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临床试验/NCT00593489
NCT00593489已完成不适用

Advancing INSIGHT Methods in General Practice

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2006年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice

研究概览

简要总结

Family Physicians, the subjects of this trial are reluctant to initiate insulin in patients with type 2 diabetes due to a lack of familiarity and comfort with this clinical strategy. This study will test the effectiveness of diabetes specialist consultation support, and community pharmacy insulin initiation support on the insulin prescribing behaviour of family physicians across Canada.

详细描述

The 2003 Canadian Diabetes Association clinical practice guidelines recommend early and sustained glycemic control targeting an glycosylated hemoglobin (A1C) < 7%. The guideline target however is not achieved in 50% of patients with type 2 diabetes in the Canadian family practice setting. Family physicians are not comfortable initiating and managing insulin for their patients the Diabetes in Canada Evaluation (DICE) study found that only 12% of the 2473 patients audited were prescribed insulin; 6% insulin alone and 6% in combination. Harris et. al. found 20% of patients prescribed insulin, 15% insulin alone and 5% in combination. A strategy to increase physicians' knowledge, skill and comfort with insulin prescription is needed to better achieve glycemic control for patients with type 2 diabetes in Canada.

Purpose - The purpose of AIM@GP is to increase family physicians clinical experience and comfort with insulin prescription and better achieve glycemic control for patients with type 2 diabetes in Canada.

Primary Objective - To determine the effectiveness of a Basal Insulin Initiation strategy on family physician insulin prescribing behaviour. The strategy, using a multifaceted behaviour facilitation approach, includes diabetes specialist consultation support, and community pharmacy insulin initiation support.

Study Design - The study design is a stratified, parallel group, randomized control effectiveness study. All physicians will attend an insulin education workshop where they will receive a Diabetes Practice Profile and randomly allocated in a 1:1 manner into the intervention or control group.

研究设计

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

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Full time family physicians (FP) >25 hours per week in office
  • •Ability to generate a listing of patients with type 2 diabetes (T2DM) from their practice or billing records.
  • •Generation of a practice list of patients with T2DM
  • •A minimum of 50 patients with type 2 diabetes in their practice.
  • •Support the generation of a Diabetes Practice Profile prior to the deadline established
  • •A minimum of 6 insulin-eligible patients
  • •Attendance at the scheduled Workshop (if unable to attend the Workshop must be available to be educated and trained by diabetes nurse educator(DNE) using a Workshop DVD)

排除标准

  • •FP does not attend Workshop or complete educational training using Workshop DVD with DNE guidance
  • •FPs who anticipate retiring within the post-intervention period, moving their practice to another city, or having locum coverage of their practice for more than 4 weeks during the post-intervention period
  • •FPs currently participating in a diabetes behaviour-change intervention trial
  • •FPs working in an academic environment
  • •FPs unlikely to comply with protocol, (uncooperative attitude, unlikelihood of completing the study).

研究组 & 干预措施

Basal Insulin Initiation Strategy

Experimental

Basal Insulin Initiation Strategy which includes:

  1. support by community pharmacist
  2. support by diabetes specialist

干预措施: Basal Insulin Initiation Strategy (Other)

Usual Practice

No Intervention

The physicians randomized to this group proceeded with their usual practice

结局指标

主要结局

Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice

时间窗: 12 months

Insulin Prescription Rate (IPR) - the number of insulin-eligible patients per 12 months who are prescribed insulin in each family physician (FP) practice (Number of patients per year per FP). The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate.

次要结局

  • Physician Score for Knowledge of Insulin Initiation & Titration(12 months)
  • Physician Score for Self-efficacy of Insulin Initiation & Titration(12 months)
  • Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop(15 months)
  • Mean Fasting Blood Glucose of Insulin-eligible Patients(15 months)
  • Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation(15 months)
  • Percentage of Patients at Target (A1C ≤ 7.0%) Per FP(15 months)
  • Percent of Patients at Target (A1C ≤ 6.5%) Per FP(15 months)
  • Change in "Insulin Prescription Rate"(12 months)
  • Physician Score for Attitude Towards Insulin Initiation & Titration(12 months)
  • Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop(12 months)

研究者

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

Stewart Harris

Professor, Family Medicine

Lawson Health Research Institute

研究点 (1)

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