Advancing Insulin Prescribing in General Practice

NCT00593489 | Completed Results

• 2 other identifiers: R-06-851Lantu-L-01961
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Insulin; Diabetes Mellitus; Practice Behaviour; Preceptor; Pharmacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop

  15 months

• Mean Fasting Blood Glucose of Insulin-eligible Patients

  15 months

• Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop

  12 months

• Percentage of Patients at Target (A1C ≤ 7.0%) Per FP

  15 months

• Percent of Patients at Target (A1C ≤ 6.5%) Per FP

  15 months

Study Arms (2)

Basal Insulin Initiation Strategy

EXPERIMENTAL

Basal Insulin Initiation Strategy which includes: 1. support by community pharmacist 2. support by diabetes specialist

Other: Basal Insulin Initiation Strategy

Usual Practice

NO INTERVENTION

The physicians randomized to this group proceeded with their usual practice

Interventions

Basal Insulin Initiation Strategy 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.

Also known as: Support by Specialist and Pharmacist

Basal Insulin Initiation Strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Sanofi: collaborator

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6A 4G5, Canada

Location

Related Publications (3)

• 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.

  PMID: 12836867 BACKGROUND

• 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.

  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.

  PMID: 23433347 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

The estimated sample size of 89 physicians/group was not achieved hence the final results may have been under-powered

Results Point of Contact

• Title: Dr. Stewart Harris
• Organization: Lawson Research Institute

sharris1@uwo.ca

519 858-5028

Study Officials

• Stewart B. Harris, MD MPH FCFP

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Family Medicine

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)