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

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ClinicalTrials.gov Identifier: NCT03451552
Recruitment Status : Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborators:
University of Ottawa
University of Ontario Institute of Technology
Laurentian University
Bruyere Research Institute
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Health Care Inequity, Patient Navigation Behavioral: Patient Navigator Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Patient Navigation in Primary Care and Access to Resources in the Community - A Randomized Controlled Trial
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451552


Contacts
Contact: Simone Dahrouge, PhD 1-613-562-6262 ext 2913 sdahrouge@bruyere.org
Contact: Andrea Perna, PhD 1-613-562-6262 ext 2920 aperna@bruyere.org

Sponsors and Collaborators
Ottawa Hospital Research Institute
University of Ottawa
University of Ontario Institute of Technology
Laurentian University
Bruyere Research Institute
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Simone Dahrouge, PhD Bruyere Research Institute
  Study Documents (Full-Text)

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03451552     History of Changes
Other Study ID Numbers: 20171215
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
Community Resources, Patient Navigator