NCT03105635

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 will be recruited. All offices will receive training on referring patients to community resources, and half of these (intervention) will have a Navigator assigned to the practice. This study will assess whether access to a Navigator increases patients' access to community social and health services. In addition, the study aims to understand whether English and French speaking individuals are as likely to benefit from a Navigator in accessing community health and social services in the language of their choice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

April 4, 2017

Last Update Submit

March 8, 2021

Conditions

Keywords

Community ResourcesHealth Navigator

Outcome Measures

Primary Outcomes (1)

  • Active Patient Utilization

    Number of community resources utilized amongst patients who could have referred during that 12 months period. Therefore, it is the number of community resources utilized by practice patients that have had a visit to the practice during the 12 months recruitment period in the practice Total # of services utilized

    12 month

Secondary Outcomes (10)

  • Referrals

    12 month

  • First Contact Access

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

  • Needs/Difficulties/Use of healthcare

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

  • Health care experienced

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

  • Quality of Life VR12

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

  • +5 more secondary outcomes

Study Arms (2)

Patients

OTHER

Participating primary care providers will be encouraged to refer their patients who could benefit from community resources to these services. They will complete the study referral form for all patients referred to a resource. They will briefly mention the study to patients who are referred to a community resource, and ask for their verbal consent to be contacted by a member of the research team to learn more about the study, and leave a "patient recruitment package" with them.

Other: Mixed method feasibility study

Practice and Provider

OTHER

Four to six practices will be recruited to participate in this feasibility study. Primary care members working in a participating practice will be invited to participate in the study. All primary care providers will be encouraged to participate and at least one primary care provider is required to participate to include the practice in the study. After the obtaining an interest from a practice member to whom the invitation email was sent, we will offer all practice members eligible for the study an information session during which the study is described and participation offered. The practice manager or lead will be provided with the Practice Information and Consent Form

Other: Mixed method feasibility study

Interventions

Participating practices will receive the following: 1. Training on community resources : An orientation regarding the availability of the local community health and social resources, and the existing navigation services that can support individuals identify the appropriate resource. 2. Facilitation to enhance referrals: help support practices to make the desired adaptations to enhance referrals 3. Promotional material to engagement patients: Practices will provide an area in the waiting room where promotional material on the benefit and availability of community resources will be displayed. 4. Navigator: The services of a Navigator

PatientsPractice and Provider

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care practices:
  • Four to six practices will be recruited to participate in this feasibility study.The eligibility criteria are:
  • A primary care practice, other than Community Health Centre, is eligible regardless of the type of model to which it belongs (Solo, groupe based (Family Health Groups, Family Health Networks, Family Health Organizations), and interprofessional teambased (Family Health Teams)
  • Having at least one primary care provider agreeing to participate in the study Primary care members Primary care members working in a participating practice will be invited to participate in the study.
  • Members are eligible if they can refer practice patients to community resources or staff members who can be involved in the referral process (including nurses, allied health professionals (e.g. social workers), and front desk staff).
  • For the purpose of simplicity all these are referred to as primary care providers in the document
  • Patients:
  • Primary care patients participating in the intervention are eligible to participate if the following criteria are met:
  • Patient identifies a primary care provider participating in the study as their main primary care provider
  • Has received a recommendation for a community resource from their primary care provider during a primary care encounter
  • Is able to communicate in English or French, or is willing to be served via a cultural interpreter.
  • Patient agrees to participate in the study (18 years of age or older), or has parental/guardian proxy consent to participate in the study (minor patients, patients with cognitive deficits rendering them unable to provide consent, or patients unable to adequately understand French or English to provide informed consent and unable/unwilling to use the services of a translator).

You may not qualify if:

  • Primary care practices:
  • A Community Health Centre
  • Practices that are not part of a reform model
  • Patients:
  • Patient has cognitive limitation that would not permit them to give consent and does not have a family member/guardian who can provide proxy consent There are no age, language or other requirements for patient eligibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Ottawa Nepean Family Health Organization

Ottawa, Ontario, K2G 4B5, Canada

Location

Related Publications (1)

  • Dahrouge S, Gauthier A, Chiocchio F, Presseau J, Kendall C, Lemonde M, Chomienne MH, Perna A, Toal-Sullivan D, Devlin RA, Timony P, Prud'homme D. Access to Resources in the Community Through Navigation: Protocol for a Mixed-Methods Feasibility Study. JMIR Res Protoc. 2019 Jan 24;8(1):e11022. doi: 10.2196/11022.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants are patients Care providers are practices
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

April 18, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations