Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
Phase: NA
Conditions: Emergencies, Aging
Sponsor: University of Wisconsin, Madison

 
Protocol  10October2016 (Version #2)                                                                                                    Page 1 of 41 
UW IRB# 2015-1197 
 
Paramedic-coached ED Care Transitions to Help Older Adults Maintain their 
Health 
 
NCT02520661 
 
PI: 
Manish N. Shah, MD MPH 
 
UW School of Medicine and Public Health 
 
Department of Emergency Medicine 
 
608-890-7187 
 
mnshah@medicine.wisc.edu 
 
Co-I: 
Amy JH Kind, MD PhD 
 
UW School of Medicine and Public Health 
 
Department of Medicine, Division of Geriatrics 
 
2500 Overlook Terrace 
 
608-280-7000 
 
ajk@medicine.wisc.edu  
 
 
 
Eva DuGoff, PhD MPP 
 
UW School of Medicine and Public Health 
 
Department of Population Health Sciences 
 
608-263-2082 
 
dugoff@wisc.edu  
 
 
 
Courtney MC Jones, PhD MPH 
 
University of Rochester School of Medicine & Dentistry 
 
Department of Emergency Medicine 
 
585-275-1206 
 
Courtney_Jones@urmc.rochester.edu 
 
Coordinator: Tisha N Kawahara, MS, CCRC 
 
UW School of Medicine and Public Health 
 
Department of Emergency Medicine 
 
 
tkawahara@medicine.wisc.edu  
 
Sponsor: 
National Institutes of Health / National Institute on Aging 
 
Participating 
Sites:  
UW Hospital & Clinics Emergency Department 
 
 
University of Rochester Medical Center 
 
 
 
-Strong Memorial Hospital Emergency Department 
 
 
 
-Highland Hospital Emergency Department 
 
 
 

 
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TABLE OF CONTENTS 
 
1.0 
PROJECT SUMMARY / ABSTRACT…………………………………………………… 
3 
2.0 
PURPOSE OF THE STUDY AND BACKGROUND…………………………………… 
3 
2.1 
PURPOSE OF THE STUDY & AIMS…………………………………………………… 
3 
2.2 
BACKGROUND EDs Care for A Large and Growing Number of Older Adults……. 
4 
2.3 
PRELIMINARY WORK…………………………………………………………………… 
6 
3.0 
STUDY DESIGN………………………………………………………………………….. 
7 
3.1 
OVERVIEW………………………………………………………………………………… 
7 
3.2 
RATIONALE FOR STUDY DESIGN AND MEASURES……………………………… 
7 
3.3 
RATIONALE FOR INTERVENTION……………………………………………………. 
8 
4.0 
CHARACTERISTICS OF THE RESEARCH POPULATION…………………………. 
9 
4.1 
SUBJECT CHARACTERISTICS………………………………………………………… 
9 
4.2 
INCLUSION AND EXCLUSION CRITERIA……………………………………………. 
10 
4.3 
DISCUSSION OF SUBJECT POPULATION…………………………………………… 
11 
5.0 
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT…………………… 
11 
5.1 
METHOD OF SUBJECT IDENTIFICATION AND RECRUITMENT…………………. 
11 
5.2 
PROCESS OF CONSENT……………………………………………………………….. 
12 
6.0 
METHODS…………………………………………………………………………………. 
13 
6.1 
CTI CLINICAL PROGRAM & ITS PROCESSES (only for the  
INTERVENTION GROUP)……………………………………………………………….. 
 
13 
6.2 
USUAL CARE (CONTROL) GROUP…………………………………………………… 
14 
6.3 
RESEARCH PROCESSES………………………………………………………………. 
14 
6.4 
EFFICACY ASSESSMENTS…………………………………………………………….. 
15 
6.5 
COSTS TO THE SUBJECT………………………………………………………………. 
16 
6.6 
PAYMENT FOR PARTICIPATION………………………………………………………. 
16 
6.7 
RETURN OF INDIVIDUAL RESEARCH RESULTS/MANAGEMENT  
OF HEALTH FINDINGS…………………………………………………………………… 
 
16 
7.0 
SUBJECT WITHDRAWALS………………………………………………………………. 
16 
8.0 
SAFETY AND REPORTABLE EVENTS………………………………………………… 
17 
8.1 
UNANTICIPATED PROBLEM DEFINITION……………………………………………. 
17 
8.2 
RECORDING UNANTICIPATED PROBLEMS…………………………………………. 
17 
8.3 
SERIOUS ADVERSE EVENT……………………………………………………………. 
17 
8.4 
RESPONSIBILITIES FOR REPORTING SERIOUS ADVERSE EVENTS………….. 
18 
9.0 
RISK/BENEFIT ASSESSMENT………………………………………………………….. 
18 
9.1 
POTENTIAL RISKS……………………………………………………………………….. 
18 
9.2 
PROTECTION AGAINST RISKS………………………………………………………… 
18 
9.3 
POTENTIAL BENEFITS TO SUBJECTS……………………………………………….. 
19 
9.4 
ALTERNATIVES TO PARTICIPATION…………………………………………………. 
19 
10.0 CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE…………………. 
19 
11.0 RESEARCH INFORMATION IN MEDICAL RECORDS………………………………. 
20 
12.0 DATA ANALYSIS AND MONITORING…………………………………………………. 
20 
12.1 SAMPLE SIZE DETERMINATION………………………………………………………. 
20 
12.2 PLANNED STATISTICAL ANALYSIS…………………………………………………… 
20 
12.3 DATA AND SAFETY MONITORING…………………………………………………….. 
23 
13.0 REFERENCES……………………………………………………………………………… 
23 
 APPENDIX A    DATA AND SAFETY MONITORING PLAN……………………………………    27 
 
 
 
 

 
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1. 
PROJECT SUMMARY / ABSTRACT 
Older adults use the emergency department (ED) as an important source of acute care, making 20 
million ED visits annually. Most older adults who visit the ED do not have conditions of sufficient severity 
to warrant hospital admission; thus, they are treated and discharged home. Unfortunately, older adults do 
poorly after being discharged home from the ED, with 20% having repeat ED visits within 30 days. The 
ED-to-home transition has been identified as a cause for these avoidable poor outcomes, but ED-
focused interventions to improve this transition have had inconclusive outcomes and have suffered from 
feasibility, sustainability and scalability problems.   
 
Coleman’s Care Transition Intervention (CTI) has been validated and is widely used to improve the 
hospital-to-home transition, decreasing both hospital readmissions and costs. The CTI uses coaches, 
usually nurses or social workers but also lay people, to support patients who are being discharged home 
by transferring skills to activate patients. Applying the CTI to the ED-to-home transition is a natural 
extension, but it has not been evaluated in this unique and demanding setting. 
 
In this study, we will test our overall hypothesis that the community-based, paramedic-coordinated 
ED-to-home CTI will improve community-dwelling older adults’ post-ED health outcomes and 
reduce costs. We will evaluate CTI process outcomes by testing if participants randomized to the CTI 1) 
demonstrate better understanding of red flags that indicate a worsening of their condition, 2) implement 
required medication changes more frequently, 3) and follow up with their primary care physicians more 
rapidly after ED discharge, as compared to patients in the control group who receive usual care. We will 
also evaluate the effectiveness and cost-effectiveness of the CTI by testing if participants randomized to 
the CTI have 1) improved Patient Activation Measure scores 30 days after discharge, 2) have decreased 
frequency of ED visits, and 3) decreased health care costs within 30 days of ED discharge. To assess 
this, we will also measure differences in PCP, specialist, and urgent care visits.  Additionally, we 
recognize that the CTI will not eliminate all repeat ED visits. Thus, we will identify factors independently 
associated with repeat ED visits among CTI recipients such that future programs can ensure their needs 
are adequately addressed.   
 
 
2. 
PURPOSE OF THE STUDY AND BACKGROUND 
2.1. 
PURPOSE OF THE STUDY & AIMS 
The emergency department (ED) is an important source of acute care for the 40 million older adults 
(age≥65) living in the US. In 2010, older adults made 20 million ED visits, 11 million of which resulted in 
the patient being discharged home.1 Older adults do poorly after being discharged home from the ED, 
with approximately 20% of these patients needing a repeat ED visit within 30 days.2,3,4,5,6,7,8,9,10 With the 
older adult population doubling by 2040, the frequency of these adverse events will increase 
unless interventions improve older adults’ ED-to-home transitions. 
 
Frequent hospital readmissions led to the development, validation, and widespread implementation of 
the Coleman Care Transitions Intervention (CTI) to improve the hospital-to-home transition.11,12,13 In 
contrast, only a few programs have been tested to improve ED-to-home transitions for older adults, 
which are almost as frequent as hospital-to-home transitions (11 vs. 13.5 million/year).14 Unfortunately, 
these ED-focused programs have demonstrated little success.15,16,17,18,19,20,21,22  
 
Our multi-disciplinary team, which has a history of successful academic-community collaborations to 
study the care delivered to acutely ill older adults, includes researchers and community partners. Building 
upon our extensive experience in geriatric emergency medicine and prehospital medicine, as well as 
Coleman’s work, we will apply the CTI to the ED setting, utilizing ambulance-based paramedics to 
improve the ED-to-home transition. Overall, we hypothesize that our community-based, paramedic-

 
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coordinated, patient-centered, ED-to-home CTI program will improve older adults’ post-ED 
outcomes. We will test this hypothesis in four aims:  
 
1. Implement a community-based, paramedic-coordinated, patient-centered, ED-to-home CTI program 
in Madison, WI and Rochester, NY for older adults treated in the ED and discharged home. 
 
2. Assess the process outcomes of our ED-to-home CTI program for older adults treated in the ED and 
discharged home, as compared to usual care.  
 
Hypothesis 1A: More CTI participants will demonstrate understanding of their ED discharge 
instructions, red flags that indicate a worsening of their condition, and how to respond to the red flags 
four days after ED discharge. 
 
Hypothesis 1B: More CTI participants will implement medication changes made in the ED within four 
days of ED discharge.  
 
Hypothesis 1C: CTI participants will have shorter time-to-follow-up with their primary providers. 
 
3. Determine the effectiveness and cost-effectiveness of the ED-to-home CTI program for older adults 
treated in the ED and discharged home, as compared to usual care.  
 
Hypothesis 2A: CTI participants will have increased patient activation 30 days after discharge.  
 
Hypothesis 2B: CTI participants will have lower odds of repeat ED use within 30 days of discharge. 
 
Hypothesis 2C: CTI participants will have lower estimated healthcare costs within 30 days of 
discharge.  
 
4. Identify biomedical and psychosocial factors independently associated with repeat ED visits within 30 
days of ED discharge among ED-to-home CTI program participants. 
 
Hypothesis 3A: Biomedical factors associated with increased odds of repeat ED visits include 
increased age, increased number of comorbidities, impaired cognition, and limited functional status. 
 
Hypothesis 3B: Psychosocial factors associated with increased odds of repeat ED visits include 
reduced social connectedness, increased anxiety symptoms, and increased depressive symptoms.   
 
In this study, we will apply evidence-based findings to evaluate a program to help older adults remain 
healthy and independent after ED care. We will address a significant deficiency in the delivery of quality 
care for a uniquely vulnerable population: the ED-to-home transition of acutely ill older adults who do not 
require hospital admission. We will use an innovative approach by adapting the widely used CTI, which 
has been validated for hospital-to-home transitions, and deliver the services using paramedics, an 
underused, highly-skilled, and highly-respected resource present in all communities. This evidence will 
guide further efforts to optimize older adults’ health following an ED visit, including dissemination and 
implementation of this ED-to-home CTI program and development of new approaches to target patients 
with repeat ED visits. 
 
2.2. 
BACKGROUND 
EDS CARE FOR A LARGE AND GROWING NUMBER OF OLDER ADULTS 
EDs are critical sources of acute, unscheduled care in the United States, with 28% of all acute illness 
encounters occurring in an ED.23 In 2009, older adults (age≥65) in the US accessed the ED for care 20 
million times, a 27% increase from 2001.1 Of these ED visits, 11 million (55%) did not require inpatient 
hospitalization and were discharged home after ED care.  
 
ED patients discharged home are not traditionally considered at risk for poor outcomes, as they do not 
have an illness of sufficient severity to warrant hospital admission. However, older adult ED patients are 
medically complex, with 33% having 3 or more chronic conditions and 41% taking 5 or more medications; 
additionally, they have poor outcomes such as readmission, nursing home placement, or death.24,25 In 
the 30 days after an ED visit, approximately 20% of older adults return to the ED for further 
care.2,3,4,5,6,7,8,9 9 Many consider these poor outcomes to be avoidable. 26,27 

 
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Of notable concern is the under-studied ED-to-home transition, during which patients suddenly assume 
responsibility for their acute health needs within the context of their broader lives, a disruption that 
requires modification of daily routines and lifestyles. Research has found that older adults have difficulty 
with this responsibility and with prioritizing their health and non-health obligations.28,29,30 Patients 
experience challenges during this ED-to-home transition because the nature of the emergency care 
system precludes planned transitions, requires rapid discharge to make room for new patients, and is 
isolated from the PCP, home health, and social services. These challenges can be categorized into: 1) 
education and engagement and 2) follow-up.8,11,31  
  
Education and engagement: Prior to ED discharge, providers give the patient/caregiver verbal and 
written information, a process that lasts an average of 4 minutes.32 Unfortunately, 78% of patients have 
deficient comprehension33 and those with impaired cognition, common among older ED patients, are at 
greater risk of poor comprehension.33,34,35,36 Reasons for poor comprehension include instructions being 
provided without: 1) accounting for health literacy;37 2) including all necessary domains, such as 
medication changes (29%); 32 3) giving patients opportunities to ask questions (43%);32 and 4) confirming 
understanding (90%).32,38 Failure of ED providers to identify cognitively impaired patients further 
complicates the older adult’s discharge.39  
 
This failure to provide quality discharge instruction has broad implications. Older adults with limited 
health literacy are known to have increased risk of having repeat ED visits.40 Without clear information, 
medication changes may not be well-understood, leading to incomplete or incorrect therapy. Also, red 
flags, symptoms for which patients should seek medical attention, may not be well-understood, leading to 
patients either inappropriately delaying care or accessing care unnecessarily.11 
 
Follow-up: Patients are told to call their PCPs to obtain follow-up after ED discharge, as routine follow-
up visits may prevent complications, such as deteriorating health status or a return visit to the ED.4,22 
Unfortunately, studies have found that PCP follow-up appointments occur in as few as 32% of patients 
within 30 days of ED discharge.41,42,43 Explanations for this include barriers such as financial constraints, 
lack of transportation, functional limitations, and incomplete instructions related to follow-up 
care.32,38,44,45,46 Also, given the challenges patients face prioritizing their activities after ED discharge, 
without clear instructions and available PCP appointments, these follow-up visits often do not occur.28. 
The poor outcomes in this large and highly vulnerable population reflect avoidable morbidity and result in 
substantial avoidable costs; thus, they require investigation and intervention. 
 
COLEMAN’S CARE TRANSITIONS INTERVENTION (CTI) 
The CTI is a four-week long program designed to empower and support patients being discharged from 
the hospital (www.caretransitions.org). The program was designed to be low-cost, low-intensity, and 
capable of being implemented in a wide variety of settings. Furthermore, it recognizes the joint role of 
patients and family caregivers as participants in a quality transition. The program uses a care transitions 
coach, who can be a nurse, social worker, or community worker, who provides one visit in the hospital 
prior to hospital discharge, as well as one home visit and three phone calls after hospital discharge to 
help patients manage their health and address their needs. During these visits, the coach uses 
motivational interviewing to provide education, models behaviors, and take part in role-playing to help 
patients care for themselves more effectively. The coach focuses on the “Four Pillars” of the program, 
which address the key deficiencies in transitions identified by Coleman (Table 1).47 Coleman 
demonstrated that the hospital-to-home CTI is effective at reducing hospital readmissions and cost-
effective.12,13 Thus, the program has been widely disseminated and implemented.48,49 
 
The CTI has not been tested for the ED-to-home transition. However, our preliminary work has shown 
that the problems seen in the hospital-to-home transition are present in the ED-to-home transition; thus, 
we believe that the CTI can be appropriately and seamlessly applied to the ED-to-home transition. 
 

 
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Table 1: Conceptual Model of the Care Transitions Intervention: The Four Pillars 
 
Medication Self-
Management 
Follow-Up 
Red Flags 
Patient-Centered Record 
Goal 
Know medications & 
have a system to 
take them 
Schedule appropriate follow-
up visits 
Know indications that a 
condition is worsening 
and how to respond 
Understand and manage a 
personal health record 
Hospital 
Visit 
Discuss importance 
of knowing 
medications 
Recommend PCP follow-up 
Discuss symptoms and 
drug reactions 
Explain the personal 
health record 
Home 
Visit 
Reconcile 
medications; correct 
discrepancies 
Emphasize importance of 
follow-up visit; practice and 
role-play questions for the 
PCP 
Discuss symptoms and 
side effects of 
medications 
Review discharge 
summary; encourage 
patient to share health 
record with PCP 
Follow-
Up Calls 
Answer any 
remaining medication 
questions 
Provide advocacy in getting 
appointment, if needed 
Reinforce when / if PCP 
should be called 
Discuss outcome of PCP 
visit 
 
While the CTI reduces hospital readmissions, it does not eliminate them.  We anticipate some patients 
discharged from the ED will return for repeat care despite the CTI. We do not know which factors are 
independently associated with repeat ED visits. This study will identify the factors associated with repeat 
ED visits among CTI recipients such that their needs can be adequately addressed.   
 
THE EMERGENCY MEDICAL SERVICES SYSTEM (EMS) AND COMMUNITY PARAMEDICINE 
The ambulance-based EMS system is a unique component of the health care system. It is staffed with 
paramedics who traditionally provide in-home assessment, acute treatments, and transport to an ED 
immediately after a call for assistance.50,51,52 This service is uniform throughout urban, suburban, and 
rural communities and is available, regardless of day of week, time of day, or location.  
 
Although the EMS system’s potential to improve community health was recognized 20 years ago in the 
“EMS Agenda for the Future,” the role has only recently gained acceptance, being called community 
paramedicine or mobile integrated health care. 53,54,55,56 EMS providers have indicated a desire to 
participate in programs to promote community health.53,57,58 EMS providers are performing blood 
pressure screening and health education; educating on topics such as driving under the influence; 
delivering immunizations; performing home safety evaluations and fall risk assessments; assisting with 
advanced care directives programs; screening for elder abuse and neglect; and identifying patient’s 
needs and referring to other community programs  
 
2.3. 
PRELIMINARY WORK 
Dr. Shah and his team have worked to understand the supports and constraints that influence the older 
adult’s transition from the ED to the community. They recently completed a qualitative study of older 
adult ED patients who were discharged, with in-home interviews after ED discharge.59,60 They found the 
issues faced by patients immediately after ED discharge must be addressed through multiple strategies, 
a role that the CTI coach can play. Specifically, they found that older patients: 1) want to be healthy, but 
do not define health as a biomedical construct; 2) desire independence, but want assistance; 3) are busy 
with family commitments / life interests, but recognize that constraints exist; and 4) have tremendous 
difficulty obtaining follow-up care with their primary care physicians as well as acute illness care. Given 
the context in which these individuals live their lives, repeat ED visits may result without the appropriate 
support and empowerment. These issues map directly to the Four Pillars of the CTI, demonstrating the 
value of the CTI conceptual model in the ED-to-home transition.  
 
Dr. Kind and her team in Madison, WI have extensive experience studying the hospital-to-home 
transition of older adults.  She is among the national leaders in care transitions for older adults.  Her 
expertise with aging, aging specific issues in care transitions, and care transitions will directly enhance 
our ability to demonstrate the value of the CTI model in the ED-to-home transition.  
 

 
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In Rochester, NY, collaborators Lifespan and VNS have been delivering the CTI program for patients 
transitioning from the hospital to home for 4 years. They have reduced hospital admissions by 
approximately 50%. Their experience has shaped this proposal and supports its feasibility. Finally, Dr. 
Coleman originally developed the CTI and is the sole provider for coach training. He has worked with an 
ED to implement the CTI for patients discharged home from the ED and found no new feasibility 
challenges as compared to the hospital-to-home program. 61 Also, by providing training for all coaches, 
Dr. Coleman’s group has an expertise critical to effectively train the paramedic coaches.  
 
 
3. 
STUDY DESIGN 
3.1. 
OVERVIEW 
We will perform a randomized controlled trial of community-dwelling, older adult ED patients being 
discharged home to test the effect of a community-based, paramedic-coordinated, ED-to-home 
transitions program that has been validated in other settings.   
 
In performing this program evaluation, we will adapt the hospital-to-home CTI program to the ED-to-
home transition, and then we will test its outcomes. Specific research activities include: 
• 
We will identify, hire, and train paramedics to serve as the CTI coaches.   
• 
We will enroll 2400 older adults (age≥60) being discharged home from the ED at the University of 
Wisconsin Hospital & Clinics (1200 subjects) and the University of Rochester (UR) Medical 
Center-Strong Memorial Hospital or Highland Hospital (1200 subjects combined).  
• 
We will enroll up to 2400 primary caregivers of the patient subjects being discharged home. 
• 
We will randomize enrolled subjects to receive either the ED-to-home CTI (intervention group) or 
usual care (control group).  
• 
We will perform research assessments at baseline (in the ED) and again via phone 4 and 30 days 
after discharge. We will also collect additional data from medical and administrative records to 
test our hypotheses, as well as from up to one informal caregiver per enrolled older adult (Figure 
1).  
 
Intervention group subjects (CTI program) will receive one home visit and up to 3 telephone calls to 
support their transition and provide coaching, as per the CTI guidelines.  Control group subjects (usual 
care) will receive no additional services.  All study procedures will be standardized at both sites. 
 
Our analyses will provide empiric evidence on the value of this intervention, thereby guiding the 
dissemination and sustainability of such a program to improve older adults’ health after ED care. 
 
3.2. 
RATIONALE FOR STUDY DESIGN AND MEASURES 
We chose a randomized controlled trial, as it is the most rigorous study design and will allow us to 
directly compare the intervention against usual care.  The alternatives, a parallel cohort study or pre- 
post- study, would not have the same level of rigor, which would undermine study findings.  The 
consequence of this weaker design is that the findings would be less likely to be integrated into practice, 
thereby wasting the resources and the efforts by the participants.  Given the existing literature, we 
decided that a high quality randomized controlled trial would be appropriate.   
 
The primary outcomes chosen—process, effectiveness, cost effectiveness—allow us to develop the 
scientific evidence to test this intervention.  The robust measures are patterned on Coleman’s initial work 
and can speak to the value proposition for this model. The specific measures are as follows: 

 
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Figure 1: Research Framework, Aims, and Processes
Enrollment
Exit
Randomization
Intervention Group
Care Transitions 
Intervention (Figure 3)
4 Day Follow-Up
(Table 6)
Telephone survey on:
Four Pillars measures
Patient activation
30 Day Follow-Up
(Table 6)
Telephone survey on:
Patient activation
Health care use
Control Group 
Usual Care
Baseline Assessment
(Table 6)
ED survey & assessment:
Sociodemographic
Clinical
System
Aim 2: Program Process 
Outcomes
Test the differences in implementing 
medication changes, PCP follow up, and 
understanding discharge instructions / 
red flags between the groups
Aim 4: Factors Associated 
With Repeat ED Visits 
Among CTI Recipients
Associations between biomedical 
and psychosocial factors and 
repeat ED use.
Aim 3: Effectiveness & 
Cost-Effectiveness 
Outcomes
Test the differences in patient 
activation, ED use, and health 
care cost between the groups. 
 
 
Socio-demographic measures (Table 2, Section 1): Standard characteristics will be collected to 
compare the intervention and control groups and if necessary include these factors as covariates in our 
analyses. Health system structural factors will also be collected. 
 
ED care & CTI program clinical measures (Table 2, Section 2): We will collect the chief complaint and 
final diagnosis to evaluate differences between the intervention and control groups and to perform sub-
analyses on specific conditions (e.g., injury). We will collect discharge information for our outcomes 
assessment. Finally, we will measure the elapsed time for the clinical activities (e.g., coaching) to assist 
with sustainability and dissemination. 
 
Covariates (Table 2, Section 3): Factors that may affect older adults’ outcomes and will be collected to 
include in our analysis. Cognitive status, depression, anxiety, and social isolation are associated with 
worse outcomes and are critical measures.62,63,64,65,66  
 
Outcomes (Table 2, Section 4): To determine the fidelity of the CTI and the acceptability of the program 
to patients and caregivers, we must evaluate the Four Pillars and program satisfaction. This will occur 
through telephone surveys performed 4 and 30 days after ED discharge.  Additionally, as part of the CTI, 
the coaches measure patients’ progress in skill transfer. This information will also be collected. 
 
The CTI aims to improve patient activation, which is measured as having the skills, knowledge, and 
motivation to participate as effective members of the care team.67 We will use the Wallston Perceived 
Health Competency Scale. 
 
Upon study exit, we will measure our primary outcome, health care use within 30 days of ED discharge, 
through survey and administrative data from both local health systems and the insurers. We will also 
measure the costs of health care as well as the CTI program.  
 
We will check the Social Security Death Index for death within 30 days for all subjects.  
 
If a subject withdraws during follow-up, we will clarify the level of withdrawal that the subject is 
requesting—cessation of subject contact or removal from the study.  If the subject requests cessation of 
contact, we will continue to review the subject’s medical record to obtain health care use (e.g., ED use) 
outcomes. If a subject is admitted to a skilled nursing facility, which occurs in less than 2% of ED patients 
discharged home, we will track that outcome and measure those costs, but we will not survey those 
subjects.  
 
3.3. 
RATIONALE FOR INTERVENTION 
We will implement and test the CTI for the intervention group because of its demonstrated effectiveness 
and cost-effectiveness, its applicability to the ED patient discharged home, its efficiency, particularly 
relating to activities in the ED, and its widespread use.  We have chosen to use community-based 

 
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paramedics as the coaches for the CTI because these individuals are highly trained, available in all 
communities, and are highly respected by patients.  Thus, paramedics are able to perform these visits in 
follow up to ED visits rapidly.  Given that the CTI program has been tested using lay people, trained 
paramedics should be able to perform the required duties. 
 
 
Table 2: Measures 
 
Measures 
Time 
Source/Approach 
1. Demo - 
graphic
Patient age, gender, marital status, race, ethnicity, education 
level, primary language, home ownership, living status, home 
address 
ED 
Patient survey 
Patient relationship with PCP 
ED 
Patient survey 
Insurance plan / number 
ED 
Epic review 
Primary Care Medical Home certification level 
ED 
Health systems 
2. Clinical 
New home services (since ED visit) 
Day 30  
Patient survey 
ED medications prior to assessment, chief complaint, final 
diagnosis (ICD-10), discharge medications, and instructions 
ED 
Epic review 
CTI Coaching & Services Forms* 
   Personal Health Record (PHR) 
   Home Visit/PHR Discussion Checklist 
   Follow-up Phone Calls Checklist 
   Patient Activation Assessment  
   Medication Discrepancy Tool 
   Care Transitions Measure - 3 
CTI Coach home 
visit & coach follow 
up calls 
CTI program records 
3. Covariates 
Medical history, including Charlson Comorbidity Index  
ED 
Patient survey 
Healthcare: Medications, home services, ED / hospital use  
ED 
Patient survey/ Epic review 
Health Status: Short Form-1268 
ED 
Patient survey 
Disability Status: ADL69 
ED 
Patient survey 
Cognition: Short Blessed Test (BOMC) 
ED 
Patient survey 
Social Isolation: PROMIS Social isolation short form 
ED 
Patient survey 
Depression: PHQ-9 
ED 
Patient survey 
Anxiety: GAD-2 
ED 
Patient survey 
Health literacy 
ED 
Patient survey 
4. Outcomes 
 
 
 
Family Caregiver Activation in Transitions 
ED, Day 30   
Caregiver survey 
Understanding of red flags 
Day 4 
Patient survey 
Medication changes implemented 
Day 4 
Patient survey 
Follow up with PCP, specialists, urgent care 
Day 4, 30 
Patient survey / Epic review 
Wallston’s Perceived Health Competency Scale (PHCS)  
 
ED, Day, 30 
Patient survey, Caregiver 
survey 
Healthcare use within 30 days of discharge 
Day 30 
Patient survey / Epic review 
Death within 30 days of discharge (Social Security Death Index) 
Day 30 
Death Index 
 
Patient experiences of continuity 
Day 30 
Patient survey 
 
Cost of healthcare and CTI program  
Day 30 
Health systems, study 
 
Program satisfaction 
Day 30 
Patient, caregiver survey 
*All forms copyrighted by Dr. Eric Coleman 
 
 
4. 
CHARACTERISTICS OF THE RESEARCH POPULATION 
4.1. 
SUBJECT CHARACTERISTICS 
Number of Subjects:  We propose to enroll 2400 ED patient subjects into the study, with 1200 of the 
enrollments coming at UW and 1200 at UR Medical Center-Strong Memorial Hospital or UR Medical 
Center-Highland Hospital.  Of the 2400 subjects, 1200 will be randomized to the intervention group and 
1200 to the control group.  We will also enroll up to one informal caregiver per ED patient, resulting in up 
to 2400 additional subjects.  Thus, the total number of subjects potentially enrolled in this study is 4800. 
 
Gender and Age of Subjects:  All patient subjects will be age 60 years and older, as this is a concern of 
the older adult population.  Both men and women will be enrolled. 

 
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Informal caregiver subjects must be age 18 or older, and will be either male or female, depending on who 
is identified by the patient subject. 
 
Racial and Ethnic Origin:  Individuals of all races and ethnicities will be included.   
 
Vulnerable Subjects:  Older adults are the focus of this study as these problems are not as prevalent 
for younger individuals; thus evaluating transitional care for them is of likely little benefit and any 
developed knowledge may not be translatable to older adults.  We will implement safeguards to protect 
this population: 
 
1. The study staff will not be directly providing ED clinical care to the participants, thus eliminating any 
potential coercion.   
2. Decisional capacity will be evaluated by the RA obtaining consent to ensure that participants 
understand the risk and benefits of the study before obtaining informed consent, unless the Health 
Care Power of Attorney has already been activated.  The decisional capacity evaluation process that 
will be used has been approved by the UR IRB.  It assesses the potential subject’s understanding of 
the study.  This process is more conservative than the UW IRB policy “Research with Adult 
Participants Lacking Capacity to Consent” (Section II) as all subjects will be tested in this minimal risk 
study. The PI (Dr. Shah, emergency medicine), co-I (Dr. Kind, geriatrician), and project director 
(McDowell, psychology degree, extensive community health/social work experience working with 
vulnerable populations) will ensure that all RAs who conduct the capacity assessment will be fully 
trained. 
3. Informed consent to participate in the study will be obtained from patients.  Patients without 
decisional capacity will be included if a caregiver with responsibility for the patient’s health care 
consents to participation in the study. Priority of decision makers is as follows: 1) research power of 
attorney, if present; 2) court appointed guardian; 3) power of attorney for healthcare; 4) next of kin in 
the following order: spouse or registered domestic partner, adult child, parent, adult sibling, 
grandparent, adult grandchild, or close friend. 
4. Informed consent will be obtained from the caregiver if present in the ED.  The caregiver will be 
assessed for decisional capacity using the same methods as with the patient subject. Caregivers 
without decisional capacity will not be eligible to join study.  
 
4.2 
INCLUSION AND EXCLUSION CRITERIA 
Patient Inclusion Criteria 
Patient Exclusion Criteria 
Age≥60 years 
Previous study participation 
English speaking  
Active enrollment in or discharge to hospice 
Dane County, WI or Monroe County, NY resident 
Homelessness 
UW or UR affiliated PCP 
Behavioral health treatment as primary reason for 
ED visit 
Independent home dwelling (no prisoners, nursing 
home, assisted living) 
Participation in a transition care team program or 
intensive care management patient 
Discharge home from the ED 
ESI 1 patient (highest acuity, assigned by ED 
staff) 
Have a working telephone 
Unable to obtain consent from patient or proxy 
 
Caregiver Inclusion Criteria 
Caregiver Exclusion Criteria 
Age≥18 years 
Unable to obtain consent / no decisional capacity 
English speaking 
 
Able to understand and complete informed 
 

 
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consent 
Have a working telephone 
 
  
 
4.3 
DISCUSSION OF SUBJECT POPULATION 
We have chosen this subject population because the existing literature has indicated that this is the 
group that is of greatest risk after being discharged from the ED.  We have limited the population as per 
the exclusion criteria to: 1) maximize study rigor; 2) eliminate conflict with existing programs; 3) protect 
patient autonomy and safety.  We are enrolling only English-speaking subjects because, based on our 
previous studies, it is rare for older adult ED patients at these two EDs to not speak English and no 
individual group (e.g., Spanish-speaking) requires translators with great frequency. We considered 
excluding patients who could not fully participate in the ED CTI due to barriers such as sensory 
limitations or impaired cognition. However, with our goal to maximize external validity and understand 
factors that lead to repeat ED visits in patients receiving the CTI, we have elected to retain these patients 
and account for them in our analysis.  We are excluding ESI 1 patients for multiple reasons: 1) these 
patients have high acuity conditions and often are receiving life-saving interventions; 2) these patients 
are rarely discharged home; 3) these patients are rarely able to provide informed consent for a study 
such as this.  Thus, we have elected to exclude them rather than unnecessarily expend time and effort to 
assess them, approach the care team, and approach the patient. 
 
 
5. 
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT 
5.1 
METHOD OF SUBJECT IDENTIFICATION AND RECRUITMENT 
All study procedures will be standardized at both sites. Subjects will be identified and recruited using 
processes based on published best practices refined by our team.70,71 Following the inclusion criteria, we 
will recruit subjects each day in the ED at UW Hospital and Clinics and UR Medical Center-Strong 
Memorial Hospital and UR Medical Center-Highland Hospital.  To ensure variability in the time of day at 
which patients present, a random time table will be created and recruiting will start at that time, and 
continue until a subject is enrolled. 
 
Recruitment Model:  An Emergency Department Research Associate (RA), who is a staff person 
employed by the Department of Emergency Medicine, will monitor the HealthLink /eRecord trackboard 
for eligible patients.  These staff members have a broader role in the ED.  They (RAs) complete duties as 
assigned by the Department Chair as it relates to the overall mission of the Department of Emergency 
Medicine (e.g., research, clinical operations such as quality improvement, communication, & process 
monitoring, etc.).  These RAs under the direction of the ED clinical providers will approach subjects for 
study recruitment purposes as described below. 
 
When a potentially eligible patient is identified, the RA will ask the primary clinical team as to whether 
they anticipate the patient being discharged home.  If the clinical team indicates that the patient will likely 
be discharged home, the RA will then approach the patient and their family / informal caregivers to 
confirm eligibility and explain the study. 
 
All participating patient subjects, regardless of assignment to intervention or control group, will be asked 
to complete three research surveys. The first survey will be completed in the privacy of their ED room 
and will take about 15 minutes to complete. The other two surveys will be completed over the telephone 
at approximately day 4 and day 30 at a time that is convenient for the subject. These survey follow-up 
calls will take about 10 minutes to complete and assess outcome measures.  All questions are voluntary. 
Subjects are free to refuse to answer any survey questions they are uncomfortable with.    
 

 
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Patient subjects randomized to the intervention arm (CTI program) must agree to one paramedic coach 
home visit and up to 3 follow up phone calls to deliver CTI program clinical care over 30 days. The 
paramedic coach home visit will ideally occur within 24 hours of ED discharge and take approximately 1 
hour. This home visit will be scheduled at a time that is convenient for the subject. During the home visit 
the paramedic coach will review the subject’s medications, educate on red flags and emphasize provider 
follow-up. The phone calls will reinforce the coaching information.  These interactions are organized 
around the validated and nationally implemented CTI program. 
 
In the event a participating subject is admitted to the hospital directly from the initial ED visit (i.e., the 
primary team changes its mind based on developing results), then the subject (and caregiver where 
applicable) will be removed from the study because they no longer meet study eligibility criteria.    
 
Caregiver subjects will be asked to complete an ED survey and one follow up research survey by phone 
at approximately day 30.  The ED survey will take approximately 15 minutes to complete, and the call will 
take approximately 10 minutes to complete and will assess outcome measures.  All questions will be 
voluntary.   
 
Randomization:  Randomization will occur at the site-level and occur after the treatment team has 
indicated that the patient will be likely discharged home, and the subject or legally authorized 
representative (LAR) has consented to participate on the study and the baseline survey has been 
completed.  At that point, the subject will be randomized. This will be a stratified randomization, based 
upon whether or not an informal caregiver provides significant support for the patient.   
 
In the infrequent event that the patient is admitted after consenting for the study and being randomized 
(but before being discharged and leaving the ED), the patient subject (and caregiver where applicable) 
will be withdrawn from study as an investigator initiated withdrawal because the subject no longer meets 
eligibility criteria (i.e hospital admission).  
 
5.2 
PROCESS OF CONSENT  
For consent, we have developed an approach (in conjunction with the UR IRB) to minimize coercion and 
undue influence.  Consent will only be performed by individuals who are listed on the IRB application and 
who are IRB approved and authorized to obtain consent.  The process has been established to provide 
enough information to allow a thoughtful decision and ensure enough time to allow a considered 
decision.  Because this study includes vulnerable subjects (older patients, patients with potentially 
diminished capacity), previously implemented processes are being used.  We estimate that less than 2% 
of the participating subjects will lack decisional capacity (~10% of older adult ED patients lack decisional 
capacity, and the vast majority are admitted to the hospital, thus excluded from this study), but have built 
mechanisms to ensure they are identified.   
 
Process:   
All study procedures will be standardized at both sites. After a potentially eligible patient (and caregiver 
where applicable) is identified, the RA will ask the primary clinical team whether they anticipate the 
patient being discharged home.  If the clinical team indicates that the patient will likely be discharged 
home, the RA will then approach the patient and their family / informal caregivers to confirm eligibility. In 
the privacy of the subjects’ ED room the RA will explain the study, its benefits and the potential risks of 
participation.  The ED patient will then be given the combined consent and HIPAA authorization form and 
allowed as much time as they need to read it and ask questions. If the patient agrees to participate, 
decisional capacity will be evaluated by the RA to ensure that participants understand the risk and 
benefits of the study before obtaining informed consent.  The decisional capacity evaluation used has 
previously been approved by the UR IRB.  It assesses the potential subject’s understanding of the study.  
This process is more conservative than the UW IRB policy “Research with Adult Participants Lacking 

 
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Capacity to Consent” (Section II). The patient will be involved in the consent process as much as 
possible and will be asked to provide assent by the researchers. The subject's assent will be required 
and will be documented on the consent form. This documentation will will be retained in the subject’s 
research record.  Surrogates (LAR) will be informed that their decisions should be based upon what the 
surrogate believes is consistent with the subjects wishes if they possessed capacity, and if a subject’s 
wishes cannot be determined, surrogate decisions should be based upon what the surrogate believes to 
be in the subject’s best interest. 
 
If the patient lacks decisional capacity, the RA will discuss the study further with a LAR present in the 
ED.  If no LAR is present, then the subject will not be included in the study.  Priority of decision makers is 
as follows: 1) research power of attorney, if present; 2) court appointed guardian; 3) power of attorney for 
healthcare; 4) next of kin in the following order: spouse or registered domestic partner, adult child, 
parent, adult sibling, grandparent, adult grandchild, or close friend.  If the LAR agrees to study 
participation, the study coordinator will confirm decisional capacity of the LAR and then ask the LAR to 
sign the combined consent and HIPAA authorization form.  If the LAR lacks decisional capacity, then the 
subject will not be included in the study.  The patient and the LAR will be given a copy of the signed 
consent forms.   
 
Informed consent will be obtained from caregivers present in the ED.  Caregivers will be assessed for 
decisional capacity using the same methods as with the patient subject. Caregivers without decisional 
capacity will not be eligible to join study.  
 
In cases where the capacity of the subject is in doubt, the RA will consult with an ED physician 
or clinician investigator. 
 
 
After completing informed consent, the patient (and caregiver when applicable) will be asked to complete 
the baseline survey. When the baseline survey is complete, the patient will be informed of their 
randomization.  If the patient is randomized to the control group, the RA will schedule the 1st follow-up 
call at a convenient time for the patient.  If the patient is randomized to the intervention group, the RA will 
ask the patient for a convenient time, within the next 24 hours, for the paramedic coach to make the 
home visit. The RA will schedule the visit and give the patient a reminder card with a photo of the coach 
and the time the home visit is scheduled.   For those patient subjects who lack capacity, the LAR 
(surrogate) will be required to attend the paramedic coach home visit.  
 
 
 
6. 
METHODS  
6.1. 
CTI CLINICAL PROGRAM & ITS PROCESSES (only for the INTERVENTION GROUP) 
We are adapting a validated and widely used program for a new setting. The only revision is to minimize 
the coaching in the ED to avoid prolonging the patients’ discharge process as that would notably impede 
ED operations, inhibiting dissemination and implementation. Thus, the review of the four pillars of the CTI 
model, which is typically covered in the hospital, will occur during the first home visit, which will ideally 
occur within 24-48 hours.  
 

 
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Paramedic Coach Identification:  The paramedic coaches will be considered part of the research team 
and will be fully trained in accordance with the UW IRB and UR IRBs.   Participating paramedic coaches 
will be will be identified and selected to participate based on their level of EMS experience and their 
interest in the research objectives. The paramedic coaches will be paid as subcontracted providers by 
the UW Dept. of Emergency Medicine. They will not have an appointment registered with the University 
of WI Human Resources. Therefore an Individual Investigator Agreement (IIA) will be completed for each 
paramedic coach. IIAs  have been obtained and the requisite human subjects training for each coach 
has been completed.   The  paramedic coaches are now officially included as members of the study team 
and listed on the ‘key personnel’ and ‘roles’ pages of the protocol application. 
 
Training: The paramedic coach will be trained following the existing national standard created by Dr. 
Coleman.  The paramedic staff will complete the on line training, then go to Denver, CO to receive the 
full training, and then will shadow coaches in Rochester, NY and Madison, WI to better understand the 
process.  The coaches will also take part in the monthly training updates that are delivered by Dr. 
Coleman’s CTI staff via webinar.   
 
Processes:   
After the patient returns home, the paramedic coach will perform the home visit, within 24-48 hours 
ideally. During this visit, the coach will follow the program as they have been trained by Dr. Coleman and 
his staff.  They will coach the patient to reconcile medications; emphasize the importance of provider 
follow-up and practice obtaining an appointment and asking the PCP questions at the visit; review red 
flags due to medications and the acute condition; and develop the Personal Health Record. As per the 
CTI, the paramedic will not do the work for the patient, but will coach and educate the patient and/or 
caregiver. During the CTI program’s follow-up calls (up to 3, not related to research activities), the 
paramedic coach will further coach and support the patient and/or caregiver.  
 
If the subject expresses need for assistance beyond coaching or the coach identifies clinical issues, then 
he/she will coach the subject to call his/her provider to obtain further guidance.  If the subject is unable to 
do so, then the paramedic coach will call the PCP directly or 911 to request an ambulance for evaluation 
and transport to an ED. Because the coach is a paramedic and has extensive medical training, he/she 
has the expertise to recognize medical issues and summon assistance.   
 
All CTI program documentation will be securely retained within the study files in the UW Department of 
Emergency Medicine and the UR Department of Emergency Medicine.  If the patient subject consents to 
the communication, a status summary will be sent to their primary care provider for inclusion in their 
medical record. This information will be sent using secure, HIPAA compliant email systems.  Because all 
UW enrolled subjects will be patients of UWHealth, the UW email system will be used and is HIPAA 
compliant.  Because all UR enrolled subjects will be patients of UR Medicine, the UR email system will 
be used and is HIPAA compliant. 
 
6.2. 
USUAL CARE (CONTROL) GROUP 
Prior to ED Discharge
Engage the patient
• Prepare the patient for ED 
discharge
• Explain the value of the 
CTI 
• Schedule the home visit
Home Visit: 
<24 Hours After Discharge
Coach the Patient
• Reconcile and review medications
• Emphasize the need for PCP follow up
• Practice obtaining an appointment and 
asking the PCP questions
• Educate about red flags
• Review Personal Health Record
Follow-up Call 1
Support the Patient
• Answer remaining 
questions
• Reinforce coaching 
and training
• Provide referral 
sources as needed
Follow-up Call 2
Support the Patient
• Answer remaining 
questions
• Reinforce coaching 
and training
• Provide referral 
sources as needed
Follow-up Call 3
Support the Patient
• Answer remaining 
questions
• Reinforce coaching 
and training
• Provide referral 
sources as needed
Figure 3: Care Transitions Intervention Processes

 
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The usual care group patients will receive the routine UW and UR discharge educational materials from 
the ED staff. There may be an effect from the research survey calls, but that would only decrease the 
magnitude of the anticipated differences between the control and intervention group.   
 
6.3. 
RESEARCH PROCESSES 
The informed consent, baseline survey and randomization will be completed in the ED by the study RA. 
To facilitate scheduling the coach home visits the RA will know the coach’s weekly availability.  For those 
subjects randomized to the intervention group, the RA will schedule the coach home visit within 24 hours 
of ED discharge ideally and then send the paramedic coach the appointment time, patient’s contact 
information and ED discharge summary via email.  To ensure that all PHI is communicated securely, UW 
coaches will be provided with UW Department of Medicine email addresses and at UR the coaches will 
also be provided with UR email addresses.  Thus, all communication will be within each institution’s 
secure, HIPAA compliant email system.  
 
Blinded research staff will be responsible for all research surveys for the patient and caregiver.  These 
are intended for all subjects (control and intervention group) and independent of the clinical CTI program 
delivered to the intervention group.    
 
Patient subjects will be contacted four days after ED discharge. The RA will telephone the subject and 
complete a survey that evaluates the program fidelity and initial outcome measures (Table 2). We chose 
this time point because patients should have made medication changes (e.g., started an antibiotic) and 
contacted their provider for follow up by then.  We anticipate that the survey will take no longer than 10 
minutes to complete.   
 
Patient subjects will be re-contacted thirty days after ED discharge. The RA will re-contact all subjects 
and complete a final survey. We anticipate that the survey will take no longer than 10 minutes to 
complete the telephone survey. The RA will inform subjects of the research phone numbers from which 
all calls will be made. It is anticipated that providing this information will re-assure subjects and give an 
increase sense of comfort knowing who is calling them.  
 
If, at the time the follow-up assessments are due (Day 4 and Day 30) the patient subject is either in the 
ED or inpatient in the hospital, research staff will go to the ED or inpatient hospital floor and request 
permission from the attending health care provider to visit the patient to complete the followup survey.  If 
the provider states the research visit is inappropriate the RA will leave the ED/inpatient area immediately.  
The patient subject can decline the RA visit and study survey at any time. This change in data collection 
does not apply to the Caregiver subject. 
 
Caregiver subjects will be re-contacted thirty days after ED discharge. The RA will re-contact all subjects 
and complete a final survey. We anticipate that the survey will take no longer than 10 minutes  to 
complete the telephone survey. The RA will inform subjects of the research phone numbers from which 
all calls will be made. It is anticipated that providing this information will re-assure subjects and give an 
increase sense of comfort knowing the who is calling them.  
 
The RA will conduct a medical record review at the end of the study.  We have built a lag time because 
we recognize that it can take months for the medical record to be fully updated with care episodes, 
discharge diagnoses, etc.  The collected data are represented in Table 2. 
 
Records Management: All data will be maintained initially on paper and then entered in REDCap, an 
electronic data management system on a secure server maintained by the UW Department of Medicine.  
The PI and coordinator are responsible for monitoring data quality in conjunction with the study team.  
Reports will be generated and reviewed regularly to show the status of all subjects and bring forward any 
problems with study processes and data completeness. 

 
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Individuals who decline to participate will not have any identifiable information retained.   We will retain 
the following variables to compare those participating to those who decline to participate: 1) age up to 89 
years  and age range for subjects ≥ 90 years, 2) sex, 3) race, 4) chief complaint, 5) reason for declining 
study participation. 
 
 
All documentation will be stored in the UW or UR Department of Emergency Medicine locked office 
space.  No later than the end of the study, the forms will be scanned and stored on secured network 
drives at UW and the paper copies will be destroyed.   
 
Table 3:  Schedule of Activities 
 
 
 
 
 EFFICACY ASSESSMENTS 
To evaluate the program, the RA who calls the subject will complete the following measures: 
 
1. Care Transitions Measure:  The CTM includes the 3 major domains that patients have identified as 
critically important to their experience with coordination out of the hospital.  This will serve as a proxy 
measure for actual changes.   
2. Medication Changes:  Survey asking if medication changes are implemented (e.g., new medications 
started, old medications stopped).  If not applicable, then that will be recorded.  The date of change 
will also be queried.   
3. Understanding of Red Flags:  The discharge instructions from the ED will be abstracted for key red 
flags.  Subjects will be asked to list the red flags for which they are monitoring their condition, and will 
be asked to explain the meaning of the red flag.  The RA will record the subject responses verbatim.  
Two physicians will review the responses and score the level of understanding on a Likert scale. 
4. Follow up with PCP:  PCP follow up will be assessed in three different manners.  The primary 
measure will be the time to in-person PCP follow-up (e.g., clinic or home visit).  The secondary 
measures will be time to any PCP follow up (e.g., in-person or phone) and the third approach will be 
contact with PCP within the time recommended by the ED (e.g., phone or in person) follow-up. 
5. Patient Self Efficacy:  Wallston’s Perceived Health Competency Scale (PHCS) is a domain-specific 
Paramedic-coached ED Care Transitions to Help Older Adults Maintain their Health
 Activity                      Day
0
1
2
3
4
5
30
Recruitment
Patient and Caregiver (CG) Identified, 
Recruited & Randomized in ED
Research Activities
Control & Intervention Groups
Patient Baseline &  Follow-up Survey  Calls
CG Baseline &  Follow-up Survey  Calls
Clincial Activities
Intervention Group
Coach Homevisit     
Coach  Follow-up Patient Calls   - TBD

 
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measure of self-efficacy. It assesses perceptions of self-efficacy specific to health-related 
situations but is not limited to any single behavior.        
6. Patient Activation Measure: The Coleman Patient Activation Measure will be the primary measure for 
this assessment. A 1 point change in score is considered clinically significant for the Coleman 
measure. 
 
6.5 COSTS TO THE SUBJECT 
Subjects will not incur any costs for participating. 
 
6.6 PAYMENT FOR PARTICIPATION 
Subjects will not be paid for participation. 
 
6.7 RETURN OF INDIVIDUAL RESEARCH RESULTS / MANAGEMENT OF HEALTH FINDINGS 
As part of this study, we may identify new health information.  During the consent process, we will obtain 
permission to disclose this information to each subject’s PCP.  This will be done via a template letter that 
will be sent by the study staff by standard postage mail to the PCP summarizing performance on the 
various tests.  If the subject declines to allow us to provide this information to their PCP, then the 
disclosure will not occur. 
 
As part of the surveys in the ED or via phone, we may identify certain findings that require physician 
review.  For the surveys completed in the ED, the findings will be reviewed with the treating physician.  
For the phone surveys, these findings will be reviewed by the physicians overseeing this study at either 
the Rochester or Madison sites and action will be taken as clinically appropriate.   
 
As part of the CTI coaching, the coach may identify clinical issues.  Then, he/she will coach the subject 
to call his/her PCP to obtain further guidance.  If the subject is unable to do so, then the coach will call 
the patient’s provider or 911 for direct ED transport.  By using trained providers (paramedics) with 
extensive clinical knowledge and having continual physician availability by phone, this decision will be 
maximally supported.  
 
 
7. 
SUBJECT WITHDRAWALS 
All subjects will be advised in the written informed consent forms that they have the right to withdraw 
from the study at any time without prejudice.  Withdrawal will only occur if the subject indicates that he / 
she no longer wishes to participate.  For subjects who withdraw from the study, we will clarify the level of 
withdrawal.  For those who wish their records to be fully expunged from the study, we will destroy all 
information except for the consent form, but add a note indicating the date and time of withdrawal.  For 
those who wish to cease participating in the CTI program and follow up activities, we will request 
permission to retain them in the study and continue medical record review until the end of study chart 
review. 
 
8. 
SAFETY AND REPORTABLE EVENTS 
The level of risk in this supportive care behavioral intervention is low, and no published literature 
regarding this widely implemented intervention has reported any problems.  All research team members 
will be involved in safety monitoring. 
 
8.1 
UNANTICIPATED PROBLEM DEFINITION 
An unanticipated problem is an event that includes any symptom, illness, or experience, which develops 
or worsens during the course of the study and that changes the subject risk/benefit ratio and that is 
directly related to subjects’ participation in the study.  
 

 
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8.2 
RECORDING UNANTICIPATED PROBLEMS 
During the study follow up calls, research staff will assess if any unanticipated problems have occurred.   
All unanticipated problems whether observed by the staff, elicited from or volunteered by the subject, will 
be documented.  Each unanticipated problem will include the date of onset, brief description of the 
experience, the relationship to CTI and any action taken with respect to the CTI. 
 
8.3 
SERIOUS ADVERSE EVENT 
A serious adverse event is defined as any adverse medical experience that results in any of the following 
outcomes: 1) death; 2) is life-threatening; 3) requires inpatient hospitalization; 4) results in persistent or 
significant disability/incapacity; 5) requires medical or surgical intervention to prevent permanent 
impairment or damage. 
 
8.4 
RESPONSIBILITIES FOR REPORTING SERIOUS ADVERSE EVENTS 
Any negative reactions that arise during the course of this study will be discussed in the weekly research 
team meetings.  All adverse events will be reviewed to determine if a change in protocol is necessary.   
 
If a serious adverse event related to study activities occurs, it will be reported to the NIH and the 
University of Wisconsin IRB within 24 hours.  If the event took place at the University of Rochester site, it 
will also be reported to the University of Rochester IRB as well as the University of Wisconsin IRB.   
 
9. 
RISK/BENEFIT ASSESSMENT 
9.1 
POTENTIAL RISKS 
One risk involves any stress caused by the survey questions or assessments, either through the 
questions themselves or frustration or fatigue from completing the questions. This risk is moderate, 
because the questions are standard questions asked by health care providers. However, the risk can be 
mitigated and made less likely by taking appropriate steps described in the “Protection Against Risk” 
section.  
 
Another risk involves the release of confidential information regarding the medical conditions for which 
subjects will be assessed and from the medical record reviews. Release of information can cause social 
or psychological harm. However, the risk for this is extremely unlikely due to the procedures used to 
mitigate this issue that are described in the “Protection Against Risk” section.  
 
A third risk is that the study team may be able to identify issues of depression or suicidal thoughts from 
the surveys.  Identification of these issues would require contacting appropriate individuals for 
intervention (e.g., your ED provider, your health care team).  
 
 A fourth risk is identification of abuse or neglect. Home visits will occur as part of this study and child 
abuse or neglect may be observed during a visit.  We are required by state law to report this to the 
appropriate authorities.  This may include reporting to local law enforcement or protective service 
agencies, resulting in legal or social risks to subjects or other members of their household.   
 
In home visit situations where the paramedic coach identifies that a home environment requires 
mandatory reporting to authorities the paramedic coach will report as mandated and also communicate 
their findings to the study Principal Investigator (PI).  Additionally, in situations where it is unclear 
whether mandatory reporting requirements are triggered the paramedic coach will communicate their 
findings to the study Principal Investigator to further discuss the case. If deemed necessary the research 
team will communicate concerns to the patient’s primary care physician for appropriate follow-up by the 
PCP. 
 

 
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A final risk is that we may refer subjects to their primary care providers or an ED for additional care. 
Following these referrals will be dependent upon the subject inclination to accept the referral. 
 
9.2  PROTECTION AGAINST RISKS 
Stress:  The risk from the stress of the questions will be mitigated by requesting consent to ask the 
questions, by asking the questions at times of their choosing, and offering to terminate the screening at 
any point that subjects request. 
 
Release of Confidential Information:  To prevent the unintentional release of confidential information for 
any of the human subjects included in the research study, all data will be stored in locked offices. All 
electronic data will be stored on secure networked computers / networked drives, as per policy. Only 
investigators and research staff directly involved in the project will be given access. All identifiers will be 
stripped from the database at the earliest possible time. For patient data, identifiers will be eliminated 
upon completion of follow up and data abstraction. 
 
Different Levels of Care:  In terms of the acute event, that will be protected against in two ways. First, the 
ED staff will have completed its primary medical care before consent is requested or assessment is 
performed. Thus, participation cannot impact ED medical care. Second, in the ED, participation cannot 
harm medical care because the research staff operates independently of the ED physician. Participation 
can benefit medical care only from the standpoint that new needs may be identified and addressed, thus 
improving the health of the older adult. 
 
Depression or Self Harm: To mitigate this risk, we will contact appropriate others to intervene (e.g., the 
ED provider, their health care team). 
 
Elder or child abuse or neglect: If either abuse or neglect is observed during the coach’s’ home visit, we 
are required by state law to and will report this to the appropriate authorities.   
 
Referral to PCP or ED:  If needed from a clinical standpoint, the subject may be referred to their PCP or 
an ED.  It will be up to the subject to decide if they wish to act up on this referral. 
 
 
9.3 
POTENTIAL BENEFITS TO SUBJECTS 
Subjects in the study who receive the intervention may benefit by having more intensive support during 
the ED to home transition.  
 
9.4 
ALTERNATIVES TO PARTICIPATION 
Subjects may elect to not participate. 
 
10 
CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE  
While the study is underway, all data will be identifiable.  However, we will take many actions to 
maximally protect the data and mitigate the risk of breach of confidentiality.   
 
1. For data collection purposes, identifiers will be used to label all collection forms.  These forms will be 
initially stored in secure URMC or UW Department of Emergency Medicine offices and will be 
destroyed once the data are uploaded into REDCap the electronic data management system. 
2. All data will be maintained in REDCap, an electronic data management system application on a UW 
Madison School of Medicine and Public Health server and maintained by its IT staff. 
3. Only the PI and research staff with direct reasons for access will be allowed to access the data. 
4. No identifiable data will be kept from those subjects who were ineligible for the study or who chose not 
to enroll. 

 
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5. For analysis procedures, all subjects will be assigned an automatically generated identification code in 
the RedCap system. This code will be used for data linkage purposes during analysis. Data will be 
reported as group data so that no individual could be identified.  
6. After study completion, direct identifiers will be removed from the datasets.   Only an auto-generated 
REDCap assigned subject number will be used for data linkage purposes.  These limited datasets will 
be retained on limited access, secure UW servers.   
7. Limited analysis datasets will be kept for 7 years after completion of the study, or longer to allow for 
secondary analysis after the study is complete.  
8. All members of the study team will complete either a UW or URMC CITI and HIPAA training.   
 
 
11 
RESEARCH INFORMATION IN MEDICAL RECORDS 
We will not add research information in medical records. 
 
 
12 
DATA ANALYSIS AND MONITORING 
12.1 
SAMPLE SIZE DETERMINATION 
This study is designed to have adequate power to test the primary hypotheses that the CTI will result in 
lower odds of repeat ED use within 30 days of discharge compared to the control group (Hypothesis 2B). 
Based on published data, we expect 20% of the subjects in the control group to have at least 1 repeat 
ED visit within the 30-day follow-up period.  In order to detect a 5% absolute decrease in the frequency of 
repeat ED visits with 80% power using a Chi-square test at a two-sided significance level of 5%, we will 
need 860 subjects per group.  We anticipate approximately 25% attrition over the 30-day follow up 
period.  As such, a final sample size of 1200 subjects in each group will be recruited for participation. We 
also calculated the minimum detectable effect size testing individual biomedical and psychosocial factors 
predicting repeat ED visit in Aim 4 for intervention group only. With an expected 15% baseline proportion 
of repeat ED visit, the sample size of 860 in the intervention group will have 80% power to detect an 
odds ratio (OR) of 1.3 per standard deviation of a normally distributed predictor. Similarly, 80% power is 
available to detect an OR ranging from 1.6-1.7 for a binary predictor prevalent in 30-50% of subjects. 
 
We will also have to adjust for clustering by site in most of the analyses below. 
 
12.2 
PLANNED STATISTICAL ANALYSIS 
Through the analytic methods used in Aims 2 and 3, we will assess differences between groups related 
to process outcome measures (Aim 2) and will assess the effectiveness and cost-effectiveness of the 
ED-to-home CTI (Aim 3). In Aim 4, we will identify predictors of repeat ED use among intervention group 
subjects. We will characterize of our study sample using descriptive statistics and corresponding 
measures of variation. We will assess for differences between groups at baseline despite randomization 
in key characteristics (e.g., demographics, comorbidities) using t-tests for continuous variables and Chi-
square tests for categorical variables, using Fisher’s exact test where appropriate. These comparisons 
will enable the identification of covariates to be controlled in our multivariable analyses. If distributional 
assumptions associated with a particular statistical procedure are violated, we will use appropriate 
transformations or non-parametric alternatives. Primary analyses will be performed under the intent-to-
treat principle, keeping subjects in the group to which they were originally randomized, regardless of 
compliance or adherence to study procedures. We will conduct sensitivity analyses among subjects who 
complete all study procedures to evaluate the effect of the intervention among those who complete all 
study-related procedures.  Hypothesis-driven comparisons will be made to control the family-wise type I 
error rate at 0.05 (two-sided) for the primary hypothesis.  
 
Caregiver Subject Analysis:  Although not an original aim of the study, we have obtained permission 
from the NIH and will perform a limited analysis of caregiver activation.  This was only recently added to 

 
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the CTI.  To compare the caregiver activation between the control and intervention groups, we will 
administer the FCAT.  The FCAT will be scored as 1-6 points per question, for a score ranging from 10-
60.  We assume that 30% of participants will have caregivers with them, the average score will be 30, 
and we will look for a 5 point difference.  Our sample size will allow a power of >0.8 for a t-test 
(alpha=0.05).   
 
Hyp 1A: More program participants will demonstrate understanding of their ED discharge instructions, 
red flags that indicate a worsening of their condition, and how to respond to the red flags three days after 
ED discharge. 
Hyp 1B: More program participants will implement medication changes made in the ED within three days 
of ED discharge.  
Hyp 1C: Program participants will have shorter time-to-follow-up with their primary care physicians. 
Hypothesis 1A & 1B: Binary outcomes such as patients’ understanding of their ED discharge 
instructions, red flags and how to respond, and accurate implementation of medication changes, will be 
compared between intervention and control group using chi-square tests. Estimates of differences 
between study groups and associated 95% confidence intervals will be provided overall and by study 
site. A separate multivariable logistic regression model will also be fitted for each of the outcome 
variables in hypotheses 1A and 1B. This will allow us to evaluate the effect of the intervention on each of 
these outcome variables while controlling for potential confounding variables, if necessary. Hypothesis 
1C: Time-to-follow-up visit with primary care physicians will be compared between groups using the Log-
Rank Test. Cox regression model will be fitted to compare the survival function after adjusting for 
potential confounding variables such as demographics, comorbidities etc., if necessary. A hazard Ratio 
and 95% confidence interval will be estimated. Because we have the issue of competing outcomes 
present (rehospitalization and follow up), we will have to account for it through the cumulative incidence 
function.72 
 
Hyp. 2A: Program participants will have increased patient activation 30 days after discharge.  
Hyp. 2B: Program participants will have lower odds of repeat ED use within 30 days of discharge. 
Hyp. 2C: Program participants will have lower estimated healthcare costs within 30 days of discharge.  
 
Hypothesis 2A & 2B: To evaluate difference in subjects’ self-care competency, Wallston scores will be 
compared between intervention and control groups using the Wilcoxon Rank Sum test.  Any repeat ED 
use and the number of ED visits during the 30-day follow up period will be compared between 
intervention and control groups using the Chi-square test and ANOVA as appropriate.  To adjust for 
potential baseline differences between intervention and control subjects, a multiple logistic regression 
model will be constructed with repeat ED use as the dependent variable, study intervention group as the 
primary independent variable, and any covariates that were found to be imbalanced at baseline in our 
bivariate analyses.  Multicollinearity between predictor variables will be assessed using multiple 
correlations (variance inflation factors).  We will use the log likelihood ratio to assess overall model fit. 
We will also check for overdispersion and use Generalized Estimating Equation (GEE) to provide robust 
estimates of standard errors. Possible interaction effects between the covariates will be inspected and 
stratified analyses will be performed if there are significant interaction effects. Standard diagnostic 
measures for logistic regression such as Pearson residual and deviance residual will be used to check 
the goodness-of-fit of the regression model assumptions and identify any outliers.   
 
Hypothesis 2C: The proposed economic assessment considers the financial costs and benefits of the 
CTI. Consistent with standard terminology,73 we define financial benefits for this study as the 
consequences of the CTI that are related to health services cost, expenses, salaries, revenues, and 
other fiscal issues. It is important to recognize that adoption of the CTI will include both fixed (e.g., 
implementation) and variable (e.g., dependent on units of care delivered/patients served) costs. 
Dissemination of the program will require additional resources to cover CTI implementation. Hence, we 

 
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include fixed and variable costs in our analysis while excluding costs associated with the research. We 
will evaluate the economic impact of CTI from the perspective of health care system/insurers, including 
both the cost of the CTI and the expected healthcare cost reduction due to altered use of ED, hospital, 
and office visits. Impact on direct healthcare costs (and hence analysis from the insurer perspective) will 
be most critical to the adoption and dissemination of this care model since insurance organizations 
(dominant stakeholders through control of payment), are unlikely to reimburse for CTI care unless they 
assess it as at cost-neutral or better.  
 
The occurrence of events contributing to healthcare costs (e.g., ED visits) will be ascertained from 
clinical information systems at both health systems. We will estimate the following CTI expenses for the 
intervention group: hardware and/or software investments; maintenance costs; direct and indirect 
costs for training; personnel salary and benefit costs, etc. We will estimate the value of direct 
healthcare resources saved or expended, including both fixed and variable costs. We will use Medicare 
reimbursement schedules to assign costs to events because of their national scope, relevance to older 
populations, and alignment with the true costs of care rather than inflated costs or discounted insurance 
plan reimbursements. We will calculate total direct costs for each individual by taking the product of the 
costs per visit (price) and utilization by visit type, and summing across categories of utilization for that 
individual. We will then estimate unadjusted and adjusted incremental costs. The adjusted cost approach 
uses multivariable regression models to eliminate the effects of differences in population characteristics 
across comparison groups, if appropriate. To do so, we will estimate the program’s monthly and annual 
costs using multivariable models and then will calculate the incremental cost of the CTI. All prices will be 
calculated in 2015 dollars. Using collected data, we will extrapolate the costs of running the program and 
expected benefits over 12-month period and annually. Finally, we will make economic projections of the 
program’s financial sustainability and scalability. We will conduct a series of sensitivity analyses by 
modifying local wages, population case-mix and program effectiveness to estimate boundaries to 
program’s sustainability and optimal operational conditions. 
 
To test the hypothesis that individual in the treatment group will have lower health care costs within the 
30-days of ED discharge, we will first calculate total direct costs for each individual by taking the product 
of the costs per visit (price) and utilization by visit type, and summing across categories of utilization for 
that individual. We expect to find that total health care expenditures will exhibit a right skewed distribution 
with no negative measures and a nontrivial number of zeros. Consistent with the literature, we will log 
transform total spending to generate a normal distribution and use the box cox and GLM family test to 
find the distribution to best in our data. We will use the recycled predications method to re-transform 
estimates back from the log scale and compare average health care spending in the treatment and 
control groups. 
 
Hyp. 3A: Biomedical factors associated with repeat ED visits include increased age, increased number 
of comorbidities, impaired cognition, and limited functional status. 
Hyp. 3B: Psychosocial factors associated with repeat ED visits include reduced social connectedness, 
increased anxiety symptoms, and increased depressive symptoms.   
 
To evaluate the relationship between biomedical and psychosocial factors with the occurrence of repeat 
ED visits among intervention subjects we will conduct bivariate analyses between patient characteristics 
and the primary outcome measure (repeat ED visits within 30 days).  To do this we will conduct bivariate 
analyses with potential predictor variables and the dependent variable (repeat ED use) using two sample 
t-tests for continuous variables or Chi-Square tests for categorical variables, using Fisher’s Exact test 
where appropriate. We will then identify independent predictors of repeat ED visits by fitting a multiple 
logistic regression model with biomedical and psychosocial factors identified in the bivariate analysis as 
independent variables. Model fitting statistics such as Akaike’s Information Criteria and difference in log 
likelihood will inform the development of the final regression model. Standard diagnostic measures such 

 
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as residual plots will be used to assess the goodness-of-fit of the regression model assumptions and 
identify any outliers.  
 
Missing Data:  Inference based on the proposed method is valid provided that missing data follows the 
missing completely at random (MCAR) assumption. However, the occurrence of missing data may 
depend on the observed response and such as missing at random (MAR) mechanism will generally bias 
the estimates. Sensitivity analysis will be performed to examine the MCAR assumption. If it is deemed to 
be severely violated, we will report treatment effects using weighted GEE that addresses the MAR 
mechanism.74,75 Biased estimates may arise if missing data does not follow the MAR mechanism, or 
non-ignorable non-response (NINR). Although unanticipated in this study, we will examine this potential 
NINR using the mixture model approach.76  
 
Future Planned Analysis:  We are requesting to retain the data in an identified form for 10 years after 
completion of this study for future analyses of health care utilization and claims data from subjects’ health 
insurance providers so as to understand if a paramedic coach reduces health care use and costs.  We 
will keep the deidentified data indefinitely.   
 
12.3 
DATA AND SAFETY MONITORING 
The data safety and monitoring plan should be commensurate with the risks of the study, as well as the 
size and complexity of the study.    This plan  includes monitoring procedures with structured adverse 
event (AE) and serious adverse event (SAE) determination, monitoring and reporting systems with 
standardized protocols and forms for referring and/or treating study participants who experience adverse 
events. AEs should be reported to the IRB, the NIA Program Officer. 
 
Appendix A details the NIA approved plan.  
 
13.0 REFERENCES  
 
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7  
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11  Coleman EA, Berenson RA. Lost in transition: challenges and opportunities for improving the quality of 
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35  Stiell A, Forster AJ, Stiell IG, vanWalraven C. Prevalence of information gaps in the emergency department and 
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60  Duckles J, Sellers C, Seshadri S, Lampo D, Shah MN.  It’s a balancing act:  Understanding relational strategies 
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76  Fitzmaurice GM, Laird NM. Generalized linear mixture models for handling nonignorable dropouts in 
longitudinal studies. Biostatistics. 2000;1:141–156. 

 
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APPENDIX A 
DATA AND SAFETY MONITORING PLAN 
 
TABLE OF CONTENTS  
Page 
 
1.0 PARTICPANTS SAFETY ............................................................................................... 28 
1.1 Potential Risks and Benefits for Participants……………………………………………….28 
1.2 Adverse Event and Serious Adverse Event Collection and Reporting…………………..29 
1.3 Protection against Study Risks ………………………………………………………………34 
2.0 INTERIM ANALYSIS ......................................................................................................... 35 
3.0 DATA AND SAFETY MONITORING ................................................................................. 35 
3.1 Frequency of Data and Safety Monitoring…………………………………………………..35 
3.2 Content of Data and Safety Monitoring Report……………………………………………..35 
3.3 Independent Safety Officer Membership and Affiliation…………………………………...36 
3.4 Conflict of Interest for Independent Safety Officers………………………………………..36 
3.5 Protection of Confidentiality .......................................................................................... 36 
3.6 Independent Safety Officer Responsibilities………………………………………………..36 
    3.7 Templates for Reports………………...………………………………………………………38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1.0 PARTICPANT SAFETY 
 
1.1 
Potential Risks and Benefits for Participants 
 
Potential Risks 
The potential subject risks associated with this study are as follows: 
1. Stress caused by the survey questions or assessments:  Either through the questions themselves 
or frustration or fatigue from completing the questions, this risk will be present. Although we 
anticipate this risk, it is expected to be commensurate with what participants would experience 
outside of the research study because the questions are standard questions asked by health care 
providers. However, the risk can be mitigated and made less likely by taking appropriate steps 
described in the “Protection Against Risk” section 1.3 below.  
2. Identification of issues of depression or suicidality:  Through the survey instruments, depression 
or suicidality may be identified.  Identification of these issues would require contacting the 
appropriate individuals for intervention, such as the ED provider or the health care team. 
3. Identification of abuse or neglect:  Home visits will occur as part of this study and abuse or 
neglect may be observed during a visit.  We are required by state law to report this to the 
appropriate authorities.  This may include reporting to local law enforcement or protective service 
agencies, resulting in legal or social risks to subjects or other members of their household.  This 
risk is disclosed in the consent document. 
4. Release of confidential information:  Through the surveys and assessments and medical record 
reviews, confidential information will be collected. Release of identifiable information outside the 
study team presents a potential risk of social or psychological harm. However, the risk for this is 
extremely unlikely due to the procedures used to mitigate this issue that are described in the 
“Protection Against Risk” section and we are not collecting sensitive information about 
participants. 
5. Referral to primary care or ED provider:  Based on the findings of the study, we may refer 
subjects to their primary care or an ED provider.  Acceptance of this referral will be dependent on 
the subject, but this referral may occur, leading to further evaluation of health conditions.  This 
referral may result in added costs to the subject. 
6. Incorrect delivery of the intervention:  If the Care Transitions Intervention is delivered incorrectly, 
a result may be an increased use of ED or hospital services.  That would include increased cost 
and a burden on subjects.  Although we anticipate this risk, it is expected to be commensurate 
with what participants would experience outside the research study when they receive the Care 
Transitions Intervention as part of their care. 
7. Risk of delayed medical care:  With the enrollment of subjects in the ED, there is a chance that 
medical care could be delayed due to the enrollment process.  This risk is somewhat limited due 
to the planned process, which includes communication with care team who will not be able to 
determine if the patient will be discharged home until critical medical care is complete.  However, 
it must be monitored.  
 
Potential Benefits 
The services provided through this study may have benefits as follows: 
1. Identification of unrecognized medical conditions:  Through the research protocol, medical 
conditions not recognized by the subject may be identified.  For instance, depression, medication 
errors, or development of acute medical problems may be identified and then receive care either 
through the coaching of the patient/caregiver or through notification of the patient’s primary care 
provider / ED provider. 
2. Health education:  Through the coaching provided, patients may better understand their health, 
develop better processes to manage their health, and even experience better health. 

 
Protocol  10October2016 (Version #2)                                                                                                    Page 29 of 41 
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1.2 
Adverse Event, Serious Adverse, Unanticipated Problem Event Collection and Reporting 
The research team will use the NIA approved definitions of adverse event (AE) and serious adverse 
events (SAE). These definitions are as follows:  
Adverse Event   
Definition:  Any untoward or unfavorable medical occurrence in a human study participant, including any 
abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally 
associated with the participants’ involvement in the research, whether or not considered related to 
participation in the research.  
 
Examples of AEs for this study include: 
• 
Stress from completion of the survey instruments 
• 
ED visit without hospitalization or other SAE criteria (below) 
o Note: a repeat ED visit without hospital admission occurs in up to 20% of older adults who 
have an index visit. Given the high incidence of this event (up to 20%) and the fact that it 
does not meet the NIA’s definition of a SAE, we are considering it an AE, not a SAE. 
 
Serious Adverse Event   
Any adverse event that: 
• 
Results in death  
• 
Is life threatening, or places the participant at immediate risk of death from the event as it 
occurred  
• 
Requires or prolongs hospitalization  
• 
Causes persistent or significant disability or incapacity  
• 
Results in congenital anomalies or birth defects  
• 
Is another condition which investigators judge to represent significant hazards 
 
Unanticipated Problem (UP) 
This is any incident, experience, or outcome that: 
• 
Is unexpected, in terms of nature, severity, or frequency, given (a) the research procedures and 
(b) the characteristics of the study population;  
• 
Is related or possibly related to participation in the research (i.e., reasonable possibility that the 
incident, experience, or outcome may have been caused by the procedures involved in the 
research);  
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
Event Collection 
Events for investigation will be collected through three mechanisms: 
1. During research activities, any voluntary responses that identify an AE or SAE will be flagged by 
study staff for review. 
2. During research activities, there will also be a systematic collection of AEs and SAEs.  As part of 
the chart review at UW, we will be collecting death, hospitalizations, ED use, and health care 
utilization.  Furthermore, through patient/caregiver surveys we will be collecting the same 

 
Protocol  10October2016 (Version #2)                                                                                                    Page 30 of 41 
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information to particularly identify death, hospitalization, ED use, and health care utilization at 
non-UW facilities.  These AEs and SAEs will be flagged by study staff for review. 
3. Independent notification, such as through an unsolicited letter or telephone call, of any events 
that meet AE or SAE criteria will be flagged by study staff for review. 
 
For each of these events, the staff will record a brief description of the experience, the date of onset, the 
date of resolution, severity, expected, relationship to study treatment, and outcome of this event.  The 
research team will utilize the NIA approved flow sheets and forms to identify and track potential AEs and 
SAEs.  
 
Events will be reviewed (within one business day of collection) to determine if they meet criteria for an 
AE or SAE, as well as whether the AEs/SAEs are UP.  Depending on the categorization, the following 
review will occur (See Figure 1): 
 
Any AE will be reviewed within 5 business days of categorization (as above): 
1. The information regarding the subject will be accessed and the NIA tracking form will be 
completed. 
2. The site PI designee (who must be a clinician with relevant expertise) will be notified to determine 
if the event is unexpected, related to participation in the research, or places participants at a 
greater risk of physical or psychological harm than was previously known or recognized. 
3. If the AE is related but expected, then the PI will report the event to the Independent Safety 
Officer and the NIA with the monthly reports. 
4. or not unexpected, then the PI will report the event to the Independent Safety Officer and the NIA 
with the monthly reports. 
5. If the AE is unexpected, the governing IRB will be notified within 10 business days of 
categorization.  
a. The other site investigators will be notified promptly for report to their IRB. 
6. The event will be discussed on the weekly study oversight call. 
 
Any SAE will be reviewed within 1 business day of categorization (as above): 
1. The information regarding the subject will be accessed and the NIA tracking form will be 
completed. 
2. The site PI designee (who must be a clinician with relevant expertise) will be notified to determine 
if the event is unexpected, related to participation in the research and places participants at a 
greater risk of physical or psychological harm than was previously known or recognized.   
3. The overall PI will be notified without unblinding the PI. 
4. The NIA and Independent Safety Officer will be notified within 1 business day of categorization. 
5. The governing IRB will be notified within 1 business day if the SAE constitutes an UP and is 
immediately life-threatening or severely debilitating to other participants.  
6. If it is unexpected, related, or possibly related, the other study investigators and sites will be 
notified promptly. 
7. The PI will provide a final update to the NIA and Independent Safety Officer within 14 business 
days of the event for all SAE cases, unless the investigation is still ongoing. 
8. The event will be discussed on the weekly study oversight call. 
 
Grading Criteria 

 
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We will utilize the NIA approved grading criteria, as indicated on the event forms including:  
 
Severity 
• 
1 = Mild- Awareness of signs or symptoms, but easily tolerated and are of minor irritant type causing 
no loss of time from normal activities. Symptoms do not require therapy or a medical evaluation; 
signs and symptoms are transient. 
• 
2 = Moderate- Events introduce a low level of inconvenience or concern to the participant and may 
interfere with daily activities, but are usually improved by simple therapeutic measures; moderate 
experiences may cause some interference with functioning 
• 
3 = Severe- Events interrupt the participant’s normal daily activities and generally require systemic 
drug therapy or other treatment; they are usually incapacitating 
 
Study Relatedness 
• 
1 = Definitely related- The adverse event is clearly related to the study procedure – i.e. an event that 
follows a reasonable temporal sequence from administration of the study intervention, follows a 
known or expected response pattern to the suspected intervention, that is confirmed by improvement 
on stopping and reappearance of the event on repeated exposure and that could not be reasonably 
explained by the known characteristics of the subject’s clinical state. 
• 
2 = Possibly related- An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention follows a known or expected response pattern to the 
suspected intervention, but that could readily have been produced by a number of other factors.   
• 
3 = Not related- The adverse event is clearly not related to the study procedure - i.e. another cause of 
the event is most plausible; and/or a clinically plausible temporal sequence is inconsistent with the 
onset of the event and the study intervention and/or a causal relationship is considered biologically 
implausible. 
 
Expectedness 
• 
Unexpected - nature or severity of the event is not consistent with information about the condition 
under study or intervention in the protocol, consent form, or relevant research literature.   
• 
Expected - event is known to be associated with the intervention under study.   
 
Event Actions 
As a result of the event and the event investigation, a number of different actions may occur, including 
the following: 
• 
Changes to the protocol 
• 
Modification of consent documents 
• 
Additional training of study staff 
• 
Termination of the study 
 
As these changes are occurring, the study may need to be stopped.  This study will use the following 
stopping rule:   

 
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In the event that a SAE is unexpected and related to the research processes, new enrollment and 
interventions will be halted but ongoing follow up procedures will continue.  This level of intervention is 
justified because the follow up is a brief survey of health status and satisfaction and lacks any 
intervention.  This decision will be confirmed with the Independent Safety Officer, the UW-IRB, and the 
NIA.   
 
Once the event has been investigated, then the study team, in conjunction with the Independent Safety 
Officer, will determine if the event actions proposed are sufficient to address the SAE that was 
unexpected.  Once it has been sufficiently addressed and approved by the governing IRB, then the study 
will be restarted. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol  10October2016 (Version #2)                                                                                                    Page 33 of 41 
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           Serious Adverse Event/Adverse Event/Unexpected Problem Process Flow 
 
Is event 
unexpected 
Re: nature, 
severity or 
frequency? 
Is adverse event
definitely related, 
probably related or
possibly related to 
participation in the 
research? 
Adverse Event 
occurs at Study 
Site 
Submit with 
monthly 
Independent Safety 
Officer reports 
PI is notified as soon as
event is known. 
Independent Safety Officer, 
or NIA may ask for 
additional information 
 
Final update to 
Independent Safety 
Office & NIA within 14 
business days of event 
being known. 
Is the serious
event 
unexpected,
related or 
possibly 
related?
Notify other study 
Investigators for 
Reporting to their IRBs
Does adverse event 
suggest that the 
research places 
participants or others 
at a greater risk of 
physical or 
psychological harm 
that was previously 
known or recognized? 
Report to IRB, 
 
within 10 
business days of 
unexpected event 
with an adverse 
effect. 
Report to other
participating sites 
for their IRB
notification 
Must be reported 
on Adverse 
Event form 
Is this 
adverse
event 
serious? 
NO 
YES
STOP 
YES 
NO
NO 
YES 
NO 
YES 
NO 
YES
STOP 
STOP
The  Independent Safety Office 
and NIA will be notified within 1 
business day of event being 
known. *If unexpected, the IRB 
will be notified in 1 business 
day of event being known.
Figure 1 

 
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1.3 
Protection Against Study Risks 
This randomized controlled trial involves the use of data on living subjects. Maximal efforts will be 
employed to ensure that subjects are appropriately selected, are exposed to minimal physical, 
psychological, social and legal risks.  
 
Informed Consent Process  
For completion of the informed consent process, we have developed IRB-approved processes to 
minimize coercion and undue influence.  Consent will only be performed by individuals who are listed on 
the IRB application and who are IRB approved and authorized to obtain consent.  The process has been 
established to provide enough information to allow a thoughtful decision and ensure enough time to allow 
a considered decision. All study procedures will be standardized at both sites.  
 
The consent process is as follows: 
After a potentially eligible subject is identified and research assistant (RA) is given permission to 
approach the individual, the RA will then approach the patient (and their caregivers where applicable) to 
confirm eligibility and interest in volunteering for the study. In the privacy of the subjects’ ED room the RA 
will explain the study, its benefits and the potential risks of participation. The ED patient will then be given 
the combined consent and HIPAA authorization form and allowed as much time as they need to read it 
and ask questions.  
 
Additionally, in the instances where the patient would like their caregiver/family member to participate, 
the RA will obtain informed consent from caregivers present in the ED utilizing the same processes as 
used for the subject as described above.  
 
All subjects will be given a copy of their completed informed consent. Copies of the IRB approved 
consent forms are included with this plan. All subjects will be reminded that they can request to be 
removed from the study at any time.  
 
Protection against Risks 
The following processes will be implemented to protect subjects from study risks: 
 
Stress:  The risk from the stress of the questions will be mitigated by requesting consent to ask the 
questions, by asking the questions at times of their choosing, and offering to terminate the screening at 
any point that subjects request. 
 
Depression or Self Harm:  This risk is limited as we are not enrolling patients with primary psychiatric 
complaints.  If we identify incidental depression or self-harm issues we will contact appropriate others to 
intervene (e.g., the ED provider, their health care team). 
 
Elder or child abuse or neglect: This risk is limited as we are not enrolling patients with primary 
abuse/neglect complaints.  If either abuse or neglect is observed during the coach’s’ home visit, we are 
required by state law to and will report this to the appropriate authorities.  
  
Release of Confidential Information:  To prevent the unintentional release of confidential information for 
any of the human subjects included in the research study, all data will be stored in locked offices. All 
electronic data will be stored on secure networked computers / networked drives, as per policy. Only 
investigators and research staff directly involved in the project will be given access. All identifiers will be 
stripped from the database at the earliest possible time. For patient data, identifiers will be eliminated 

 
Protocol  10October2016 (Version #2)                                                                                                    Page 35 of 41 
UW IRB# 2015-1197 
 
upon completion of follow up and data abstraction. 
 
Referral to PCP or ED:  There is no way to prevent this risk, as this is the hypothesized outcome of the 
study and it is very common (up to 20%) currently without the program being tested.  One could further 
argue that this is a benefit.  If needed from a clinical standpoint, the subject may be referred to their PCP 
or an ED.  It will be up to the subject to decide if they wish to act upon this referral.  
 
 
2.0 INTERIM ANALYSIS 
No interim analysis of the study was proposed in the original funded grant proposal to consider this study 
for early termination, and thus no interim analysis is planned for this protocol. Furthermore, to achieve 
the final aim of the funded proposal the full sample size is needed.  Early termination would limit our 
ability to achieve that aim.  
 
 
3.0 DATA AND SAFETY MONITORING  
3.1 
Frequency of Data and Safety Monitoring  
This data safety and monitoring plan is commensurate with the risks as well as the size and complexity 
of the study.  This plan outlines the appropriate oversight and monitoring of the conduct and progress of 
the study to ensure that important information that may affect the safety and welfare of subjects is 
collected, recognized, and acted upon quickly while still ensuring the validity and integrity of the data.  
This monitoring plan includes structured adverse event (AE) and serious adverse event (SAE) 
determination, monitoring and reporting systems with standardized protocols and forms for referring 
and/or treating study participants who experience adverse events. AEs will be reported to the NIA 
Program Officer and the Independent Safety Monitor.  UP will be reported to the reviewing IRB in 
accordance with its reporting policies. 
 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily basis. The 
Independent Safety Officer will act in an advisory capacity to the NIA to monitor participant safety, data 
collection and evaluate the progress of the study.    
 
Section 1.2 includes the full details of AE and SAE collection and action.   
 
From a quantitative standpoint, the following will occur: 
1. A monthly report to the Independent Safety Officer and to the NIA Project officer will be sent for 
review to further monitor subject safety.  This will include monthly and cumulative data to identify 
trends in the events between the intervention and control groups.   
2. A cumulative data and safety monitoring annual report will be sent to the Independent Safety Officer, 
the NIA Project officer, and reviewing IRBs (at the time of continuing review). 
 
3.2 
Content of Data and Safety Monitoring Report   
The monthly Data and Safety Monitoring Report will summarize the safety metrics described in this plan.  
Specifically, by site it will include the number of subjects enrolled, randomized, active, completed, and 
discontinued from the study.  Furthermore, it will include the events, the grading, the determination 
(related to research procedures), and the outcome.  
 

 
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Templates of this report are provided. 
 
 
3.3 
Independent Safety Officer Membership and Affiliation 
The following individual has accepted the position of Independent Safety Officer for this protocol pending 
review and approval by the NIA. Should there be any questions regarding the independence of the 
Independent Safety Officer it will be addressed and corrected if necessary at that time.   
 
We are proposing either of the two individuals listed below to act as the Independent Safety Officer who 
will conduct these reviews is listed below.  Neither Dr. Adit Ginde nor Dr. Raj Shah have any direct 
involvement with the study, investigators or intervention.  Their detailed CVs/biosketches are included 
with this submission.  
 
Name:            Adit Arun Ginde, M.D., M.P.H. 
Title:               Associate Professor of Emergency Medicine 
Organization: University of Colorado School of Medicine  
                      Department of Emergency Medicine 
                      12401 E. 17th Avenue, B215 
 
           Aurora, CO 80045 
Telephone:    (720) 848-6777 
Email:            adit.ginde@ucdenver.edu 
 
 
 
3.4 
Conflict of Interest for Independent Safety Officer’s  
The Independent Safety Officer will adhere to the NIH Conflict of interest reporting requirements.  The 
Independent Safety Officer will have no direct involvement with the study investigators or intervention.  
The Independent Safety Officer will sign a Conflict of Interest (COI) Statement which includes current 
affiliations and any other relationship that could be perceived as a conflict of interest related to the study 
and / or associated with commercial interests pertinent to study objectives.  He will complete this COI 
annually.   
 
This COI report will be submitted to the NIA project officer in the annual report. The approved NIA COI 
statement will be used. 
 
3.5 
Protection of Confidentiality  
All subject reports and subsequent discussions are confidential.  Only investigators and research staff 
directly involved with the project will have access to identifiable subject information. 
 
All data reports will be presented in a blinded manner to the Independent Safety Officer to assure 
protection of confidentiality for all participating subjects. At no time will the Independent Safety Officer 
know the identity of any study subjects. 
  
3.6 
Independent Safety Officer Responsibilities 
The Independent Safety Officer responsibilities include: 

 
Protocol  10October2016 (Version #2)                                                                                                    Page 37 of 41 
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1. Review the plans for data safety and monitoring 
2. Recommend subject recruitment be initiated after receipt of a satisfactory protocol 
3. Review study performance, make recommendations and assist in the resolution of problems 
reported by the Principal Investigator. 
4. Help ensure the safety of the study participants through data monitoring and advising the 
study team; 
5. Report to NIA on the safety and progress of the trial 
6. Make recommendations to the NIA Project Officer and the Principal Investigator concerning 
continuation, termination or other modifications of the trial based on the observed beneficial or 
adverse effects of the treatment under study. 
 
 
 
 

 
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UW IRB# 2015-1197 
 
Templates for Reports 
 
Table 1: Participant Enrollment Status by Site 
 
Data as of:________________ 
 
Date of report:_____________ 
 
Site:_____________________ 
 
 
 
 
N 
% 
Enrolled 
  
100 
Active  
  
  
Completed 
  
  
  
 
 
Discontinued from Study 
  
100 
Lost to follow- up                                      
  
SAE/AE/UP 
  
  
Withdrew Consent 
 
 
Other 
 
 
 
 
 

 
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UW IRB# 2015-1197 
 
Table 2: Incidence of Adverse Events 
 
 
Data as of:________________ 
 
Date of report:_____________ 
 
 
Intervention Group 
 
Outcome 
Total N=n* Total N=Events*** Total N= (%)** 
Overall 
 
 
 
ED Re-admission   
  
  
Hospitalization 
  
  
  
Death 
  
  
  
Other 
  
  
  
 
 
Control Group 
 
Outcome 
Total N=n* Total N=Events*** Total N= (%)** 
Overall 
 
 
 
ED Re-admission   
  
  
Hospitalization 
  
  
  
Death 
  
  
  
Other 
  
  
  
 
 

 
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UW IRB# 2015-1197 
 
Table 3: Severity of Adverse Events 
 
 
Data as of:________________ 
 
Date of report:_____________ 
 
 
Intervention Group 
 
Preferred Term* 
Total N=Mild 
n** (%)*** 
Total 
N=Moderate n 
(%) 
Total 
N=Severe n 
(%) 
Overall 
 
 
 
ED Re-admission 
 
 
 
Other 
 
 
 
 
 
Control Group 
 
Preferred Term* 
Total N=Mild 
n** (%)*** 
Total 
N=Moderate n 
(%) 
Total 
N=Severe n 
(%) 
Overall 
 
 
 
ED Re-admission 
 
 
 
Other 
 
 
 
 
 

 
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UW IRB# 2015-1197 
 
Listing 1: Serious Adverse Events by Site 
 
Data as of:________________ 
 
Date of report:_____________ 
 
 
Intervention Group 
 
Site 
Participant 
ID 
Onset 
Date 
Stop 
Date 
Expected  
(Y/N) 
Relationship to 
Intervention* 
Outcome** 
Description 
of SAE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*  
Definite, Possible, Not Related 
**  
Outcome: 
 
Recovered, without treatment 
 
Recovered, with treatment 
 
Still Present, no treatment 
 
Still Present, being treated 
 
Residual effect(s) present – no treatment 
 
Residual effect(s) present- being treated 
 
Subject died 
 
Control Group 
 
Site 
Participant 
ID 
Onset 
Date 
Stop 
Date 
Expected  
(Y/N) 
Relationship to 
Intervention* 
Outcome** 
Description 
of SAE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*  
Definite, Possible, Not Related 
**  
Outcome: 
 
Recovered, without treatment 
 
Recovered, with treatment 
 
Still Present, no treatment 
 
Still Present, being treated 
 
Residual effect(s) present – no treatment 
 
Residual effect(s) present- being treated 
 
Subject died