Automated Reminders and Physician Notification to Promote Immunosuppression Adherence Among Kidney Transplant Recipients: A Randomized Trial.
Reese PP, Bloom RD, et al.American Journal of Kidney Diseases 2016 [record in progress]
Aims
To determine whether automated reminders alone or paired with provider notification improve tacrolimus adherence, compared to adherence monitoring alone among kidney transplant recipients.
Interventions
Participants were randomly assigned to one of three treatments, either adherence monitoring with customized reminders (arm 1, reminders group), adherence monitoring with customized reminders plus provider notification (arm 2, reminders-plus-notification group), or wireless pill bottle use alone (arm 3, control group).
Participants
120 kidney transplant or kidney-pancreas recipients aged ≥ 18 years who were taking immediate-release tacrolimus.
Outcomes
The primary outcome measured was adherence calculated for the final 90 days of the intervention period. Secondary outcomes measured included pill-bottle measured adherence between 14 days and the end of the study, the coefficient of variation of tacrolimus blood concentrations, the coefficient of variation of any morning tacrolimus blood concentration, and the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS).
Follow-up
6 months
CET Conclusions
This single centre, 6-month RCT investigated whether adherence monitoring with automated reminders alone or paired with notification when adherence was low versus adherence monitoring alone (control) improved tacrolimus adherence recorded in the final 90 days of the intervention. The trial randomised 120 kidney or kidney-pancreas transplant recipients who were given a wireless pill bottle for tacrolimus that recorded pill-cap openings. The primary outcomes was adherence and a sample size of 120 participants was needed to provide 80% power for detection of an 8% improvement in adherence in the two reminder groups compared to the control group and to allow for 25% dropout. The principal investigator, pharmacist, and statistical data analysts were blinded to the intervention. The modified intention to treat analysis (n=117) showed that both reminder interventions were significantly more effective in improving tacrolimus adherence when compared to the control intervention. However the difference between the reminder plus notification and the reminder alone intervention was marginal with the 95% confidence interval ranging from 0% to 19%. This preliminary analysis shows the potential of wireless bill bottles plus a reminder strategy for improving medication adherence. Further investigation is needed to study the effect of such intervention on clinical outcomes.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01541384