Harris 2013.
Study characteristics | ||
Methods |
Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial Clustered RCT (15 clusters and 154 providers), conducted in 1) Intervention conducted in family physician clinics and community pharmacies across Canada. The University of Western Ontario Centre for Studies in Family Medicine served as the co‐ordinating centre. 2) 15 diabetes specialist sites and 107 community pharmacists provided the intervention. In Canada. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (family physicians education on insulin initiation) (intervention arm) |
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Participants | Control arm N: 2788 Intervention arm N: 2858, NA, NA Diabetes type: 2 Mean age: 49.75 ± 5.9 % Male: 74.15 Longest follow‐up: 15 months |
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Interventions |
Control arm: (usual care) 1) Clinician education Intervention arm: (family physicians education on insulin initiation) 1) Audit and feedback 2) Team change 3) Clinician education 4) Clinician reminder |
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Outcomes | Glycated haemoglobin | |
Funding source | This study was sponsored by Sanofi‐Aventis including the provision of LantusW or NPH insulin to all insulinised patients for 6 months. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. All eligible physicians were stratified by the study geographic site and their level of comfort prescribing insulin (determined by questionnaire) and randomly allocated (1:1) in a blocked manner to an insulin initiation strategy (intervention) or usual care (control) by the co‐ordinating centre. Sanofi‐Aventis generated the mechanism used to implement the random allocation sequence. |
Allocation concealment (selection bias) | Low risk | Clustered RCT. Randomly allocated (1:1) in a blocked manner to an insulin initiation strategy (intervention) or usual care (control) by the co‐ordinating centre. |
Provider's baseline characteristics (selection bias) | High risk | Table 2. Some characteristics have P values at or under 0.05 (mean age, mean years in practice, CME attendance, mean number of patients seen per day per physician). |
Patient's baseline characteristics (selection bias) | Unclear risk | Not reported. |
Patient's baseline outcomes (selection bias) | Low risk | Table 3. All P values above 0.05. Patient summary data (Table 3) were computed for consenting patients (49.6% consent rate) and were comparable between study groups. |
Incomplete outcome data (attrition bias) | Unclear risk | The paper is unclear about the number of patients initially recruited. Out of the 75 physicians randomised to the intervention arm, 2 did not receive the workshop and 3 withdrew (6.7%). In the control arm, out of the 79 physicians, 1 physician did not attend the workshop and 3 withdrew (5.1%). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcome (HbA1c). |
Selective reporting (reporting bias) | High risk | Prospectively registered protocol (protocol first posted on January 2008, study was conducted from July 2006 to April 2010). Not reported in paper: 1) mean A1C of insulin‐eligible patient per family physician post‐workshop (only provided baseline data). 2) Proportion of patients at target (A1C ≤ 6.5%) at time of the workshop and post, 2) mean glycaemic control (A1C, FPG) at insulin initiation, 3 months post initiation and 6 months post initiation (only in text). Also, physician scores for knowledge, attitude and self‐efficacy of glycaemia control insulin initiation and titration not reported. |
Risk of contamination (other bias) | Unclear risk | Risk of contamination of the control physicians could have occurred if they practiced in the same location as an intervention physician. However, this situation occurred for only 3 control physicians thus we do not believe it affected the overall results. Study sites hosted insulin initiation workshops for all physicians enrolled in the study to ensure comparable knowledge on the appropriate use of insulin therapy in T2DM. All physicians received a complete registry of insulin‐eligible patients in their practice. Pharmacists attended the same programme but were educated separately to avoid contamination. In addition, diabetes specialists and pharmacists did not provide support to the control physicians in the study. |
Other bias | Unclear risk | Participation bias may have led to the inclusion of physicians with a more active interest in insulin initiation. Pharmacist recruitment challenges delayed the start of the intervention for some physicians, perhaps impacting the intervention and potential outcomes. The estimated sample size of 89 physicians per group was not achieved hence the final results may have been underpowered. |