Evaluating the Impact of Resource Navigators to Support Long-term Care and Retirement Home Staff During and Beyond COVID-19
Phase: NA
Conditions: Wellness, Burnout, Caregiver, Burnout, Professional, COVID-19, Vaccine Refusal
Sponsor: Unity Health Toronto

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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Protocol: Evaluating the impact of 
resource navigators to support LTC 
and RH staff during and beyond 
COVID-19 
Standard Protocol Items: Recommendations For Interventional Trial Guidelines 
 
 
Primary Investigators: Dr. Christine Fahim and Dr. Sharon E Straus 
 
 
Knowledge Translation Program 
Li Ka Shing Knowledge Institute 
St. Michael’s Hospital 
 
Contact: 
Dr. Christine Fahim 
 
E: christine.fahim@unityhealth.to 
 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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Table of Contents 
Table of Contents.......................................................................................................................... ii 
1.0 Administrative Information .................................................................................................... 4 
1. Title.............................................................................................................................................. 4 
2. Trial Registration ......................................................................................................................... 4 
3. Protocol Version.......................................................................................................................... 5 
4. Funding ....................................................................................................................................... 6 
5. Roles & Responsibilities ............................................................................................................. 6 
Introduction ................................................................................................................................... 7 
6. Background and Rationale ......................................................................................................... 7 
7. Objectives ................................................................................................................................... 9 
8. Trial Design ............................................................................................................................... 10 
Methods: Participants, Interventions, Outcomes ................................................................... 10 
9. Study Setting ............................................................................................................................. 10 
10. Eligibility Criteria ..................................................................................................................... 10 
11. Interventions ........................................................................................................................... 11 
12. Outcome Measures ................................................................................................................ 12 
13.  Participant Timeline  .............................................................................................................. 14 
14. Sample Size ............................................................................................................................ 15 
15. Recruitment ............................................................................................................................. 16 
Methods: Assignment of Interventions (for controlled trials) ............................................... 16 
16. Allocation................................................................................................................................. 16 
17. Blinding ................................................................................................................................... 16 
Methods: Data collection, management, and analysis .......................................................... 17 
18. Data Collection Methods ........................................................................................................ 17 
19. Data Management .................................................................................................................. 19 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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20. Statistical Methods .................................................................................................................. 20 
Methods: Monitoring .................................................................................................................. 21 
21. Data Monitoring....................................................................................................................... 21 
22. Harms ...................................................................................................................................... 21 
23. Auditing ................................................................................................................................... 21 
Ethics & Dissemination .............................................................................................................. 21 
24. Research Ethics Approval ...................................................................................................... 21 
25. Protocol Amendments ............................................................................................................ 22 
26. Consent or Assent .................................................................................................................. 22 
27. Confidentiality ......................................................................................................................... 23 
28. Declaration Of Interests .......................................................................................................... 23 
29. Access to Data ........................................................................................................................ 23 
30. Ancillary and Post-Trial Care .................................................................................................. 24 
31. Dissemination Policy ............................................................................................................... 24 
Appendices .................................................................................................................................. 24 
32. Informed consent materials .................................................................................................... 24 
Timeline ........................................................................................................................................ 25 
Budget .......................................................................................................................................... 26 
References ................................................................................................................................... 27 
 
 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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1.0 Administrative Information 
The following protocol outlines the details of this randomized controlled study following guidance 
from the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT). [1]  
1. Title  
Evaluating the impact of resource navigators to support Long-Term Care and Retirement Home 
Staff during and beyond COVID-19.  
2. Trial Registration 
2a: Registry 
This study will be registered on clinicaltrials.gov.  
2b: Data Set 
Items from the World Health Organization Trial Registration data set will be included and 
updated once the study is registered in clinicaltrials.gov.  
Data category 
Information 
Primary registry and trial identifying number 
- 
Date of registration in primary registry 
- 
Secondary identifying numbers 
- 
Source(s) of monetary or material support 
Canadian Institutes of Health Research 
(CIHR) – Operating Grant  
University of Toronto Temerty Faculty of 
Medicine - Knowledge Translation Grant 
Primary sponsor 
KT Program, St. Michael’s Hospital, Unity 
Health Toronto 
Secondary sponsor(s) 
- 
Contact for public queries 
Olu Odole-akinyemi, MPH  
Olu.Odole-akinyemi@unityhealth.to  
Contact for scientific queries 
Christine (Tina) Fahim,  PhD, MSc 
Christine.fahim@unityhealth.to  
1-416-360-4000 ext 77300 
Public title 
Evaluating the impact of resource navigators 
to support Long-Term Care and Retirement 
Home staff during and beyond COVID-19 
Scientific title 
Evaluating the impact of resource navigators 
to support Long-Term Care and Retirement 
Home staff during and beyond COVID-19 
Countries of recruitment 
Canada 
Health condition(s) or problem(s) studied 
Long-term care and retirement home staff 
wellness 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
5 
Intervention(s) 
Control: educational resources 
Comparator: 1:1 tailored support from a 
resource navigator + educational resources  
Key inclusion and exclusion criteria 
Inclusion Criteria 
Age requirement: ≥18 years 
Employment status requirement: full-time or 
part-time PSW or other Long-term care and 
retirement home support staff employed in an 
Ontario Long-term care and retirement home 
Language requirement: English 
Technological requirement: email access  
 
Exclusion Criteria  
Not employed as a PSW or other support 
service staff in an Ontario Long-term care 
home; uncomfortable speaking or reading 
English; lack of email access 
Study type 
Interventional 
Allocation: randomized 
Intervention model: parallel assignment 
Masking: non-blinded 
Primary purpose: prevention & management 
Phase IV 
Date of first enrolment 
Not yet enrolling 
Target sample size 
154 (77 participants per arm) 
Recruitment status 
Not yet recruiting 
Primary outcome(s) 
Long-term care home staff wellness 
Key secondary outcomes 
Long-term care  and retirement home  staff 
burnout, knowledge of, access to and use of 
wellness supports; SARS-CoV-2 infection; 
rate of SARS-CoV-2 vaccinations; 
hospitalizations; and deaths 
 
3. Protocol Version  
Issue date: September 07, 2022  
Protocol amendment number: 0 
Authors: Dr. Christine Fahim, Dr. Sharon E. Straus, Dr. Stefan Baral, Dr. Adrienne Chan, Dr. 
Linn Holness, Dr. Sharmistha Mishra 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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4. Funding 
This study is funded by the Canadian Institutes of Health Research (CIHR) – Operating Grant 
and the University of Toronto Temerty Faculty of Medicine - Knowledge Translation Grant. The 
educational resources and online repository that will be used for this study were developed 
through funding from the COVID-19 Immunity Task Force (CITF), the Ontario Ministry of Labour 
Training and Skills Development (MOLTSD) and the Canadian Immunization Research Network 
(CIRN). 
5. Roles & Responsibilities 
5a: Contributorship 
(CF) Dr. Christine Fahim, Unity Health Toronto, St. Michael's Hospital, Li Ka Shing Knowledge 
Institute, 7th Floor, East Building, 209 Victoria Street, Toronto Ontario M5B 1T8, Canada 
(SES) Dr. Sharon E. Straus, Unity Health Toronto, St. Michael's Hospital, Li Ka Shing 
Knowledge Institute, 7th Floor, East Building, 209 Victoria Street, Toronto Ontario M5B 1T8, 
Canada 
(SB) Dr. Stefan Baral, Johns Hopkins- Bloomberg School of Health, E7146, 615 North Wolfe 
Street Baltimore Maryland 21205, United States 
(AC) Dr. Adrienne Chan, Sunnybrook Health Sciences,  2075 Bayview Avenue, Toronto, 
Ontario, M4N 3M5 
(DH) Dr. Dorothy Linn Holness, Division of Occupational Medicine, St Michael's Hospital, 30 
Bond St, Toronto Ontario M5B 1W8, Canada 
(SM) Dr. Sharmistha Mishra, Division of Infectious Diseases, St. Michael's Hospital, University 
of Toronto, 30 Bond Street, Toronto Ontario M5B 1W8, Canada 
(BP) Dr. Ba’ Pham, Unity Health Toronto, St. Michael's Hospital, Li Ka Shing Knowledge 
Institute, 7th Floor, East Building, 209 Victoria Street, Toronto Ontario M5B 1T8, Canada 
(ID) Ian DaSilva, Ontario Personal Support Workers Association, 101 Holiday Inn Drive, PO Box 
29045, Cambridge, Ontario N3C 0A0  
(MF) Miranda Ferrier, Ontario Personal Support Workers Association, 101 Holiday Inn Drive, PO 
Box 29045, Cambridge, Ontario N3C 0A0 
CF and SES conceived of the study. CF, SES, SB, AC, DH, and DM initiated the study design 
and implementation. BP provided statistical expertise in clinical trial design and will conduct the 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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primary statistical analysis. All authors contributed to refinement of the study protocol and will 
support and approve the final manuscript.  
5b: Sponsor Contact Information 
Trial Sponsor: Unity Health Toronto, St. Michael's Hospital, Li Ka Shing Knowledge Institute  
Sponsor’s Reference: N/A 
Contact name: Drs. Sharon Straus and Christine Fahim 
Address: Li Ka Shing Knowledge Institute, 7th Floor, East Building, 209 Victoria Street, Toronto 
Ontario M5B 1T8, Canada 
Telephone: 416-864-3068 and 416-3604000 ext: 77300 
Email: sharon.straus@utoronto.ca and christine.fahim@unityhealth.to  
5c: Sponsor and Funder 
The sponsor-investigators (CF, SES) developed the study design and will be involved in the 
analysis and interpretation of implementation data, manuscript preparation, and dissemination of 
results. The funding sources had no role in the design of this study and will not have any role 
during its execution, data analysis, interpretation of the data, or decision to submit results. 
5d: Committees 
A project steering committee with stakeholders will be established and will support study 
recruitment, monitoring, and the dissemination of study results. All data collection tools will be 
reviewed by the steering committee for acceptability, clarity of language and feasibility of format 
(e.g., mobile friendly access). ). An honorarium will be provided for up to 6 long-term care and 
retirement home support staff who agree to take part in our steering committee. Steering 
committee members will be compensated for their time and contribution to steering committee 
meetings and any feedback they provide on project activities. We use the CIHR Strategy for 
Patient Oriented Research (SPOR) compensation framework for knowledge users to guide this 
[2]. 
 
Introduction 
6. Background and Rationale 
6a. Background And Rationale 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
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Version Number: 2 
 
 
 
 
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More than 80% of the people who have died of COVID-19 in Canada lived or worked in long-
term care homes and assisted living facilities.[3] Almost 60% of long-term care home staff are 
personal support workers (PSWs), who provide over 90% of direct resident care.[4-6] PSWs’ 
essential, frontline work places them at increased risk of SARS-CoV-2 infection.[6] Additionally, 
PSWs are an unregulated workforce who are underpaid and undervalued.[4-6,8] Lack of 
workplace protections, constant fear of contracting or transmitting the SARS-CoV-2 virus, and 
longstanding systemic inequities can impact the overall wellness of PSWs and place them at 
increased risk of burnout and other challenges.[9-11]  In addition, other long-term care and 
assisted living staff including those in nutrition and environmental services provide direct care 
and support for the residents that has been critical during the pandemic. These groups have 
similarly been affected by the pandemic and their needs have not been adequately met.[12] 
In response to this, the Knowledge Translation Program (KTP) at St. Michaels Hospital launched 
efforts to support PSWs. Via in-depth discussions and surveys, >200 PSWs were canvassed to 
identify their needs during the pandemic. Four areas of need were identified, which included 
supports for:  
1. Wellness, burnout and mental health 
2. Infection Prevention and Control (IPAC) 
3. Wraparound resources (e.g., access to food banks, caring for a family member with 
COVID-19) and  
4. Vaccine information 
Additionally, using the Theoretical Domains Framework, the KTP identified the following barriers 
that impact PSWs’ and/or other long-term care and retirement home staff’s ability to navigate the 
pandemic [13]:  
• 
lack of knowledge of available resources 
• 
perceptions of identity within the long-term care home context, resource challenges (e.g., 
lack of occupational health programs), and  
impact of social influences on beliefs (e.g., family and peer perceptions of vaccine 
efficacy and safety).  
These barriers were mapped to corresponding implementation strategies via the Behaviour 
Change Wheel framework to identify education and enablement (e.g., supporting individuals’ 
own self-efficacy) as interventions to mitigate the identified barriers.[13] Utility of these 
interventions was confirmed by our long-term care home staff partners and the Ontario PSW 
Association (OPSWA, who support >50,000 members), who believed routine check in calls 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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would reduce social isolation and support PSWs and other long-term care staff to find and use 
available resources to address their needs.[13]  
Through funding from the COVID-19 Immunity Task Force (CITF), the Ontario Ministry of Labour 
Training and Skills Development (MOLTSD) and the Canadian Immunization Research Network 
(CIRN), the KTP developed educational resources compiled in a single online repository for 
long-term care home staff on optimizing infection prevention and control (IPAC) [14-17] in long-
term care home, promoting wellness and preventing burnout [18,19] providing ‘wraparound’ [20, 
21] resource supports to individuals (e.g., access to food banks, resources on self-isolation, 
caring for a family member with COVID-19), and addressing SARS-CoV-2 vaccine [22-24] 
myths and questions (via infographics and town halls created in partnership with OPSWA).[25, 
26] 
 However, currently long-term care and retirement home staff access these resources passively 
and many do not have the capacity or skills to implement the resources effectively. A navigator 
is the missing link to putting these resources into practice. 
Research Question 
Through this clinical trial, we aim to answer the following research question:  
What is the impact of tailored 1:1 support from a resource navigator and educational resources 
(intervention arm) compared to educational resources only (control arm) on the wellness of long-
term care and  retirement home staff (primary outcome), burnout, knowledge of, access to and 
use of wellness resources, SARS-CoV- 2 vaccination status, self-reported SARS-CoV-2 
infection and hospitalization (secondary outcomes). 
 
6b. Choice of Comparators 
Aligning with the findings and work completed to date, a resource navigator for long-term care 
and retirement home staff was identified as a missing link to putting educational resources into 
practice. This was selected as our choice of comparator for the purposes of this study and 
identified needs. 
7. Objectives  
The aim of this study is to implement and evaluate the impact of implementing resource 
navigation for long-term care and retirement home staff in enhancing the uptake of available 
resources. For the purposes of this study, long-term care and retirement home staff will refer to 
PSWs and other support workers (including those who provide direct resident care or support 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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resident care through ancillary services such as nutrition, housekeeping and laundry) in long-
term care and retirement home settings. To achieve our study aim we will:  
1. Conduct a trial, which will randomize PSWs and other support service staff to receive 6 
months of tailored 1:1 support from a resource navigator and educational resources 
(intervention arm) versus educational resources only (control arm) to navigate the pandemic.  
2. Evaluate the impact of the intervention on PSW’s and other support service staff’s wellness 
(primary outcome), burnout, knowledge of, access to and use of wellness resources, 
alignment of provincial public health guidelines related to SARS-CoV-2 vaccine outcomes, 
SARS-CoV-2 infection, hospitalization, and death (secondary outcomes).  
3. Conduct a process evaluation to assess quality and delivery of the study intervention. 
 
8. Trial Design  
This study is designed as a non-blinded, randomized controlled trial with long-term care and 
retirement home staff with two parallel groups to identify the impact of tailored 1:1 support from 
a resource navigator and educational resources compared to the use of educational resources 
only to navigate the SARS-CoV-2 (COVID-19) pandemic and beyond. Randomization will be 
performed using computer software to generate a 1:1 allocation sequence. 
Methods: Participants, Interventions, Outcomes 
 9. Study Setting  
This study will take place in Long-Term Care and Retirement Homes in Ontario. Long-term care 
homes are defined as residences where older adults can live and receive support with daily 
living. Long-term care homes also provide 24-hour nursing, primary medical and personal care. 
[27] Retirement homes are privately-owned residence that provides rental accommodation with 
care and services for seniors who can live independently with minimal to moderate support and 
are able to fund this lifestyle on their own [28]. Long-term care homes are funded by the 
provincial government and are regulated under the Long-Term Care Homes Act, 2007. In 
Ontario, there are 626 long-term care homes with 58% privately owned homes, 24% are non-
for-profit, and 16% are municipal. Long-term care and retirement homes will be selected for the 
clinical trial by type, including privately owned, non-for-profit, and municipal. [29] This study will 
build on the existing partnerships of another KTP project, the Wellness Hub. The Wellness Hub 
project contains a network of 70 long-term care home who will all be eligible for participation in 
this study [29]. 
10. Eligibility Criteria 
Inclusion Criteria  
Participants eligible for the trial must meet the following criteria at randomization:  

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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1. 
A fulltime or part-time employee aged 18 years and older identified as a Long-Term Care 
and Retirement Home staff (PSW’s and other support service staff in those in nutrition, 
housekeeping and laundry) [12];   
2. 
Work in an Ontario Long-term care or retirement home;  
3. 
Comfortable speaking and reading English; and 
4. 
Access to and willingness to use email for study communications 
Exclusion Criteria  
Participants will not be eligible to participate in the study if they:  
1. 
Do not identify as or are not employed as a PSW and other support service staff;  
2. 
Do not work in an Ontario long-term care or retirement home; and  
3. 
Uncomfortable speaking or reading English.  
4. 
Do not have access to or unwillingness to use email for study communications 
A resource navigator will perform the study intervention. While the navigator will not directly 
provide counselling or mental health supports, they will serve as a liaison to link the PSWs and 
other long-term care and retirement home support service staff to these supports. The 
navigators will hold a degree or diploma in social services/work, psychology or a related field 
and have at least 2 years experience in these sectors.. 
 
11. Interventions 
11a. Interventions 
Each month, participants in the intervention arm will receive a PDF package by email from a 
research staff member, which will include wellness, burnout and mental health resources (e.g., 
how to use the free, self-referral Centre for Addiction and Mental Health service [18]; tips on 
reducing/preventing burnout [21]), SARS-CoV-2 vaccine infographics [22], a wraparound [20] 
resource package, and IPAC [17] tips/guidance. Participants that indicated they would like a 
print copy of the resources in the pre-screening survey (Appendix C) will be provided a copy via 
mail. Participants will also receive two hours (2, 1-hour sessions) of navigation support sessions 
from the resource navigator (by phone/zoom) per month for six months (Total 12, 1-hour 
sessions). While the resource navigator will not directly provide counselling or mental health 
supports, they will serve as a liaison to link the PSWs and other support service staff (where 
applicable) to these supports. The resource navigators will hold a degree or diploma in social 
services/work, psychology or a related field and have at least 2 years of experience in these 
sectors. 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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In the control arm, participants will receive the monthly educational resources only.  
Both intervention and control arms will complete a baseline survey, exit survey (at 6 months) 
and interview if selected to participate 
11b. Modifications 
Participants may be inconvenienced by taking part in components of the study (e.g., exit 
interviews). The COVID-19 pandemic is also a stressful situation to many; therefore, risks will be 
mitigated by ensuring participants are aware that they have the option to participate and/or not 
answer any questions they do not wish to answer. Participants will be able to withdraw from the 
study at any point with no consequences by notifying a study coordinator, investigator or the 
resource navigator. Participants may have to withdraw due to end of employment or personal 
concerns. Preliminary sample size estimations have been calculated to account for participant 
attrition.  
11c. Adherence 
To facilitate adherence to the intervention, participants in the intervention arm will receive a 
package that includes educational resources by email and/or mail each month. Resource 
navigators will directly reach out to participants in the intervention arm (via email/phone) and will 
provide them with two hours of navigation support sessions (by phone/zoom) per month for six 
months. Additionally, during the course of the intervention, the resource navigation will also 
identify processes to enhance adherence for the six-month period through various methods 
including personalization of sessions (participant’s communication and time preference) and 
providing ambient information pre-session (session reminders, goal of each session). 
11d. Concomitant Care 
Due to the nature of this study, all participants will be assessed if they are receiving other 
interventions related to wellness, which can be self-directed or organization directed. This will 
also enable the identification co-intervention bias, which can impact on the study outcome 
 
12. Outcome Measures   
1. Primary Outcome Measures 
The primary outcome for this study is the impact of the intervention on staff wellness. This will 
be measured by determining the impact of resource navigation on the change in wellness 
between the 6-month time point and baseline for those who received educational resources and 
resource navigation compared to those who received educational resources alone.  
Participant wellness will be assessed using the Personal Wellbeing Score.[31] The Personal 
Wellbeing Score measure was selected to align with the World Health Organization’s 2004 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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definition of wellness: “the optimal state of health of individuals and groups. There are two focal 
concerns: the realization of the fullest potential of an individual physically, psychologically, 
socially, spiritually, and economically, and the fulfilment of one’s role expectations in the family, 
community, place of worship, workplace and other settings.”  p.5, World Health Organization 
[32] 
The Personal Wellbeing Score is a short, 4-item measure that takes a few minutes to complete. 
These features increase accessibility and reduce participant burden compared to longer 
wellness assessment tools. The scale has good internal reliability (Cronbach’s α =0.90) and 
correlates with health status (r=0.58) and health confidence (r=0.60[).[31] The analysis will use 
mean Personal Wellbeing Scores of participants and will be conducted at baseline and 6-
months post-intervention.   
2. Secondary Outcome Measures  
Secondary outcome measures will include burnout, knowledge, access to and use of wellness 
supports, vaccination status, SARS-CoV-2 infection, hospitalization, and death. All measures 
will be assessed through a baseline and exit survey (at the 6-month time point) that includes the 
Personal Wellbeing Score.  
Burnout will be assessed with the 22-item Maslach Burnout Inventory for Medical Personnel. 
[33] This measure takes approximately 10 minutes to complete, demonstrates good reliability 
and validity, has been tested among diverse stakeholder populations including PSWs, and tests 
for relevant domains (e.g., emotional exhaustion). [33-36] To assess knowledge, access to and 
use of wellness supports, Likert scale questions directly related to outcomes will be developed. 
Demographic information will also be collected, and questions will be developed using the 
PROGRESS-Plus framework. [37] The PROGRESS-Plus framework will assess characteristics 
such as place of residence, race/ethnicity/culture/ language, occupation, gender, sex, religion, 
education, socioeconomic status, and social capital) to determine effects on the study 
outcomes.  
Via participants’ Ontario Health Insurance Plan (OHIP) number, we will link to the ICES 
provincial administrative database to obtain participants’ vaccine status, and rates of SARS-
CoV-2 infection, hospitalization and death, over the study period.[38, 39]. Unique to the exit 
survey, study participants will be asked about their satisfaction with the intervention. A process 
evaluation will be conducted to assess quality and delivery of the study intervention. The 
resource navigator will track the number, duration and focus of the 1:1 sessions per participant 
at the end of each individual session using a Process Evaluation- Intervention Tracking Form 
(Appendix Q). Participant experiences, suggestions for improvement and planning for 
sustainability will be collected via individual interviews with the resource navigator. A sample of 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
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control (n=8-10) and intervention (n=8-10) participants will be interviewed. We will purposively 
sample the group, with an aim to reflect diversity in gender, age, race and other PROGRESS-
plus characteristics 
13.  Participant Timeline  
As noted above, the primary and secondary outcomes will be assessed using a multi-measure 
baseline and exit survey. Baseline surveys will be conducted 0-30 days after randomization and 
exit surveys will be conducted at 6 months (182 days) after the randomization date.  
Process evaluation data will be collected throughout the duration of the intervention (from 0 days 
after randomization until the end of intervention (182 days)).  
Post-intervention exit interviews will then be conducted at approximately 6-7 months (182-213 
days) after the randomization date. These interviews will include a subsample of 8-10 
participants from the intervention arm and 8-10 participants from the control arm of the study. 
See Figure 1 for flow of participants. Note: this will be a rolling recruitment.   
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
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.   
Figure 1. Flow of Participants  
 
 
 
14. Sample Size 
This study estimates that the standard deviation (SD) across mean Personal Wellbeing Scores 
is 10.2.[31] Assuming we will use a t-test to compare the scores across the intervention groups, 
a medium effect size of 0.5, a SD estimate of 10.2, a false positive error rate of 5% and a power 
of 80%, the estimated sample size is 64 participants per arm or 128 for the two arms. Including 
a buffer for participation attrition of 20%, the study will require a total of 154 participants (77 per 
arm).  
 

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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15. Recruitment  
The study team will be using multiple recruitment strategies: circle of contacts, snowball, and 
advertisements (Appendix A, B,Y). The study team will also leverage partnerships with OPSWA, 
Ontario LTC Association (OLTCA), Family Councils Ontario (FCO), and other Long Term Care 
and retirement organizations to recruit PSWs and other service support staff working in Ontario 
long-term care and retirement homes. All interested potential participants will be provided with a 
pre-screening survey to determine eligibility, the study information sheet and a consent form.. 
 
Methods: Assignment of Interventions (for controlled trials) 
16. Allocation  
16a. Sequence Generation 
Participants will be randomly assigned to either control or intervention group with a 1:1 allocation 
sequence using computer software and will use block randomization with randomly selected 
block sizes to keep the enrollment sizes in each arm similar throughout the trial. [40] This will be 
done under the supervision of the study statistician (BP). 
16b. Concealment Mechanism 
The study team will use a secure web application called Research Electronic Data Capture 
(REDCap) to randomly allocate participants to the intervention and control arms, which will 
conceal the sequence and allocation until the point of assignment. [40] 
 
16c. Implementation 
All participants who provide consent for participation and who fulfil the inclusion criteria will be 
randomized. A statistician from the study team will generate the random allocation sequence. 
Research coordinators of the study will enroll participants and assign them to a study arm 
(control or intervention arm). 
17. Blinding 
17a. Blinding (Masking) 
Due to the nature of the intervention, neither participants nor researchers will be blinded to the 
study arm; however, statisticians conducting the outcome analysis will be blinded to which arm 
participants were assigned. PSWs and other support service staff in the same long-term care 
and retirement home may be randomized to different study arms, which may cause 
contamination; however, this is unlikely since those in the control arm will not have access to the 
navigators. 

 
 
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17b. Emergency Unblinding  
Since direct study participants and researchers will not be blinded throughout the duration of the 
study, unblinding procedures will not be required or necessary for the purposes of this trial 
 
Methods: Data collection, management, and analysis 
18. Data Collection Methods 
18a. Data Collection Methods  
 
Data will be collected by the Knowledge Translation Program, Li Ka Shing Knowledge Institute, 
Unity Health Toronto (KTP-UHT). Baseline and exit surveys will be administered online via 
REDCap.  
 
The study will use the Dillman Total Design Method (follow up at 1, 3, 7, 10 weeks) to increase 
survey responsiveness. [40] Participants who indicate interest and meet study criteria will be 
asked to complete a baseline survey at the beginning of the study (0 weeks). If they do not 
respond immediately, they will receive reminder emails at 1, 3, 7 and 10 weeks. At the 6-month 
mark, after study completion (26 weeks), participants will be asked to complete an exit survey. If 
they do not respond immediately, they will also receive reminder emails at 1, 3, 7 and 10 weeks. 
However, based on whether there are delays in the ability to recruit participants due to a lack of 
response to recruitment emails and reminders, there is a possibility that the surveys will not take 
place at the exact times noted above. If this occurs, we will make sure to note this in our 
limitations. All survey questions have been reviewed by the steering committee for acceptability, 
clarity of language and feasibility of format (e.g., mobile friendly access). 
 
As mentioned above data will be collected using a baseline and exit survey in addition to an exit 
interview. Refer to table 1 for a description of the data that will be collected for each data 
collection method.  
 
Table 1 
Data 
Collectio
n Tool  
Objective 
Number of 
participants 
Data Collection 
Time Point 
Factors Assessed 
Measures used 
Baseline 
Survey  
• Outcome 
evaluation 
• Demographi
c 
information  
 
• up to 154 
participants (77 
per arm) 
• At 0 month, 
Study 
Coordinator 
and Assistant 
will collect 
Baseline  
survey data  
• Wellbeing 
• PROGRESS-
Plus factors 
(gender, sex, 
religion, 
education, 
socioeconomic 
• Personal 
Wellbeing Score 
(Primary 
Outcome) 
• Demographic 
questionnaire- 
PROGRESS-Plus 

 
 
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status, and 
social capital) 
• Knowledge 
• Access to 
supports 
• Use of wellness 
supports 
Framework and 
OHIP number 
• Maslach Burnout 
Inventory 
• Likert scale 
questions 
evaluating 
knowledge, 
access to and use 
of wellness 
supports 
Field 
Notes/Log
s 
• Process 
evaluation 
/Implement
ation quality 
 
• tracking data 
for 77 
participants 
• At 0-6 months, 
Resource 
Navigator will 
collect field 
notes during 
intervention 
• Implementation 
quality   
 
• Number of 1:1 
resource 
navigation 
sessions 
• Duration of 1:1 
resource 
navigation 
• Focus of 1:1 
resource 
navigation 
sessions 
• adoption (e.g., 
uptake, utilization, 
intention to try) of 
the materials and 
resources 
provided 
Exit 
Survey  
• Outcome 
evaluation  
• Demographi
c 
information 
 
• up to 154 
participants (77 
per arm) 
• At 6 months, 
Study 
coordinator 
and Assistant  
will collect Exit 
Survey data 
after 
completion of 
intervention 
• Wellbeing 
• PROGRESS-
Plus factors 
(gender, sex, 
religion, 
education, 
socioeconomic 
status, and 
social capital) 
• Knowledge 
• Access to 
supports 
• Use of wellness 
supports 
• Satisfaction with 
the intervention 
• Personal 
Wellbeing Score 
(Primary 
Outcome) 
• Demographic 
questionnaire- 
PROGRESS-Plus 
Framework and 
OHIP number (if 
not collected at 
baseline) 
• Maslach Burnout 
Inventory 
• Likert scale 
questions 
evaluating 
knowledge, 
access to and use 

 
 
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of wellness 
supports 
Exit 
Interview 
• Outcome 
evaluation 
• Process 
evaluation 
/Implement
ation quality 
 
• 8-10 
participants 
from 
intervention 
arm 
• 8-10 
participants 
from control 
arm 
 
• At 6-7 months, 
Research 
coordinator will 
collect 
interview 
feedback post 
intervention 
• Barriers and 
facilitators 
• Wellbeing 
• Participant 
experiences 
• Suggestions for 
improvement 
• Planning for 
sustainability 
• Implementation 
quality 
• Interview 
questions 
ICES 
provincial 
administr
ative 
database 
• Outcome 
evaluation  
• up to 154 
participants (77 
per arm) (data 
linkage using 
OHIP#) 
• At 6-7 months, 
Study 
coordinator 
and Assistant  
will use OHIP 
number to link 
administrative 
data 
• Vaccine status 
• Rates of SARS-
CoV-2 infection 
• Hospitalization 
• Death 
• ICES provincial 
administrative 
database fields 
 
18b. Retention 
Once a participant is enrolled and randomized into the study, the team will make a concerted 
effort to ensure participants are followed throughout the study. Since the study has a short 
intervention period (6 month) that will be adapted to align current work practices, we anticipate 
that withdrawal will be minimal. To meet our proposed sample size, we included a buffer for 
participation attrition of 20%, requiring a total of 154 participants (77 per arm).  To address 
retention of participants in completing data measures, the study will provide an incentive to 
complete the study surveys, all participants will receive a $20 gift card upon each survey 
completion. The study will use the Dillman Total Design Method (follow up at 1, 3, 7, 10 weeks) 
to increase survey responsiveness. 
 
19. Data Management  
Participant data will be de-identified using a participant I.D. and stored on St Michael’s Hospital- 
Unity Health Toronto’s secure server. Identifiers and unique study IDs will be recorded on a 
master linking log. All study information will be stored according to the process described above 
until 7 years after the end of the study, after which it will be securely destroyed. Only the study 
team will have access to the identifying personal information collected for this study.  
 
Baseline and exit surveys will be submitted electronically via REDCap. The survey results will be 
stored on REDCap until downloaded onto our secure encrypted servers at St. Michael's 
Hospital- Unity Health Toronto for analysis. We will analyze the quantitative responses using 
descriptive statistics, and the qualitative data using content analysis. 

 
 
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The interviews will be audio recorded and transcribed verbatim by a member of the study team 
or NVivo transcription, an automated transcription service. We may use a rapid framework 
analysis approach to analysis the interview data [41- 45]. Transcripts from the interviews will be 
double coded in NVivo 11 by two researchers who will independently read transcripts to gain 
familiarity with the content, conduct open coding and develop a codebook to guide the 
remainder of the analysis. We will use an intersectional qualitative approach to assess 
participants’ perceptions of wellness and access to resources during the pandemic. [46, 47] (nb: 
these intersectionality-analysis approaches are nascent, and we will use this study to further 
contribute to the methodological body of literature). The codebook will be iteratively refined on 
an ongoing basis and previously coded data will be modified accordingly. The two researchers 
will double-code 20% of randomly selected transcripts. Inter-rater reliability will be determined by 
calculating kappa statistics. Coding discrepancies between -1 and 0.6 will be discussed and 
resolved via a consensus meeting with a third reviewer. Researchers with continue to double-
code sets of three transcripts until an interrater reliability of 0.60 or higher is achieved. The 
remaining transcripts will be single-coded by one of the two researchers who were involved in 
the consensus meeting.  
 
We will conduct 1-hour semi-structured exit interviews via phone, virtual platform or in-person. 
During these semi-structured interviews, we aim to ask questions to capture the participants’ 
description of their various identities and relationships among the identities; encourage 
conversations about the interactions between their identities and social institutions (e.g., work 
place, social relationships, and community); explore participants’ descriptions about their 
perception of wellness associated with these identities and social institutions; and discuss the 
narratives about their identities and capacity to access wellness resources during the pandemic 
[46]. All Interview participants will receive $50 gift card after completion of the interview 
20. Statistical Methods 
20a. Outcomes  
We will use descriptive statistics to report participant demographics and study outcomes. We will 
use t-tests to compare outcomes for the intervention and control groups. We will disaggregate 
data by sex, gender, age, long-term and retirement home staff type, and long-term care home 
type (e.g., for-profit, municipally owned). Where possible (for cells with n≥5), we will 
disaggregate data by other PROGRESS-Plus demographics, in line with an intersectionality-
based approach. [31, 37, 44-45, 48].  
 
20b. Additional Analysis  
 
There is no additional analysis that has been identified for this research study. 
 
20c. Analysis Population and Missing Data  
 

 
 
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The analysis of the population, as earlier identified, includes a t-test for the comparison of both 
the control and intervention groups, and also qualitative analysis with the use of NVivo. All 
questions are optional and participants can skip questions they do not feel comfortable 
answering. We will consult with a study statistician to develop a plan for missing data.  
Methods: Monitoring  
21. Data Monitoring  
21a. Formal Committee & (b) Interim Analysis 
Due to the length and minimal risks associated with the study, a Data Monitoring Committee and 
interim analysis will not be required. Data will be monitored throughout the duration of the study 
by the Research Coordinator and Research Assistant in accordance with the Unity Health 
Toronto Institutional Review Board guidance and standards. The Research Ethics Board may 
request to review the study records for monitoring purposes. 
22. Harms 
Participation in this research study is voluntary and there are no known harms associated with 
this study. The COVID-19 pandemic is a stressful situation to many; therefore, risks will be 
mitigated by ensuring participants are aware that they have the option to participate and/or not 
answer any question during the baseline survey, exit survey, intervention and/or  interview if 
selected to participate. It is possible that the survey or interview questions may lead to an 
emotional response or stress for participants as they recall their experiences during the 
pandemic. If this happens, we will recommend participants to seek support through their 
organization’s employee assistant program or if their organization does not have such a 
program, we will provide a list of free support resources. If participants decide that they no 
longer want to participate or have their data included as part of the research study, they can let 
a study team member know and their data can be removed up until the data analysis stage. 
23. Auditing 
We have not included budget for an independent auditing of this study given the nature of the 
study but will make all study documents available if the funder requests an audit. 
Ethics & Dissemination 
24. Research Ethics Approval 
We will apply for ethics approval from Unity Health Toronto Institutional Review Board. 
 

 
 
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22 
25. Protocol Amendments  
Any important amendments to the protocol will be communicated to study investigators, Unity 
Health Toronto Institutional Review Board, and study participants. 
 
26. Consent or Assent 
26a. Consent or Assent  
 
All interested potential participants (PSW’s and other support workers in long-term care and 
retirement homes) will receive a link to the pre-screening survey (Appendix C) to determine 
eligibility. If eligible, participants will receive a pre-screening confirmation email (Appendix D) 
which will contain the link to the study information sheet and informed consent process 
(Appendix E). Contact information for members of the study team will also be provided. 
Participants will be encouraged to reach out with any questions. Participants will be asked to 
review all the study details and provide consent by selecting one of the two consenting 
statements at the end of the survey. Participants will then be emailed their unique study ID and 
the link to the baseline survey. The study team will reach out again at 6 months with a link to 
complete an exit survey.  
Consent at enrollment includes participating in: 
• 
1:1 sessions with the resource navigator and access to educational resources (if 
assigned to intervention arm. Access to educational resources only (if assigned to the 
control arm) 
• 
Participation in the baseline survey and exit survey. Participants will be assigned to 
either an intervention or control arm and will be invited by email (Appendix F - initial 
email, G - reminder email) to complete the baseline survey, a demographic questionnaire 
(Appendix H). The baseline survey will be used to select a diverse participant group 
(purposive sample). Participants will be given the opportunity to consent and provide 
their OHIP number for data linkage. An invitation email (Appendix I – initial email, J – 
reminder email) will also be sent to complete the exit survey (Appendix K) where they will 
also be given the opportunity to provide their OHIP number for data linkage if not 
provided during the baseline survey. 
• 
Participants’ response to any questionnaire will be kept confidential. Participants will be 
provided with a unique study ID (Appendix F, I) to complete the baseline and exit survey 

 
 
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(Appendix H, K) so that their responses remain de-identified. Identifiers and unique study 
IDs will be recorded on a master linking log (Appendix L). 
At 6 months, we will select and invite 10 participants from the intervention arm and 10 
participants from the control arm to take part in a brief key informant interview (mentioned above 
as an exit interview). We will purposefully sample participants for diversity in role, race/ethnicity, 
and age. Participants will coordinate with a research staff member for a date/time that works 
best and also identify their preferred form of communication (Appendix M). Participants will be 
provided with a reminder email (Appendix N) 2 business days prior to the interview date/time.  
Verbal consent will be obtained prior to the start of the interview by the interviewer using a pre-
determined script (Appendix O, P) and participants will be given the opportunity have any 
questions answered. Verbal consent will be captured and recorded once the audio recorder is 
turned on. Participants will only be identified by participant IDs in the consent recording. 
Consent to participate will also be recorded on the master linking log (Appendix L). Participants 
are free to skip questions and/or withdraw from the study.   
As an incentive to complete the study surveys, all participants will receive a $20 gift card upon 
completion of each survey ($20 gift card per survey x 2 surveys = $40 gift card). Participants 
that complete the interview will also receive a $50 gift card.  
27. Confidentiality 
All study-related information will be stored on a secure server. In accordance with all applicable 
privacy legislation, including the Personal Health Information Protection Act (PHIPA) of Ontario, 
Canada, participant personal information will be kept private and confidential.  
Participant data will be de-identified using a participant ID and stored on Unity Health’s secure 
server. Identifiers and unique study IDs will be recorded on a master linking log (Appendix L). All 
study information will be stored according to the process described above until 7 years after the 
end of the study, after which it will be securely destroyed. 
28. Declaration Of Interests 
There are no competing interests or conflicts of interest to declare. 
29. Access to Data 
All participant who complete the baseline survey, intervention and exit survey will be requested 
to link their study data to their OHIP number. Only the study team will have access to the 
identifying personal information collected for this study.  

 
 
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30. Ancillary and Post-Trial Care 
Ancillary and post-trial care are not applicable for this study. 
31. Dissemination Policy 
31a. Trial Results 
We will use the CIHR End of Grant (EoG) framework to guide EoG dissemination activities 
tailored to each end user.[48] We will publish our findings in open-access peer reviewed 
journals, and alongside OPSWA, will present at relevant national conferences. We will use 
various active and passive strategies to disseminate the findings to knowledge users, including 
our >20 collaborators via the CITF-funded study including the OLTCA, FCO, Toronto and 
Ottawa LHINs, Ministries of Health and of LTC, Public Health Agency of Canada, Public Health 
Ontario, and Healthcare Excellence Canada.[49]  We will report the study results using the 
relevant reporting guidelines including the Consolidated Standards of Reporting Trials 
(CONSORT) statement, the Template for Intervention Description and Replication (TIDieR) 
checklist, and the Sex and Gender Equity in Research (SAGER) guidelines.[29, 50-51]  
 
31b. Authorship  
We will use the International Committee of Medical Journal Editors (ICMJE) criteria for 
authorship and no professional writers will be used.  
 
31c. Reproducible Research 
As per the funder’s guidelines, the study team will make data available after the study has been 
submitted. The study protocol will also be registered and available via clinicaltrials.gov. 
Appendices 
32. Informed consent materials 
 

 
 
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Timeline 
Milestone Tasks 
 
 
Project Month 
 
June-July 
2022 
Aug-Sep 
2022 
Oct-Nov 
2022 
Dec 2022 – 
Feb 2023 
March-April 
2023 
May – June 
2023 
Assign participants to intervention arm  
X 
 
 
 
 
 
Baseline survey 
X 
 
 
 
 
 
Conduct intervention 
 
X 
X 
X 
 
 
Process evaluation tracking  
 
X 
X 
X 
 
 
Exit survey 
 
 
 
 
X 
 
Conduct exit interviews  
 
 
 
 
X 
 
Analyze data  
 
 
 
 
X 
X 
Write final report 
 
 
 
 
 
X 
 

 
 
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26 
Budget 
 
 
FTE
hours
Salary
Benefits
Subtotal
In-Kind
Total
Rate 
Resource Navigator/Officer (RC I)
2.65
5168
$182,554.13
$41,987
$224,542
$224,542
$35.33
Research Coordinator II (0.5FTE)
0.50
975
$38,025.00
$8,746
$46,771
$46,770
$39.00
Research Assistant I (1.0TE)
1.00
1950
$52,767.00
$12,136
$64,903
$64,903
$27.06
Statistician 
0.07
133
$7,559.72
$1,739
$9,298
$9,391
$56.84
Summer students (x2) 
0.17
336
$6,232.78
$0
$6,233
$6,233
$18.54
Total personnel
$351,839
MATERIALS, SUPPLIES, and SERVICES
Expendables 
quantity
per unit
Subtotal
Total
Cellphone & data/voice plan (2 phones)
2.00
$1,626.00
$3,252
$3,252
Jabber line 
1.00
$10/m
$120
$120
Voice recorders
2.00
$75.00
$150
$150
Printing costs (154 participants x ~$10/package)
$3,100
$3,100
Services 
REDCap 
1.00
$2,000
$2,000
$2,000
Transcription Services
100
$33.28
$3,328
$3,328
ICES Services 
$35,000
$35,000
Translation Services 
$25,000
$25,000
Knowledge Translation and IKT (Other)
Maslach Burnout Inventory Scale
$400
$400
PSW Partners compensation ($400/partner/yr CIHR; $300/part/yr T)
6.00
$400
$2,100
$2,100
OPSWA Compensation 
$13,750
$13,750
Participant Survey Reimbursement (154 p x 2 surveys/ each grant)
616
$10
$6,160
$6,160
Participant Interview Reimbursement
20.00
$50
$1,000
$1,000
Manuscript Publication
4.00
$3,707
$14,828
$14,828
End of Grant dissemination materials 
$3,500
$3,500
Total materials
$113,688
$113,688
Travel  
Travel & Presentation at National Conferences
$2,400
$2,400
Total Travel
$2,400
$2,400
EQUIPMENT
Laptops (Dell Latitude 7400)
3.00
$3,500
$10,500
$10,500
Audio voice recorders 
1.00
$75
$75
$75
Total equipment
$10,575
$10,575
TOTAL
$478,502
Budget Item
Funds requested YEAR 1
RESEARCH STAFF (excluding trainees)

 
 
Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
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27 
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11. Overworked and undervalued, a crisis for personal support workers. CBC News. 
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22. What you need to know about getting the COVID-19 vaccine. Wellness Hub. 
https://wellness-hub.ca/res/what-you-need-to-know-about-getting-the-covid-19-vaccine/. 
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23. February 2nd, 2021 OPSWA Town Hall #2: COVID vaccine questions answered. 
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Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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Evaluating the impact of resource navigators to support long-term care and retirement home staff during 
and beyond COVID-19  
Principal Investigators: Drs. Christine Fahim and Sharon Straus  
Research ethics protocol 
Version Dates: Sept 7th, 2022 
Version Number: 2 
 
 
 
 
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