Trial Outcomes & Findings for Advancing Insulin Prescribing in General Practice (NCT NCT00593489)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

154 participants

Primary outcome timeframe

12 months

Results posted on

2020-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Basal Insulin Strategy Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care usual care - no intervention
Allocation STARTED	75	79
Allocation COMPLETED	73	78
Allocation NOT COMPLETED	2	1
Analysis STARTED	73	78
Analysis COMPLETED	73	78
Analysis NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Basal Insulin Strategy Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care usual care - no intervention
Allocation did not attend workshop; allocation not	2	1

Baseline Characteristics

Advancing Insulin Prescribing in General Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basal Insulin Strategy n=75 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=79 Participants usual care - no intervention	Total n=154 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 8.81 • n=5 Participants	48.2 years STANDARD_DEVIATION 9.06 • n=7 Participants	49.6 years STANDARD_DEVIATION 9.12 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	59 Participants n=7 Participants	112 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=73 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=78 Participants usual care - no intervention
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	2.29 patients per year Standard Error 0.25

SECONDARY outcome

Timeframe: 15 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=73 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=76 Participants usual care - no intervention
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop Workshop	7.12 Mean % glycolyslated hemoglobin per FP Standard Deviation 0.42	7.20 Mean % glycolyslated hemoglobin per FP Standard Deviation 0.52
Mean A1C of Insulin-eligible Patient Per Family Physician Post-Workshop End of Study	7.09 Mean % glycolyslated hemoglobin per FP Standard Deviation 0.41	7.15 Mean % glycolyslated hemoglobin per FP Standard Deviation 0.51

SECONDARY outcome

Timeframe: 15 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=71 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=70 Participants usual care - no intervention
Mean Fasting Blood Glucose of Insulin-eligible Patients Workshop	7.86 mean mmol/L per physician Standard Deviation 0.67	7.89 mean mmol/L per physician Standard Deviation 0.69
Mean Fasting Blood Glucose of Insulin-eligible Patients End of Study	7.78 mean mmol/L per physician Standard Deviation 0.68	7.82 mean mmol/L per physician Standard Deviation 0.68

SECONDARY outcome

Timeframe: 12 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=73 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=76 Participants usual care - no intervention
Percent of Insulin-eligible Patients With Intensification of Diabetes Management Per FP Post - Workshop	31.59 % of pts with intensification per FP Standard Deviation 14.17	32.80 % of pts with intensification per FP Standard Deviation 14.91

SECONDARY outcome

Timeframe: 15 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=73 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=76 Participants usual care - no intervention
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP Workshop	58.4 percentage of patients per physician Standard Deviation 16.20	55.95 percentage of patients per physician Standard Deviation 15.65
Percentage of Patients at Target (A1C ≤ 7.0%) Per FP End of Study	58.68 percentage of patients per physician Standard Deviation 15.40	57.58 percentage of patients per physician Standard Deviation 16.12

SECONDARY outcome

Timeframe: 15 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=70 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=73 Participants usual care - no intervention
Percent of Patients at Target (A1C ≤ 6.5%) Per FP At time of Workshop	36.76 percent of patients per physician Standard Deviation 14.95	36.62 percent of patients per physician Standard Deviation 12.55
Percent of Patients at Target (A1C ≤ 6.5%) Per FP 15 months post Workshop	36.13 percent of patients per physician Standard Deviation 15.06	36.61 percent of patients per physician Standard Deviation 14.28

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=39 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=44 Participants usual care - no intervention
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation Initiation	8.82 Mean % glycosylated hemoglobin per FP Standard Deviation 1.098	9.37 Mean % glycosylated hemoglobin per FP Standard Deviation 1.354
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation 3 months post initiation	8.32 Mean % glycosylated hemoglobin per FP Standard Deviation 1.24	9.05 Mean % glycosylated hemoglobin per FP Standard Deviation 1.344
Glycemic Control (A1C) at Insulin Initiation, 3 and 6 Months Post Initiation 6 months post initiation	7.97 Mean % glycosylated hemoglobin per FP Standard Deviation 1.003	8.57 Mean % glycosylated hemoglobin per FP Standard Deviation 1.382

SECONDARY outcome

Timeframe: 12 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=59 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=59 Participants usual care - no intervention
Physician Score for Knowledge of Insulin Initiation & Titration Pre-Workshop	15.5 units on a scale Standard Deviation 2.2	15.5 units on a scale Standard Deviation 2.5
Physician Score for Knowledge of Insulin Initiation & Titration Post-Workshop	16.3 units on a scale Standard Deviation 1.9	16.9 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 12 months

Population: The analysis of secondary data was based on available data"

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.

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=59 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=59 Participants usual care - no intervention
Physician Score for Attitude Towards Insulin Initiation & Titration Pre-Workshop	28.9 units on a scale Standard Deviation 4.9	29.7 units on a scale Standard Deviation 5.3
Physician Score for Attitude Towards Insulin Initiation & Titration Post-Workshop	26.1 units on a scale Standard Deviation 4.1	27.3 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 12 months

Population: The analysis of secondary data was based on available data

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

Outcome measures

Outcome measures
Measure	Basal Insulin Strategy n=59 Participants Basal Insulin Strategy 1. Support by community pharmacist 2. Support by diabetes specialist	Usual Care n=59 Participants usual care - no intervention
Physician Score for Self-efficacy of Insulin Initiation & Titration Pre Workshop	35.8 score on a scale Standard Deviation 4.67	35.7 score on a scale Standard Deviation 3.94
Physician Score for Self-efficacy of Insulin Initiation & Titration Post Workshop	40.6 score on a scale Standard Deviation 3.73	39.6 score on a scale Standard Deviation 4.0

Adverse Events

Basal Insulin Strategy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stewart Harris

Lawson Research Institute

Phone: 519 858-5028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place