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| ID | Type | Description | Link |
|---|---|---|---|
| Lantu-L-01961 | Other Grant/Funding Number | Sanofi-aventis |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basal Insulin Initiation Strategy | Experimental | Basal Insulin Initiation Strategy which includes:
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| Usual Practice | No Intervention | The physicians randomized to this group proceeded with their usual practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basal Insulin Initiation Strategy | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stewart B. Harris, MD MPH FCFP | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lawson Health Research Institute | London | Ontario | N6A 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12836867 | Background | Harris SB, Stewart M, Brown JB, Wetmore S, Faulds C, Webster-Bogaert S, Porter S. Type 2 diabetes in family practice. Room for improvement. Can Fam Physician. 2003 Jun;49:778-85. | |
| Background | Harris, Stewart B., Ekoe, J. M., and Webster-Bogaert, M. S. The Diabetes in Canada Evaluation (DICE) Study: Are Primary Care Physicians Achieving Target A1c? Diabetes 52(Supplement 1), A499. 2003. | ||
| 23433347 |
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There is no plan to make individual participant data available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Basal Insulin Strategy | Basal Insulin Strategy
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| FG001 | Usual Care | usual care - no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
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| Analysis |
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Number of physicians randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Basal Insulin Strategy | Basal Insulin Strategy
|
| BG001 | Usual Care | usual care - no intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | patients per year | 12 months |
|
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ClinicalTrials.gov definition of adverse event (AE) is not applicable as the intervention was directed towards changing physician behaviour.
Non-systematic Assessment was chosen Collection Approach for Table Default because it was a required field
AE information was not gathered so zeros were entered for Numbers of Patients Affected and Numbers of Participants at Risk of AE. Zero was entered into Frequency Threshold for Reporting Other Adverse Events because it required a response.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basal Insulin Strategy | Basal Insulin Strategy
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The estimated sample size of 89 physicians/group was not achieved hence the final results may have been under-powered
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stewart Harris | Lawson Research Institute | 519 858-5028 | sharris1@uwo.ca |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010595 | Pharmacists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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|
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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 |
| Derived |
| Harris SB, Gerstein HC, Yale JF, Berard L, Stewart J, Webster-Bogaert S, Tompkins JW. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial. BMC Health Serv Res. 2013 Feb 21;13:71. doi: 10.1186/1472-6963-13-71. |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | The gender of the physician was ascertained by questionnaire and by direct communication | Count of Participants | Participants |
|
usual care - no intervention
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| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | Mean % glycolyslated hemoglobin per FP | 15 months |
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|
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| Secondary | Mean Fasting Blood Glucose of Insulin-eligible Patients | mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | mean mmol/L per physician | 15 months |
|
|
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| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | % of pts with intensification per FP | 12 months |
|
|
|
| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | percentage of patients per physician | 15 months |
|
|
|
| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | percent of patients per physician | 15 months |
|
|
|
| Secondary | Change in "Insulin Prescription Rate" | change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop | In an updated version of the statistical analysis plan this variable was not calculated from the data set and not included in the analysis | Posted | 12 months |
|
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| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | Mean % glycosylated hemoglobin per FP | 15 months |
|
|
|
| Secondary | 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. | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | 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. | The analysis of secondary data was based on available data" | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
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| Secondary | 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 | The analysis of secondary data was based on available data | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | usual care used as the control | 0 | 0 | 0 | 0 |
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| D006946 | Hyperinsulinism |
| 6 months post initiation |
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