Diabetes Mellitus Type 2 Clinical Trial
— E4EOfficial 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
Verified date | October 2015 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Canadian Institutes of Health Research |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 860 |
Est. completion date | November 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Studies in Primary Care, Department of Family Medicine, Queen's University | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University | Laurentian University, University of British Columbia, University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinic visits--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Other | Referrals (to whom and date)--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | Diabetes process of care measures (date only)--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Secondary | Other laboratory tests (values and date)--change is being assessed | 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: Triglycerides HDL LDL Total cholesterol: HDL Total cholesterol eGFR/Creatinine Clearance Serum Creatinine A:C ratio 24 hour urine It is hypothesized that adherence to recommended tests and test results will be improved since physicians participate in the E4E intervention. |
a 12-month period prior to the start of the E4E intervention; a 12-month period after completion of the E4E intervention | No |
Secondary | Blood pressure (systolic, diastolic, date)--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention | No |
Secondary | BMI (value, date)--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Secondary | Medications--change is being assessed | Medications that physicians prescribe for their Aboriginal patients with type 2 diabetes will be examined, including: Anti-hyperglycemic medications Anti-hypertensive medications Lipid lowering medications 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. |
a 12-month period prior to the start of E4E intervention; a 12-month period post completion of E4E intervention | No |
Secondary | Diabetes counseling and education--change is being assessed | Diabetes counseling and education that physicians provide to their Aboriginal patients with type 2 diabetes will be examined, including: exercises weight diet smoking cessation hypoglycemic event adjustment of treatment plan 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. |
a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Secondary | Documentation of self-management goals--change is being assessed | 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. | a 12-month period prior to the start of E4E intervention; a 12-month period post the completion of E4E intervention | No |
Secondary | Psychosocial self-efficacy scale of Aboriginal patients with type 2 diabetes (Diabetes Empowerment Scale Short Form)--change is being assessed | 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. |
within 2 weeks after the E4E workshop; 1 year after the completion of E4E intervention | No |
Secondary | Patient experiences of healthcare service (Canadian Institute of Health Information (CIHI) Patient Experience Survey)--change is being assessed | 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 |
within 2 weeks after the E4E workshop; 1 year later after the completion of E4E intervention | No |
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