ClinicalTrials.gg
CompletedNCT03315728Updated Apr 27, 2022

Pathways for Health Equity Quality Improvement Strategy

An observational study in Diabetes Mellitus Type 2 With Hyperglycemia, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Western University, Canada · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 493 studies in Diabetes Mellitus with a site in Canada — 39 open to participants now, 55 under way, 5 of them phase 3. Diabetes Mellitus · Canada.

Enrollment
70th of 92
4 · median 100
Started
2017
with 33 others
Observational
92 of 493
14 open now
Registered
357th of 493
by date

Among the 493 studies in Diabetes Mellitus with a site in Canada, this one is the 70th largest by enrollment of the 92 observational ones that give a count, is one of 34 that started in 2017, is one of 92 observational ones, and was the 357th registered.

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

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Open to participants now

39 of the 493 studies in Diabetes Mellitus with a site in Canada are open now. Recruiting first, the newest first:

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All 39 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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 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

  1. Engage community partners and key stakeholders to support meaningful participation and leadership
  2. Review, improve and adapt the diabetes quality improvement strategy with community partners
  3. Evaluate the effectiveness of the adapted diabetes quality improvement strategy
  4. 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.

03

Conditions studied

  • Diabetes Mellitus Type 2 With Hyperglycemia

Keywords

  • Quality improvement
  • Indigenous
  • First Nation
  • Participatory
  • Diabetes
  • Chronic Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Indigenous Communities in Canada:

  1. On-reserve community
  2. Community Band Council approval to participate and collaboration
  3. Community healthcare facility approval or willingness to participate including both prevention and management/treatment arms if separate
  4. 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:

  1. Age 18 or older.
  2. Diagnosed with type 2 diabetes

Exclusion criteria

Exclusion Criteria:

Indigenous Communities:

  1. Communities that are unlikely to comply with the protocol (uncooperative attitude, unlikelihood of completing the program)
  2. Healthcare facility unwilling to participate or uncooperative.

Patient Chart Exclusion Criteria for chart audit component:

  1. Less than 18 years old
  2. Diagnosed with type 1 or gestational diabetes
  3. is less than 6 months
  4. Inactive patient (no clinic visit in the last 12 months)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: Quality Improvement Strategy

Interventions

  • OtherQuality Improvement Strategy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: November 2017 - April 2019

Secondary outcomes

  1. Glycated hemoglobin (A1C)

    Improvement in A1C will be assessed using the community's FNDSS portal.

    Time frame: November 2017 - April 2019

07

Study locations

1 site
  • Western University
    London, Ontario N6C 4Z9, Canada
08

References and documents

Individual participant data

Plan to share: No — There is no sharing of individual participant data.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Mar 2022, 53 months.

Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's 53 months is above that.

Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2017
First posted
Oct 20, 2017
StartActual
Oct 26, 2017
Primary completionActual
Mar 31, 2022
CompletionActual
Mar 31, 2022
Last update
Apr 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03315728
Collaborators
Canadian Institutes of Health Research (CIHR), AstraZeneca, Juvenile Diabetes Research Foundation
Responsible party
Stewart Harris (Principal Investigator, Western University, Canada) — Principal investigator
First posted
Oct 20, 2017
Start date
Oct 26, 2017
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022
Last update
Apr 27, 2022

Study contacts

Stewart Harris, MD
principal investigator · Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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