Background: Lipid-lowering treatment with statins has proven to be effective in reducing cardiovascular events and mortality. In daily practice, however, adherence to medication is often low and this compromises the therapeutic effect. The aim of this study was to assess the effectiveness of an electronic reminder device (ERD) with or without counseling to improve refill adherence and persistence for statin treatment in non-adherent patients.Methods: A multicenter, community pharmacy-based, randomized controlled trial was conducted in 24 pharmacies in the Netherlands among patients with pre-baseline refill adherence rates between 50 and 80%. Eligible patients aged 65 years or older were randomly assigned to 1 of 3 groups: (1) counseling with an ERD (n = 134), (2) ERD with a written instruction (n = 131), and a (3) control group that received the usual treatment (n = 134).Main outcome measure: refill adherence to statin treatment for a 360-day period after inclusion (PDC360). Patients with a refill rate ≥80% were considered adherent. The effect among subgroups was also assessed.Results: There were no relevant differences at baseline. In the counseling with ERD group 54 of 130 eligible patients received the counseling with ERD. In the ERD group, 117 of 123 eligible patients received the ERD. The proportions of adherent patients in the counseling with ERD-group (69.2%) and in the ERD group (72.4%) were not higher than in the control group (64.8%). Among women using statins for secondary prevention, more patients were adherent in the ERD group (86.1%) than in the control group (52.6%) (p < 0.005). In men using statins for secondary prevention the ERD was found to have no effect.Conclusion: In this randomized controlled trial, no statistically significant improvement of refill adherence was found if an ERD was used with or without counseling. However, in a subgroup of women using statins for secondary prevention the ERD did improve adherence significantly.
BackgroundAdherence to medication is often low. Pharmacists may improve adherence, but a one-size-fits-all approach will not work: different patients have different needs. Goal of the current study is to assess the effectiveness of a patient-tailored, telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence, satisfaction with information and counselling and the beliefs about medicines.Methods/DesignA cluster randomized controlled intervention trial in 30 Dutch pharmacies, randomly assigned to 1 of 2 intervention groups. Each group consists of an intervention arm and an usual care arm. The intervention arm in the first group is the usual care arm in the second group and vice versa. One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system (RAS)-inhibitors. The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription. A random sample of pharmacies will send questionnaires 3 months after the first prescription. This contains socio-demographic questions, a measure of beliefs about medicines (BMQ), satisfaction with information received (SIMS, abbreviated) and frequency of pharmacy counselling (Consumer Quality Index, CQI, abbreviated). The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention. Patients’ beliefs on medication, perception of the quality of information received and pharmacy counselling are secondary outcomes.DiscussionThe TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment. By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence. Finally the study will provide information on which patients are most likely to benefit from this intervention.Trial registrationThe trial is registered at http://www.trialregister.nl under the identifier NTR3237.
The frequency of pharmaceutical consultations in private is low, but may be improved by reorganisation of the pharmacist's activities. The possibility of personal consultations by e-mail is not yet well-developed. Further research is needed to assess the patient's view of pharmaceutical consultations in private.
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