Advancing Insulin Prescribing in General Practice (AIM@GP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00593489
First received: January 4, 2008
Last updated: July 6, 2009
Last verified: July 2009

January 4, 2008
July 6, 2009
July 2006
March 2010   (final data collection date for primary outcome measure)
Insulin Prescription Rate - the number of insulin-eligible patients per 12 months who are prescribed insulin in each FP practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00593489 on ClinicalTrials.gov Archive Site
  • mean A1C of insulin-eligible patient per family physician post-Workshop [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • mean FBG of insulin-eligible patient per family physician post-Workshop [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Proportion of insulin-eligible patients with intensification of diabetes management (increase dose of OAD or insulin, OAD score, the addition of insulin) per FP post - Workshop [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • proportion of patients at target (≤ 7.0%) at time of the Workshop and post - Workshop [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • proportion of patients at target (≤ 6.5%) at time of the Workshop and post - Workshop [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • mean glycemic control (A1C, FPG) at insulin initiation, 3 months post initiation and 6 months post initiation; [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • physician score for knowledge of glycemia control and insulin initiation & titration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • physician score for attitude towards glycemia control insulin initiation & titration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • physician score for self-efficacy of glycemia control insulin initiation & titration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Advancing Insulin Prescribing in General Practice
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Diabetes Mellitus
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 Name: Support by Specialist and Pharmacist
  • Experimental: Basal Insulin Initiation Strategy
    Intervention: Other: Basal Insulin Initiation Strategy
  • No Intervention: Usual Practice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full time physicians >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 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).
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00593489
R-06-851, Lantu-L-01961
No
Stewart Harris, Principal Investigator, Lawson Health Research Institute
Lawson Health Research Institute
Sanofi
Principal Investigator: Stewart B. Harris, MD MPH FCFP Lawson Health Research Institute
Lawson Health Research Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP