Advancing Insulin Prescribing in General Practice

Not Applicable

Completed

Conditions: Diabetes Mellitus

Interventions: Other: Basal Insulin Initiation Strategy

Registration Number: NCT00593489

Lead Sponsor: Lawson Health Research Institute

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

Inclusion Criteria

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)

Exclusion Criteria

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basal Insulin Initiation Strategy	Basal Insulin Initiation Strategy	Basal Insulin Initiation Strategy which includes: 1. support by community pharmacist 2. support by diabetes specialist

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop	15 months	mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
Physician Score for Knowledge of Insulin Initiation & Titration	12 months	physician score for knowledge of insulin initiation \& titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge.
Mean Fasting Blood Glucose of Insulin-eligible Patients	15 months	mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation	15 months	Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP	15 months	Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
Percent of Patients at Target (A1C ≤ 6.5%) Per FP	15 months	Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
Change in "Insulin Prescription Rate"	12 months	change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
Physician Score for Attitude Towards Insulin Initiation & Titration	12 months	physician score for attitude towards insulin initiation \& titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude.
Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop	12 months	Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop
Physician Score for Self-efficacy of Insulin Initiation & Titration	12 months	physician score for self-efficacy of insulin initiation \& titration where the minimum value was 10 and the maximum was 50. A value of 50 indicated complete self efficacy to initiate and titrate insulin