Advancing Insulin Prescribing in General Practice

NCT ID: NCT00593489

Last Updated: 2020-12-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Keywords

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Insulin Diabetes Mellitus Practice Behaviour Preceptor Pharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Basal Insulin Initiation Strategy

Basal Insulin Initiation Strategy which includes:

1. support by community pharmacist
2. support by diabetes specialist

Group Type EXPERIMENTAL

Basal Insulin Initiation Strategy

Intervention Type OTHER

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.

Usual Practice

The physicians randomized to this group proceeded with their usual practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Support by Specialist and Pharmacist

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Stewart Harris

Professor, Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stewart B. Harris, MD MPH FCFP

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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Lawson Health Research Institute

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 12836867 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 23433347 (View on PubMed)

Other Identifiers

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Lantu-L-01961

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R-06-851

Identifier Type: -

Identifier Source: org_study_id