Tsuyuki 2016.
Study characteristics | ||
Methods |
The effectiveness of pharmacist interventions on cardiovascular risk: the multicenter randomized controlled RxEACH trial RCT (NA clusters and NA providers), conducted in 1) The RxEACH study was conducted in 56 community pharmacies in the province of Alberta, Canada. 2) Patients randomised to the intervention group received a Medication Therapy Management consultation from their pharmacist (in Alberta, called a Comprehensive Annual Care Plan or Standard Medication Management Assessment). In Canada. 2 arms: 1. Control (usual pharmacist care) (control arm) and 2. Intervention (medication review and risk assessment by pharmacist) (intervention arm) |
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Participants | Control arm N: 287 Intervention arm N: 286, NA, NA Diabetes type: 2 Mean age: 61.15 ± NR % Male: 58 Longest follow‐up: 3 months |
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Interventions |
Control arm: (usual pharmacist care) Intervention arm: (medication review and risk assessment by pharmacist) 1) Case management 2) Team change 3) Patient education |
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Outcomes | Lipid‐lowering drugs Antihypertensive drug Glycated haemoglobin |
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Funding source | Funding for the RxEACH study was provided by Alberta Health (Grant no. RES0020309) (Workforce Planning), and the Cardiovascular Health and Stroke Strategic Clinical Network of Alberta Health Services (Grant no. RES0027161). Merck Canada (Grant no. RES0019426) (investigator‐initiated funding for the educational program) provided the funds to develop the educational materials. Dr. Tsuyuki has received investigator‐initiated research grants from Merck, Sanofi, and AstraZeneca. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomised in a 1:1 ratio to intervention or usual care groups using a centralised secure website at the data management centre (Epidemiology Coordinating and Research (EPICORE) Centre). The randomisation scheme was blocked (random block size) and stratified by pharmacy. |
Allocation concealment (selection bias) | Low risk | Patients were randomised in a 1:1 ratio to intervention or usual care groups using a centralised secure website at the data management centre (Epidemiology Coordinating and Research (EPICORE) Centre). The randomisation scheme was blocked (random block size) and stratified by pharmacy. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. The 2 treatment groups were well balanced in baseline demographic and clinical parameters. No P values. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. The 2 treatment groups were well balanced in baseline demographic and clinical parameters. No P values. |
Incomplete outcome data (attrition bias) | Low risk | Lost 29 patients out of 723 randomised (4.0%). 19 out of 370 (5.1%) in the intervention group and 10 out of 353 (2.8%) in the control group. Reasons reported and more patients withdraw their consent in the intervention group (n = 8) compared to usual care (n = 3), but low numbers. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcome of interest was objectively assessed (HbA1c). |
Selective reporting (reporting bias) | Low risk | Prospectively registered protocol. They do not report data about exercise. |
Risk of contamination (other bias) | High risk | Physicians might have changed their approach with control patients after receiving recommendations and medication management reports from pharmacists taking care of patients in intervention group. Pharmacists involved in both groups have a broad scope of practice that includes independent prescribing and the ability to order laboratory tests. Further, due to the nature of the intervention, blinding was not possible. Pharmacists who provided the interventions also conducted the assessment and entered the information into the study’s online system where CV risk was calculated. This could have introduced bias. |
Other bias | Low risk | None identified. |