Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatment basal insulin initiation strategy
Sponsor Lawson Health Research Institute
Collaborator Sanofi
Start date July 2006
End date March 2010
Trial size 240 participants
Trial identifier NCT00593489, Lantu-L-01961, R-06-851

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
basal insulin initiation strategy Support by Specialist and Pharmacist
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.
(No Intervention)

Primary Outcomes

Measure
Insulin Prescription Rate - the number of insulin-eligible patients per 12 months who are prescribed insulin in each FP practice
time frame: 12 months

Secondary Outcomes

Measure
mean A1C of insulin-eligible patient per family physician post-Workshop
time frame: 14 months
mean FBG of insulin-eligible patient per family physician post-Workshop
time frame: 14 months
Proportion of insulin-eligible patients with intensification of diabetes management (increase dose of OAD or insulin, OAD score, the addition of insulin) per FP post - Workshop
time frame: 12 months
proportion of patients at target (≤ 7.0%) at time of the Workshop and post - Workshop
time frame: 14 months
proportion of patients at target (≤ 6.5%) at time of the Workshop and post - Workshop
time frame: 14 months
change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop
time frame: 12 months
mean glycemic control (A1C, FPG) at insulin initiation, 3 months post initiation and 6 months post initiation;
time frame: 14 months
physician score for knowledge of glycemia control and insulin initiation & titration
time frame: 12 months
physician score for attitude towards glycemia control insulin initiation & titration
time frame: 12 months
physician score for self-efficacy of glycemia control insulin initiation & titration
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Full time physicians >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 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).

Additional Information

Official title Advancing INSIGHT Methods in General Practice
Principal investigator Stewart B. Harris, MD MPH FCFP
Description The 2003 Canadian Diabetes Association clinical practice guidelines recommend early and sustained glycemic control targeting an 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 DICE study5 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.