ARC -Access to Resources in the Community

March 8, 2021 updated by: Ottawa Hospital Research Institute

ARC - Access to Resources in the Community/Acces Aux Ressources Communautaires

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.

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

This project brings together two funding partners. The first, 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 resources and how these can be overcome.

The second funding partner is the Ontario Ministry of Health and Long Term Care, through the Ontario SPOR Support Unit, in support of the Working Group on Ontario's Francophone Communities. This funding support aims specifically at addressing the access needs for Ontario Francophones living in minority situations.

These two initiatives now form the Access to Resources in the Community/Accès aux Resources Communautaires (ARC) project. ARC builds upon previous activities of the IMPACT project, under the OHSN Research Ethics Board Protocol #20140131-01H and Bruyère Continuing Care Research Ethics Board Protocol #M16-14-021. That phase of the IMPACT project enabled Dr. Dahrouge and her team to develop a Local Innovation Partnership (LIP) within the Champlain LHIN. This partnership led to the assembly of a LIP Core Team in July 2015, and includes patients of various minority communities who contribute their experience and expectations, 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 best approach to the integration of the two sectors, and 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. These stakeholders have identified poor access to community based services as a priority access gap, and have selected linkage/collaboration between primary care and community resources to address this gap. The LIP Core Team is comprised of the research team, and representatives from the regional health authority (Champlain LHIN), home and community care services (Champlain Community Care Access Centre), Ontario 211, Champlain Healthline, the University of Ottawa Office of Social Accountability, local Community Health Centres, primary care providers, and community members (Additional information: 5 Champlain LIP Core Team).

The research team has also conducted several interviews and focus groups (as part of the IMPACT project) with community stakeholders to inform the approach to the ARC intervention so that it is acceptable to all. 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 community resources 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.

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. That component will be established in the Champlain Local Health Integration Network (LHIN). The proposed work will build on team members' experience, the foundational work and existing partnerships established by Dr. Dahrouge and her team.

Hypothesis leading to the present study

Based on the work done to date, we have determined it is warranted to a study an intervention to optimize equitable access to community resources for Ontarians based on the following activities:

  1. Improving referrals to community resources by

    • Raising population and providers' awareness of community resources and the existing navigation tools that can help identify where the services are delivered.
    • Engaging the participation of members of the vulnerable communities, including Francophones living in minority situations, and care delivery personnel in our work.
    • Training staff in primary care practices on the use of the electronic and telephone navigation tools
    • Supporting practices to adopt processes that will allow them to incorporate community services into the basket of services they already coordinate (e.g. specialty care)

  2. Improving the continuity of care across the two sectors (primary care and community services) by

    - Establishing communication and coordination processes between the primary care practices and the patient navigator.

  3. Supporting individuals with social complexities to overcome barriers to adequately access by

    • Increasing awareness of the resources within communities at higher risk of poor access (including Francophones living in minority situations)
    • Providing support to these individuals in the form of a "Navigator" to assist them in overcoming barriers to access.

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.
82

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, K2G 4B5
        • West Ottawa Nepean Family Health Organization

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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).

Exclusion Criteria:

  • There are no exclusion criteria for primary care providers.

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

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.
Other: Patients
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

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
Other: Practice and Provider

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

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

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
Active Patient Utilization
Time Frame: 12 month
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 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
Referrals
Time Frame: 12 month
The number of patients referred will be determined based on the referral forms completed. Primary care providers are asked to complete a referral form for all referrals they make to a community resource. The primary care provider then explains that a study is being done, and asks the patient for verbal consent to be contacted by the study team. All referrals having been made, regardless of the patient's interest in participating in the study will be captured. (Referral forms completed for all patients referred to a community resource will be collected by the research team. Patients' name and contact information will appear on referral forms ONLY for patients that consented to this information being provided to the research team).
12 month
First Contact Access
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section A in patient survey
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
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section B in patient survey
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
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section C in patient survey
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
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section E in patient survey
baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Self Efficacy
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section F in patient survey
baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Engagement with primary medical care and appropriateness of care
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section G in patient survey
baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Ability to engage
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section H in patient survey
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 Action Process Approach
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section O in patient survey
baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Patient Activation Measure
Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Section P in patient survey
baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months 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)
Ontario Ministry of Health and Long Term Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 18, 2017

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 30, 2018

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.
March 30, 2018

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).
April 4, 2017

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.
April 4, 2017

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.
April 10, 2017

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.
March 10, 2021

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.
March 8, 2021

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.
March 1, 2021

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.
  • 20160914-01H

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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