跳至主要内容
临床试验/NCT01989962
NCT01989962Unknown2 期

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

Queen's University2 个研究点 分布在 1 个国家目标入组 860 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
860
试验地点
2
主要终点
Hemoglobin A1C values--change is being assessed

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

E4E Intervention Group

Experimental

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

干预措施: E4E intervention (Other)

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.

干预措施: E4E intervention (Other)

结局指标

主要结局

Hemoglobin A1C values--change is being assessed

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

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

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

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

次要结局

  • 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)
  • 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)
  • 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)
  • Documentation of self-management goals--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)
  • 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)
  • Diabetes counseling and education--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)
  • Psychosocial self-efficacy scale of Aboriginal patients with type 2 diabetes (Diabetes Empowerment Scale Short Form)--change is being assessed(within 2 weeks after the E4E workshop; 1 year after the completion of E4E intervention)
  • Patient experiences of healthcare service (Canadian Institute of Health Information (CIHI) Patient Experience Survey)--change is being assessed(within 2 weeks after the E4E workshop; 1 year later after the completion of E4E intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. 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

研究点 (2)

Loading locations...

相似试验