Clinical trial NCT02234973: Transformation of Indigenous Primary Healthcare Delivery
Official title: Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Western Ontario, Canada
name: First Nation Community Partners
name: Health Canada
name: First Nations and Inuit Health Branch
name: Assembly of First Nations
name: Canadian Diabetes Association
name: Ontario Stroke Network
name: Heart and Stroke Foundation of Canada
name: Toronto Health Economics and Technology Assessment Collaborative
name: Tri-Ethnic Research Center Colorado State University
name: Hindsight Healthcare Strategies
name: AstraZeneca
First posted: 2014-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indigenous community and clinic team members

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.


Eligibility 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

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.

Primary outcomes:
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
timeFrame: repeated measures: baseline (12 months prior to the start of the program)
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
timeFrame: repeated measures: 6 month after program start date
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
timeFrame: repeated measures: 12 month after program start date
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
timeFrame: repeated measure: 18 months after program start
measure: mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
timeFrame: repeated measure: 24 months after program start
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Centre for Studies in Family Medicine, Western University
state: Ontario
Study officials:
affiliation: Western University
name: Stewart B Harris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.