Lauffenburger 2019a.
Study characteristics | ||
Methods |
Effectiveness of targeted insulin‐adherence interventions for glycemic control using predictive analytics among patients with type 2 diabetes: a randomized clinical trial RCT (NA clusters and NA providers), conducted in 1) This trial used data from Horizon Blue Cross Blue Shield of New Jersey, Newark, the largest health insurer in New Jersey, United States. 2) Intervention involved tailored telephone by a pharmacist from a pharmacy benefit management company. In United States of America. 3 arms: 1. Control (untargeted, low‐intensity insulin‐adherence Interventions) (control arm) and 2. Intervention 1 (partially targeted, moderate‐intensity insulin‐adherence interventions) (intervention arm), 3. Intervention 2 (highly targeted, high‐intensity insulin‐adherence Interventions) (other arm) |
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Participants | Control arm N: 2000 Intervention arm N: 2000, 2000, NA Diabetes type: 2 Mean age: 55.9 ± 7.89 % Male: 59.8 Longest follow‐up: 12 months |
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Interventions |
Control arm: (untargeted, low‐intensity insulin‐adherence Interventions) 1) Promotion of self‐management Intervention arm: (partially targeted, moderate‐intensity insulin‐adherence Interventions) 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders Intervention arm: (highly targeted, high‐intensity insulin‐adherence Interventions) 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders |
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Outcomes | Glycated haemoglobin Harms |
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Funding source | This research was supported by Sanofi | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised by Horizon in a 1:1 ratio to the intervention or usual care group using a random number generator. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1, age and gender at baseline are reported. No information on education. Intervention patients were slightly less likely to be female and slightly more likely to have had a prior stroke/transient ischemic attack. |
Patient's baseline outcomes (selection bias) | Low risk | Baseline HbA1C is reported in Table 1, looks balanced. |
Incomplete outcome data (attrition bias) | High risk | 71% loss in the control group (684‐196/684), 71% loss in the intervention arm (678‐196/678). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objectively measured outcome HbA1c. |
Selective reporting (reporting bias) | High risk | There is a published protocol, but they do not talk about the qualitative outcomes in the protocol. However, they report the qualitative outcomes in the study. |
Risk of contamination (other bias) | Low risk | Control group was not contacted in any way, pharmacists only contacted those in intervention group. |
Other bias | Low risk | No evidence of other bias. |