NCT01989962

Brief Summary

Education for Equity (E4E)intervention intends to improve care delivery through a well designed educational program that address not only the issues of diabetes care delivery to Aboriginal patients with diabetes, but also the issues of effective cross-cultural and culturally safe communication between healthcare providers and Aboriginal patients, and the issues related to effective implementation of appropriate chronic disease management programs for Aboriginal patients in a range of practice settings. The purpose of this study is to evaluate the effectiveness of the E4E education program through measuring patient clinical outcomes, patient experience with their doctors, and the changes in physicians' approaches to care perceived by Aboriginal diabetic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
860

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

October 15, 2013

Last Update Submit

October 13, 2015

Conditions

Keywords

Aboriginal HealthDiabetes Mellitus Type 2Cultural CompetencyContinuing Medical Education

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1C values--change is being assessed

    The primary outcome measure of A1C value will be used to identify the impact of the E4E program on clinical outcomes of Aboriginal patients with type 2 diabetes. It is hypothesized that the A1C value of the patients at or above 8.0% prior to their physicians' participation in the E4E intervention will be reduced since their physicians participate in the E4E intervention.

    a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention

  • Cultural safety, bias and discrimination--change is being assessed

    Physicians' cultural safety, bias and discrimination will be measured with a Cultural Competence, Sensitivity and Discrimination scale\* from patients' perspectives. It is hypothesized that Aboriginal patients with type 2 diabetes will perceive increased cultural safety and decreased cultural bias/discrimination in their interactions with physicians since physicians participate in the E4E intervention. \*Haggerty J, Burge F, Gass D, Santor D, Levesque JF, Beaulieu MD, Pineault R, Beninguisse G, Beauliur C. Evaluating the Quality of Primary Health Care from the Consumer Perspective: Validation of Instruments Adapted to the Canadian Context.(February 2006). Retrieved May 18th, 2013. Available at http://www.smhc.qc.ca/ignitionweb/data/media\_centre\_files/624/Mapping%20of%20PHC%20Attributes%20to%20Questionaries%20\_%20final%20report%202006.pdf

    within 2 weeks after the E4E workshop; 1 year later after completetion of E4E intervention

Secondary Outcomes (9)

  • Diabetes process of care measures (date only)--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention

  • Other laboratory tests (values and date)--change is being assessed

    a 12-month period prior to the start of the E4E intervention; a 12-month period after completion of the E4E intervention

  • Blood pressure (systolic, diastolic, date)--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention

  • BMI (value, date)--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention

  • Medications--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention

  • +4 more secondary outcomes

Other Outcomes (2)

  • Clinic visits--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention

  • Referrals (to whom and date)--change is being assessed

    a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention

Study Arms (2)

E4E Intervention Group

EXPERIMENTAL

E4E Intervention Group is a group of family physicians who will participate in the first wave of E4E intervention.

Other: E4E intervention

E4E Late Intervention Control Group

SHAM COMPARATOR

E4E Late Intervention Control Group is a group of family physicians who will participate in the second wave of E4E intervention 12 month later after the completion of the first wave of E4E intervention.

Other: E4E intervention

Interventions

The E4E intervention consists of a one-day face-to-face workshop and a series of follow-up online learning modules. Workshop and online content will be tailored to meet individual participants' needs determined by a pre-program needs assessment. E4E intervention will emphasize clinically based case scenarios and are designed to reinforce the workshop concepts and stimulate reflection. Participating family physicians will attend the workshop and engage in reflections and small-group interactions.

Also known as: E4E continuing medical educational intervention
E4E Intervention GroupE4E Late Intervention Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • Participate in the early or late E4E MAINPRO-C workshop
  • minimum 6 months in practice working with Aboriginal population
  • Minimum of 20 Aboriginal type 2 diabetic patients in patient roster
  • Intend to remain in practice location for 12 months post early intervention.

You may not qualify if:

  • Locum physician or plan to relocate before the study is completed
  • minimum 18 years of age
  • See the same physician for care over the course of study
  • minimum 5 years diagnosed with type 2 diabetes
  • Self identified as Aboriginal
  • A1C ≥ 8.0% at baseline (one year prior to the start of early E4E intervention)
  • \<18 years of age
  • Living in a nursing home
  • Physicians did not consent to audit
  • Type 1 diabetes or gestational diabetes diagnosis or impaired glucose
  • Not self-identified as Aboriginal population
  • A1C \< 8.0% at baseline one year prior to intervention
  • Patients participating in Patient Experience Survey
  • minimum 18 years of age
  • See the same physician for care over the course of study
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Studies in Primary Care, Department of Family Medicine, Queen's University

Kingston, Ontario, K7L 5E9, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Green, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director for Centre for Health Services and Policy Research, Associate Director for Centre for Studies in Primary Care

Study Record Dates

First Submitted

October 15, 2013

First Posted

November 21, 2013

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations