Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
Phase: NA
Conditions: Transitional Care, Caregivers, Patient Discharge, Aging, Frailty
Sponsor: University of North Carolina, Chapel Hill

 
Connect-Home: Testing the Efficacy of Transitional Care of Patients 
and Caregivers during Transitions from Skilled Nursing Facilities to 
Home  
 
 
 
NCT number NCT03810534 
Document Date 07/13/2020 
 

Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers during Transitions 
from Skilled Nursing Facilities to Home  
Version 2.0
Protocol  
13 July 2020
Connect-Home Protocol v2.0 13Jul2020 
1
Connect-Home: Testing the Efficacy of Transitional Care 
of Patients and Caregivers during Transitions from 
Skilled Nursing Facilities to Home  
Principal Investigator: Mark Toles 
Funded by: National Institute of Nursing Research  
Version 2.0 
13 July 2020 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 Section 2, 5, 6, 8 
10 
 Recruitment procedures updated to allot 
for virtual recruitment  
 COVID-19 safety precautions 
 
Table of Contents 
Statement of Compliance .............................................................................................................................................. 3 
1 Protocol Summary ...................................................................................................................................................... 4 
1.1 Synopsis ............................................................................................................................................................... 4 
1.2 Schedule of Activities (SoA) ................................................................................................................................. 7 
2 Introduction .............................................................................................................................................................. 10 
2.1 Study Rationale .................................................................................................................................................. 10 
2.2 Background ........................................................................................................................................................ 10 
2.3 Risk/Benefit Assessment.................................................................................................................................... 11 
2.3.1 Known Potential Risks ................................................................................................................................. 11 
2.3.2 Known Potential Benefits ........................................................................................................................... 13 
2.3.3 Assessment of Potential Risks and Benefits ............................................................................................... 14 
3 STUDY OBJECTIVES ................................................................................................................................................... 15 
4 Study Design ............................................................................................................................................................. 19 
4.1 Overall Design .................................................................................................................................................... 19 
4.2 Scientific Rationale for Study Design ................................................................................................................. 20 
4.3 End of Study Definition ...................................................................................................................................... 20 
5 Study Population ...................................................................................................................................................... 21 
5.1 Inclusion Criteria ................................................................................................................................................ 21 
5.2 Exclusion Criteria ............................................................................................................................................... 21 
5.3 Screen Failures ................................................................................................................................................... 22 
5.4 Strategies for Recruitment and Retention ......................................................................................................... 22 
6 Study Intervention .................................................................................................................................................... 24 
6.1 Study Intervention(s) Administration ................................................................................................................ 24 

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6.1.1 Study Intervention Description ................................................................................................................... 24 
6.2 Measures to Minimize Bias: Randomization and Blinding ................................................................................. 27 
6.3 Study Intervention Compliance ......................................................................................................................... 27 
7 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal ................................................. 29 
7.1 Discontinuation of Study Intervention .............................................................................................................. 29 
7.2 Participant Discontinuation/Withdrawal from the Study .................................................................................. 29 
7.3 Lost to Follow-Up ............................................................................................................................................... 30 
8 STUDY ASSESSMENTS AND PROCEDURES ................................................................................................................ 31 
8.1 Efficacy Assessments ......................................................................................................................................... 31 
8.2 Adverse Events and Serious Adverse Events ..................................................................................................... 35 
8.2.1 Definition of Adverse Events (AE) ............................................................................................................... 35 
8.2.2 Definition of Serious Adverse Events (SAE) ................................................................................................ 35 
8.2.3 Classification of an Adverse Event .............................................................................................................. 35 
8.2.4 Time Period and Frequency for Event Assessment and Follow-Up ............................................................ 36 
8.2.5 Adverse Event Reporting ............................................................................................................................ 36 
8.2.6 Serious Adverse Event Reporting................................................................................................................ 36 
8.3 Unanticipated Problems .................................................................................................................................... 37 
8.3.1 Definition of Unanticipated Problems (UP) ................................................................................................ 37 
8.3.2 Unanticipated Problem Reporting .............................................................................................................. 37 
9 Statistical Considerations ......................................................................................................................................... 38 
9.1 Statistical Hypotheses ........................................................................................................................................ 38 
9.2 Sample Size Determination................................................................................................................................ 38 
9.3 Populations for Analyses ................................................................................................................................... 39 
9.4 Statistical Analyses............................................................................................................................................. 39 
9.4.1 General Approach ....................................................................................................................................... 39 
9.4.2 Analysis of the Primary Efficacy Endpoint(s) .............................................................................................. 40 
9.4.3 Analysis of the Secondary Endpoint(s) ....................................................................................................... 40 
9.4.4 Baseline Descriptive Statistics .................................................................................................................... 41 
10 Supporting Documentation and Operational Considerations ................................................................................ 43 
10.1 Regulatory, Ethical, and Study Oversight Considerations ................................................................................ 43 
10.1.1 Informed Consent Process ........................................................................................................................ 43 
10.1.2 Study Discontinuation and Closure ........................................................................................................... 43 
10.1.3 Confidentiality and Privacy ....................................................................................................................... 44 
10.1.4 Future Use of Stored Specimens and Data ............................................................................................... 44 
10.1.5 Safety Oversight ........................................................................................................................................ 44 
10.1.6 Clinical Monitoring .................................................................................................................................... 45 
10.1.7 Quality Assurance and Quality Control ..................................................................................................... 45 
10.1.8 Data Handling and Record Keeping .......................................................................................................... 45 
10.1.9 Protocol Deviations................................................................................................................................... 45 
10.1.10 Publication and Data Sharing Policy ....................................................................................................... 46 
10.1.11 Conflict of Interest Policy ........................................................................................................................ 46 
10.2 Abbreviations ................................................................................................................................................... 47 
10.3 Protocol Amendment History .......................................................................................................................... 48 
11 References .............................................................................................................................................................. 49 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on Harmonization Good Clinical 
Practice (ICH GCP) and the following: 
  
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR 
Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) 
  
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible 
for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of the study and 
consent form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study.  In addition, 
all changes to the consent form will be IRB-approved; a determination will be made regarding whether a 
new consent needs to be obtained from participants who provided consent, using a previously approved 
consent form. 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Connect-Home: Testing the Efficacy of Transitional Care of 
Patients and Caregivers during Transitions from Skilled 
Nursing Facilities to Home 
Study Description: 
The proposed study will test the efficacy of Connect-Home, a 
transitional care intervention, targeting seriously ill Skilled 
Nursing Facility (SNF) patients who discharge to home and 
their primary caregivers. The study will be set in six North 
Carolina SNFs and in the patient’s home (during intervention 
periods only).  Using a stepped-wedge cluster-randomized 
trial design, six SNFs will be randomly allocated to standard 
discharge planning (control period) vs. the Connect-Home 
intervention (intervention period) over six sequential time-
periods.  
  
Patients will be identified by consultation with SNF clinical 
staff and medical record review. After informed consent, 
baseline enrollment surveys will be collected for patients and 
caregivers.  Additionally, a medical record review for data 
related to continued health outcomes will be conducted for 
patients. Telephone questionnaires will be used to survey 
patients and caregivers at 7, 30, and 60 days after patients 
return home.   
Objectives: 
Primary Objective:   
1.1: To assess patient preparedness for discharge seven days 
after discharge from a skilled nursing facility.  
 
1.2: To assess caretaker preparedness for the caregiving role 
seven days after discharge from a skilled nursing facility.  
  
Secondary Objectives:   
2.1 To assess patient quality of life 30 and 60 days after 
discharge from a skilled nursing facility. 
  
2.2. To assess patient function 30 and 60 days after discharge 
from a skilled nursing facility.  
  
2.3 To assess patient days of acute care use 30 and 60 days 
after discharge from a skilled nursing facility.  
  
2.4 To assess caregiver burden 30 and 60 days after 
discharge from a skilled nursing facility.  

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from Skilled Nursing Facilities to Home  
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2.5 To assess caregiver distress 30 and 60 days after 
discharge from a skilled nursing facility.  
Endpoints: 
Primary Endpoint:  
1.1 The Care Transitions Measure-15 (CTM-15),26 assessed at 
seven days post discharge. 
1.2  The Preparedness for Caregiving Scale (PCS),29 assessed 
at seven days post discharge. 
 
Secondary Endpoints:  
2.1 The McGill Quality of Life Questionnaire-Revised (MQoL-
R), 85 assessed at 30- and 60-days post discharge. 
  
2.2 The Life Space Assessmen86, assessed at 30- and 60-days 
post discharge. 
  
2.3 The self-reported combined number of days the patient 
spends in the ED or hospital in 30- and 60-days post 
discharge.87 
  
2.4 The Zarit Caregiver Burden Scale88, assessed at 30- and 
60-days post discharge. 
  
2.5 The Distress Thermometer, 89 assessed 30- and 60-days 
post discharge. 
Study Population: 
This study will enroll 360 seriously ill patients in SNFs and 360 
caregivers.  
 
Patients must be English speaking, have a minimum data set 
of 3.0, Section GG Mobility Assessment Score of 3 or less, 
indicating the patient requires at least 25-50% assistance for 
functional mobility, be diagnosed with at least 1 serious 
medical illness, and have a caregiver who can be enrolled in 
the study.  
 
Caregivers must be English speaking and self-report that they 
assist the patient at home. For patients with cognitive 
impairment, documentation in the medical record of a 
caregiver who is the patient's legally authorized 
representative, consent of the caregiver to participate in the 
study as the patient's representative is additionally required. 
  
  
  
Phase: 
 N/A 

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Description of 
Sites/Facilities Enrolling 
Participants:  
Six SNFs owned by one organization will participate in this 
study (none participated in the Connect-Home pilot study). 
Inclusion criteria for SNFs: location within 120 miles of UNC 
and at least 15 post-acute admissions per month. Six SNFs 
and six home health nurses and two alternate SNFs and two 
alternate home health nurses for each SNF have agreed to 
participate. If a study site or a home health nurse becomes 
unavailable to participate, the alternate SNFs and nurses will 
participate in Connect-Home training. 
Description of Study 
Intervention: 
Connect-Home is a two-step transitional care intervention: 1) 
SNF staff create an individualized Transition Plan or Care and 
prepare the patient and caregiver to manage the patient's 
illness at home; and 2) within 24 hours of SNF discharge, a 
Connect-Home Activation RN visits the patient's home and 
helps the patient and caregiver implement the written 
Transition Plan of Care.  Both intervention steps focus on 6 
key care needs to optimize patient and caregiver outcomes: 
1) home safety and level of assistance; 2) advance care 
planning; 3) symptom management; 4) medication 
reconciliation; 5) function and activity; and 6) coordination of 
follow-up medical care. 
Study Duration: 
This study will be ongoing for four years. 
Participant Duration: 
Participants will be recruited during the SNF stay, when 
baseline data will be collected, and they will participate in 
the study for up to 60 days post-discharge.  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.2 SCHEDULE OF ACTIVITIES (SOA) 
Schedule of Activities for Patients (Control): 
 
Assessments and 
Procedures 
Screening  
Pre-
Discharge 
Discharge 
24 Hours 
Post-
Discharge 
7 Days 
Post-
Discharge 
(+ 10/- 3 
days) 
30 Days 
Post-
Discharge 
(+/- 7 
days) 
60 Days 
Post-
Discharge 
(+/- 7 
days) 
Informed Consent  
X 
  
  
 
  
  
  
Confirm Eligibility 
X 
  
  
 
  
  
  
Study of Osteopathic 
Fractures Index 
  
X 
  
 
  
  
  
ENRICHD Social 
Support Inventory 
  
X 
  
 
  
  
  
SNF Chart 
Abstraction 
 
 
 
 
X 
 
 
CTM-15 
  
  
  
 
X 
  
  
MQoL-R 
  
  
  
 
  
X 
X 
Life Space 
Assessment 
  
  
  
 
  
X 
X 
Falls Assessment 
  
  
  
 
  
X 
X 
Hospice Enrollment 
Assessment 
  
  
  
 
  
X 
X 
Home Health Care 
Chart Abstraction 
  
  
  
 
  
  
X 
Hospital Use 
Assessment 
  
  
  
 
  
X 
X 
Emergency 
Department Use 
Assessment 
  
  
  
 
  
X 
X 
  
 
 
 

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Schedule of Activities for Patients (Intervention): 
 
Assessments and 
Procedures 
Screening  
Pre-
Discharge 
Discharge 
24 Hours 
Post-
Discharge 
7 Days 
Post-
Discharge 
(+ 10/- 3 
days) 
30 Days 
Post-
Discharge 
(+/- 7 
days) 
60 Days 
Post-
Discharge 
(+/- 7 
days) 
Informed Consent  
X 
  
  
 
  
  
  
Confirm Eligibility 
X 
  
  
 
  
  
  
Study of Osteopathic 
Fractures Index 
  
X 
  
 
  
  
  
ENRICHD Social 
Support Inventory 
  
X 
  
 
  
  
  
SNF Chart Abstraction 
 
 
 
 
X 
 
 
Connect-Home 
Intervention in SNF 
(Step 1) 
 
X 
 
 
 
 
 
Connect-Home 
Intervention in Home 
(Step 2) 
 
 
 
X 
 
 
 
CTM-15 
  
  
  
 
X 
  
  
MQoL-R 
  
  
  
 
  
X 
X 
Life Space 
Assessment 
  
  
  
 
  
X 
X 
Falls Assessment 
  
  
  
 
  
X 
X 
Hospice Enrollment 
Assessment 
  
  
  
 
  
X 
X 
Home Health Care 
Chart Abstraction 
  
  
  
 
  
  
X 
Hospital Use 
Assessment 
  
  
  
 
  
X 
X 
Emergency 
Department Use 
Assessment 
  
  
  
 
  
X 
X 
 
  

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Schedule of Activities for Caregivers (Control):  
 
Assessments and Procedures 
Screening  
Pre-
Discharge 
Discharge 
24 Hours 
Post-
Discharge 
(+3 days) 
7 Days 
Post-
Discharge 
(+/- 2 
days) 
30 Days 
Post-
Discharge 
(+/- 7 
days) 
60 Days 
Post-
Discharge 
(+/- 7 
days) 
Informed Consent 
X 
  
  
  
  
  
  
Confirm Eligibility 
X 
  
  
  
  
  
  
Baseline Questionnaire 
 
X 
 
 
 
 
 
Preparedness for Caregiving 
Scale 
  
  
  
  
X  
  
  
Zarit Caregiver Burden Scale 
  
  
  
  
  
X  
X 
Distress Thermometer 
  
  
  
  
  
X 
X 
Death Assessment 
  
  
  
  
  
X  
X 
 
Schedule of Activities for Caregivers (Intervention):  
 
Assessments and Procedures 
Screening  
Pre-
Discharge 
Discharge 
24 Hours 
Post-
Discharge 
(+3 days) 
7 Days 
Post-
Discharge 
(+/- 2 
days) 
30 Days 
Post-
Discharge 
(+/- 7 
days) 
60 Days 
Post-
Discharge 
(+/- 7 
days) 
Informed Consent 
X 
  
  
  
  
  
  
Confirm Eligibility 
X 
  
  
  
  
  
  
Baseline Questionnaire 
 
X 
 
 
 
 
 
Connect-Home Intervention in 
SNF (Step 1) 
 
X 
 
 
 
 
 
Connect-Home Intervention in 
Home (Step 2) 
 
 
 
X 
 
 
 
Preparedness for Caregiving 
Scale 
  
  
  
  
X  
  
  
Zarit Caregiver Burden Scale 
  
  
  
  
  
X  
X 
Distress Thermometer 
  
  
  
  
  
X 
X 
Death Assessment 
  
  
  
  
  
X  
X 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Skilled nursing facility (SNF) patients are medically complex with incurable chronic conditions, 
dependence on caregivers for activities of daily living, and have a recent acute illness, such as septicemia 
and hip and femur procedures.1-3  Despite the high prevalence of acute care use and mortality after SNF 
patients return home (>50% in 90 days),3 SNF patients and their caregivers do not receive transitional 
care that prepares them to manage the patient’s serious illnesses at home.  No efficacy studies of 
transitional care have targeted this population, or measured whether interventions resulted in improved 
patient and caregiver outcomes.4 This study will test the efficacy of Connect-Home, a successfully 
piloted transitional care intervention, targeting both seriously ill SNF patients who discharge to home 
and their caregivers. 
  
 Connect-Home will generate a new model of transitional care not dependent on research staff for 
delivery, thereby accelerating translation of the intervention from research to clinical practice. 
  
2.2 BACKGROUND 
Annually, 1.7-1.8 million older adults undergo episodes of care consisting of hospitalization followed by 
a “short stay” in a nursing home, where they use the Medicare SNF benefit for rehabilitation, medical 
and nursing care. 1-3 SNF patients are seriously ill: 56-62% are ≥80 years old; 100% have recent acute 
illness (e.g., hip fracture, heart failure, genitourinary and pulmonary infections with & without sepsis); 
28-34% are treated in intensive care during the index hospital stay; and 29-43% have ≥1 hospitalization 
in the year prior to the index hospital and SNF stay.2,4-7 In addition, these individuals have underlying 
incurable chronic conditions:  29-35% are cognitively impaired; 46% have Charlson Comorbidity scores 
≥2, 28% have scores ≥3; and nearly all experience multi-morbidity, for example, 82% of those with heart 
failure have 5 co-occurring chronic conditions.2,8-10 SNF patients also are functionally impaired and frail 
with an average of three or more geriatric syndromes (e.g., depressive symptoms, poor sleep, 
unplanned weight loss) and depend on caregivers for 3-6 activities of daily living.6,8,11,12 Complicating 
these challenges, 25% of SNF patients live alone and 20-25% are co-insured with Medicaid. After 
returning home, former SNF patients are at high risk for falls and functional impairment; in a recent 
study, 61% showed little or no functional improvement one year after SNF discharge.13-15 
  
SNF patients are also at an exceptionally high risk for return to acute care, continued functional decline, 
and death. In a preliminary analysis of 55,000 SNF patient transitions to home, >50% of patients 
returned to the hospital within 90 days of discharge or died: 25.9% used ED services, 20.1% were re-
hospitalized, and 8.1% died within 90 days of returning home.3 Moreover, lacking advance directives and 
goals of care, 33% of discharged SNF patients who died within the next month, died in hospital rather 

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than at home.16 Thus, SNF patients are a seriously ill and functionally impaired population, supported by 
stressed caregivers. 
  
These seriously ill patients, as they draw closer to the end-of-life, also experience multiple transitions 
between healthcare providers and settings.17-19 Much evidence demonstrates that hospital-based 
transitional care improves patients’ preparedness for discharge and decreases the rate of re-
hospitalization within 30 days of discharge.20-22 However, in a systematic review of SNF-based 
transitional care, no randomized clinical trials were identified and only a limited set of observational 
studies of transitional care were found.4 In the set of observational studies, there were substantial 
limitations, including intervention designs lacking caregiver support, advance care planning, and home 
follow-up after SNF discharge and serious methodological flaws (non-experimental designs with small 
samples and no reliable measurement of intermediate and 30 or 60 day patient- and care-giver 
outcomes).4  Lacking transitional care, SNF patients (and their caregivers) are not prepared to manage 
the patient's serious illness at home, and are at high risk for new acute medical events, diminished 
quality of life and other poor health outcomes.23-26 
  
Systematic reviews of studies, describing the efficacy of transitional care interventions to prepare 
hospital patients for transitions to home, established that transitional care, compared to usual discharge 
planning, reduced the rate of re-hospitalization 30 days after patient discharge. Findings from the pilot-
test of Connect-Home and systematic review of related observational studies provided foundational 
evidence to support the premise that transitional care of SNF patients and their caregivers will prepare 
seriously ill patients for discharge, promote quality of life and function at home, and reduce hospital 
readmissions.27 Targeting patients with caregivers is a logical extension, because they provide the direct 
care needed for seriously ill patients to bridge the vulnerable period following SNF discharge.28-32 
  
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
  
Physical Risks: 
  
Patients and caregivers in control periods will receive discharge planning in the SNF, and those in 
intervention periods will receive transitional care in the SNF and in the patient’s home.  Discharge 
planning and transitional care activities involve verbal assessments, conversation, education, and 
planning.  There is a possibility that participants could be fatigued from participation in the data 
collection activities.  For example, while participating in a care-planning meeting, a patient might feel 
fatigued or need to take a break.   
  
If any participant has a physical injury, the study team will help them seek immediate medical attention. 
If a SNF patient or caregiver expresses fatigue during data collection, the data collection session will be 
terminated immediately, and a follow-up appointment scheduled. 

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Psychological Risks: 
  
Emotional distress related to learning more about medical and functional challenges and plans for care 
at home is a potential psychological risk. During the control and intervention periods, staff in the SNF 
and in the home health agency will engage patients and caregivers in conversations to plan strategies 
for managing the patient’s serious illness at home.  Also, during enrollment and data collection 
activities, staff will assess the patients’ quality of life, functional mobility, falls at home, days at home 
without acute care use and caregivers’ burden and distress related to the caregiving role. Staff will also 
review the patient’s advance directives.  These study-related activities may also involve a chance for 
emotional distress. 
  
The study team will refer distressed patients and caregivers to their attending or primary care physicians 
for support with emotional distress.  
  
Social Risks: 
  
During enrollment and data collection activities, study staff will collect data from participants about 
their health, function and quality of life; if others observed patients or caregivers participating in these 
activities, there is a chance that it could embarrass or distress patients or caregivers.  
  
In intervention and control periods, the study team will recruit and collect baseline data for participants 
in a private room.  When necessary, this data may also be obtained virtually when research personnel 
are not able to encounter face to face interactions with study participants.  When these occasions arise, 
all virtual interactions will be conducted at a time when the patient is alone and not able to be 
overheard.  Study team will conduct these in private settings as well ensuring that no questions and/or 
responses will be overheard.  During telephone calls to collect outcome data, the identity of patients will 
be confirmed.  All research staff will be trained by the PI and other study team members to collect data 
with the utmost respect and sensitivity to support participants and help them feel comfortable during 
data collection activities.  The research team members will remind participants that participation in the 
study is voluntary, and that they have the right to withdraw from the study at any time if they are not 
comfortable.  The team will assure patients and caregivers that withdrawal from the study will not have 
an impact on their medical care.  
  
Risk of Loss of Confidentiality:  
  
During enrollment and data collection activities, staff will obtain health information about patients and 
caregivers.  Thus, a potential risk to SNF patients and caregivers is loss of confidentiality.   
  
All research study personnel will be trained in IRB and HIPAA guidelines to maintain the security and 
confidentiality of the data.  During the consenting process, the study team will explain the 

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confidentiality protections and will inform the participants of their right to skip items, pause during 
participation, and withdraw from the study at any time. When face to face interaction is not feasible, 
study discussions will occur in a virtual manner.  In order to avoid a loss of confidentiality, these 
interactions will be conducted in a private area where the discussions will not be overheard.   
  
Risks for loss of confidentiality will be minimal secondary to use of procedures to protect confidentiality, 
including (a) using study codes on data documents and keeping a separate document that links the 
study code to subjects’ identifying information locked in a separate location and restrict access to this 
document to certain members of the study team; (b) de-identification of data to remove the possibility 
that data could be connected to individuals that consented to participate in the study; (c) encrypting 
identifiable data; and (d) securely storing data documents within locked locations.  All identifying 
information will be destroyed at the earliest possible time following completion of the study.  In 
addition, data will be reported in aggregate form, without identifying information by site or 
individual.  Publications arising from the study will not contain personal information.  All SNF patients or 
caregiver participants will continue to receive routine medical care from their health care providers 
throughout the study.  
  
  
2.3.2 KNOWN POTENTIAL BENEFITS 
  
The major potential benefit of this study is new knowledge about ways to improve outcomes for 
seriously ill SNF patients and/or their caregivers. The intervention patients will receive valuable 
information, training and plans about their diagnosis, indicators of emerging medical problems, 
medications, treatments, advance care directives, follow-up appointments and studies, home care 
services, questions to ask their community physicians, strategies to avoid falls at home, self-care at 
home in the context of the COVID-19 pandemic (when applicable), and discrepancies in their home 
medications that should be addressed with community or SNF physicians.  Their family caregivers will 
also receive this information and training as well as training to support the patient and strategies to 
relieve stress and hardship related to the caregiver role.  Participants in the control periods in the SNFs 
will receive usual discharge planning.  
  
As a result of the research, we will know whether and to what degree the intervention, compared to 
usual care, increased the capacity of SNF patients to achieve health care goals at home after SNF 
discharge and caregivers to avoid burden and distress related to the caregiving role.  If the intervention 
is successful, this study will provide an evidence-based practice rationale for intervention with seriously 
ill SNF patients or their caregivers. It will also provide new knowledge related to care of adults with 
serious illness in the context of the COVID-19 pandemic. 
 
 

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2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
  
The predicted risks for this study are minimal, and feasible precautions will be taken to protect all 
subjects in this study. The benefits that will be obtained, both as direct benefits to the participants in the 
intervention phase and potential benefits to the community at large, do not exceed the risks outlined in 
section 2.3.1. 
 

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3 STUDY OBJECTIVES 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
1.1 To assess patient 
preparedness for 
discharge seven days after 
discharge from a skilled nursing 
facility. 
  
 
 
 
1.2 To assess caretaker 
preparedness for caregiving 
seven days after discharge from a 
skilled nursing facility. 
 1.1 The Care Transitions Measure-15 
(CTM-15), assessed at seven days post 
discharge.33,34 
  
  
 
 
 
 
1.2 The Preparedness for Caregiving 
Scale (PCS), assessed at seven days post 
discharge.35 
 1.1 The CTM-15 has a high 
reliability (alpha range = 0.93-
0.95) and measures self-
reported knowledge and skills 
for continuing care at home. 
Higher scores are associated 
with less acute care use after 
discharge. 
  
1.2 The PCS has moderate to 
high reliability (alpha= 0.86-
0.92). Range = 0-32; higher 
scores are associated with 
less anxiety103  
Secondary 
 2.1 To assess patient quality of 
life 30 and 60 days after 
discharge from a skilled 
nursing facility. 
  
 
 
 
2.2. To assess patient function 30 
and 60 days after discharge from 
a skilled nursing facility.  
  
 
 
 
 
2.3 To assess patient days of 
acute care use 30 and 60 days 
 2.1 The McGill Quality of Life 
Questionnaire (MQoL-R), assessed at 
30- and 60-days post discharge.36,37 
  
 
 
 
 
2.2 The Life Space Assessment, 
assessed at 30- and 60-days post 
discharge.38,39 
  
  
 
 
 
2.3 The self-reported combined 
number of days the patient spends in 
 2.1 The MQoL-R has 
moderate reliability (alpha= 
.80); the scale is 
recommended for studies of 
palliative care 72 and 
measures quality of life 
across disease trajectories. 85 
  
2.2 The Life Space 
Assessment has high 
reliability (alpha=0.96). Range 
is 1-120, and lower scores are 
associated with falls and 
hospitalization.  
  
 
2.3 This composite variable 
indicating total acute care is a 
reliable measure of the 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
after discharge from a skilled 
nursing facility.  
  
 
2.4 To assess caregiver burden 30 
and 60 days after discharge from 
a skilled nursing facility.  
  
 
 
 
 
 
 
 
 
 
2.5 To assess caregiver distress 
30 and 60 days after discharge 
from a skilled nursing facility.  
the ED or hospital in 30- and 60-
days post discharge.40 
  
 
2.4 The Zarit Caregiver Burden Scale, 
assessed at 30- and 60-days post 
discharge.41,42 
  
 
 
 
 
 
 
 
 
 
2.5 The Distress Thermometer, 
assessed 30- and 60-days post 
discharge.28 
patients’ time at home after 
SNF care is interrupted by 
subsequent acute care needs. 
 
2.4 The Zarit Caregiver 
Burden Scale has high 
reliability (alpha-0.89), 
measures caregiver 
perceptions that "caregiving 
has an adverse effect on their 
emotional, social, financial, 
physical and spiritual 
functioning." Scores range 0-
48; higher scores associated 
with depression and social 
isolation. 
  
2.5 The Distress 
Thermometers includes 1 
item on an 11-point scale, 
measuring negative affect 
related to caregiving for a 
severely ill 
person. Score ranges 0-10, 
with scores >4 associated 
with poor coping and 
depression. 
Tertiary/Exploratory 
 E.1 To assess the number of 
patients falls with injury 30 and 
60 days after discharge from a 
skilled nursing facility.  
  
 
 
 
 
 E.1 Patient assessment of number of 
falls with injury, assessed 30- and 60-
days post discharge. Falls are defined 
as an "unintentional change in position 
resulting in a resident coming to rest on 
the ground or lower level."43 
  
 
 
 E.1 Prior exploratory studies 
suggest that falls are a 
frequent event in the 
immediate post-discharge 
period. The count of falls in 
this study will be among the 
first to describe the impact of 
a transitional care 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
 
 
 
E.2 To assess patient enrollment 
in hospice 30 and 60 days after 
discharge from a skilled nursing 
facility.  
  
 
 
 
 
E.3 To assess the patient's 
number of days in home health 
care 30 and 60 days after 
discharge from a skilled nursing 
facility.  
  
 
 
 
 
 
 
E.4 To assess the patient's 
number of hospital readmissions 
(acute or observational stays), 30 
and 60 days after discharge from 
a skilled nursing facility.  
  
 
 
 
 
 
E.5 To assess the patient's 
number of emergency 
department visits without a 
 
 
 
E.2 Patient assessment of enrollment in 
hospice, assessed 30- and 60-days post 
discharge. 
  
 
 
 
 
 
E.3 Nurse and rehabilitation therapist 
assessment of number of days in home 
health care, assessed 30- and 60-days 
post discharge. 
  
 
 
 
 
 
 
 
E.4 Patient assessment of count of 
hospital readmissions, assessed 30- and 
60-days post discharge. 
  
  
 
 
 
 
 
 
E.5 Patient assessment of the count of 
emergency department visits without a 
intervention on the falls rate 
in the post discharge period. 
 
E.2 No prior transitional care 
study reports the rate of 
hospice enrollment after SNF-
home transfers. Data 
collected with this item will 
suggest hospice use in a 
severely ill sample of SNF 
patients.   
 
E.3 Data collected wit this 
measure will indicate the 
intensity of home care 
services in the post discharge 
period.  These data will 
support a secondary analysis 
to determine the degree that 
outcomes of the Connect-
Home intervention are 
mediated by the intensity of 
home health care use.  
 
E.4 All cause re-
hospitalizations is the most 
widely used measure of 
transitional care 
interventions.  These data 
will be collected to estimate 
the representativeness of the 
study sample and the 
generalizability of the study 
findings. 
 
E.5 ED use is a most widely 
used measure of transitional 
care interventions.  These 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
hospital stay 30 and 60 days after 
discharge from a skilled nursing 
facility.  
  
 
 
 
E.6 To assess caregiver-reported 
death of the patient 30 and 60 
days after discharge from a 
skilled nursing facility.  
hospital stay, assessed 30- and 60-days 
post discharge. 
  
  
 
 
 
E.6 Caregiver reported death of the 
patient, assessed 30- and 60-days post 
discharge. 
data will be collected to 
estimate the 
representativeness of the 
study sample and the 
generalizability of the study 
findings. 
 
E.6 Change in the rate of 
patient death is not an 
expected study outcome; 
however, these data will be 
used to describe the sample. 

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
Connect-Home is a stepped-wedge cluster randomized trial (SW-CRT) to test the Connect-Home 
intervention against standard discharge planning (control), using both patients discharged to home 
(N=360) and their caregivers (N=360) in 6 SNFs.44  In this design, SNFs will be randomly allocated to one 
of six sequences of time-periods defined by the month at which a SNF begins the control condition and, 
after a two-month staff training period, the time-period (or "step") that begins the Connect-Home 
protocol condition (Figure 2). 45 Thus, all SNFs will contribute data for both the Connect-Home 
intervention and standard care in a uni-directional crossover design at the cluster (SNF) level; a patient 
and their caregiver receives either standard discharge planning or Connect-Home consistent with the 
treatment condition of the SNF at the time of the patient's enrollment.  
 
Randomization will be conducted for all sites simultaneously by a study statistician blinded to SNF identity. 
The randomized allocation sequence of the SNF will determine the beginning and end dates for three 
phases of patient and caregiver enrollment: (1) standard care, (2) the pre-implementation phase when 
staff are trained and neither patients nor caregivers are enrolled, and (3) the implementation phase when 
newly enrolled patients and their caregivers receive Connect-Home. 
 
  
Patients and caregivers will be enrolled on a rolling basis at the rate of 4-5 dyads per month anytime 
during the control or intervention period. There will be three phases of patient and caregiver 
enrollment: (1) standard of care (indicated by blue boxes in Figure 2), (2) the pre-implementation phase 
when staff are trained and neither patients nor caregivers are enrolled (indicated by orange boxes in 
Figure 2), and (3) the implementation phase when newly enrolled patients and their caregivers receive 
the Connect-Home intervention (indicated by green boxes in Figure 2). 
  
 
  
The primary objectives will be assessed 7 days after discharge. The secondary and exploratory outcomes 
will be assessed 30 and 60 days after discharge.  
 

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4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The study will utilize a SW-CRT, as it retains statistical power to evaluate efficacy of the intervention on 
the primary outcome in a relatively small number of SNFs. Observing SNF's under standard practice 
followed by the Connect-Home intervention is also consistent with the actual practice of implementing 
organizational change in SNFs and provides opportunities for evaluating implementation 
procedures.  Cluster randomization at the nursing home level reduces risk of contamination between 
control and Connect-Home participants (Figure 2).  
4.3 END OF STUDY DEFINITION 
The end of study will be when the study team completes the final enrolled participant's 60-day 
assessments, and all data (including the final home health care chart reviews) have been collected from 
all study subjects.  If a subject is withdrawn from the study due to an early termination caused by 
hospitalization, SNF re-admission and/or death; end of study for these patients will occur on day of early 
termination.  
 
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
Patients must satisfy all the following inclusion criteria prior to being enrolled: 
1. English-speaking; 
2. Have a Minimum Data Set 3.0, Section GG Mobility Assessment Score of 3 or less, indicating the patient 
requires at least 25-50% assistance for functional mobility;  
3. Diagnosed with at least 1 serious medical illness (neurodegenerative dementia, cancer, chronic kidney 
disease, cirrhosis, congestive heart failure, chronic obstructive or interstitial lung disease, acute infection 
with sepsis, acute major motor stroke, acute coronary syndrome, acute hip fracture, diabetes with end 
organ complications, or intensive care for > 3 days while hospitalized); 
4. Have a caregiver who can be enrolled in the study. 
For patients with cognitive impairment, (defined as documented diagnosis of dementia and/or a Brief 
Interview for Mental Status score of ≤ 12 in Section C of the Minimum Data Set) additional criteria 
include: 
1. Documentation in the medical record of a caregiver who is the patient's legally authorized representative; 
2. Consent of the caregiver to participate in the study as the patient's representative.  
  
Caregivers must satisfy all of the following inclusion criteria prior to being enrolled: 
1. Must self-report assisting the patient at home; 
2. English-speaking. 
 
5.2 EXCLUSION CRITERIA 
Patients will not be entered into Connect-Home if the criterion below is satisfied: 
1.  Planned hospital readmission for procedures or treatments within 90 days post enrollment. 
Caregivers in the study have no noted exclusion criteria.  
 
 
 
 

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5.3 SCREEN FAILURES 
Subjects who discontinue following consent (i.e., post in-person questionnaires at recruitment) but prior 
to receiving the Connect-Home intervention or control will be considered screen failures. No additional 
data will be collected from the time of screen failure, but data collected prior to screen failure and 
reason for screen failure will be kept. 
5.4 STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment: 
  
The study team will obtain a limited waiver of HIPAA authorization to allow pre-screening for patient 
eligibility. The team will consult at least weekly with the Minimum Data Set Nurse, social worker, or 
other personnel involved in coordinating clinical care for newly admitted patients in each SNF by phone, 
email, or in-person to identify patients that are expected to be discharged from the SNF to home, and 
subsequently screen the medical records of all patients expected to discharge from the SNF to home.  
  
After identifying potentially eligible patients, the study team will recruit SNF patients and their 
caregivers in-person (or, when risk mitigation related to COVID-19 prevents in-person contact, we will 
recruit virtually, using an iPad and connection via ZOOM) within 10 days of their admission and will 
review the patient's medical record to confirm eligibility. For patients with cognitive impairment, the 
team will recruit the patient's legally authorized representative to respond to survey questions as the 
patient's proxy.  
  
Recruitment will be conducted in the SNFs through in-person interactions (or, when risk mitigation 
related to COVID-19 prevents in-person contact, we will recruit virtually, using an iPad and connection 
via ZOOM). If necessary, recruitment can also be conducted by telephone for caregivers. All participants 
will provide written informed consent (or, when risk mitigation related to COVID-19 prevents in-person 
contact, we will obtain consent verbally using an iPad and connection via ZOOM) for study participation.  
When written consent is not feasible, we will obtain witnessed verbal consent with the assistance of 
nursing home personnel via the iPad and Zoom connection). Legally authorized representatives will give 
consent for patients with cognitive impairment.  Consent and HIPAA Authorization could also be 
obtained verbally in the situation that a participant is unable to physically sign these documents.   
  
  
Retention: 
  
During recruitment, study personnel will give the patient and caregiver a study flyer providing the study 
team's contact information, a schedule of planned follow-up calls, and information regarding 
compensation for completing data collection. When study personnel is unable to provide these study 
flyers directly to the patient, the study team will provide flyers to NH staff to announce the study and 
the possibility that a study team member will speak with potential study participants in-person or 

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virtually (using an iPad) about participating in the study.  The study team will also mail reminder letters 
to patients and caregivers one week before 30 and 60-day data collection calls 
  
The study team will also continuously monitor retention throughout the study. If retention falls below 
the anticipated rate, study personnel will further emphasize data collection in recruitment and will send 
additional written reminders to participants.  
 
 

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6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 The Connect-Home intervention will introduce new organizational structure to support staff delivery of 
transitional care processes for seriously ill patients being discharged from the SNF to home.27 New 
elements of organization structure in the Connect-Home intervention include: 
• 
The "Transition Plan of Care Template" EHR tool, to be installed in the SNF EHR system prior to 
randomization.  It contains domains that SNF staff and home visit RNs use to record and deliver the two-
step Connect-Home intervention.27 
• 
The "Connect-Home Toolkit", a bound workbook that contains a description of the EHR template and 
other EHR tools, the two-step Connect-Home intervention protocol, checklists and cue sheets, and the 
intervention schedule.27  
• 
Site leadership training, where the Investigator trains 1-5 SNF project leaders on the Connect-Home 
protocol and study procedures. 
• 
Executive sponsor and QI nurse monthly calls during intervention phase 
• 
Monthly accountability calls with QI nurses and individual facilities to maintain accountability to protocol 
• 
Staff Training, where the Investigator will train social workers, nurses, rehabilitation therapists, and the 
Connect-Home Activation RN on patient and caregiver key care needs, protocols for using the two-step 
intervention to address patient's key care needs, using the "Transition Plan of Care Template" EHR tool, 
advance care planning, and integrating SNF-based and home-based care.27 The training will also include 
American Geriatrics Society recommendations for self-care at home in the context of the COVID-19 
pandemic (when applicable). 
• 
Focused training for the Connect-Home Activation RN, where the Investigator will train the Connect-
Home activation RN on strategies for implementing transition plans of care, home safety screening, 
responding to medical needs, and handing off care to home health nurses. 
 
After these elements of organizational structure are in place, the SNF staff will use the Connect-Home 
intervention care processes to deliver the 2-step transitional care intervention.27 Further details are 
provided in Table 1.   
• 
In Step 1, SNF nurses, rehabilitation therapists, and social workers will develop a Transition Plan of Care 
and prepare the patient and caregiver to manage the patient's serious illness and functional needs at 
home. Staff also will use American Geriatrics Society recommendations for self-care at home in the 
context of the COVID-19 pandemic (when applicable). 

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• 
In Step 2, the Connect-Home Activation RN (employed in the collaborating home health agency) will visit 
the patient and caregiver at home within 24 hours of discharge; the nurse will work with them to activate 
the Transition Plan of Care at home. Nurses also will use American geriatrics Society recommendations for 
self-care at home in the context of the COVID-19 pandemic (when applicable). 
 
Table 1. Connect-Home: Transitional Care Processes (Time estimates based on 20 day SNF stay) 
Process 
Patient/Caregiver Services and Supports 
Day 
Step 1. 
Transitional 
care in the 
SNF27 
  
  
Set goals for home-based care (45 minutes) 
Consulting with the patient/caregiver, SNF staff use the EHR template to 
describe goals in the patient’s Transition Plan of Care, targeting 6 key care 
needs (home safety and level of assistance, advance care planning, symptom 
management, medication reconciliation, function and activity and 
coordination of follow-up medical care). Staff will use American Geriatrics Society 
recommendations for self-care at home in the context of the COVID-19 pandemic 
(when applicable). 
• 
Nurses create goals for planned treatments at home, and responses to 
emerging symptoms or other health changes at home 
• 
Rehabilitation therapists create goals for mobility, transfers and self-care at 
home. 
• 
Social worker creates goals for caregiver support, follow-up care & discharge 
disposition. 
2 - 17 
Meet to plan the patient’s transition to home-based care (30 minutes) 
In dialogue with the patient/caregiver, the treating nurse, social worker and 
therapists will develop a plan for home-based care, targeting 6 key care needs 
(home safety and level of assistance, advance care planning, symptom 
management, medication reconciliation, function and activity, and 
coordinator of care). 
 
• 
Nurses focus on medications, elements of advance care planning and 
symptom management. 
• 
All staff help the patient and caregiver describe their needs for continuing 
medical, supportive and rehabilitative care at home. 
• 
Social worker reviews participation in Connect-Home, including the 
Transition Plan of Care and the Connect-Home Activation RN Visit. 
 
 
 
5 - 10 

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Prepare the patient and caregiver for home-based care (2.5 hours) 
1. Teach skills and plans for home-based care, targeting 6 key care needs 
(home safety and level of assistance, advance care planning, symptom 
management, medication reconciliation, function and activity, and 
coordinator of care). Staff will use American Geriatrics Society 
recommendations for self-care at home in the context of the COVID-19 
pandemic (when applicable). 
• 
Nurses teach symptom management (e.g., pain), clarify advance care 
planning preferences, and reconcile medication orders 
• 
Rehabilitation Therapists teach skills for function, safety and continuing 
rehabilitation at home. 
• 
Social worker schedules and explains appointments, home-based care & cost 
2. Initiate hand-off to home-based care (over the last 1-2 days before 
discharge) 
• 
SNF staff send medical records and copies of any advance care planning 
documents to the patient’s physician and the Connect-Home Activation RN 
• 
Nurses: 1) reconcile medications, 2) provide supplies and medications, and 3) 
re-teach the written Transition Plan of Care and medication list. 
• 
Social Worker coordinates the hand-off of care to the Connect-Home 
Activation Nurse. 
6 - 20 
Step 2.  
Transitional 
care in the 
patient’s 
home 
Implement the Transition Plan of Care at home (2 hours) 
      Connect-Home Activation Nurse visits the patient and caregiver at home 
to: 
• 
Reconcile medications on the discharge medication list and in the home, 
• 
Reviews TPOC and adds materials for patient care as needed 
• 
Help family implement new care routines, addressing 6 key care needs (home 
safety and level of assistance, advance care planning, symptom management, 
medication reconciliation, function and activity, and coordinator of care). 
• 
Conduct a brief home safety & falls prevention screen, and 
• 
Coordinate care and communicate the plan of care to follow-up clinicians and 
home health care nurses, and others as applicable. Nurses will use American 
Geriatrics Society recommendations for self-care at home in the context of 
the COVID-19 pandemic (when applicable). 
  
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6.2 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Randomization 
  
Randomization will be conducted for all 6 sites simultaneously by a study statistician blinded to SNF 
identity. The randomized allocation sequence of the SNF will determine the beginning and end dates for 
three phases of patient and caregiver enrollment: (1) standard of care, (2) the pre-implementation 
phase when staff are trained and neither patients nor caregivers are enrolled, and (3) the 
implementation phase when newly enrolled patients and their caregivers receive the Connect-Home 
intervention.  
  
 
Blinding 
  
Professional data collectors from the Carolina Survey Research Lab (CSRL) will collect data from patients 
and caregivers at 7, 30, and 60 days post-discharge. These data collectors will be blinded to both the 
study hypothesis and to treatment group assignment.  
 
6.3 STUDY INTERVENTION COMPLIANCE 
The NIH Behavior Change Consortium’s “Treatment Fidelity Protocols” will be used to ensure fidelity to 
the intervention.46 Fidelity will be assessed in five domains as described below. 
  
Design: The researchers will use standardized tools (e.g., Connect-Home Toolkit, the EHR template and 
staff training protocols) to deliver the intervention. 
  
Training: To prevent contamination between SNFs during the intervention phase, the researcher will 
train staff in individual SNFs and Connect-Home Activation RNs in individual home health care offices. A 
detailed training protocol will be used, specifying the researcher roles, content, participants, and time 
required for training activities. 
  
Delivery: A researcher will observe staff training activities on a random schedule to assess fidelity of the 
trainer to the staff training protocols. The research team will develop plans to address deviations from 
the training protocol. A Training Contact Database will be used, in which researchers will record staff 
participation in training activities. Staff members will be assigned identification numbers for tracking 
participation. 
  
Receipt of Treatment: Researchers will administer post-tests to all participating staff after the staff 
training session; additional one-to-one re-training will be provided as needed for those who score 

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<100%. Researchers will also use return demonstration of home visit procedures with Connect-Home 
Activation RNs, followed by re-training as needed until nurses demonstrate a high level of ability. 
  
Enactment of Skills: The study team will audit medical records for intervention patients to assess fidelity 
to the study protocol.  Protocol elements to be assessed will include the following: a) completing the 
Transition Plan of Care; b) convening care plan meetings; c) reviewing advance directives in the SNF; d) 
scheduling follow-up medical appointments; e) transmitting records to follow-up clinicians; g) 
completing home visits within 24 hours after dis-charge; h) reconciling medications in the patient’s 
home; i) completing the home safety evaluation; and j) communicating patient status to the on-coming 
home health nurse. As part of enactment monitoring, the Connect-Home Activation RN will keep a log 
describing medication discrepancies and the patients referred for a rehabilitation therapy after 
discharge home. Further, the researcher will host at least one 30-minute monthly meeting, during the 
intervention phase in each SNF, to relay feedback and discuss findings from fidelity monitoring with SNF 
staff and the Connect-Home Activation RN. Finally, a researcher will observe 10% of staff as they deliver 
Connect-Home and, using a standard checklist, the researcher will provide feedback about enactment of 
the Connect-Home protocols. If in-person observations are not possible (owing to risk mitigation related 
to COVID-19), we will monitor enactment fidelity via Zoom-based observations of care plan meetings 
and/ or day of discharge teaching sessions. SNFs failing to achieve 70% of operationalized fidelity steps 
will undergo re-training. 
 
 
 

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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
The study will adhere to the following stopping rules: 
1. The intervention is associated with adverse effects that significantly impact the risk-benefit ratio 
2. Study recruitment or retention becomes futile 
3. Any new information becomes available during the trial that necessitates stopping the trial 
4. Other situations occur that might warrant stopping the trial 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects have the right to discontinue their participation in the Connect-Home study for any reason 
without penalty. The Investigator also may discontinue subjects from the study if he feels as if it is in the 
best interest of the subject, or if the subject is noncompliant.  
  
Due to the inclusion criteria requiring patient and caregiver participation, if either the patient or the 
caregiver withdraws or is discontinued from the study, the other subject will automatically be 
withdrawn.  
  
The study team will cease data collection for an individual as soon as the subject withdraws from the 
study. The study team will retain data collected while the subject was participating in the Connect-Home 
trial. 
  
If a patient enrolled in the study does not transfer from the SNF to home (i.e., they die in the SNF or are 
transferred from the SNF to the hospital or to long-term care), their data will not be analyzed, and the 
patient and the caregiver will be withdrawn.  
  
If a patient is discharged from the SNF to home, and then dies prior to all data being collected, the data 
that was collected prior to the subject's death will be retained and included in analysis.  If a patient has a 
reported death after discharge, only the data collected prior to the date of death will be used for data 
collection.  
 
If a patient is discharged from the SNF to home, and then has a hospitalization and/or re-admission to a 
SNF; the patient will be withdrawn from the study by research team as they are now non-compliant for 
data collection.  The data that was collected prior to the event will be retained and included in analysis.  
  
  

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7.3 LOST TO FOLLOW-UP 
After patient discharge from the SNF, study subjects will be considered lost to follow-up if 3 data 
collection phone calls have been made to the subject with no response.  
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 EFFICACY ASSESSMENTS 
The procedures and assessments described in this section will be performed at the time point(s) 
described in the schedule of activities schedule in section 1.3. 
  
All variables will be measured with chart reviews and/or interview-questionnaires with patients and 
caregivers. Data collection will be identical for intervention and control periods.  
  
Care Transitions Measure-15 (CTM-15)33 
  
Self-reported preparedness for discharge will be assessed using the CTM-15. It includes 15 questions on 
a 4-point scale, with a summary score ranging from 0-100. Higher scores are associated with less acute 
care use after discharge.  
  
This measure will be assessed at 7 days post-discharge, through telephone interview with the patient (or 
with the patient's legally authorized representative, responding to survey questions as the patient's 
proxy in cases of patients with cognitive impairment). 
   
Preparedness for Caregiving Scale (PCS)35 
  
Self-reported preparedness for caregiving will be assessed using the PCS. It includes 8 questions on a 5-
point Likert scale (0-4), with a range of 0-32. Higher scores are associated with less anxiety. 
  
This measure will be assessed at 7 days post-discharge, through telephone interview with the caregiver. 
  
  
McGill Quality of Life Questionnaire - Revised (MQoL-R)37 
  
Quality of life across disease trajectories is measured using the MQoL-R. It includes 16 items on a 0-10 
point Likert scale. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
  
  
 
 

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Life Space Assessment38 
  
Patient function is measured using the Life Space Assessment. It includes 5 Likert scales that correspond 
to a hierarchy of levels of mobility (each scored 0-4). Weights are the product of the "Life-space Level" 
(range 1-5) and the "independence" score (range 1-2). Score ranges from 1-120, and lower scores are 
associated with falls and hospitalization.  
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
   
Zarit Caregiver Burden Scale41,42 
  
Caregiver burden is measured using the Zarit Caregiver Burden Scale. It includes 12 items on a 5-point 
scale. Scores range 0-48, and higher scores are associated with depression and social isolation.  
  
This measure will be assessed at 30 and 60 days post-discharge, through telephone interview with the 
caregiver.  
   
Distress Thermometer28 
  
Caregiver distress is measured using the Distress Thermometer.  It includes 1 item on an 11 point 
scale. Scores range 0-10, with scores >4 associated with poor coping and depression. 
  
This measure will be assessed at 30 and 60 days post-discharge, through telephone interview with the 
caregiver.  
   
Number of Patient Falls with Injury and Without Injury 
This assessment is self-reported by the patient; falls are defined as an "unintentional change in position 
resulting in a resident coming to rest on the ground or lower level."  
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
  
MD Visit 
 
This assessment is self-reported by the patient; it is asked in a yes/no question format.   
 
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient’s legally authorized representative, responding to survey questions as the 
patient’s proxy in cases of patients with cognitive impairment). 

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Hospice Enrollment 
  
This assessment is self-reported by the patient; it is asked in a yes/no question format. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
  
Home Health Care Use 
  
This assessment is reported by the nurses and rehabilitation therapists of the patient, as a count of the 
number of days in home health care. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with 
the nurses or rehabilitation therapists. 
  
Hospital Readmissions 
  
This assessment is self-reported by the patient; it is a count of hospital readmissions, either acute or 
observational stays after SNF discharge. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
  
Emergency Department Use 
  
This assessment is self-reported by the patient; it is a count of emergency department visits without a 
hospital stay after SNF discharge. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
patient (or with the patient's legally authorized representative, responding to survey questions as the 
patient's proxy in cases of patients with cognitive impairment). 
  
Death Report by Caregiver 
  
This assessment is self-reported by the caregiver regarding patient death after SNF discharge. 
  
This measure will be assessed at 30 and 60 days post discharge, through telephone interview with the 
caregiver. 
  

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Co-variate assessments will be collected in-person and from the medical record. For some caregivers, 
co-variate data can be collected by phone. Co-variate data are as follows: 
  
• 
Patient Data collected in person:  
o 
Study of Osteopathic Fractures Index 109, measuring frailty of the patient 
o 
ENRICHD Social Support Inventory 110, measuring social support of the patient 
• 
Patient data collected with SNF chart abstraction:  
o 
Demographics 
o 
Health insurance status 
o 
Medical Information 
o 
Depression (Minimum Data Set section D) 94 
o 
Function (Minimum Data Set section GG) 94 
o 
Cognitive status (Minimum Data Set section C) 94, 111 
o 
SNF care (i.e., SNF length of stay, urgent or acute treatment while in the SNF) 
o 
Discharge destination 
o 
Charlson Comorbidity Index scores 112 (calculated using the problem list in the medical record) 
o 
Yes or No that the SNF admission date was before the mandated pause in research activities 
(related to the COVID-19 pandemic) 
o 
History of COVID-19 diagnosis and treatment in the index hospitalization and/or in the SNF 
• 
Caregiver data collected in-person or by phone:  
o 
Demographics 
o 
Relationship to patient 
o 
Employment 
o 
Count of days per week providing patient care 
o 
History of COVID-19 diagnosis and treatment 
  

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8.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
  
8.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
 Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for 
example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated 
with the subject's participation in the research, whether or not considered related to the subject's 
participation in the research. Adverse events encompass both physical and psychological harms. 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
 An adverse event is serious when the outcome for the subject is: 
• 
Death; 
• 
Life- threatening (place the subject at immediate risk of death from the event as it occurred); 
• 
Inpatient hospitalization or prolongation of existing hospitalization; 
• 
Persistent or significant disability/incapacity; 
• 
congenital anomaly/birth defect; or 
when the event does not fit the other outcomes but, based upon appropriate medical judgement, may 
jeopardize the subject's health and may require medical or surgical intervention to prevent one of the 
other outcomes. 
8.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
 There will be no classification of adverse events for this minimal-risk study. 
8.2.3.1 SEVERITY OF EVENT 
 The severity of all AEs will be characterized as "mild, moderate, or severe" according to the following 
definitions: 
Mild 
An event that does not have an impact on the 
patient 
Moderate 
An event that causes the patient some minor 
inconvenience 
Severe 
 
Potentially Life-Threatening 
 
Death 
 
An event that causes substantial disruption to the 
patient's well-being.  
An event that places the subject at immediate risk 
of death 
An event resulting in death 
 

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8.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 All AE's will be categorized according to the likelihood that they are related to the study intervention, 
using the following terms: 
• 
Unrelated to study intervention 
• 
Possibly related to study intervention 
• 
Probably related to study intervention 
or 
• 
Definitely related to study intervention 
8.2.3 EXPECTEDNESS 
 Due to the severity of illness present in the study population, unrelated, adverse events are expected to 
happen during this study that result in worsening of existing medical conditions, hospitalizations, life-
threatening events and/or death.  All adverse events will be documented and reported to the DSM and 
reported on a yearly basis.  
8.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 Given that no adverse events are expected related to this minimal risk intervention, adverse events will 
be documented and assessed as they occur and will be followed until resolution. 
8.2.5 ADVERSE EVENT REPORTING 
 Adverse events must be promptly documented and recorded. All adverse events observed or reported 
must be recorded, regardless of causality and/or clinical significance.  
8.2.6 SERIOUS ADVERSE EVENT REPORTING 
 Unexpected and/or intervention-related serious adverse events will be reported by the principal 
investigator within 24 hours to the independent monitor. A report will also be sent to the University of 
North Carolina IRB and the NIH in accordance with requirements. 
  
Anticipated or unrelated serious adverse events will be reported by the principal investigator within one 
week to the independent monitor. A report will also be sent to the University of North Carolina IRB and 
the NIH in accordance with requirements on an annual basis.  
 
 
 

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8.3 UNANTICIPATED PROBLEMS 
8.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 An Unanticipated Problem (UP) is any incident, experience, or outcome that: 
• 
Is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB -approved research protocol and informed 
consent document; an(b) the characteristic of the participant population being studied; 
• 
Is related or possibly related to a participant's participation in the research; and 
• 
Is serious or suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) that was previously known or recognized.  
8.3.2 UNANTICIPATED PROBLEM REPORTING 
 All unanticipated problems must be reported to the IRB within 7 calendar days of the event. 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
Specific aims of this research study include: 
1. Evaluate the efficacy of Connect-Home to improve SNF patient and caregiver preparedness for care at 
home.  
a. Hypothesis 1a: Compared to patients enrolled in control periods, Connect-Home patients will 
experience greater preparedness for discharge (primary outcome, measured with the CTM-15), 
assessed 7 days after discharge home 
b. Hypothesis 1b: Compared to caregivers of patients enrolled in control periods, Connect-Home 
caregivers will experience greater preparedness for caregiving (primary outcome, measured with 
the Preparedness for Caregiving Scale), assessed 7 days after discharge home.  
2. Evaluate the efficacy of Connect-Home to improve SNF patient and caregiver outcomes after discharge 
home. 
a. Hypothesis 2a: Compared to patients enrolled in control periods, Connect-Home patients will 
experience better quality of life and function (secondary outcomes), and fewer falls requiring 
medical assistance (exploratory), measured 30 and 60 days after discharge home 
b. Hypothesis 2b: Compared to caregivers from control periods, Connect-Home caregivers will 
experience less burden and caregiver distress (secondary outcomes), measured 30 and 60 days 
after discharge home 
3. Evaluate the efficacy of Connect-Home to prevent acute care use up to 60 days after SNF discharge.  
a. Hypothesis 3a: Compared to patients enrolled in control periods, Connect-Home patients will 
have fewer days of acute care use (composite of emergency department and hospital use) 
(secondary outcome) and more hospice enrollment (exploratory), measured 30 and 60 days after 
discharge home 
 
9.2 SAMPLE SIZE DETERMINATION 
Computer simulations were used to calculate statistical power for comparing control (standard 
discharge procedures) and intervention (Connect-Home) conditions for primary outcomes and selected 
secondary outcomes. For each scenario,  1000 simulated datasets were generated with outcomes 
clustered within SNFs for the stepped-wedge design in Figure 2 and the respective linear mixed models 
(Log CTM-15, Preparedness for Caregiving Scale, MQoL-R, Life Space Assessment, Zarit Caregiver Burden 
scale) and MZIP random intercept model (Days of acute care use). Based on preliminary data for Aim 1, 
we assumed that the group difference in log CTM-15 scores was θ=0.15. We also assumed that 
responses from patients within the same SNF in the same period would have an intra-cluster correlation 
of 0.10 (ICCW).  We assumed that responses from patients or caregivers in the same site but from 
different periods would have an intra-cluster correlation of 0.05 (ICCB); together with the total variance 
of the outcome (SD2), these values determine   and in the linear mixed models of Aims 1 and 2. Under 
these assumptions and accounting for 23% dropouts, 277 patients at 7 days post-discharge will provide 
89% power to detect an increase of 0.15 in the mean log CTM-15 score (equivalent to a 16% increase in 

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the mean CTM-15 score) among intervention patients relative to control patients, using a two-sided test 
at the 5% significance level. Power for Caregiver Preparedness is similarly determined.  Power for 
secondary outcomes at 30 days post-discharge assumes a 30% dropout rate. For the control group in 
Aim 3, we assumed a prevalence of 22% of patients having at least one day of acute care use and, 
among those patients, a truncated-at-zero mean of 4.0 days. These assumptions imply that the overall 
mean number of acute care use days is 0.881 and the excess zero probability is 0.776. For the 
intervention group, we assumed an overall mean acute care use days of 1.8 and excess zero probability 
0.685. Thus, assuming 30% dropout and (optimistically) zero intraclass correlation within SNFs, the MZIP 
model for independent outcomes has 82% power (not shown); however, the MZIP model with empirical 
standard errors adjusting for possible clustering within SNFs has 71% power. If there is positive 
intraclass correlation, power will be lower. However, for days of acute-care use within 60 days of 
discharge, power is higher than for 30 days due to higher prevalence and mean number of days of acute 
care use. 
 
9.3 POPULATIONS FOR ANALYSES 
An intent to treat analysis will be used in which all patients/caregivers are included in the analysis 
according to their treatment allocation at enrollment, regardless of whether they receive the full 
intervention. 
 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
  
Descriptive statistics will be used for all variables. If patients or caregivers with missing covariates are 
few (< 5%), unconditional mean imputations will be used to impute missing values for continuous 
covariates and unconditional mode imputation for categorical covariates. If 5%-15% of patients or 
caregivers have missing covariates, conditional mean imputation will be used. If missing covariate data 
exceed 15%, multiple imputation will be used. Missing outcomes will not be imputed. For continuous 
variables that are highly skewed, the statistical team will log-transform the data for analysis. All 
statistical tests will be two-tailed with 0.05 significance levels. Also, descriptive statistics will be used to 
describe intervention fidelity (receipt, delivery and enactment). Finally, in the absence of strong 
temporal effects, balance in covariates is expected between control and intervention patients; 
supplemental analyses will involve assessing the impact of the covariates (i.e., insurance provider, SNF 
length of stay, race, gender, and others determined with bivariate analyses) on outcomes in the 
statistical models for aims 1-3.  
 
Finally, to determine the extent the intervention effect can be attributed to home health care use, a 
general multilevel approach will be used to causal mediation analysis to evaluate home health care use 
as a mediator for intervention effect on outcomes as a secondary analysis. This approach uses two 

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random effects models within the counterfactual framework: 1) for the mediator (number of days of 
home health care use) as a function of treatment condition and covariates and 2) for the outcome as a 
function of treatment condition, mediator, and covariates. Outputs include indirect and direct effects of 
the intervention. 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
  
In the models for patient preparedness for discharge (CTM-15 score), data will be included that was 
provided by the patient or by caregiver (for patients that are not able to answer survey questions). We 
will use hierarchical linear models (HLM) to compare observations between intervention and usual care 
periods for CTM-15 score at seven days post-discharge. Linear mixed models or HLM allow for different 
numbers of patients per site, while accounting for correlated responses between patients within the 
same SNF. Let Yijk denote the CTM-15 score for patient k in SNF i and period (enrollment month) j; (i = 1, 
6; j = 1, …, 22). The basic HLM is, where is an intercept term, is a random effect for SNF, accounts for a 
potential linear temporal trend,  is a random effect for period j nested within SNF i, is an indicator for 
the treatment condition (i.e., 1 if Connect-Home; 0 is standard discharge procedures), θ is the treatment 
effect, and  is an error term. Furthermore, we assume a variance components structure such that all 
random effects are independent with, and where subscripts “c”, “p” and “e” denote cluster (i.e., SNF), 
period and error variance components, respectively. The correlation structure induced by these random 
effects allows the within-SNF correlation of outcomes from two patients enrolled in the same month 
(ICCW) to be different from the within-SNF correlation of outcomes from patients enrolled in different 
months (ICCB). Specifically, by denoting the total variance, the intraclass correlations are ICCW =, and ICCB 
=.  For CTM-15, the basic HLM model will be amended by including additional explanatory variables as 
fixed effects: CTM-15 score source (patient or caregiver), patient age, gender and race. Due to skewness 
of the CTM-15 score distribution found in our preliminary data, we expect this outcome will be log-
transformed prior to analysis. The group difference in log CTM-15 scores (intervention vs. control) across 
the study periods will be estimated along with a 95% confidence interval. A sensitivity analysis will be 
conducted to assess whether the effect of Connect-Home depends on the number of months that an 
SNF has been operating under the Connect-Home protocol. This is achieved by extending the HLM so 
that separate effects of Connect-Home are estimated when the Connect-Home protocol has been 
implemented for ≤ 3 months versus > 3 months in order to examine whether the impact of Connect-
Home is sustained three months following its initial implementation in the staff training period. A similar 
linear mixed model will be applied for the Preparedness for Caregiving outcome, except that respondent 
source is not included.  
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
  
In Aim 2, linear mixed models will be used that are extensions of those in the Aim 1 analysis for the 
analysis of quality of life (MQoL-R), patient function (Life Space Assessment), patient falls (exploratory 
outcome), caregiver burden (Zarit scale) and distress (Distress Thermometer). The statistical team will 
augment the basic HLM in the Aim 1 analysis with a random effect for patients and additional fixed 
effects for visit and treatment by visit interactions to model the day 30 and 60 outcomes simultaneously 

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as repeated measures. A statistically significant visit by treatment condition interaction would indicate 
that the impact of Connect-Home varies according to elapsed days since discharge. Because the main 
interest is in day 30 and 60 outcomes, differential treatment effects will be examined at these two time 
points and, if differences exist, estimate the effect of the Connect-Home intervention and its 95% 
confidence at each time point. In hypothesis 2b, separate Poisson mixed models will be used with log 
link for each post-discharge time point in the assessment of the intervention effect on falls with a similar 
structure for fixed and random effects as described in the Aim 1 analysis. Therefore, instead of modeling 
the repeated outcomes as the number of falls between day 0-30 and between days 31-60, 
respectively, the statistical team will separately model the cumulative number of falls by day 30 and 60, 
respectively, to assess whether the Connect-Home intervention reduces the cumulative fall rates post-
discharge at these two time points. We will estimate the incident rate ratio and its 95% confidence 
interval. 
  
The main outcome for Aim 2.3, the number of cumulative days of acute care use, (i.e., days due to re-
hospitalizations and emergency department visits), will be modeled using separate marginalized zero-
inflated Poisson (MZIP) models with log link. The statistical team will test and estimate the overall effect 
of Connect-Home relative to standard discharge procedures through exponentiation of the treatment 
regression coefficient for the overall mean as an incidence rate ratio (IRR) and its 95% confidence 
interval, basing these on empirical standard errors to allow for possible intraclass correlation within 
SNFs. MZIP was chosen over the standard ZIP model because although a large number of zero counts 
(event outcomes) are anticipated, the overall exposure effect of Connect-Home is of interest, and not its 
effect on an unobserved subpopulation (i.e., latent class). Separate time point-specific generalized linear 
mixed models (GLMM) with logit link  will be used for the binary outcome of whether a resident visited 
the ED within 30 or 60 days of discharge, respectively, from the SNF. This model type is an extension of 
ordinary logistic regression that includes random intercepts and period effects for SNFs to account for 
the within SNF correlation induced by the stepped-wedge design. A similar GLMM will be applied to 
compare the proportion of hospice referrals between standard discharge procedures and Connect-
Home. When events are sparse, SNFs will be treated  as fixed effects to mitigate model non-
convergence problems. 
9.4.4 BASELINE DESCRIPTIVE STATISTICS 
 Co-variate data will be collected about patients in person and from the medical record. Data about 
caregivers will be collected in person or by phone. 
Patient data collected in person: 
• 
Frailty (Study of Osteopathic Fractures Index)47 
• 
Social support (ENRICHD Social Support Inventory)48 
Patient data collected with SNF chart abstraction: 
• 
Demographics 
• 
Health insurance status (Medicare Advantage/Medicare fee-for-service/Medicaid/private) 

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• 
Living arrangements before index hospitalization 
• 
Medical history (primary diagnosis in the hospital discharge summary, hospital care (critical care, surgery 
and length of stay) 
• 
Depression (Minimum Data Set section D)49 
• 
Function (Minimum Data Set section GG)49 
• 
Cognitive status (Minimum Data Set section C)49 
• 
SNF care (i.e., SNF length of stay, urgent or acute treatment while in the SNF)49 
• 
Discharge destination 
Using the problem list in the medical record, the Charlson Comorbidity Index scores will be calculated 
for each patient.50 
  
Patient data collected with Home Health Care chart abstraction: 
• 
Number of days of home health care use in 30 and 60 days after SNF discharge40 
Caregiver data collected in person or by phone: 
• 
Demographics 
• 
Relationship to patient 
• 
Living arrangements 
• 
Employment 
• 
Count of days per week providing patient care. 
  
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
 The informed consent process will be held with consideration to the patients' privacy. The consent 
discussion will be led by study personnel delegated to conduct the consent process. The study subjects 
will have the opportunity to read through the consent form, while study personnel will explain the 
consent form to the subject. The study subject will have the opportunity to ask any questions they may 
have regarding the consent before signing. A copy of the consent will be given to the patient for their 
records, and the consent process will be documented in each study subject's file. 
 
Consent could also be obtained verbally in the situation that a participant is unable to physically sign 
these documents or if risk mitigation procedures, related to the COVID-19 pandemic in the nursing 
homes, require that virtual contact (with an iPAD via Zoom) is needed. When this occurs, the study team 
will document in study records that the full consent form was read to the subject and/or LAR as well as 
any notes of the consent conversation.  
  
For the caregivers in this study, informed consent will be obtained through an IRB approved verbal 
consent script. The study team will take the same considerations for consent in these instances as they 
do for patient written consent and will document the caregivers' responses.  
  
In cases where the subject has a cognitive impairment, the subject's legally authorized representative 
will be involved in the consent process in place of the patient. The same procedure as detailed above 
will be followed by study personnel.  
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 The study team will provide a copy of the signed consent form to all participants who consent to the 
study. For cases where virtual consent is necessary, copies of blank consent forms will be provided to 
staff in the nursing homes so that they can be provided to the participants. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 The study team will document the informed consent process on a paper form. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 The study team will retain all study files for the duration of time that is required by the UNC IRB and/or 
the NIH.  When the required time for retaining the identifiable data expires, all files with identifiers will 
be destroyed.  
 

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10.1.3 CONFIDENTIALITY AND PRIVACY 
  
The study team will use multiple procedures to protect confidentiality, including: 
• 
Using study codes on data documents; 
• 
Keeping a separate document that links the study code to subjects’ identifying information locked in a 
separate location, to be stored on password-protected, encrypted computers; 
• 
De-identification of data to remove the possibility that data could be connected to individuals that 
consented to participate in the study; 
• 
Encrypting identifiable data; 
• 
Securely storing data documents within locked locations.   
All identifying information will be destroyed at the earliest possible time following completion of the 
study.  In addition, data will be reported in aggregate form, without identifying information by site or 
individual.  Publications arising from the study will not contain personal information.   
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
 No identifiable data will be shared beyond the study team nor used in future studies. 
10.1.5 SAFETY OVERSIGHT 
  
This study will require a Data Safety Monitoring Committee and Plan.  An Executive Committee and 
Adverse Event Monitoring Committee will be created to assure that the study meets expectations and 
any risk to participants are reduced to a minimum.  These committees will meet on a regular basis as 
laid out in the Data Safety and Monitoring Plan.  
 
Study progress and safety will be reviewed monthly (and more frequently if needed).  Progress reports, 
including patient recruitment, retention/attrition, and AEs will be updated regularly and distributed to 
the committees on a frequent schedule laid out in the Data Safety and Monitoring Plan.  An annual 
report will be compiled and will include a list and summary of AEs. In addition, the annual report will 
address (1) whether adverse event rates are consistent with pre-study assumptions; (2) reason for 
dropouts from the study; (3) whether all participants met entry criteria; (4) whether continuation of the 
study is justified on the basis that additional data are needed to accomplish the stated aims of the study; 
and (5) conditions whereby the study might be terminated prematurely. The annual report will be 
signed by the independent monitor and will be forwarded to the IRB and NIH. The IRB will review 
progress of this study on an annual basis. 
 
 
 

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10.1.6 CLINICAL MONITORING 
  
The Independent Monitor for this study is Dr. Linda Beeber, Professor of Nursing at the University of 
North Carolina; she is an expert in clinical trials research with a long history of NIH funded research.  Dr. 
Beeber is not associated with this research project, and she is qualified to review the patient safety data 
generated by this study because of her unique expertise in the area of clinical trials research.  
 
10.1.7 QUALITY ASSURANCE AND QUALITY CONTROL 
  
The study team will review all data collection forms on an ongoing basis for data completeness and 
accuracy as well as protocol compliance.  A statement reflecting the results of the review will be sent to 
the NIH in the annual report (non-competing continuation).   
 
10.1.8 DATA HANDLING AND RECORD KEEPING 
10.1.8.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
 All data collected by the study team will be kept in strict confidence, and all data will only be identified 
using an identification code unique to the subject. 
  
The database used to manage the data will be secured with password protection, and it will only be 
available to members of the study team. This database only includes coded information, and data are 
entered into the database under those identification numbers. Electronic communication with outside 
collaborators involves only unidentifiable information. The study database will comply with current data 
security standards, and will provide real-time data entry validation, and will provide audit trails 
documenting any changes or corrections of the study data.  Data entry or review will require logging into 
a secure portal with a username and password.  The database is hosted by the School of Nursing at the 
University of North Carolina-Chapel Hill and is HIPAA-compliant.  Explicit identifying information will be 
recorded on separate forms and will NOT be sent to the database; these forms will be maintained in a 
secure  
10.1.8.2 STUDY RECORDS RETENTION 
 Study records will be retained per NIH guidelines. 
10.1.9 PROTOCOL DEVIATIONS 
 All protocol deviations will be promptly reported to the principal investigator and logged on a protocol 
deviation log. All deviations that are classified as unanticipated problems will be reported to the IRB 
within 7 days of the event. 

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10.1.10 PUBLICATION AND DATA SHARING POLICY 
 No identifying data will be shared for this study.  All results will be shared as de-identified and 
aggregated data.   
 
Publications arising from the study will not contain personal information.   
10.1.11 CONFLICT OF INTEREST POLICY 
The University of North Carolina at Chapel Hill's Policy on Conflicts of Interest and Commitment includes 
a rebuttable presumption that an investigator may not conduct human subjects’ research that is related 
to a financial interest of the investigator (or immediate family) except in compelling circumstances. 
Compelling circumstances are those facts that convince the reviewer that a covered individual who has a 
financial interest should be permitted to conduct human subjects’ research, taking into account the 
following factors: 
• 
The nature of the research,  
• 
The nature and magnitude of the financial interest  
• 
How closely the financial interest is related to the research 
• 
The extent to which the interest may be affected by the research  
• 
The degree of risk to the human subjects involved that is inherent in the research protocol  
• 
The extent to which the investigator is uniquely qualified to perform a research study with important 
public benefit  
• 
The extent to which the interest is amenable to effective oversight and management.  
The applicable UNC-Chapel Hill COI Chair and/or Committee takes into these criteria into account when 
reviewing any disclosed conflict of interest in the context of the human study. 
• 
The COI Chair or Committee considers the following factors into their review: How the research is 
supported or financed, 
• 
The nature and extent of the conflict,  
• 
The role and responsibilities of the conflicted individual in the design, conduct, and reporting of the 
research, and  
• 
The ability of the conflicted individual to influence the outcome of the research. 
The IRB has final authority to determine whether the research, the COI, and the related management 
plan, if any, allow the research to be approved. 

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10.2 ABBREVIATIONS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CTM-15 Care Transitions Measure-15 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
EHR 
Electronic Health Record 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MQoL-R McGill Quality of Life Questionnaire-Revised 
MSDS 
Material Safety Data Sheet 

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NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PCS 
Preparedness for Caregiving Scale 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RN 
Registered Nurse 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SNF 
Skilled Nursing Facility  
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SW-CRT Stepped-Wedge Cluster-Randomized Trial 
UP 
Unanticipated Problem 
US 
United States 
 
 
10.3 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
 2.0 
2020Jul02 
 Addition of virtual recruitment 
methods due to COVID-19 risk 
mitigation procedures 
Because in-person interactions 
will not be possible during 
COVID-19 risk mitigation 
periods, virtual recruitment and 
study retention methods needed 
to be initiated within this study 
protocol.   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 

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