Valley State University

 
OFFICIAL TITLE OF STUDY: 
 
Statewide Implementation of CAPABLE- 
Community Aging in Place, Advancing Better 
Living for Elders in the Michigan Medicaid 
Home and Community Based Waiver Program 
 
NCT NUMBER:  NCT03634033  
Registered August 16, 2018 
 
DOCUMENT DATE: APRIL 30, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY PROTOCOL: MAIN TRIAL  
 
NIA 1 R15 AG058193-01A1 
 
Protocol Title: Statewide Implementation of CAPABLE-Community Aging in Place, Advancing Better Living 
for Elders in the Michigan Medicaid Home and Community Based Waiver Program 
 
ClinitalTrials.gov Identifier:  
NCT03634033 Registered August 16, 2018 
Funding Source:  
 
 
NIA 1 R15 AG058193-01A1 
Funding Period:  
 
 
9/1/2018 to 8/30/2021 (3-years) 
 
IRB Determination Numbers:  
GVSU 19-061; MDHHS 201811-08-EA; MSU Study00002391 
 
Primary Investigator:  
 
Sandra L. Spoelstra, PhD, RN,  FGSA, FAAN; Email: spoelsts@gvsu.edu 
 
Co-Investigator Biostatistician: 
Alla Sikorskii, PhD; Email alla.sikorskii@hc.msu.edu 
 
Project Manager: 
 
 
Monica Schueller, BS; Email: schuelmo@gvsu.edu 
 
This is a pragmatic Dissemination & Implementation study, designed to implement and improve care delivery 
and beneficiary outcomes within a “real-world” complex multi-component Medicaid setting across the State of 
Michigan (MI). 
TABLE OF CONTENTS 
Number 
Topic 
1.1
Definitions of Terms Used in Study
1.2
Background and Significance
1.3
Specific Aims
1.4
Design
1.5
Sample
1.6
Setting
1.7
Inclusion/Exclusion Criteria
1.8
Approvals, Contracts, and Data Use Agreements
1.9
Organizations Associated with Study
1.10
Evidence-based Intervention: CAPABLE
1.11
Implementation Strategies
1.12
Measures and Tools
1.13
Data Collection, Management, Safety, and Storage
1.14
Data Analysis
1.15
Sample Size and Power Considerations
1.16
Randomization
1.17
Study Participation
1.18
Informed Consent 
1.19
HIPAA Compliance
1.20
Study Withdrawal/Discontinuation
1.21
Potential Risks and Benefits for Participation
1.22
Adverse Events and Protection against Study Risks
1.23
Roles and Responsibilities and Training
1.24 
Record Retention  

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1.25
Dissemination Plan
1.26
Data Resource and Sharing Plan
1.26
List of Attachment
1.28
References
1.1 DEFINITIONS OF TERMS USED IN STUDY 
A table of terms, their acronyms, and definitions are provided for the protocol that follows. 
Construct 
Term (acronym) 
Definition 
 
 
Groups 
participating in 
study 
Site 
A Home and Community Based Services Provider under contract with the 
State of MI to provide MiChoice services in the Medicaid program. 
Clinician 
A Home and Community Based Services provider employee who is a clinician 
that provides either care to beneficiaries or a supervisor who oversees clinician 
care and is an RN, SW, OT. 
Beneficiary 
A person who is a Medicaid recipient of care and services in the Home and 
Community Based Services. 
Components 
implemented in 
study 
Community Aging in Place, 
Advancing Better Living for 
Elders (CAPABLE)
Evidence-based intervention implemented in the Home and Community Based 
Services program in Michigan. 
MiCAP 
A package of implementation strategies that will be used to implement 
CAPABLE in the Home and Community Based Services in Michigan in this 
project.
External facilitator (EF) 
A supervisor at a Home and Community Based Services program site in 
Michigan where we performed our prior work and who was an early adopter 
of CAPABLE and will guide the work of IFs (e.g., fidelity to CAPABLE, 
engaging clinicians for training, understanding the benefits of CAPABLE) in 
one arm of the study.
Internal facilitator (IF) 
A supervisor at a Home and Community Based Services program site in 
Michigan who will be trained and will facilitate and lead the CAPABLE 
implementation, and oversee clinician training and performance of 
CAPABLE; and oversees the provision of usual “waiver” care.
Interdisciplinary 
Coordination (IDC) 
Coordination between and among the RN, OT, and SW during the 
performance of CAPABLE to assure the beneficiary’s person-centered service 
plan is enacted as desired.
Occupational Therapist (OT)
Clinician who is licensed as an OT.
Registered Nurse (RN)
Clinician who is licensed as an RN.
Social Worker (SW)
Clinician who is licensed as an SW.
Organizations 
associated with 
study 
Center for Information 
Management (CIM)
Software company that houses the electronic health record for beneficiaries in 
the waiver program.
Center for Medicare and 
Medicaid Services (CMS)
Oversight body of all Medicaid and Medicare programs. 
Institutional Review Board 
(IRB)
Human Subjects oversight board. 
Grand Valley State 
University (GVSU)
University 
Michigan Department of 
Health and Human Services 
(MDHHS)
The oversight organization of Medicaid programs for the State of Michigan. 
National Institute on Aging 
(NIA)
Grant funder. 
General terms 
used in study 
Activities of daily living 
(ADL)
Activities such as bathing, walking, transfers that are performed to carry out 
daily living.
Blackboard (Bb)
Software used to house training modules.

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1.2 BACKGROUND AND SIGNIFICANCE 
There are 39 million Americans over age 65;1-2 and 42% of older adults report problems with function, which 
can lead to difficulty with activities of daily living (ADLs),3 falls and nursing home placement.4 Consequently, 
implementing evidence-based models focused on aging-in-place in older adults is a public health priority. One 
evidence-based model is Community Aging in Place, Advancing Better Living for Elders (CAPABLE).6-9 
CAPABLE is a person-centered, delivered at home by clinicians (occupational therapist [OT] and registered 
nurse [RN]), 20-week intervention supported by assistive devices and home modification to improve function 
and factors that impact function (i.e., balance, pain, depression).  
 
The goal of this Stage Ib project is to examine implementation of CAPABLE in Home and Community Based 
Service waiver program sites (N=18) in MI. The waiver supports 15,000 low-income, nursing home eligible, 
disabled and older adults in the community, providing 19 services (i.e., personal care, meals, etc.) and case 
management through home visits by 575 clinicians (RNs and social workers [SW]). This research is premised 
on prior work that translated10-12 CAPABLE at one site (Hartford/CMS; 2014); and pilot tested implementation 
strategies (MiCAP: training, facilitation, coalition building, audit and feedback) at four sites (Hillman/CMS; 
2015-17).  
 
Building on our prior work, objectives for this project are: 
1. To test primary site-level outcomes of adoption and sustainability of CAPABLE after deploying 
MiCAP implementation strategies; and  
2. To examine secondary beneficiary-level outcomes (ADL/IADLs, pain, depression, falls, ED/hospital 
use) after deploying MiCAP implementation strategies. 
 
Continuous Quality 
Assessment Review 
(CQAR)
Quality review process for Medicaid waiver program. 
Electronic health record 
(EHR)
Electronic record where beneficiaries care is documented. 
HIPAA
Health Insurance Portability and Accountability Act
Instrumental activities of 
daily living (IADL)
Activities such as shopping, banking, and cleaning that are performed to carry 
out daily living.
Michigan (MI)
A state.
Person Centered Service 
Plan (PCSP)
Plan of care for waiver beneficiaries in the electronic health record. 
Progress Note (PN)
Notation of care in the electronic health record.
Self-efficacy (SE)
A feeling of worth or self-esteem.
Study team at 
university 
Primary Investigator (PI) 
Investigator is the PhD trained scientist to be responsible for conducting trial 
and assuring all approvals, compliance requirements, and assurances are met 
according to NIH expectation. (Spoelstra)
Project Manager (PM) 
The PM assists the PI in performing responsibilities for conducting trial and 
assuring all approvals, compliance requirements, and assurances are met in 
accordance to NIH expectation. (Schueller)
Research Assistant (RA) 
A GVSU student (required in AREA grant funded projects) who is a research 
team member.
Tools used in 
study 
EBPAS
Evidence-Based Practice Attitude Scale
GSE
General Self-efficacy 
ILS 
Implementation Leadership Scale 
MDS
Minimum Data Set for Home Care Tool
ORCA
Organization Readiness to Change
SIC
Stages of Implementation Completion

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Work at 18 program sites will include readiness assessment, training, coalition building, audit, feedback, and 
facilitation. Internal facilitators (IFs) and external facilitators (EFs), who were prior work adopters of 
CAPABLE, will facilitate. 
 
Testing will occur in a 3-year community-based participatory research13 with Hybrid-314-15 mixed method trial 
design.16-18  With rolling enrollment, sites will be randomized to MiCAP with IF or MiCAP with IF+EF and 
baseline assessments of the characteristics of sites and clinicians will be completed. CAPABLE will be 
provided to beneficiaries. Clinicians (RNs/OTs/SWs) and IFs will be trained in CAPABLE. IFs and EFs will be 
trained in facilitation techniques. Post-implementation data, site Stages of Implementation Completion (SIC), 
and clinician satisfaction will be collected; an implementation fidelity checklist (including IF/EF fidelity) will 
be completed monthly. Clinician attitude and self-efficacy will be measured at baseline and 9 months. 
Beneficiary level data will be collected during usual care and includes assessment prior to and after CAPABLE 
and any assessments that occurred between the two time points. 
 
The significance of this project is in the use of the evidence-based model, CAPABLE, in an underfunded 
Statewide Medicaid environment, where change is difficult to attain. This work will impact implementation 
science by testing two approaches to implementation of an evidence-based intervention to improve outcomes 
among older adults in a Medicaid waiver program. This natural setting approach has high generalizability for 
waiver sites, as we learn what intensity of implementation strategies is needed to adopt and sustain evidence, 
potentially transforming programs of care for our nation’s most vulnerable older adults who are aging-in-place. 
This study is also significant as it addresses a critical barrier to implementation of evidence-based interventions 
to improve function in older adults living in the community to age-in-place (CAPABLE). The National Institute 
on Aging focuses on ways to improve function once considered an inevitable part of aging. Likewise, the 
American Association of Retired Persons, National Aging in Place Council, and National Association of Area 
Agencies on Aging have aging-in-place as a priority. Evidence suggest 90% of older adults prefer to age-in-
place; yet a gap exists between their desire and ability.29 Thus, further testing of efficacy of an intervention 
(CAPABLE) in a Medicaid waiver population will fill a gap in science and build evidence.  
 
1.3 SPECIFIC AIMS 
The specific aims are as follows.  
 
Aim A1 To test the effects of MiCAP with IF alone versus MiCAP with IF+EF with respect to the site-level 
outcomes of adoption and sustainability (primary) and beneficiary-level outcomes of ADL/IADLs, pain, 
depression, falls, emergency department (ED) visits and hospitalizations (secondary) over the next 12 months.  
 
Aim A2 Mechanism-of-action To determine whether the effects of EF+IF versus IF on primary outcomes are 
mediated by clinician attitude or self-efficacy at 9 months.  
Aim A3 To benchmark the effects of IF and EF+IF on beneficiary outcomes following implementation as 
compared to pre-intervention. 
Exploratory Aim A4 To compare the primary and secondary outcomes within 12 months, potential mediators 
at 9 months, and baseline leadership and readiness for sites with SIC of >50% versus sites with SIC<50% at 6 
months in each arm.  
Exploratory Aim A5 To explore whether baseline site leadership and readiness moderate the impact of EF+IF 
compared to IF on primary and secondary outcomes within 12 months in order to determine which sites may 
require facilitation that is more intensive.  
Exploratory Aim A6 To evaluate clinician satisfaction at 1 month, and the cost of implementation and policy 
impact for IF and IF+EF at 12 months.  

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The National Institutes of Health (NIH) defines Implementation Science (IS) as the process of applying 
evidence to the treatment or prevention of human disease.19-20 A scientific study of methods to promote uptake 
of evidence into routine care to improve quality and effectiveness of healthcare through the study of influences 
on clinician and organizational behavior.21 This study is significant because it addresses testing of multimodal 
implementation strategies of an evidence-based intervention (CAPABLE) in a Medicaid setting to improve the 
quality and effectiveness of a waiver.  
 
We will utilize implementation strategies22 refined in prior work (MiCAP; Hartford/Hillman/CMS) where we 
trained clinicians (N=34), modified the EHR, and provided CAPABLE for beneficiaries (N=270). We extend 
our work and train all RNs, OTs, and SWs (N=575) in the 18 waiver sites in MI to implement the CAPABLE 
model of care for all Medicaid waiver beneficiaries (N=15,000). Guided by site managers, our team will select 
and train Internal Facilitators (IFs), who are supervisors/employees that work for the waiver site, to conduct 
facilitation at each site as “Champions”. We will utilize waiver employees as the External Facilitators (EFs), 
who were early adopters of CAPABLE in our prior work, as “Super-Champions” for Arm 2.  
 
Further, we focus on a topic of particular IS import: sustainability of implementation efforts.23-26 In a recent 
scoping review of 62 trials and 41 reports in the field of knowledge translation, few studies focused on 
sustaining interventions.27 Without sustainment, true practice change may not occur and healthcare outcomes 
may not improve. Further, we will be one of the first to examine implementation strategy (MiCAP) mechanisms 
of action - awareness, commitment, confidence, and trust - identified in the work of Abramowicz and 
colleagues in 2016,28 while implementing a complex intervention (CAPABLE).  
 
1.4 DESIGN 
This 2-arm, 3-year randomized study that will examine implementation strategies (MiCAP) to adopt and sustain 
CAPABLE and improve beneficiary outcomes14-15. The Hybrid-3 approach was selected as we will be testing 
implementation intervention strategies (MiCAP) while simultaneously gathering information on the evidence-
based intervention (CAPABLE) and related outcomes in a new setting, the waiver program sites.15 
 
1.5 SAMPLE  
The sample includes the following groups: 
1. Sites: The 18 Medicaid Waiver program sites in the State of MI.  
2. Clinicians: The 575 RNs/OTs/SWs employed by the site to provide care to beneficiaries. 
3. Beneficiaries: The 15,000 Medicaid beneficiaries who are recipients of care in the site.  
 
1.6 SETTING  
The setting is the MI Medicaid waiver sites.  
 
1.7 INCLUSION AND EXCLUSION CRITERIA  
Inclusion Criteria 
Included are waiver sites under contract as a waiver provider in MI who use the Center for Information 
Management (CIM) electronic health record (EHR); clinicians employed at the site who are trained in 
CAPABLE; and beneficiaries who receive care from a clinician trained in CAPABLE.  
Exclusion Criteria  
Sites not contracted as a waiver site or those not using CIM’s EHR will be excluded. 
 
1.8 APPROVALS, DATA USE AGREEMENTS, AND CONTRACTS  
The following will occur for this study. 

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Institutional Review Board (IRB) Approval  
In compliance with GVSU and MDHHS policy, prior to data collection we will obtain IRB approval from the 
following.  
1. GVSU 
2. MDHHS 
We will update the IRBs as changes occur over the course of the study. 
 
Data Use Agreements (DUA) 
In compliance with GVSU policy, we will collaborate with the Center for Scholarly and Creative Excellence to 
fully execute the following DUAs prior to data collection or use. 
1. Between the university and MDHHS for: MDS (2017-2021), administrative (2018), Continuous Quality 
Assessment Review (CQAR) scores (2015-2017), and cost (2020) data 
2. Between the university and the 18 sites and CIM for data from EHRs MDS, person centered service plan 
(PSCP), and progress notes (PNs) data (2017-21). 
We will update the DUAs as changes occur over the course of the study. 
 
 
Contracts to be Execute  
In compliance with GVSU policy, we will collaborate with the Center for Scholarly and Creative Excellence to 
fully execute the following contracts prior to working with a site or data analysis by the statistician. 
1. Between the university and the 18 site prior to initiating the project (role and responsibilities; training; tasks; 
duties; timelines; actions; and use of CAPABLE with fidelity to the intervention).  
2. Between the university and the biostatistician prior to data analysis. 
We will update the contracts as changes occur over the course of the study. 
 
1.9 ORGANIZATIONS ASSOCIATED WITH THE STUDY 
NIA The National Institutes of Aging funded the project (NIA 1 R15 AG058193-01A1). As such, for this study, 
all requirements (i.e., privacy, confidentiality, Health Insurance Portability and Accountability Act (HIPAA), 
IRB, budget, report, dissemination, data sharing, protocol, etc.) will be met through execution and 
implementation of the Notice of Award (NOA) agreement with the university. 
 
CMS The Center for Medicare and Medicaid Services is the oversight organization of MDHHS. As such, for 
this study, all requirements (i.e., privacy, confidentiality, HIPAA, etc.) will be met through execution and 
implementation of the MDHHS IRB and DUA.  
 
MDHHS The Michigan Department of Health and Human Services (MDHHS) is the oversight organization of 
all Medicaid programs for the State of Michigan, and as such, contracts with each of the waiver sites to manage, 
hire, or contract employees, and provide care to beneficiaries in the waiver program. As an oversight 
organization, MDHHS collects administrative, CQAR, and beneficiary data and has access to all current and 
past data of this nature. We will execute an IRB and DUA with MDHHS to perform this study. 
 
Sites Home and Community Based Services Provider waiver program sites are under contract with State of MI 
MDHHS to manage, hire or contract employees, and provide care to beneficiaries in the waiver program. We 
will execute a contract and DUA with each site that agrees to participate to perform this study. Deployment will 
occur in a staged manner, with 2—4 sites each month until all are deployed. 
 
CIM Center for Information Management (CIM) is under contract with MDHHS and 18 sites (20 years) to 
house and manage the EHR and billing software for the State of MI Medicaid waiver program. This platform 
contains beneficiary level data for all Medicaid beneficiaries in the waiver program where our study will occur. 

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The website (www.ciminc.com/) provides a description of CIM’s mission and purpose; and contains a statement 
of HIPAA compliance, required by CMS and MDHSS. We will obtain a DUA. The following will occur. 
1. De-identified data on beneficiaries outcomes from care by clinicians trained in CAPABLE at sites who do 
not opt-out will be obtained from CIM. 
2. Data transfer to the university (PI/PM) will be electronic through a CIM data secure encrypted portal as the 
data will be de-identified.  
3. Data would be downloaded by PI/PM on encrypted jump drives; and stored in a locked file cabinet in 
GVSU CHS Room 323 (Research Center) with a door that is locked at all times and only accessed by 
faculty approved to use the room. Only the PI/PM have access to the locked files cabinet.  
4. Clinicians (RNs/SWs/OTs) and IFs, who are also the supervisors of the clinicians at the sites, already have 
access to all identifiable CIM data in the EHR (Medicaid beneficiary data) to provide usual care.  
5. Clinicians (RNs/SWs/OTs) and IFs will not use the data the university (PI/PM) obtained from CIM.  
1.10 EVIDENCE-BASED INTERVENTION: CAPABLE 
A multi-component model of care, CAPABLE, was designed to reduce the effect of problems with physical 
function among low-income older adults living at home by addressing an individual’s capabilities and the home 
environment.11 12 CAPABLE is a 16-week structured program delivered by OTs who conduct 6 home visits and 
provide assistive devices, RNs who conduct 4 home visits, and a handyman who provides home alterations (i.e., 
installs devices, environmental modifications, and home repair).15-19 CAPABLE is interdisciplinary team 
provides consultation with older adults to help them identify daily activity goals (e.g., taking a shower, walking 
to the bathroom), evaluate barriers to achieving those goals, and attain outcomes collaboratively.11, 18 The OT 
assists older adults to carryout ADLs, instrumental activities of daily living (IADLs) and discretionary activities 
that are challenging at home such as functional mobility, meal preparation, bathing, and dressing. The RN 
targets underlying issues that influence ADLs, IADLs, and discretionary activities at home, such as pain 
reduction, improvement in mood, fall prevention, medication review and management, primary care physician 
communication, incontinence management, sexual health, and smoking cessation. The Disablement Process,20 
Life Span Theory of Control,21 and Szanton-Gill Resilience Model22 underpin CAPABLE. CAPABLE has 
demonstrated a 49% reduction in the number of ADL difficulties; and 75% of beneficiaries improved their level 
of ADL performance from baseline to follow-up at 5-months.17  
 
Prior Work In prior work of this team, Normalization Process Theory23 underpinned identification of six 
adaptations of CAPABLE to fit the waiver population and setting. This included: assigning a team leader (RN), 
adding SWs to address social and emotional needs, utilizing an RN to conduct medication review rather than a 
pharmacist, flexibility in the number and type of home visits delivered and the number of weeks (extended to 32 
weeks) CAPABLE was provided, care coordinated among the RN, OT, and SW face-to-face, by phone, Skype, 
or email with the supervisor. A toolkit that included the 12 most common aging-in-place problems (i.e., falls, 
balance and strength exercises) was provided to beneficiaries; and home alterations were done when medically 
necessary (Medicaid rule). 
 
1.11 IMPLEMENTATION STRATEGIES 
Strategies deployed in this project to implement CAPABLE are shown in the figure; and described below.   
 
Pre-Implementation Strategies 
Relationship Building Informal relationships (collaborative work/meetings) are in place between sites and the 
university team from decades of prior work; and will continue to be built. Formal relationships (contracts) with 
MDHHS, CIM, and sites will delineate responsibilities and actions for this project.  
Readiness to implement and leadership of the site and attitude of clinicians will be collected.  

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Champion Coalition Building IFs are clinicians with exemplary clinical practice and supervisory experience 
and are expected to be early adopters.  
 
MiCAP Implementation Strategies Deployed in this Project and Domains Affected by Strategies 
 
DOMAIN 
AFFECTED 
BY 
STRATEGY 
MiCAP IMPLEMENTATION STRATEGIES DEPLOYED IN THIS PROJECT 
Pre-implementation 
Implementation: Education & Training 
Centralize 
Oversight 
Audit & 
Feedback 
Organization 
readiness 
Build IF 
Coalition 
IF  
Champions 
Train 
clinicians 
Develop clinical 
teams 
EF  
 
Implementation 
intervention 
outcomes 
Definition 
Aspects of an 
organization 
determine 
readiness to 
implement22 
IFs coalition to 
share 
implementation 
knowledge22 
Dynamic 
interactive 
training via 
varying learning 
methods; & 
supervision 
focused on 
implementation22 
Training to 
conduct 
intervention 
Develop/implement 
teams of clinicians 
who meet, reflect, 
& share learnings22 
Makes things 
easier for 
others: 
support to 
change 
attitudes, 
habits, skills, 
way of 
thinking & 
working22.
Collect & 
summarize 
clinical 
performance & 
monitor, 
evaluate, modify 
clinician 
behavior22 
Actors 
Spoelstra, 
Schueller, 
waiver 
clinician
IF, research 
team 
Research team 
for IF 
IF for 
clinicians 
IF, clinicians 
EF 
Spoelstra, 
Schueller, IF, EF 
Actions 
Administer 
tools; analyze 
results 
Online Bb 
forum to build 
capacity; share 
best 
implementation 
strategies
Identify and train 
train-the-
trainers/IF;  
Pre/post-test 
Train 
clinicians; 
Pre/post-
test; 
Remediate 
IF leads 
interdisciplinary 
coordination; 
feedback on 
implementation/ 
Intervention
Assistance to 
IF (Arm 2) 
Monitor Bb & 
EHR; SIC 
(scorecard); low 
adopters moved 
to Arm 1/2 per 
protocol
Target of the 
action 
Site 
IFs 
IFs 
Clinicians  
Clinicians  
IF 
Clinicians 
Temporality 
3-months after funded 
When starting implementation 
1-month after 
implement 
1 week after 
CAPABLE & 
ongoing
Dose 
Surveys 
completed 
Baseline 
 
 
1-hour 
discussion 
weekly  
2-hr Bb and 2-hr 
training; 
Remediate prn  
4-hr online 
Bb and 4-hr 
in person 
training 
Meet weekly 1-
hour 
Weekly for 30 
minutes to 1 
hour until 
issues 
resolved 
Weekly results 
to scorecard in 
Bb and IF 
reviews with 
clinicians; EF 
reviews with IF
Outcomes 
affected 
Acceptability, 
readiness 
Acceptability 
Adoption, sustainability 
Adoption, 
sustainability 
Adoption, 
sustainability, 
outcomes
 
Implementation Strategies 
 
Training Clinicians (RNs/OTs/SWs) will be trained in CAPABLE principles, approaches, techniques, and 
documentation (4-6 hours; pre/post-test). 
Interdisciplinary coordination (RNs/OTs/SWs) will be led by IFs, focused on care coordination to promote 
teamwork; using brainstorming/problem solving care issues to support beneficiary goal attainment.  
IFs will facilitate and EFs will provide centralized oversight for Arm 2 IFs. An IF at each site and an EF (from 
prior work and were trained and early adopters of CAPABLE) will be selected by the PI and will be trained (2 
hours; and take a pre/post-test) in facilitation. IFs will encourage clinicians to complete CAPABLE training; 
and for those trained, provide feedback; facilitate fidelity to CAPABLE; and conduct remediation as needed 
from Month 1 through 9. EF will facilitate IF’s work with clinicians trained in CAPABLE and assistance will 
be tailored to a site’s needs. 

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Audit and Feedback on CAPABLE and implementation strategy fidelity data will be provided to IFs to be used 
to provide feedback to clinicians and develop an improvement plan as needed. The EF will use the data to 
facilitate IFs and develop an improvement plan as needed.  
 
1.12 MEASURES AND TOOLS 
In this study, we will measure three levels of data: 
1. Site level data: Characteristics, leadership, readiness, and implementation completion.  
2. Clinician level data: Characteristics, attitude toward evidence-based care, efficacy, and training knowledge 
and completion. 
3. Beneficiary level data: Characteristics and outcomes.  
We will also examine fidelity to implementation strategies and CAPABLE. Each are described and shown in 
the Table below. 
 
Characteristic Measures 
Characteristics of site, clinician, and beneficiaries will be collected at baseline. Site level data includes size, 
CQAR scores, number of supervisors/clinicians, number of beneficiaries, and years contracted in waiver. 
Clinician level data (RN/OT/SW/IF) includes age, race, gender, discipline, and years working in waiver 
program site. Beneficiary level data includes age, gender, and race. 
 
Tools 
Implementation Leadership Scale (ILS) will be collected at baseline from clinicians to examine organizational 
leader behavior and actions that actively support implementation of evidence-based practice.77-78 ILS has 12 
items with sub-scales (Cronbach’s alpha): proactive leadership (.94); knowledgeable leadership (.97); 
supportive leadership (.93); and perseverant leadership (.94), each with 3-items. Items are scored on a 5-point 
scale indicating the degree to which a leader performs specific behavior.  
 
Organizational Readiness to Change Assessment (ORCA) will be collected at baseline from clinicians 
(Cronbach’s alpha  .88) and used to examine site readiness to implement evidence-based practice.79 There are 
115 items in the manager tool and 124 in the clinician tool and each has 3-open ended questions regarding 
readiness. In systematic review of organizational assessments, the TCU-ORC ranked highest for reliability and 
validity of those available to date.79 Scoring for each scale are obtained by summing responses among each 
scale; then divide by the number of items; and then multiply the mean by 10. Sub-scales include needs 
(clinician, program, training); pressure for change; resources (offices, clinician, training, equipment, internet, 
supervision); and attributes (growth, efficacy, influence, adaptability, satisfaction, and orientation). 
 
Evidence-Based Practice Attitude Scale (EBPAS) and General Self-efficacy (GSE) will be collected from 
clinicians at baseline and 9 months. EBPAS is a 50-item tool with 12 sub-scales that measures four constructs: 
openness; appeals of the new intervention (appeal); willingness to using required interventions (requirements); 
and conflict between clinical experience and research results (divergence).80 Questions are on a 5-point scale. 
GSE is a 10-item tool (Cronbach’s alpha .79-.90) with items rated on a 4-point scale summed to produce a score 
ranging from 10 to 40.  
 
MDS-HC Data on demographic characteristics (age, race, and gender), health status (I/ADLs, pain, depression, 
and falls), ED visits, and hospitalizations collected on the Minimum Data Set-Home Care (MDS-HC) collected 
in the EHR as part of usual care will be obtained. The MDS-HC is a self-reported, person-centered assessment 
for the collection of minimum essential nursing data, developed by InterRai, with reliability and validity, and 
used in the waiver since 1993. 

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Stages of Implementation (SIC) is an 8-stage tool examining implementation with 3 phases (pre-
implementation, implementation [adoption], sustainability). Items delineate the date a site completes activities, 
yielding an assessment of duration (time to complete a stage), proportion (stage activities completed), and a 
general measure of how far a site moved in the process.81 82Three scores will be derived:  
1. Number of stages completed is a simple count of progression through stages; the score is the last stage in 
which at least one activity was performed.  
2. Time spent in each stage is calculated by taking the difference between the date of completion of the first 
activity in the stage and the date of completion of the last activity in the same stage. Skipped activities are 
not included. If a site skips the last activity in a stage and completes an activity in a subsequent stage, they 
automatically move to the subsequent stage. However, if they later complete the skipped activity, the 
duration score is adjusted for the original (earlier) stage to include the activity.  
3. Completed all 8 stages: the completion date is logged in stage 8. For sites that chose to discontinue 
implementation at any point in the process, the date is logged in the furthest stage that the site enters. In the 
case where data are summarized before the stage is complete but a site has not discontinued implementation, 
the site data are treated as being censored, just as it would in a standard time-to-event or survival analysis.83 
Proportion of activities completed is calculated as the number of activities completed divided by the number 
of possible activities in each stage. Activities in each stage are ordered based on their logical progression up 
to the last activity the site completes in the stage or completion of the final activity in the stage. 
Achievement of either activity indicates completion of that stage. 
 
 
Measures 
DOMAIN 
CONSTRUCT 
CONCEPT(S) 
Aims* 
Who Measured 
 How 
Measured 
Collected 
by 
 
Inner  
Setting 
 
Readiness for 
Implementation  
Leadership Engagement  
 
 
A5 
 
Sites 
ILS  
PM 
Readiness to implement  
ORCA
Size of WA Agency
Admin Data 18
 
- 
CQAR Scores 
CQAR 2016-
18
 
 
Individual: 
Site 
and/or  
person 
 
Demographics 
Site # employees/ beneficiary#, CQAR, 
cost 
 
 
- 
Sites 
Admin Data 
Clinician: age/race/ethnicity/sex/discipline/ 
degree/year experience/in WA
Clinician 
Survey 
PM 
Age, sex, race, ethnicity, comorbidities 
Beneficiary/patient 
MDS   
- 
Clinician: 
engagement 
1. 
Attitude 
2. 
Self-efficacy  
A2 
Clinician 
1. 
EBPAS  
2. 
GSE  
PM 
Beneficiary/patient  
outcomes 
I/ADLs, falls, pain, depression/ED/hospital 
A3 & 
A4 
Beneficiary/patient 
MDS  
- 
 
 
Process 
Training 
Knowledge with CAPABLE 
 
 
A2 
Clinician 
Survey  
PM 
Knowledge with IF/EF 
IF/EF 
Team Building
Interdisciplinary coordination
Beneficiary/patient
PNs in EHR
-
Coalition Building
Occurrence/type
IF
Data tool
 
 
Inner  
Setting 
 
Adoption 
Fidelity to training 
 
A1 & 
A2 
Clinician 
Type/date/# 
done
PM 
Fidelity to IF/EF 
IF/EF 
IF Data tool 
RAs 
Fidelity to CAPABLE
Beneficiary/patient
PSCP in EHR
-
Sustainability
Fidelity to change
Sites
SIC 
RAs
Acceptability 
Satisfaction with training  
A6 
Clinician IF EF 
Survey 
PM 
Cost 
 $  
A6 
Clinician IF EF 
beneficiary/patient
Wages, 
benefits 
PM 
Outer 
Setting
Policy  
Payment for incentive 
A6 
CMS Contract 
Contract 10/1 
PM 

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R15 Protocol V9 4-30-2019 
 
Fidelity Measures  
Implementation Strategies Data on implementation strategy fidelity (monthly for 12-months) includes 
readiness assessment (yes/no by manager/clinician), training (#CAPABLE certification), IF/EF (#/type), and 
audit and feedback (# reports viewed/# actions). Actions coded will include training, coaching, consultation, 
supervision, modeling, problem solving, and providing feedback, supporting, instructing, demonstrating, and 
assisting with evaluation.  
Acceptability of training by clinicians, IFs, and EFs will be evaluated by number completing training and via 
conduction of pre-/post- tests devised in our prior work.  
Costs of implementation will be estimated based on the time spent in Bb, training, and meetings.  
Measure of policy impact will be examined in the waiver contract.  
 
CAPABLE An EHR assessment (OT [baseline assessment]/SW [mood]/RN [medication review), PSCP 
(presence of desire of beneficiary), and PN (documentation of brainstorming, problem solving, role modeling) 
review will provide data of use of CAPABLE as a measure of fidelity comparing pre/post CAPABLE.   
 
1.13 DATA COLLECTION, MANAGEMENT, SAFETY, AND STORAGE  
This pragmatic, real-world setting study utilizes employees who are either a supervisor (IF), who is a clinician 
that oversees the provision of care, or a clinician, who conducts usual waiver care and/or CAPABLE. Both 
supervisors and clinicians have access to the electronic health records of all their beneficiaries at their site.  
 Clinicians and IFs have access to beneficiary data where employed. 
 IFs have access to which clinicians are trained in CAPABLE. 
 EFs will not have access to beneficiary data at a site where they are not employed. 
 Clinician, IF, or EF will not have access to study data. 
 
Protected Health Information 
For this study we will collect the beneficiary, clinician, and IF names and IF phone number. The names will be 
used by the PI/PM in the key to assign a study number and will be used to track progression. All data (Excel 
sheets) will use the study number (not the name). Only the PI/PM have access to the study key. The Research 
Assistants will call the internal facilitator’s using the provided phone number. No other PHI will be collected 
for the study. 
 
Data Collection and Management for this study will include site, clinician, beneficiary, and fidelity data. 
1. Site data will be collected from MDHHS (administrative data) at baseline; and clinicians’ leadership and 
readiness from electronic survey in Qualtrics.  
2. Clinician data collection (characteristics, attitude toward evidence-based care, efficacy) will be from an 
electronic survey in Qualtrics and from the Bb platform (training knowledge and completion). 
3. Beneficiary outcome data (de-identified) will be from CIM (characteristics and outcomes).  
4. Fidelity data on:  
a. Implementation completion (SIC) will be collected from telephone survey conducted by RAs at the 
university.  
b. Implementation strategy use (IF/EF Data Tool) will be collected from telephone survey conducted 
by RAs at the university. 
c. CAPABLE will be collected from the PI/PM examination of the EHR (assessment, PCSP, and PNs). 
The only study members that will have access to identifiable data are the PI and PM. The PM will assign study 
numbers and keep a key with site and clinician identifiers, separate from any data Excel sheets, so that all Excel 
data sheets remain de-identified (no name, address, phone, Medicaid#, etc.).  
 
MDHHS 

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R15 Protocol V9 4-30-2019 
 
Per the DUA, MDHHS will provide administrative data via a data transfer to the university (PI/PM). This will 
occur electronically through a CIM data secure encrypted portal. Data would be downloaded by PI/PM on 
encrypted jump drives; and stored in a locked file cabinet in GVSU CHS Room 323 (Research Center) with a 
door that is locked at all times and only accessed by faculty approved to use the room. Only the PI/PM have 
access to the locked files cabinet.  
 
CIM 
Per the DUA, CIM will provide de-identified beneficiary outcome data via a data transfer to the university 
(PI/PM) at the end of the site’s project time period.  
 This will occur electronically through a CIM data secure encrypted portal.  
 Data would be downloaded by PI/PM on encrypted jump drives; and stored in a locked file cabinet in 
GVSU CHS Room 323 (Research Center) with a door that is locked at all times and only accessed by 
faculty approved to use the room.  
o Only the PI/PM have access to the locked files cabinet. 
 Data for the study would not be available to the site, clinicians, or supervisors. 
 
Qualtrics  
Qualtrics is a web-based survey creation, collection, and analysis software tool that can be used for the creation 
of open surveys, targeted (panel) surveys, and open polling. Qualtrics provides secure, intuitive, web-based 
interfaces for users to enter data, and users with approved permissions/passwords can access the system with an 
Internet connection. Qualtrics servers are hosted in world-class data centers with all the necessary physical 
security controls (e.g., 24/7 monitoring, cameras, visitor logs, entry requirements.). Qualtrics has Transport 
Layer Security (TLS) enabled to encrypt respondent traffic. Communications are sent over TLS connections, 
which protects communications by using both server authentication and data encryption. This ensures that data 
in transit is safe, secure, and available only to intended recipients. Qualtrics software is available to all 
university faculty and staff as a site license, centrally funded. Qualtrics survey data is protected, and only 
available to the survey designers.  
 For this project, the PI/PM will construct all electronic and phone surveys in a Qualtrics platform.  
o Surveys were designed so each question on the survey will be voluntary and may be skipped.  
o Only the PI/PM will have access to the Qualtrics platform where surveys will be deployed for this 
study. 
o Only the PI/PM will have access to the Qualtrics platform identifiable data for this study.   
o RAs conducting the telephone surveys of IFs will complete a survey in Qualtrics. 
 After completion of a survey, the data will be downloaded in an Excel format by the PI/PM on encrypted 
jump drives; and stored in a locked file cabinet in GVSU CHS Room 323 (Research Center) with a door 
locked at all times and only accessed by faculty approved to use the room.  
o Only the PI/PM have access to the locked files cabinet.  
 Data will be de-identified by the PI/PM prior to use of the data by RAs or statistician.  
o De-identified data would be stored on encrypted jump drives; and stored in a locked file cabinet in 
GVSU CHS Room 323 (Research Center) with a door that is locked at all times and only accessed 
by faculty approved to use the room. 
 Data for the study would not be available to the site, clinicians, or supervisors. 
 
Bb 
Blackboard (Bb) is a virtual learning environment and course management system developed by Blackboard 
Inc. Bb is Web-based server software features course management, customizable open architecture, and scalable 
design that allows integration with information systems and authentication protocol. For this study, we will 
deploy clinician (RN/OT/SW) and IF/EF training in Bb.  

14 
 
R15 Protocol V9 4-30-2019 
 
 The Bb training course’s identifiable data will be solely available to designers (PI/PM) and not available to 
other project or site staff at any time.  
 Data collection on clinician (RN/OT/SW) and IF/EF training knowledge (pre/post-test) and completion 
(finished training) will be collected from Bb by the PI/PM.  
 Data from Bb would be downloaded by PI/PM on encrypted jump drives; and stored in a locked file cabinet 
in GVSU CHS Room 323 (Research Center) with a door that is locked at all times and only accessed by 
faculty approved to use the room.  
o Only the PI/PM have access to the locked files cabinet. 
 Data will be de-identified by the PI/PM prior to use of the data by RAs or statistician.  
o De-identified data would be stored on encrypted jump drives; and stored in a locked file cabinet in 
GVSU CHS Room 323 (Research Center) with a door that is locked at all times and only accessed 
by faculty approved to use the room. 
 Data for the study would not be available to the site, clinicians, or supervisors. 
 
Month 
obtained 
DATA COLLECTION: Obtained from and What Obtained 
MDHHS 
Clinicians (RN/OT/SW)
IFs 
EFs 
CIM 
0 
#beneficiaries 
#staff 
#supervisors 
#years MiChoice 
CQAR 2015-17
Consent 
Demographics 
ILS 
ORCA 
Consent 
Demographics 
ILS 
ORCA 
Consent 
Demographics 
ILS 
ORCA 
MDS in EHR 
1 
 
Consent 
Demographics 
EBPAS 
GSE 
Train: CAPABLE 
pre/post/satisfaction 
Consent 
Demographics 
EBPAS 
GSE 
Train: CAPABLE 
pre/post/satisfaction  
Train: Facilitation 
pre/post/satisfaction
Consent 
Demographics 
EBPAS 
GSE 
Train: CAPABLE 
pre/post/satisfaction 
Train: Facilitation 
pre/post/satisfaction
 
2
SIC; IF/EF Data Tool
PSCP & PNs in EHR
3
SIC; IF/EF Data Tool
PSCP & PNs in EHR
4
SIC; IF/EF Data Tool
PSCP & PNs in EHR
5
SIC; IF/EF Data Tool
PSCP & PNs in EHR
6
SIC; IF/EF Data Tool
PSCP & PNs in EHR
7
SIC; IF/EF Data Tool
PSCP & PNs in EHR
8
SIC; IF/EF Data Tool
PSCP & PNs in EHR
9 
 
EBPAS 
GSE 
EBPAS 
GSE 
SIC; IF/EF Data Tool
EBPAS 
GSE 
PSCP & PNs in EHR 
10
SIC; IF/EF Data Tool
PSCP & PNs in EHR
11
SIC; IF/EF Data Tool
PSCP & PNs in EHR
12 
Cost
SIC; IF/EF Data Tool
MDS, PSCP, PNs in EHR
Policy
Review of CMS Contract
 
The above table depicted deployment of data collection activities by month, where the data will be collected 
from, from whom the data source is (site, clinician, IF, beneficiary), and which measures (characteristics/tool) 
and tools (SIC, GSE, EBPAS, etc.) are used to collect the data. 
 
Data Security 
Data storage and security will be assured as per GVSU policies and placed in secure password-protected 
platforms and is described in detail in the Data Safety Monitoring Plan (DSMP) and overseen by the Data 
Safety Monitoring Board (DSMB) as stated in the DSMP Charter. 
 
1.14 DATA ANALYSIS 
Preliminary analysis 

15 
 
R15 Protocol V9 4-30-2019 
 
The distributions of outcomes, mediators, and potential covariates will be assessed, outliers will be investigated 
by inspecting the residuals, and models described below will be fit with and without outliers to examine their 
influence on the results. Analyses will be implemented in SAS 9.4 as follows: 
 
Aim A1 To test the effects of MiCAP with IF alone versus MiCAP with IF+EF with respect to the site-level 
outcomes of adoption and sustainability (primary) and beneficiary-level outcomes of ADL/IADLs, pain, 
depression, falls, emergency department (ED) visits and hospitalizations (secondary) over the next 12 months. 
Primary outcomes will be analyzed using a linear mixed effects model with repeated measures: 11 monthly 
measures of the SIC, 11 monthly summary records of clinician’s actions based on EHR documentation, and 
monthly for 9 months measures from IF tools (statistical model #1). Covariates will include trial arm, variables 
used in randomization (site’s size and CQAR score), and time entered as a class variable to model potentially 
non-linear patterns. In addition, we will use general liner model to analyze clinicians’ fidelity training data. 
Log-rank test and Cox proportional hazard modeling will be employed to analyze time spent in each stage 
(treated as censored if a site does not complete a given implementation stage).    The test of significance of the 
coefficient of the trial arm variable will yield the formal test of hypothesis associated with this aim for the main 
(time-averaged) effect of IF+EF v. IF alone. The analysis of secondary beneficiary-level outcomes will employ 
use generalized linear model with appropriately distributed errors and the random effect of site added to account 
for nesting of individuals within sites. For counts of falls and health service use, Poisson error distribution will 
be specified. Alternatively, as a zero-inflated Poisson or negative Binomial model based on the distribution of 
the counts will be fit. The explanatory variables including trial arm will be evaluated as predictors of zero 
inflation (whether or not the count is zero), and as predictors of the magnitude of the count when it is not zero. 
Pre-intervention MDS assessment will be used to obtain baseline version of each outcome, which will be 
included as a covariate to explain the variation in post-intervention outcomes.   
 
Aim A2 Mechanism-of-action To determine whether the effects of EF+IF versus IF on primary outcomes are 
mediated by clinician attitude or self-efficacy at 9 months. In addition to statistical model #1, statistical model 
#2 will be fit at the clinician level with site as a random effect to account for nesting of clinicians within sites. 
To test for mediation, trial arm will be treated as the independent variable; each of the potential mediators (one 
at a time) will be tested for their effect on the outcome variable. We will use a bias corrected bootstrapping 
analytic strategy86-87 based on 5000 bootstrap samples to estimate confidence intervals around the indirect effect 
of the trial arm on the outcome variable, through the mediator. To establish mediation, the 95% confidence 
interval around the indirect must not include 0.   
Aim A3 To benchmark the effects of IF and EF+IF on beneficiary outcomes following implementation as 
compared to pre-intervention. The analysis of this aim will use 2 repeated measures of beneficiary outcomes: at 
the start of this study (pre-intervention) and in the following 12 months. Time by trial arm interaction will be 
included. The least square (LS) means according to the interaction term will be output from this model, and 
differences from pre-to-post CAPABLE will be evaluated for each arm to gauge the magnitude and practical 
meaning of improvements.  
Exploratory Aim A4 To compare the primary and secondary outcomes within 12 months, potential mediators 
at 9 months, and baseline leadership and readiness for sites with SIC of >50% versus sites with SIC<50% at 6 
months in each arm. General or generalized linear models (as appropriate based on outcome or potential 
mediator distribution) will include the binary indicator of whether SIC at 6 months is >50% or <50% in 
interaction with the trial arm variable.  Differences between LS means according to SIC level will be tested 
within each arm. Because these analyses are exploratory, in addition to formal tests of significance, the effect 
sizes will be estimated. 
Exploratory Aim A5 To explore whether baseline site leadership and readiness moderate the impact of EF+IF 
compared to IF on primary and secondary outcomes within 12 months in order to determine which sites may 

16 
 
R15 Protocol V9 4-30-2019 
 
require facilitation that is more intensive. To address this aim, statistical models described under analysis for 
Aim 1 will be modified to include trial arm by potential moderator interaction. The effect sizes that correspond 
to the interaction term will be estimated. 
Exploratory Aim A6 To evaluate clinician satisfaction at 1 month, and the cost of implementation and policy 
impact for IF and IF+EF at 12 months. We will use descriptive statistics to summarize clinician satisfaction 
with training and the cost of implementation. We will use qualitative thematic analysis to analyze all qualitative 
data on survey tools. We will report on the policy impact as evidenced in the State Contract for the Medicaid 
Waiver program.  
 
1.15 SAMPLE SIZE AND POWER CONSIDERATION   
Aim 1: The sample size considerations for this study are based on the number of available sites given the 
project scope and timeline: N=18 sites will participate. With N=9 randomized to each condition, correlation of 
0.7 between pairs of 11 repeated measures, the detectable adjusted effect size for the site-level outcomes is 
approximately 1.2, expressed as Cohen’s d, difference between trial arm means in the standard deviation units. 
If the observed differences are smaller than 1.2 of the standard deviation, statistical significance will not be 
reached, then the estimate of the effect size will be obtained and used to formally power a subsequent R01-size 
study that will be proposed based on the results obtained in this R15 project. For the beneficiary-level 
outcomes, we assumed an average N=750 beneficiaries analyzed per site and conservative intraclass correlation 
coefficient of 0.01 for planning purposes to obtain the design effect factor DEFF=8.49. In the comparison of the 
trial arms for the beneficiary-level outcomes, the sample size adjusted for the design is 795 per trial arm, and it 
allows to detect the effect size as small as 0.14 Larger effects were seen in the preliminary studies for the 
beneficiary-level data, and 1/3 of the standard deviation or larger is often used as a threshold for clinical 
significance.88-89 Since even small effects could be detected as statistically significant, the study is well powered 
to detect any meaningful differences between IF and IF+EF in beneficiary outcomes. The tests of mediation 
effects in Aim 2 will have an even greater power because of further reduction in error variance due to 
controlling for the mediator. Aim 3 benchmarks the outcomes against the pre-intervention period and has no 
associated hypotheses. Thus, power considerations are not applicable. Similarly, exploratory aims 4-6 have no 
associated hypotheses; thus, the results will be used for generation of hypotheses for the future R01-scope trial. 
 
1.16 RANDOMIZATION 
Randomization for this study occurs at the site level. Sites will be randomized by the PM, to Arm 1 (MiCAP 
with IF) or Arm 2 (MiCAP with IF+EF) using the following steps. 
Step 1: Data on site size (number of beneficiaries [patients]) and Clinical Quality Assessment Review (CQAR) 
scores will be obtained.  
Step 2: We will block sites in pairs with similar size and CQAR scores, and flip a coin to determine Arm 1 or 
Arm 2 assignment for study. 
The PM will maintain a confidential file documenting study Arm by site. Only the PI/PM will know Arm 
assignment by site. 
 
1.17 STUDY PARTICIPATION  
Voluntary study participation from sites, clinicians (RNs/OTs/SWs/IFs), and beneficiaries will occur.  
 
Sites and clinicians will be informed of the benefits of CAPABLE from prior work; beneficiaries who received 
CAPABLE had improved ADL/IADLs, fewer falls and hospitalizations as well as being highly satisfied; and 
clinicians with increased knowledge in CAPABLE improved those beneficiaries outcomes. 
 

17 
 
R15 Protocol V9 4-30-2019 
 
Sites: PI/PM will contact a site via phone to confirm intent to participate; then provide the contract for review. 
Sites who sign a contract agree to be a part of the study.  
Clinicians: PI will ask clinicians (RN, OT, and SW, IFs) to complete CAPABLE training using a flyer/email. 
Clinicians who sign the consent, agree to be a part of the study.  
Beneficiaries: The state and sites will provide the Opt-out Consent document to the beneficiaries, which 
includes an option to opt out of the study by calling the PI, if desired.   
1.18 INFORMED CONSENT AND HIPAA COMPLIANCE 
Clinician Informed Consent Clinician (RN/OT/SW/IF) informed consent will be conducted and an electronic 
signature obtained on the consent form approved by IRB prior to data collection and CAPABLE training. The 
consent form will be modified and approved by the IRBs, if changes are necessary, prior to use. 
Beneficiary Opt-out Consent and HIPAA (Health Insurance Portability and Accountability Act) 
Authorization Alteration via a waiver of documentation of informed consent for the Medicaid beneficiaries 
will occur via two modes.  
 For current Waiver beneficiaries: the State or sites will mail the Opt-out Consent document or the sites 
will hand deliver opt-out consent form to the beneficiary during the next home visit.  
 For new Waiver beneficiaries: sites will include Opt-out Consent document in enrollment packets, 
which will be hand delivered to the beneficiary during their initial home visit in the Mi Choice program.   
 
1.19 PRIVACY AND CONFIDENTIALITY ISSUES 
Any information about the individuals in the study, including identity and answers to questions are confidential 
and will not be shared with others. In addition, the responses will be combined with those of all others in the 
study. All study team members are Human Subjects and HIPAA trained and follow all privacy and 
confidentiality requirements. 
 
1.20 STUDY WITHDRAWL OR DISCONTINUATION 
A site, clinician, and/or a beneficiary may withdraw and/or discontinue their participation at any point in the 
project by notification of the internal facilitator and/or PI/PM via email, phone call, or in writing. Withdrawal 
and discontinuation are included in the contracts. Decisions to participate or not will not affect their current or 
future employment or status as a Medicaid program in the State. Three attempts at data collection will occur and 
if no response, no further contact will be attempted, and be considered a discontinuation. 
 
1.21 POTENTIAL RISKS AND BENEFITS TO PARTICIPATION 
Sites, clinicians and beneficiaries will be assured of the confidentiality of all information given and be protected 
in the following manner: 1) use of identification numbers rather than names with computerized data entry; 2) 
release of data in aggregate form only; and 3) omission of identifiers in all reports and presentations. Therefore, 
risk/benefit ratio is heavily weighted in favor of benefit for sites, and individual clinicians and beneficiaries. 
 
Benefits of Participation 
Sites There may or may not be direct benefits for the sites. Sites may gain knowledge from this study will help 
determine ways to assist waivers caring for disabled individuals living in the community, may improve 
retention of clinicians, and may save costs. Findings may help future waiver sites, clinicians, and beneficiaries.  
Clinicians There may or may not be direct benefits for the clinicians. Clinicians will not be placed at increased 
physical, financial, or legal risk as a result of taking part in this study. Clinicians will learn new knowledge and 
skills that may or may not benefit ability to perform their duties when employed as a clinician. It may take some 
time and effort for clinicians to complete the training and to answer questions. 
Beneficiaries There may or may not be direct benefits for the beneficiaries. Beneficiaries may experience 
improvement in activities of daily living, instrumental activities of daily living, pain, falls, depression, hospital 

18 
 
R15 Protocol V9 4-30-2019 
 
and ED visits. Beneficiaries will not be placed at increased physical, financial, or legal risk as a result of taking 
part in the study. It may take some time and effort for beneficiaries to answer questions and adapt to the extra 
home visits. Beneficiaries will continue to receive care under the direction of their waiver clinicians, even if the 
beneficiaries choose not to take part in this study.  
 
Protection against Study Risks 
Sites can agree or not agree to participate in the study. A contract will be obtained prior to data collection. 
Clinicians Clinicians can agree or not agree to participate in the study. Clinicians (RNs/OTs/SWs/IFs) 
employed by the sites will participate in this study. A consent will be obtained from a clinician prior to 
completing surveys. Clinicians will be informed that completing a survey is voluntary and their responses will 
be kept confidential. Any report of this research will not include their name or any other information by which 
they could be identified. For those clinicians who consent and complete CAPABLE training: The IF who is also 
a supervisor at the site where the clinician is employed and performs "usual" Waiver care will have access to 
"all" beneficiary electronic health records, and be informed of CAPABLE trained fidelity performance/non-
performance by a clinician and/or be informed by PI/PM of need a for a clinicians to have remediation for 
fidelity to CAPABLE. To minimize the risk, IFs will be trained in how to motivate and conduct remediation. 
Will include in the contract with sites that need for clinician remediation would not impact a clinicians 
employee status if consent to participate in the study. 
Beneficiaries Beneficiaries have the option to opt out of the study if desired; and will to receive “usual” waiver 
care regardless of decision to participate or not participate in the study. 
Protecting Confidentiality Identifying information (name, address, date of birth, Social Security or Medicare 
numbers) are not used to identify those who participate in the study. Those who participate will be assigned an 
identification number which will become the identifier of records for all who participate. This number will be 
given to study personnel to enter into the study database. Only the PI/PM will link the identification number 
with the data to the central location for review. 
 
1.22 ADVERSE EVENTS AND PROTECTION AGAINST STUDY RISKS 
Adverse Events 
This study is “low risk” and no adverse events are anticipated. A Serious Adverse Event (SAE) is defined as a 
breach of confidentiality; whereas a Non-Serious Adverse Event (NSAE) is defined as data storage or security 
without breach of confidentiality. Tracking of events will occur by the PI/PM who will enter all SAE/NSAE into 
an Excel database compiled for reporting. Reporting of an SAE to PI will occur within 24 hours. If PI evaluates 
SAE to be moderate or serious, will convene the Data Safety Monitoring Board (DSMB). All events determined 
by DSMB to be an SAE will be reported to the GVSU IRB and NIA Project Official within 48 hours. NSAE 
events will be reported to PI within 7-days. If PI evaluates NSAE to be of nature needing further reporting, will 
report to the IRB, DSMB, and NIA as appropriate. We do not anticipate any SAEs or NSAEs. 
 
1.23 ROLES, RESPONSIBILTIES, AND TRAINING 
Study Personnel 
PI is a PhD, NIH trained experienced “trial” scientist, having completed over 40 trials, able to carry out the role 
and responsibilities to carry out the study, as approved by NIA. 
PM is BS prepared individual, and experienced PM with over 10 projects completed with this PI; and able to 
carry out the role and responsibilities to carry out the study, as approved by NIA. 
RAs The following training will occur for all students (undergraduate and graduate) who will act as “research 
assistants” in this study. 
Role and Responsibilities Training Each RA prior to interacting with any site, IF, clinicians, or beneficiaries or 
with collecting data will complete online, reading, and in-person orientation and training: 

19 
 
R15 Protocol V9 4-30-2019 
 
1. Complete CITI training and submit certificate to the PM the first week working on the project, and prior to 
interacting with study clinicians, IFs, or beneficiaries or data. 
2. Receive a job description, and review, understand, and sign, which includes the role and responsibilities 
entailed within the position.  
3. Receive a position manual, and review, understand, and deploy in their role. 
4. Review and understand the DSMP and DSMP Charter, Study Protocol, measures, literature supporting 
project evidence and approach; and the quality assurance-monitoring plan. 
5. Report directly to PM with weekly schedule, activities, needs, requests, problems, or any other issues that 
may arise. 
6. Review, attend, and participate in team meetings when not in class. 
7. Conduct DUMMY data collection in a HIPAA and confidentially protected manner and accept feedback 
from PM until conducted correctly. 
8. Complete the orientation checklist as defined in position manual. 
If needed, remediation will occur on any deficit area by the PM, until all areas are satisfactory. 
 
1.24 FOLLOW-UP AND RECORD RETENTION 
The duration of the study is 3-years. Record retention will be maintained in a locked file cabinet in the 
university in a locked office and kept 7-years after the completion of the study. The method for destruction of 
written records will occur via shredding using a HIPAA compliant provider; and only archiving of de-identified 
information will occur. 
 
1.25 DISSEMINATION PLAN 
The following dissemination activities will occur as a result of this NIA funded clinical trial.  
ClinicalTrials.gov 
1. The clinical trial under this award will be registered within 21-days of initiation of data collection. 
2. The clinical trial results information will be submitted to ClinicalTrials.gov within 11 months after the 
trial’s primary completion date. 
3. Informed consent documents for this clinical trial will include a specific statement relating to posting of 
clinical trial information at ClinicalTrials.gov; and 
4. GVSU has an internal policy in place to ensure that clinical trials registration and results reporting occur in 
compliance with policy requirements 
Peer Reviewed Publication 
1. The protocol for this trial will be written into a manuscript and submitted to Implementation Science for 
publication in early 2019.  
2. The results of this trial will be written into a manuscript and submitted to Implementation Science for 
publication in 2021. 
Peer Reviewed Presentations 
1. The results of this trial will be written into an abstract and submitted to the Academy of Health 
Dissemination and Implementation Science annual conference for presentation in 2021. 
2. The results of this trial will be written into an abstract and submitted to the Gerontological Society of 
America annual conference for presentation in 2021. 
Formal Reports to MDHHS and 18 sites: 
1. Annual written report of clinical trial progress will be written and submitted each September (2019, 2020) 
2. A final report of clinical trial progress will be written and submitted in September 2021 
Other dissemination activities will occur as opportunities arise. 
 
1.26 DATA RESOURCE AND SHARING PLAN 
The activities will occur as a result of this clinical trial.  

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R15 Protocol V9 4-30-2019 
 
Data Sharing GVSU will share de-identified data from this clinical trial in the following manner: 
1. ScholarWorks@GVSU is an open-access repository maintained by the GVSU Libraries that displays and 
maintains works by GVSU Research Scientists.  
2. PI will prepare de-identified and labeled data set(s) from this trial in excel format and attach a codebook. 
3. PI will provide dataset to the GVSU Library for publication on ScholarWorks platform. 
4. GVSU Library will set up notice of clinical trial data availability in ScholarWorks. 
5. GVSU Library will accepts requests for the clinical trial data in ScholarWorks, which is an Open Access 
platform accessible worldwide. 
6. GVSU will provide the required data release form to those requesting the data from this clinical trial. 
7. Upon receipt of the complete data release form the individual requesting the data, the GVSU Library will 
provide data to requester. 
8. GVSU Library will notify Principal Investigator (Spoelstra) of data sharing. 
9. GVSU Library will compile a list of all data sharing and provide to NIA, the PI, or others as appropriate as 
requested. 
  
Resource Sharing GVSU will share resources, to include the SAS code used to process sand analyze the data 
in this trial and the codebook used to prepare data for analysis from this clinical trial in the following manner: 
1. ScholarWorks@GVSU is an open-access repository maintained by the GVSU Libraries that displays and 
maintains works by GVSU Research Scientists.  
2. PI will prepare SAS analytic codes used to process, analyze trial data in WORD format, and attach an 
EXCEL format codebook. 
3. PI will provide SAS analytic codes and the Codebook to the GVSU Library for publication on 
ScholarWorks platform. 
4. GVSU Library will set up notice of clinical trial SAS analytic codes and Codebook availability in 
ScholarWorks. 
5. GVSU Library will accepts requests for the SAS analytic codes and Codebook in ScholarWorks, which is 
an Open Access platform accessible worldwide. 
6. GVSU will provide the required data release form to those requesting the SAS analytic codes and Codebook 
from this clinical trial. 
7. Upon receipt of the complete data release form the individual requesting the SAS analytic codes and 
Codebook, the GVSU Library will provide data to requester. 
8. GVSU Library will notify PI of data resources sharing. 
9. GVSU Library will compile a list of all data resources sharing and provide to NIA, the PI, or others as 
appropriate as requested. 
 
1.27 LIST OF ATTACHMENTS 
Number
Attachment 
A1
NIA Application (resubmission)
A2
Study Protocol V4 10-31-2018
A3
Consent Form (clinicians [RN/OR/SW/IF])
A4
Measures (administrative data, characteristics)
A5
ILS
A6
EBPAS
A7
GSE
A8
SIC
A9
IF/EF Tool
A10
Email/flyer for clinician training participation

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