Diabetes Mellitus Type 2 Clinical Trial
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
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.
Two waves of the E4E intervention will be delivered to family physicians who have Aboriginal
patients with type 2 diabetes on and off reserves. A mix-method approach will be employed in
this evaluation study. Evaluation instruments include: (1) chart reviews and (2) patient
experience surveys.
1. Chart review: A randomized, controlled, pre- and post intervention study design will be
used to evaluate the effect of the E4E intervention on type 2 diabetes clinical
outcomes of the Aboriginal patients. A retrospective chart audit will be used to gather
the clinical data from 12 months prior to and 12 month after the intervention, not
including the time during intervention.
Sample Size for chart review: The primary outcome measure of HbA1C value will be used
to identify the impact of E4E intervention on the clinical outcome of Aboriginal
patients with type 2 diabetes. It is hypothesized that the A1C value would be reduced
in the E4E Intervention Group's patients whose A1C values are at or above 8.0% prior to
the E4E intervention (baseline) compared to the patients in E4E Late Intervention
Control Group. A 0.5% difference of patients' A1C values between these two groups will
be a clinically significant difference. The sample size needed to detect such a
difference is estimated to be 98 eligible patients charts with A1C at or above 8.0%
from E4E Intervention Group and 98 eligible patient charts from E4E Late Intervention
Control Group, with an a=0.05 and ß=0.15. Given the proportion of 61.1% of Aboriginal
patients with type 2 diabetes having A1C at or above 8.0%, we need to review 163
patient charts to obtain 98 eligible charts from each group. When 10 charts extractions
per physician are performed, we need 17 physicians from each group. Considering a
possible 20% loss to follow up, we need to recruit 20 physicians from E4E Intervention
Group and 20 physicians from E4E Late Intervention Control Group, a total of 40
physicians to be invited to participate in chart reviews.
Recruitment of physicians: After obtaining ethics approval from Queen's University
Research Office, we will recruit 8-10 physicians to participate in the project at each
potential site. Once recruitment is completed on each site, physicians will be
randomized into E4E Intervention Group and E4E Late Intervention Control Group (sham
comparator) who will participate in the second wave of E4E intervention 12 month later.
Letters of information and consent form will be sent to the physicians to obtain their
signed consent to participating in E4E chart review, patient survey and patient
interview.
Data collection regarding chart reviews for diabetes: The evaluation team will require
the consenting physicians to create a list of all of their Aboriginal patients with
type 2 diabetes using billing code 250, removing non-Aboriginal patients. This process
can either be managed by the practice (with staff being reimbursed for time required)
or can be conducted by the research staff at time of the chart audit. Each physician
will then be asked to review the list for accuracy. Random number generation will be
used to select charts at random from the list until the required number of eligible
patient charts has been identified. Chart reviewers will be trained staff from the
evaluation team and travel to each selected location to conduct chart audits.
2. Patient experience survey: Two (2) patient experience surveys will be conducted to
evaluate the experience of Aboriginal patient with type 2 diabetes with his/her
physician, respectively at the point of 3-month after the E4E intervention and at the
point of 12-month after the intervention.
Sample size for patient experience surveys: An effective sample size needed for patient
experience survey, with an a=0.05 and power 85% (ß=0.15), is estimated to be 102 eligible
Aboriginal type 2 diabetic patients from E4E Intervention Group and the same number of
eligible Aboriginal patients from E4E Late Intervention Control Group. We will recruit 10
eligible Aboriginal patients from each of the physicians in E4E Group A and 10 eligible
Aboriginal patients from each of the physicians in E4E Group B. A total of 400 patients will
be recruited to participate in Patient Experience surveys. This sample size (200 from each
group) is more than sufficient to achieve 85% power even after allowing for drop out of
physicians and any unanticipated difficulties in patient recruitment.
Data collection regarding patient experience surveys: The Patient Experience Surveys will
take approximately 15-20 minutes to complete and will be completed on the day of patient
visit. Patient Experience Survey is designed in two sections: pre-visit section and post
visit section. Consent needs to be obtained from patients in pre-visit section.
- The receptionist of the selected practice will notify eligible patients about the
study, and ask if they are willing to discuss with support/research staff about
participating in a Patient Experience Survey. If the patient is interested, the
receptionist will refer her/him to the onsite support/research staff, or provide access
to a private phone with toll free number to contact support/research staff.
- Support/Research staff will review the information letter with the patient and obtain
informed consent.
- The patient completes the pre-visit section and sign on the consent before seeing the
doctor.
- After seeing the doctor, the patient will be asked to complete the post-visit survey
and return it to the support/research staff before leaving the clinic. For patients who
are not able to do so, they will be offered a choice to complete the survey by toll
free telephone or fill in a hard copy of questionnaire and mail it out by pre-paid
mail.
- Regular updates will be performed during data collection process to keep tack of
patients participation in the survey.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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