Pathways for Health Equity Quality Improvement Strategy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03315728
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : May 3, 2018
Canadian Institutes of Health Research (CIHR)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Stewart Harris, Western University, Canada

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Type 2 With Hyperglycemia Other: Quality Improvement Strategy

Detailed Description:


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.


  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


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.


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.


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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Transformation of Indigenous Primary Healthcare Delivery: Enhancement and Adaptation of Community-driven Innovations and Scale-up Toolkits
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Glycated hemoglobin (A1C) [ Time Frame: November 2017 - April 2019 ]
    Improvement in A1C will be assessed using the community's FNDSS portal.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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:

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. Life expectancy is less than 6 months
  4. Inactive patient (no clinic visit in the last 12 months)

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 identifier (NCT number): NCT03315728

Contact: Stewart Harris, MD 519-661-2111 ext 22057
Contact: Mariam Naqshbandi Hayward, MSc 519-661-2111 ext 22115

Canada, Ontario
Western University Recruiting
London, Ontario, Canada, N6C 4Z9
Contact: Stewart Harris    519-858-5028   
Contact: Mariam Hayward    519-661-2111 ext 20067   
Sponsors and Collaborators
Western University, Canada
Canadian Institutes of Health Research (CIHR)
Juvenile Diabetes Research Foundation
Principal Investigator: Stewart Harris, MD Western University

Responsible Party: Stewart Harris, Principal Investigator, Western University, Canada Identifier: NCT03315728     History of Changes
Other Study ID Numbers: R2722A59
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no sharing of individual participant data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stewart Harris, Western University, Canada:
Quality improvement
First Nation
Chronic Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases