Advancing Insulin Prescribing in General Practice (AIM@GP)

Advancing INSIGHT Methods in General Practice

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Basal Insulin Initiation Strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • Lawson Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basal Insulin Initiation Strategy; Basal Insulin Initiation Strategy which includes: support by community pharmacist; support by diabetes specialist	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 Names: Support by Specialist and Pharmacist
No Intervention: Usual Practice; 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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Sanofi
• Investigators: Principal Investigator: Stewart B. Harris, MD MPH FCFP, Lawson Health Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Insulin; Diabetes Mellitus; Pharmacy; Preceptor; Practice Behaviour
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: R-06-851; Lantu-L-01961 (Other Grant/Funding Number: Sanofi-aventis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers