A community pharmacist-led intervention to improve adherence to lipid-lowering treatment by counseling and an electronic reminder device: Results of a randomized controlled trial in The Netherlands

Background and objective: Adherence to medication is often poor. Studies demonstrated that adherence to lipid lowering treatment (statins) in daily practice is substantially worse compared to adherence observed in the controlled setting of randomized controlled trials. The aim of this study was to assess the effectiveness of counselling and an electronic reminder device (ERD) to improve adherence to statin treatment in non-adherent patients. Setting and methods: We performed a randomized controlled trial. In 27 community pharmacies in The Netherlands, patients of 65 years and older with poor refill adherence rates (50-80 % in 12 months prior to inclusion) were randomly assigned to 1 of 3 groups: (1) counselling with an ERD (n = 143), (2) ERD with a written instruction (n = 137) and (3) usual care (n = 143). We used logistic multilevel analysis to study the effect on the dichotomous outcome and included the levels patient, general practitioner and pharmacist. The secondary outcome of complete discontinuation is assessed using Cox-proportional hazards. Main outcome measures: The primary outcome was refill adherence to statin treatment in 360 days after inclusion (Proportion of Days Covered, PDC). Patients with a refill rate >80 % were considered adherent. In a second analysis, we assessed the effect among subgroups. The secondary outcome is complete discontinuation. Results: There were no relevant differences at baseline. In the counselling + ERD-arm 38 % of 143 patients received the counselling with ERD. In the ERD-arm, 85 % of 137 patients received the ERD. The median PDC (25th-75th percentile) was 90.0 % (76.0-98.0) in the Counselling/ERD Group, 91.0 % (75.5-99.0) in the ERD-only group and 87.0 % (75.0-98.0) in the control group. The proportion of adherent patients in Counselling + ERD group and in the ERD-only group was non-significantly higher than in the control group: odds ratios: 1.3 >95 % CI 0.77-2.1] and 1.5 [0.78-2.7]. Among women using statins for secondary prevention, in the ERD group more women were adherent than in the usual care group (odds ratio 9.4 [2.3-38.1]). In the Counseling/ERD-Group 7.7 % of the patients discontinued treatment with statins, compared to 8.0 % in the ERDgroup and 11.2 % in the Control Group. The hazard ratio for the Counseling/ERD group versus usual care was 1.2 [0.48-3.0] and for the ERD-group 1.3 [0.49-3.2] Conclusions: In this randomized controlled trial, we found that in the overall population, ERD with or without counselling nonsignificantly improved statin adherence. However, in a subgroup of women using statins for secondary prevention, ERD improved adherence of statins significantly.