CAPABLE Transitions: A Randomized, Unblinded, 60-Subject Clinical Trial of an Occupational Therapy-Led In-Home Intervention to Help Older Adults Transition to Their Homes Following Hospital or Post-Acute Care Facility Discharge
Phase: NA
Conditions: Care Transitions, Dementia
Sponsor: University of Rochester

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CAPABLE Transitions Protocol 
 
November 2022 
 
 
 

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CAPABLE TRANSITIONS 
 
A randomized, care-as-usual-comparator, unblinded, 60-subject clinical trial of an occupational 
therapy-led in-home intervention designed to help older adults successfully transition to their 
homes following a hospital or post-acute care facility discharge.  
 
 
Principal Investigator: Adam Simning, MD, PhD 
Assistant Professor 
Departments of Psychiatry and Public Health 
University of Rochester Medical School 
Rochester, NY 
 
 
Supported by: 
The National Institute on Aging 
Grant Number: K23 AG058757 
Supplemental Grant: K23 AG058757-03S1 
 

Version 2.5 – November 2022, pg. iii 
TABLE OF CONTENTS 
Page 
PRÉCIS ..................................................................................................................................... 1 
Study Title .............................................................................................................................. 1 
Objectives .............................................................................................................................. 1 
Design and Outcomes ............................................................................................................ 1 
Interventions and Duration ..................................................................................................... 2 
Sample Size and Population .................................................................................................. 2 
STUDY TEAM ROSTER ............................................................................................................ 3 
Principal Investigator (PI) ....................................................................................................... 3 
Sub-Investigators (SIs) ........................................................................................................... 3 
PARTICIPATING STUDY SITES ............................................................................................... 4 
Primary Study Site ................................................................................................................. 4 
1 
Study objectives ............................................................................................................... 5 
1.1 
Primary Objective ....................................................................................................... 5 
1.2 
Secondary Objectives ................................................................................................. 5 
2 
BACKGROUND AND RATIONALE ................................................................................... 5 
2.1 
Background on POST-ACUTE CARE-to-Home Transition .......................................... 5 
2.2 
Study Rationale .......................................................................................................... 5 
3 
STUDY DESIGN ...............................................................................................................13 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ...................................................13 
4.1 
Inclusion Criteria ........................................................................................................13 
4.2 
Exclusion Criteria .......................................................................................................14 
4.3 
Study Enrollment Procedures ....................................................................................14 
5 
STUDY INTERVENTIONS ................................................................................................15 
5.1 
Interventions, Administration, and Duration ...............................................................15 
5.2 
Handling of Study Interventions .................................................................................23 
5.3 
Concomitant Interventions .........................................................................................24 
5.3.1 
Allowed Interventions .............................................................................................24 
5.3.2 
Required Interventions ...........................................................................................24 
5.3.3 
Prohibited Interventions .........................................................................................24 

Version 2.5– November 2022, pg. iv 
5.4 
Adherence Assessment .............................................................................................25 
6 
STUDY PROCEDURES ....................................................................................................26 
6.1 
Schedule of Evaluations ............................................................................................26 
6.2 
Description of Evaluations .........................................................................................32 
6.2.1 
Initial Screening .....................................................................................................32 
6.2.2 
Baseline Assessment, Enrollment, and Randomization Visit ..................................32 
6.2.3 
Intervention Visits (<11 total visits) .........................................................................34 
6.2.4 
Follow-Up and Final Assessment Visit ...................................................................34 
7 
Risk/Benefit assessment ................................................................................................35 
7.1 
Risk Category/Potential Risk .....................................................................................35 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ....36 
7.3 
Protection Against Risks ............................................................................................36 
7.3.1 
Informed Consent Process ....................................................................................36 
7.3.2 
Protection Against Risks ........................................................................................38 
8 
INTERVENTION AND STUDY DISCONTINUATION ........................................................40 
9 
STATISTICAL CONSIDERATIONS ..................................................................................41 
9.1 
General Design Issues ..............................................................................................41 
9.2 
Sample Size and Randomization ...............................................................................42 
9.2.1 
Treatment Assignment Procedures ........................................................................42 
9.3 
Interim analyses and Stopping Rules .........................................................................42 
9.4 
Outcomes ..................................................................................................................42 
9.4.1 
Primary Outcomes .................................................................................................42 
9.4.2 
Secondary Outcomes ............................................................................................43 
9.5 
Data Analyses ...........................................................................................................43 
10 
DATA COLLECTION AND QUALITY ASSURANCE ........................................................43 
10.1 
Data Collection Forms ...............................................................................................43 
10.2 
Quality Assurance .....................................................................................................44 
10.3.1 
Training ..............................................................................................................44 
10.3.2 
Quality Control Committee .................................................................................44 
10.3.3 
Metrics ...............................................................................................................44 
10.3.4 
Protocol Deviations ............................................................................................44 
10.3.5 
Monitoring ..........................................................................................................44 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ..........................................................45 
11.1 
Institutional Review Board (IRB) Review ....................................................................45 
11.2 
Informed Consent Forms ...........................................................................................45 
11.3 
Participant Confidentiality ..........................................................................................46 

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11.4 
Study Discontinuation ................................................................................................46 
12 
ETHICAL CONSIDERATIONS ..........................................................................................46 
13 
COMMITTEES ..................................................................................................................47 
14 
PUBLICATION OF RESEARCH FINDINGS .....................................................................47 
15 
REFERENCES ..................................................................................................................47 
 

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PRÉCIS 
Study Title 
CAPABLE Transitions: A Home Health Agency-Based Intervention to Optimize the 
Hospital or Post-Acute Care Facility-to-Home Transition 
Objectives 
This study’s primary objective is to serve as a feasibility study of an intervention to assist 
older adults in the hospital or post-acute care facility-to-home transition and to test and 
refine procedures as they relate to: 
• 
screening, enrollment, and retention of study participants 
• 
fidelity to and perceived benefit of the intervention 
• 
data completeness with regard to our intermediate and primary outcomes 
This study’s secondary objective is to obtain preliminary data on home time, quality of life, 
and health care utilization at three and six months following post-acute care facility 
discharge. 
Design and Outcomes 
This study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of an 
occupational therapy (OT)-led in-home intervention designed to help older adults with and 
without dementia successfully transition to their homes following a hospital or post-acute 
care facility discharge. In total, we plan to recruit 60 adults (36 in the intervention and 24 
in the CAU arms) aged 65 years and older recently discharged from a hospital or post-
acute care facility and admitted to a Medicare-certified home health agency (CHHA). 
Throughout the study, we will continually seek to enhance and optimize the study protocol 
and procedures to enhance recruitment. Our pilot study’s main outcomes relate to the 
feasibility of the study. These outcomes include study recruitment and retention, fidelity to 
and perceived benefit of the intervention, and data completeness with regard to our 
intermediate and primary clinical outcomes (home time, quality of life, health care 
utilization). We will assess participants at the time of study enrollment and three and six 
months following hospital or post-acute care facility discharge with a combination of in-
person interviews and review of medical health records.  
 

Version 2.5– November 2022, pg. 2 
 
Interventions and Duration 
CAPABLE Transitions: The intervention group will receive an OT-led multidisciplinary in-
home intervention in which the study OT (<6 visits), RN (<5 visits), and handyworker (<2 
visits) work with participants over three months. Study staff will follow participants for six 
months with assessments occurring at study enrollment as well as three and six months 
following hospital or post-acute care facility discharge. The intervention group also will 
receive CHHA CAU services. Figure 1 only shows the intervention and assessment 
sessions (CHHA CAU are not shown). 
Care-as-Usual: The comparator group, receives CHHA CAU services, which can include 
nursing, home health aide, medical social work, and occupational, physical, and speech 
therapy services. CHHA clinicians will determine the types and duration of services that 
CHHA clients in this group receive, which will be completely independent of the research 
study. The duration of CHHA can vary dramatically across CHHA clients (e.g., range from 
a single visit to having weekly visits for more than a year). Regardless of the types or 
duration of CHHA services received, study staff will follow the CAU group for six months 
with assessments occurring at study enrollment as well as three and six months following 
hospital or post-acute care facility discharge. Even if study participants are receiving 
CHHA CAU services beyond six months, participation in the research study will end at the 
sixth month assessment.  
Sample Size and Population 
Our target population consists of English-speaking adults aged 65 years and older with 
and without dementia who live in the Rochester region and are admitted to a CHHA 
following a hospitalization or post-acute care facility stay. We will continue to revise the 
study protocol as needed to enhance recruitment. We will utilize a stratified random 
permuted block method of randomization.1 Study staff will stratify participants into two 
groups based on the presence or absence of moderate or severe cognitive impairment as 
determined by a Mini-Mental Status Exam (MMSE) score. Following stratification, the 
study will use permuted block randomization to randomize participants to the intervention 
or CAU groups). We thereby anticipate enrolling 60 participants in this pilot study.  

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STUDY TEAM ROSTER 
Principal Investigator (PI) 
Adam Simning, MD, PhD 
 
University of Rochester Medical Center 
 
300 Crittenden Blvd, Box Psych 
 
Rochester, NY 14642 
 
Phone: 585-273-2492 
 
Fax: 585-276-2065 
 
Email:  adam_simning@urmc.rochester.edu  
Main responsibilities: Primary responsibility over the entire 
clinical trial, which includes hiring and training staff, developing 
study protocol and procedures in accordance with good clinical 
practice, developing study forms and materials, supervising 
study performance, ensuring that participants’ well-being and 
safety are protected, monitoring and reporting adverse events, 
and submitting documents to regulatory bodies. 
Sub-Investigators (SIs) 
Thomas V Caprio, MD 
 
Professor 
 
Departments of Medicine, Public Health Sciences, Nursing, 
and Dentistry 
 
Monroe Community Hospital 
 
435 East Henrietta Road 
 
Rochester, NY 14620 
 
Phone: 585-760-6364 
 
Fax: 585-760-6376 
 
Email: thomas_caprio@urmc.rochester.edu  
Main responsibilities: Assisting with the development of the 
study protocol and procedures and facilitating implementation 
of the intervention within UR Medicine Home Care. 
 
Yeates Conwell, MD 
 
Professor and Vice Chair 
 
Department of Psychiatry 
 
University of Rochester Medical Center 
 
300 Crittenden Blvd, Box Psych 
 
Rochester, NY 14642 
 
Phone: 585-275-6739 
 
Fax: 585-273-1066 
 
Email: yeates_conwell@urmc.rochester.edu  
Main responsibilities: Assisting with overseeing the entire 
clinical trial to ensure that the study adheres to the protocol and 
good clinical practice. 
 

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PARTICIPATING STUDY SITES 
Primary Study Site 
UR Medicine Home Care 
 
2180 Empire Boulevard 
 
Webster, NY 14580 
 
 
 
Medical Director: Thomas V Caprio, MD 
 
Phone: 585-787-2233 
 
Fax: 585-760-6376 
 
Email: thomas_caprio@urmc.rochester.edu  
Main responsibilities: This Medicare certified home health 
agency’s clinicians will deliver the intervention to study 
participants. 
 
 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
This study’s primary objective is to serve as a feasibility study of an intervention to assist 
older adults in the hospital or post-acute care facility-to-home transition and to test and 
refine procedures as they relate to: 
• 
screening, enrollment, and retention of study participants 
• 
fidelity to and perceived benefit of the intervention 
• 
data completeness with regard to our intermediate and primary outcomes 
Achieving this objective will inform the development of a larger clinical trial. This larger 
clinical trial will test the hypothesis that, among older adults discharged from hospitals or 
post-acute facilities (e.g., inpatient rehabilitation facilities and skilled nursing facilities) and 
admitted to a CHHA, those who receive CAPABLE Transitions will spend more days alive 
in their homes, have a higher quality of life, and have decreased utilization of emergency 
department, acute medical, and SNF care compared to older adults who receive CHHA 
CAU. 
1.2 Secondary Objectives 
This study’s secondary objectives are to obtain preliminary data on home time, quality of 
life, and health care utilization at three and six months following hospital or post-acute 
care facility discharge. 
2 
BACKGROUND AND RATIONALE 
2.1 Background on Hospital and Post-Acute Care Facility-to-Home Transitions 
Older adults with chronic illnesses often experience repeated transitions in care, especially 
people with dementia.2-6 These transitions can be burdensome to individuals and their 
caregivers7 and are associated with complications, health status decline, and poor quality 
of care.2, 8-10 In 2018, 1.6 million fee-for-service (FFS) Medicare beneficiaries used SNFs 
at least once.11 Although 84% of those admitted to SNFs desire community discharge,12 
only 56% of post-acute care SNF admissions are discharged to the community within 100 
days.13 Even among those discharged from the SNF, many struggle with the transition 
back to the community.14, 15 For instance, among older adult post-acute SNF care 
Medicare beneficiaries in North and South Carolina, 22% use acute services within 30 
days of SNF discharge (67% of whom were rehospitalized).14 There is also wide variation 
in discharge outcomes between higher and lower performing SNFs (e.g., 30-day 
potentially avoidable readmission rates of 3.9% and 7.8% for the 25th and 75th 
percentiles),11 indicating an opportunity for improving discharge outcomes. Furthermore, 
if SNF discharge outcomes were improved, SNF providers may be more willing to 
discharge “high-risk” patients to the community, potentially resulting in fewer post-acute 
care SNF patients transitioning to nursing home long-term care. 
2.2 Study Rationale 
There are numerous barriers to a successful hospital and post-acute care facility-
to-home discharge: Although care transitions are common among older adults,3-5 these 
transitions are fraught with risk that older adults and their caregivers may be poorly 
prepared to manage.7 The reasons why many older adults struggle with the hospital or 

Version 2.5– November 2022, pg. 6 
post-acute care facility-to-home transition are complex and multifactorial. For example, 
patient-level (e.g., male gender, cognitive impairment, functional impairment, Medicaid 
eligibility) and SNF-level (e.g., SNF quality) factors can affect an older adult’s ability to 
return to and remain in the community.14, 16-22 Additionally, following discharge, the medical 
care of the older adult must transfer from the hospital or SNF providers to the PCP and 
other outpatient medical providers in a timely and effective manner, and there can be 
breakdowns in communication between health care providers. Transitions of care also can 
exacerbate medication-related issues7 (e.g., ability to manage medications, redundant 
medications). Furthermore, unmet health-related social needs are frequently overlooked 
during health care transitions and can negatively affect health outcomes and services 
utilization.23 Many older adults discharged from the hospital or post-acute SNF care also 
have had a significant medical event that has decreased their level of functioning, placing 
their ability to manage in the homes at risk. Over the past two decades, there have been 
many efforts to address these issues to improve care transitions – efforts that have 
successfully reduced rehospitalizations, SNF readmissions, and mortality.24 
Prior to the COVID-19 pandemic, many older adults were referred to home health 
agencies from SNFs. However, there is evidence that the pandemic is dramatically 
changing post-acute and home health care- in 2018, 66% of home agency referrals 
nationally came from doctors’ offices.25 Due to the dramatic reduction in SNF referrals to 
home health agencies and in consideration of the likely dramatic post-acute care changes 
nationwide, our recruitment criteria will include referrals from hospitals, inpatient 
rehabilitation facilities, and skilled nursing facilities. A review of Medicare inpatient hospital 
claims from June 2020 estimates a 4.6% increase in home health care compared to June 
2019, and a 25.4% decrease in SNF discharges.26 Although we designed our intervention 
with the SNF-to-home transition in mind, CAPABLE Transitions is a care transitions 
intervention that will work similarly in the hospital-to-home transition and would involve no 
additional modifications to do so. 
Care transition interventions overview and knowledge gap: Care transition 
interventions have included advanced practice nurses who serve as transition coaches,27-
29 nurse discharge coordinators,24, 30, 31 pharmacists,30 telemonitoring,32, 33 telephone 
support,32, 33 and home visits,24, 29, 33 which have emphasized educational components 
(e.g., medication self-management) and care coordination. Complex interventions 
targeting the patients’ capacity for self-care appear particularly effective34 as do 
interventions bridging pre- and post-discharge settings.24 “The vast majority of care 
transitions literature has been hospital-focused…”,24 however, and the evidence to inform 
post-acute care facility-to-home discharges, specifically, is limited. Additionally, many of 
the interventions designed for the hospital settings are too resource-intensive (e.g., 
reliance on nurse practitioners, pharmacists) for post-acute care SNFs to easily adapt and 
adopt. A 2015 review found only two SNF-based interventions designed to reduce hospital 
readmissions.35 Project ReEngineered Discharge (“Project RED”) is one such intervention, 
which reduced 30-day hospitalization following SNF discharge from 18.9% to 10.2%. 
Although effective, this intervention is unlikely to be widely disseminated as it consists of 
11 components that necessitate comprehensively overhauling the SNF discharge process 
and requires actions by social workers, nurse practitioners, secretaries, nursing, and home 
care liaisons and coordinators.36 The second intervention consisted of a specialized 
geriatric rehabilitation unit that included a comprehensive geriatric assessment, a 
geriatrician, a geriatric nurse practitioner, and follow-up telephone case management. A 
pilot study suggested that this intervention resulted in fewer ED visits and hospital 
readmissions after SNF discharge.37 This pilot study was conducted in 2005 and, to our 
knowledge, has not been examined in a follow-up randomized clinical trial. Efforts are 

Version 2.5– November 2022, pg. 7 
underway to optimize the SNF-to-home transition, and Connect-Home is a four-step 
transitional care intervention to be delivered by SNF staff. Connect-Home’s four steps are 
as follows: step 1 is to create transition of care plan, step 2 consists of a care plan meeting, 
step 3 is to implement the care plan, and step 4 consists of a social worker calling the 
patient or caregiver within 72 hours of discharge.38 Overall, there is little empirical evidence 
on how to optimize the SNF-to-home transition, however. To our knowledge, no study has 
examined a CHHA-based intervention to assist older adults in transitioning from the SNF 
to home. 
To address this critical gap in knowledge and improve outcomes for older adults 
experiencing the SNF-to-home transition, we are proposing to conduct a pilot study of a 
targeted intervention, CAPABLE Transitions, which will assist older adults who are 
discharged not only from the hospital, but also from post-acute care facilities (SNFs or 
inpatient rehabilitation facilities) to CHHA services in the community. 
Original CAPABLE: Community Aging in Place, Advancing Better Living for Elders 
(CAPABLE) includes an interdisciplinary team of a registered nurse (RN), OT, and 
handyworker. The CAPABLE intervention consists of an assessment-driven, client-
specific package of interventions that are delivered over approximately four months by an 
OT (<6 visits), RN (<4 visits) and a handyworker team.39 CAPABLE has been shown to 
decrease ADL impairment (by 30% and 45% when compared to an active control or 
baseline impairment, respectively) 40 as well as home hazards and depression in 
community-dwelling older adults.39, 41 CAPABLE also reduces utilization of inpatient and 
outpatient medical services among older adults.42 CAPABLE is becoming widely 
disseminated. Of note, CAPABLE was originally designed for functionally limited, but 
medically stable and cognitively intact older adults. CAPABLE excluded those who had 4+ 
hospitalizations in the prior 12 months or were receiving in-home physical therapy, OT, or 
nursing services. These exclusions are pertinent to older adults transitioning from the 
hospital or post-acute care facility-to-home as this group has high levels of acute medical 
care use, cognitive impairment, and home health services utilization.14, 43 Whether 
CAPABLE performs similarly in those with more acute medical needs and/or cognitive 
impairment is uncertain. It is also unclear whether CAPABLE can be delivered from within 
a CHHA organization. We therefore have developed CAPABLE Transitions, an 
intervention that adapts CAPABLE to this more vulnerable population, adds a transitions 
of care component, and is designed to be delivered within a CHHA.  
CAPABLE Transitions – A home health agency-based intervention for older adults 
transitioning from the hospital or post-acute care facility to home: We have designed 
CAPABLE Transitions to help older adults return to and remain in the community. Similar 
to CAPABLE, CAPABLE Transitions consists of an OT-led multidisciplinary team in which 
the study OT (<6 visits), RN (<5 visits), and handyworker (<2 visits) deliver an in-home 
intervention over approximately three months. Also similar to CAPABLE, CAPABLE 
Transitions aims to harness the older adult’s motivation by addressing functional goals 
that the older adult or dyad prioritizes as well as changing home factors in support of these 
functional goals and to improve home safety. CAPABLE Transitions expands upon 
CAPABLE, however, by also focusing on care transitions, and thereby has two core 
elements. The first element consists of an RN-delivered brief care transitions intervention. 
The care transitions element is informed in part by Coleman’s Care Transitions 
Intervention Model.27 This element seeks to ensure connection to and communication with 
the PCP and outpatient medical services, to address barriers to medication management, 
and to screen for and link older adults to appropriate services for unmet health-related 
social needs. 

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Whereas the first element primarily aims to facilitate the transfer of care from the hospital 
or post-acute care facility to the outpatient and home settings, CAPABLE Transitions’ 
second element seeks to optimize the ability of the older adults to function in their homes. 
To do so, we modified CAPABLE in four ways. First, given the acuity of the older adults 
our intervention targets, the Study OT and RN visits will occur more frequently in the first 
few weeks following the transition relative to the original CAPABLE intervention (e.g., 
every 1-2 weeks rather than every 2-4 weeks, with flexibility to account for participant 
preference, participant availability (e.g., may be hospitalized), and varying CHHA clinical 
demands). Second, following the transition home, all the CHHA clients in our study will be 
receiving CHHA nursing services and many also will be receiving CHHA OT services. For 
CHHA clients randomized to our intervention arm, in addition to CHHA RN +/- CHHA OT 
services, they will receive CAPABLE Transitions RN and OT services delivered by the 
same CHHA RN and CHHA OT. The CAPABLE Transitions intervention can be delivered 
either at the end of a CAU RN and OT in-home session or at a separate in-home visit. Of 
note, CAPABLE Transitions’ OT services focus on client-prioritized functional goals while 
CAPABLE Transitions’ RN services target client-prioritized conditions and syndromes that 
may be impairing function (e.g., depression, pain, incontinence) as well as fall prevention 
and communication with the PCP. In contrast, CHHA CAU OT and RN services are 
generally directed by a physician’s order and tend to focus on a specific medical problem 
identified by the physician (e.g., wound care, diabetes management, upper extremity 
mobility). Third, our intervention will include those with moderate or severe cognitive 
impairment (including dementia), regardless if they have live-in caregivers, who may 
potentially live alone. Optionally, we may deliver the intervention to a caregiver-participant  
dyad, regardless of cognition, if there is a caregiver willing to serve as a study partner. An 
MMSE score of 20 or less indicates that a moderate or severe cognitive impairment is 
present.44, 45,86 Fourth, CHHA clients and dyads will determine the dose of the intervention 
and whether to participate in the various components of the intervention. The different 
intervention components include: 
• 
RN care transitions home visit 
• 
OT comprehensive assessment and development of client-prioritized functional 
goals 
• 
client-OT work towards addressing functional goals 
• 
handyworker home safety repairs 
• 
handyworker home modifications to support patient-prioritized functional goals 
• 
RN in-depth assessment on pain, depression, strength/balance, medication 
concerns, and outpatient medical provider communication and development of 
client-prioritized goals as they relate to these issues 
• 
client-RN work on addressing RN domain goals 
It is important to note that the services provided by the Study OT and RN differ from those 
offered by CHHA CAU OT and RN visits. Whereas CHHA CAU OT and RN services are 
often focused on a specific problem or on disease management (e.g., diabetes, wound 
care, heart failure), Study OT and RN visits are designed to: 1) Let the client drive the 
treatment plan, 2) enhance client self-efficacy (e.g., change comes from the client), 3) 
customize treatment strategies to client-identified concerns, capabilities, and environment, 
4) address the environment (e.g., assess the clients’ functioning in their home), 5) 
coordinate with handyworker services to optimize the environment for function and safety, 
and 6) focus on function rather than disease management.  

Version 2.5– November 2022, pg. 9 
We expect that this clinical trial will present minimal risk to study participants. This study 
will involve questionnaires, interviews, function-focused physical activity and exercises, 
and examination of medical records for which the primary risk is invasion of privacy, 
breach of confidentiality, or the participants becoming fatigued or stressed.  
Theoretical foundation: Our intervention is based on several different theoretical 
foundations. First, Freedman’s Disability Framework (which is informed in part by the 
World Health Organization’s International Classification of Functioning and Disability, 
Nagi’s disability model, and others) indicates that environment impacts an older adult’s 
health conditions, impairments, and capacity, which can in turn be mitigated by 
accommodations (e.g., changes to the environment, compensatory strategies).46 Second, 
Andersen’s Behavioral Model considers how predisposing (e.g., sociodemographics), 
enabling (e.g., social support, environment, insurance), and need (e.g., medical 
conditions, functional and cognitive impairment) can impact health care access and 
utilization as well as health outcomes.47, 48 Third, the Cumulative Complexity Model 
considers how the balance of older adult workload (illness management requirements) 
and capacity (ability to manage illness) help determine (along with other factors) the 
success or failure of transitions of care.49 Lastly, we will draw upon Dr. Coleman’s Care 
Transitions Intervention framework, which identifies “four pillars” (e.g., medication self-
management, dynamic patient-centered record, PCP follow-up, identification of red flag 
symptoms) as being critical to care transitions.50 

Version 2.5– November 2022, pg. 10 
Table 1. Overview of CAPABLE Transitions – An Intervention to Optimize the hospital or post-acute care facility-to-Home Transition 
Study Population: older adults with and without dementia admitted to a certified home health agency (CHHA) services after being discharged from a hospital 
or post-acute care facility.  
Inclusion Criteria: aged 65 years or older, English-speaking, admitted to CHHA following a hospitalization or post-acute facility admission, live in the 
Rochester, NY region. 
Exclusion Criteria: have a terminal diagnosis, receiving active cancer treatment, plan to move within one year, and who are COVID-19 positive, have 
suspected COVID-19 infection, or resides with a person who is COVID-19 positive or has suspected COVID-19. 
Intervention Time Frame. Although we will have optimal visit timeframes, these timeframes are guidelines. We expect that real-world situations will 
sometimes result in intervention visits that occur outside of these “optimal” timeframes:  
- OT Home Visits (6 total visits): 
#1 ideally as soon as possible after RN visit #1 (optimally within 1-2 weeks; may occasionally occur prior to RN visit #1),  
#2-4 optimally within 1-2 weeks thereafter OT visit #1,  
#5-6 optimally within 3-4 weeks thereafter OT visit #4, 
- Handyworker Home Visits: as soon as possible after OT visit #2 (ideally completed within 3 weeks from CHHA admission, which typically occurs within 
several days of hospital or post-acute care facility discharge) 
- RN Home Visits (5 total visits):  
#1 will occur as soon as possible after CHHA admission (optimally within 1-2 weeks),  
#2 optimally within 1-2 weeks after RN visit #1,  
#3-5 optimally within 2-4 every weeks thereafter RN visit #2. 
- As this is a feasibility study, we will have relatively broad study windows for when the intervention can be administered. The study intervention will 
not extend past 5 months following hospital or post-acute care facility discharge, however. Of note, the intervention will be discontinued for study 
participants with a prolonged hospitalization as described in Section 8 of the protocol. 
- After each OT or RN visit, the study participants will be asked whether they would like to continue with the intervention.  
 
Core Function 
(“Objectives”) 
Forms (“Activities”) 
Theory 
Intermediate Outcomes 
Primary Outcomes 
Care 
Transition 
Component 
(RN Home 
Visit #1) 
Ensure linkage to PCP and 
other medical providers. 
CHHA clients create list of medical 
providers, recent or scheduled 
appointments, and barriers to 
attending appointments; RN 
assists clients in overcoming 
barriers and in linking to outpatient 
medical services. 
CHHA clients identify key 
symptoms as well as questions 
and concerns for their medical 
providers; RN assists clients in 
identifying key symptoms, 
answering questions, and 
communicating with medical 
providers. 
Andersen’s 
Behavioral 
Model, 
Coleman’s Care 
Transitions 
Intervention 
Model 
Increased timeliness and 
frequency of outpatient 
medical appointments 
Increased 
communication with 
providers (e.g., office 
visits or calls, electronic 
messaging) 
1) Increased home time 
(i.e., days spent alive at 
home or in the 
community) 
2) Improved quality of life 
3) Decreased emergency 
department, 
hospitalization, and 
SNF utilization 

Version 2.5– November 2022, pg. 11 
Reduce barriers to effective 
medication management. 
CHHA clients complete a 
comprehensive medication 
management assessment; based 
on the assessment, study RN 
assists the client in developing 
strategies to more effectively 
management medications. 
Andersen’s 
Behavioral 
Model, 
Coleman’s CTI 
Model 
Increased medication 
adherence 
Address health-related 
social needs. 
CHHA clients complete a health-
related social needs 
questionnaire23; based on the 
screener, RN completes referrals 
for identified health-related social 
needs. 
Cumulative 
Complexity 
Model, 
Andersen’s 
Behavioral 
Model 
Decreased anxiety 
symptoms 
Decreased depression 
symptoms 
OT and 
Handyworker 
in the Home 
(OT Home 
Visits #1-6) 
Develop and implement a 
treatment plan based on 
patient-determined 
functional priorities. 
CHHA clients complete 
comprehensive functioning 
assessment. 
CHHA clients work with OT to 
develop a priority list of functional 
goals; based on this list, OT 
assists client in addressing client-
prioritized functional goals (e.g., 
via education, exercises, obtaining 
and practicing with devices). 
Freedman’s 
Disability 
Framework, 
Cumulative 
Complexity 
Model 
Improved self-efficacy51 
Improved ADL 
functioning 
Improved IADL 
functioning 
Improve home safety. 
OT completes a home safety 
assessment. 
CHHA clients work with OT to 
develop a priority list of home 
repairs. 
Handyworker works with CHHA 
client and OT to make appropriate 
repairs. 
Freedman’s 
Disability 
Framework, 
Cumulative 
Complexity 
Model 
Fewer home hazards 
Decreased fear of falling 
Improved mobility 
Optimize home 
environment for function. 
Based on the CHHA clients’ 
comprehensive functioning 
assessment and prioritized list of 
functional goals, client works with 
OT to create a list of home 
modifications for HM to complete 
and accommodative devices for 
OT to obtain. 
CHHA clients work with OT to 
enhance clients’ ability in using the 
home modifications and 
accommodative devices. 
Freedman’s 
Disability 
Framework, 
Cumulative 
Complexity 
Model 
Improved self-efficacy 
Improved ADL 
functioning  
Improved IADL 
functioning 

Version 2.5– November 2022, pg. 12 
RN in the 
Home (RN 
home visit 
#2-5) 
Identify and decrease 
barriers to daily functioning 
such as pain, depressive 
symptoms, 
strength/balance 
difficulties, medication 
issues, and poor 
communication with 
medical providers. 
CHHA clients complete an RN 
assessment focused on pain, 
depression, strength and balance, 
medication management, and 
communication with medical 
providers that impact functioning.  
CHHA clients work with RN to 
develop a priority list of functional 
goals; based on this list and with a 
behavioral activation approach, 
client and RN develop a plan to 
address these goals (e.g., pain 
management techniques, balance 
exercises). 
Freedman’s 
Disability 
Framework, 
Cumulative 
Complexity 
Model 
Improved ADL 
functioning 
Decreased pain 
Decreased depressive 
symptoms 
Improved mobility 
Improved medication 
adherence 
Increased 
communication with 
providers (e.g., office 
visits or calls, electronic 
messaging) 

Version 2.5– November 2022, pg. 13 
3 
STUDY DESIGN 
This study is a randomized, CAU-comparator, unblinded clinical trial of an in-home 
multidisciplinary intervention, CAPABLE Transitions, designed to help older adults 
successfully transition to their homes following hospital or post-acute care facility 
discharge. We plan to conduct this study for three years and to recruit 60 adults (36 in the 
intervention and 24 in the CAU arms) aged 65 years and older with and without dementia 
recently discharged from a hospital or post-acute care facility and admitted to a CHHA. 
Prior to randomization, we will stratify the 60 participants based on the presence or 
absence of moderate or severe cognitive impairment. CAPABLE Transitions consists of 
an OT-led multidisciplinary team in which the study OT (<6 visits), RN (<5 visits), and 
handyworker (<2 visits) deliver an in-home intervention over three months. Study staff will 
follow participants for six months with assessments occurring at study enrollment as well 
as three and six months —following hospital or post-acute care facility discharge.  
Our pilot study’s primary outcomes relate to the feasibility of the study and include study 
recruitment and retention, fidelity to and perceived benefit of the intervention, and data 
completeness. The pilot study’s secondary outcomes are to obtain preliminary data on 
home time, quality of life, and health care utilization at three and six months following 
hospital or post-acute care facility discharge. 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 Inclusion Criteria 
This study’s target population is older adults living in an urban area who are admitted to a 
CHHA after discharge from a hospital or post-acute care facility. To participate in the study, 
with few exceptions (e.g., active cancer treatment, terminal diagnosis), there will be no 
restrictions based on sex, health status, or medical conditions, and all of the following 
inclusion criteria must be met: 
• 
admitted to CHHA following a hospitalization or post-acute care facility stay (if 
not referred from CHHA, we will collect data on where patient referral is from)  
• 
live in the Rochester, NY region 
• 
aged 65 years or older 
• 
English-speaking 
• 
agree to study participation 
We will deliver this intervention within a CHHA and with CHHA clinicians to enhance the 
scalability and the ease of dissemination if CAPABLE Transitions is effective. However, it is 
acceptable if patients have been admitted and then discharged from CHHA within the 
screening timeframe, or if participants may be working with other CHHA (staff such as PT or 
OT) and do not currently have an assigned CHHA registered nurse.  
CHHA clients, regardless of their cognition, will have the option to include a study 
partner that may live with the study subject and be a primary caregiver to the study 
subject. Study partners may attend home visits and intervention sessions and be available 
via phone to answer questions from the research assistant. If needed, they must be available 
for other information via phone to be obtained from study staff. They may be asked general 
questions (e.g., age, sex) and about their relationship to the study participants and the 
participant’s daily functioning, wellbeing, and health services use. 

Version 2.5– November 2022, pg. 14 
4.2 Exclusion Criteria 
We will exclude potential participants from study participation who do not satisfy all of the 
inclusion criteria or meet any of the following exclusion criteria at baseline: 
• 
plan to move within one year 
• 
has a terminal diagnosis (e.g., <1 year life expectancy, in hospice) 
• 
receiving active cancer treatment (active treatment includes surgery or a 
course of radiation or chemotherapy; it does not include long-term 
maintenance treatment such as daily hormonal treatment of prostate cancer) 
• 
inability or unwillingness of individual or legal guardian/representative to give 
written informed consent. 
• 
has been discharged to home from a hospital or post-acute care facility for 
more than 28 days  
• 
are COVID-19 positive, have suspected COVID-19 infection, or resides with a 
person who is COVID-19 positive or has suspected COVID-19. 
4. 3 Study Enrollment Procedures 
We will recruit older adults newly admitted to UR Medicine Home Care following discharge 
from a hospital or post-acute care facility. UR Medicine Home Care is a CHHA that 
provides services to a six-county region in Upstate New York.  
• 
Identification: The CHHA has clinical teams based on geographic region. The 
study OT and RN will be on the same CHHA team, which will be assigned to a 
region in Monroe County, NY that includes the Rochester region. The study RN 
and OT will regularly screen all of their CHHA intakes to identify potential study 
participants (e.g., discharged from post-acute care facility, does not have a 
terminal condition). The study RN and study OT will ask clients passing the initial 
screen if they are interested in participating in our research study. The study RN 
and OT will also offer participants a recruitment brochure to introduce and provide 
information to home health patients if they are interested. For residents indicating 
an interest to participate in the research study and agree to have a study staff 
member visit them to provide more information, the study RN, OT, and CRC will 
work together to schedule an in-person screening visit that is convenient to the 
potential participant. In addition to the URMHC interventionists recruiting 
participants among their new admissions, we will contact potentially eligible 
URMHC clients who have indicated that they are interested in participating in 
research when they complete the new consent process via URMHC. This new 
consent process is for ALL URMHC patients admitted to URMHC services in which 
they can "opt in" or "opt out" of being contacted by a UR researcher if there is a 
study they qualify for. Only patients who have consented will be contacted by the 
CRC.  
• 
Study sample representativeness: At each stage of the screening and 
recruitment process, we will document the proportion of CHHA clients who are 
not eligible for our study, are not interested in participating in our study, or are 
lost to follow-up. For these CHHA clients we will only keep basic demographic 
information such as age, sex, and race and ethnicity to allow us to track those 
who do and do not participate in our study; those older than 89 will be grouped 
in a 90+ age category. We will also utilize ICD-10 codes as part of the 

Version 2.5– November 2022, pg. 15 
screening process for the CHHA to help us identify participants that have 
dementia or cognitive impairment. However, we will not base our recruitment 
criteria or numbers based on this dementia category but will prioritize people 
with dementia. This information will help us determine the representativeness 
of our study sample and to examine whether there are subgroups that are 
unlikely to participate in the study (in which case, we made need to bolster 
recruitment efforts for certain subgroups). 
• 
Consent procedures: As part of the consent process, study staff will 
systematically assess capacity for consent with a series of open-ended 
questions administered to the potential participant that follows explanation of 
the study (see Determination of Consent Capacity Form). These questions will 
address the participant’s knowledge and understanding of the study’s 
objectives, the voluntary nature of participation, ability to withdraw at any time, 
and possible risks and benefits of participation. For those unable to 
demonstrate capacity for consent, we will seek to obtain surrogate consent. 
Surrogate consent for dementia research is widely accepted by the general 
public,54, 55 and we will only enroll older adults with a surrogate consent if the 
older adult also assents to participate in the study and the surrogate consenter 
is able to demonstrate capacity for consent. We will not enroll any older adult 
who is unable to demonstrate capacity to provide informed consent if they do 
not have surrogate consent available. Although we will not enroll these older 
adults, we will compensate them with $10 for completing the screening 
procedures.  
• 
Randomization: 
Immediately 
following 
termination 
of 
the 
baseline 
assessment interview, study staff will randomly assign participants via a 
stratified random permuted block method.1 Randomization will be stratified 
based on cognitive impairment status (moderate/severe cognitive impairment 
present: MMSE score < 20; moderate/severe cognitive impairment absent: 
MMSE > 21).44, 45,86 Block randomization will then occur within each strata to 
ensure appropriate allocation to the treatment and CAU groupings. REDCap56 
will track the randomization groupings. 
5 
STUDY INTERVENTIONS 
5.1 Interventions, Administration, and Duration 
CAPABLE Transitions overview: CAPABLE Transitions is informed by theory and 
evidence-based practices (Table 1) and consists of <11 in-home visits by an OT and RN 
over three months. Every participant that completes the CAPABLE Transitions 
intervention will receive each component of the intervention (e.g., care transitions 
assistance, assessment, education, problem-solving activities), but the interventionists will 
tailor the content to each participant’s goals and risk profile. University of Rochester 
Medicine Home Care will document information about study participation in the older 
adults’ electronic health records. Table 2 provides a detailed overview of the intervention 
timeline and content. The RN/OT visits will occur as soon as possible following the 
minimum possible number of weeks after the prior visit. The study visit timeline will be 
flexible to accommodate for both the interventionists and the participants needs. In 
instances where there is a deviation from our protocol, we will complete a Note to File in 
our regulatory file (e.g., if an interventionist is on sick leave or if the participant has been 
hospitalized). To help ensure fidelity to the intervention, the Study OT and RN will 

Version 2.5– November 2022, pg. 16 
complete standardized training for CAPABLE provided by Johns Hopkins School of 
Nursing. We will augment this training with training specific to CAPABLE Transitions that 
accounts for the care transitions RN visit and other adaptations we are making to 
CAPABLE (e.g., increased frequency of visits early on, involvement of a Study Partner). 
 

Version 2.5– November 2022, pg. 17 
Table 2. CAPABLE Transitions timeline and content. 
Session 
Timing 
Content 
Interventionist (OT, RN, Handyworker) 
Follow-up 
Occupational Therapy 
Visit #1 
As soon as possible after RN visit #1 
(or, in some unusual circumstances, 
as soon as possible after CHHA 
admission) 
Introduction to OT portion of CAPABLE. 
Issue intervention folder. 
Function-focused OT assessment, including functional mobility, 
ADL, and IADL. 
Determine participant’s functional goals. 
Physical therapy screen. 
 
Visit #2 
As soon possible after visit #1 ideally 
1-2 wks after OT #1 
Fall risk and recovery education. 
Conduct home safety assessment and identify necessary repairs 
or modifications. 
Develop work order for home 
repairs/modifications for handyworker. 
Visit #3 
 As soon possible after visit #2, ideally 
1-2 wks after OT #2 
Brainstorm and develop action plan with participant for 
participant-identified goal #1 (e.g., safely bathing, going upstairs, 
and preparing food). 
 
Visit #4 
As soon possible after visit #3, ideally 
1-2 wks after OT #3 
Review action plan #1. 
Brainstorm and develop action plan with participant for 
participant-identified goal #2. 
Review handyworker work and train participant on new assistive 
devices as able. 
Issue assistive devices or medical 
equipment as available. 
Visit #5 
 As soon possible after visit #4, ideally 
2-4 wks after OT #4 
Review action plan #2. 
Brainstorm and develop action plan with participant for 
participant-identified goal 3. 
Issue assistive equipment and durable medical equipment (if not 
already done) and train participant on new assistive devices and 
modifications. 
 
Visit #6 
As soon possible after visit #5, ideally 
3-4 wks after OT #5 
Review OT section of the Flipbook. 
Help participant generalize solutions for future problems and 
problem-solving techniques. 
Review goals and participant’s achievement of them. 
Review readiness score. 
Ask if participant has any final questions. 
 
Handyworker  
Visit #1 
As soon as possible after OT #3 
Visit home to assess which materials to purchase for ordered 
modification and repairs. 
For common types of repairs and modifications involving 
materials on hand, begin repairing and modifying the home. 
 

Version 2.5– November 2022, pg. 18 
Visit #2 
Once supplies are available 
Repair and modify home based on participant goal-prioritized 
work order. 
Notify OT when this is complete.  
Registered Nurse 
Visit #1 
As soon as possible after client has 
been admitted to Certified Home 
Health Agency (CHHA) 
CHHA clients and RN work together to: 
1) Create list of medical providers, recent or scheduled 
appointments, and barriers to attending appointments; RN 
assists clients in overcoming barriers and linking to outpatient 
medical services. 
2) Identify key symptoms as well as questions and concerns for 
their medical providers; RN assists clients in communicating with 
medical providers. 
3) Complete a comprehensive medication management 
assessment. Based on the assessment, RN assists the client in 
developing strategies to more effectively manage medications. 
4) Complete a health-related social needs questionnaire23; 
based on the screener, RN completes referrals for identified 
health-related social needs. 
If indicated: 
1) Correspond with outpatient medical 
providers to communicate concerns or 
schedule an appointment. 
2) Assist with referral to community-
based agencies or CHHA social 
worker. 
3) Connect with medical transportation 
services. 
4) Communicate medication concerns 
to study pharmacist and/or outpatient 
providers. 
Visit #2 
As soon possible after visit #1, ideally 
1-2wks after RN #1 
Introduction to RN portion of CAPABLE. 
Function-focused RN assessment including pain, mood, 
strength, balance, medication information, and need for health 
care provider (e.g., PCP) advocacy/communication. 
Correspondence to PCP if necessary. 
Visit #3 
As soon possible after visit #2, ideally 
2--4 wks after RN #2 
Determine goals in RN domain together. Start to brainstorm goal 
#1 (e.g., pain in standing, fall prevention). 
Demonstrate CAPABLE exercises. 
Review medication calendar. 
Discuss participant/PCP communication. 
Correspondence to PCP if necessary. 
Visit #4 
As soon possible after visit #3, ideally 
22-4 wks after RN #3 
Complete brainstorming/problem-solving process. 
Develop action plans for identified goals with participant. 
Assess PCP response to communication of participant needs. 
Review, assess, and troubleshoot exercise regimen. 
Issue health care passport. 
Correspondence to PCP if necessary. 
Visit #5 
As soon possible after visit #4, ideally 
2--4 wks after RN #4 
Review progress and use of strategies for all target areas. 
Issue and review RN section of Flipbook that summarizes 
program. 
Evaluate achievement of goals and readiness to change scale. 
Help participant generalize brainstorming process for future 
health issues. 
Discuss participant/PCP communication. 
Ask if participant has any final questions. 
Correspondence to PCP if necessary. 

Version 2.5– November 2022, pg. 19 
Intervention delivery characteristics: CAPABLE Transitions consists of an OT-led 
multidisciplinary team in which the study OT (<6 visits), RN (<5 visits), and handyworker 
(<2 visits) deliver an in-home intervention over approximately three months with each OT 
and RN visit lasting about 60-90 minutes. The OT and RN visits are more frequent earlier 
in the intervention to assist older adults with the hospital or post-acute care facility-to-
home transition. We gradually increase the timing interval between visits so that 
participants have time to practice strategies or activities following the in-home sessions. 
All study participants who decide to receive the full dose of the intervention will receive a 
total of 6 OT visits and 5 RN visits. The number of handyworker visits will depend on the 
modifications and repairs that are needed by the participant (e.g., if everything can be 
completed in 1 visit, then participants only will have 1 handyworker visit). There may be 
rare instances for which the handyworker visits the home more than twice (e.g., perhaps 
the participant has a change in functioning during the course of the intervention that would 
benefit from an additional home modification). Additionally, the handyworker services may 
be unnecessary for all participants (e.g., some participants may decline handyworker 
services if they already live in an age-friendly home or community). While receiving the 
study intervention, CHHA clients also will receive CAU from the CHHA (which may include 
OT services). The study OT and RN will be the same clinicians who deliver CHHA CAU. 
To do so, they will either lengthen the CAU visit or have a separate visit solely for the 
intervention. Data from the CHHA indicate that the median length of a home health 
episode of care is 29 days (Q1: 17 days, Q3: 47 days). For study participants who 
complete the CAPABLE Transitions intervention, we anticipate that most will complete the 
OT and RN sessions in approximately 90 days, and the intervention sessions will not 
continue past 5 months following hospital or post-acute care facility discharge (unless 
there is an exception noted in a Note to File document). Therefore, we expect that the 
majority of study participants will have CHHA CAU that temporarily overlaps with the 
CAPABLE Transitions intervention. We anticipate that there will be minimal “leakage” of 
the study intervention services to the CHHA CAU because the OT and RN actions for 
CAPABLE Transitions will follow a manual based on CAPABLE training and these actions 
are markedly different from their usual CHHA CAU roles.  
The clinical research coordinator (CRC) will maintain a calendar to facilitate coordination 
of the intervention and ensure that study visits occur as detailed in the study protocol. A 
secure share site (UR Box) that can be remotely accessed will enhance communication 
between the OT, RN, and handyworker. This site also will enable study staff to monitor 
electronic documentation for study fidelity and to help assess study costs. The OT will 
have responsibility for case coordination with the CHHA staff and other interventionists 
and for identifying the necessary supplies to order, which include home modifications and 
repairs. Monthly to bimonthly meetings with the OT, RN, handyworker, CRC, and PI will 
ensure communication, adequate supervision, and appropriate fidelity to the intervention. 
Of note, CHHA clients and dyads will determine the dose of the intervention (e.g., number 
of visits) and whether to participate in the various components of the intervention (e.g., 
types of visits such as OT, RN, and handyworker services). More specifically, after each 
OT or RN visit, the study participants will be asked whether they would like to continue 
with the intervention. The study participants can thereby determine the dose of the 
intervention they receive as they can discontinue participation in the intervention at any 
time (see Section 8 for additional detail regarding intervention discontinuation), but still 
continue their participation in the study assessments. Our interventionists may also 
terminate the study intervention if identified goals are completed (or unable to be 
completed) and there are no further participant-interventionist agreed-upon goals to work 
on. 

Version 2.5– November 2022, pg. 20 
As previously stated, the study interventionists are practicing home health clinicians that 
are highly experienced working with older adults who have cognitive impairment. Our 
study’s goal is to improve home safety and functioning and the intervention is catered 
directly to the needs, ability, and goals of the participants – no two participants will receive 
the same intervention. The clinicians will not have participants perform exercises or tasks 
that are unsafe or beyond their ability. 
 The different intervention components include: 
• 
RN care transitions home visit 
• 
OT comprehensive assessment and development of client-prioritized functional 
goals 
• 
client-OT work towards addressing functional goals 
• 
handyworker home safety repairs 
• 
handyworker home modifications to support patient-prioritized functional goals 
• 
RN in-depth assessment on pain, depression, strength/balance, medication 
concerns, and outpatient medical provider communication and development of 
client-prioritized goals as they relate to these issues 
• 
client-RN work on addressing RN domain goals 
Intervention protocol, OT: This OT intervention protocol was adapted from the original 
CAPABLE intervention.40 The OT meets with participants for up to six sessions within 
approximately three months of randomization.  
In the 1st and 2nd OT sessions, the OT meets with participants and conducts a semi-
structured clinical interview using the Client-Clinician Assessment Protocol (C-CAP) that 
has been tested for its psychometric properties for use in home-based and home 
modification programs.57 The C-CAP provides a systematic approach from which to 
identify and prioritize performance areas that are problematic to participants. For each 
performance area identified, the OT observes the participant’s performance and evaluates 
safety, efficiency, difficulty, and presence of environmental barriers and supports. The OT 
will provide a three-ring binder (CAPABLE notebook) which will contain educational 
materials, contact information and a calendar to integrate the sessions by the RN and 
handyworker interventionists. Also, in the course of this session, the OT assesses the 
environmental home safety (common safety and mobility risks include holes in walkways, 
uneven carpeting, and absent railings or banisters). Based on the environmental 
assessment, observation of ADL activities, and identification of the participant’s goals, the 
OT and participant discuss possible environmental modifications. The OT then creates a 
list of agreed upon assistive devices and housing repairs for the handyworker.  
In 3rd, 4th, and 5th OT sessions, the OT engages the participant in problem-solving to 
identify behavioral and environmental contributors to performance difficulties and 
strategies for attaining functional goals. The OT trains participants to use specific 
strategies such as energy conservation techniques, simplifying tasks and the environment, 
and using assistive devices. Also, the OT provides balance and fall recovery techniques 
to decrease fear of falling. In each session, the OT reinforces strategy use, reviews 
problem-solving, refines strategies, and provides education and resources to address 
future needs. Home modifications (grab bars, rails, raised toilet seats) are coordinated 
with the handyworker to assure that they are provided in a timely manner and meet the 
needs of the participant. The OT follows up with training in their use.  

Version 2.5– November 2022, pg. 21 
In the final (6th) OT session, the OT reviews all techniques, strategies and devices, and 
helps the participant to generalize success to other situations. 
Intervention protocol, RN: This RN intervention protocol was adapted from the original 
CAPABLE intervention.40 The RN meets with participants for up to five sessions within 
approximately three months of randomization.  
In the 1st RN session, the RN meets with the participants and works with the CHHA client 
to create a list of medical providers and scheduled appointments and to identify any 
barriers to attending outpatient medical appointments. The RN emphasizes the 
importance of follow-up outpatient appointments and works with the participant to address 
barriers to attending appointments or any questions the participants may have for the 
medical providers. At this initial visit, the RN also assesses the participant’s medications 
as well as the participant’s ability to manage her own medications and tailors intervention 
as indicated by the assessment. Additionally, the RN will work with the participant to 
identify key symptoms and signs to monitor for that should prompt an urgent medical work-
up. Lastly, the RN conducts a health-related social needs screener and works with the 
participant to make appropriate referrals to community resources as needed.  
The 2nd RN session occurs approximately 2-3 weeks after the first RN session. In this 
session, the RN assesses the participant using the C-CAP RN developed specifically for 
CAPABLE in which the RN focuses on how and whether pain, depression, strength and 
balance, medication management, and communication with PCP impact daily function.58 
In this assessment, the RN and the participant identify and prioritize goals, and make plans 
to achieve those goals. The RN also adds educational resources to the CAPABLE 
notebook to reinforce its use as a resource. 
In the 3rd and 4th RN sessions, the RN and the participant work on the goals identified 
through the C-CAP RN. In each session, the RN reinforces strategy use, reviews problem-
solving, refines strategies, and provides education and resources to address future needs 
(e.g., pill box for medication management). 
In the final (5th) RN session, the RN reviews the participant’s strategies and helps to 
generalize them to other possible challenges. 
Intervention protocol, handyworker: This handyworker intervention protocol was 
adapted from the original CAPABLE intervention.40  
The hand worker portion is contracted through handyworker services provided by a local 
non-profit aging services agency, Lifespan (Lifespan, Rochester, NY). Lifespan has a 
program entitled, “Home-Safe-Home,” which has been available to the community for over 
20 years.59 The Home-Safe-Home Program provides home modifications such as grab 
bars, tub grips, shower seats, handheld showers, commodes, railing modifications, and 
other simple yet effective modifications that reduce the risk of falling. It modifies 
approximately 900-1000 homes a year. This program is funded in part through grants from 
various organizations. In an evaluation of this program, 82 (94%) of surveyed Home-Safe-
Home participants reported feeling more comfortable in their home since the home 
modifications and 57 (65.5%) reported increased independence, most frequently with 
bathing (68.4%), followed by use of the bathroom and stairs (49.1%).60 To deliver the 
Home-Safe-Home Program, Lifespan employs a handyworker (the current handyworker 
has been in this role since 2014). Upon agreeing to participate in this study and after being 
randomly assigned to the CAPABLE Transitions intervention arm, study participants will 
be enrolled in Lifespan’s Home-Safe-Home Program. Lifespan also has liability insurance 
for this program and, should any participants have problems with the handyworker 

Version 2.5– November 2022, pg. 22 
modifications or installations, they can follow-up with Lifespan and the handyworker. Of 
note, study participants will not need to identify themselves to Lifespan as they will be 
enrolled in the Home-Safe-Home Program via their participation in our study. Furthermore, 
the handyworker, Ken Posman, is Lifespan’s Home-Safe-Home Program coordinator and 
will be doing the handyworker modifications for all of our study participants. As such, 
additional study communication with Lifespan will not be needed as Lifespan will be fully 
aware of all of the study participants’ involvement in the Home-Safe-Home Program as 
well as their participation in our study. We will pay Lifespan to deliver the Home-Safe-
Home handyworker services to our CAPABLE Transitions participants. The handyworker 
will help coordinate the ordering of the assistive devices as well as the repair and 
modification supplies. The handyworker has extensive experience working with older 
adults in the area, and will make as many home visits as it takes to provide the study 
renovations/modifications. The budget for home repairs, home modifications, and 
assistive devices is $1,200 per household, similar to CAPABLE’s $1,300,40 an amount that 
was adequate for most renovations necessary for safer, more functional homes. We also 
have extra funds available if necessary, for unusual situations (e.g., if we need to replace 
or repair equipment we purchased/installed during the course of the study). 
If home repairs or modifications outside the Handyworker’s scope of practice are indicated 
(e.g., plumbing, carpentry, or electrical work), participant compensation may include 
additional cash payments for home repair and modification services performed through 
Catholic Family Center’s HomeWorks Program. HomeWorks is a program that provides 
low-cost home maintenance/repair support to older adults. These additional cash 
payments of $100 would cover the expense of enrolling in HomeWorks (for 3 months) and 
obtaining an initial estimate of the cost of the modifications/repairs and/or the expense of 
minor home repairs and modifications that are recommended and agreed upon by our 
study interventionists and performed by Catholic Family Center's HomeWorks contractors. 
Of note, HomeWorks limits the maximum service charge to $500. As many of the 
participants may not have funds available to pay for the costs of these services upfront, 
the study team will provide this compensation to the participants in cash prior to having 
the participants pay for these services (maximum compensation for HomeWorks services 
would be $500 per participant, and is included in the $1,200 budget for home 
repairs/modifications and assistive devices). Participants will be notified at time of 
informed consent that depending on the amount they are paid, they may be asked to 
submit a W-9 form, which includes their Social Security Number. No repairs or 
modifications to the participants’ homes, however, will be made without the participants’ 
permission 
Similar to above, if larger home repairs or modifications outside of both Lifespan and 
Catholic Family Center’s scope of practice are indicated (e.g., masonry, bathroom 
remodeling), participant compensation may include additional cash payments for home 
repair and modification services performed by another person (e.g., a handy worker or 
separate contractor) or agency (e.g., bathroom modelers) within our allowed budget. This 
will allow participants to complete indicated home repairs or modifications that are outside 
the scope of both Lifespan and CFC capabilities. We will only reimburse participants for 
agreed upon repairs and modifications that are consistent with the objectives of the 
CAPABLE Transitions intervention. Additionally, we plan to obtain an estimate of the work 
prior to agreeing to reimburse it. These additional cash payments would cover obtaining 
an initial estimate of the cost of the modifications/repairs as well as the expense of the 
home repairs and modifications that are recommended and agreed upon by our study 
interventionists and performed by these contractors or agencies. The total cost of these 
and other services provided to the participant will not exceed the $1,200 budget for home 

Version 2.5– November 2022, pg. 23 
repairs/modifications and assistive devices. In unusual circumstances (e.g., much needed 
home safety repair), we may also be able to reimburse participants for expenses 
exceeding $1,200 if necessary to improve home safety or function and our budget allows. 
No repairs or modifications to the participants’ homes, however, will be made without the 
participants’ permission. Participants will be responsible for any costs that are associated 
with maintaining or replacing these items following the termination of the study. 
5.2 
Handling of Study Interventions 
Study staff and interventionists will conduct CAPABLE Transitions as outlined by this 
protocol. This protocol has been adapted from the original CAPABLE intervention with 
several notable changes. First, the OT visits will occur more frequently in the first few 
weeks following the transition relative to the original CAPABLE intervention. Second, we 
will adapt CAPABLE Transitions so that CHHA OTs and RNs deliver the intervention within 
a CHHA setting. Third, our intervention will include those with moderate or severe 
cognitive impairment who may live alone. If they have caregivers interested and willing to 
participate, we may deliver the intervention to the dyad consisting of an older adult 
regardless of cognition and their Study Partner. Some participants with intact cognition 
may appreciate having a study partner available throughout the intervention.  Fourth, 
CHHA clients and dyads will determine the dose of the intervention and whether to 
participate in the various components of the intervention. We will offer flexibility for the 
intervention visits to meet the needs of the interventionists and the participants.  
The CRC will systematically monitor the delivery of the intervention to make sure that the 
study interventionists are adhering to the intervention’s protocol. Additionally, to help 
ensure fidelity to the intervention, the interventionists will receive standardized training 
offered through The Johns Hopkins University School of Nursing.61 This training will 
complement the content presented in the intervention’s protocol. Johns Hopkins University 
School of Nursing CAPABLE Training courses include the following (of note, no person 
identifiers of the study participants will be shared):  
• 
Training manuals for RNs and OTs 
• 
OT and RN initial assessment forms 
• 
Documentation forms for all ten home visits 
• 
Brainstorming and action planning forms 
• 
CAPABLE exercise book, Health Passport, medication calendar and items for 
participant's folders 
• 
Tip book for participants 
• 
Webinars for additional training and information sharing. These are offered live 
and recorded and archived by topic for later access 
• 
Office hours so trained clinicians, program administrators and construction 
partners can ask questions, discuss challenging cases, share equipment 
solutions and participant successes 
• 
Review of up to 3 work orders for each CAPABLE trained OT during office hours 
• 
Access to Vimeo video clips of visit scenarios 
• 
Access to other CAPABLE sites' outcomes and experiences through an online 
user group 

Version 2.5– November 2022, pg. 24 
We will monitor the following fidelity components: intervention adherence, intervention 
exposure/dose, quality of delivery, participant engagement, and differentiation between 
critical intervention features.62-64 Adherence consists of the extent to which intervention 
components were delivered as prescribed in the study manuals. Exposure considers the 
number of intervention sessions and the time interventionists spent assisting participants. 
Quality of intervention delivery considers qualitative aspects of the delivery independent 
of the intervention content such as interventionist enthusiasm and global estimates of 
intervention effectiveness. Participant engagement is a measure of participant enthusiasm 
and degree of participation in the intervention. Intervention differentiation will help us 
identify which elements of the intervention are essential and a check to make sure that 
the participants in the intervention only received the plan intervention.64 To assess these 
varied fidelity domains, we will use a combination of direct assessment (e.g., observation 
via audiotapes) and indirect measures (e.g., OT/RN self-report).62 Similar to prior work, 
we also rely upon a combination of Likert and yes/no items to measure fidelity.65 More 
specifically, the CRC will review the audio recorded intervention sessions and will 
complete the Likert and yes/no items while listening to the recording (no transcripts of the 
recordings will be generated). As a group, we will review the fidelity scores generated by 
the CRC review of the audiotapes during our regularly scheduled CAPABLE Transitions 
meetings and will use these findings to identify any potential issues that the Study OT and 
RN should address to improve the quality of their administration of CAPABLE Transitions. 
Tracking these fidelity metrics longitudinally should provide us with near real-time 
feedback to allow us to improve the delivery of the intervention as we move forward. We 
will use an encrypted voice recorder for this purpose. We will label these audio recordings 
using de-identified numbers only and will store the recordings on secure University of 
Rochester servers and/or the CRC and PI’s computers. Access to these audio recordings 
will be password protected and audio recordings will be destroyed consistent with federal 
guidelines and the University of Rochester RSRB Policy 405.  
For this pilot study, the research staff, interventionists, and participants will not be blinded 
to randomization assignment.  
5.3 Concomitant Interventions 
5.3.1 Allowed Interventions 
With the exception of hospice services and active cancer treatment, participants are 
allowed to receive any medication, treatment, or in-home or outpatient medical services 
while in the study. If study participants are briefly hospitalized, we will plan to continue the 
intervention. Prolonged hospitalization would substantially interfere with the delivery of the 
intervention (i.e., 14+ days in first month of intervention, 21+ following the first month), 
however, and we would discontinue the intervention if prolonged hospitalization were to 
occur. 
5.3.2 Required Interventions  
The only required intervention is that study participants have to be admitted to CHHA 
services following discharge from a hospital or post-acute care facility.  
5.3.3 Prohibited Interventions 
We will exclude older adults who are receiving hospice services or active cancer 
treatment. 

Version 2.5– November 2022, pg. 25 
5.4 Adherence Assessment 
We will ensure and monitor study adherence and fidelity through several mechanisms. 
First, study interventionists will complete the standardized training offered through The 
Johns Hopkins University School of Nursing, which will complement the study’s protocol. 
Second, for the care transitions intervention component, the RN will participate in-person 
training and role-playing sessions to reinforce the procedures outlined in the study’s 
training manual. Third, monthly to bimonthly meetings with the OT, RN, handyworker, 
CRC, and PI will ensure communication, adequate supervision, and appropriate fidelity to 
the intervention. Fourth, we will routinely audio record intervention sessions to monitor 
fidelity and for quality control review. These audio records will be randomly assessed and 
scored by a fidelity checklist that examines session content (e.g., are the main content 
areas covered?) and study staff and interventionist competence (e.g., greets patient, 
listens, shows positive regard). Fifth, we will monitor the proportion of study participants 
that complete each portion of the study (e.g., OT intervention, RN intervention, 
handyworker home repairs and modifications). Lastly, we will routinely monitor whether 
the after/between visit actions (e.g., communication with handyworker, completion of 
indicated referrals) are performed.

Version 2.5– November 2022, pg. 26 
6 
STUDY PROCEDURES 
6.1 
Schedule of Evaluations 

Version 2.5– November 2022, pg. 27 
Study Activities 
Initial 
Screening 
(Day-28 to Day-
1) 
All Participants 
Baseline 
Enrollment, 
Assessment, and 
Randomization 
Visit (Day 0) 
All Participants 
Intervention Arm: OT and RN 
Visits (< 11 total visits within 
5 months)) AND CHHA CAU 
Services* (variable intensity 
and timeframe) 
Comparator Arm: 
ONLY CHHA CAU 
Services* (variable 
intensity and 
timeframe) 
2nd Assessment 
Visit (Day 90) 
All Participants 
Final Assessment Visit 
(Day 180) 
All Participants 
Inclusion/Exclusion Criteria 
X 
X 
X 
X 
 
 
Informed Consent (Written) 
 
X 
X 
X 
 
 
Determination of Capacity for 
Informed Consent 
 
X 
X 
X 
X 
X 
Enrollment/Randomization 
 
X 
X 
X 
 
 
Study Intervention 
Study OT Visits (<6 Visits, 
Occur at 1-4 Week 
Intervals) 
 
 
X 
 
 
 
Study RN Visits (<5 Visits, 
Occur at 1-4 Week 
Intervals) 
 
 
X 
 
 
 
Study Handyworker Visits 
(<2 Visits, Occur at ~2 
Week Intervals) 
 
 
X 
 
 
 
Study Assessments 
Sociodemographics 
 
X 
X 
 
X 
 
Health and Functioning 
 
X 
 
 
X 
X 
Mental Health and 
Cognitive Functioning 
 
X 
 
 
X 
X 
Home Environment 
 
X 
 
 
X 
X 
Medical and Non-Medical 
Services Use (Self-
Reported) 
 
X 
 
 
X 
X 
Study Partner Questions (If 
Applicable)  
 
X 
 
 
X 
X 

Version 2.5– November 2022, pg. 28 
Chart Extraction (e.g., 
Conditions, Medications, 
Medical Services Use, 
Communications) 
 
X 
 
 
X 
X 
Study Fidelity Measures 
(e.g., Participant 
Engagement) 
 
 
X 
 
X 
X 
Intervention Feedback 
 
 
 
 
X 
X 
Adverse Events 
 
X 
X 
 
X 
X 
 
 
 
 
 
 
 
*Both treatment groups receive CHHA CAU services (intervention arm receives CAPABLE Transitions and CHHA CAU; comparator arm only receives CHHA CAU). CHHA 
CAU services can include nursing, home health aide, medical social work, and occupational, physical, and speech therapy services. CHHA clinicians will determine the types 
and duration of services that CHHA clients in this group receive, which will be completely independent of the research study. The duration of CHHA can vary dramatically 
across CHHA clients (e.g., range from a single visit to having weekly visits for more than a year).  

Version 2.5– November 2022, pg. 29 
Table 3. Operationalization of the primary and secondary outcomes and study covariates. 
Variable 
Variable Type 
Assessment 
Schedule 
Data Source 
Primary Outcomes 
• Participants Screened, Enrolled, and 
Retained 
Continuous, 
Proportion 
Monthly 
Study Documentation 
• Intervention Fidelity: Adherence, Dose, 
Quality 
Continuous, 
Proportion 
Varies 
Audio Recording, Study 
Documentation, Self-Report 
• Intervention Perceived Benefit (based 
on Szanton et al., 201940) 
Likert Items, 
Open-Ended 
3, 6 Months 
Self-Report, Proxy-Report 
• Data Completeness for Clinical 
Outcomes 
Proportion 
6 Months 
Study Documentation 
Secondary Outcomes (Primary Clinical Outcomes) 
• Home Time 
Continuous 
3, 6 Months 
Chart Extraction, Self-
Report 
• Quality of Life (EQ-5D-5L, ICECAP-O66, 
67) 
Variety of 
Variable Types 
Baseline, 3 and 
6 months 
Self-Report 
• Service Utilization: ED, Hospital, 
Nursing Home Use 
Continuous 
Baseline, 3 and 
6 months 
Chart Extraction, Self-
Report 
Sociodemographics 
• Contact Information  
Address, Phone 
Number 
Baseline, 3 and 
6 Months 
Self-Report 
• Age, Date of Birth 
Continuous, 
Date 
Baseline 
Self-Report 
• Race, Ethnicity, Sex 
Categorical 
Baseline 
Self-Report 
• Formal Education, Marital Status, Living 
Arrangement, Income, Home Ownership 
and Type 
Categorical 
Baseline 
Self-Report 
• Caregiver or Receive Caregiving 
Categorical 
Baseline, 3 and 
6 Months 
Self-Report 
• Children and Siblings 
Continuous 
Baseline 
Self-Report 
• Health Insurance 
Categorical 
Baseline 
Self-Report 
Health and Functioning 
• Social Needs Questionnaire23  
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• Self-Rated Health Status (Adapted from 
JHU)  
Likert Items 
Baseline, 3 and 
6 Months  
Self-Report  
• Main Medical Problem, Concerns, and 
Goals 
Open-Ended 
Baseline, 6 
Months 
Self-Report 
• Medication Adherence Measure (DOSE-
Non-Adherence)68-71 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• ADL (Adapted from JHU) 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• IADL (Adapted from JHU)  
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• PROMIS* – Isolation v2.0, Mobility v2.0, 
Pain Interference v1.1, Ability to 
Participate v2.072 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• Self-Reported Falls (based on CDC’s 
Behavioral Risk Factor Surveillance 
System)73 
Variety of 
Variable Types 
Baseline, 3 and 
6 months 
Self-Report 
• Intervention Perceived Benefit (based 
on Szanton et al., 201940) 
Likert Items, 
Open-Ended 
3, 6 Months 
Self-Report 
• COVID-19 Effect Scale (modified from 
Impact of Event Scale-677).  
Likert Items,  
Open-Ended  
Baseline, 3 and 
6 Months  
Self-Report  
Mental Health and Cognitive Functioning 

Version 2.5– November 2022, pg. 30 
• MMSE44, 45,86 
Continuous 
Baseline 
Self-Report 
• PROMIS* – Anxiety v1.0, Depression 
v1.0, Social Isolation v2.0, Medication 
Management Self-Efficacy v1.0 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
Home Environment 
• Aging Gracefully Home Safety Checklist 
Variety of 
Variable Types 
Baseline, 3 and 
6 Months 
Interviewer Scored 
• Falling Efficacy (FES-I)74 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
Medical and Non-Medical Services Use (Self-Reported) 
• Non-Medical Human Services Use75 
Continuous 
Baseline, 3 and 
6 Months 
Self-Report 
• Outpatient Medical Appointments 
Variety of 
Variable Types 
Baseline, 3 and 
6 Months 
Self-Report 
Study Partner Questions 
• Contact Information, age, sex, 
race/ethnicity, relationship with 
participant 
Variety of 
Variable Types 
Baseline, 3 and 
6 Months 
Proxy-Report 
• Caregiver Support (Adapted from 
NHATS NSOC Study)76 
Categorical, 
Continuous 
Baseline, 3 and 
6 Months 
Proxy-Report 
• Quality of Life (EQ-5D-5L, ICECAP-O66, 
67) 
Variety of 
Variable Types 
Baseline, 3 and 
6 months 
Proxy-Report 
• Main Medical Problem, Concerns, and 
Goals 
Open-Ended 
Baseline, 6 
Months 
Proxy-Report 
• ADL40, 77, 78 Modified for Proxy Report  
Continuous 
Baseline, 3 and 
6 Months 
Proxy-Report 
• IADL40, 79Modified for Proxy Report  
Continuous 
Baseline, 3 and 
6 Months 
Proxy-Report 
• Self-Reported Falls (based on CDC’s 
Behavioral Risk Factor Surveillance 
System)73 
Variety of 
Variable Types 
Baseline, 3 and 
6 months 
Proxy-Report 
• Intervention Perceived Benefit (based 
on Szanton et al., 201940) 
Likert Items, 
Open-Ended 
3, 6 Months 
Proxy-Report 
• Modified Caregiver Strain Index84 
Categorical  
Baseline, 3 and 
6 Months  
Proxy-Report  
• 
Caregiver Confidence in Medical 
Sign/Symptom Management85 
Likert Items  
Baseline, 3 and 
6 Months  
Proxy-Report  
Chart Extraction 
• Number of Medical Conditions 
Counts 
Baseline 
Chart Extraction 
• Number of Medications 
Counts 
Baseline, 3 and 
6 Months 
Chart Extraction 
• PCP Visits 
Counts, Dates 
6 Months 
Chart Extraction 
• Non-PCP Medical Visits 
Counts, Dates 
6 Months 
Chart Extraction 
• Participant Communication with Medical 
Providers 
Counts, Dates, 
Short Narrative 
6 Months 
Chart Extraction 
• Health Insurance Status  
Open-ended  
Baseline and 6 
Months  
Chart Extraction  
Study Fidelity Measures 
• Participant and Study Partner 
Engagement (Adapted from Kortte et 
al., 200780) 
Likert 
Intervention 
Session, 
Intervention 
Termination 
Audio Recording, 
Interventionist-Report 
• 
Main Medical Problem, Concerns, 
and Goals 
Open-ended  
Intervention 
Session, 
Intervention 
Termination  
Interventionist-Report  
• Differentiation 
Binary, Open-
Ended 
Monthly, 3 and 
6 Months 
Audio Recording, Self-
Report 

Version 2.5– November 2022, pg. 31 
*Computerized Adaptive Testing Survey Type. 
 

 
Version 2.5– November 2022, pg. 32 
6.2 Description of Evaluations 
6.2.1 Initial Screening 
The initial screening will be conducted by the study RN and OT who also function as 
CHHA clinicians. The RN and OT will regularly screen all of their CHHA intakes to 
identify potential study participants (e.g., discharged from a post-acute care facility, 
does not have a terminal condition). The RN and study OT will ask clients passing the 
initial screen if they are interested in participating in our research study. For residents 
indicating an interest to participate in the research study, screening and study 
enrollment must be completed in 28 or fewer days since hospital or post-acute care 
facility discharge as the timing of the CAPABLE Transitions is an important aspect of 
the intervention. We will exclude CHHA clients for whom we are unable to screen and 
enroll in the study within this 28-day period. In addition to the URMHC interventionists 
recruiting participants among their new admissions, we will contact potentially eligible 
URMHC clients who have indicated that they are interested in participating in research 
when they complete the new consent process via URMHC. This new consent process 
is for ALL URMHC patients admitted to URMHC services in which they can "opt in" or 
"opt out" of being contacted by a UR researcher if there is a study they qualify for. Only 
participants who have consented to be contacted will be contacted by the CRC.  
Study staff will regularly work with the RN and OT to review the study inclusion and 
exclusion criteria to consider whether any new admissions scheduled for CHHA 
services may qualify for the study. Unless the potentially eligible CHHA client 
expresses interest in participating in the study, CHHA clinicians will not share 
identifiable information with study staff. The RN, OT, and research coordinator will 
examine the following criteria: 
• 
admitted to CHHA following a hospital or post-acute care facility discharge  
• 
live in the Rochester, NY region 
• 
age 65 years and older 
• 
English-speaking 
• 
has a terminal diagnosis or receiving active cancer treatment 
• 
able and willing to participate in a research study 
 
6.2.2 Baseline Assessment, Enrollment, and Randomization Visit 
This evaluation must occur in 28 or fewer days of hospital or post-acute care facility 
discharge and will make the final determination as to whether the CCHA client is 
eligible for the study. 
Consenting Procedure 
Study staff will introduce the study and obtain written informed consent from the CHHA 
client (or from a surrogate decision maker if CHHA client is unable to provide informed 
consent but assents to the study). Written informed consent will occur prior to 
conducting the cognitive test (MMSE), which will determine if moderate or severe 
cognitive impairment is present.44, 45 Following recommendations86, we will modify the 
MMSE orientation questions to reflect our administration in community-dwelling older 
adults, rather than clinical or hospital settings. Study enrollment is stratified by 
cognitive impairment status, and we will prioritize recruitment of people with dementia 

 
Version 2.5– November 2022, pg. 33 
over those without. Additionally, if moderate or severe cognitive impairment is present, 
study staff will only finalize enrollment of a CHHA client into the study if they are able 
to provide informed consent or provide assent with the presence of a LAR. If a potential 
participant is unable to provide informed consent and does not have a LAR available 
for informed consent, study staff will terminate the interview prior to collecting any 
additional research information and compensate the participant $10 for completing the 
screening procedures 
Study participants and Study Partners will sign two copies of the consent form 
documents. They will keep one signed copy and the study staff will keep the other 
signed copy. For the study staff copies of the consent form, we will upload the signed 
consent forms and associated documents into an electronic database (UR Box) for 
maintenance and long-term storage of the consent forms. We will also retain paper 
copies of the consent documents and all other paper source documents in the study 
files. No study documents will be destroyed during the RSRB required period for 
retention of records, though we may additionally scan and upload materials into a 
secure UR Box folder only accessible to study personnel, for backup purposes. Only 
after completing the consent process and obtaining written informed consent, will 
study staff commence with the screening process and baseline assessment interview.  
Enrollment 
CHHA clients who satisfy our inclusion and exclusion eligibility criteria will be 
considered enrolled in the study after they (or a surrogate decision-maker) have signed 
the informed consent form.  
Baseline Assessments 
For participants who have been successfully screened for eligibility and are enrolled 
into the study, baseline assessments are performed against which to measure the 
study’s intermediate and primary outcomes as well as to account for pertinent 
covariate data. The baseline assessment will examine the following domains (see 
Section 6.1 for detailed description of measurements): 
• 
Sociodemographics 
• 
Health and Functioning 
• 
Mental Health and Cognitive Functioning 
• 
Home Environment 
• 
Medical Services Use (Self-Reported) 
• 
Study Partner Questions (If Applicable) 
• 
Chart Extraction regardless of PCP affiliation (e.g., Medical Conditions, 
Medications, and Medical Services Use, Communication) 
 
Randomization 
Immediately following termination of the baseline assessment interview, study staff will 
randomly assign participants via a stratified random permuted block method.1 
Randomization 
will 
be 
stratified 
based 
on 
cognitive 
impairment 
status 
(moderate/severe cognitive impairment present: MMSE score < 20; moderate/severe 
cognitive impairment absent: MMSE > 21).44, 45,86 Block randomization will then occur 

 
Version 2.5– November 2022, pg. 34 
within each strata to ensure appropriate allocation to the treatment and CAU 
groupings. REDCap56 will track the randomization groupings. The study intervention 
will commence as soon as possible following randomization.  
Compensation 
Of note, in addition to receiving compensation for their time participating in the 
research assessment interviews, participant compensation may include additional 
cash payments to cover the expense of home repairs and modifications that are 
recommended and agreed upon by our study interventionists and performed by 
Catholic Family Center's HomeWorks contractors (up to a maximum of $500 per 
participant). 
6.2.3 Intervention Visits (<11 total visits) 
The intervention will proceed as outlined in the CAPABLE Transitions’ protocol. In 
addition to delivering the intervention, the study OT and RN will assess the 
engagement of the study participant or dyad with the intervention. The study OT and 
RN also will monitor for the presence of study-related adverse events at each visit.  
6.2.4 Follow-Up and Final Assessment Visit 
Including the baseline assessment visit (on day 0), study staff will conduct the follow-
up and final assessment visits at approximately 90 days (+/- 15 days) and 180 days 
(+/- 30 days), respectively. Of note, many participants likely still will be receiving the 
intervention at the 90 day assessment. At the 180 day assessment, however, no 
participants will be receiving the intervention. These assessment visits will examine 
the same domains that the baseline assessment examines, but also will include 
questions to obtain information on intervention feedback. The follow-up assessments 
will examine the following domains: 
• 
Sociodemographics 
• 
Health and Functioning 
• 
Mental Health and Cognitive Functioning 
• 
Home Environment 
• 
Medical Services Use (Self-Reported) 
• 
Study Partner Questions (If Applicable) 
• 
Chart Extraction regardless of PCP affiliation (e.g., Medical Conditions, 
Medications, and Medical Services Use, Communication) 
• 
Study Fidelity 
• 
Intervention Feedback (intervention arm only) 
The CRC or research assistant also will perform the determination of capacity for 
informed consent at these 3- and 6-month intervals to screen for whether participants 
who initially demonstrated capacity for informed consent may have lost the ability to 
provide informed consent. If they are unable to demonstrate capacity for informed 
consent, we will go through the entire consent process again, and those unable to 
demonstrate informed consent only will be able to continue with study participation if 
they have a legally authorized representative (LAR; see Section 7.3.1 for definition of 
LAR) who also will need to demonstrate capacity to provide informed consent prior to 
signing the informed consent document. If the older adult is unable to provide informed 

 
Version 2.5– November 2022, pg. 35 
consent and does not have a LAR able to provide informed consent, they will not be 
able to continue with the study and the in-person assessments and interventions 
sessions will cease. 
Additionally, for participants who discontinue the study intervention, unless the 
participants refuse to participate in the study assessments, the CRC or research 
assistant will continue to conduct assessments per the assessment schedule. 
Assessment for adverse events will terminate when in-home assessment visits are 
concluded at approximately 180 days following hospital or post-acute care facility 
discharge, which also marks the period for when participation in the study terminates. 
Of note, this last assessment visit will occur after the OT and RN intervention sessions 
have been completed (for many participants, the last assessment visit will occur 
approximately 2 months following the termination of the intervention). Possible 
reasons for early termination of the study intervention include participants are no 
longer willing to participate in the intervention or that participants have moved, 
transitioned to a nursing home for long-term care, or died (see Section 8 below for a 
detailed list of intervention discontinuation procedures). 
7 
RISK/BENEFIT ASSESSMENT 
7.1 Risk Category/Potential Risk 
Minimal risks to study participants are expected. For the assessment interviews, the 
primary risk is invasion of privacy, breach of confidentiality (if safety issues such as elder 
abuse are detected), or mild reactions of distress or fatigue. Given that assessments are 
conducted in the participant’s homes, others could be present, which risks revealing the 
participant’s involvement in the study. Participants will have full discretion in having others 
present. Assessment measures and procedures have been safely used in previous 
research with older adults; no sustained negative effects from assessments are expected, 
but negative outcomes cannot be ruled out. 
Similarly, with regard to the intervention sessions, some participants may experience 
some discomfort, or fatigue in having study staff in their homes for the intervention 
sessions. Additionally, as the intervention sessions may include exercises to enhance 
function and reduce the risk of falls, some patients may be physically fatigued at the end 
of these sessions (in particular, the OT sessions can include physical activities such as 
simplifying tasks and the environment, using assistive devices, and balance and fall 
recovery techniques to decrease fear of falling). The original CAPABLE was well received 
and tolerated by older adult participants, however, who uniformly reported that the 
intervention benefited them.81, 82 Additionally, as CAPABLE Transitions likewise aims to 
improve home safety by reducing the presence of environmental hazards (home hazards 
is an intermediate outcome), we expect that those participating in our intervention will be 
at less risk of experiencing adverse events such as falls.  
If a participant’s cognition declines such that she is unable to work towards her study 
goals, our interventionists will work with the participant to identify new goals to work on. If 
the capability of a participant changes (for worse or better) such that there are no further 
identified feasible goals to work on, we will end the intervention. Our intervention is 
multifaceted (e.g., handyworker, OT, and RN), meaning that only those components for 
which there are no clear objectives or workable goals may terminate. This also could occur 
if a participant achieves their goals quickly, thereby only requiring a few of the 
interventionist sessions rather than all of the possible sessions. 

 
Version 2.5– November 2022, pg. 36 
We will train both the study interviewers and interventionists to handle these minimal 
discomforts if they occur (e.g., if a participant is becoming fatigued, can change activities 
or terminate the session) and will conduct assessments regarding intervention safety at 
every in-home visit. During these assessments, study staff will regularly query for the 
occurrence of adverse events. Although we do not anticipate there to be any serious 
adverse events related to our intervention, staff will systematically monitor for these events 
during the intervention and follow-up periods and report them should they occur 
(consistent with RSRB policy 801, “Reporting Research Events”). 
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
At each intervention session, study staff will inquire about the occurrence of adverse 
events and significant adverse events since the last visit (timing of intervention sessions 
shown in Table 2). This schedule of assessments is such that, as the intensity of the 
intervention is the greatest, so will we monitor for the occurrence of adverse events most 
intensely, which will help us identify the presence of any study-related adverse events.  
7.3 Protection Against Risks 
This section provides information on how risks to participants in the study will be mediated 
and specifies events that would preclude a participant from continuing with the 
intervention. This section also includes the informed consent procedures and measures 
to protect participants against risk during the study. 
7.3.1  Informed Consent Process 
This section explains the informed consent process and how it is used to protect 
participants. 
• 
The consent process informs a volunteer about the study, indicates the 
participation is voluntary, and states that the volunteer has the right to stop at any 
time. Risks are delineated in the informed consent form and described orally during 
the consent process. 
• 
Individuals will provide written informed consent prior to the start of the in-person 
screening activities or the baseline interview. Consent forms only will be used if 
they have a current IRB approval stamp. The informed consent process will be 
conducted in a manner to facilitate questions from potential study subjects. If a 
study team member is unable to answer a question, an investigator will be 
contacted. All questions from potential subjects will be answered prior to obtaining 
a signature. The PI, a Co-I, or an IRB-approved consent designee must be present 
when a subject signs the informed consent form. That member of the study team 
must sign the informed consent form at the same time and in the presence of the 
subject. The consent form must be signed and dated by the subject and the 
consent designee. No subjects will be involved in research activities unless an 
investigator or a designated study staff has obtained documentation of legally 
effective informed consent of the subject. The collection of protected health 
information and questionnaires are considered to be research activities requiring 
prior documentation of informed consent. 
• 
The study RN will regularly screen all of her CHHA intakes to identify potential 
study participants (e.g., discharged from a post-acute care facility, does not have 
a terminal condition). The study RN will ask clients passing the initial screen if they 
are interested in participating in our research study. For residents indicating an 

 
Version 2.5– November 2022, pg. 37 
interest to participate in the research study and agree to have a study staff 
member visit them to provide more information, the study RN and CRC will work 
together to schedule an in-person screening visit that is convenient to the potential 
participant. Consent only will be sought under circumstances that provide the 
prospective subject sufficient opportunity to consider whether to participate and 
that minimize the possibility of coercion or undue influence. The information that 
is given to the subject or representative shall be in language understandable to 
the subject. Potential study subjects will be given ample time to read and consider 
the consent form. All subjects will be reminded of the voluntary nature of study 
participation. Using the consent form to structure discussion, research personnel 
will explain the study, its potential benefits and risks, and alternatives, and 
document the consent process by signature of the subject and the person 
obtaining consent. During informed consent procedures, individuals will be told 
about possible risks and benefits of participation. This will include information that 
questions asked may cause them to feel uncomfortable or upset. Subjects will be 
informed that they may withdraw from an assessment at any time for any reason 
and receive full reimbursement for that assessment, and that they may withdraw 
from the research study at any time without negative consequences. Subjects are 
further informed that research staff will perform an immediate evaluation of their 
safety should safety concerns arise during assessments or intervention sessions. 
For non-acute medical or psychological concerns research staff identify, we will 
recommend that subjects follow-up with their primary care physicians. Research 
staff will assess the subject’s capacity with an RSRB-approved Determination of 
Consent Capacity Form that has been successfully implemented in other studies 
of older adults and consists of open-ended questions that will address the potential 
subject’s knowledge and understanding of the study’s objectives, general 
procedures, voluntary nature of participation (ability to withdraw), and possible 
risks and benefits of participation. For individuals who have difficulty in one or 
more of these areas, further review of the relevant elements of the study will be 
provided in order to improve their knowledge and understanding to a level that 
enables them to make a meaningful choice about participation. Those who 
demonstrate adequate capacity to consent will be invited to sign the informed 
consent form to enroll as a research subject. The consent will be an ongoing 
process during the study. Explanations of the study and verbal consent will be 
conducted at each data collection. Subjects will be reminded that their participation 
is voluntary and that they can withdraw at any time for any reasons. 
• 
For potential subjects who lack the capacity to provide informed consent, study 
staff will only proceed with the research study if the potential subject assents to 
the study and a legally authorized representative (LAR) is willing to: 1) enroll 
the participant in the research study, 2) demonstrates capacity for consent, and 3) 
signs the consent form. A LAR is an individual authorized to consent on behalf of 
a prospective research participant. Of note, failure to object is not assent and 
resistance to a research procedure in a non-verbal subject is an indication of 
dissent for that procedure. Federal regulations (45 CFR 46.116 and 21 CFR 50.20) 
defer to state law for persons authorized to provide such consent. Consistent with 
RSRB policy and congruent with New York State Public Health Law, Article 29-C 
and Article 29-CC (Family Health Care Decision Act), the persons listed below in 
order of authority, may act as a LAR to give consent to research participation for 
persons with decisional impairment. If a person listed is not reasonably available, 
or is unwilling or incompetent to make a decision regarding research participation 

 
Version 2.5– November 2022, pg. 38 
on behalf of the subject, the authority falls to the person of next highest priority. 
1. A health care agent properly designated on a health care proxy form; 
2. A court-appointed guardian under the New York Mental Hygiene Law Article 
81; 
3. A research proxy (individual designated by the research subject, while 
retaining the decisional capacity to do so), to make decisions for her/him 
regarding participation in research; 
4. A family member or friend (in the priority listed below) pursuant to the New 
York State Family Health Care Decisions Act (Public Health Law Article 29-
CC): 
a. A spouse or domestic partner; 
b. An adult son or daughter;  
c. A parent;  
d. An adult brother or sister; or 
e. A close friend, who is an adult (18 years or older) and has a close 
personal relationship with the subject, provided that the individual 1) 
provides a signed written statement, in a format approved by the 
RSRB, to the PI that he/she is a close friend of the subject, 2) that 
he/she has maintained such regular contact with the patient as to be 
familiar with the patient’s activities, health, religious or moral beliefs, 
and 3) stating the facts and circumstances that demonstrate such 
familiarity. 
7.3.2 Protection Against Risks 
This section describes measures to protect participants against study specific risks, as 
well as plans for notifying participants of trial results during and after the conclusion of the 
trial and providing the participants’ health providers with the appropriate information from 
the trial, as needed, concerning individual participants. Study procedures, both 
assessments and interventions, pose minimal risk to participants. Below we describe 
potential risks and study procedures to protect against these risks. 
The PI (Dr. Simning) will be responsible for prompt reporting of new information and other 
study-related safety information such as study-related or unexpected adverse events and 
protocol deviations that involve a safety issue to the RSRB, sponsor, federal agencies, 
and other required entities. Expected, non-study-related adverse events also will be 
tracked and reported on in the RSRB continuing reviews. The study will be modified to 
address safety issues or even put on hold if necessary. The PI will review the data 
periodically to identify any problems and potential risks. 
• 
In order to protect the confidentiality of subject information, we will take a 
number of precautions. These include training research interviewers in 
confidentiality procedures; entry and storage of data using coded identification 
labels; maintenance of project computers in secure locations with restricted 
access by enforced password protection; and use of Health Insurance Portability 
and Accountability Act (HIPAA) compliant data management software (e.g., 
REDCap, Box). Back-ups of study files will be made daily to allow for recovery of 
data due to disk failure. All data, including assessment measures, will be obtained 

 
Version 2.5– November 2022, pg. 39 
with the written consent of the patient. Information pertaining to individual 
participants will be released with the patient's informed and written consent only, 
except in unusual cases where withholding the information might pose a serious 
risk or danger to the participant or others. All data will be identified by a uniquely 
coded study number assigned to each participant. Access to the master list of 
study numbers will be restricted to the PI and CRC. Confidentiality will be further 
maintained by the storage of "hard copy" data in locked files in a locked office. 
Access to computerized data is restricted and subject to review by the PI. 
Publications or presentations will report only cumulative data or descriptions 
certain to maintain participants' anonymity. All data collection involving human 
subjects will be HIPAA compliant. All data involving human subjects will be 
stripped of any identifiers; the data will be stored in secure programs called 
REDCAP and Box, which manage protected health information in a HIPAA 
compliant manner. Audio recordings will occur on encrypted devices, will be 
password protected, and will be destroyed in accordance with local and federal 
guidelines to protect the security and confidentiality of identifiable information. 
• 
In order to protect subjects’ privacy, audio recordings of intervention session only 
will be made with subjects’ written consent; subjects will be free to refuse to 
answer any questions they would prefer to not answer; and interviews will be 
conducted in private settings. 
• 
Risks associated with emotional distress or fatigue will be minimized by 
employment of research personnel and interventionists with appropriate 
backgrounds and work experience with older adult subjects. The baseline 
research interview will last approximately two hours in total. Given the length of 
time involved for this assessment, and concerns regarding subject health and well-
being, subjects will be reminded that if they become fatigued, they may terminate 
the interview at any time, and that the interview can be conducted over multiple 
sessions as needed. Research personnel will be trained to recognize potential 
signs of fatigue among older adult subjects, and to actively suggest alternative 
data collection strategies (e.g., telephone-based and mail-in interviews), in order 
to reduce the possibility of overwhelming study subjects and to ensure 
completeness of data collection. These strategies have been employed effectively 
in the PI’s past research involving older adult populations. 
o During the course of assessment interviews, research staff will monitor 
subjects' reactions for signs of distress or fatigue. If necessary, subjects may 
take breaks from the interview, or complete the interview over several sessions 
if fatigue becomes a concern. 
o If a subject’s level of emotional distress becomes a concern, the research staff 
member will evaluate the subject's emotional state and safety and will briefly 
attempt to de-escalate the patient's distress. If these measures do not 
effectively reduce the subject’s distress within 10-15 minutes and, depending 
on the severity of the subject’s distress, research staff will call Dr. Simning (or 
the person covering for him), who will maintain a cell phone for this purpose. 
o The study subjects will consist of a population of functionally impaired older 
adults with a recent acute medical illness. Research staff therefore will be 
trained in the study’s safety protocols for managing acute medical events (e.g., 
chest pain, loss of consciousness), suicide risk, and elder abuse. Subjects will 
be informed that study staff will perform an immediate evaluation of their safety 

 
Version 2.5– November 2022, pg. 40 
should concerns arise during assessments or treatment sessions. Subjects 
also will be informed that their confidentiality may be breached should 
concerns arise about their safety (e.g., if emergency medical services are 
needed). Finally, they will be informed that suspected child abuse will be 
reported, as mandated by law, as well suspected elder abuse. Any subject 
who endorses death or suicidal ideation will be asked additional questions to 
assess her/his safety. Any endorsements of active suicidal ideation will involve 
notifying Dr. Simning for review of risk and protective factors and consideration 
of emergency psychiatric services. Dr. Simning is a board-certified geriatric 
psychiatrist with expertise in suicide evaluation and management and 
regularly provides clinical care to older adults who are distressed and at risk 
for suicide. While it is expected (based on prior research) that only a small 
minority of subjects for the current study will report significant distress (and 
even fewer suicide ideation or elder abuse), research staff will be trained in 
the study’s safety protocol and data from each assessment will be reviewed 
with Dr. Simning weekly, or more often if needed. A small minority of 
participants may experience elder abuse. In the case of suspected elder 
abuse, subjects will be given an immediate referral to appropriate community-
based resources (e.g., Adult Protective Services, the Elder Abuse Prevention 
Program of Rochester), which provide crisis intervention services, and the 
primary care provider will be contacted via a letter and/or a phone call. Any 
suspected cases of elder abuse will be immediately reviewed with the PI 
before research staff sends the assessment. Situations involving potential 
imminent safety concerns may involve the use of emergency services and law 
enforcement authorities. A similar safety protocol has been used successfully 
in Dr. Simning’s prior studies as well as other University of Rochester studies 
involving older adults. 
o The study PI (Dr. Simning) will provide weekly (and as needed) supervision to 
research staff. In addition, Dr. Simning is a licensed geriatric psychiatrist and 
is experienced in working with older adults, including those experiencing 
emotional distress and will available as needed. 
o To ensure appropriate safety precautions when conducting in-person study 
procedures, the process for conducting in-person visits outlined in the Guidance 
for Human Subject Research will be followed to mitigate risk for COVID-19. 
When/if a participant or a caregiver develops COVID or there is a suspicion of 
COVID, we will reschedule/postpone visits accordingly.  
8 
INTERVENTION AND STUDY DISCONTINUATION 
There are several ways this intervention and/or study can terminate for study participants: 
1) Intervention discontinuation by the study participant: Study participants may withdraw 
voluntarily from participation in the study at any time and for any reason. If the participant 
withdraws from participating in the intervention, with the permission of the participant, we 
will continue with the follow-up assessment interviews (at three and six months) to monitor 
their response to the intervention via intention-to-treat principles and to help capture study-
related AE and SAEs. If a participant were to experience an AE, we also would ask their 
permission to follow them until the AE has resolved (even if this extends past the study 
period). Of note, there are two subgroups within this category. The first subgroup consists 
of those who are satisfied with the intervention (e.g., perceive that they have benefited 
from the intervention), but no longer want to receive it (e.g., they want a smaller “dose” of 

 
Version 2.5– November 2022, pg. 41 
the intervention). The second subgroup consists of those who elect to discontinue to the 
intervention because they are not satisfied with the intervention (e.g., do not perceive that 
they have benefited from the intervention), and therefore no longer want to receive it. 
2) Study withdrawal by the study participant: Study participants may withdraw voluntarily 
from participation in the study at any time and for any reason. This category will be for 
participants who decide to withdraw participation from any additional study activities 
including the intervention and study assessments. 
3) Intervention discontinuation by the study team: We will discontinue the intervention in 
the situations outlined below. Of note, if the participant is agreeable and able, we will 
continue to conduct the study assessments after the intervention is discontinued.  
• 
Death (many of the participants will have severe, chronic medical comorbidities 
and we anticipate that some may die during the course of the study) 
• 
Changing residences (including transitioning to nursing home long-term care) 
• 
Prolonged hospitalization that substantially interferes with the delivery of the 
intervention (i.e., 14+ days in first month of intervention, 21+ days following the 
first month) 
We will not replace participants who withdraw from the study. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues 
This study is a randomized, CAU-comparator, unblinded, 60-subject clinical trial of an OT-
led in-home intervention designed to help older adults successfully transition to their 
homes following a hospital or post-acute care facility discharge. This research project is 
designed to be an iterative pilot study whose primary objective is to examine the feasibility 
of the CAPABLE Transitions intervention and the assessment of the study’s intermediate 
and primary outcomes. Guided by research staff experiences, feedback from the study 
interventionists and participants, and our treatment fidelity data, we will continually seek 
to enhance and optimize the study protocol and procedures to improve recruitment. Such 
modifications could include adjustments to the intervention schedule or content or updates 
to our recruitment and retention process.  
Given the focus on feasibility rather than hypothesis testing, this study is not blinded. This 
lack of blinding will enable the study CRC, research assistant, and/or PI to work closely 
with the study interventionists and treatment group participants to identify ways to enhance 
the study and its procedures.  
Our analyses will largely consist of univariate statistics to examine the proportions and 
means and variance of the primary and secondary outcomes listed below and in Table 3. 
Primary outcomes: 
• 
screening, enrollment, and retention of study participants 
• 
fidelity to and perceived benefit of the intervention 
• 
data completeness with regard to our intermediate and primary outcomes 
Secondary outcomes (at three and six months following hospital or post-acute care facility 
discharge): 

 
Version 2.5– November 2022, pg. 42 
• 
home time 
• 
quality of life 
• 
health care utilization 
9.2 Sample Size and Randomization 
The total sample size of 60 is consistent with a prior pilot study of the original CAPABLE 
intervention, which had 40 participants.81 This sample size is not powered to test 
hypotheses or to compare differences across the care-as-usual and treatment groups.  
9.2.1 Treatment Assignment Procedures 
Study staff will randomly assign participants via a stratified random permuted block 
method.1 Randomization will be stratified based on cognitive impairment status 
(moderate/severe cognitive impairment present: MMSE score < 20; moderate/severe 
cognitive impairment absent: MMSE > 21).44, 45,86 We will conduct block randomization to 
ensure that there is appropriate allocation to the treatment and CAU groups across 
moderate/severe cognitive impairment strata. REDCap56 will track the randomization 
groupings. In total, 60 participants will enroll in this study. We will prioritize the recruitment 
of people with dementia over those without, but aim to increase our recruitment of non-
cognitively impaired patients as well. Because the goal of this pilot study is to focus on 
feasibility, the bias that may be introduced by having unblinded research staff is of minimal 
concern at this stage.  
9.3 Interim analyses and Stopping Rules 
As the primary objective is to examine CAPABLE Transitions’ feasibility rather than clinical 
effect, we are not planning to conduct interim analyses with associated stopping rules. 
9.4 Outcomes 
9.4.1 Primary Outcomes 
The primary study outcomes consist of the feasibility measures listed below. 
1) Screening, enrollment, and retention of study participants: We will conduct 
univariate analyses to evaluate how many CHHA participants we screened, how 
many enrolled, and how many successfully finished the study. 
2) Fidelity to and perceived benefit of the intervention (at three and six months):  
a. To assess fidelity to the intervention, study staff will examine audio 
recordings of the intervention sessions and in-between session procedures 
(e.g., handyworker work order completed) and score whether the OT/RN 
completed the critical components associated with the intervention 
session. We will score completion of the critical components as “yes” or 
“no” and will then conduct univariate analyses to examine OT/RN 
adherence to the study protocol for the intervention sessions.  
b. To evaluate perceived benefit of the intervention, study staff will conduct 
interviews at three and six months to obtain survey responses to Likert item 
scales on CAPABLE Transitions perceived benefit and burdensomeness 
to study participants. We will analyze these Likert item responses with 
univariate statistics. For narrative feedback, we will examine individual 
participant quotes and reported concerns for which we will not conduct 

 
Version 2.5– November 2022, pg. 43 
statistical analyses. 
3) Data completeness with regard to our primary and intermediate outcomes at three 
and six months: We will use univariate statistics to examine the proportion of the 
CAU and intervention group participants who have information on our primary (i.e., 
home time, quality of life, health care utilization) and intermediate (e.g., timing and 
frequency of medical appointments, frequency of communication with medical 
providers, medication adherence, anxiety and depressive symptoms, physical 
functioning, home hazards, fear of falling, mobility, self-efficacy, pain) outcomes.  
9.4.2 Secondary Outcomes 
This study’s secondary objectives are to obtain preliminary data on home time, quality of 
life, and health care utilization at three and six months following hospital or post-acute 
care facility discharge. Univariate analyses will provide the means and standard deviations 
for these outcomes. 
9.5 Data Analyses 
Data analyses will consist of univariate analytic approaches. For this pilot study, we have 
no plans to perform across groups comparisons or to test hypotheses. Although our 
sample size is too small to facilitate across group comparisons or hypotheses testing, the 
24 CHHA CAU participants will provide precision and variance estimates for our primary 
clinical outcomes among the comparator group, which subsequently will be used to inform 
sample size calculations for the large-scale clinical trial to follow.83 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
Study staff (e.g., CRC, research assistant) will collect and obtain study data directly from 
the participants (via in-person interviews) as well as from the participant’s medical records. 
The collection, transfer and storage of data will be conducted in compliance with HIPAA 
and structured to minimize risk of protected health information disclosure. All records 
related to a participant’s research will be stored in locked filing cabinets or on computers 
protected with passwords. Furthermore, study staff will record data directly into data 
collection forms that are present in REDCap and all web-based information transmission 
is encrypted. We also will rely on UR Box to store electronic information, which is HIPAA 
compliant. The database servers are housed in secure institutional data center facilities at 
University of Rochester. Additionally, audio recordings of intervention sessions will monitor 
fidelity and assist with quality control review. These audio recordings will be labeled using 
de-identified numbers only and will be stored on secure University of Rochester servers 
and/or the CRC and PI’s computers. We will also use an encrypted voice recorder to 
protect participants’ protected health information. Access to these audio recordings will be 
password protected and audio recordings will be in accordance with local and federal 
guidelines. The protocol includes a list of the study survey measures (Table 3). During the 
RN and OT intervention sessions, the RN and OT may decide to skip certain 
questions/items to focus on issues that are most relevant to each participant.  
Consequently, study interventionists can, at their discretion, skip or not complete 
questions in these assessments that they feel are less relevant to the participants they are 
working with for the study intervention visits. For fields/questions we believe are critical to 
the study, we will make sure that they require a response in REDCap and cannot be 
skipped, such as Adverse Event assessments. 

 
Version 2.5– November 2022, pg. 44 
10.2 Quality Assurance 
10.3.1 Training 
To ensure appropriate human research knowledge, all study personnel with access to 
subject research data will have completed mandatory training in the protection of 
human research participants per guidelines issued by the U.S. Department of Health 
and 
Human 
Services, 
Office 
for 
Human 
Research 
Protections 
(https://www.hhs.gov/ohrp/) and per guidelines of University of Rochester Medical 
Center (URMC). Any additional personnel will complete this training before having 
access to the study databases. Consistent with University of Rochester Medical 
Center RSRB policy, all investigators and research staff will complete certification by 
the RSRB, which requires completion of a course that contains topics such as “History 
and Ethical Principles,” “Privacy and Confidentiality,” “Informed Consent,” and “The 
Federal Regulations.” This course provides a substantial resource to the investigators 
for understanding the ethics and regulations governing research with human subjects. 
Research staff also will be trained to assess, de-escalate, and activate appropriate 
levels of care for those experiencing emotional distress 
10.3.2 Quality Control Committee 
Not applicable. 
10.3.3 Metrics 
Audiotaping of intervention sessions will be routinely conducted for fidelity and quality 
control review. OT/RN adherence to the intervention also will be quantified. 
Additionally, the PI and CRC will regularly monitor the database to ensure that data 
are appropriately recorded and complete.  
10.3.4 Protocol Deviations 
Study staff must not deviate from the protocol, except to protect the life and physical 
well-being of a participant in an emergency. All deviations from the protocol, with the 
reason for the deviation and the date of occurrence, will be documented using the 
Protocol Deviation Tracking Log Form. Protocol deviations will be reviewed and 
evaluated on an ongoing basis and, as necessary, appropriate corrective and 
preventive actions will be instituted. 
10.3.5 Monitoring 
The principal investigator will be responsible for monitoring the study. Routine 
monitoring will occur to verify that: 
• 
participant enrollment is being achieved 
• 
the inclusion/exclusion criteria has been met at enrollment 
• 
the correct version of the informed consent has been signed by the subject 
• 
AEs and SAEs have been captured and properly reported 
• 
verify that the data are accurate and complete 

 
Version 2.5– November 2022, pg. 45 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY 
11.1 Institutional Review Board (IRB) Review 
The University of Rochester Medical Center’s RSRB will review and approve this study’s 
protocol and its informed consent document and any subsequent modifications. 
11.2 Informed Consent Forms 
We will obtain signed consent forms from each participant. As many of our participants 
may have cognitive impairment that could affect their ability to provide informed consent, 
we will systematically evaluate their capacity for informed consent. To do so, the CRC or 
research assistant will read the consent form to participants, who will be encouraged to 
ask questions throughout the process. To determine capacity for informed consent, at the 
conclusion of the consent process and prior to signing the consent form, study staff will 
ask all participants the following questions: 
• 
Could you please tell me what this study is about? 
• 
What are the potential risks to you of participating in this study?  
• 
What are the benefits for participating in this study?  
• 
Do you understand that your participation in this study is voluntary and that you 
may stop at any time or not answer any questions that you feel uncomfortable 
answering?  
• 
Do you have any questions about the interview?  
If in answering these questions the participant is unable to demonstrate an understanding 
or appreciation of the issues, research staff and the participant will further review the 
consent form and repeat the pertinent questions. Participants who achieve a 
demonstrated understanding of the study will be determined to have capacity to provide 
informed consent. For those who do not, research staff will attempt to identify a legally 
authorized representative (LAR; see Section 7.3.1 for definition of LAR) who also will need 
to demonstrate capacity to provide informed consent prior to signing the informed consent 
document. If the older adult is unable to provide informed consent and does not have a 
LAR able to provide informed consent, we will thank them for their time with $10 for 
completing the screening and procedures and inform them that they are not eligible for the 
study. Participants’ answers are tracked on a Determination of Consent Capacity Form 
that is kept with the research record as documentation of the consent process. For 
participants/LARs unable to provide informed consent, however, we will document the 
reason for study ineligibility on the Determination of Consent Capacity Forms. On these 
forms, we will not include any personal identifiers, but rather will use a screening ID 
number to track completion of these forms for participants and, if applicable, LARs. For 
participants and LARs unable to provide informed consent and who are not enrolled in the 
study, the screening ID number will not be linked to any personal identifiers. For enrolled 
participants who thereby demonstrate and provide informed consent or who have an LAR 
that provides informed consent, however, we will link these screening ID numbers with an 
assigned study-specific ID number that can be linked to identifiers we are collecting for 
the study. We will not keep any identifiable information for older adults/LARs who do not 
or are unable to sign consent to participate in our study. Rather, we will only keep basic 
demographic information such as age, sex, and race and ethnicity to allow us to track 
those who do and do not participate in our study; those older than 89 will be grouped in a 
90+ age category.  

 
Version 2.5– November 2022, pg. 46 
11.3 Participant Confidentiality 
All participant data, including assessment measures, will be obtained with the written 
consent of the participant or surrogate decision-maker. All data collection will be HIPAA 
compliant, and a uniquely coded study number assigned to each participant will identify 
participant data (i.e., a participant ID number). To protect the confidentiality of participant 
information, we will take a number of precautions: 
• 
use research personnel trained in confidentiality procedures 
• 
enter and store data on highly secure servers 
• 
maintain project computers in secure locations (e.g., locked offices) 
• 
restrict access to study data to study personnel on a needed to know basis that 
is enforced with password protection 
• 
minimal reliance on paper documents 
• 
publications or presentations will report only cumulative data or descriptions 
certain to maintain participants' anonymity 
In particular, we will rely on URMC’s REDCap servers housed in a local data center at the 
University of Rochester (all web-based information transmission is encrypted). REDCap 
was developed in a manner consistent with HIPAA security requirements and is 
recommended to University of Rochester researchers by the URMC Research Privacy 
Officer and Office for Human Subject Protection. Access to computerized data is restricted 
and subject to review by the PI. In accordance with local and federal guidelines, we will 
keep study data for a minimum of three years following submissions of the final reports to 
NIA. 
Furthermore, information pertaining to individual participants will be released with the 
participant’s informed and written consent only, except in unusual cases where 
withholding the information might pose a serious risk or danger to the participant or others. 
If necessary, information also may be released without written permission of the 
participant for monitoring by the RSRB, NIA, OHRP, or other governmental agency.  
11.4 Study Discontinuation 
The study may be discontinued at any time by the RSRB, the NIA, the Office for Human 
Research Protections, or other government agencies as part of their duties to ensure that 
research participants are protected.  
12 
ETHICAL CONSIDERATIONS 
This research study will be conducted only after receiving approval from University of 
Rochester Medical Center’s Research Subjects Review Board. Human research at 
University of Rochester is grounded in foundational ethical principles. These guiding 
ethical principles are embodied in the Nuremberg Code of 1947, the Declaration of 
Helsinki of 1964 and its subsequent revisions (World Medical Association), and particularly 
in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research issued by the National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research in 1979. The Belmont Report principles 
of respect for persons, beneficence and justice are accepted as critical for the ethical 
conduct of human subject research. Additionally, this study will adhere to the principles of 
NIH’s Good Clinical Practice designed to help assure the safety, integrity, and quality of 

 
Version 2.5– November 2022, pg. 47 
clinical trials and address elements related to the design, conduct, and reporting of clinical 
trials. 
13 
COMMITTEES 
Given that CAPABLE Transitions is a minimal risk study, a data and safety monitoring 
board is not warranted. Instead, this study will have a research mentorship committee that 
will provide broad oversight of the study. This committee will include mentors on the K23 
award and will have broad oversight on all aspects of the study and will provide expert 
feedback as needed should the study experience difficulties in its operationalization and 
implementation.  
14 
PUBLICATION OF RESEARCH FINDINGS 
Although this pilot study is neither designed nor powered to test a hypothesis, we 
nonetheless plan to publish and/or present on the intervention’s protocol, development, 
and preliminary findings.  
15 
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