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Diabetes MellitusAIM@GPNCT00593489

Advancing Insulin Prescribing in General Practice

A study testing Basal Insulin Initiation Strategy in people with Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Basal Insulin Initiation Strategy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteCanada
Study dates
Jul 2006to Mar 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Lawson Health Research Institute

    London, Ontario, N6A 4G5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Basal Insulin Initiation Strategy
Keywords
Insulin, Diabetes Mellitus, Practice Behaviour, Preceptor, Pharmacy
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basal Insulin Initiation StrategyOther

    Also called Support by Specialist and Pharmacist

    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.

Study groups in NCT00593489
Study groupRoleWhat they receive
Basal Insulin Initiation StrategyExperimentalBasal Insulin Initiation Strategy which includes: 1. support by community pharmacist 2. support by diabetes specialist
Receives: Other: Basal Insulin Initiation Strategy
Usual PracticeNo interventionThe physicians randomized to this group proceeded with their usual practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)

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

    mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period

    Measured: 15 months

  2. Mean Fasting Blood Glucose of Insulin-eligible Patients

    mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop

    Measured: 15 months

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

    Percent of insulin-eligible patients with intensification of diabetes management (increase dose of oral anti-diabetes drug (OAD) or insulin, OAD score, the addition of insulin) per FP post - Workshop

    Measured: 12 months

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

    Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop

    Measured: 15 months

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

    Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop

    Measured: 15 months

  6. Change in "Insulin Prescription Rate"

    change in "Insulin Prescription Rate" from baseline prior to the Workshop to 12 months post - Workshop

    Measured: 12 months

  7. Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation

    Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician

    Measured: 15 months

  8. Physician Score for Knowledge of Insulin Initiation & Titration

    physician score for knowledge of insulin initiation \& titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge.

    Measured: 12 months

  9. Physician Score for Attitude Towards Insulin Initiation & Titration

    physician score for attitude towards insulin initiation \& titration The minimum score is 11 and the maximum is 55 with a lower score indicating the ideal attitude.

    Measured: 12 months

  10. Physician Score for Self-efficacy of Insulin Initiation & Titration

    physician score for self-efficacy of insulin initiation \& titration where the minimum value was 10 and the maximum was 50. A value of 50 indicated complete self efficacy to initiate and titrate insulin

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00593489
Sponsor's protocol ID
R-06-851
Other IDs
Lantu-L-01961
Acronym
AIM@GP
Status last verified
Nov 2020
First submitted
4 Jan 2008
Last updated
3 Dec 2020
Data monitoring committee
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers

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.

    PubMed 12836867

  • 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.

  • 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.

    PubMed 23433347

Questions about this trial

What is this clinical trial studying?

A study testing Basal Insulin Initiation Strategy in people with Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00593489, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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