Patient Navigation in Primary Care and Access to Resources in the Community (ARC)

October 14, 2020 updated by: Ottawa Hospital Research Institute

Patient Navigation in Primary Care and Access to Resources in the Community - A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. The investigators 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 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. 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. 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.

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.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C7
        • Bruyere Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

There are 3 levels of participation in this study: primary care practices, primary care providers, and primary care patients.

1) Primary care practices

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • None

Primary care patients:

Inclusion criteria:

  • 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)

Exclusion criteria:

  • Unable to provide consent and does not have a family member/guardian who can provide proxy consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control (211 services)
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.
Experimental: Intervention (Patient Navigator)
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Access to Community Resources
Time Frame: Three months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ability of the intervention to address equity
Time Frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Patient sociodemographic characteristics captured in the baseline survey (e.g. income, language, sex, age, immigration status) will be used to evaluate the intervention's success in supporting patients access the desired resource (main outcome variable) across various social strata.
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
Time Frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section B in patient survey - related to ability to pay
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
Time Frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section B in patient survey - related to relationship with providers
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
Time Frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section C in the patient survey, one scale (including three concepts)
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
Time Frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section F in patient survey
Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Health Action Process Approach
Time Frame: Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section L in the patient survey - related to self efficacy and behaviour change
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Patient Activation Measure
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Section M of patient survey - related to knowledge, confidence, and motivation to access services
Baseline(i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Community service evaluation
Time Frame: Assessed after the three month patient intervention period.
Section O in Patient Survey: used to evaluate whether the community service(s) were appropriate for the needs of the patient
Assessed after the three month patient intervention period.
Navigator Assessment (intervention arm only)
Time Frame: Assessed after the three month patient intervention period.
An assessment of the Patient Navigator service received by patients in the intervention arm
Assessed after the three month patient intervention period.
Attitudes with reference to vulnerable populations
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
An assessment of primary care providers attitudes with reference to socially vulnerable populations
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Practices with reference to vulnerable populations
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
An assessment of primary care providers practices with reference to socially vulnerable populations
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Knowledge with reference to vulnerable populations
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
An assessment of primary care providers' Knowledge with reference to socially vulnerable populations
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Contextual factors (e.g., organizational structure)
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
An assessment of the organization's (primary care organizations) organizational structure (section B of Provider survey)
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change valence
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Section C of the provider survey
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change Climate
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Section D of the provider survey
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Organizational readiness for change
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Section E of Provider Survey; An assessment of the organization's readiness to implement the navigator intervention
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Implementation effectiveness
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Section F of Provider SurveyAn assessment of the effectiveness of the navigator intervention within the primary care practice
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Experience with the Navigator
Time Frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Section G of Provider Survey; An assessment of the providers' experience with the patient navigator, and how the intervention has affected their practice
Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Ontario Ministry of Health and Long Term Care
Laurentian University
Bruyere Research Institute
University of Ontario Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simone Dahrouge, PhD, Bruyere Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20171215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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