Clinical trial NCT00593489: Advancing Insulin Prescribing in General Practice
Official title: Advancing INSIGHT Methods in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Insulin
Diabetes Mellitus
Practice Behaviour
Preceptor
Pharmacy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-01-15
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice
timeFrame: 12 months
Secondary outcomes:
measure: Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop
timeFrame: 15 months
measure: Mean Fasting Blood Glucose of Insulin-eligible Patients
timeFrame: 15 months
measure: Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop
timeFrame: 12 months
measure: Percentage of Patients at Target (A1C ≤ 7.0%) Per FP
timeFrame: 15 months
measure: Percent of Patients at Target (A1C ≤ 6.5%) Per FP
timeFrame: 15 months
measure: Change in "Insulin Prescription Rate"
timeFrame: 12 months
measure: Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation
timeFrame: 15 months
measure: Physician Score for Knowledge of Insulin Initiation & Titration
timeFrame: 12 months
measure: Physician Score for Attitude Towards Insulin Initiation & Titration
timeFrame: 12 months
measure: Physician Score for Self-efficacy of Insulin Initiation & Titration
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Stewart B. Harris, MD MPH FCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.