Transformation of Indigenous Primary Healthcare Delivery

NCT02234973 | Completed

• 1 other identifier: 0000031372
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

  repeated measures: baseline (12 months prior to the start of the program)

• mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

  repeated measures: 6 month after program start date

• mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

  repeated measures: 12 month after program start date

• mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

  repeated measure: 18 months after program start

• mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)

  repeated measure: 24 months after program start

Study Arms (1)

11 First Nations Community and Clinical Teams

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

Behavioral: Quality Improvement

Interventions

Quality Improvement BEHAVIORAL

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

11 First Nations Community and Clinical Teams

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indigenous community and clinic team members

You may qualify if:

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

You may not qualify if:

• less than 18 years of age
• off-reserve residents of participating or non-participating Indigenous community partners
• Clinic team members
• Health centers of participating Indigenous community partners
• Current type 2 diabetes mellitus registry and surveillance system
• Health centers of non-participating Indigenous community partners
• No registry or surveillance system
• Diabetes Registry
• adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%
• gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life expectancy \<6 months.

Sponsors & Collaborators

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

Study Sites (1)

Centre for Studies in Family Medicine, Western University

London, Ontario, N6G2M1, Canada

Location

Related Publications (3)

• 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.

  PMID: 30382912 DERIVED

• 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.

  PMID: 28335823 DERIVED

• 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.

  PMID: 27456349 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Study Officials

• Stewart B Harris, MD, MPH

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: March 31, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-02

Locations

CA (1)