Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/10/2016
Date assigned
07/10/2016
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is a lifelong condition where the pancreas doesn't produce enough insulin or the body's cells don't react to insulin, causing a person's blood sugar level to become too high. It is well known that type 2 diabetes impacts Indigenous/First Nations people across the world, including Canada. Overall, the rate of type 2 diabetes in First Nations communities is 3-5 times higher than the general Canadian population. Healthcare for people with type 2 diabetes is becoming more of a team effort with patients not only seeing physicians, but nurses, dieticians, pharmacists and other healthcare providers. It's important that clinical information is tracked, shared, reviewed and individualized. Most people living in First Nations communities are isolated, with limited access to regular healthcare and specialist services. Most healthcare is delivered by nurses and community health workers, making team-based care challenging and expensive. Often it is up to the patients to navigate and seek the best care. This gap in services, along with other challenges like physician/nursing shortages, cultural barriers and living in remote communities, leads to high rates of diabetes complications, like dialysis, blindness, and shorter life expectancy. RADAR is a project focused on caring for people with type 2 diabetes living on First Nation reserves in Alberta. RADAR combines information systems (for tracking and registering patients) and a care coordinator. The aim of this study is to assess the effectiveness of RADAR at improving the quality of clinical care of First Nations people living with type 2 diabetes on reserve.

Who can participate?
Patients aged 18 or over with type 2 diabetes who have recently (within last 1-2 years) received care from the First Nations health facility

What does the study involve?
RADAR works behind the scenes, and patients may not even know about it. It provides a service to local nurses and community health workers to help them manage their type 2 diabetes patients. It improves care and ensures that it is provided in the best available manner. RADAR is introduced sequentially to the participating communities in consecutive 4-6 month periods, based on the communities 'readiness'. The care coordinator works with local healthcare workers to identify patients with type 2 diabetes and register them into the CARE platform, a secure system that helps record, track and assess people with diabetes in the community. The care coordinator works with local healthcare workers to manage patients with type 2 diabetes. Success is measured through improvements in A1c (a blood sugar test), blood pressure and cholesterol. Other areas of diabetes care are also looked at, like foot and eye examinations, receipt of vaccinations, smoking cessation counselling, and the proportion of patients linked to a health services provider.

What are the possible benefits and risks of participating?
If RADAR can better organize care, there may be savings to the healthcare system. The largest benefits will be seen by patients through the improvement of care for their diabetes. Community health workers will have greater knowledge of diabetes and its care, helping to provide the best care to patients. There are no risks to patients. All activities are the same as those for regular diabetes clinical care. The only potential harms are related to privacy of health information. All data provided to the research team will be non-identifiable. As a result, any such risk is minimal.

Where is the study run from?
1. Bigstone Health Commission (Canada)
2. Aakom Kiiyi Health (Canada)
3. Saddle Lake Cree Nation (Canada)

When is the study starting and how long is it expected to run for?
January 2015 to September 2020

Who is funding the study?
1. Alberta Innovates Health Solutions (AIHS) (Canada)
2. Canadian Institutes for Health Research (CIHR) (Canada)
3. Lawson Health Research Institute (Canada)

Who is the main contact?
Dr Dean Eurich

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dean Eurich

ORCID ID

http://orcid.org/0000-0003-2197-0463

Contact details

2-040 Li Ka Shing Centre for Health Research Innovation
University of Alberta
Edmonton
T6G 2E1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Pro00048714

Study information

Scientific title

Reorganizing the Approach to Diabetes through the Application of Registries: a non-randomized cross-over trial

Acronym

RADAR

Study hypothesis

Our primary objective is to implement and assess the effectiveness of an integrated population based electronic health record (EHR)/registry system specifically designed for First Nations communities (Community Assessment Response and Empowerment [CARE] platform), coupled with dedicated support from a centralized care coordinator (CC) to systematically organize proactive diabetes care in the communities to improve diabetes-related outcomes. Thus, RADAR is the combination of the CARE platform and the CC support. We hypothesize that RADAR will result in an overall improvement in the quality of clinical care of First Nations people living with type 2 diabetes on reserve, as measured by evidence-based outcomes (A1c, BP, cholesterol) and quality of care indicators (e.g., foot and eye examinations). We believe that RADAR will help promote timely management of people with type 2 diabetes and increase diabetes knowledge and management practices among local healthcare workers. In addition, managers can use the EHR/registry to track diabetes trends, determine the effectiveness of diabetes programs, and assist in resource planning.

Ethics approval

University of Alberta Health Research Ethics Board, 17/08/2015, ref: Pro00048714

Study design

Modified stepped wedge controlled trial design

Primary study design

Interventional

Secondary study design

Non-randomized cross-over trial

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Type 2 diabetes

Intervention

This is a modified stepped-wedge controlled implementation trial. It's a cross-over design, whereby each community serves as its own control before 'switching' to the intervention at different time points. In essence, RADAR will be implemented sequentially to the communities in consecutive 4-6 month periods, based on the communities 'readiness'. By the end of the evaluation period, RADAR will have been implemented in all the communities.

The RADAR model incorporates two distinct elements: a custom EHR, integrated with a population-based diabetes registry and analytics platform – CARE platform; and, a centralized care coordinator (CC). The CARE platform was designed by OKAKI Health Intelligence Inc. to meet the specific requirements of nursing-driven health programs currently being delivered on reserve in Canadian First Nations communities.

The CC is a First Nations registered nurse and certified diabetes educator with significant experience with care on reserve. The CC will work remotely with the local healthcare workers on reserve to improve quality of care for people with diabetes, facilitated through shared use of the CARE platform and web conferencing technologies. The CC supports systematic review of patients and case conferencing activities to support and prioritize care, problem-solves system or patient-level care issues, and provides education to local healthcare workers. In addition, the CC acts as a bridge between the First Nations communities and other service providers to help coordinate patient care on and off reserve. Together, both RADAR elements address the 5Rs in organizing diabetes care, that is, recognize, register, relay, recall, and resource, in the First Nations context. In addition, managers and researchers can use the analysis of population-level data for epidemiological assessments, quality-improvement, and decision-making.

Specifically, during the baseline phase, the CC will work with local healthcare workers to identify patients with type 2 diabetes and register them into the CARE platform, but not make any management recommendations. All patients will be registered into the CARE platform, including their demographic and clinical data (e.g. A1c, blood pressure, lipids, eye exams, foot care), where available. Patient information to populate the baseline data will be obtained from all potential sources (e.g., medical records, patient interviews, Alberta's provincial EHR for laboratory results (Netcare)). All available data up to 18 months prior to the end of the baseline period will be used to populate CARE, as patient encounters with the health system may not be consistent.

During the intervention phase, the CC will work with local healthcare workers to proactively manage patients with type 2 diabetes, including monitoring and recall of patients, relaying clinical information and coordinating care, facilitated through the shared use of the CARE platform.

At the end of the intervention (minimum 1 year, depending on the community), clinical data (e.g., A1c, blood pressure, lipids, eye exams, foot care) will be extracted from the CARE platform. All relative changes will be analyzed using the last known recorded value.

The intervention will last approximately 1 year, depending on the community's capacity. Towards the end of the intervention phase, the Care Coordinator will gradually diminish support and transfer responsibilities.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. A1c
2. Blood pressure
3. Cholesterol
Data collected for regular clinical care is used to assess the primary and secondary outcomes. There is no additional data collected from patients specific to the RADAR study. It may be considered a type of chart review. Timepoints: baseline, end of Intervention (minimum 1 year, depending on the community).

Secondary outcome measures

1. The proportion of clinical measures and tasks completed in accordance with Canadian Diabetes Association Clinical Practice guidelines (e.g., A1c, BP, cholesterol, foot and eye examination, receipt of vaccinations, smoking cessation counseling)
2. The number of patients registered in CARE
3. The proportion of patients linked to a health services provider
Data collected for regular clinical care is used to assess the primary and secondary outcomes. There is no additional data collected from patients specific to the RADAR study. It may be considered a type of chart review. Timepoints: baseline, end of Intervention (minimum 1 year, depending on the community).

Overall trial start date

01/01/2015

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients >18 years of age diagnosed with type 2 diabetes
2. Recently (within last 1-2 years) received care from the First Nations health facility
3. Provided verbal consent for First Nations health care workers to manage their diabetes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Patients with type 1 diabetes
2. Patients <18 years of age
3. Those who are subsequently discovered not to have type 2 diabetes (and were not initially in the baseline period)
4. Those refusing care within the First Nations health facility; patients with type 2 diabetes identified after the conclusion of the baseline phase of the project

Recruitment start date

01/01/2015

Recruitment end date

30/08/2019

Locations

Countries of recruitment

Canada

Trial participating centre

Bigstone Health Commission

T0G 2K0
Canada

Trial participating centre

Aakom Kiiyi Health
T0K 0H0
Canada

Trial participating centre

Saddle Lake Cree Nation
T0A 3T0
Canada

Sponsor information

Organisation

University of Alberta, School of Public Health

Sponsor details

3-300 Edmonton Clinic Health Academy
11405-87th Ave
Edmonton
T6G 1C9
Canada
+1 (0)780 492 9954
school.publichealth@ualberta.ca

Sponsor type

University/education

Website

http://www.ualberta.ca/public-health

Organisation

Alliance for Canadian Health Outcomes Research in Diabetes (ACHORD)

Sponsor details

2-040 Li Ka Shing Centre for Health Research Innovation
University of Alberta
Edmonton
T6G 2E1
Canada

Sponsor type

Research organisation

Website

http://www.achord.ca

Funders

Funder type

Industry

Funder name

Alberta Innovates - Health Solutions

Alternative name(s)

AIHS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Canada

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Lawson Health Research Institute

Alternative name(s)

Lawson

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Canada

Results and Publications

Publication and dissemination plan

1. Protocol intended to be published 2016/2017
2. Quantitative and qualitative results publication to be confirmed at a later date

IPD sharing plan
The data used to evaluate the primary and secondary outcomes are clinical measures routinely collected for clinical care. The data used for evaluation is non-identifying health information, provided by the custodian to the research team for the purpose of research. All patient level data remains with the communities and custodians. A single copy of the de-identified data will be stored on a password protected, encrypted, and secured university server maintained by the Academic Information and Communication Technologies (AICT) group at the University of Alberta. However, as we are not the data custodians, we cannot share any patient data.

Intention to publish date

30/09/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes