A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness

Abstract

BackgroundMedication nonadherence is common in the treatment of serious mental illness (SMI) and leads to poor outcomes. The digital medicine system (DMS) objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS.Materials and methodsAn 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application). Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM) during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM) were also assessed.ResultsAll enrolled patients (n=49) used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD) number of calls made by patients was 2.8 (3.5). Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days.ConclusionIn this pilot study, the integrated call center facilitated DMS implementation in patients with SMI on stable doses of oral aripiprazole. In clinical practice, the call center and the DMS will facilitate objective measurement of adherence and potentially improve rates of adherence in patients with SMI.

Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

“…One paper, for example, stresses that data can be successfully transmitted only if the user's phone has signal [37]. Or else, in another paper [42] it is underlined that data transmission can occur successfully only if patients regularly keep their phone near them. Another study [49] also underlines the necessity for patients of contacting technical support to troubleshoot connectivity issues.…”

“…Other studies, however, claim that DP require more interventions and more interaction with medical professionals since "participants preferred real-time transfer of ingestion data to their physician, especially if their physician could use their ingestion data to intervene at potential times of escalating use [of the medicine]" [37]. Other studies claim that DP are adaptable in this respect, since "assistance from a caregiver was allowed; however, patients were encouraged to use the DMS [acronym for DP] independently" [42]. Eight studies also insist on the idea that DP allow healthcare providers to receive data concerning medication adherence that is "actual" or "objective", in contrast to other methods relying on patients' information (e.g.…”

“…self-reporting). For example, one study [42], although not providing any direct evidence as to the accuracy of data collected through DP, claims that DP "addresses daily adherence by detecting and registering the ingestion of actual doses taken by a patient, it provides an alternative and objective means of closely managing medication therapy to ensure adherence and optimal outcomes" (emphasis added). Another study [36] stresses that "digital pills [ …] can provide direct and definitive evidence of medication ingestion" (emphasis added).…”

Digital aripiprazole or digital evergreening? A systematic review of the evidence and its dissemination in the scientific literature and in the media

“…We found no prospective, double-blind RCTs comparing digital aripiprazole with the non-digital formulation, other active comparators or placebo. The three included studies (one was unpublished) were non-comparative uncontrolled cohorts25 26 (see table 1 for study characteristics), involving 67 patients with schizophrenia, 49 psychiatric patients (22 with bipolar 1 disorder, 12 with major depressive disorder and 15 with schizophrenia) and 58 psychiatric patients (35 with bipolar disorder and 23 with major depressive disorder). Effects on adherence, total withdrawals, withdrawals due to adverse events, serious adverse events, total adverse events and effectiveness of the digital ingestion tracking system (indicating that the chip is working) are presented in table 1.…”

Ingestible Sensors and Medication Adherence: Focus on Use in Serious Mental Illness

“…A digital medicine system (DMS) provides an objective real-time recognition of non-adherence with medications [27,28]. The Proteus DMO can capture medication ingestions (if the sensor is combined with medications) and other health information, which are later viewable by providers and patients [22].…”