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Sponsors and Collaborators: |
Lawson Health Research Institute Sanofi-Aventis |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00593489 |
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.
Condition | Intervention |
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Diabetes Mellitus |
Other: Basal Insulin Initiation Strategy |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Advancing INSIGHT Methods in General Practice |
Estimated Enrollment: | 240 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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2: No Intervention |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Lawson Health Research Institute | |
London, Ontario, Canada, N6A 4G5 |
Principal Investigator: | Stewart B. Harris, MD MPH FCFP | Lawson Health Research Institute |
Responsible Party: | Lawson Health Research Institute ( Stewart Harris, Principal Investigator ) |
Study ID Numbers: | R-06-851, Lantu-L-01961 |
Study First Received: | January 4, 2008 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00593489 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Insulin Diabetes Mellitus Practice Behaviour Preceptor Pharmacy |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |