E4E-Health Professional Education for Improving Care for Canadian Aboriginal Populations

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Queen's University
Sponsor:
Collaborators:
University of Calgary
Laurentian University
University of British Columbia
Information provided by (Responsible Party):
Michael Green, Queen's University
ClinicalTrials.gov Identifier:
NCT01989962
First received: October 15, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Cultural Competency
Other: E4E intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase 2: Evaluation of Education for Equity (E4E)--Exploring How Health Professional Education Can Reduce Disparities in Chronic Disease Care and Improve Outcomes for Indigenous Populations

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Hemoglobin A1C values--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    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.

  • Cultural safety, bias and discrimination--change is being assessed [ Time Frame: within 2 weeks after the E4E workshop; 1 year later after completetion of E4E intervention ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Diabetes process of care measures (date only)--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    Frequency of exams for complications of diabetes(eye, foot, ECG, waist circumference, neuropathy) is an indicator of quality of care related to physicians' adherence to diabetes care guidelines. It is hypothesized that the adherence to recommended screening for complications will be increased since physicians participate in the E4E intervention.

  • Other laboratory tests (values and date)--change is being assessed [ Time Frame: a 12-month period prior to the start of the E4E intervention; a 12-month period after completion of the E4E intervention ] [ Designated as safety issue: No ]

    Frequency of other laboratory tests is an indicator of physicians' adherence to recommended control and prevention of complications. Test results are indicators of clinical outcomes of diabetes control in Aboriginal patients. The tests that will be examined are:

    1. Triglycerides
    2. HDL
    3. LDL
    4. Total cholesterol: HDL
    5. Total cholesterol
    6. eGFR/Creatinine Clearance
    7. Serum Creatinine
    8. A:C ratio
    9. 24 hour urine

    It is hypothesized that adherence to recommended tests and test results will be improved since physicians participate in the E4E intervention.


  • Blood pressure (systolic, diastolic, date)--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention ] [ Designated as safety issue: No ]
    Frequency of blood pressure (BP) check is an indicator of physicians' adherence to recommended diabetes control and prevention of complications. BP values are an indicator of clinical outcome of diabetes control in Aboriginal patients with type 2 diabetes. It is hypothesized that physicians' adherence to recommended BP check and the BP results of Aboriginal patients with type 2 diabetes will be improved since physicians participate in the E4E intervention.

  • BMI (value, date)--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    Frequency of BMI check is an indicator of physicians' adherence to recommended diabetes control and prevention of complications. BMI values are an indicator of clinical outcomes of diabetes control in Aboriginal patients with type 2 diabetes. It is hypothesized that the adherence to BMI check will increased and BMI values will decrease since physicians participate in E4E intervention.

  • Medications--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention ] [ Designated as safety issue: No ]

    Medications that physicians prescribe for their Aboriginal patients with type 2 diabetes will be examined, including:

    1. Anti-hyperglycemic medications
    2. Anti-hypertensive medications
    3. Lipid lowering medications
    4. Anti-coagulants (ASA, warfarin, etc.)

    It is hypothesized that the adherence to recommended control and prevention of complications will be increased since physicians participate in E4E intervention.


  • Diabetes counseling and education--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]

    Diabetes counseling and education that physicians provide to their Aboriginal patients with type 2 diabetes will be examined, including:

    1. exercises
    2. weight
    3. diet
    4. smoking cessation
    5. hypoglycemic event
    6. adjustment of treatment plan
    7. use of traditional medicine

    It is hypothesized that the adherence to recommended patient counseling and education will be increased since physicians participate in E4E intervention.


  • Documentation of self-management goals--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    Self-management goal is an indicator of efficacy of Aboriginal diabetic patients to self-management. It is hypothesized that Aboriginal patients with type 2 diabetes meet self-management goal better since their physicians participate in the E4E intervention.

  • Psychosocial self-efficacy scale of Aboriginal patients with type 2 diabetes (Diabetes Empowerment Scale Short Form)--change is being assessed [ Time Frame: within 2 weeks after the E4E workshop; 1 year after the completion of E4E intervention ] [ Designated as safety issue: No ]

    Psychosocial self-efficacy scale of Aboriginal patients with type 2 diabetes will be examined through a Diabetes Empowerment Scale Short Form (DES SF)*. It is hypothesized that Aboriginal patients with type 2 diabetes will improve psychosocial self-efficacy since their physicians participate in the E4E intervention.

    * Anderson RM, Fitzgerald JT, Gruppen LD, Funnel MM, Oh MS. Diabetes Empowerment Scale Short Form (DSL SF). Diabetes Care 2003, 26(5):1641-2.


  • Patient experiences of healthcare service (Canadian Institute of Health Information (CIHI) Patient Experience Survey)--change is being assessed [ Time Frame: within 2 weeks after the E4E workshop; 1 year later after the completion of E4E intervention ] [ Designated as safety issue: No ]

    Patients' healthcare experience will be assessed using the CIHI Patient Experience Survey* and the Diabetes Empowerment Scale Short Form immediately after the E4E workshops being delivered and one year after the workshops. A co-primary outcome is Summary Patient Experience Score. It is hypothesized that Aboriginal patients will have better healthcare experiences with their physicians who participated in the E4E intervention.

    * CIHI (2012). "Measuring Patient Experiences in Primary Health Care Survey". Retrieved September 10, 2013. Available at http://www.cihi.ca/CIHI-ext-portal/pdf/internet/INFO_PHC_PATIENT_EN



Other Outcome Measures:
  • Clinic visits--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    number of visits to healthcare providers is an indicator of adherence to control and prevention of complications. It is hypothesized that Aboriginal patients will increase visits to family physicians and allied healthcare providers (nurse, dietitian, social worker, pharmacist, diabetes nurse educator, traditional healer, etc.) since physicians participate in E4E intervention.

  • Referrals (to whom and date)--change is being assessed [ Time Frame: a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention ] [ Designated as safety issue: No ]
    Physician's referral of their Aboriginal patients with type 2 diabetes to other healthcare providers is an indicator of adherence to control and prevention of complications. It is hypothesized that since participating in E4E intervention, physicians will increase referral to a wider range of healthcare professionals such as diabetes specialist, diabetes education center (DEC), diabetes educator, pedorthist, chiropodist, optometrist, ophthalmologist, nephrologist, cardiology, EMG/Neurologist, dietician, urologist, internist, traditional healer, etc.


Estimated Enrollment: 860
Study Start Date: June 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E4E Intervention Group
E4E Intervention Group is a group of family physicians who will participate in the first wave of E4E intervention.
Other: E4E intervention
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.
Other Name: E4E continuing medical educational intervention
Sham Comparator: E4E Late Intervention Control Group
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
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.
Other Name: E4E continuing medical educational intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Family physicians Inclusion criteria

    • 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.

    Exclusion criteria:

    • Locum physician or plan to relocate before the study is completed

  2. Patient chart inclusion criteria:

    Inclusion criteria

    • 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)

    Exclusion criteria:

    • <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
  3. Patients participating in Patient Experience Survey

    Inclusion criteria:

    • 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
    • Patients participating in interviews.

    Exclusion criteria:

    • <18 years of age
    • Living in a nursing home
    • Type 1 diabetes or gestational diabetes diagnosis or impaired glucose
    • Not self-identified as Aboriginal population
  4. Patient participating in interview Inclusion and exclusion criteria: same as the above (3) inclusion criteria. Exclusion Criteria: same as the above (3) exclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989962

Contacts
Contact: Michael Green, MD 613-533-6000 ext 77098 michael.green@dfm.queensu.ca
Contact: Han Han, PhD 613-533-9300 ext 79605 han.han@dfm.queensu.ca

Locations
Canada, Ontario
Centre for Studies in Primary Care, Department of Family Medicine, Queen's University Not yet recruiting
Kingston, Ontario, Canada, K7L 5E9
Principal Investigator: Michael Green, MD         
Sponsors and Collaborators
Queen's University
University of Calgary
Laurentian University
University of British Columbia
Investigators
Principal Investigator: Michael Green, MD Queen's University
  More Information

No publications provided

Responsible Party: Michael Green, Associate Professor, Director for Centre for Health Services and Policy Research, Associate Director for Centre for Studies in Primary Care, Queen's University
ClinicalTrials.gov Identifier: NCT01989962     History of Changes
Other Study ID Numbers: EPID-439-13-E4E
Study First Received: October 15, 2013
Last Updated: May 6, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Queen's University:
Aboriginal Health
Diabetes Mellitus Type 2
Cultural Competency
Continuing Medical Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014