Transformation of Indigenous Primary Healthcare Delivery

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Quality Improvement

• Registration Number: NCT02234973
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Primary Completion: 2017-06
• Status Verified: 2020-02
• Study Completion: 2020-03-31
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Exclusion Criteria:

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

Diabetes Registry

Inclusion Criteria:

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

Exclusion Criteria:

• gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life expectancy <6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
11 First Nations Community and Clinical Teams	Quality Improvement	11 Community \& Clinical Teams in each First Nation community participated in the intervention.

Primary Outcome Measures

Name	Time	Method
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)	repeated measure: 24 months after program start

Trial Locations

Locations (1)

Centre for Studies in Family Medicine, Western University; 🇨🇦 London, Ontario, Canada