Problems With Access to Health CareNCT03105635
ARC -Access to Resources in the Community
A study testing Mixed method feasibility study in people with Problems With Access to Health Care, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problems With Access to Health Care
- What is being tested?
- Mixed method feasibility study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
West Ottawa Nepean Family Health Organization
Ottawa, Ontario, K2G 4B5
About this study
Official title: 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.
Read the 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:
- 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)
- 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.
- 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.
- Conditions
- Problems With Access to Health Care
- Being tested
- Mixed method feasibility study
- Keywords
- Community Resources, Health Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed method feasibility studyOther
Participating practices will receive the following:
- 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.
- Facilitation to enhance referrals: help support practices to make the desired adaptations to enhance referrals
- 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.
- Navigator: The services of a Navigator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Mixed method feasibility study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (10)
Referrals
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).
Measured: 12 month
First Contact Access
Section A in patient survey
Measured: 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
Section B in patient survey
Measured: 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
Section C in patient survey
Measured: 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
Section E in patient survey
Measured: 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
Section F in patient survey
Measured: 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
Section G in patient survey
Measured: 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
Section H in patient survey
Measured: 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
Section O in patient survey
Measured: 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
Section P in patient survey
Measured: baseline (i.e. the time of referrals (Pre-intervention) as well six months later, at the end of the patient six months intervention period .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start18 Apr 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problems With Access to Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105635
- Sponsor's protocol ID
- 20160914-01H
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30679151
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARC - Access to Resources in the Community/Acces Aux Ressources Communautaires
- ClinicalTrials.gov ID
- NCT03105635
- Acronym / sponsor ID
- 20160914-01H
- Conditions
- Problems With Access to Health Care
- Keywords
- Community Resources, Health Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Mixed method feasibility studyParticipating 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. |
| Practice and Provider | Other | Other: Mixed method feasibility studyFour 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- There are no exclusion criteria for primary care providers.
- A Community Health Centre
- Practices that are not part of a reform model
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed method feasibility studyParticipating 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 | Patients, Practice and Provider |
Primary outcome
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
10 secondary outcomes
Referrals
Time frame: 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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 30679151Dahrouge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed method feasibility study in people with Problems With Access to Health Care, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Patient Utilization (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.