Transformation of Indigenous Primary Healthcare Delivery

NCT02234973 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-06-11

No results posted yet for this study

Summary

Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health outcomes compared to the general population because of a wide array of factors: social determinants of health, lifestyle, genetic susceptibility, and historic-political and psycho-social factors. Barriers to care that are unique to First Nations communities exacerbate the problem with fragmented healthcare, poor chronic disease management, healthcare staff turnover, and limited, or non-existent, surveillance.

Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research program aims to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease prevention and management in First Nations communities in Canada. Participants will consist of Indigenous community and clinic team members that will take part in multiple interrelated projects including community profiling, readiness consultations, diabetes registry and surveillance, and quality improvement workshops and action periods.

Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical process and outcomes measures, 2) details about community-driven innovations, and 3) knowledge about the experience and cost of attempting to improve primary delivery in individual Indigenous communities.

Intervention/Instrument: Survey, literature review, 15 month intervention (readiness consultations, implementation and maintenance of a registry and surveillance system, community and clinic focused quality improvement workshops), interviews.

Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline); Secondary-clinical process and outcome measures, change in stage of readiness, description of participation and innovation facilitators and barriers.

Policy Implications: The outcomes of this research program have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities. Policy recommendations will be made to help support Indigenous communities in adopting successful innovations to help address issues related to diabetes and other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the subsequent policy decisions may enhance chronic disease prevention and management for Indigenous peoples across the country.

Conditions

Interventions

BEHAVIORAL

Quality Improvement

Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • University of Western Ontario, Canada

    collaborator OTHER
  • First Nation Community Partners

    collaborator UNKNOWN
  • Health Canada

    collaborator OTHER_GOV
  • First Nations and Inuit Health Branch

    collaborator UNKNOWN
  • Assembly of First Nations

    collaborator UNKNOWN
  • Canadian Diabetes Association

    collaborator OTHER
  • Ontario Stroke Network

    collaborator OTHER
  • Heart and Stroke Foundation of Canada

    collaborator OTHER
  • Toronto Health Economics and Technology Assessment Collaborative

    collaborator UNKNOWN
  • Tri-Ethnic Research Center Colorado State University

    collaborator UNKNOWN
  • Hindsight Healthcare Strategies

    collaborator UNKNOWN
  • AstraZeneca

    collaborator INDUSTRY
  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Stewart B Harris, MD, MPH · Western University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-06-30
Completion
2020-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234973 on ClinicalTrials.gov