Diabetes Mellitus Type 2 With HyperglycemiaNCT03315728
Pathways for Health Equity Quality Improvement Strategy
An observational study of Diabetes Mellitus Type 2 With Hyperglycemia, run by Western University, Canada at 1 site in Canada.
Trial summary
The PATHWAYS for Health Equity research program builds on the 5-year FORGE AHEAD Indigenous diabetes quality improvement research program (2013 - 2017). PATHWAYS for Health Equity, a 3-year research program (2017 - 2019), is a great opportunity to continue our important collaborative diabetes quality improvement… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2 With Hyperglycemia
- What is being tested?
- Quality Improvement Strategy
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2017to 31 Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: First Nation Community Partners, their local leadership, members (inclusive of Elders, youth, and women), and those who provide healthcare and prevention programs to community members, will be involved on the Implementation Research Team and lead enhancements/ adaptations of the QI Strategy prior to implementation, AND oversee the intervention and research in each of the communities. Community partners are a diverse group of Indigenous communities reflecting a wide variation in contextual factors including healthcare delivery and funding models, population size, remoteness, governance structures, access to primary, secondary and tertiary care, and readiness to participate in a QI program.
Who may be able to join
- Indigenous Communities in Canada:
- On-reserve community
- Community Band Council approval to participate and collaboration
- Community healthcare facility approval or willingness to participate including both prevention and management/treatment arms if separate
- Signed Community Research Agreement (including Financial Agreement) by the custodian of community medical charts, health leadership, and community leadership (if required). Access to community medical charts is required for FNDSS
- Patient Chart Inclusion Criteria for chart audit component:
- Age 18 or older.
- Diagnosed with type 2 diabetes
Who cannot join
- Indigenous Communities:
- Communities that are unlikely to comply with the protocol (uncooperative attitude, unlikelihood of completing the program)
- Healthcare facility unwilling to participate or uncooperative.
- Patient Chart Exclusion Criteria for chart audit component:
- Less than 18 years old
- Diagnosed with type 1 or gestational diabetes
- Life expectancy is less than 6 months
- Inactive patient (no clinic visit in the last 12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transformation of Indigenous Primary Healthcare Delivery: Enhancement and Adaptation of Community-driven Innovations and Scale-up Toolkits
The PATHWAYS for Health Equity research program builds on the 5-year FORGE AHEAD Indigenous diabetes quality improvement research program (2013 - 2017).
PATHWAYS for Health Equity, a 3-year research program (2017 - 2019), is a great opportunity to continue our important collaborative diabetes quality improvement research with an increasing number of Indigenous partnering communities and researchers and key stakeholders (collaborators, policymakers and knowledge-users). Four partnering First Nations communities will join the Pathways program to develop community-driven quality improvement initiatives championed by a Community Facilitator and supported by a Community Data Coordinator.
Read the detailed description
GOAL
To improve the health and health equity of Indigenous peoples by strengthening the effectiveness, sustainability and scalability of a promising community-driven and culturally-relevant quality improvement strategy through meaningful conversations and engagement with our community partners.
OBJECTIVES
- Engage community partners and key stakeholders to support meaningful participation and leadership
- Review, improve and adapt the diabetes quality improvement strategy with community partners
- Evaluate the effectiveness of the adapted diabetes quality improvement strategy
- Develop community-driven plans for sustainability and scale-up for the adapted diabetes quality improvement strategy
WHY IS PATHWAYS IMPORTANT?
In Canada, there are significant inequalities between the health status of Indigenous peoples and the general population concerning diabetes. Community-driven initiatives using promising diabetes quality improvement strategies can potentially reform local healthcare in Indigenous communities and improve care for those living with diabetes.
WHAT IS INVOLVED IN PATHWAYS?
Community-based champions called Community Facilitators and Community Data Coordinators will be trained to provide leadership and support to community-based teams to make priority improvements to diabetes programs/ services and clinical care. The 18-month quality improvement intervention includes:
- educational workshops on diabetes and quality improvement
- support, communication, and coaching for action planning and quality improvement
- readiness consultation tools
- diabetes registry \& surveillance system
An evaluation consisting of interviews and questionnaires may be used to understand the process of adapting the diabetes quality improvement strategy to each community's context and factors that influence the program's success.
Our strong, multidisciplinary and cross-jurisdictional PATHWAYS Team includes Indigenous community representatives and healthcare providers, nonIndigenous healthcare providers, clinician scientists and academic researchers, as well as policy decision-makers and knowledge-user organizations.
The timely program will provide community leaders and knowledge-users with policy recommendations and a quality improvement strategy that can be implemented, sustained and spread to Indigenous community settings and regions across Canada and internationally.
COMMUNITY PARTNERS
Four community partners will be engaged and will partner in the Pathways program (two in Ontario and two in Atlantic Canada). Formal Community Research Agreements will represent participation and partnership.
- Being tested
- Quality Improvement Strategy
- Keywords
- Quality improvement, Indigenous, First Nation, Participatory, Diabetes, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement StrategyOther
Quality improvement strategy The 18 month Quality Improvement Strategy includes 3 months preparation, 12 months intervention, 3 months local knowledge translation. The intervention includes Readiness Consultations to assist in understanding available resources to address and adopt diabetes and chronic disease prevention and care strategies. Community teams receive a series of 3 workshops (in-person/virtual) followed by action periods where the team carry out and evaluate PDSAs they develop to improve diabetes care. Coaching is provided by Western during the 3-4 month action periods. FNDSS is a webbased secure community portal system for communities to develop a diabetes registry/surveillance system and generate reports and plan QI initiatives.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Strategy | First Nations communities partners are a diverse group of Indigenous communities reflecting wide variation in contextual factors: healthcare delivery and funding models; population size; remoteness; governance structures; and access to primary, secondary and tertiary care. Four diverse communities will partner in the program (two in Ontario and two in Atlantic Canada). All four communities will undertake an 18- month Quality Improvement Strategy intervention where they develop community-driven and culturally-relevant initiatives to improve diabetes care and management in their community Receives: Other: Quality Improvement Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the influence of community context on the implementation of the QI Strategy as assessed by the Consolidated Framework for Implementation Research
Qualitative information will be collected by interviews or focus groups to understand how context influences the implementation of the QI strategy. Questions on the interview are guided by the Consolidated Framework for Implementation Research, which includes questions on intervention characteristics, outer community setting, inner community setting, characteristics of individuals/teams, and implementation processes.
Measured: November 2017 - April 2019
Secondary outcomes (1)
Glycated hemoglobin (A1C)
Improvement in A1C will be assessed using the community's FNDSS portal.
Measured: November 2017 - April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start26 Oct 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 With HyperglycemiaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), AstraZeneca, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Stewart Harris, Western University, Canada
- Investigators
- Stewart Harris, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315728
- Sponsor's protocol ID
- R2722A59
- Status last verified
- Apr 2022
- First submitted
- 3 Oct 2017
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no sharing of individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformation of Indigenous Primary Healthcare Delivery: Enhancement and Adaptation of Community-driven Innovations and Scale-up Toolkits
- ClinicalTrials.gov ID
- NCT03315728
- Acronym / sponsor ID
- R2722A59
- Keywords
- Quality improvement, Indigenous, First Nation, Participatory, Diabetes, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), AstraZeneca, Juvenile Diabetes Research Foundation
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Oct 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.
The PATHWAYS for Health Equity research program builds on the 5-year FORGE AHEAD Indigenous diabetes quality improvement research program (2013 - 2017).
PATHWAYS for Health Equity, a 3-year research program (2017 - 2019), is a great opportunity to continue our important collaborative diabetes quality improvement research with an increasing number of Indigenous partnering communities and researchers and key stakeholders (collaborators, policymakers and knowledge-users). Four partnering First Nations communities will join the Pathways program to develop community-driven quality improvement initiatives championed by a Community Facilitator and supported by a Community Data Coordinator.
Detailed description
GOAL
To improve the health and health equity of Indigenous peoples by strengthening the effectiveness, sustainability and scalability of a promising community-driven and culturally-relevant quality improvement strategy through meaningful conversations and engagement with our community partners.
OBJECTIVES
- Engage community partners and key stakeholders to support meaningful participation and leadership
- Review, improve and adapt the diabetes quality improvement strategy with community partners
- Evaluate the effectiveness of the adapted diabetes quality improvement strategy
- Develop community-driven plans for sustainability and scale-up for the adapted diabetes quality improvement strategy
WHY IS PATHWAYS IMPORTANT?
In Canada, there are significant inequalities between the health status of Indigenous peoples and the general population concerning diabetes. Community-driven initiatives using promising diabetes quality improvement strategies can potentially reform local healthcare in Indigenous communities and improve care for those living with diabetes.
WHAT IS INVOLVED IN PATHWAYS?
Community-based champions called Community Facilitators and Community Data Coordinators will be trained to provide leadership and support to community-based teams to make priority improvements to diabetes programs/ services and clinical care. The 18-month quality improvement intervention includes:
- educational workshops on diabetes and quality improvement
- support, communication, and coaching for action planning and quality improvement
- readiness consultation tools
- diabetes registry \& surveillance system
An evaluation consisting of interviews and questionnaires may be used to understand the process of adapting the diabetes quality improvement strategy to each community's context and factors that influence the program's success.
Our strong, multidisciplinary and cross-jurisdictional PATHWAYS Team includes Indigenous community representatives and healthcare providers, nonIndigenous healthcare providers, clinician scientists and academic researchers, as well as policy decision-makers and knowledge-user organizations.
The timely program will provide community leaders and knowledge-users with policy recommendations and a quality improvement strategy that can be implemented, sustained and spread to Indigenous community settings and regions across Canada and internationally.
COMMUNITY PARTNERS
Four community partners will be engaged and will partner in the Pathways program (two in Ontario and two in Atlantic Canada). Formal Community Research Agreements will represent participation and partnership.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Strategy | – | Other: Quality Improvement StrategyFirst Nations communities partners are a diverse group of Indigenous communities reflecting wide variation in contextual factors: healthcare delivery and funding models; population size; remoteness; governance structures; and access to primary, secondary and tertiary care. Four diverse communities will partner in the program (two in Ontario and two in Atlantic Canada). All four communities will undertake an 18- month Quality Improvement Strategy intervention where they develop community-driven and culturally-relevant initiatives to improve diabetes care and management in their community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First Nation Community Partners, their local leadership, members (inclusive of Elders, youth, and women), and those who provide healthcare and prevention programs to community members, will be involved on the Implementation Research Team and lead enhancements/ adaptations of the QI Strategy prior to implementation, AND oversee the intervention and research in each of the communities. Community partners are a diverse group of Indigenous communities reflecting a wide variation in contextual factors including healthcare delivery and funding models, population size, remoteness, governance structures, access to primary, secondary and tertiary care, and readiness to participate in a QI program.
Key inclusion criteria (8 listed)
- On-reserve community
- Community Band Council approval to participate and collaboration
- Community healthcare facility approval or willingness to participate including both prevention and management/treatment arms if separate
- Signed Community Research Agreement (including Financial Agreement) by the custodian of community medical charts, health leadership, and community leadership (if required). Access to community medical charts is required for FNDSS
- Age 18 or older.
Key exclusion criteria (8 listed)
- Communities that are unlikely to comply with the protocol (uncooperative attitude, unlikelihood of completing the program)
- Healthcare facility unwilling to participate or uncooperative.
- Less than 18 years old
- Diagnosed with type 1 or gestational diabetes
- Life expectancy is less than 6 months
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 |
|---|---|---|
| Quality Improvement StrategyQuality improvement strategy The 18 month Quality Improvement Strategy includes 3 months preparation, 12 months intervention, 3 months local knowledge translation. The intervention includes Readiness Consultations to assist in understanding available resources to address and adopt diabetes and chronic disease prevention and care strategies. Community teams receive a series of 3 workshops (in-person/virtual) followed by action periods where the team carry out and evaluate PDSAs they develop to improve diabetes care. Coaching is provided by Western during the 3-4 month action periods. FNDSS is a webbased secure community portal system for communities to develop a diabetes registry/surveillance system and generate reports and plan QI initiatives. | Other | Quality Improvement Strategy |
Primary outcome
Understand the influence of community context on the implementation of the QI Strategy as assessed by the Consolidated Framework for Implementation Research
Time frame: November 2017 - April 2019
Qualitative information will be collected by interviews or focus groups to understand how context influences the implementation of the QI strategy. Questions on the interview are guided by the Consolidated Framework for Implementation Research, which includes questions on intervention characteristics, outer community setting, inner community setting, characteristics of individuals/teams, and implementation processes.
1 secondary outcome
Glycated hemoglobin (A1C)
Time frame: November 2017 - April 2019
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 27 Apr 2022.
- Description of Pathways for Health Equity WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no sharing of individual participant data.
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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.
Stewart Harris, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 With Hyperglycemia, run by Western University, Canada 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 8 inclusion and 8 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 27 Apr 2022. 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?
Understand the influence of community context on the implementation of the QI Strategy as assessed by the Consolidated Framework for Implementation Research (time frame: November 2017 - April 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022.