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BACKGROUND Suboptimal medication adherence is a significant problem for patients with serious mental illness (SMI). Measuring medication adherence through subjective and objective measures can be challenging, time consuming and inaccurate. OBJECTIVE We evaluated a digital medicine system (DMS) compared to treatment as usual (TAU) on adherence to oral aripiprazole and patient and provider perspectives on the feasibility and acceptability of a DMS. METHODS This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semi-structured interviews with patients and providers were used to examine feasibility and acceptability of using the DMS. RESULTS We enrolled 46 patients across 2 Veterans Affairs (VA) sites: (21 in DMS and 25 in TAU). There was no difference in medication refill over 3 and 6 months, respectively (82% and 75% DMS vs. 86% and 82% TAU). The DMS arm had 85% days covered during the period they were engaged with the DMS (144 days on average). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient themes included: pre-enrollment adherence strategies and interest in the DMS, positive impact on medication adherence, system usability challenges, support needs, and suggested design/functionality improvements. Provider themes included: concerns for patient medication adherence and interest in the DMS, concerns with the DMS, DMS dashboard usability, challenges of the DMS, and suggestions to increase provider use. CONCLUSIONS There was no observed difference in refill rates. Among those who engaged in the DMS arm, refill rates were relatively high (85%). The qualitative analyses highlighted areas for further refinement of the DMS. CLINICALTRIAL NCT03881449

Background Suboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate. Objective The primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence. Methods This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS. Results We enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers. Conclusions There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS. Trial Registration ClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449