Advancing Insulin Prescribing in General Practice - Full Text View

Sponsors and Collaborators:	Lawson Health Research Institute Sanofi-Aventis
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00593489

Purpose

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.

Condition	Intervention
Diabetes Mellitus	Other: Basal Insulin Initiation Strategy

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Advancing INSIGHT Methods in General Practice

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	240
Study Start Date:	July 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: No Intervention

Arms

Assigned Interventions

1: Experimental

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.

2: No Intervention

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593489

Contacts

Contact: Stewart B. Harris, MD MPH FCFP	519 858-5028	sharris1@uwo.ca
Contact: Susan Webster-Bogaert, MA	519 661-2111 ext 22105	mwebster@uwo.ca

Locations

Canada, Ontario
Lawson Health Research Institute	Recruiting
London, Ontario, Canada, N6A 4G5
Principal Investigator: Stewart B. Harris, MD MPH FCFP

Sponsors and Collaborators

Lawson Health Research Institute

Sanofi-Aventis

Investigators

Principal Investigator:

Stewart B. Harris, MD MPH FCFP

Lawson Health Research Institute

More Information

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.

Responsible Party:	Lawson Health Research Institute ( Stewart Harris, Principal Investigator )
Study ID Numbers:	R-06-851, Lantu-L-01961
Study First Received:	January 4, 2008
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00593489
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Insulin
Diabetes Mellitus
Practice Behaviour
Preceptor
Pharmacy

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009