Transformation of Indigenous Primary Healthcare Delivery

NCT ID: NCT02234973

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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11 First Nations Community and Clinical Teams

11 Community \& Clinical Teams in each First Nation community participated in the intervention.

Quality Improvement

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* on-reserve residents of participating Indigenous community partners


* Health centers of participating Indigenous community partners
* Current type 2 diabetes mellitus registry and surveillance system


* adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%

Exclusion Criteria

* less than 18 years of age
* off-reserve residents of participating or non-participating Indigenous community partners

Clinic team members


* Health centers of non-participating Indigenous community partners
* No registry or surveillance system

Diabetes Registry


* gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life expectancy \<6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

First Nation Community Partners

UNKNOWN

Sponsor Role collaborator

Health Canada

OTHER_GOV

Sponsor Role collaborator

First Nations and Inuit Health Branch

UNKNOWN

Sponsor Role collaborator

Assembly of First Nations

UNKNOWN

Sponsor Role collaborator

Canadian Diabetes Association

OTHER

Sponsor Role collaborator

Ontario Stroke Network

OTHER

Sponsor Role collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Toronto Health Economics and Technology Assessment Collaborative

UNKNOWN

Sponsor Role collaborator

Tri-Ethnic Research Center Colorado State University

UNKNOWN

Sponsor Role collaborator

Hindsight Healthcare Strategies

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stewart B Harris, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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Centre for Studies in Family Medicine, Western University

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Tompkins JW, Mequanint S, Barre DE, Fournie M, Green ME, Hanley AJ, Hayward MN, Zwarenstein M, Harris SB; FORGE AHEAD Program Team. National Survey of Indigenous primary healthcare capacity and delivery models in Canada: the TransFORmation of IndiGEnous PrimAry HEAlthcare delivery (FORGE AHEAD) community profile survey. BMC Health Serv Res. 2018 Nov 1;18(1):828. doi: 10.1186/s12913-018-3578-8.

Reference Type DERIVED
PMID: 30382912 (View on PubMed)

Hayward MN, Mequanint S, Paquette-Warren J, Bailie R, Chirila A, Dyck R, Green M, Hanley A, Tompkins J, Harris S; FORGE AHEAD Program Team. The FORGE AHEAD clinical readiness consultation tool: a validated tool to assess clinical readiness for chronic disease care mobilization in Canada's First Nations. BMC Health Serv Res. 2017 Mar 23;17(1):233. doi: 10.1186/s12913-017-2175-6.

Reference Type DERIVED
PMID: 28335823 (View on PubMed)

Naqshbandi Hayward M, Paquette-Warren J, Harris SB; FORGE AHEAD Program Team. Developing community-driven quality improvement initiatives to enhance chronic disease care in Indigenous communities in Canada: the FORGE AHEAD program protocol. Health Res Policy Syst. 2016 Jul 26;14(1):55. doi: 10.1186/s12961-016-0127-y.

Reference Type DERIVED
PMID: 27456349 (View on PubMed)

Related Links

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Other Identifiers

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0000031372

Identifier Type: -

Identifier Source: org_study_id

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