Advancing Insulin Prescribing in General Practice

Advancing INSIGHT Methods in General Practice

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00593489

Acronym

AIM@GP

Enrollment

154

Registered

2008-01-15

Start date

2006-07-31

Completion date

2010-03-31

Last updated

2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Insulin, Diabetes Mellitus, Practice Behaviour, Preceptor, Pharmacy

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.

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.

Interventions

OTHERBasal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice	12 months	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.

Secondary

Measure	Time frame	Description
Mean Fasting Blood Glucose of Insulin-eligible Patients	15 months	mean fasting blood glucose (FBG) of insulin-eligible patient per family physician post-Workshop
Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop	12 months	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
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP	15 months	Percentage of patients at target (A1C ≤ 7.0%) per FP at time of the Workshop and post - Workshop
Percent of Patients at Target (A1C ≤ 6.5%) Per FP	15 months	Percent of patients at target (A1C ≤ 6.5%) per FP at time of the Workshop and post - Workshop
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop	15 months	mean A1C of insulin-eligible patient per family physician participant during the post-Workshop period
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation	15 months	Glycemic control (A1C) at insulin initiation, 3 months post initiation and 6 months post initiation for those prescribed insulin per family physician
Physician Score for Knowledge of Insulin Initiation & Titration	12 months	physician score for knowledge of insulin initiation & titration minimum score of 0 maximum score of 17. The greater the score the greater the knowledge.
Physician Score for Attitude Towards Insulin Initiation & Titration	12 months	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.
Physician Score for Self-efficacy of Insulin Initiation & Titration	12 months	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
Change in Insulin Prescription Rate	12 months	change in Insulin Prescription Rate from baseline prior to the Workshop to 12 months post - Workshop

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Basal Insulin Strategy Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	75
Usual Care usual care - no intervention	79
Total	154

Withdrawals & dropouts

Period	Reason	FG000	FG001
Allocation	did not attend workshop; allocation not	2	1

Baseline characteristics

Characteristic	Basal Insulin Strategy	Usual Care	Total
Age, Continuous	51.4 years STANDARD_DEVIATION 8.81	48.2 years STANDARD_DEVIATION 9.06	49.6 years STANDARD_DEVIATION 9.12
Sex: Female, Male Female	22 Participants	20 Participants	42 Participants
Sex: Female, Male Male	53 Participants	59 Participants	112 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.

Time frame: 12 months

Arm	Measure	Value (MEAN)	Dispersion
Basal Insulin Strategy	Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice	2.28 patients per year	Standard Error 0.27
Usual Care	Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice	2.29 patients per year	Standard Error 0.25

Comparison: The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariatep-value: 0.9695% CI: [0.8, 1.24]Poisson Regression

Secondary

Change in Insulin Prescription Rate

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

Time frame: 12 months

Population: In an updated version of the statistical analysis plan this variable was not calculated from the data set and not included in the analysis

Secondary

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

Time frame: 15 months