Developing a Digital Medicine System in Psychiatry

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

doi:10.4088/jcp.16m10643

Cited by 24 publications

(18 citation statements)

References 15 publications

(19 reference statements)

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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: Discussionsupporting

confidence: 90%

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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: Discussionsupporting

confidence: 90%

“…The DMS has previously been shown to detect 97% of ingested doses of oral aripiprazole within approximately 1 minute. 13 …”

Section: Methodsmentioning

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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“…11 The system provides continuous feedback to patients on medication ingestion and also collects data on patient activity, patient rest, self-rated mood, and self-rated rest quality that may improve patient engagement and inform an HCP’s decision making. 12 Early clinical experience with the system has been reported in healthy volunteers 13 ; patients with tuberculosis, heart failure, or hypertension 14 ; and in patients with schizophrenia, MDD, or bipolar disorder. 15 – 17 The DMS consists of a digital sensor–enabled medication, a wearable sensor (patch), and software applications that enable secure collection and sharing of information using a patient mobile interface (ie, patient application) and corresponding web-based interface (dashboard) for HCPs and caregivers ( Figure 1 ).…”

Section: Introductionmentioning

confidence: 99%

Human factors evaluation of a novel digital medicine system in psychiatry

Peters-Strickland

Hatch

Adenwala

et al. 2018

NDT

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BackgroundThe digital medicine system (DMS), a drug–device combination developed for patients with serious mental illness, integrates adherence measurement with pharmacologic treatment by embedding an ingestible sensor in a pill, allowing for information sharing among patients, health care providers (HCPs), and caregivers via a mobile interface. Studies conducted during the DMS development process aimed to minimize cognitive burden and use-related risks and demonstrated effective use of the technology.MethodsHuman factors (HF) studies assessed the system’s safe and effective use by the intended users for the intended uses. The patient interface was tested in six formative HF studies followed by a validation study. The HCP/caregiver interface was tested in one study before validation. All tasks critical to safety or necessary for effective use were included. Formative studies identified use-related risks and the causes of use problems to guide design modification. Validation of the patient and HCP/caregiver interfaces assessed risks of the final product.ResultsDuring the patient formative studies, design improvements were made to address problems and mitigate risks thought to be associated with a suboptimal system design or patient understanding of the system. In the validation study of the patient interface, 35 patients attempted 23 performance tasks, for a total of 805 attempts; 783/805 attempts were completed with success. One close call, 15 failures, and 6 difficulties occurred on these user tasks; only 3 of these were on a critical task. Residual risks resistant to mitigation were found to be of low severity based on the US Food and Drug Administration 2016 guidance.ConclusionThe final design of the DMS reflects input by the intended user populations through a comprehensive development methodology. In alignment with the US Food and Drug Administration goals for HF studies, the system was found to be safe and effective for the intended users, uses, and use environments.

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Developing a Digital Medicine System in Psychiatry

Abstract: Background: A digital medicine system (DMS) has

Cited by 24 publications

References 15 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

Human factors evaluation of a novel digital medicine system in psychiatry

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Developing a Digital Medicine System in Psychiatry

Abstract: Background: A digital medicine system (DMS) has

Cited by 24 publications

References 15 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

Human factors evaluation of a novel digital medicine system in psychiatry

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Product

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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