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ARC -Access to Resources in the Community

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03105635
First Posted: April 10, 2017
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
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.

Condition Intervention
Problems With Access to Health Care Other: Mixed method feasibility study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Participants are patients Care providers are practices
Primary Purpose: Health Services Research
Official Title: ARC - Access to Resources in the Community/Accès Aux Ressources Communautaires

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 468
Actual Study Start Date: May 18, 2017
Estimated Study Completion Date: July 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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): NCT03105635


Locations
Canada, Ontario
West Ottawa Nepean Family Health Organization
Ottawa, Ontario, Canada, K2G 4B5
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03105635     History of Changes
Other Study ID Numbers: 20160914-01H
First Submitted: April 4, 2017
First Posted: April 10, 2017
Last Update Posted: September 22, 2017
Last Verified: September 2017
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
Health Navigator