Patient Navigation in Primary Care and Access to Resources in the Community

NCT03451552 | Completed

• 1 other identifier: 20171215
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Care Inequity, Patient Navigation

Keywords

Community Resources, Patient Navigator

Outcome Measures

Primary Outcomes (1)

• Access to Community Resources

  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 community resource. We will assess this outcome in both arms (control and intervention) three months after enrolment in the study through a patient survey. The outcome will be a count of the CRs accessed (as a patient may access more than one CR).

  Three months

Secondary Outcomes (18)

• Ability of the intervention to address equity

  Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period

• Needs/Difficulties

  Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period

• Use of Healthcare

  Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period

• Ability to engage

  Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period

• Quality of Life VR-12

  Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period

Study Arms (2)

Control (211 services)

NO INTERVENTION

Patients allocated to the control arm will be directed to the Ontario 211 navigation service, which is already available to the general public free of charge. After consenting to participate in the study and completing the telephone survey, the research assistant will inform these patients that they can use existing navigation services provided by Ontario 211 to help them access the CR referred to them by their PHCP. The research assistant will instruct patients to dial 2-1-1 to obtain additional information on the nature of this service.

Intervention (Patient Navigator)

EXPERIMENTAL

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.

Behavioral: Patient Navigator

Interventions

Patient Navigator BEHAVIORAL

Navigators will support patients to access community based resources for healthy living and self-management, rather than providing specific information about health issues. Navigators will teach patients how to identify available and relevant programs to meet their health-related goals, in their language of choice. The navigator will ensure that the individual understands the reason for referral and potential benefits. They will discuss social barriers potentially affecting patients' access to community health resources, and 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).

Intervention (Patient Navigator)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any practice providing comprehensive primary care services (i.e. excludes practices that provide walk in services only), except for Community Health Centres. 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 listed 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

You may not qualify if:

• 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
• Primary care providers:
• 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.
• None
• Primary care patients:
• 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.
• 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)
• Unable to provide consent and does not have a family member/guardian who can provide proxy consent

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator
• University of Ontario Institute of Technology: collaborator
• Laurentian University: collaborator
• Bruyère Health Research Institute.: collaborator
• Ontario Ministry of Health and Long Term Care: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Bruyere Research Institute

Ottawa, Ontario, K1N 5C7, Canada

Location

Related Publications (1)

• Saluja K, Mahbub A, Gauthier AP, Lemonde M, Timony P, Durand F, Dahrouge S. Understanding patient barriers and enablers to accessing community resources: a qualitative study to inform navigation service delivery. BMC Prim Care. 2025 Oct 24;26(1):322. doi: 10.1186/s12875-025-03029-z.

  PMID: 41136927 DERIVED

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Simone Dahrouge, PhD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in the study.The participant, their primary care provider, and the study team will know which arm the patient is in.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 mixed method design is a sequential, explanatory design. 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. 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.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: March 1, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)