Advancing Insulin Prescribing in General Practice (AIM@GP)
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|ClinicalTrials.gov Identifier: NCT00593489|
Recruitment Status : Unknown
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : January 15, 2008
Last Update Posted : July 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Basal Insulin Initiation Strategy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advancing INSIGHT Methods in General Practice|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||March 2010|
|Experimental: Basal Insulin Initiation Strategy||
Other: Basal Insulin Initiation Strategy
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.
Other Name: Support by Specialist and Pharmacist
|No Intervention: Usual Practice|
- Insulin Prescription Rate - the number of insulin-eligible patients per 12 months who are prescribed insulin in each FP practice [ Time Frame: 12 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593489
|Lawson Health Research Institute|
|London, Ontario, Canada, N6A 4G5|
|Principal Investigator:||Stewart B. Harris, MD MPH FCFP||Lawson Health Research Institute|