Patient Navigation in Primary Care and Access to Resources in the Community - A Randomized Controlled Trial
Phase: NA
Conditions: Health Care Inequity, Patient Navigation
Sponsor: Ottawa Hospital Research Institute

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ARC 
Accès aux Ressources Communautaires 
Access to Resources in the Community 
 
 

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1 Lay Summary ................................................................................................................... 5 
2 Background ..................................................................................................................... 5 
2.1 
Work conducted in preparation for this project .................................................................................. 5 
2.2 
Primary Health Care ........................................................................................................................... 6 
2.3 
Community Resources........................................................................................................................ 7 
2.3.1 
Access ............................................................................................................................................................... 8 
2.3.2 
Utilization .......................................................................................................................................................... 9 
2.3.3 
Navigation ......................................................................................................................................................... 9 
3 Purpose ......................................................................................................................... 11 
4 Objectives and Deliverables ........................................................................................... 11 
5 Context .......................................................................................................................... 11 
6 Intervention ................................................................................................................... 13 
6.1 
Practice Changes .............................................................................................................................. 13 
6.1.1 
Practices/Providers ......................................................................................................................................... 13 
6.1.2 
Patients ........................................................................................................................................................... 17 
7 Method .......................................................................................................................... 18 
7.1 
Design ............................................................................................................................................. 18 
7.2 
Randomization ................................................................................................................................ 18 
7.3 
Participants and Eligibility ................................................................................................................ 18 
7.3.1 
Primary care practices .................................................................................................................................... 18 
7.3.2 
Primary care providers .................................................................................................................................... 19 
7.3.3 
Primary care patients ...................................................................................................................................... 19 
8 Recruitment ................................................................................................................... 20 
8.1 
Practices/Providers .......................................................................................................................... 20 
8.1.1 
Prioritizing neighbourhoods ........................................................................................................................... 20 
8.1.2 
Identifying practices ....................................................................................................................................... 20 
8.1.3 
Practice Recruitment Approach ...................................................................................................................... 20 
8.1.4 
Provider Recruitment Approach ..................................................................................................................... 21 
8.1.5 
Patient Recruitment Approach ....................................................................................................................... 21 
9 Tools and Measurements ............................................................................................... 22 
9.1 
Quantitative Tools and Measurements ............................................................................................. 22 
9.1.1 
Referral assessment: ....................................................................................................................................... 22 
9.1.2 
Practice Survey: .............................................................................................................................................. 23 
9.1.3 
Provider Survey: .............................................................................................................................................. 23 
9.1.4 
Patient Survey: ................................................................................................................................................ 23 
9.1.5 
Health Administrative Data: ........................................................................................................................... 24 
9.1.6 
Navigator Training Assessment ...................................................................................................................... 24 
9.1.7 
Rapid Cycle Evaluation: ................................................................................................................................... 24 
9.2 
Qualitative Tools and Measurements ............................................................................................... 25 

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December 27, 2017 
9.2.1 
Timing ............................................................................................................................................................. 25 
9.3 
Study Documentation ...................................................................................................................... 26 
9.3.1 
Practice Set-Up Log ......................................................................................................................................... 26 
9.3.2 
Navigator Log .................................................................................................................................................. 26 
10 
Data Analyses ........................................................................................................... 26 
10.1 Definitions ....................................................................................................................................... 26 
10.1.1 
Primary Outcome: Access ............................................................................................................................... 26 
10.1.2 
Secondary outcomes ...................................................................................................................................... 27 
10.2 Quantitative Analyses ...................................................................................................................... 28 
10.2.1 
Descriptive ...................................................................................................................................................... 28 
10.2.2 
Comparative ................................................................................................................................................... 29 
10.2.3 
Regression analyses ........................................................................................................................................ 29 
10.2.4 
Multivariable analyses to assess equity .......................................................................................................... 29 
10.2.5 
Health Administrative Data ............................................................................................................................ 30 
10.3 Qualitative Analyses ........................................................................................................................ 30 
11 
Sample size calculations ............................................................................................ 32 
11.1 Qualitative Sample........................................................................................................................... 32 
11.1.1 
Providers ......................................................................................................................................................... 32 
11.1.2 
Patients ........................................................................................................................................................... 33 
12 
Ethical Considerations ............................................................................................... 33 
12.1 Obtaining Consent ........................................................................................................................... 33 
12.1.1 
Practice and provider consent ........................................................................................................................ 33 
12.1.2 
Patient consent ............................................................................................................................................... 34 
12.2 Participant Compensation ................................................................................................................ 34 
12.2.1 
Practice/Providers .......................................................................................................................................... 34 
12.2.2 
Patients ............................................................................................................... Error! Bookmark not defined. 
13 
Potential Risks and Benefits....................................................................................... 35 
13.1 Risks ................................................................................................................................................ 35 
13.1.1 
Practices/Providers ......................................................................................................................................... 35 
13.1.2 
Patients ........................................................................................................................................................... 35 
13.2 Privacy:.................................................................................................... Error! Bookmark not defined. 
13.3 Benefits ........................................................................................................................................... 35 
13.3.1 
Practices/Providers: ........................................................................................................................................ 35 
13.3.2 
Patients ........................................................................................................................................................... 36 
14 
Privacy and security of study data ............................................................................. 36 
15 
Timeline ............................................................................ Error! Bookmark not defined. 
16 
Research Team .......................................................................................................... 37 
17 
Relevance ................................................................................................................. 39 
2. 
References ................................................................................................................ 40 
ADDITIONAL INFORMATION ................................................................................................ 47 

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3. 
Additional information: 1 Examples of Health Related Resources ............................... 47 
4. 
Additional information: 2 Examples of Social Resources ............................................. 47 
5. 
Additional information: 3 Access Framework ............................................................. 47 
6. 
Additional information: 4 Navigator Framework ....................................................... 47 
7. 
Additional information: 5 Champlain Advisory Committee ......................................... 47 
8. 
Additional information: 6 – Profile and Qualifications of the Navigator ...................... 47 
9. 
Additional Information 7 – Role and Activities of the Navigator ................................. 49 
APPENDICES ........................................................................................................................ 51 
10. 
Appendix: A – Draft Referral Form ............................................................................. 51 
11. 
Appendix: B – Promotional Material .......................................................................... 51 
12. 
Appendix: C – Navigator Feedback Form .................................................................... 51 
13. 
Appendix: D – Practice/Provider Recruitment package............................................... 51 
14. 
Appendix: E– Patient Information Sheets and Consent forms ..................................... 51 
15. 
Appendix: F – Practice Activities ................................................................................ 52 
16. 
Appendix: F – Data Collection Tools ................................... Error! Bookmark not defined. 
17. 
Appendix: E – Practice Survey .................................................................................... 52 
18. 
Appendix: F – Provider Survey ................................................................................... 52 
19. 
Appendix: G – Patient Survey ..................................................................................... 52 
20. 
Appendix: H – Navigator Training Assessment ........................................................... 52 
21. 
Appendix: I – Rapid Cycle Evaluation ......................................................................... 52 
22. 
Appendix: J – Navigator Log ...................................................................................... 53 
23. 
Appendix: K – Practice Set Up Log .............................................................................. 53 
24. 
Appendix: L – Provider Qualitative Themes ................................................................ 52 
25. 
Appendix: M – Patient Qualitative Themes ................................................................ 53 
26. 
Appendix: N – Navigator Qualitative Assessment Themes .......................................... 53 
27. 
Appendix: O – Consent Pathways .............................................................................. 53 
28. 
Appendix: S– Statement of Relationship with SWCHC ................................................ 53 
 
 

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1 LAY SUMMARY 
Some people living with health problems require extra support to properly manage their 
conditions, as family doctors are only able to spend limited time in the office with these patients. 
There are many resources and programs in the community that can provide the necessary time 
and support for these patients, yet many patients are unaware that such resources exist. Patient 
navigators have been shown to be useful in helping patients with certain conditions (such as 
cancer) to get to the resources they need, especially when they have social challenges that make 
it difficult for them to reach these programs (for example, language or transportation barriers, 
poverty, or poor social support). This study will look at how helpful Navigators are to link 
patients at family doctors’ offices to community resources. To do this, family doctors’ offices in 
Ottawa and Sudbury will be recruited. All offices will receive training on directing patients to 
CRs and will be assigned a patient navigator to support patients access CRs. Half of the patients 
referred to CRs by their providers will have access to the navigator (intervention) assigned to the 
practice. This study will assess whether access to a navigator increases patients’ access to 
community health and social services compared to usual standard of care.  In addition, the study 
aims to understand whether English and French speaking individuals are as likely to benefit from 
a navigator in accessing community resources in the language of their choice.  
2 BACKGROUND 
2.1 
WORK CONDUCTED IN PREPARATION FOR THIS PROJECT 
The proposed project builds on work conducted between 2013 and today. 
The Canadian Institutes of Health Research’s Community Based Primary Health Care Team 
Grant SPOR initiative funded a five-year program of research (known as IMPACT: Innovative 
Models Promoting Access-to-Care Transformation, http://www.impactresearchprogram.com/). 
The goal of the IMPACT Project is to increase access to community-based primary health care 
for vulnerable populations. The lead for the Ontario arm of the IMPACT project, Simone 
Dahrouge, has undertaken a community engagement initiative within the Champlain Local 
Health Integration Network (LHIN) to understand the barriers patients face to adequately access 
community based health and social resources (CRs) and how these can be overcome. Under that 
funding, the team undertook an extensive consultation process to identify a regional priority gap, 
select and adapt an intervention, and implement and evaluate a single arm intervention. We are 
currently in the last phase of that project, which is serving as a feasibility phase for the 
randomized controlled trial. The feasibility study is evaluating the acceptability, demand, 
implementation, adaption, integration, and practicality of the study intervention and related 
activities to optimize appropriate access to CRs for primary care patients. Enrolment for that 
project will be completed by March 2018. This study received ethics approval from the OHSN 
Research Ethics Board (Protocol #20160914-01H), Bruyère Continuing Care Research Ethics 
Board (Protocol #M16-1616-055), Hôpital Montfort Research Ethics Board (Protocol # SD-DP-
27-02-17), and the University of Ottawa Research Ethics Board (Protocol # A05-17-04).That 
trial is a registered clinical trial: NCT03105635. 
During the feasibility phase the team established a regional stakeholder advisory group 
(Champlain LHIN). The composition of the advisory group has been adapted to meet the needs 
of the study. In the initial phase the composition was broad until the region identified the priority 

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area and approach to addressing the gap. The committee is now composed of patients of various 
minority communities who contribute their lived experience, primary care providers from 
different care models and leaders from organizations responsible for community services 
(Community Care Access Centres and Community Health Centres) who inform the feasibility of 
the approach for each context, and best approach to integrating of the two sectors, health 
planners (the LHIN Primary Care Lead, senior integration specialist and others) who bring their 
broader context health services knowledge as well as resources (such as practice transformation 
facilitation services) to the project, as well as other stakeholders that inform specific components 
of the intervention (Ontario 211, Champlain Healthline). That Committee meets regularly and 
contributes directly to the direction of the study design, implementation, evaluation and 
dissemination (See Additional information: 1 Champlain Advisory Committee) for additional 
information. Because the committee fundamentally represents the interests of the region, it is 
often referred to in this document as ‘the region”. 
The initial consultative phase identified poor access to CRs as a priority access gap. Examples of 
these include self-management, smoking cessation, care giver support, and falls prevention 
programs. The research team relied on a scoping review conducted for the IMPACT program 
and conducted several interviews and focus groups with community stakeholders to inform the 
best approach addressing this gap. The region selected to implement a patient navigator who can 
assist patients for whom the use of a community service is recommended by their primary care 
provider achieve access to that service. Primary care providers rarely make specific 
recommendations to access CRs; largely because they are unaware of these. They make general 
recommendations to improve healthy behaviours, but do not refer to specific types of services. 
Two realist reviews have been commissioned and completed by a team of experts to help us 
understand the critical success factors and shape our intervention. One review is focused on 
“community navigators” and the other on “primary care referral to community services” to help 
the team understand the factors that support us. This information was used to develop the ARC 
intervention. A number of themes identified in these reviews including training for clinical staff 
to identify and refer to relevant CRs to address patients’ social barriers; implementing a 
champion within practice to integrate referral into usual care; use of electronic health records to 
prompt provider referral and share information between provider and the community; and 
developing a screening process and promotional material to prompt referral. 
As a result, the region developed the Access to Resources in the Community/Accès aux 
Resources Communautaires (ARC) intervention. The ARC project will build on this work by 
focussing on improving access to community resources in patients’ language of choice and 
emphasizing access to French-language resources for Francophones in Ontario. 
2.2 
PRIMARY HEALTH CARE 
Primary care provides essential services that help prevent the onset of disease and the 
deterioration of existing ones. Primary health care is a broader approach to health that also 
includes supporting patients to overcome the challenges posed by their social context.  
In the current primary care context, with the exception of team based practices (e.g. Family 
Health Teams and Community Health Centres), the primary care providers’ role in promoting 
healthy lifestyles or addressing challenges associated with the social determinants of health, 
which contribute to the risk of developing an acute illness or a chronic disease, are usually 

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limited to brief health promotion counseling. However, patients require additional support to 
achieve their habit changing goals or improve their social situation.  
Ontario jurisdictions have invested heavily in CRs that can support patients to achieve good 
health through education and by assisting them in their healthy choices (e.g. self-management, 
nutritional counseling, falls prevention) (1-4) and services that help patients overcome barriers to 
adequate access and address social determinants of health (5;6) (e.g. translation services, 
transportation, advocacy, financial assistance, housing). But these are critically underused (7), 
especially by those with the greatest needs,(6) and as such, opportunities to achieve better health 
are missed. A sub group of Francophones living in minority situations face not only language 
barriers, but also further amplified health disparities resulting from social risk factors such as 
poverty, unemployment, and low education.(8) 
The recent work conducted by Price and colleagues to inform Ontario’s restructuring of the 
primary health care system, suggests that primary care practices will need to rely increasingly on 
CRs within specific geographic areas to provide the necessary interprofessional care required to 
meet the needs of their patients.(9) Our work to date has demonstrated that, with the exception of 
the home care services offered by the Community Care Access Centres, primary care providers 
are largely unaware of the resources available to their patients within their community and this 
situation could be worse concerning the social and health care services in the Francophone 
community. Linkages between these two sectors need to be strengthened.  
2.3 
COMMUNITY RESOURCES  
CRs play an important role in supporting individuals to achieve health goals. The U.S. 
Preventive Services Task Force Recommendation Statement strongly recommends that 
individuals with known cardiovascular disease risk factors be provided education and support to 
overcome risks associated with poor dietary and sedentary lifestyle.(10) A scientific statement 
from the American Heart Association makes strong recommendations in support of community 
based wellness programs.(11) Similarly National Guidelines for Diabetes Management highlight 
the role self-management education and support programs provided in the community in 
achieving healthy outcomes.(12) Several review studies have concluded that community 
resources’ target population and approaches vary, including educational group programs,(13;14) 
group visits,(13) interventions targeted at high risk population,(15) including the elderly,(16;17) 
and other approaches.(18;19)  Another review stresses the benefit of an integrated approach to 
addressing health determinants.(20)  
Primary Care providers address the health needs of all patients throughout the lifespan. They are 
the first point of contact with the healthcare system, provide patient centered care that includes 
health promotion, chronic disease management, and palliative services, and are best suited to 
coordinate patient care across these sectors. To achieve better access to CRs, primary care 
practices must be oriented to these services and the navigation tools that can help them identify 
the ones that meet the need of their patients in order to improve referral.  
The Change Foundation identifies poor integration within an increasingly complex healthcare 
system as a growing concern of the healthcare sustainability: “Ontario’s healthcare community 
has begun to fully absorb the consequences of an unintegrated healthcare system. Individuals 
seeking care can get lost as they move among different healthcare providers who are not 

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connected to one another. At times, this can have a serious effect on clinical outcomes, and it 
frequently duplicates efforts, wastes everyone’s time and increases costs.”(21) 
Without additional support, the likelihood that patients with social barriers realize access to the 
recommended service is low. This challenge is compounded when more than one obstacle is 
faced such as for Francophones living in minority situations and who experience constraints 
related to poverty, poor literacy, or social isolation. For these individuals, linkage between 
primary care and CRs is especially important. (16) Community Resources in each Region 
There are numerous CRs that exist in each region, to which primary care patients could be 
referred. The tables contained in Additional information: 2 Examples of Health Related 
Resources provide examples of resources based on the areas identified by our stakeholder 
consultations as most relevant, which include cardiovascular disease and diabetes prevention and 
management (such as smoking cessation and nutrition), mental health, falls prevention and pain 
management. Additional information: 3 Examples of Social Resources also provides examples of 
CRs that can help address social barriers to utilization of CRs such as transportation and 
translation services. 
2.3.1 Access  
The concept of access to primary health care is complex, as barriers can be manifest at the 
individual/patient or provider/organizational level and are dependent upon where and when 
access is sought.  The conceptual framework of access to health care proposed by Levesque et al. 
(22) suggests five dimensions of accessibility that pertain to available healthcare service: 1) 
approachability, 2) acceptability, 3) availability and accommodation, 4) affordability, and 5) 
appropriateness. These dimensions are corollaries to individuals’ abilities which vary based on 
individuals’ knowledge, culture, and available resources, including 1) ability to perceive the need 
for care, 2) ability to seek care, 3) ability to reach care, 4) ability to pay for care, and 5) ability to 
engage in care. The framework (see: Additional information: 4 Access Framework) depicts these 
dimensions on a continuum that ranges from the early stages of health care access (understanding 
one’s health care needs, perceiving that there is care available, and seeking that care), to later 
stages of access (getting an appointment, managing the direct and indirect costs of participation, 
and receiving care that is appropriate for the individual). True access then, is only achieved if 
barriers are overcome at each stage.  
It is important to understand and address system-level barriers, like lack of services in 
geographical regions, or poor integration between health care organizations, to reduce barriers to 
access. These changes, however, are often controlled by health authorities and involve 
collaboration among multiple stakeholders to affect change. Addressing individual-level barriers 
may be more feasible to affect improvements in access, as it has been demonstrated with 
interventions such as patient navigation, which has been shown to increase individuals’ abilities 
to seek and reach needed services. Equitable access can also be improved by patient navigation 
services targeted at individuals facing social barriers to accessing care. (23) Additionally, this 
approach has been demonstrated acceptable and feasible to link primary care providers and CRs 
to address lifestyle risk factors. (24)  
2.3.1.1 Francophones living in Minority situations 
Linguistic barriers limit Franco-Ontarians’ ability to access needed services. The impact of these 
barriers is especially evident for preventive and social services because these rely more heavily 

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on communication. This includes mental health care, health promoting services such as falls 
prevention, diet, as well as services that address the social determinants of health. These gaps in 
Francophone care result in an increased use of emergency services and unnecessary tests.(8) 
Despite considerable evidence demonstrating the importance of language consideration in care 
delivery, disparities in care for Franco-Ontarians persist. This is in part because there remain 
significant gaps in our understanding of how to overcome these challenges.(25) It is well 
documented that linguistic concordance between patient and care provider is associated with 
better care.(26) Awareness of the barriers and attempts to better respond to the patients’ needs, 
including offering appropriate accommodations (such as translations), help reduce the mental 
health care gaps, but does not eliminate disparities.(27) 
In fact, a study relying on the Ontario sample from the Survey on Vitality of Official-Language 
Minorities (SVOLM) which assesses the experience of Canadians of either official language 
living in a minority situation has documented that only 33% of Francophones in Ontario receive 
primary care services in French.(28) 
2.3.2 Utilization 
The likelihood of individuals utilizing a service they have been referred to varies considerably 
across studies, and is related to the service to which the individual is referred, and the support 
provided to enhance utilization (e.g. patient navigation, resource staff contact patients, etc.).  
The literature on uptake of smoking cessation services demonstrates very low utilization (0.3%-
2.3% of patients achieve contact with the resource) when no measures are implemented to 
support access. (29) (30) Interventions solely targeted at providers are generally ineffective, (30) 
or increase only marginally (3.9%).(29) Significantly increased utilization is achieved when 
interventions involve individual(s) reaching out to patients after the referral is given rather than 
relying on patients’ initiative. For example, when practices employed the ‘Ask, Advise, Connect’ 
approach 11.4% of smokers talked with someone from the Quitline (the Quitline called them), 
compared to 0.6% of smokers in a practice with the ‘Ask, Advise, Refer’ approach that relied on 
patients calling the Quitline (OR for reach = 17.38; 95% CI=8.08-37.36). (31)   
Even greater utilization of resources is achieved when interventions target high-risk patients 
(29), or particularly vulnerable populations such as women experiencing partner violence (4.4% 
contacted the intended resource), (32) or mothers with high socioeconomic need (39% enrol in a 
resource).(33)   
2.3.3 Navigation 
The challenge faced by many initiatives intended to support individuals to achieve better health 
is the inequities in their utilization,(34;35) and more intensive support is recommended for 
individuals with social complexities.(36)  
2.3.3.1 Electronic and Telephone Navigation Resources 
Navigation tools such as the Healthline and Ontario 211 (37;38) catalogue existing CRs and offer 
on-line directories and telephone support services to assist Ontarians identify the services and 
programs they require.  
Ontario 211 is a non-profit agency that helps Ontarians connect to a variety of resources in their 
community through an online directory of available health and social resources and a telephone 
helpline. 

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The Healthline provides a similar online directory of community based programs across Ontario 
including the Champlain region and North East region.  
Individuals can obtain information on services available in their community and details on the 
specific programs offered (e.g., location, cost, etc.) by searching the Healthline and 211 online 
directories, or by speaking with a 211 representative for additional assistance. These navigation 
tools act as information channels that help individuals identify programs of interest located in 
their community and in turn, aim to address an important barrier to access: individuals’ lack of 
information on available CRs.   
Unfortunately, our interviews and focus groups with primary care healthcare providers (PHCPs) 
and community members have demonstrated limited awareness of these navigation tools. In 
addition, while these tools provide information on the types of services available in the 
community, they are limited in their ability to consider individual barriers to access and support 
people to overcome these barriers and reach the service that is most appropriate for them. 
2.3.3.2 Patient Navigation 
Despite increased knowledge and awareness of available community health and social resources, 
many individuals face additional barriers that limit their access to these resources  and require 
additional support to achieve their health goals and overcome difficulties in obtaining needed 
services. 
Patient navigation has been conceptualized as an approach to empower individuals, promote 
patient engagement, and address health disparities among underserved and vulnerable 
populations. A Patient Navigator is an individual who supports and guides patients in 
overcoming barriers to access health and social care and achieve \service utilization. These 
individuals are also sometimes called Community Health Workers/aides/brokers/etc., lay health 
workers, promotoras, and other similar terms. Common to these is the role the individual plays in 
assisting the patient to navigate the health care system. This involves helping patients identify 
the services that could respond to their health priorities and assist them in overcoming barriers to 
access required services. This includes harnessing existing services (e.g. translation, 
transportation, and financial), advocating for the patient, supporting self-management, and 
generally helping the patient overcome access barriers. The second aspect of this role that has 
emerged as essential is the trust that develops between the patient and the Navigator, an aspect of 
the relationship that is strengthened when the Navigator and patient share common profiles. This 
aspect is particularly applicable for Francophone patients where there will be a shared language 
spoken (French). 
The navigator role has been developed in the context of cancer patients. Recent review on the 
subject underlines the usefulness of the patient navigation in the integration of a fragmented 
health care system, and its importance for those more vulnerable either because of their medical 
(39) or social status. (23) 
Several jurisdictions, including Vancouver, Saskatchewan, and Manitoba have had significant 
success using patient navigators (referred to herein as Navigators), (40) although most do not 
have formal evaluations. Navigators that have addressed challenges experienced in cultural and 
linguistic minorities have been successfully employed in many regions. A recent systematic 
review of the literature concluded that “Several studies reported significant improvements in 
participants’ chronic disease prevention and self-management outcomes and meta-analyses 

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December 27, 2017 
identified a positive trend associated with multi-cultural health worker intervention.” (41)  
Community health workers (CHWs) have been employed throughout Canadian regions most 
commonly to support access to health care, health promotion and education care, and the 
determinants of health. Similarly another 2015 scoping review on the subject concluded that 
CHWs can improve a wide range of health issues, can reduce disparities across social groups, 
including linguistic groups, and that those that focused on primary health care and health 
promotion “have demonstrated both actual and potential control of high costs of medical services 
and inappropriate use of emergency services when and if CHWs and their interventions are 
integrated into the health care systems.” (18) A 2017 scoping review of patient navigation in 
primary care reported a number of positive outcomes  including improved patient health and 
wellness, self-efficacy, increased access to care, and  improved follow-up with primary care 
providers and care coordination (42).  
The authors conclude that additional research is required to better understand the potential for 
these Navigators to increase access to care, reduce health care costs and address social 
determinants of health, and that the role of the Navigator needs to be better defined. 
Willis et al. have developed a framework to describe the similarities and differences across 
navigator types with a focus on clarifying the unique roles and responsibilities of patient 
navigators in different settings ranging from the community to healthcare institutions (Additional 
information: 5 Navigator Framework) (43). This framework delineates the similarities and 
differences across three navigator types: community health workers, patient navigators, and 
clinically licensed navigators. Patient navigation, situated within primary care is described in this 
framework as a ‘patient navigator.’  
3 PURPOSE  
The purpose of this project is to optimize appropriate access to community based services for 
socially complex primary care patients, including Franco-Ontarians living in minority situations, 
and promote the continuity of information across primary and community care.  
4 OBJECTIVES AND DELIVERABLES 
Objective A: Optimize equitable utilization of community based resources  
 
Deliverable 1: Effectiveness of a patient navigator on utilization of CRs 
Deliverable 2: Make policy recommendations to address remaining gaps 
Deliverable 3: Establish a model of navigation that is transferable and scalable. 
Objective B: Support continuity of information across Primary and Community Care 
Deliverable 4: Establish a process that support appropriate exchange of information 
across the two sectors 
5 CONTEXT 

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December 27, 2017 
The intervention is set in primary care practices. The intent is to integrate primary care and CRs 
to optimize appropriate access to CRs by individual patients. Within Ontario, 96% of residents 
have a primary care provider. (44)  
There are four predominant types of primary care practices in Ontario. 1) The majority 
(approximately 50%) of individuals receive care in practices in which family physicians’ 
remuneration is derived principally by the fee they earn for each service they deliver. These are 
called Fee-For-Service, and include the Family Health Groups and Comprehensive Care Models. 
2) Approximately 40% of Ontarians receive care in practices in which family physicians’ 
remuneration is based principally on capitation, which is based on the number (age and sex 
adjusted) of patients enrolled under their care. These are called Family Health Networks and 
Family Health Organizations. These practices, like the Family Health Groups and 
Comprehensive Care Model have a traditional team composition made up of a group of family 
physicians working with some nurses and front staff. 3) Approximately half the capitation 
practices are also Family Health Teams. Family Health Teams have a larger and more varied 
team. In addition to the family physicians, nurses, and front staff, these practices host ministry-
funded allied health professionals such as nurse practitioners, pharmacists, and social workers. 
These professionals work alongside family physicians to provide patients with comprehensive 
primary care. 4) The last model is the Community Health Centre. Community Health Centres are 
also an interprofessional model. In these practices all professionals, physicians included, are 
salaried. The model’s principal mandate is to provide better care for vulnerable populations (e.g. 
individuals of low-socioeconomic status, immigrants and refugees). (45)  
The context in which Franco-Ontarians reside can influence the barriers to adequate access to 
social and health care services in their mother tongue. The breadth of existing CRs, the number 
available in French, the extent to which social services that help individuals overcome barriers to 
access vary considerably by regions and are largely influenced by population density. For this 
reason, to better understand the issues Francophones living in minority situations face, we will 
conduct ARC in two contexts: Ottawa (central and eastern regions of Champlain Local Health 
Integration Network -LHIN) and Sudbury within the North East LHIN. These regions have a 
sufficient Francophone population to allow us to understand how access to community health 
and social resources in the patient’s language of choice may be different between Anglophone 
and Francophone patients.  We are recruiting practices in regions with at least 20-25% of 
Francophone residents. 
The Champlain LHIN is a large, geographically-delineated health jurisdiction spanning nearly 
18,000km2. (46) The most urban region of the Champlain LHIN (downtown Ottawa) is 
designated Health Link Area 5*, which spans over 173 km2, and has a population of over 354,022 
residents. (47) Across the Champlain LHIN, about 20% of residents are Francophone, 18% are 
immigrants, 15% are visible minorities, 11% live below the poverty cut off, and about 3% are 
Aboriginal. (46) It is estimated that 38% of the population aged 12 years and up have a chronic 
condition, and 15% have multiple chronic conditions. 16% of residents in the Champlain LHIN 
have a mental health or substance abuse disorder; these rates are higher among youth and young 
                                                 
*Health Link Area 5 - The Ottawa central Ottawa region including Nepean, Glebe, Old Ottawa South, Industrial East, Riverview, 
Playfair Park and Huntclub. It excludes Vanier and Overbrooke. The region is bounded by the Ottawa River to the north, Conroy 
and Leitrim to the east, Earl Armstrong and Crestway to the south and Woodroffe to the west. 

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December 27, 2017 
adults.(48). Compared to the Champlain region, in Health Link 5 about 13% of residents are 
Francophone, 1.7% have no knowledge of English or French, 26% are immigrants, 24% are 
visible minorities, 18% live below the poverty cut off,  and about 1.5% are Aboriginal.(46) The 
eastern region of Ottawa (Champlain LHIN) is an urban community with ethnically diverse 
populations. Ensuring access to quality health services for Francophones in this region is a key 
priority, as 18.8% of its 1.32 million residents report French as their first language. 
The North East LHIN is the second largest LHIN in Ontario with a population of over 564,000 
residents. The North East LHIN has the largest proportion of Francophone residents (23%) in the 
province, as well as a large Aboriginal population (11%). Compared to provincial averages, 
residents of the North East LHIN are older, have a shorter life expectancy, have lower levels of 
education and are more likely to be unemployed, and report poor health practices and a higher 
prevalence of chronic diseases. (49) 28% of residents of the North East LHIN are limited in their 
activities due to a chronic physical or mental condition or health problem. (50) North-eastern 
Ontarians have also expressed difficulties accessing health care services and a desire for 
increased home a community based services (49) The City of Greater Sudbury is Northern 
Ontario’s largest urban center with a population of 160,770, nearly 27% of which are 
francophone (51) and 8.2% self-identifying as Aboriginal. (52) Furthermore, compared to 
provincial averages, Sudburians have higher rates of cardiovascular disease and certain types of 
cancer, have higher rates of smoking, alcohol consumption and obesity and are more likely to be 
hospitalised or visit an emergency department. (53) Considering the linguistic diversity of the 
region and its poor health outcomes, Sudbury was chosen to join ARC as an effort to improve 
access to linguistically appropriate CRs. 
6 INTERVENTION 
All practices will have access to the intervention. Practices will receive the practice changes to 
promote patient referrals to CRs. Patients referred to CRs will be randomized to either the 
intervention or the control arm.   
Patients allocated to the control arm will receive information on Ontario 211, an electronic and 
telephone navigation service. Patients allocated to the intervention arm will be offered the 
services of the Patient Navigator. The fundamental role of the Navigator is to provide 
appropriate support to primary care patients to overcome barriers to accessing CRs (e.g. assisting 
the patient in identifying the most appropriate resource, providing the patient with transportation 
services, etc.) and reach and utilize these services.  
6.1 
PRACTICE CHANGES 
All practices participating in the study will receive the following support to facilitate the 
implementation of the intervention in the practice: 
6.1.1 Practices/Providers 
6.1.1.1 To increase providers’ awareness of CRs (Objective A) 
All practices will receive an orientation on the breadth of available community based health and 
social resources.  
Approach: Participating providers will receive information on the breadth of available resources, 
including the benefit of these resources to their patients and their practice. Because providers are 

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December 27, 2017 
hesitant to recommend the use of health promoting CRs to individuals with social barriers 
because they are unlikely to utilize the resources, the orientation will include information on 
resources that address social barriers (e.g. no transportation, low health literacy, social isolation, 
language barrier) to demonstrate that even more socially complex patients can access support 
services to overcome their barriers and utilize health promoting resources to which they were 
referred.  
6.1.1.2 To support practices streamline the process of referring patients to CRs into their 
existing structures (Objective A) 
To better integrate the referral process into usual practice, we will work with each participating 
practice to implement the referral approach best suited for them.  
Approach:  Assess the practice/providers ‘current referral practices and determine their preferred 
approach to referring patients to CR. The research team will work with PHCPS and practice staff 
to determine the optimal process to prompt provider referral and adapt the process based on 
PHCPs’ needs and preferences.  
The referral process will require the PHCP to record the necessary information regarding the 
patient’s needs relating to the CR. A referral form (see form: Appendix: A – Draft Referral 
Form) has been created for the feasibility study and will be used as a starting point for this study. 
This form may be adapted to better suit the needs of the practice relating to communication. We 
anticipate most practices to integrate the referral process directly into their EMR (where one 
exists). The practice may use the referral form provided to them or adapt an existing form they 
currently use for the purpose of this study. A paper copy of the referral form given to patients 
will serve as a tangible reminder to access the resource and increase the likelihood of 
compliance. 
Once this process is established, we will train all participating PHCPs on how to use the referral 
form and support the practice to establish a process to integrate the use of the referral form into 
their daily routine. The research team created an infographic outlining the study process and an 
instructional video explaining the details of the referral process to share with participating 
providers (See Additional Information: 6 Instructional Information). 
Note that Objective B of this study is to establish a best communication strategy that enhances 
information continuity between primary health care and CRs. The referral form will necessarily 
be part of the information exchange, and will therefore be adapted as we learn about the 
preferred communication approach (See section 6.1.1.5) 
6.1.1.3 To increase patients’ awareness of CR and to encourage a discussion regarding 
these resources with their provider (Objective A) 
Practices will receive promotional material (e.g., posters, flyers, videos) to promote the breadth 
of existing community based health and social resources and the process by which navigation 
services can support individuals access these resources.  
Approach: The ARC promotional poster (see poster: Appendix: B – Promotional Material) and 
the ARC promotional video (see link: Appendix: B –Promotional Material) will be displayed in 
the waiting room and patient examining rooms (where feasible) of all participating practices. The 
ARC promotional material will highlight the breadth of available CR and navigation support via 
the ARC study. Patients will be encouraged to discuss the benefits of these resources with their 
primary care provider. 

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December 27, 2017 
6.1.1.4 To facilitate the integration of the patient navigator in the practice (Objective A) 
A patient navigator will be attached to each primary care practice participating in the study. The 
research coordinator will work with the practices to determine the most optimal strategy for 
integrating the navigator into each practice.  
Approach: Consideration will be given to practice/providers’ expectations relating to the days 
and times when the navigator would be expected to be on site, including regular “office hours” to 
schedule appointments with patients and/or PHCPs, and any internal meetings that would be 
beneficial for the navigator to attend (e.g., staff and/or physician meetings).  
Practice staff will be asked to establish a time (usually one half day a week) where the navigator 
can use a designated space in the practice to meet with the patients referred to the CRs. The 
research coordinator will also be aware of existing resources within the practices for which 
external referrals should not be encouraged. This is especially relevant for interprofessional 
practices (FHTs) since these offer a number of services internally (e.g. dietitian services) which 
they may wish to prioritize for their patients.  
6.1.1.5 To support continuity of information between Primary and Community Care 
(Objective B) 
The research coordinator will work with each practice to establish a communication strategy best 
suited for that practice. This will cover information needs between PHCPs and the navigator as 
well as information needs between PHCPs and CRs.  
PHCP  Navigator:  
The approach through which the navigator and practice staff will communicate about patient 
needs to overcome barriers to accessing care, and experience using that community resource will 
be established by the research coordinator according to the practice/providers’ needs and 
preferences. The approach to and extent of communication between the navigator and practice 
staff, including meeting times, frequency of meetings, communication medium, etc. will be 
determined individually for each practice.  
Approach: We will begin by implementing the approach adopted during the feasibility study for 
the exchange of information between PHCPs and the navigator. The first point of communication 
begins with PHCPs completing a brief referral form (Appendix: A – Draft Referral Form) for 
each  patient they direct to a CR. This form captures standardized information that is required by 
the navigator (e.g., patient’s language, needs, contact information), and serves as a reminder for 
the patient about their discussion with their PHCP. During the feasibility phase, all participating 
practices integrated this form into their EMR. PHCPs completed the form in each patient’s 
medical record so that a record of the referral is maintained in the chart. They provided patients 
with a printed copy of the form and faxed a copy to the ARC research team. The content of that 
referral form was sufficient for the purpose of navigation.  
Once the patient was enrolled in the study and met with the navigator, PHCPs received updates 
from the navigator and a final report on the status of their patient’s access to the CR via a 
standardized reporting form (Appendix: C – Navigator Feedback Form).Practices were asked to 
establish their preferred method for receiving this reporting form such as, for example, 
integrating the form into their EMR. Because the navigator is not a member of the clinical care 
team, the practices participating in the feasibility study opted to receive these communications by 
fax. This will be proposed to the participants in this study. 

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December 27, 2017 
The communication between PHCPs and the navigator was tailored according to PHCP needs 
and preferences. All PHCPs agreed to receive information from the navigator about the status of 
their patients by fax at least twice: once after the initial encounter between the patient and the 
navigator and a second time after the navigator discharged the patient and closed their file. Any 
interim communication would occur only as needed (e.g., if the patient identifies a health care 
need that cannot be addressed by the navigator). After the first meeting with the patient, the 
navigator would forward information to the PHCP about the priority needs identified by the 
patient and information on available resources identified by the navigator. A final report was 
faxed to the PHCP once the navigator had determined that the patient had accessed the resource, 
or when the appropriate level of support was provided and the patient felt empowered to access 
the resource. Information on the recommended resource and the next steps (e.g., appointment 
made, wait list, etc.) to take was also shared with the PHCP. The information shared between the 
navigator and the PHCP is limited to the services provided by the navigator to support patients 
overcome barriers to accessing the service recommended by their PHCP, as well as other 
services identified by the patient. Any additional information on the patient’s utilization of these 
services was not included. 
To achieve Objective B, we will determine whether this communication approach is appropriate 
or whether it can be improved. We will evaluate the feasibility, acceptability and utility of the 
approach used. 
PHCP  CRs:  
In the feasibility study, no standard information was transmitted to the CRs to which patients 
were referred. Only relevant information to determine the appropriate resource for the patient  
(e.g. eligibility for services, location and cost) was shared by the navigator verbally when 
required. Similarly, neither the CR nor the navigator provided the PHCP with information 
relating to the patient’s experience accessing the CR.  
In this study, each participating practice and the CRs they prioritize will be consulted to develop 
a standardized/generic communication approach that can be tailored to individual practices’ 
context and needs. We will assess the information needs of CRs to which the patients are most 
often referred in order to determine what information would be required to best inform the care 
of the patients they serve. We will determine whether that information need can be met by the 
PHCPs. 
Factors to be considered include: CR information needs (e.g., content of the generic referral 
form); PHCP information needs regarding patient access to the CR; and means, frequency and 
confidentiality of communications across the sectors.  
We will determine whether such information is required and test the feasibility, acceptability and 
utility of any new approach proposed. 
Approach: Establish a standardized communication approach across the sectors through the 
Navigator. The referral form (Appendix: A – Draft Referral Form) will serve as means of for 
PHCPs to communicate information about the patient to the navigator. The navigator will share 
this information and any additional information they obtain with the CR. 
The navigator will provide the PHCP with updates and a final report on the status of their 
patient’s access to the CR through a standardized reporting form (Appendix: C – Navigator 
Feedback Form). The means of communication (e.g. through EMR, by fax, …) will be tailored to 

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December 27, 2017 
each practice’s preference. We will assess whether that communication strategy remains feasible, 
acceptable and useful to the practices participating in the RCT. 
Because the CRs do not provide information on the patient’s encounters with them, and the 
contact with the navigator will be terminated before the patient has completed the utilization of 
the community resource, that information will not be available to us, and will not be included in 
any communication.  
6.1.2 Patients  
6.1.2.1 Control arm 
Patients allocated to the control arm will be directed to the Ontario 211 services (see section 
Electronic and Telephone Navigation Resources). After consenting to participate in the study and 
completing the first telephone survey, the research assistant will inform these patients of the 
navigation services provided by Ontario 211 to help them access the CR recommended to them 
by their PHCP. Patients requesting information about the nature of the service will be informed 
that it is free, bilingual and available 24hours 7 days/week. The research assistant will instruct 
patients to dial 2-1-1 if they wish obtain additional information on the nature of this service. 
6.1.2.1 Intervention arm 
Patients allocated to the intervention arm will be offered the services of the ARC Patient 
Navigator. After consenting to participate in the study and completing the telephone survey, the 
research assistant will inform these patients that they can use the services offered by the ARC 
patient navigator to help them access the CR referred to them by their PHCP. Following a brief 
description of the services provided by the navigator (e.g., arrange transportation, make 
appointments, fill out forms, etc.), patients will be offered to be contacted by the navigator by 
telephone or to meet with the navigator in person on a day and time that is most convenient for 
them.  
The profile and qualifications of the navigator are described in Additional Information 7 – 
Profile and Qualifications of the Navigator. 
Role of the Navigator  
Practices will receive support from a Navigator to assist patients to access CRs identified by their 
PHCP on the referral form (Appendix: A – Draft Referral Form). The navigator will help patients 
identify their priority needs and support them in accessing the CRs that can help address these 
needs. Navigators can support patients to access resources that were not identified by their 
PHCP, unless these are medical services that require a physician referral, or that are outside the 
scope of practice of the lay navigator.  
The Navigator links patients, primary care, and community care by acting as an informational 
channel, champion, and advocate for patients. Navigators are intended to act as an integral 
member of the primary care practice team, and are defined by a clear scope of practice that is 
non-clinical and distinguishes their role and responsibilities from that of care providers. 
Navigators will develop effective interpersonal skills and communication skills with the PC 
team, patients and community program staff to assist patients to reach the appropriate CR, and 
address social barriers to care. Navigators will be assigned and paid to work with a specific 
practice to ensure timely meetings with patients and to act as a central liaison with providers, 
practices, and community resources.  

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December 27, 2017 
 
Navigation will be provided by fully bilingual individuals. Specific attention will be paid to 
meeting the language needs of Francophones. The “Active Offer” of services in the language of 
the individual’s choice will be prioritized. That is, the Navigator will actively identify that their 
service is available in French and English. If the patient speaks neither, the Navigator will seek 
the services of a cultural interpreter/translator, preferably a family member. The Navigator will 
also actively encourage individuals to use services in their language and seek the language 
appropriate services for the individual, where these are available, or offer the services of a 
translator. 
The Navigator role and activities are described in more details in Additional Information 8: Role 
and Activities of the Navigator.  
7 METHOD 
7.1 
DESIGN  
This is a prospective, mixed method (patient) randomized controlled trial of navigation services 
provided by Ontario 211 vs. navigation services provided by a lay Patient Navigator. 
Randomization is 1:1 control:intervention.  
The protocol is the second phase of a single arm study involving a lay Patient Navigator 
intervention (BRI-REB # M16-16-055,055,OHSN REB #201609014-01H20160914, Hôpital 
Montfort REB # SD-DP-27-02-17, and the University of Ottawa REB # A05-17-04). The mixed 
method design is a sequential, explanatory design in which the collection and analysis (at least 
partial) of quantitative data is followed by the collection of qualitative data that will aim to 
explore the findings emerging from the quantitative data so as to gain a more in depth 
understanding of the results. 
7.2 
RANDOMIZATION 
Patients having consented to participate in the study will complete a survey, after which their 
random assignment to one of two arms (intervention or control) will be revealed.   
The randomization schedule will be blocked at the practice level to ensure a balance of control 
and intervention patients for each practice, including all providers. The randomization schedule 
will be developed by an independent statistician and arm allocation will be concealed.   
Patients randomized to the intervention arm will have access to services provided by the ARC 
Patient Navigator, whereas patients randomized to the control arm will be directed to the Ontario 
211 navigation service.  
7.3 
PARTICIPANTS AND ELIGIBILITY 
7.3.1 Primary care practices  
Primary care practices that meet the following criteria are eligible to participate in the study: 
7.3.1.1 Inclusion 
 Any practice providing comprehensive primary care services (i.e. excludes practices that 
provide walk in services only), except for Community Health Centres.  

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December 27, 2017 
This includes Reformed Fee For Service (Family Health Groups, Comprehensive Care 
Model), Capitation based models (Family Health Networks, Family Health 
Organizations), and interprofessional models (Family Health Teams)  
 Located in a neighbourhood of the Champlain (Ottawa area) or North East (Sudbury 
area) LHIN that has a francophone population of 20% of greater, as identified in the 
Ottawa Neighbourhood Study and in custom neighbourhoods created by the city of 
Greater Sudbury for city planning purposes, both linked to Statistics Canada’s 2011 
Population Census, respectively. 
 Having at least one primary care provider agreeing to participate in the study 
7.3.1.2 Exclusion 
 A Community Health Centre or clinics providing walk-in services only 
 Practices that are under the traditional fee for service remuneration 
 Located in a neighbourhood with less than 20% Francophone residents 
7.3.2 Primary care providers 
Providers care providers that meet the following criteria are eligible to participate in the study: 
7.3.2.1 Inclusion 
 Work in a practice that meets the eligibility criteria participating practice will be invited 
to participate in the study.  
 Is a Primary Health Care Provider: A health professional that may refer patients to CRs 
such as physicians, nurses, and social workers.  
For the purpose of simplicity all these are referred to as Primary Health Care Providers in the 
document. 
7.3.2.1 Exclusion 
There are no exclusion criteria for primary care health care providers 
7.3.2.2 Qualitative Interviews 
We will use a purposeful sampling approach to identify PHCPs who will be invited for the 
interview. The selection criteria will aim to get maximum variation while guided by the 
summary findings from the provider surveys that might show differences in responses across 
provider/practice profile. We will recruit PHCPs to maximize variation in profession and 
experience with the intervention, while also ensuring a good representation of males and females 
and PHCPs of different age groups. 
7.3.3 Primary care patients 
Primary care patients are eligible to participate if they meet the following criteria: 
7.3.3.1 Inclusion 
 Patient identifies a primary care provider participating in the study as their main primary 
care provider 
 Has received a recommendation for a CR from their PHCP  
 Is able to communicate in English or French, or is willing to be served via a cultural 
interpreter/translator, preferably a family member.  

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December 27, 2017 
 Is able to provide consent for the study (18 years of age or older), or has 
parental/guardian proxy to provide consent (minor patients, patients with cognitive 
deficits) 
7.3.3.2 Exclusion 
 Unable to provide consent and does not have a family member/guardian who can provide 
proxy consent 
There is no age, language or other requirements for patient eligibility. 
7.3.3.3 Qualitative Interviews 
We will use a purposeful sampling approach to identify patients who will be invited for the 
interview. The selection criteria will aim to get maximum variation while guided by the 
summary findings from the patient surveys that might show differences in responses across 
provider/practice profile. We will recruit patients to maximize variation in social complexity and 
experience with the intervention, while also ensuring a good representation of males and females 
and different age groups. 
8 RECRUITMENT 
8.1 
PRACTICES/PROVIDERS 
A practice is defined as a clinic site where providers share a common charting system and at 
least one staff resource. Sites where solo practitioners share a common waiting room and front 
staff but do not share the charting system are considered to have multiple practices, each one 
representing the solo practitioner. Also, in Ontario several practice sites have come together 
under a common primary care organization for administrative purposes. These organizations 
have more than one practice site, each with a different physical address, and each of these sites 
are considered a distinct practice.  
The pool of potentially eligible practices will be identified via established lists (held by the 
Champlain and North East LHINs), online searches, and telephone inquiries for each of the two 
study regions. A list of all practices in the two regions within neighbourhoods having at least 
20% francophone population will be established. To the extent feasible, the list will identify the 
practice address and neighbourhood, practice model, manager, lead physician (if applicable), and 
contact information (clinic telephone number, mailing and email address).  
8.1.1 Prioritizing neighbourhoods  
Neighbourhoods with a higher proportion of francophone population will be prioritized. For 
examples, practices in neighbourhoods that have a 50% francophone population will be targeted 
for recruitment before practices that have a 30% francophone population.  
8.1.2 Identifying practices 
Within a neighbourhood, practices will be randomly ordered using a random number generator, 
and recruitment will proceed down the list beginning with the neighbourhood of highest 
francophone populations.  
8.1.3 Practice Recruitment Approach 

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December 27, 2017 
Invitations to participate will be sent to the number of practices required in each region to meet 
its sample size requirement in the order described above. When a practice refuses, the next 
practice will be sent an invitation. Recruitment will proceed with that approach until the sample 
size requirement is reached.  
We will use the Dillman Tailored Design Method(54) to recruit practices (Appendix: D – 
Practice/Provider Recruitment Package). Using that method, eligible practices are contacted up 
to three times to encourage participation. Firstly, an invitation letter will be emailed (or mailed if 
no email is available) to the individual we identify as most likely to be the practice lead. An 
information brochure (Appendix: D – Practice/Provider Recruitment Package) will be included 
(i.e., as an attachment) with the invitation letter. Secondly, a reminder email will be sent after 
two weeks. Finally, we will follow up these email contacts (three weeks after the initial email 
invitation) with a telephone call to the practice manager, lead physician or other primary care 
provider to offer practice members additional information about the study.  
8.1.4 Provider Recruitment Approach 
After obtaining an interest from a practice member to whom the invitation email was sent, we 
will offer all practice members (PHCPs) eligible for the study an information session during 
which the study is described and participation offered. The Practice Information and Consent 
Form and information on Navigation Services (Appendix: D—Practice/Provider Recruitment 
Package) will be provided to all PHCPs prior to or during the information session. All PHCPs 
will be encouraged to participate. At least one PHCP is required to participate to include the 
practice in the study.   
A practice “champion” (practice clinical or administrative staff) will be identified in each 
practice, and will be the liaison between the practice and the research team and the main person 
responsible for overseeing the study implementation in the practice. Each practice Champion 
will receive a letter (see Appendix: D—Practice/Provider Recruitment Package) providing 
information on the nature of the study and their role as practice Champion. 
8.1.4.1 Recruitment for Interviews  
After completing the post-intervention survey, PHCPs will be informed that they may be asked 
to participate in an interview, and their permission to be contacted for their consent should they 
be selected to participate will be requested. Those who agree will make up our pool of potential 
participants. 
All providers who complete the post-intervention survey and agree to be contacted will be 
invited to participate in an individual in-person interview.  A conscious effort will be made to 
recruit a variety of providers (e.g. physicians, nurses and other participating health care 
providers) which reflect the provider profiles of the practices in the study.   
8.1.5 Patient Recruitment Approach 
PHCPs participating in the study will be encouraged to refer their patients who could benefit 
from CRs to these services. PHCPs will be asked complete the study referral form (Appendix: A 
– Draft Referral Form) for all patients for whom they identify a need that can be addressed by 
accessing a CR, briefly mention the study to these patients, and ask for their verbal consent to be 
contacted by a member of the research team to learn more about the study. Patients who agree 
will receive a copy of the completed referral form and a sealed package containing two copies of 

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December 27, 2017 
the patient study information sheet and consent form (see Appendix: E – Patient Information and 
Consent Forms) and a pre-paid envelop to mail their written consent to the study team.   
PHCPs will fax completed patient referrals to the study team. Upon receiving a copy of the 
patient referral, a member of the research team (i.e. Research Assistant) will contact the patient 
by telephone to explain the study and obtain their verbal consent to participate.  They will also 
instruct the patient to mail a copy of their signed consent form (see Appendix: E – Patient 
Information and Consent Forms) to the research team using the pre-paid envelope in their patient 
study information package.   
Upon receiving the patient’s verbal consent, the research assistant will administer a survey, after 
which they will reveal the concealed arm allocation and inform the patient of the arm to which 
they are randomized (control or intervention) (see Section 6.1.2).  
A more detailed description of the consenting process is provided in section 12.2: Obtaining 
consent. 
8.1.5.1 Recruitment for Interviews 
After completing the post-intervention survey, patients will be informed that they may be asked 
to participate in an interview, and their permission to be contacted at that time for their consent 
should they be selected to participate will be requested. Those who agree will make up our pool 
of potential participants.  Patients may also be invited to participate in an interview at the end of 
the survey. The interview would then be scheduled at the respondent’s convenience. 
9 TOOLS AND MEASUREMENTS 
Quantitative data will be obtained principally from surveys, although study personnel notes, 
including the navigator documentation of interactions with the patient, providers and CRs will be 
used for the process evaluation. A diagram showing the schedule for these measurements is 
found in Additional Information: 6 – Instructional Information 
S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Additional Information 
Additional Info 6A - English RCT Study Process (2017-Dec-28) 
Additional Info 6B – English ARC Referral Form RCT video (2017-Dec-27) 
https://www.powtoon.com/online-presentation/fUFWyTAINPD/rct-arc-referral-form/?mode=movie 
 
Additional information: 7 –  Timeline. 
9.1 
QUANTITATIVE TOOLS AND MEASUREMENTS 
9.1.1 Referral assessment: 
A baseline referral rate will be calculated using a method for collecting observational data (i.e., 
card study) (55). For a period of 1 week prior to the study implementation, participating PHCPs 
will be asked to indicate (on a designated card) each patient that he or she referred/recommended 
to attend a community program.  

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December 27, 2017 
In addition to completing referral forms for all patients directed to a CR during the 12 month 
study period, post-study implementation referral rates will be calculated using a similar method 
for observational data collection (i.e., card study). Since we anticipate seasonal variation in 
referral rates, a post-intervention referral rate will be measured for a period of 1 week exactly 12 
months after the initial assessment to eliminate the impact of that variation.  
9.1.2 Practice Survey:  
This survey tool (see Appendix: G – Practice Survey ) captures general information on the 
practice profile, services offered, equity orientation, and collaboration with other healthcare 
providers and organizations.  
This survey will be given to the practice “Champion” who will be instructed to get the assistance 
of any other practice member to complete it at baseline only. 
9.1.3 Provider Survey:  
A survey tool (Appendix: H – Provider Survey) will capture the profile of participating PHCPs, 
their confidence in managing complex patients, as well as several dimensions of work that will 
help us understand in which context the intervention is most effective. These dimensions are: 
Section A: Knowledge, attitudes, & practice, with reference to vulnerable populations 
Section B: Contextual factors 
Section C: Change valence 
Section D: Climate 
Section E: Organization readiness for change 
Section F: Implementation effectiveness 
Section G: Experience with Navigator 
All participating PHCPs will complete the survey at baseline before patient enrolment begins, as 
well as near the end of the intervention period, but before the intervention is removed so as to not 
contaminate the responses by the effect of removing the intervention. 
9.1.4 Patient Survey: 
This survey tool (Appendix: K – Rapid Cycle Evaluation ) captures the attributes listed below. 
Items in red will be administered to patients in allocated to the intervention arm only. 
Section A: First Contact Access  
Section B:  Needs/Difficulties/Use of healthcare  
Section C:  Ability to engage 
Section D:  Risk assessment score 
Section E: Health/Chronic condition 
Section F: Quality of Life VR-12 
Section G: Social support 
Section H: Social vulnerability index questions  
Section I: Socio demographic  
Section J: Pre-Intervention Community Resource Referral 
 
 
Section K: Pre-Intervention Experience with other Community Resources 
 
Section L: Health Action Process Approach  

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Section M: Patient Activation Measure  
Section N: Post-Intervention Main Outcome 
 
Section O: Post-Intervention Community Service Evaluation 
 
Section P: Post-Intervention Navigator assessment 
 
This survey will be administered at patient enrolment (i.e., pre-intervention) and at the end of the 
patient three month intervention period (i.e., post-intervention). Some questions are only asked at 
baseline (pre-intervention), and others are only asked after the three month intervention period 
(post-intervention). 
9.1.5 Health Administrative Data: 
Health administrative data housed at the Institute for Clinical Evaluative Sciences (ICES) will be 
used to understand the impact of the intervention on the utilization of health care services. These 
include measures of physician visits, emergency room utilization, and hospitalization. Data from 
participating patients and practices will be uploaded to ICES and linked to their corresponding 
profiles within ICES databases. Consent for this linkage is included in the practice and patient 
information and consent sheet.  
9.1.6 Navigator Training Assessment  
The Navigator will complete a survey about their training which assesses their motivation to 
learn (before the training), motivation to transfer learning (completed immediately after the 
training), use of knowledge and skills in their everyday work, and an evaluation of the training 
program (Appendix: J – Navigator Training Assessment). Assessment is also incorporated 
throughout the online learning modules with multiple choice tests, case studies and reflective 
exercises.   
The Patient Navigator Training website also includes a Navigator Workbook and a Discussion 
Board which provide a means of self-assessment and ongoing learning. The Navigator 
Workbook is designed to help the Navigator reflect on their learning, integrate their knowledge 
with previous experience, and think about how to apply this information in their Navigator role. 
Navigators will respond to guided questions about educational content.  
The Discussion Board is a community forum that is used during the online training, and prior to 
and after each of the face-to-face (F2F) sessions. Navigators can post questions about topics and 
learning materials, view videos, respond to case studies, and share learning resources. This space 
will also help Navigators prepare for the F2F sessions and support their ongoing learning through 
dialogue following the training program.  
9.1.7 Rapid Cycle Evaluation: 
This tool (Appendix: K – Rapid Cycle Evaluation) will allow the researchers to determine 
whether the processes established in that practice meet the expectation of the practice and how 
these need to be adapted to respond to the practice’s need. This tool may be modified by 
information we collect as the progresses. Its intent is to allow us to document the fidelity of the 
intervention, and adapt the implementation based on practice feedback. Any adaptation of the 
implementation will be limited to the aspects described in this protocol. Such adaptation may 
include changing the type of flyers available in the waiting room or eliminating the waiting room 
stand entirely; adapting the referral form to facilitate referral or capture information the practice 
deems essential. This will also be an opportunity to address problems that had not been brought 
to our attention earlier. 

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The Rapid Cycle Evaluation (RCE) will be conducted as followed:  
1. A first evaluation survey will be administered near the end of the “implementation phase” of 
the study (1 month period) to help the research team understand the success of the study set up in 
the practice. This survey will be completed by a member of the practice once. It may be 
administered a second time depending on the answers provided in the initial survey.  
2. A second evaluation survey will be administered during the “study phase” (12 month period) 
to help inform the research team on the integration of study activities in the practice. This survey 
will be completed by a member of the practice monthly, or more or less frequently depending on 
the status of the previous assessment. 
The RCE will be completed by a member of the practice either by phone (administered by the 
Research Assistant or Research Coordinator) or electronically (i.e., email).   
9.2 
QUALITATIVE TOOLS AND MEASUREMENTS   
 
The questions in the following three Appendices are a template for the interviews that will be 
carried out with the providers, patients and navigators (Appendix: L – Provider Qualitative 
Themes,  
Appendix: M – Patient Qualitative Themes, Appendix: N – Navigator Qualitative Assessment ).  
A mix of exploratory and predominantly explanatory questions will be used for provider 
(Appendix: L – Provider Qualitative Themes) and patient ( 
Appendix: M – Patient Qualitative Themes) interviews.  Exploratory questions capture patient or 
provider’s perspectives about access to primary care, patient vulnerability and navigation. 
Explanatory questions are specific to each of the study objectives. The qualitative assessment is 
intended to be explanatory to the quantitative assessment. As such, the qualitative assessment 
will always follow the quantitative assessment. The explanatory questions will be based on 
survey results and will vary from one study condition to the next. As such, the qualitative tools 
are grounded in the quantitative findings. (56) The qualitative data collection from patients will 
emulate the staggered approached initiated with the quantitative data collection. Thus, at this 
point in time, we can only anticipate that the line of questioning will be based on broad 
constructs from the surveys, and more specific interview guides will be developed once the 
quantitative analyses are completed. Thus, the interview questions may change as the findings 
from the quantitative data will be used to inform these questions. 
 
9.2.1 Timing 
Provider interviews (Appendix: L – Provider Qualitative Themes) will be conducted on a 
purposefully recruited sample (see Section 8.1.4.1) within 2 months after they have completed 
the follow-up (post-intervention) survey but before the intervention is removed so as to not 
contaminate the responses by the effect of removing the intervention.  
A member of the practice (i.e., the practice “Champion”) will answer a series of questions 
pertaining to the activities carried out throughout the study (i.e., practice wrap-up assessment).  
 

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Patient interviews ( 
Appendix: M – Patient Qualitative Themes) will be conducted on a purposefully recruited 
sample (see Section 8.1.5.1) at the end of the three months intervention period (Post-
intervention). Patient interviews will be conducted within two-months after having completed the 
intervention period, as soon as possible after having completed the Post-Intervention survey.  
 
Navigator interviews (Appendix: N – Navigator Qualitative Assessment ) will take place at the 
end of study period to help us understand the strengths and challenges of the navigation 
approach.  
 
9.3 
STUDY DOCUMENTATION 
9.3.1 Practice Set-Up Log 
The Research Coordinator will document all encounters with the practice to keep track of the 
implementation of study activities in the practice (e.g., referral process, promotional material, 
navigator integration), practice/provider needs and preferences, and required adaptations to 
facilitate the implementation of the intervention in the practice. The type of documentations to be 
captured is shown in Appendix: O – Practice Set Up Log. Note that this log may be adapted as 
required. 
9.3.2 Navigator Log  
The navigator will document encounters with patients, primary care practice personnel and CRs. 
The type of documentations to be captured in the Navigator log is shown in Appendix: O – 
Practice Set Up Log 
S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Appendices\Appendix O-Practice Set Up Log 
Appendix P - Practice Set-Up Log (2017-Dec-27) 
Appendix: P – Navigator Log. Note that this log may be adapted as required. 
10 DATA ANALYSES 
10.1 DEFINITIONS 
10.1.1 Primary Outcome: Access 
The primary outcome measure is access to CRs amongst the patients participating in the study. 
This outcome reflects the ability of the navigator to help patients overcome barriers to access and 
reach the CR.  We will assess this outcome in both arms (control and intervention) three months 
after enrolment in the study through a patient survey (Appendix: I – Patient Survey). The 
outcome will be a count of the CRs accessed (as a patient may access more than one CR). 
A community resource is defined as: A service, a resource, a program that is offered in the 
community and that addresses social or health needs. Access is defined as: the use of a 
community resource. “Use” includes having attended the program; received the service; obtained 
the resource. The goal of the navigator is to support the patient obtain the resource they need. If 
the patient attends the resource at least once, it will be considered a positive outcome. Therefore, 

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even if the patient decides that the resource does not meet their needs and discontinues 
utilization, utilization will be considered achieved. Information available about the extent of 
utilization and whether the patient discontinued the service and the reason for discontinuing will 
be captured. 
Many resources have a waiting period before the individual can make use of the service. Being 
on a waiting list does not constitute utilization as it is not given that all individuals on a wait list 
eventually utilize the service. Our patient partners felt that in cases where the desired resource 
has a lengthy waiting period, the navigator should connect the patient with another resource that 
can help address the need to at least some extent. However, being on a wait list for a service and 
having had an “intake” visit for that service (contact of any sort, telephone, face to face or other) 
should be considered utilization. 
Therefore, Access is achieved if: 
- 
The patient accesses the resource at least once 
- 
The patient is on the waiting list AND has had an intake visit for that service. 
10.1.2 Secondary outcomes 
10.1.2.1 Patient survey 
Patients’ social barriers captured in the Navigator log (Appendix: O – Practice Set Up Log 
S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Appendices\Appendix O-Practice Set Up Log 
Appendix P - Practice Set-Up Log (2017-Dec-27) 
Appendix: P – Navigator Log) and patient characteristics captured in the patient survey 
(Appendix: I – Patient Survey) will be used to assess the abibility of the intervention to address 
equity: 
Section I:   Social vulnerability index questions  
Section J: Socio demographic 
 
 
The patient survey captures a number of outcome measures that reflect the following dimensions 
(Appendix: I – Patient Survey):   
Section B: Needs/Difficulties/Use of healthcare - Multiple questions, including two scales 
(ability to pay and enduring relationship) 
Section C: Ability to engage – One scale (including three concepts) 
Section F: Quality of Life VR-12  - One scale 
Section L: Health Action Process Approach - One scale (including eight concepts) 
Section M: Patient Activation Measure - One scale 
 
Section O: Community service evaluation 
Section P: Navigator assessment (intervention arm only) 
10.1.2.2 Provider surveys 

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Measures captured in the provider survey will allow us to understand the impact of the 
intervention at that level. These measures include: 
Provider (Appendix: H – Provider Survey) 
Section A: Knowledge, attitudes, & practice, with reference to vulnerable populations 
Section B: Contextual factors (e.g., organizational structure) 
Section C: Change valence 
Section D: Climate 
Section E: Organizational readiness for change 
Section F: Implementation effectiveness  
Section G: Experience with the Navigator 
 
10.1.2.3 Health administrative data 
In addition, health administrative data housed at the Institute for Clinical Evaluative Sciences 
(ICES) will be used to understand the impact of the intervention on the utilization of health care 
services. These include measures of physician visits, emergency room utilization, and 
hospitalization. ICES captures all health care services that are covered through the Ontario 
Health Insurance Plan (OHIP). It is hypothesized that better access to community health and 
social resources (the majority of which are not covered by OHIP) would reduce the need for visit 
to primary care practices, and reduce the risk of poor outcomes, such as emergency room visits 
and hospitalizations. The following measures exemplify the type of data that will be analyzed 
- 
Visits to primary care physicians (OHIP) 
- 
Visits to specialists (OHIP) 
- 
Emergency room visits (National Ambulatory Care Reporting System [NACRS]) 
- 
Hospitalizations (Discharge Abstract Database [DAD]) 
The analyses of ICES data will be conducted under the section 45 of PHIPA. “Section 45 of 
PHIPA is designed to enable the work of organizations like ICES that conduct analysis and 
compile statistics about the management and effectiveness of health care.” 
http://www.ices.on.ca/Data-and-Privacy/Privacy%20at%20ICES. 
10.2 QUANTITATIVE ANALYSES 
All analyses will be performed using an intent-to-treat approach. 
10.2.1 Descriptive 
Quantitative measures will be reported descriptively, with measures of central tendencies and 
dispersion. Descriptive analyses will also be used to represent the profile of the practices, 
providers, and the profile of patients in the two study arms to allow a visual assessment of 
potential differences. 
Provider scales of effectiveness (Knowledge, attitudes, & practice, with reference to vulnerable 
populations) at Pre-intervention, post-intervention, as well as the difference between these two 
scores will be reported using summary measures and measures of dispersion.  

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10.2.2 Comparative 
The main analysis to address Objective A, Deliverable 1 will be a comparison of total number 
of CRs accessed by the patients in the Control and Intervention arms.  
Because the primary outcome is a count, we will use a Poisson regression to compare the two 
arms. Other measures will be analyzed using chi Square or t-tests and linear, as appropriate. 
10.2.3 Regression analyses 
The unit of analysis for all regression analyses will be the individual patient.  
For the outcome measures obtained from data collected during the study, we will conduct 
regression analyses where the dependent variable will be, in turn, the measures of effectiveness 
identified above, while the independent variables will be practice, provider, and patient level co-
variates that may help us under what attributes are associated with better outcome.  
10.2.3.1 Patient Level Outcomes 
For outcomes measured at the patient level, the following regressions will be carried out 
- 
Unit of analysis: Patient 
- 
Type of analysis: Linear for continuous scales, Logistic for dichotomous outcomes, Poisson 
for count data.  
- 
Dependent variable: In turn: each outcome measurement 
- 
Moderator: Arm (control vs intervention) 
- 
Other independent variables: Some measures of patient, provider and practice characteristics 
that could help explain the impact of the outcome  
 
The regressions aim to compare the effectiveness of the intervention accounting for potential 
differences in confounders in the two arms, as well as understand the factors that are predictive 
of better outcomes. In the latter, variables having a p value smaller than 0.10 will be retained. 
10.2.3.2 Provider Level Outcomes 
Bootstrap moderated mediation analyses will be carried out to test associations between change 
readiness predictors and outcomes predicted by the theory. Results will be considered 
statistically significant based on p values equal or smaller than 0.10. 
- 
Unit of analysis: Practice (and individual when theoretically justified) 
- 
Type of analysis: Linear bootstrap 
- 
Predictors: Psychological safety, Satisfaction with operational procedures, 
Psychological uncertainty, Change fatigue, Supporting infrastructure, Team type 
- 
Moderator: Arm (control vs intervention) 
- 
Mediators: Appropriateness, Personnel benefit, Role overload, ambiguity and conflict, 
Impact empowerment, Interprofessional conflict, Climate support for innovation, 
Commitment to change, Task interdependence, Quality of idea implemented 
- 
Outcome: Implementation effectiveness + Provider survey scales measuring 
effectiveness 
10.2.4 Multivariable analyses to assess equity 
The main analysis will include all patients enrolled in the trial, regardless of language preference. 
Secondary analyses will assess separately and compare the impact of the intervention on 

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individuals’ ability to access health or social resources in their language of choice for French 
speaking and English speaking participants.  In these analyses, the language variable will be used 
as an effect modifier. 
10.2.5 Health Administrative Data 
Patients participating in the study were asked to provide their Ontario Health Insurance Program 
(OHIP) number, and providers participating in the study were asked to provide their OHIP 
billing code. We will link the study data to health administrative data housed at the Institute for 
Clinical Evaluative Sciences using the patient OHIP number and provider billing code. 
10.2.5.1 Representativeness  
We will compare the profile of providers participating in the study to others in their practice and 
in the region. We will also compare the profile of patients having participated in the study to all 
patients of participating providers. This will allow us to understand the profile of patients who 
are more likely to be referred to navigation services. 
10.2.5.2 Outcome data  
Some outcome measures will be obtained from health administrative data housed at the Institute 
for Clinical Evaluative Sciences.  For these analyses, the date of patient enrolment is the start of 
year 1. The two years that follow the start of the intervention are years 1 and 2. Year 0 is the 12 
month interval preceding the enrolment date.  
The mean difference in Visits to primary care physicians (OHIP) and Visits to specialists (OHIP) 
measures between year 1 (ramp up year) and year 0, and year 2 (full effect) and year 0 will be 
assessed and compared in the intervention and control arm. 
The rate of Emergency room visits (National Ambulatory Care Reporting System [NACRS]) and 
Hospitalizations (Discharge Abstract Database [DAD]) in year 1 and year 2 in the control and 
intervention arm will be compared.  
10.3 QUALITATIVE ANALYSES 
Consistent with principles of an explanatory sequential design of a phenomenological tradition, 
we will begin by collecting and analyzing the patient and provider surveys, the results of which 
will guide the qualitative line of questioning which will seek to further explore survey findings.  
The interviews with providers will be used to further contextualize survey results, while patient 
interviews will allow us to explain certain differences experienced by the intervention and 
control groups while also accounting for the regional context (Ottawa vs. Sudbury). Preliminary 
questions for the patient interview guide and provider interview guide were developed from the 
ARC project objectives. These questions were aligned with elements of the study’s conceptual 
framework including the Access Framework and the Health Action Process Approach to provide 
a theoretical underpinning for the qualitative analysis. The interview questions will be further 
developed based on the quantitative results from the first participating providers and patients. As 
further quantitative data is gathered, interview guides will evolve based on a combination of the 
quantitative and qualitative results stemming from the surveys and interviews respectively. 
The overarching research question guiding this qualitative phase is: What is the provider and 
patient experience with the navigation to CRs?  Data will be analysed inductively, including an 
in-depth within-case analysis (e.g. data of patient participants in the control arm) and an in-depth 

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between-case analysis (e.g. data of patient participants in the control arm compared to data of the 
participants in the intervention arm(s). A between region analysis will be conducted to explore 
the different ways in which Ottawa and Sudbury contexts understood and experienced access to 
CR and navigation. Data collection, coding and analysis will follow a sequential iterative 
process.  
These interpretative thematic analyses will be completed using an iterative process. (57;58) Data 
analyses will be completed in six phases as described by Braun and Clarke (2006). Phase 1: 
Interviews will be audio recorded and then transcribed verbatim. As data continues to be 
gathered, the research assistants and researchers will independently read the entire transcripts 
repeatedly to immerse themselves in the data. These transcripts will be entered into NVivo 11 
(computer software program) for subsequent coding and analysis. Phase 2: Research assistants 
will do the initial coding of the data by identifying individual segments of text. Individual 
segments of text with similar codes will be collated. A process of inter-rater reliability will be 
followed for the first 3-4 transcripts. Independently coded transcripts will be compared to 
identify similarities and differences in the coding process. Discrepancies will be addressed by 
coding or recoding. Discrepant interpretations may identify areas for further exploration with a 
subset of participants to enrich the analysis by including multiple interpretations. (59)  Phase 3:  
Members of the research team will work through the rest of the analyses: Phases 3-6.  As the 
researchers assemble similar codes they will identify preliminary themes with illustrative 
examples from the data, including any recurring, converging, and contradictory patterns, or any 
linkages to theory. As more data are collected and reviewed, coded themes will be revised and 
refined. Phase 4: Identified themes will be reviewed in relation to the coded extracts and the 
entire data set followed by producing a thematic map to represent the entire analysis. Phase 5: 
Each theme will then be defined and named accordingly. Phase 6: Examples from coded extract 
for each final theme (quotes) will be retrieved and used as supportive evidence for final 
reporting. Throughout this process, researchers will maintain a reflexive journal. 
 
Within this research study, several of Guba and Lincoln’s (60)  trustworthiness criteria will be 
adopted. Specifically, the study’s rigor will be ensured by applying methods of credibility, 
transferability, dependability and confirmability. For credibility, several members of the research 
team will be involved in the analyses. As such we will work collectively to come to our 
conclusions by using a process of negotiation and consensus. (61;62) Therefore, multiple 
perspectives on the study will be considered. (62)  This will be instrumental in establishing that 
the findings of the proposed research inquiry are authentic and credible. (63) Further, member 
checks will also be incorporated within the protocol to ensure accuracy of the findings by 
presenting the analyses and findings back to a select number of patients and providers (members) 
who contributed to the data. The purpose of member-checking is to confirm that the 
interpretation and understanding of the researchers is what was intended by the participants. (63) 
For transferability, thick descriptions will be compiled and developed to elucidate all of the 
research processes (methodological choices, purposeful sampling, data collection, data analyses) 
that were completed within this study. (63) This will allow the researchers to make sure that this 
study can be applied to different settings with the same potential for different populations. (62) 
For dependability, a detailed audit trail will be kept to ensure that the processes used throughout 
the collection of data and analyses are consistent for the duration of the study. (63) For instance, 
a detailed account of the research activities and decisions that are made will be kept in order to 
detail how the data obtained were collected, documented and examined. For confirmability, 

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through the process of reflexive journaling, the researchers will identify their assumptions, 
conceptions, and experiences and how this might impact upon their analysis of the data. The 
journals will enable researchers to explore this subjective element and allow them to discuss 
these as part of the coding and interpretation process. (61) The investigators will use ‘bracketing’ 
to set aside personal biases, knowledge and perspectives. (64)  
11 SAMPLE SIZE CALCULATIONS  
We established the minimally clinically important difference at 20% absolute, and 50% relative. 
A total sample size of 368 patients (184 in each arm) is required to detect an absolute difference 
in 20% from 40%-60% (relative difference of 50%), given a type I error or 5% and type II error 
of 10%, accounting for continuity correction and a dropout rate of 25%.  
Assuming an average practice size of 3 participating providers, an annual referral rate of 68 
patients per practice, a 60% participation rate, recruiting 9 practices will achieve a sample size of 
365. Assuming 25% drop out rate for the practices, we will recruit 12 practices, 8 practices in the 
Champlain LHIN and 4 in the North East LIHN to ensure we are adequately powered. 
Referral Assumptions: Three physicians per practice, each with a panel size of 1500 patients of 
which half will have a condition for which a community resource could be beneficial, of whom 
60% 1350 will have at least one encounter during the 12 month study period (4500 x 50% x 60% 
= 1350). Assuming a 5% referral rate, and a participation rate of 60%, we estimate 41 
participants per practice.   
We assumed a relatively low referral rate of 5%, based on physician self-reported measures of 
the likelihood of referring patients to CRs to address health risk factors, which suggest that this 
is not a commonly used practice. One study indicates that 17% usually or always provide 
referrals to smoking cessation programs, 4% to physical activity, 7% for management of alcohol 
consumption, and 6% for nutrition.(65) Yet another study suggested that 42% of physicians refer 
patients to physical activity. (66;66) Referrals for the management of chronic conditions are 
higher. A study conducted in Canada reported that 50% of physicians referred to diabetes 
education programs (67) but it remains unclear what proportion of their patients these physicians 
refer. Another Canadian statistic suggest that approximately 25% of individuals with chronic 
condition who could benefit from accessing CRs are referred to these services.(68) The statistics 
on referrals vary considerably, and are related to the type of CRs sought.(29;65-67;69-79) There 
is no documentation on the actual referral rates to a community resource of any kind available in 
the community by primary care provider; the target of this study.  
Control Access Rate Assumption: Previous studies reported broadly different access rates to 
community resources, ranging between 2.5% and 70%, depending on the resource.(29-33;80) 
We powered the study to detect a change from 40% to 60% because these estimates produced the 
largest sample size requirements.  
11.1 QUALITATIVE SAMPLE 
11.1.1 Providers 
Given the potential participation of group practices with large number of providers, a limit of 2 
providers per practice will be invited to participate in an individual interview.  Selection criteria 
will be applied to ensure an even distribution of providers based on number of vulnerable 

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patients within the practice and level of difficulty in providing care to individuals with social 
vulnerability. Further selection criteria (gender, language, years worked in primary care) will be 
applied to achieve a sample which is representative of providers. We anticipate 12-15 providers 
will be required to reach saturation.(81) Providers will continue to be recruited until response 
saturation has been achieved, likely 8-10 in Ottawa and 4-5 in Sudbury.  
11.1.2 Patients 
We will recruit approximately 35-40 patients to participate in an interview.  We will seek an 
even distribution of respondents by regions based on the number of participating practices in the 
region (see patient selection flow chart below).  For instance, we are expecting 8-10 practices to 
participate in the Ottawa region and between 4-5 in Greater Sudbury region, or a ratio of 2:1.  
Patient recruitment will follow this 2:1 ratio.   
Participants will be recruited from all study conditions; 1) those in the intervention group who 
contacted and utilized the Patient Navigator, 2) those in the intervention group who did not 
utilize the Patient Navigator, 3) those in the control group who utilize the 211 services, and 4) 
those in the control group who did not utilize the 211 services. Patients will also be purposefully 
selected to language of choice, and to represent both those who accessed a community resource 
and those who did not.  
Selection criteria will be applied at the regional level to ensure an even distribution of patients 
based on language and barriers to access (low to high number based on post-intervention patient 
survey). Further selection criteria (age, gender, the percentage of patients who accessed a CR 
during the study period ) will be applied to achieve a sample which is representative of patients 
who participated in the quantitative portion of the study (based on descriptive results from the 
surveys).  We will then recruit patients for interviews accordingly.  Recruitment will continue 
until saturation within each subgroup has been achieved.  
12 ETHICAL CONSIDERATIONS 
12.1 OBTAINING CONSENT 
12.1.1 Practice and provider consent 
Details of practice and provider recruitment are provided in section 8.1 Practice and Provider 
Recruitment.  
A diagram representing the different consent points is shown in Appendix: Q – Consent 
Pathways. Following the presentation delivered at the practice, if at least one PHCP is interested 
in participating in the study, the practice invitation letter and study information sheet and consent 
form (Appendix: D – Practice/Provider  Package) as well as selected promotional material will 
be left with the practice to be circulated by a person designated by the practice to all practice 
members (they see fit to invite), and encouraging individuals desiring more information will 
contact the study team. Those agreeing to participate will affix their signature on the consent 
form.  
12.1.1.1 Post intervention interviews 
At the end of the provider’s second survey (near the end of the intervention), some purposely 
selected providers will be invited to participate in the study interviews. Signed consent will be 
obtained at the time of the interview. 

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12.1.2 Patient consent 
The steps in the patient consenting pathway are depicted in Appendix: Q – Consent Pathways. In 
all practices, when the PHCP wishes to direct a patient to a community resource that could 
benefit them, and feels that the patient could benefit from navigation services, the PHCP and 
patient will have a discussion about the need for that resource and its potential benefit, introduce 
the ARC navigation study using a brief scripted explanation, and request the patient’s permission 
to provide their name to the study team so they can explain further what is involved.  
Patients consenting to be contacted by the research team, will receive a copy of the referral form 
required for the study and a study information and consent package. They will be told that a 
member of the research team will follow up with them with more information. The study 
information and consent package contains two copies of the Study Information Sheet and 
Consent Form (Appendix: E– Patient Information Sheets and Consent forms) as well as a 
stamped envelope addressed to the research study office.  
The referral form will be faxed to the research team or otherwise provided through a standard 
secure practice process to trigger the recruitment process. A research assistant will telephone 
patients, review the Study Information Sheet and Consent Form, and seek their verbal consent to 
participate in the study. The consent covers participating in the navigation service to which will 
be randomized, completing a telephone baseline and post intervention survey, and providing 
their OHIP # to allow it to be linked to health administrative databases (via ICES) to conduct 
analyses related to the study intervention. Agreeing to provide their OHIP # is not a requirement 
for participating in the study and receiving the navigation services. Patients will then also 
informed that approximately one in 10 patients will be invited to an interview at the end of the 
study period, and that if they were to be selected, their consent for that component of the study 
would be sought at that time. The research assistant then asks if this is an appropriate time to 
administer the baseline patient survey. If not, a separate meeting is scheduled for that. 
Consenting patients will be asked to sign the study consent forms and mail one copy to the 
research office using the stamped envelope. The consent form will separately indicate patients’ 
consent/non-consent for study participation and to have their OHIP# linked to health 
administrative databases. Following the baseline survey, the research assistant will enter the 
patient study information in a program provided by the statistician that will reveal the treatment 
allocation for that patient. 
12.1.2.1 Post intervention interviews 
Patients selected to participate in the post intervention interview will be identified during the 
post-intervention survey (3 months after recruitment) based, in part, on their response to that 
survey. These patients will be invited to participate in the interview at that time and the interview 
process will be explained. Consenting patients will be asked to sign separate consent form (see 
Appendix: E– Patient Information Sheets and Consent forms). Interviews will take place in 
person (preferably) or by telephone. Participants will be asked to sign signed separate consent 
form at the time of the face to face interview or provided with a consent form to complete and 
return by mail if the interview is done by telephone. 
12.2 PARTICIPANT COMPENSATION 
12.2.1 Practice/Providers 

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Some study related requirements may cost the practice time. These include the time spent by 
front staff requesting patient consent to be contacted by the study team or time spent by primary 
care providers to complete a survey. To offset the opportunity costs associated with the 
practices’ participation in this study, we offer $400 per practice, plus $200 per primary care 
provider (up to $800) (physician/nurse practitioner who refers patients) for their participation in 
the study.  
13 POTENTIAL RISKS AND BENEFITS 
13.1 RISKS 
13.1.1 Practices/Providers  
The participation in this study could be disruptive to practices and/or providers regular work 
flow as such resulting in potential physical or psychological risk (i.e., fatigue, stress). The study 
team will work collaboratively with practices and providers to define necessary research tasks, 
determine reasonable expectations, and minimize potential disruption to all. There is also 
potential for social risk whereas some providers within a participating practice who prefer not to 
participate may be viewed negatively by their peers, thus compromising their professional 
relationships or a provider may feel obligated to participate if they are part of a participating 
practice. A clear statement outlining such social risks is included in the letter of information and 
it is stated that employers/colleagues will not be made aware of who is participating and who is 
not.  
13.1.2 Patients 
There is minimal risk for patients involved in this study. There is the risk that patients’ personal 
identifying information and OHIP# used for study purposes could be accessed by unauthorized 
individuals. To mitigate against this risk, all reasonable steps will be taken to secure this data, 
including using a secure online database (SSL) that is maintained in Canada, encrypted and 
password protected, and only accessible to the Navigators/Coordinator assigned to the patient 
(personal identifying information, but not OHIP#) and study staff (personal identifying 
information and OHIP#). 
Completing the survey and participating in the interview can cause a burden to the patients.  To 
minimize this burden, we will conduct all surveys by telephone at a time of the patient’s 
choosing (removing the need for patients to complete the survey themselves and eliminating the 
need for further travel).  . Interaction with the Navigator or with the Ontario 211 services could 
cause unexpected stress potentially as social barriers are discussed or as the Navigator helps the 
patient learn how to navigate the system. The Navigator will take all possible steps to overcome 
such social barriers when assisting the patients to access the community resource which they 
were referred to. Ontario 211 is a publically available service that uses trained respondents.  
13.2 BENEFITS 
13.2.1 Practices/Providers:  
Participation could benefit the provider because they will learn about existing CRs that can help 
meet their patients’ needs, and this may allow them to provide more comprehensive care to their 
patients. Also, when their patients receive navigation services to access CR, they may be more 

Page 36 of 53 
December 27, 2017 
likely to utilize these services and this may result in reduced number of visits or duration of visits 
time with their PHCP provider for concerns that may be addressed by these resources.  
Patients who participate in the study may be more resourceful at identifying and accessing 
services that they need, thereby potentially reducing the level of support required for them by the 
practice members.  
13.2.2 Patients 
All patients may benefit from participation by learning through Ontario 211 or the patient 
navigator about CRs available to them to address their primary health care needs and may be 
more likely to use them, thereby reducing unmet needs. Patients randomized to the intervention 
arm, the Patient Navigator, may receive additional support to address social barriers, which we 
postulate will increase their ability to utilize the necessary CRs.  
14 PRIVACY AND SECURITY OF STUDY DATA 
All data collected will be securely stored in the study database using all reasonable protection 
steps (encryption, secure network, limited access, password protection). Only members of the 
study team will have access to the entire dataset.  For the purpose of analyses, all data will be 
stripped of the respondent’s (practice, provider, and patient) identifiable information and will be 
identified by an undecipherable study code.  A separate Microsoft Access database will be used 
to track patient participation (e.g., completion of study activities) and allow the participants’ 
study code to be linked to their information for the purpose of communication between the 
research team and study participants. This tracking database will be password protected and will 
be stored securely and separately from the study data. 
Information on the referral form will be securely transmitted from the practice to the research 
team. The current plan is for communication between the research team and the practice to take 
place through fax. The research team will use a fax number dedicated to the study, and store the 
fax machine securely in a locked filing cabinet. Only members of the research team will have 
access to these documents. The Research Assistant will enter the information provided on the 
faxed referral form and patients’ OHIP # with specific consent electronically in the tracking 
database containing identifiable patient information and a corresponding patient ID.  
Should a participating practice chose a different method of communicating patient information 
with the research team, we will ensure that the approach meets the TCPS-2 privacy 
confidentiality requirements.  
Qualitative study data will be audiotaped and transcribed verbatim with consent, and transcripts 
will be securely stored in locked filing cabinets and/or on a password-protected, encrypted server 
in the investigator’s office at the Bruyère Research Institute or at Laurentian University.  Data 
collected in the Sudbury region will be stored on a secure server maintains and backed up by the 
IT department at Laurentian University conforming to industry standards for security. Data 
sharing between the Sudbury and Chaplain regions will be conducted using secure methods. 
Patient survey data will be securely transmitted to a secure, encrypted, password-protected online 
database. The server for this database (https://www.qualtrics.com/) is maintained in Canada and 
conforms to industry standards for security (https://www.qualtrics.com/security-statement/). The 
flow of data from the patient-provider encounter to the study personnel, storage of data, and 
transfer of data from study to the Institute of Clinical and Evaluative Sciences (ICES) for linking 

Page 37 of 53 
December 27, 2017 
to health administrative data will be performed according to ICES procedures. ICES applies a 
variety of measures to protect the information entrusted to it. Physical security measures, 
technological safeguards like encryption and a robust framework of policies and procedures 
work together to protect information. 
These data are securely held in encoded form and analyzed at the Institute for Clinical Evaluative 
Sciences (ICES, www.ices.on.ca). All relevant datasets were linked using unique, encoded 
identifiers and analyzed at ICES.  
The Institute for Clinical Evaluative Sciences (ICES) is an independent, not-for-profit research 
institute funded by an annual grant from the Ontario Ministry of Health and Long-Term Care 
(MOHLTC). The opinions, results and conclusions reported in this paper are those of the authors 
and are independent from the funding sources. No endorsement by ICES or the Ontario 
MOHLTC is intended or should be inferred. 
15 RESEARCH TEAM 
 
The team is composed of a good mix of senior and junior researchers with expertise in health 
service delivery and equity in primary care (Dahrouge), project management, teamwork and 
collaboration (Chiocchio), rural and northern health (Gauthier), access to French health care 
services and equity (Lemonde), chronic diseases, women’s health and health of Francophone 
populations living in a minority situation (Prud’homme). 
 
Simone Dahrouge, PhD (Nominated-PI) is the Director of the C.T. Lamont Primary Health 
Care Research Centre, the research arm of the Department of Family Medicine for the University 
of Ottawa. Dr. Dahrouge’s work focuses on optimizing equity and access to primary care, and 
understanding the impact of interventions in primary care reform on quality of care and patient 
outcomes. Dr. Dahrouge is an Adjunct Scientist with the Institute of Clinical Evaluative Sciences 
(Primary Care and Population Health Research Program) and will lead all analyses related to 
health administrative data.  
 
François Chiocchio, PhD (Co-Principal Investigator) 
François Chiocchio is Professor of Organisational Behaviour and Human Resource Management 
at University of Ottawa's Telfer School of Management. His research focuses on projects, 
teamwork, and collaboration in various organizational environments, including health care 
organizations in Canada and Africa. A measure and assessment specialist, he developed several 
instruments for selection purposes or that provide feedback on competency development; work 
for which he was praised with national (i.e., Canada) and provincial (i.e., Québec) awards. Dr. 
Chiocchio is one of the only academics specialized in industrial-organizational psychology 
certified as a Project Management Professional by the Project Management Institute and as a 
Certified Human Resources Professional (CHRP) by the Canadian Council of Human Resources 
Associations. 
 
Alain Gauthier, PhD (Co-Principal Investigator) 
Alain Gauthier is an Associate Professor with the School of Human Kinetics and Faculty 
Investigator at the Centre for Rural and Northern Health Research (CRaNHR) at Laurentian 
University. Dr. Gauthier is primarily interested in research related to the health of 

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December 27, 2017 
sociolinguistic minorities, with a particular emphasis on rural and northern areas. He currently 
leads the Francophones Health research program at CRaNHR related to the access to, and quality 
of, French Language Health Services for persons residing in northern Ontario. He is a member 
of the Board of Directors of the Centre de santé communautaire du Grand Sudbury and of the 
Club Richelieu Les Patriotes du Sudbury. 
 
Justin Presseau, PhD (Investigator) 
Dr. Presseau is a Scientist and health psychologist at the Ottawa Hospital Research Institute and 
Assistant Professor in the School of Epidemiology, Public Health and Preventive Medicine at the 
University of Ottawa. His research draws upon theories and approaches from health psychology 
and behavioural medicine to develop and evaluate interventions focused on changing healthcare 
professional behaviours and health behaviours of patients and the public. He has expertise in the 
use of theories of behaviour and behaviour change to inform the development and evaluation of 
interventions designed to change the behaviour of healthcare professionals, patients and the 
public. 
 
Manon Lemonde, RN, PhD (Investigator) 
Manon Lemonde is an Associate Professor in the Faculty of Health Sciences, at the University of 
Ontario Institute of Technology (UOIT). She is also an Instructor at Laurentian University in 
Sudbury. Dr. Lemonde’s research areas of specialty include chronic disease management and 
seniors’ health. She is investigating how francophone seniors are able to access French health-
care services in Ontario, as well as the barriers and facilitators for obtaining these services. She is 
also investigating self-management options for seniors dealing with chronic diseases.  
 
Claire Kendall, MD, PhD (Investigator) 
Dr. Claire Kendall is an Associate Professor with the Department of Family Medicine, 
University of Ottawa; Clinician Investigator at the C.T. Lamont Primary Health Care Research 
Centre, Bruyère Research Institute; and practicing family physician with the Bruyère Family 
Health Team. She is an Adjunct Scientist at the Institute for Clinical Evaluative Sciences 
(ICES) and in the Clinical Epidemiology Program at The Ottawa Hospital Research Institute. 
Dr. Kendall has established a program of research aimed at improving the delivery of primary 
health care for populations with or at risk for HIV. Dr. Kendall is Principal Investigator on the 
Participatory Research in Ottawa: Understanding Drug Use (the PROUD) study, a community-
based participatory research cohort study which aims to prioritize community engagement and 
involvement in understanding HIV risk among people who use drugs in Ottawa. Her research 
relies on multiple methodologies, including secondary analysis of the health administrative 
data held at ICES, primary collected cohort survey data, qualitative methods, and the 
meaningful involvement of patients and people with lived experience. 
 
Rose-Ann Devlin, PhD (Investigator) 
Earning her Ph.D. in economics from the University of Toronto, Rose Anne Devlin has been a 
professor in the Department of Economics, University of Ottawa, since 1991. Dr. Devlin is 
currently the vice-dean of research for the Faculty of Social Sciences. Professor Devlin has 
published work on a broad range of topics, including: the incentive effects of physician 
remuneration schemes, the structure of primary-care practices (including decisions to 
collaborate with other health-care professionals), and how supplemental insurance affects 

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December 27, 2017 
health care usage. Recently, she has been working on issues associated with accessing regular 
primary care physicians and the role of social supports. 
 
Denis Prud’homme, MD, MSc (Investigator) 
Denis Prud’homme is the Associate vice-president Research and the Scientific director of the 
Institut de recherche de l’Hôpital Montfort. He obtained a medical degree and a Specialist’s 
Certificate in Family Medicine as well as a bachelor degree in kinesiology and a master degree in 
exercise physiology at Laval University. He is a Full Professor at the School of Human Kinetics 
and he was Dean of the Faculty of Health Sciences from 2002 to 2012. He is also an active 
clinician at the Sports Medicine Clinic Outaouais. Dr. Prud’homme is involved in research on the 
effects of exercise in patients with health problems such as obesity, diabetes, and metabolic 
syndrome. 
 
Monica Taljaard, PhD (Investigator) 
Dr. Taljaard is a Senior Scientist with the Clinical Epidemiology Program, Ottawa Hospital 
Research Institute and an Associate Professor in Epidemiology and Community Medicine at the 
University of Ottawa. Dr. Taljaard is biostatistician and member of the Ottawa Methods Center, 
where she works with researchers and clinicians from a variety of backgrounds to design and 
analyze cluster randomized trials, standard clinical trials, and observational studies. She has co-
authored more than 100 publications in peer-reviewed journals and more than 100 research 
presentations at national and international conferences. Dr. Taljaard has established successful 
and productive collaborations with many clinicians and scientists and she has been a co-
applicant, statistical advisor and collaborator on over 50 funded clinical and health services 
research projects.  
16 RELEVANCE 
This project is grounded in primary care, the foundational pillar of our healthcare system, a 
sector that is arguably the most efficient at achieving population health and reducing disparities. 
(31) It builds on existing provincial investments (211, CRs, the Healthline) and aligns with 
upcoming primary care reforms which are anticipated to promote a better integration between 
primary care and CRs. It is patient centered and directly addresses three Ministry and Long Term 
Care’s 2015 strategic objectives: Access to the right care, Integration and coordination of 
community care, and supporting patients achieve health goals through information and 
education. (34-36;39;82;83)  
The program will assess the implementation and subsequent use of a Francophone navigation 
strategy to optimize access to care received by Francophone living in minority situations. It will 
support Franco-Ontarians overcome barriers to care across the various access dimensions. 
Finally, it will also provide a better understanding of the gaps in resources serving the 
Francophone population.  
The results of this project will also support decision makers regarding the objectives cited in the 
recent Price report(9), specifically the objectives 18 and 19 regarding “System Collaboration, 
Coordination and Scale Economies”. 
 
 

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December 27, 2017 
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of their physician resulted in increased colon cancer screening referrals. World J 
Gastrointest Oncol 2014 Jul 15;6(7):257-62. 
 (81)  Guest G, Bunce A, Johnson L. How Many Interviews Are Enough? Field Methods 2006 
Feb 1;18(1):59-82. 
 (82)  Ontario Ministry of Health and Long-Term Care. Patients First: Action Plan for Health 
Care.  2015.  
 (83)  Pearson TA, Lewis C, Wall S, Jenkins PL, Nafziger A, Weinehall L. Dissecting the 
"black box" of community intervention: background and rationale. [Review] [40 refs]. 
Scandinavian Journal of Public Health Supplement 2001;56:5-12. 
 (84)  Mayer MK, Urlaub DM, Guzman-Corrales LM, Kowitt SD, Shea CM, Fisher EB. 
"They're Doing Something That Actually No One Else Can Do": A Qualitative Study of 
Peer Support and Primary Care Integration. J Ambul Care Manage 2016 Jan;39(1):76-86. 
 (85)  Kangovi S, Grande D, Carter T, Barg FK, Rogers M, Glanz K, et al. The use of 
participatory action research to design a patient-centered community health worker care 
transitions intervention. Healthc (Amst) 2014 Jul;2(2):136-44. 
 (86)  Calhoun EA, Whitley EM, Esparza A, Ness E, Greene A, Garcia R, et al. A National 
Patient Navigator Training Program. Health Promot Pract 2010 Mar 1;11(2):205-15. 
 (87)  Najafizada SA, Bourgeault IL, Labonte R, Packer C, Torres S. Community health 
workers in Canada and other high-income countries: A scoping review and research gaps. 
Can J Public Health 2015;106(3):157-64. 
 (88)  Ustjanauskas AE, Bredice M, Nuhaily S, Kath L, Wells KJ. Training in Patient 
Navigation: A Review of the Research Literature. Health Promot Pract 2015 Dec 8. 

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 (89)  Howard MB, Freund KM, Battaglia TA. Caseload for patient navigation: What is keeping 
navigators busy? Cancer Epidemiol Biomarkers Prev 19[Suppl 10], A26. 2010.  
Ref Type: Abstract 
 
 
ADDITIONAL INFORMATION 
3. ADDITIONAL INFORMATION: 1 CHAMPLAIN ADVISORY COMMITTEE 
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Additional Info 1 - Champlain Advisory Committee 
4. ADDITIONAL INFORMATION: 2 EXAMPLES OF HEALTH RELATED RESOURCES  
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Additional Info 2 – Examples of Health Related Resources 
5. ADDITIONAL INFORMATION: 3 EXAMPLES OF SOCIAL RESOURCES  
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Appendices\Additional Information 
Additional Info 3-Examples of Social Resources 
6. ADDITIONAL INFORMATION: 4 ACCESS FRAMEWORK  
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Additional Info 4-Conceptual framework of access to health care 
7. ADDITIONAL INFORMATION: 5 NAVIGATOR FRAMEWORK 
S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
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Additional Info 5-Navigator Framework 
8. ADDITIONAL INFORMATION: 6 – INSTRUCTIONAL INFORMATION 
S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Additional Information 
Additional Info 6A - English RCT Study Process (2017-Dec-28) 
Additional Info 6B – English ARC Referral Form RCT video (2017-Dec-27) 
https://www.powtoon.com/online-presentation/fUFWyTAINPD/rct-arc-referral-form/?mode=movie 

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9. ADDITIONAL INFORMATION: 7 – PROFILE AND QUALIFICATIONS OF THE 
NAVIGATOR 
Lay navigators will be recruited based on their language skills, interpersonal skills, ability to 
adapt to different situations as well as their personal experience or knowledge of a) navigating 
the health care system or community resources, b) overcoming social barriers, and/or c) living 
with and effectively managing health conditions, so as to reflect the primary care population that 
they will work with. (41;84) Bilingual Navigators will be selected, recognizing the importance of 
shared culture and language on optimizing access to community based services for Franco-
Ontarian primary care patients. No previous health professional experience is required of the 
navigators.  
Navigators will complete a period of training organized by the research team to develop the 
knowledge, skills and abilities to assist patients with social complexities identify appropriate 
community resources and support them in overcoming barriers to adequate access. This training 
program was successfully piloted during the Feasibility study. 
The training curriculum for the navigators is based on the literature and similar evidence-
informed navigator training programs including the Colorado Patient Navigator Training 
Collaborative, Individualized Management for Patient-Centered Targets (IMPaCT) Training 
Manual (85) and the McMaster University Health TAPESTRY Health Connector Training 
Program (http://healthtapestry.ca). The core training content includes the principles and scope of 
navigation (communication, cultural competency, developing trust relationships), identifying 
patient goals and prioritizing, overcoming barriers to care (e.g. financial, transportation), 
providing psychosocial support, empowering patients to participate in wellness behaviours, self-
management, and health promotion; record-keeping, and working as a member of a primary care 
team. Participants will gain knowledge about, and practice in navigating community resources 
and services for the priority health programs targeted by ARC: mental health, healthy living, 
chronic disease management, and seniors’ health. This may evolve depending on the health 
programs identified as most pertinent to the primary care practices’ in the study.  
Three training formats will be used to address the scope and complexity of the navigation role: 
online learning, face-to-face sessions, and community mentorship to support navigators as they 
carry out their role. Online modules and learning resources including a discussion board and a 
reflective workbook are housed on a Patient Navigator Training website for the project. This 
format and related content will be guided by adult learning theory and leverage collaboration 
among navigators to enable them to act as a resource for each other in their navigation role. 
(85;86) The training is consistent with the literature which identifies that navigators are trained 
for specific roles and services in the community, most commonly by the organizations that hire 
them. (41;87;88) 
Several relevant organizations and their staff will be engaged to participate in the training of 
navigators based on their expertise with information and referral to community services, self-
management support, and/or providing culturally competent care. These organizations include, 
but are not limited to the following: navigation tools (e.g. 211-finding community resources), 
Active Offer (e.g. Le Réseau des services de santé en francais Somerset West Community Health 
Centre Multicultural Health Navigators (learning from experienced navigators),  social workers 

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December 27, 2017 
from Community Health Centres/Family Health Teams (identifying and addressing social 
barriers to health); self-management programs, motivational interviewing); and mental health 
services (e.g. Royal Ottawa Mental Health Centre and Montfort Renaissance (peer support for 
mental health and addictions).  
10. ADDITIONAL INFORMATION: 8 – ROLE AND ACTIVITIES OF THE NAVIGATOR 
Navigators will support patients to access community based resources for healthy living and self-
management, rather than providing specific information about health issues.(41;43) Navigators 
will empower patients to seek and use community resources by teaching them how to identify 
available and relevant programs to meet their health-related goals, in their language of choice. 
Navigators may also provide social support, , arrange appointments or accompaniment to 
resources, assist with completing forms, explain the purpose and components of community 
programs, and advocate on patients’ behalf to support access to resources.  
The Navigator will meet patients at the primary care practice or in a location acceptable to the 
practice and patient (e.g. community health centre) or by telephone.  
 
At the initial encounter:  
o The navigator will ensure that the individual understands the reason for referral, 
potential benefits, and what is involved to participate in the resource(s) to which 
they were referred  
o Discuss social barriers potentially affecting patients’ access to community health 
resources  
o Assist patients to prioritize their health goals and relevant resources to achieve 
these 
 
The navigator will then assist patients to access the community-based services in the 
language of their choice to which they have been referred. The navigator may assist the 
patient in making appointments, coordinating transportation, and/or accompaniment to 
resources as required). 
The navigator will work with the practices to  
 
Optimize communication and understanding between providers and patients by 
demonstrating linguistic sensitivity, interpreting cultural norms, roles or beliefs that may 
affect their understanding of needed care, and seeking of resources 
 
Document patient encounters, maintain accurate and complete records of navigation 
services provided   
 
Provide information and feedback to facilitate informational continuity between primary 
care providers and patients 
These activities are based upon previously defined functional domains of patient navigation, (43)  
online repositories of patient navigator job descriptions, and detailed manuals for implementing 
community health workers within community settings. Navigators will not be involved in 
activities that are clinically oriented, such as promoting medication adherence, referring to 
treatment or specialist services, or providing individuals with coping strategies to manage their 
illness or disease. In these situations the Navigator will inform the  the primary care provider 
about the patient’s health care needs.  
All navigators will have access to their peer Navigators, and/or the Navigation Coordinator for 
debriefing about their interactions with patients, learning, and for social support for their 

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December 27, 2017 
navigation role. Patients with very complex needs and those requiring activities beyond the scope 
of the Navigator, will be referred to their primary care physician for follow-up. In the Champlain 
region, the Executive Director of the Somerset West Community Health Centre has agreed to 
support the ARC project by providing access to peer support for Navigators and space for 
Navigators to meet with each other, and with patients if needed. Navigators may be able to refer 
patients with complex needs for other CHC services as appropriate and upon agreement by their 
primary care provider (see Appendix: R – Statement of Relationship with SWCHC). Similar 
support will be sought from the CHC in Sudbury within the North East LHIN. 
The Navigators will also be invited to act as co-researchers throughout the study. All Navigators 
will be supplied with a series of self-reflection questions in relation to their experience and will 
be asked to keep a weekly journal of their activities. The Navigators, with selected members of 
the research team, will be invited to co-author a manuscript based on their firsthand account of 
their experience.   
Patients assigned to the intervention arm will be offered the services of the Navigator. Patients 
that accept the services will be scheduled to meet with the Navigator by telephone or in person 
on at a time and place (e.g., at their practice, at a CHC) that is most convenient for them. They 
will meet with the Navigator for up to one hour to allow sufficient time to establish rapport, 
identify potential barriers, and set patient-led priorities.  
It is expected that patients’ needs will vary, and some patients will receive sufficient support 
during the initial encounter, while others may require multiple contacts. Patients will be able to 
access the Navigator after the initial meeting, by phone or in-person, to address any relevant 
questions or issues arising from the referral to the community resource. If required, subsequent 
meetings will be scheduled for 30 minutes. As the potential caseload for a navigator varies 
considerably depending on the extent of their roles and responsibilities, (89) we anticipate that 
the Navigator will have time-limited contact with each patient, that ends three months from the 
initial meeting, or when access to the appropriate resource is achieved, whichever comes first. 
The Navigator will follow-up with patients by phone within the 1-2 weeks following their 
meeting where recommendations were made so as to assess community resource utilization and 
address barriers encountered. 
Patients that meet with the Navigator may identify additional needs and/or resources of interest 
that were not indicated by their PHCP on the referral form (Appendix: A – Draft Referral Form). 
Consent will be obtained from participating PHCPs (see Appendix: D—Practice/Provider 
Recruitment Package) to allow the Navigator to support patients access resources that they did 
not recommend. The Navigator can support the patient access services that can help address 
additional needs, unless these are of a medical nature. Patients that identify health needs that are 
clinically relevant and fall outside the Navigator’s scope of practice cannot be addressed by the 
Navigator. The Navigator will follow-up with PHCPs after the initial encounter with the patient 
to inform the PHCP of the patient’s priority needs and resources identified. Any additional need 
identified by the patient, including those that can and cannot be addressed by the Navigator, will 
be shared with their PHCP.    

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APPENDICES 
 
11. APPENDIX: A – DRAFT REFERRAL FORM 
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Appendix A1 - English ARC Referral Form RCT (2017-Dec-11) 
12. APPENDIX: B – PROMOTIONAL MATERIAL 
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Appendices\Appendices\Appendix B-Promotional Material 
Appendix B1 - ARC Bilingual Promotional Poster (2017-Dec-22) 
Appendix B2 - ARC RCT English Promotional Video (2017-Dec-21): 
https://www.powtoon.com/online-presentation/dQWHRiqDLTZ/rct-promotional-video/  
13. APPENDIX: C – NAVIGATOR FEEDBACK FORM 
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Appendix C - English ARC Navigator Feedback Form 
14. APPENDIX: D – PRACTICE/PROVIDER RECRUITMENT PACKAGE 
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Appendices\Appendices\Appendix D-Practice_Provider Recruitment Package 
Appendix D1 - English Practice Invitation letter (2017-Dec-12) 
Appendix D2 – English Practice and Provider Information and Consent Form (2017-Dec-12)  
Appendix D3 - English Provider Information and Consent Form- Interview - (2017-Dec-12) 
Appendix D4 - English Practice Reminder Email (2017-Dec-12) 
Appendix D5 - English Practice Reminder Phone Call (2017-Nov-21) 
Appendix D6 – English Information Brochure (2017-Dec-27) 
Appendix D7 – English Navigation Services (2017-Mar-20) 
Appendix D8 – English Letter to Champion (2017-Dec-12)  
15. APPENDIX: E– PATIENT INFORMATION SHEETS AND CONSENT FORMS 

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S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Appendices\Appendix E-Patient Information and Consent Forms 
Appendix E1 – English Participant Information Consent Form (2017-Dec-27) 
Appendix E2 - English Participant Interview Consent Form (2017-Dec-27) 
Appendix E3 - English Patient Instructions (2017-Nov-10) 
16. APPENDIX: F – STUDY TIMELINE  
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Appendix F – Study Timeline (2017-Dec-27) 
17. APPENDIX: G – PRACTICE SURVEY  
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Appendices\Appendices\Appendix G-Practice Survey 
Appendix H – English Practice Survey _Baseline only (2017-Dec-27) 
18. APPENDIX: H – PROVIDER SURVEY 
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Appendix H - English Practitioner Survey (2017-Dec-27) 
19. APPENDIX: I – PATIENT SURVEY 
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Appendices\Appendices\Appendix I - Patient Survey Appendix I - English Patient Survey (2017-
Dec-27) 
20. APPENDIX: J – NAVIGATOR TRAINING ASSESSMENT 
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Appendix J - English Navigator Training Assessment (2017-Mar-20) 
21. APPENDIX: K – RAPID CYCLE EVALUATION  
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Appendix K - English Rapid Cycle Evaluation (2017-Dec-27) 
22. APPENDIX: L – PROVIDER QUALITATIVE THEMES 

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S:\CTLC-Investigators\Dahrouge\2. Projects\1.2 ARC RCT\1. Protocol and 
Appendices\Appendices\Appendix L-Provider Interview Guide  
Appendix L – English Provider Interview Guide (2017-Dec-27) 
23. APPENDIX: M – PATIENT QUALITATIVE THEMES 
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Appendix M – English Patient Interview Guide (2017-Nov-16)  
24. APPENDIX: N – NAVIGATOR QUALITATIVE ASSESSMENT  
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Appendix N – English Navigator Interview (2017-Nov-16) 
25. APPENDIX: O – PRACTICE SET UP LOG 
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Appendix P - Practice Set-Up Log (2017-Dec-27) 
26. APPENDIX: P – NAVIGATOR LOG 
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Appendix P - Navigator Log (2017-Nov-23) 
27. APPENDIX: Q – CONSENT PATHWAYS 
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Appendix Q - Consent Pathways RCT (2017-Dec-27)  
28. APPENDIX: R– STATEMENT OF RELATIONSHIP WITH SWCHC 
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Appendix R – Statement of Relationship with SWCHC (2017-May-18)