Advancing Insulin Prescribing in General Practice

Diabetes Mellitus Clinical Trial

— AIM@GP  

Official title:

Advancing INSIGHT Methods in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593489
• Other study ID #: R-06-851
• Secondary ID: Lantu-L-01961
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: March 2010

Study information

• Verified date: November 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Sanofi

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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	15 months
Secondary	Mean Fasting Blood Glucose of Insulin-eligible Patients	mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop	15 months
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	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	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	15 months
Secondary	Change in "Insulin Prescription Rate"	change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop	12 months
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	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.	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.	12 months
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	12 months