Optimization of a Digital Medicine System in Psychiatry

Rohatagi, Shashank; Profit, Deborah; Hatch, Ainslie; Zhao, Cathy; Docherty, John P.; Peters-Strickland, Timothy

doi:10.4088/jcp.16m10693

Cited by 29 publications

(39 citation statements)

References 23 publications

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“… 13 – 15 Notably, patients in this trial had relatively minor issues with use of the DMS patch, a finding that is consistent with previous reports in healthy volunteers. 13 , 14 Identification of appropriate patients who will likely be able to use and benefit from the DMS is an important consideration. As previously noted, patients enrolled in this trial were clinically stable on oral aripiprazole and had the capacity to use the DMS technology and a smartphone.…”

Section: Discussionmentioning

confidence: 99%

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

Kopelowicz

Baker

Zhao

et al. 2017

NDT

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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.

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Section: Discussionmentioning

confidence: 99%

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

Kopelowicz

Baker

Zhao

et al. 2017

NDT

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“…A digital medicine system that is being developed for patients with serious mental illness uses medication with an embedded sensor that detects an ingestion event 13,14. The usability of this system has been demonstrated in patients with schizophrenia 26.…”

Section: Discussionmentioning

confidence: 99%

“…Pharmacy records, electronic monitoring systems, such as the MEMSCap™ Medication Event Monitoring System (WestRock Healthcare, Norcross, GA, USA), and monitoring for serum levels of antipsychotic drugs do not directly record medication ingestion in real time 8. Alternatively, newer technologies, such as video-observed therapy12 and a digital medicine system using medication embedded with an ingestible sensor,13,14 allow for direct observation and recording of an ingestion event, respectively, thereby providing credible estimates of adherence. Such information has the potential to lead to better-informed clinical decisions.…”

Section: Introductionmentioning

confidence: 99%

Access to credible information on schizophrenia patients’ medication adherence by prescribers can change their treatment strategies: evidence from an online survey of providers

Shafrin¹,

May²,

Shrestha³

et al. 2017

PPA

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ObjectiveOverestimating patients’ medication adherence diminishes the ability of psychiatric care providers to prescribe the most effective treatment and to identify the root causes of treatment resistance in schizophrenia. This study was conducted to determine how credible patient drug adherence information (PDAI) might change prescribers’ treatment decisions.MethodsIn an online survey containing 8 clinical case vignettes describing patients with schizophrenia, health care practitioners who prescribe antipsychotics to patients with schizophrenia were instructed to choose a preferred treatment recommendation from a set of predefined pharmacologic and non-pharmacologic options. The prescribers were randomly assigned to an experimental or a control group, with only the experimental group receiving PDAI. The primary outcome was the prescribers’ treatment choice for each case. Between-group differences were analyzed using multinomial logistic regression.ResultsA convenience sample (n=219) of prescribers completed the survey. For 3 nonadherent patient vignettes, respondents in the experimental group were more likely to choose a long-acting injectable antipsychotic compared with those in the control group (77.7% experimental vs 25.8% control; P<0.001). For 2 adherent but poorly controlled patient vignettes, prescribers who received PDAI were more likely to increase the antipsychotic dose compared with the control group (49.1% vs 39.1%; P<0.001). For the adherent and well-controlled patient vignette, respondents in both groups made similar treatment recommendations across all choices (P=0.099), but respondents in the experimental arm were more likely to recommend monitoring clinical stability (87.2% experimental vs 75.5% control, reference group).ConclusionThe results illustrate how credible PDAI can facilitate more appropriate clinical decisions for patients with schizophrenia.

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“…The process of developing a drug–device combination such as the DMS requires usability testing of each individual component and of the whole system, in addition to assessment of safety and tolerability. 17 The International Organization for Standardization defines usability as: the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use. 18 …”

Section: Introductionmentioning

confidence: 99%

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

Peters-Strickland

Pestreich

Hatch

et al. 2016

NDT

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102

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ObjectiveDigital medicine system (DMS) is a novel drug–device combination that objectively measures and reports medication ingestion. The DMS consists of medication embedded with an ingestible sensor (digital medicine), a wearable sensor, and software applications. This study evaluated usability of the DMS in adults with schizophrenia rated by both patients and their health care providers (HCPs) during 8-week treatment with prescribed doses of digital aripiprazole.MethodsSix US sites enrolled outpatients into this Phase IIa, open-label study (NCT02219009). The study comprised a screening phase, a training phase (three weekly site visits), and a 5-week independent phase. Patients and HCPs independently rated usability of and satisfaction with the DMS.ResultsSixty-seven patients were enrolled, and 49 (73.1%) patients completed the study. The mean age (SD) of the patients was 46.6 years (9.7 years); the majority of them were male (74.6%), black (76.1%), and rated mildly ill on the Clinical Global Impression – Severity scale (70.1%). By the end of week 8 or early termination, 82.1% (55/67) of patients had replaced the wearable sensor independently or with minimal assistance, based on HCP rating. The patients used the wearable sensor for a mean (SD) of 70.7% (24.7%) and a median of 77.8% of their time in the trial. The patients contacted a call center most frequently at week 1. At the last visit, 78% (47/60) of patients were somewhat satisfied/satisfied/extremely satisfied with the DMS.ConclusionA high proportion of patients with schizophrenia were able to use the DMS and reported satisfaction with the DMS. These data support the potential utility of the DMS in clinical practice.

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Optimization of a Digital Medicine System in Psychiatry

Abstract: Background: Nonadherence to medication

Cited by 29 publications

References 23 publications

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

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

Access to credible information on schizophrenia patients’ medication adherence by prescribers can change their treatment strategies: evidence from an online survey of providers

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

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Optimization of a Digital Medicine System in Psychiatry

Abstract: Background: Nonadherence to medication

Cited by 29 publications

References 23 publications

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

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

Access to credible information on schizophrenia patients&rsquo; medication adherence by prescribers can change their treatment strategies: evidence from an online survey of providers

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

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Access to credible information on schizophrenia patients’ medication adherence by prescribers can change their treatment strategies: evidence from an online survey of providers