Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: A Pragmatic Randomized Controlled Trial
Phase: NA
Conditions: Homeless Persons, Case Management, Primary Care, Hospital Readmission
Sponsor: Unity Health Toronto

October 12, 2021 
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Official Title: Effect of a Navigator Program on Post-Hospital Outcomes for Homeless Adults: 
A Pragmatic Randomized Controlled Trial  
 
Brief Title: Navigator Program for Homeless Adults  
 
Unique Protocol ID: 21-058  
 
Date: October 12, 2021  
 
NCT Number: 04961762 
 
 
 

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Abstract 
Individuals experiencing homelessness often have complex health and social needs. They also 
face disproportionate systemic barriers to accessing healthcare services and social supports. 
Some of these barriers include not having a primary care provider, needing to meet other 
competing priorities, and difficulties affording medications. These barriers contribute to 
discontinuities in care, poor health outcomes, and high acute healthcare utilization after 
hospitalization among this population. This study aims to evaluate the effect of a unique case 
management intervention – the Navigator program – on post-hospital outcomes for individuals 
experiencing homelessness after hospitalization. This study will examine follow-up with primary 
care providers, acute healthcare utilization, quality of care transition, and overall health for those 
receiving the Navigator program compared to those receiving usual care over 180-days after 
hospital discharge.  
 
 
 
 
 
 
 
 

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Background and Rationale   
In 2014, there were 235,000 Canadians who were experiencing homelessness, of which 27.3% 
were women, 18.7% were youth, and a growing number were identifying as Indigenous, a 
veteran, and/or LGBTQ.1 Homeless individuals experience disproportionate intersecting 
physical, mental, and social burdens that greatly increase morbidity and mortality relative to the 
general population.2–4 For example, rates of acute and chronic physical health problems, trauma, 
mental illness, and substance use are much higher among homeless adults.5,6 These complex 
social- and health-related needs often require support from traditional healthcare providers and 
multiple community services, including case managers, housing workers, and harm reduction 
counsellors.7,8   
 
Despite these health inequities, homeless individuals often experience substantial barriers to 
obtaining healthcare and frequently suffer from many unmet health needs.9–11 Many have other 
immediate competing priorities such as securing food and shelter that preclude consistent 
engagement with healthcare services.12 Homeless individuals are met with considerable systemic 
challenges in relation to healthcare access, including financial barriers to transportation and 
medication and difficulty obtaining government-issued identification.13 Studies have shown that 
homeless individuals are much less likely to have a primary care provider (PCP) or receive 
outpatient care compared to the general population.14,15 Much literature has demonstrated that 
continuity of care provided by PCPs contributes to better health outcomes, a greater focus on the 
social determinants of health, and reductions in episodic care at emergency departments (EDs) 
and hospitals.16–18 Indeed, homeless adults rely heavily on acute care services, resulting in a 

October 12, 2021 
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higher rate of ED use and hospitalization among homeless adults compared to the general 
population.19–23  
 
Studies across the US and Canada have shown high rates of hospital readmission rates among 
homeless adults compared to that of the general population.22–26 Care providers and 
policymakers have long sought to reduce readmissions given that they are suboptimal from a 
patient perspective and financially costly from a societal perspective.27,28 Many readmissions for 
homeless individuals are thought to be preventable with more complete treatment and better 
coordination of health and social services following discharge.29,30 Although the literature is 
inconclusive, studies have shown that leaving against medical advice and not having a PCP post-
discharge are associated with readmission among homeless adults.24,31,32 While patients usually 
require ongoing healthcare after discharge, much of their needs can be treated or well-managed 
by PCPs and outpatient services in the community.20,33 Qualitative studies have also revealed that 
homeless individuals face diverse health and social challenges following discharge from the 
hospital. Some of these include difficulties storing medication, inability to find shelter, not being 
provided appropriate discharge instructions, and juggling competing priorities such as food 
insufficiency.34–37 Altogether, systemic barriers to care, competing priorities, and poor care 
transition all contribute toward poor post-hospital outcomes and reliance on acute healthcare 
services among homeless individuals. 
 
Case managers are a main component of care for homeless individuals, serving as central points 
of contact to coordinate health and social services.38 The Case Management Society of America 
defines case management as a “collaborative process of assessment, planning, facilitation, care 

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coordination, evaluation, and advocacy for options and services to meet an individual’s and 
family’s comprehensive health needs through communication and available resources to promote 
patient safety, quality of care, and cost-effective outcomes.” Case management programs have 
been adapted and implemented for several subgroups of homeless individuals, including frequent 
users of acute healthcare services and those with complex needs and mental illness.39–41 A 
systematic review reported that general case management for homeless individuals is effective in 
improving housing stability, reducing substance abuse, and removing barriers to securing 
employment.42  Other systematic reviews and studies have found that case management 
programs are effective in reducing hospitalization and ED use, decreasing length of hospital stay, 
and improving patient outcomes among other populations.43–45 
 
This present study builds upon a recent prospective cohort study conducted by our team that 
identified factors contributing to poor post-hospital outcomes among homeless adults. We 
identified that having an active case manager, sending the discharge summary to patient PCPs, 
and informal support are associated with reduced readmissions among this population.46 We 
have used these findings to develop a hospital-based intervention. Accordingly, this study seeks 
to investigate the effectiveness of an adapted Critical Time Intervention (CTI) case management 
program – the Navigator program – in improving post-hospital outcomes among homeless adults 
admitted to St. Michael’s Hospital. The Navigator program features a Homeless Outreach 
Counsellor– whose role is to create strong links between community services and patients 
through regular contact, supporting patients in following their post-discharge care plans, and 
helping patients in meeting their competing priorities. The Homeless Outreach Counsellor meets 
patients upon admission to a medical ward at St. Michael’s Hospital (General Internal Medicine 

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service, any Medicine subspecialty service, the Cardiac Intensive Care Unit, and the Medical 
Surgical Intensive Care Unit) and continues to work with them for up to 90-days post-discharge. 
The first Homeless Outreach Counsellor position was created in February 2019 and has since 
been expanded and adapted through conversations with community partners and medical staff. 
The Navigator Program is fully funded by the St. Michael’s Hospital Foundation and now 
includes two full-time Homeless Outreach Counsellors and a part-time Program Coordinator. 
Ultimately, the goal of the Navigator program is to support discharged patients overcome 
systemic barriers and discontinuities in care that often result in poor health and high acute 
healthcare utilization among individuals experiencing homelessness.  
 
Study Objectives  
This study seeks to evaluate the effectiveness of the Navigator program in improving post-
hospital outcomes among homeless adults using a randomized controlled trial design. It will 
specifically evaluate outcomes relating to follow-up with a PCP, acute healthcare use, social 
service use, continuity of care, patient perception of care transition, and overall health following 
discharge. Results from this study will provide insight into how health systems can provide 
better post-discharge care to homeless individuals to improve patient outcomes and reduce acute 
healthcare use. 
 
Research Questions and Study Hypotheses 
We hypothesize that patients receiving the Navigator program, compared to usual care 
participants, will: 

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1. Be more likely to follow-up with a primary care provider within 14-days of hospital 
discharge (primary outcome) 
2. Have reduced composite all-cause hospital readmission or mortality within 30-, 90-, and 
180-days post-discharge (secondary outcome) 
3. Have reduced number of ED visits within 30-, 90-, and 180-days post-discharge 
(secondary outcome) 
4. Have reduced number of days in hospital within 30-, 90-, and 180-days post-discharge 
(secondary outcome) 
5. Have a better self-reported experience of care transition after hospital discharge 
(secondary outcome) 
6. Have a greater reduction in competing priorities at the time of the 30-day interview 
relative to baseline (secondary outcome) 
7. Have a greater increase in health status at the time of the 30-day interview relative to 
baseline (exploratory outcome) 
8. Be less likely to leave against medical advice at index discharge (exploratory outcome) 
9. Have greater medication adherence at the time of the 30-day interview (exploratory 
outcome) 
10. Be more likely to be connected to a case manager at the time of 30-day interview 
(exploratory outcome) 
11. Be more likely to attend any non-PCP healthcare appointments within 180-days post-
discharge (exploratory outcome) 
12. Have a longer time to all-cause hospital readmission or mortality after index discharge 
(exploratory outcome) 

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Research Approach   
We will use a pragmatic randomized controlled design to conduct a clinical trial evaluating the 
effectiveness of the Navigator program. Adults experiencing homelessness on the General 
Internal Medicine service, any Medicine subspecialty service, the Cardiac Intensive Care Unit, 
and the Medical Surgical Intensive Care Unit at St. Michael’s Hospital will be eligible to 
participate in the study. After completion of eligibility screening, enrollment, and the baseline 
interview, participants will be randomized to either receive the Navigator program or usual care 
(Appendix G, Eligibility Screening). The research team will conduct another interview with 
participants around 30-days after hospital discharge to assess healthcare use, connection to 
community services and supports, care transition experience, health status, and competing 
priorities. The research team will conduct one chart review after hospital discharge to ascertain 
characteristics of the index admission, information about the discharge, and participant health 
information. The research team will conduct a second chart review at St. Michael’s Hospital and 
use administrative data linkage 180-days after hospital discharge to determine if patients visited 
the ED or were hospitalized at any hospitals in the area, including St. Michael’s Hospital, St. 
Joseph’s Hospital, Toronto General Hospital, Toronto Western Hospital, Mount Sinai Hospital, 
and Michael Garron Hospital. During this time, with participant consent, the research team will 
also contact primary care providers and other healthcare providers to confirm appointment 
attendance. Finally, patient consent will be requested for administrative data linkage to determine 
any acute healthcare use prior to the index hospital admission and after hospital discharge.  
 
 
 

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Study Eligibility and Recruitment  
Potential participants will be recruited by the research team on weekdays. The research team will 
identify potentially eligible participants through regular discussions with clinical staff about 
patients admitted to the General Internal Medicine service, any Medicine subspeciality service, 
the Cardiac Intensive Care Unit, and the Medical Surgical Intensive Care Unit at St. Michael’s 
Hospital. Once identified, a member of the patient’s circle of care will obtain permission from 
the patient to introduce the patient to the research staff. Research staff will confirm patient 
eligibility and explain the purpose, process, risks, and benefits of the study to potential 
participants. Participants can then choose to participate in the study by providing written 
informed consent.  
 
Inclusion Criteria 
To be eligible for the study, patients must meet the following criteria during their index 
admission: 
- 
18 years of age or older 
- 
Have an unplanned admission for any medical cause to the General Internal Medicine 
service, any Medicine subspecialty service, the Cardiac Intensive Care Unit, and the 
Medical Surgical Intensive Care Unit 
- 
Identified as being homeless at the time of admission or anytime during the index 
hospital admission. This includes patients who are: unsheltered (absolutely homeless and 
living on the streets or in places not intended for human habitation), emergency sheltered 
(staying in overnight shelters for people who are homeless, as well as shelters for those 

October 12, 2021 
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impacted by family violence), or provisionally accommodated (whose accommodation is 
temporary or lacks security of tenure).47  
 
Exclusion Criteria 
Patients will be excluded from the study if they meet any of the following criteria: 
- 
Unable to provide informed consent to the study  
- 
Previously received services from the Homeless Outreach Counsellor within 90 days of 
admission 
 
Given the pragmatic nature of this study, all participants who survive to discharge from the index 
hospitalization will be retained in the study, regardless of discharge location. For example, 
participants discharged to hospice, nursing homes, rehabilitation facilities, or other institutional 
settings (e.g. jail or palliative care) will be included in the study. Participants in both arms of the 
study will be able to access any other hospital-provided and community support services 
normally available to them, including the Coordinating Access to Care for People Experiencing 
Homelessness (CATCH) program.  
 
When the study begins, access to the Homeless Outreach Counsellors will be limited to only 
participants in this study who are randomized to the Navigator program group. However, there 
will be two exceptions in which the Homeless Outreach Counsellors may work with patients 
outside of the study. First, prior to the beginning of the study, the Homeless Outreach 
Counsellors will have been working with some patients. These patients may continue to receive 
services from the Homeless Outreach Counsellors until 90-days post-discharge but will be 

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ineligible to participate in the study until they have had no contact with the Homeless Outreach 
Counsellors for another 90 days. Second, the Homeless Outreach Counsellors may provide 
services to patients with persistent and irreversible conditions (e.g. dementia) who are incapable 
of providing informed consent and therefore excluded from participating in this study.  
 
Capacity to Provide Informed Consent 
We anticipate that most patients will be able to understand and participate fully in the consent 
process. However, if there are any doubts, an Additional Consent Measures Checklist will be 
used to confirm participants’ understanding of key aspects of the letter of information and 
consent form prior to signing (Additional Consent Measures Checklist, Appendix F). 
Additionally, during recruitment and interview scheduling, we will offer access to a professional 
interpreter for anyone with difficulty communicating in English.  In these cases, the interpreter 
will be asked to sign the “Interpreter Declaration” section of the consent form. If the interpreter 
is providing interpretation services remotely, the research assistant will ask for verbal consent to 
sign the consent form on behalf of the interpreter.  
 
Procedure for Verbal Informed Consent  
Upon participant request or in the event of special circumstances (e.g. COVID-19 precautions), 
we will offer patients the option to provide verbal informed consent over the phone. Participants 
will be read the letter of information over the phone and will be provided with a written copy in-
person or by email. If participants provide their informed consent, the research assistant will sign 
two copies of the consent form on the participants’ behalf. One completed form will be kept by 
the research team and another completed form will be provided to the participant.  

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Study Population 
Characteristics of study participants are expected to be similar to what our team has found in our 
previous prospective cohort study of homeless adults admitted to the St. Michael’s Hospital 
General Internal Medicine Service.46 Of 129 participants recruited between November 2017 and 
February 2019, the mean age was 54.6 (SD:13.9), 101 (78%) were male, 90 (70%) were White, 
and 87 (68%) had a high school education or more. 45 participants (35%) had a mental health 
condition, 80 (62%) had documented alcohol or substance use, and 32 (25%) had a Charlson 
Comorbidity Index score greater than or equal to 3. Finally, the median length of hospital stay 
for all participants was 7 (IQR: 4-14.5) days, 30 (23%) had been admitted to the study hospital in 
the past 3 months, and 61 (47%) saw a case manager in the past 2 months. However, it is 
possible that characteristics of participants in this study may be different given that the study 
population will be expanded to include other Medicine services, the Cardiac Intensive Care Unit, 
and the Medical Surgical Intensive Care Unit. 
 
Sample Size Justification 
No previous data are available to ascertain 14-day PCP follow-up rates after hospitalization 
among homeless individuals under usual care. However, a previous study found that 14-day PCP 
follow-up rates after hospitalization among low socioeconomic status (SES) patients was 48%.48 
We assume that the 14-day PCP follow-up rate after hospitalization among homeless individuals, 
under usual care, is around 2/3 that of low SES patients at 32%. The table below shows total 
sample sizes needed in each group to achieve 80% power to detect various differences in group 
proportions with a significance level of 0.05 using a two-sided Z-test with pooled variance.  

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For this study, we estimate that 12% more participants allocated to the Navigator arm will 
follow-up with a PCP within 14-days of discharge relative to the control arm. A 12% risk 
difference is equivalent to a 37.5% increase in relative risk of following-up with a PCP within 
14-days of discharge. With a 20% attrition rate, we estimate that 320 participants will be needed 
in each group – for a total of 640 participants.  
 
Homeless Outreach Counsellor Caseload 
It is anticipated that the Homeless Outreach Counsellors will always have the capacity to accept 
new participants during the study. Since February 2019, one Homeless Outreach Counsellor has 
successfully provided services to 30 active participants at one time.46 This number is consistent 
with past reviews of case management.42 Past observations have revealed that around 30 adults 
experiencing homelessness are admitted to the General Internal Medicine service at St. 
Michael’s Hospital each month. With the additional Medicine services, the Cardiac Intensive 
Care Unit, and the Medical Surgical Intensive Care Unit, we estimate that there will be around 
Control 
32% of participants 
follow-up with a 
PCP within 14 days 
of hospital 
discharge 
6% Risk 
Difference (RD) 
32%+6%=38% 
8% RD  
32%+8%=40% 
 
10% RD 
32%+10%=42% 
 
12% RD 
32%+12%=44% 
 
14% RD 
32%+14%=46% 
 
16% RD 
32%+16%=48% 
 
Total Sample Size 
1982 
1128 
730 
512 
380 
292 
Total Sample Size 
with Adjustment 
for 20% Attrition 
Rate  
2478 
1410 
912 
640 
476 
366 

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40 adults experiencing homelessness that will be eligible for study enrollment each month. Our 
past study found an enrollment rate of 65%, meaning that around 26 participants could be 
enrolled into the study each month. Over 90 days, this equates to 78 total participants or 39 
participants that are randomized to the intervention arm. The estimated peak of 39 participants is 
well within the capacity of 60 active participants between the two Homeless Outreach 
Counsellors.  
 
Given that the estimated total sample size needed for the study is 640 participants, we estimate 
that we will require around 24 months to finish enrollment for the study given a monthly 
enrollment rate of 26 participants per month.  
 
Randomization  
Following enrollment, participants will be randomized by a third-party internet randomization 
service (“randomize.net”). The resulting study allocation will be displayed on the tablet of the 
research staff who oversaw patient enrollment and communicated to participants. The 
randomization service will assign participants to either the intervention or the usual care arm 
using permuted-block randomization, with a 1:1 allocation ratio and random permuted blocks. 
This technique will maintain balanced group sizes between the intervention and usual care arms 
at intermediate points in the recruitment process and minimize the possibility of the research 
team predicting study allocation.49 The research team will have no role in determining the study 
allocation of participants.  
 
 

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Blinding  
Due to the active involvement of the Homeless Outreach Counsellor in the intervention and the 
collaborative relationship between the Homeless Outreach Counsellor and the participant’s circle 
of care, it will not be possible to blind participants, the Homeless Outreach Counsellors, or the 
participant’s circle of care to the allocation of participants. However, several measures will be 
put in place to blind specific members of the research team, in particular the data collectors, data 
analysts, and outcome adjudicators.  
 
There are three circumstances where a member of the research team will not be blinded to the 
study allocation of certain participants. First, the research assistant who revealed study allocation 
to the participant after enrollment will no longer be blinded to the study allocation of that 
particular participant. To mitigate potential bias, this research assistant will not be involved in 
the 30-day interview for that particular patient. Second, there is a possibility that research 
assistants might become unblinded during chart reviews if they come across information about 
the Homeless Outreach Counsellor. However, the chart abstraction process only involves 
extraction and not interpretation of objective data. If a research assistant becomes unblinded 
during discharge chart review, this research assistant will not be involved in the 30-day interview 
for that particular patient. Third, the Principal Investigator of this study is a Staff Physician on 
the General Internal Medicine service at St. Michael’s Hospital. There is a possibility that he will 
become unblinded to study allocation of certain participants while on service. To mitigate 
potential bias, the Principal Investigator will only be involved in the analysis of de-identified 
data and he will not be involved in patient interviews and data collection. Unblinding events are 

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not expected to occur during the 30-day interview given that it has been designed such that no 
questions should prompt participants to reveal their study allocation. No other unblinding events 
are expected during hospitalization given that the research team – outside of the Principal 
Investigator - is not involved in participant care or have direct participant interaction outside of 
the 30-day interview.  
 
After enrollment, participants will be assigned a unique study identifier number which will be 
used in the data collection and analysis processes. A Master Linking Log with participant 
identifiers will only be made available to a designated member of the Survey Research Unit who 
will have no contact with participants and will not participate in any data collection (Master 
Linking Log, Appendix E). Research assistants conducting interviews and performing chart 
reviews will only have access to the name of participants, their unique study identifier, and 
information to access health records with participant consent.  
 
The Intervention  
Active Intervention 
Participants in the intervention arm will be assigned to one of two Homeless Outreach 
Counsellors following randomization. The Navigator program is an adaptation of the Critical 
Time Intervention (CTI) model of case management. CTI is a time-limited case management 
program which delivers focused case management at critical times or situations in the lives of 
clients, such as transitioning from hospital care to community care.42 CTI has been previously 
shown to improve housing stability, health outcomes, and psychiatric symptomatology for adults 
experiencing homelessness.50–52 

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The Homeless Outreach Counsellors will connect with participants as soon as possible during 
their admissions and will provide support up to 90 days after hospital discharge. The main role of 
the Homeless Outreach Counsellor is to support continuity and comprehensiveness of care by 
helping participants follow their post-discharge plans and facilitating strong links with 
community-based health and social services. The Homeless Outreach Counsellor also helps 
address specific needs of participants, develop comprehensive care plans with members of 
patient’s multidisciplinary circle of care, and facilitate the transition of clients to long-term 
community-based health and social services. Day-to-day activities of the Homeless Outreach 
Counsellor include maintaining therapeutic rapport with participants to facilitate post-discharge 
plans, helping patients attend healthcare appointments post-discharge, and providing outreach 
support to connect participants with resources and services in the community. The intensity and 
types of support from the Homeless Outreach Counsellor will be tailored to the specific needs of 
the participant. The Homeless Outreach Counsellor will document all interactions with 
participants, healthcare teams, and community services in case notes developed specifically for 
the Navigator program.  
 
Usual Care 
Participants in the usual care arm will be discharged without transitional case management from 
the Homeless Outreach Counsellor. However, participants on the General Internal Medicine 
service will still receive support from Care Transition Facilitators (CTFs) and participants on 
other services will still receive support from social workers. CTFs work with patients during 
their hospital stay to arrange discharge plans and make follow-up arrangements. However, unlike 

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the Homeless Outreach Counsellors, CTFs do not work with patients after hospital discharge. 
The typical discharge process also involves counselling from the discharging physician and 
healthcare team, who make recommendations or appointments for follow-up care as needed. 
Moreover, participants will be provided with a written discharge summary and prescription(s) as 
needed. If the participant has a PCP, they may also receive a copy of the discharge summary. 
 
Methodology  
Interviews will be conducted with all participants at baseline and around 30-days post-discharge. 
The following categories of information will be collected with the corresponding survey 
instruments: 
1. Demographic information, including age, gender, race/ethnicity, education level, sources 
of income, and housing status (only at baseline) 
2. Healthcare use and access to healthcare, including information about PCP, past history of 
PCP visits, recent ED visits, and recent hospitalizations  
3. Social service use, including information about encounters with case managers, housing 
workers, and addiction or harm reduction workers 
4. Health status using the EQ5D 
5. Competing priorities using the RAND Course of Homelessness Scale  
6. Self-reported quality of post-hospital care transition using the CTM-3 (only at the 30-day 
interview) 
7. Medication adherence using the Morisky Medication Adherence Scale 8 (only at the 30-
day interview) 
 

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Information about number of ED visits, hospital admissions, and days in hospital in the past year 
and 180-days post-discharge will be collected from participant hospital charts from St. Michael’s 
Hospital, and through administrative data linkage at 180-days post-discharge. Linkage to 
administrative databases at ICES will also be performed to ascertain healthcare use. Mortality 
data will be collected from St. Michael’s Hospital charts or follow-up with community contacts. 
Contact will be made with participants’ primary care providers and other healthcare providers to 
confirm attendance of appointments. Information about the number of contacts and nature of 
contacts between the Homeless Outreach Counsellors and participants, community service 
providers, and healthcare team will be ascertained from the Homeless Outreach Counsellor.  
 
This study is seeking approval from the Research Ethics Boards of St. Michael’s Hospital. 
 
Outcomes 
The primary outcome is follow-up with a PCP within 14-days of hospital discharge. Early 
primary care follow-up after hospitalization has been associated with better patient outcomes.53–
55 The definition of a PCP includes both family doctors and nurse practitioners. In-person visits 
(e.g., hospital clinics, shelter clinics, and community health centers), virtual encounters (with 
video), and phone calls (without video) will be considered as follow-up with a PCP. These 
modes of PCP follow-up are in line with those outlined by quality standards from Health Quality 
Ontario.56 We will ascertain a PCP follow-up through both self-report by participants at the 30-
day interview and confirmation by contacting the PCP office. However, it is acceptable to 
confirm only with the PCP office if the participant is unreachable and also acceptable via only 

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participant self-report if the PCP office is unreachable. If there is any discrepancy, the PCP 
office will take precedence over participant self-report. 
Secondary outcomes include all-cause hospital readmission or mortality (composite) within 30-, 
90-, and 180-days post-discharge, total number of days spent in hospital within 30-, 90-, and 
180-days post-discharge, number of ED visits within 30-, 90-, and 180-days post-discharge, self-
reported quality of care transition after hospital discharge, and self-reported change in competing 
priorities at the time of the 30-day interview relative to baseline. Measuring acute healthcare use 
outcomes within 30-days post-discharge is standard for such outcomes in health systems across 
Canada.57 However, we will also measure acute healthcare use outcomes within 90-days and 
180-days post-discharge because we observed low event rates within 30-days post-discharge in 
our previous prospective cohort study.46 All acute healthcare use outcomes will not include 
labour/delivery visits, planned readmissions, and transfers between services within the hospital. 
All acute healthcare use outcomes will also be ascertained from the 30-day interview, 180-day 
chart review, and administrative databases at ICES. Self-reported quality of post-hospital care 
transition will be ascertained at the 30-day interview and competing priorities will be ascertained 
at both the baseline and 30-day interviews.  
 
Exploratory outcomes include change in health status at the time of the 30-day interview relative 
to baseline, leaving against medical advice at index discharge, medication adherence at the time 
of the 30-day interview, connection to a case manager at the time of the 30-day interview, 
attendance of any non-PCP healthcare appointment within 180-days post-discharge, and time to 
all-cause hospital readmission or mortality after index discharge. Only non-PCP healthcare 
appointments made by the time of discharge and written in the discharge summary from the 

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index admission will be assessed for attendance. Time to all-cause hospital readmission or 
mortality will be defined as the number of days from index discharge to the first all-cause 
hospital readmission or mortality during the 180-day observation period. Only participants that 
did not previously report contact with a case manager in the 30-days prior to the baseline 
interview will be assessed for the connection to a case manager outcome. Health status will be 
measured at both baseline and 30-days interviews. All acute healthcare use outcomes will be 
ascertained from the 30-day interview, and administrative databases at ICES. All other 
exploratory outcomes will be ascertained from the 30-day interview.   
 
Data Collection 
Baseline and 30-day interviews will be conducted at baseline and around 30-days post-discharge 
with all study participants. Interviews will be completed by trained research assistants from the 
Survey Research Unit at the MAP Centre for Urban Health Solutions at St. Michael’s Hospital. 
To minimize study attrition, at the baseline interview, study participants will be asked to provide 
detailed contact information, as well as the names and contact information of family, friends, and 
other service providers that can be contacted (with participant consent) if the research team 
cannot reach the participant (Contact Information Form, Appendix D). Information from the 
Contact Information Form will be stored securely by the Survey Research Unit.  
 
Interviews 
The baseline interview will be conducted prior to randomization and as soon as possible after 
participant enrollment (Baseline Admission Interview, Appendix C1). It will take approximately 

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30 minutes. The baseline interview must be conducted prior to discharge from the index 
admission and may be conducted in-person or remotely.  
 
The 30-day interview will take place at least 30 days (but no later than 40 days) after the index 
admission discharge date (30-Day Interview, Appendix C3) and will take approximately 45 
minutes. The 30-day interview may be conducted in-person or remotely. The participant will be 
given a card at discharge with the time and date of the interview and the contact information of 
the research team (with the EQ5D VAS scale on the back of the card for the 30-day interview). If 
the interview is to take place in-person, the meeting location will be set at St. Michael’s Hospital 
or somewhere in the community that is convenient for the participant. Research staff will contact 
participants two weeks following discharge and the day before the interview to confirm the time, 
date, and meeting location.  
 
The interviews contain validated scales and questions which were selected based on their 
relevance, psychometric properties, ease of implementation, and prior use in research among the 
homeless population. The research team will be collecting data with tablets using electronic 
based surveys hosted by SNAP Professional Software. Please note that SNAP Professional 
Software has been reviewed and approved for use by St. Michael’s Hospital. The SNAP Server 
is owned by the Survey Research Unit and is located inside the St. Michael’s Hospital network.  
 
 
 
 

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The following domains will be assessed in the interviews: 
Domain and Selected 
Instrument 
Instrument or Variable 
Sociodemographic 
Variables 
Research staff will collect the following information: basic demographic information 
(gender, race/ethnicity, partner status, education, prescription drug coverage), 
smoking status, housing status, and income support).  
Healthcare Use and 
Access to Care  
Research staff will collect the following information: 
-Name of PCP, PCP location, and last time participant visited the PCP 
-ED visits in the past ~30 days  
-Hospitalizations in the past ~30 days 
-Whether the participant felt they did not receive needed healthcare in the past ~30 
days  
-Whether the participant saw a PCP within 14 days of discharge date 
Social Service Use  
Research staff will collect the following information: 
-Whether the participant is connected with a case manager, housing worker, or 
addiction or harm reduction worker. 
-How many times the participant saw any of the above service providers in the past 
~30 days 
-Whether the participant is currently applying for any social benefits or supports 
Health Status/Functional 
Status  
EQ-5D-3L 
The EQ-5D-3L is a generic measure of health-related quality of life that has been 
widely used among the homeless population.58 The EQ-5D-3L includes five 3-level 
items concerning mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression that are weighted to produce a single utility score between 0 and 1. 
The Visual Analog Scale (VAS) of the EQ-5D-3L will also be included, which will 
allow participants to rate their overall health, mental health, and physical health from 
0 to 100. 
Medication Adherence/ 
Barriers to Medication 
Adherence 
Morisky Medication Adherence Scale-8 
The MMAS-8 is the most accepted self-reported measure for medication-taking 
behavior that has been used among disadvantaged patients and those with chronic 
illnesses.59,60  

October 12, 2021 
24 
The MMAS-8 consists of 8 items, the first 7 of which are yes/no questions, and the 
last of which is a 5-point Likert-scale rating.61 Each ‘‘no” response is rated as ‘‘1” and 
each ‘‘yes” is rated as ‘‘0” except for item 5, in which each response ‘‘yes” is rated as 
‘‘1” and each ‘‘no” is rated as ‘‘0”. For item 8, if a patient chooses response ‘‘0”, the 
score is ‘‘1” and if they choose response ‘‘4”, the score is ‘‘0”. Responses ‘‘1, 2, 3” 
are respectively rated as ‘‘0.25, 0.75, 0.75”. Total MMAS-8 scores can range from 0 
to 8 and have been categorized into three levels of adherence: high adherence (score = 
8), medium adherence (score of 6 to 8), and low adherence (score< 6).  
If a participant answers “yes” to question 2 (in the past 2 weeks, were there any days 
you did not take your medications), the participant will be asked about reasons for 
non-adherence using a questionnaire developed by our team specifically for homeless 
adults.62 
Care Transition 
Care Transitions Measure-3 
The most widely used measure of care transition quality is the Care Transition 
Measure (CTM).63–65 The CTM-3 is an abbreviated version of the original CTM-15, 
which measures the extent to which the healthcare team accomplished essential care 
processes in preparing the patient for discharge and participating in post-hospital self-
care activities.  
The CTM-3 consists of 3 items with a 4-point scale with responses ranging from 
“Strongly Disagree” (1) to “Strongly Agree” (4) to the following questions: 
-During this hospital stay, staff took my preferences into account in deciding what my 
healthcare needs would be when I left. 
-When I left the hospital, I had a good understanding of the things I was responsible 
for in managing my health. 
-When I left the hospital, I clearly understood the purpose for taking each of my 
medications 
Items are scored by summing the responses and then linear transforming to a 0-100 
range.  
Competing Priorities  
RAND Course of Homelessness Scale  
Developed specifically for homeless populations12, the RAND scale is a 5-item index 
of self-reported difficulty in meeting the following subsistence needs over the past 30 
days: frequency of difficulty in finding shelter, enough to eat, clothing, a place to 
wash, and a place to use the bathroom. Possible responses to each item are never (1), 
rarely (2), sometimes (3), or usually (4) with total scores between 5-20.  
 
 

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Honorariums 
Participants will be provided honorariums to compensate them for their time. Participants will be 
given a $20 Tim Horton’s gift card for their participation in the baseline interview. Gift cards are 
a suitable form of honorarium for the baseline interview given that cash may incentivize patients 
to leave the hospital prematurely. Tim Horton’s is an accessible café with various locations both 
within the hospital and in the community. Upon completion of the 30-day interview, participants 
will be compensated with an honorarium of $40 and the cost of round-trip public transportation 
fare (if the participant traveled to the interview). This honorarium will be paid either as cash after 
the interview, cash for pick-up at a later day, e-transfer, or mailed cheque.  
 
Chart Review 
At patient discharge, a discharge chart review will be conducted using patient charts from St. 
Michael’s Hospital (Discharge Chart Review, Appendix C2). At 180-days post-discharge, data 
will be collected from patient charts from St. Michael’s Hospital. Data on the number and nature 
of interactions between the Homeless Outreach Counsellor and participants, community service 
providers, and healthcare team will be collected from the Homeless Outreach Counsellors during 
the 180-day chart review. Finally, during the 180-day chart review, the research team will 
contact the participant’s PCP (PCP Questionnaire, Appendix C4) and other healthcare providers 
to confirm appointment attendance.  
 
ICES Linkage 
 
Data linkage will be conducted at the Institute for Clinical Evaluation Sciences (ICES), where 
population-based health information is available at the patient level for all Ontarians using 
formal health services. Health service use will be examined in the National Ambulatory 

October 12, 2021 
26 
Reporting System (NACRS), the Discharge Abstract Database (DAD), the Ontario Mental 
Health Reporting System (OMHRS), and the Ontario Health Insurance Plan (OHIP) for PCP 
visits, ED visits and inpatient hospitalizations. This project will attain health service use data for 
all consenting participants from 3 years prior to the index admission to 1 year following index 
admission discharge.  
 
The following variables will be ascertained using chart review and administrative data: 
 
Domain 
Variable 
Sociodemographic Variables 
- Age 
- Sex 
Hospitalization characteristics 
 
- Admission date 
- Admitting diagnosis 
- Outpatient specialties listed 
- Discharge date  
- Length of index hospital stay  
- Whether the patient left against medical advice  
- Discharge diagnoses 
- Comorbidities list 
- Charlson Comorbidity Index Score66 
- Number of medications prescribed at discharge 
- Non-PCP healthcare appointments made and reported in discharge 
summary  
- Whether a PCP was copied on discharge summary  
Prior Healthcare Use 
- Hospitalizations and ED visits to all study hospitals combined in the 
past year  
• Dates of hospital visit, length of stay, and reason for admission  
- Hospitalizations and ED visits to any hospital in Ontario combined in 
the past year 
• Dates of hospital visit, length of stay, and reason for admission 
-Dates of PCP visits in Ontario in the past year  
Alcohol and Substance Use 
- Alcohol: non-drinker vs current drinker; if yes, how many drinks per 
day on average  
- Illicit drug use: none vs current use; if yes, which drugs (open response) 
 

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27 
Healthcare Use Post-Discharge 
- Hospitalizations and ED visits to all study hospitals combined in the 30-
, 90-, and 180-days following discharge   
• Dates of hospital visit, length of stay, and reason for admission  
- Hospitalizations and ED visits to any hospital in Ontario combined in 
the 30-, 90-, and 180-days following discharge   
• Dates of hospital visit, length of stay, and reason for admission 
-Dates of PCP visits in Ontario 180-days following discharge 
-Number of healthcare (non-PCP) appointments from the discharge 
summary the patient attended 180-days following discharge 
• Name of healthcare provider, specialty, location, and date of 
appointment  
Mortality 
-Date of participant death  
-Mode of mortality verification  
- Note that the research team will also contact community organizations to 
ascertain possible participant mortality if participants are not reachable 
and such data is not available through chart review and administrative 
databases  
 
Data Analysis  
All analyses will follow the intention-to-treat principle. Sample characteristics will be 
summarized by descriptive statistics (mean, standard deviation, median, interquartile range, and 
proportion). We will also construct graphs (histograms, box plots, scatterplots, spaghetti plots) to 
explore relationships and estimate correlations between selected participants’ characteristics and 
outcomes. Descriptive comparisons between group baseline characteristics and outcomes will be 
performed with χ2 or Fisher exact tests for categorical variables and with t-tests or Wilcoxon 
rank sum tests for continuous or count variables.  
Primary Outcome  
The primary analysis will be performed using the χ2 test to compare two independent proportions 
of 14-day PCP follow-up. The difference in proportions (risk difference, RD) and 95% 

October 12, 2021 
28 
confidence interval (CI) will be estimated using Wald’s method.67 Two secondary analyses will 
be conducted. The first is a log-binomial regression model including the intervention arm 
indicator as the covariate. The risk ratio (RR) and 95% CI will be estimated from the model. The 
second is a logistic regression model including the intervention arm indicator as the covariate. 
The odds ratio (OR) and 95% CI will be estimated from the model.  
 
To explore potential subgroup effects, we will construct multivariable logistic models for the 
primary outcome including each of the following pre-specified co-variates, one-at-a-time and 
with corresponding interaction terms with the intervention arm: age, sex, current illicit drug use, 
current risky alcohol use68, Charlson Comorbidity Index Score, and prior acute healthcare use for 
a mental health reason.  
 
Secondary Outcomes 
For the composite all-cause hospital readmission or mortality binary outcomes within 30-, 90- 
and 180-days post-discharge, we will use logistic regression models to estimate odds ratios and 
95% CIs using the outcomes as the dependent variables and intervention arm indicator as the 
covariate. For the count outcomes (number of ED visits and number of days in the hospital 
within 30-, 90- and 180-days post-discharge), we will use Poisson regression models or negative 
binomial regression models (if over-dispersion is suggested by the data) to estimate rate ratios 
and 95% CIs using the outcomes as the dependent variables and the intervention arm indicator as 
the covariate. For CTM-3 score (cross-sectional continuous outcome), we will use a linear 
regression model using the outcome as the dependent variable and the intervention arm indicator 
as the covariate. For competing priorities score at baseline and time of the 30-day interview 

October 12, 2021 
29 
(longitudinal continuous outcome), we will use generalized estimating equation (GEE) linear 
regression models. The models will include the intervention arm indicator, time (baseline versus 
time of 30-day interview), and the interaction of intervention arm by time. A significant 
interaction will indicate that the change in competing priorities score from baseline is different 
between the study groups. This difference and 95% CI will be estimated.  
 
Exploratory Outcomes 
For binary outcomes (leaving against medical advice at discharge, connecting to a case manager 
at the time of the 30-day interview, and attending any non-PCP healthcare appointment noted in 
the St. Michael’s Hospital discharge summary or administrative data linkages within 180-days 
post-discharge), we will use logistic regression models to estimate odds ratios and 95% CIs using 
the outcomes as the dependent variable and intervention arm indicator as the covariate. For 
MMAS-8 score at the time of the 30-day interview (cross-sectional continuous outcome), we will 
use a linear regression model using the outcome as the dependent variable and the intervention 
arm indicator as the covariate. For longitudinal continuous outcomes (EQ5D VAS and 3L health 
status scores at baseline and time of the 30-day interview), we will use GEE linear regression 
models. The models will include the intervention arm indicator, time (baseline versus time of the 
30-day interview), and the interaction of intervention arm by time. Significant interactions will 
indicate that the changes from baseline are different between the study groups. These differences 
and 95% CIs will be estimated. For time to all-cause hospital readmission or mortality after 
index discharge (time to event outcome), we will perform survival analyses. Cumulative event 
rates will be calculated with the Kaplan-Meier method, with event or censoring times calculated 

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30 
from the date of discharge. Differences in Kaplan-Meier survival curves between the 
intervention arms will be assessed using the log-rank test. 
 
Finally, we will also consider any missing data and will perform multiple imputations as 
sensitivity analyses if indicated.69 All analyses will be conducted using R (Version 3.6.3) or 
STATA (Version 16). All statistical tests will be two-sided and a p-value of 0.05 or less will 
indicate statistical significance. Adjustments will not be conducted for multiple comparisons.  
 
Fidelity  
Fidelity of the intervention will be assessed based on whether or not services provided by the 
Homeless Outreach Counsellors were consistent with the outlined Theory of Change (Appendix 
K). More specifically, Homeless Outreach Counsellors should meet the following five groups of 
activities and outputs:  
1. Make connections and referrals to community-based providers 
2. Support and advocate for patients during hospital stay and discharge process 
3. Support patient with health care-related matters during post-discharge period 
4. Support patient with social-related matters during post-discharge period 
5. Transfer patient-related information to other health care providers and community-based 
providers  
This information will be obtained by research assistants from charts maintained by the Homeless 
Outreach Counsellors.  
 
 

October 12, 2021 
31 
Patient Safety 
This study will not have a Data and Safety Monitoring Board (DSMB). The Navigator program 
is unlikely to cause any harm to participants and so a DSMB is not necessary. No interim 
analysis of data is anticipated.  
 
Data Retention 
The research team will make every effort to keep personal health information private and 
confidential in accordance with all applicable privacy legislation, including the Personal Health 
Information Protection Act (PHIPA) of Ontario. Any health information that is recorded for 
study purposes will be de-identified by using a random unique study identifier number instead of 
any personally identifying information and stored in a Master Linking Log. This information will 
only be used to get in touch with participants and access health records with participant consent. 
It will only be seen by research staff who are not connected to any part of participants’ care and 
will stay at St. Michael’s Hospital’s secure computer server in a password protected file. Only 
the designated member of the Survey Research Unit will be in control of the Master Linking 
Log.  
 
At each interview, responses will be collected using tablets with an electronic web version of 
SNAP Professional Software. All of the electronic data will be kept on a secure server at St. 
Michael’s Hospital in an unreadable format for anyone outside of the study. Only authorized 
members of the research team will have access to the interview data. All study information will 
be kept for a period of 7 years from the end of the study and then destroyed. The Principal 
Investigator will protect participant records and keep all information confidential to the greatest 

October 12, 2021 
32 
extent possible by law.  
 
Research staff may use texting and email to contact participants, if they indicated on their 
Contact Information Form that they wished to be contacted in this way. There is no obligation to 
text or email – participants may always contact the research team by phone or through their 
Homeless Outreach Counsellor. The research team will not collect any participant personal 
health information through email or texting. In the consent form, participants are advised that 
email and text messages are not secure modes of communication, asked not to send any personal 
health information via text or email, and directed not to use text or email in emergency 
situations. Research staff will only use a participant’s first name in a text message. If the research 
team does receive personal health information or a notice of an emergency by text or email, the 
research team will follow up with a phone call.  
 
Participants will be asked if they are interested in being contacted regarding additional related 
research for 3 years after the completion of the study. If so, participant contact information will 
be maintained for this time period. If not, it will be destroyed after study completion.  
 
         Study Limitations 
 
Several limitations of the proposed study can be noted. First, the study is taking place in a single 
urban center in Ontario and findings may not be generalized to other contexts with unique 
challenges in supporting care transitions for individuals experiencing homelessness. Therefore, 
findings from this initial study should inform multi-site randomized controlled trials across 
Canada and other countries that are tailored to local contexts. Second, due to the nature of the 

October 12, 2021 
33 
intervention, participants and the participants’ circles of care are not blinded to participant 
assignment.70,71 Knowledge of participant assignment might affect clinical course in the hospital 
and patient behaviour post-discharge. For example, care teams might be more inclined to 
discharge a participant in the intervention arm earlier knowing that post-discharge supports are 
available to the participant. However, the research team and Homeless Outreach Counsellors will 
actively minimize this potential bias by emphasizing the clinical equipoise surrounding the 
effectiveness of the Navigator program in improving post-hospital outcomes. Finally, given the 
recent COVID-19 pandemic72, participants may experience barriers in engaging with the 
Homeless Outreach Counsellors and attending in-person interviews. However, this study has 
been designed to allow for remote encounters with participants and the Homeless Outreach 
Counsellors have been trained to communicate and work remotely with participants.  
 
Research Team  
The research team is led by Dr. Stephen Hwang (Principal Investigator) and includes Dr. Vicky 
Stergiopoulos, Dr. Rosane Nisenbaum, Dr. Anita Palepu, Dr. Gabriel Fabreau, and Dr. Kerry 
McBrien (Study Investigators).  
 
Dr. Stephen Hwang, MD, MPH, is a clinician-scientist, the Director of the Centre for Urban 
Health Solutions at St. Michael’s Hospital, and a Professor of Medicine at the University of 
Toronto. He has an outstanding track record of leading interdisciplinary research teams and 
conducting studies to improve the health of individuals experiencing homelessness. Dr. Vicky 
Stergiopoulos, MD, MHSc, is a clinician-scientist, the Physician-in-Chief at the Center for 
Addiction and Mental Health, and Professor and Vice Chair, Clinical and Innovation in the 

October 12, 2021 
34 
Department of Psychiatry at the University of Toronto. Her expertise includes mental health 
services research, including the design, implementation, and evaluation of interventions for 
individuals experiencing homelessness using both qualitative and quantitative methods. Dr. 
Rosane Nisenbaum, PhD, is a Senior Biostatistician at the Centre for Urban Health Solutions and 
an Assistant Professor at the University of Toronto. She has extensive experience designing and 
analyzing datasets from intervention studies to improve health and housing outcomes for 
individuals experiencing homelessness. Dr. Anita Palepu, MD, MPH is the Providence Health 
Care Head of Medicine and a Professor and Eric Hamber Chair of Medicine at the University of 
British Columbia. She is a General Internal Medicine Specialist and conducts her research at the 
Centre for Health Evaluation and Outcome Sciences and has a research program that falls under 
the broad umbrella of urban health research with a particular interest in the health outcomes of 
individuals experiencing homelessness. Dr. Gabriel Fabreau, MD, MPH, is a clinician-scientist, 
Assistant Professor in the Departments of Medicine and Community Health Sciences at the 
University of Calgary, and an active member of the O’Brien Institute for Public Health. He is a 
practicing internal medicine specialist with clinical and academic interests in refugee health, 
socially vulnerable populations, and designing health system innovations for socially vulnerable 
populations. Dr. Kerry McBrien, MD, MPH, is an Associate Professor in the Departments of 
Family Medicine and Community Health Sciences at the University of Calgary. She is a 
clinician-scientist with an active practice in family medicine. Her research focuses on health 
services and health economics, with a specific interest in models of care that can improve the 
quality and efficiency of chronic disease management in primary care. Dr. Angela Cheung, MD, 
PhD, is a Senior Scientist at University Health Network and Professor of Medicine at the 
University of Toronto. She is a clinician-scientist with broad research interests and particular 

October 12, 2021 
35 
expertise in clinical epidemiology, knowledge translation, and health services research. Dr. 
Matthew To, MD, is a physician and researcher in the Departments of Family and Community 
Medicine at St. Joseph’s Health Centre. He has particular expertise in research surrounding 
homelessness, primary care, and public health.  
 
Research Staff 
The Survey Research Unit at the Centre for Urban Health Solutions (St. Michael’s Hospital) will 
provide research staff for study recruitment and data collection. The Survey Research Unit has 
completed multiple projects involving individuals experiencing homelessness at St. Michael’s 
Hospital. Cheryl Pedersen is the Research Project Manager for multiple projects within the 
Survey Research Unit. Cheryl has many years of research management experience in the 
healthcare sector. Rebecca Brown is a Research Coordinator in the Survey Research Unit who 
coordinates the day-to-day operations of multiple projects. Her work centers around quantitative 
and qualitative data collection, interviewing, and thematic coding. Rebecca is also an 
experienced interviewer and has conducted a large number of interviews with individuals 
experiencing homelessness. Michael Liu is a Medical Student and Research Coordinator at the 
MAP Centre for Urban Health Solutions. Michael has experience at St. Michael’s Hospital with 
quantitative project planning, data collection, and data analysis, with a particular focus on 
homelessness, health services, and outcomes research. Kate Francombe Pridham is a Research 
Coordinator at the MAP Centre for Urban Health Solutions that has been developing and 
implementing the Navigator program. Kate has experience at St. Michael’s Hospital with 
quantitative and qualitative project management, data collection, and data analysis, with a 
particular focus on mental health and homelessness studies.  

October 12, 2021 
36 
 
Risks and Benefits 
Risks 
Involvement in this research poses no to minimal risks to participants. The baseline and 30-day 
interviews do not involve questions that are anticipated to cause emotional distress among 
participants. There is still a possibility that some participants may find certain interview 
questions to be challenging or uncomfortable. However, participants may choose to not answer 
specific questions. Participants may withdraw from the study at any point in time. Should an 
individual choose to withdraw from the study entirely, they will keep any honorariums, still have 
access to usual care, and can request that all information collected from them to that point be 
destroyed. The Study Investigators bring extensive experience in the design, implementation, and 
evaluation of interventions for the target population, providing an excellent foundation for early 
identification and prompt response to potential emerging challenges.  
 
Benefits 
Study participants who are assigned to the intervention arm will receive the Navigator program 
and may directly benefit from the services of the Homeless Outreach Counsellors. Study 
participants in the usual care arm will not receive any direct benefits 
 
References 
1.  
Gaetz, S., Gulliver, T., & Richter T. The State of Homelessness in Canada.; 2016. 
2.  
Hwang SW, Wilkins R, Tjepkema M, O’Campo PJ, Dunn JR. Mortality among residents 
of shelters, rooming houses, and hotels in Canada: 11 Year follow-up study. BMJ. 

October 12, 2021 
37 
2009;339(7729):1068. doi:10.1136/bmj.b4036 
3.  
Aldridge RW, Story A, Hwang SW, et al. Morbidity and mortality in homeless 
individuals, prisoners, sex workers, and individuals with substance use disorders in high-
income countries: a systematic review and meta-analysis. Lancet. 2018;391(10117):241-
250. doi:10.1016/S0140-6736(17)31869-X 
4.  
Hwang SW. Mortality among men using homeless shelters in Toronto, Ontario. J Am Med 
Assoc. 2000;283(16):2152-2157. doi:10.1001/jama.283.16.2152 
5.  
Hwang SW. Homelessness and health. CMAJ. 2001;164(2):229-233. 
doi:10.7748/ns.3.48.30.s54 
6.  
Fazel S, Geddes JR, Kushel M. The health of homeless people in high-income countries: 
Descriptive epidemiology, health consequences, and clinical and policy recommendations. 
Lancet. 2014;384(9953):1529-1540. doi:10.1016/S0140-6736(14)61132-6 
7.  
Padgett DK, Tiderington E, Tran Smith B, Derejko K-S, Henwood BF. Complex 
recovery: Understanding the lives of formerly homeless adults with complex needs. J Soc 
Distress Homeless. 2016;25(2):60-70. doi:10.1080/10530789.2016.1173817 
8.  
Canavan R, Barry MM, Matanov A, et al. Service provision and barriers to care for 
homeless people with mental health problems across 14 European capital cities. BMC 
Health Serv Res. 2012;12(1):222. doi:10.1186/1472-6963-12-222 
9.  
Kushel MB, Gupta R, Gee L, Haas JS. Housing instability and food insecurity as barriers 
to health care among low-income Americans. J Gen Intern Med. 2006;21(1):71-77. 
doi:10.1111/j.1525-1497.2005.00278.x 
10.  
Kushel MB, Vittinghoff E, Haas JS. Factors associated with the health care utilization of 
homeless persons. J Am Med Assoc. 2001;285(2):200-206. doi:10.1001/jama.285.2.200 

October 12, 2021 
38 
11.  
Omerov P, Craftman ÅG, Mattsson E, Klarare A. Homeless persons’ experiences of 
health- and social care: A systematic integrative review. Heal Soc Care Community. 
2020;28(1):1-11. doi:10.1111/hsc.12857 
12.  
Gelberg L, Gallagher TC, Andersen RM, Koegel P. Competing priorities as a barrier to 
medical care among homeless adults in Los Angeles. Am J Public Health. 
1997;87(2):217-220. doi:10.2105/AJPH.87.2.217 
13.  
Campbell DJT, O’Neill BG, Gibson K, Thurston WE. Primary healthcare needs and 
barriers to care among Calgary’s homeless populations. BMC Fam Pract. 2015;16(1):139. 
doi:10.1186/s12875-015-0361-3 
14.  
Fischer PJ, Shapiro S, Breakey WR, Anthony JC, Kramer M. Mental health and social 
characteristics of the homeless: A survey of mission users. Am J Public Health. 
1986;76(5):519-524. doi:10.2105/AJPH.76.5.519 
15.  
Khandor E, Mason K, Chambers C, Rossiter K, Cowan L, Hwang SW. Access to primary 
health care among homeless adults in Toronto, Canada: Results from the street health 
survey. Open Med. 2011;5(2):94-103. /pmc/articles/PMC3148004/?report=abstract. 
Accessed July 28, 2020. 
16.  
O’Toole TP, Buckel L, Bourgault C, et al. Applying the chronic care model to homeless 
veterans: effect of a population approach to primary care on utilization and clinical 
outcomes. Am J Public Health. 2010;100(12):2493-2499. doi:10.2105/AJPH.2009.179416 
17.  
Andermann A. Taking action on the social determinants of health in clinical practice: A 
framework for health professionals. CMAJ. 2016;188(17-18):E474-E483. 
doi:10.1503/cmaj.160177 
18.  
Gill JM, Mainous AG, Nsereko M. The effect of continuity of care on emergency 

October 12, 2021 
39 
department use. Arch Fam Med. 2000;9(4):333-338. doi:10.1001/archfami.9.4.333 
19.  
Martell J V., Seitz RS, Harada JK, Kobayashi J, Sasaki VK, Wong C. Hospitalization in 
an urban homeless population: The honolulu urban homeless project. Ann Intern Med. 
1992;116(4):299-303. doi:10.7326/0003-4819-116-4-299 
20.  
Salit SA, Kuhn EM, Hartz AJ, Vu JM, Mosso AL. Hospitalization Costs Associated with 
Homelessness in New York City. N Engl J Med. 1998;338(24):1734-1740. 
doi:10.1056/NEJM199806113382406 
21.  
Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among 
the homeless and marginally housed: Results from a community-based study. Am J Public 
Health. 2002;92(5):778-784. doi:10.2105/AJPH.92.5.778 
22.  
Miyawaki A, Hasegawa K, Figueroa JF, Tsugawa Y. Hospital Readmission and 
Emergency Department Revisits of Homeless Patients Treated at Homeless-Serving 
Hospitals in the USA: Observational Study. J Gen Intern Med. 2020;35(9):2560-2568. 
doi:10.1007/s11606-020-06029-0 
23.  
Khatana SAM, Wadhera RK, Choi E, et al. Association of Homelessness with Hospital 
Readmissions—an Analysis of Three Large States. J Gen Intern Med. 2020;35(9):2576-
2583. doi:10.1007/s11606-020-05946-4 
24.  
Saab D, Nisenbaum R, Dhalla I, Hwang SW. Hospital Readmissions in a Community-
based Sample of Homeless Adults: a Matched-cohort Study. J Gen Intern Med. 
2016;31(9):1011-1018. doi:10.1007/s11606-016-3680-8 
25.  
Kertesz SG, Posner MA, O’Connell JJ, et al. Post-hospital medical respite care and 
hospital readmission of homeless persons. J Prev Interv Community. 2009;37(2):129-142. 
doi:10.1080/10852350902735734 

October 12, 2021 
40 
26.  
Doran KM, Ragins KT, Iacomacci AL, Cunningham A, Jubanyik KJ, Jenq GY. The 
revolving hospital door: Hospital readmissions among patients who are homeless. Med 
Care. 2013;51(9):767-773. doi:10.1097/MLR.0b013e31829fafbb 
27.  
Jencks SF, Williams M V., Coleman EA. Rehospitalizations among patients in the 
medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428. 
doi:10.1056/NEJMsa0803563 
28.  
Bueno H, Ross JS, Wang Y, et al. Trends in length of stay and short-term outcomes 
among medicare patients hospitalized for heart failure, 1993-2006. JAMA - J Am Med 
Assoc. 2010;303(21):2141-2147. doi:10.1001/jama.2010.748 
29.  
Kripalani S, LeFevre F, Phillips CO, Williams M V., Basaviah P, Baker DW. Deficits in 
communication and information transfer between hospital-based and primary care 
physicians: Implications for patient safety and continuity of care. J Am Med Assoc. 
2007;297(8):831-841. doi:10.1001/jama.297.8.831 
30.  
Auerbach AD, Kripalani S, Vasilevskis EE, et al. Preventability and causes of 
readmissions in a national cohort of general medicine patients. JAMA Intern Med. 
2016;176(4):484-493. doi:10.1001/jamainternmed.2015.7863 
31.  
Dirmyer VF. The Frequent Fliers of New Mexico: Hospital Readmissions among the 
Homeless Population. Soc Work Public Health. 2016;31(4):288-298. 
doi:10.1080/19371918.2015.1101036 
32.  
Racine MW, Munson D, Gaeta JM, Baggett TP. Thirty-Day Hospital Readmission among 
Homeless Individuals with Medicaid in Massachusetts. Med Care. 2020;58(1):27-32. 
doi:10.1097/MLR.0000000000001234 
33.  
White BM, Ellis C, Simpson KN. Preventable hospital admissions among the homeless in 

October 12, 2021 
41 
California: A retrospective analysis of care for ambulatory care sensitive conditions. BMC 
Health Serv Res. 2014;14(1):511. doi:10.1186/s12913-014-0511-7 
34.  
Kertesz SG, Posner MA, O’Connell JJ, et al. Post-hospital medical respite care and 
hospital readmission of homeless persons. J Prev Interv Community. 2009;37(2):129-142. 
doi:10.1080/10852350902735734 
35.  
Baggett TP, O’Connell JJ, Singer DE, Rigotti NA. The unmet health care needs of 
homeless adults: A national study. Am J Public Health. 2010;100(7):1326-1333. 
doi:10.2105/AJPH.2009.180109 
36.  
Coe AB, Moczygemba LR, Gatewood SBS, Osborn RD, Matzke GR, Goode JVR. 
Medication adherence challenges among patients experiencing homelessness in a 
behavioral health clinic. Res Soc Adm Pharm. 2015;11(3):e110-e120. 
doi:10.1016/j.sapharm.2012.11.004 
37.  
Greysen SR, Allen R, Lucas GI, Wang EA, Rosenthal MS. Understanding transitions in 
care from hospital to homeless shelter: A mixed-methods, community-based participatory 
approach. J Gen Intern Med. 2012;27(11):1484-1491. doi:10.1007/s11606-012-2117-2 
38.  
Pottie K, Kendall CE, Aubry T, et al. Clinical guideline for homeless and vulnerably 
housed people, and people with lived homelessness experience. CMAJ. 
2020;192(10):E240-E254. doi:10.1503/cmaj.190777 
39.  
McCormack RP, Hoffman LF, Wall SP, Goldfrank LR. Resource-limited, collaborative 
pilot intervention for chronically homeless, alcohol-dependent frequent emergency 
department users. Am J Public Health. 2013;103(SUPPL. 2):S221. 
doi:10.2105/AJPH.2013.301373 
40.  
Nelson G, Aubry T, Lafrance A. A review of the literature on the effectiveness of housing 

October 12, 2021 
42 
and support, assertive community treatment, and intensive case management interventions 
for persons with mental illness who have been homeless. Am J Orthopsychiatry. 
2007;77(3):350-361. doi:10.1037/0002-9432.77.3.350 
41.  
Sadowski LS, Kee RA, Vanderweele TJ, Buchanan D. Effect of a housing and case 
management program on emergency department visitsand hospitalizations among 
chronically Ill homeless adults a randomized trial. JAMA - J Am Med Assoc. 
2009;301(17):1771-1778. doi:10.1001/jama.2009.561 
42.  
De Vet R, Van Luijtelaar MJA, Brilleslijper-Kater SN, Vanderplasschen W, Beijersbergen 
MD, Wolf JRLM. Effectiveness of case management for homeless persons: A systematic 
review. Am J Public Health. 2013;103(10):e13. doi:10.2105/AJPH.2013.301491 
43.  
Norris SL, Nichols PJ, Caspersen CJ, et al. The effectiveness of disease and case 
management for people with diabetes: A systematic review. Am J Prev Med. 2002;22(4 
SUPPL. 1):15-38. doi:10.1016/S0749-3797(02)00423-3 
44.  
Grover CA, Sughair J, Stoopes S, et al. Case management reduces length of stay, charges, 
and testing in emergency department frequent users. West J Emerg Med. 2018;19(2):238-
244. doi:10.5811/westjem.2017.9.34710 
45.  
Hudon C, Chouinard M-C, Lambert M, Dufour I, Krieg C. Effectiveness of case 
management interventions for frequent users of healthcare services: a scoping review. 
BMJ Open. 2016;6(9):e012353. doi:10.1136/bmjopen-2016-012353 
46.  
Wang A, Pridham KF, Nisenbaum R, Pedersen C, Brown R, Hwang SW. Factors 
Associated with Readmission Among General Internal Medicine Patients Experiencing 
Homelessness. J Gen Intern Med. January 2021:1-7. doi:10.1007/s11606-020-06483-w 
47.  
Canadian Observatory on Homelessness. Canadian Definition of Homelessness.; 2012. 

October 12, 2021 
43 
48.  
Kangovi S, Mitra N, Grande D, et al. Patient-centered community healthworker 
ntervention to improve posthospital outcomes: A randomized clinical trial. JAMA Intern 
Med. 2014;174(4):535-543. doi:10.1001/jamainternmed.2013.14327 
49.  
Suresh K. An overview of randomization techniques: An unbiased assessment of outcome 
in clinical research. J Hum Reprod Sci. 2011;4(1):8-11. doi:10.4103/0974-1208.82352 
50.  
Kasprow WJ, Rosenheck RA. Outcomes of critical time intervention case management of 
homeless veterans after psychiatric hospitalization. Psychiatr Serv. 2007;58(7):929-935. 
doi:10.1176/ps.2007.58.7.929 
51.  
Herman D, Opler L, Felix A, Valencia E, Wyatt RJ, Susser E. A critical time intervention 
with mentally ill homeless men: Impact on psychiatric symptoms. J Nerv Ment Dis. 
2000;188(3):135-140. doi:10.1097/00005053-200003000-00002 
52.  
Jones K, Colson PW, Holter MC, et al. Cost-effectiveness of critical time intervention to 
reduce homelessness among persons with mental illness. Psychiatr Serv. 2003;54(6):884-
890. doi:10.1176/appi.ps.54.6.884 
53.  
Misky GJ, Wald HL, Coleman EA. Post-hospitalization transitions: Examining the effects 
of timing of primary care provider follow-up. J Hosp Med. 2010;5(7):392-397. 
doi:10.1002/jhm.666 
54.  
Brooke BS, Stone DH, Cronenwett JL, et al. Early primary care provider follow-up and 
readmission after high-risk surgery. JAMA Surg. 2014;149(8):821-828. 
doi:10.1001/jamasurg.2014.157 
55.  
Hernandez AF, Greiner MA, Fonarow GC, et al. Relationship between early physician 
follow-up and 30-day readmission among medicare beneficiaries hospitalized for heart 
failure. JAMA - J Am Med Assoc. 2010;303(17):1716-1722. doi:10.1001/jama.2010.533 

October 12, 2021 
44 
56.  
Health Quality Ontario. Transitions Between Hospital and Home - Care for People of All 
Ages.; 2020. 
57.  
Canadian Institute for Health Information. All-Cause Readmission to Acute Care and 
Return to the Emergency Department.; 2012. 
58.  
Stergiopoulos V, Hwang SW, Gozdzik A, et al. Effect of scattered-site housing using rent 
supplements and intensive case management on housing stability among homeless adults 
with mental illness: A randomized trial. JAMA - J Am Med Assoc. 2015;313(9):905-915. 
doi:10.1001/jama.2015.1163 
59.  
Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for 
medication adherence: A systematic review and meta-analysis of the Morisky Medication 
Adherence Scale-8. PLoS One. 2017;12(11). doi:10.1371/journal.pone.0187139 
60.  
Feehan M, Morrison MA, Tak C, Morisky DE, Deangelis MM, Munger MA. Factors 
predicting self-reported medication low adherence in a large sample of adults in the US 
general population: A cross-sectional study. BMJ Open. 2017;7(6). doi:10.1136/bmjopen-
2016-014435 
61.  
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported 
measure of medication adherence. Med Care. 1986;24(1):67-74. doi:10.1097/00005650-
198601000-00007 
62.  
Hunter CE, Palepu A, Farrell S, Gogosis E, O’Brien K, Hwang SW. Barriers to 
Prescription Medication Adherence Among Homeless and Vulnerably Housed Adults in 
Three Canadian Cities. J Prim Care Community Health. 2015;6(3):154-161. 
doi:10.1177/2150131914560610 
63.  
Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development 

October 12, 2021 
45 
and testing of a measure designed to assess the quality of care transitions. Int J Integr 
Care. 2002;2(2). doi:10.5334/ijic.60 
64.  
Chan B, Goldman LE, Sarkar U, et al. The Effect of a Care Transition Intervention on the 
Patient Experience of Older Multi-Lingual Adults in the Safety Net: Results of a 
Randomized Controlled Trial. J Gen Intern Med. 2015;30(12):1788-1794. 
doi:10.1007/s11606-015-3362-y 
65.  
Goldstein JN, Hicks LRS, Kolm P, Weintraub WS, Elliott DJ. Is the Care Transitions 
Measure Associated with Readmission Risk? Analysis from a Single Academic Center. J 
Gen Intern Med. 2016;31(7):732-738. doi:10.1007/s11606-016-3610-9 
66.  
Sundararajan V, Henderson T, Perry C, Muggivan A, Quan H, Ghali WA. New ICD-10 
version of the Charlson comorbidity index predicted in-hospital mortality. J Clin 
Epidemiol. 2004;57(12):1288-1294. doi:10.1016/j.jclinepi.2004.03.012 
67.  
Fagerland MW, Lydersen S, Laake P. Recommended confidence intervals for two 
independent binomial proportions. Stat Methods Med Res. 2011. 
doi:10.1177/0962280211415469 
68.  
Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. Primary care validation of a 
single-question alcohol screening test. J Gen Intern Med. 2009;24(7):783-788. 
doi:10.1007/s11606-009-0928-6 
69.  
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation 
be used for handling missing data in randomised clinical trials - A practical guide with 
flowcharts. BMC Med Res Methodol. 2017;17(1):162. doi:10.1186/s12874-017-0442-1 
70.  
Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: 
who, what, when, why, how? Can J Surg. 2010;53(5):345-348. 

October 12, 2021 
46 
http://www.ncbi.nlm.nih.gov/pubmed/20858381. Accessed August 4, 2020. 
71.  
Day SJ, Altman DG. Blinding in clinical trials and other studies. Br Med J. 
2000;321(7259):504. doi:10.1136/bmj.321.7259.504 
72.  
Gates B. Responding to Covid-19 - A once-in-a-century pandemic? N Engl J Med. 
2020;382(18):1677-1679. doi:10.1056/NEJMp2003762