Advancing Insulin Prescribing in General Practice

Study Overview
=================
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.

Official Title
-----------------
Advancing INSIGHT Methods in General Practice

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Basal Insulin Initiation Strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
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).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal Insulin Initiation Strategy<br>Basal Insulin Initiation Strategy which includes: support by community pharmacist support by diabetes specialist | Other: Basal Insulin Initiation Strategy<br>* This multifaceted intervention consists of (1) Diabetes Specialist Consultation Support which entails specialists and educators providing consultation for insulin initiation and titration for the 12 months following the Workshop. Support will consist of prearranged and scheduled communications to review and advise for the first 2 months and will continue on an ad hoc basis for the remaining 10 months, with communication initiated by the physician (2)Community Pharmacy Insulin Initiation consists of trained community pharmacists providing patient education insulin initiation. Education will consist of one individual teaching session, one hour in duration, to review the insulin prescription protocol, insulin injection method, management of hypoglycemia, and self-monitoring of blood glucose.<br>* Other names: Support by Specialist and Pharmacist;|
| No Intervention: Usual Practice<br>The physicians randomized to this group proceeded with their usual practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop | mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period | 15 months | 
| Mean Fasting Blood Glucose of Insulin-eligible Patients | mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop | 15 months | 
| Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop | 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 | 12 months | 
| Percentage of Patients at Target (A1C ≤ 7.0%) Per FP | Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop | 15 months | 
| Percent of Patients at Target (A1C ≤ 6.5%) Per FP | Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop | 15 months | 
| Change in Insulin Prescription Rate | change in Insulin Prescription Rate from baseline prior to the Workshop to 12 months post - Workshop | 12 months | 
| Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation | Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician | 15 months | 
| Physician Score for Knowledge of Insulin Initiation & Titration | physician score for knowledge of insulin initiation & titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge. | 12 months | 
| Physician Score for Attitude Towards Insulin Initiation & Titration | 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. | 12 months | 
| Physician Score for Self-efficacy of Insulin Initiation & Titration | 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 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, Diabetes Mellitus, Practice Behaviour, Preceptor, Pharmacy