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Transformation of Indigenous Primary Healthcare Delivery

Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02234973
Acronym
FORGE AHEAD
Enrollment
500
Registered
2014-09-09
Start date
2014-09-30
Completion date
2020-03-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief 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.

Interventions

BEHAVIORALQuality 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

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of Western Ontario, Canada
CollaboratorOTHER
First Nation Community Partners
CollaboratorUNKNOWN
Health Canada
CollaboratorOTHER_GOV
First Nations and Inuit Health Branch
CollaboratorUNKNOWN
Assembly of First Nations
CollaboratorUNKNOWN
Canadian Diabetes Association
CollaboratorOTHER
Ontario Stroke Network
CollaboratorOTHER
Heart and Stroke Foundation of Canada
CollaboratorOTHER
Toronto Health Economics and Technology Assessment Collaborative
CollaboratorUNKNOWN
Tri-Ethnic Research Center Colorado State University
CollaboratorUNKNOWN
Hindsight Healthcare Strategies
CollaboratorUNKNOWN
AstraZeneca
CollaboratorINDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Community members Inclusion Criteria: * 18 years of age or older * on-reserve residents of participating Indigenous community partners

Exclusion criteria

* less than 18 years of age * off-reserve residents of participating or non-participating Indigenous community partners Clinic team members Inclusion Criteria: * Health centers of participating Indigenous community partners * Current type 2 diabetes mellitus registry and surveillance system

Design outcomes

Primary

MeasureTime frame
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)repeated measures: baseline (12 months prior to the start of the program)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026