Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia

Cohen, Elan A; Skubiak, Taisa; Boskovic, Dusica Hadzi; Norman, Keinya; Knights, Jonathan; Fang, Hui; Coppin-Renz, Antonia K; Peters-Strickland, Timothy; Lindenmayer, Jean-Pierre; Reuteman-Fowler, J Corey

doi:10.4088/jcp.21m14132

Cited by 10 publications

(52 citation statements)

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“…45 A recent, phase 3b, mirror-image, open-label, single-arm clinical trial compared outcomes for patients with schizophrenia who had a history of psychiatric hospitalization when they used standard-of-care (SOC) oral antipsychotics versus when they used ABILIFY MYCITE ® (aripiprazole tablets with sensor [AS]). 46 AS consists of aripiprazole tablets embedded with an ingestible event-marker sensor, wearable sensor patches and a smartphone application, and is indicated for the treatment of adults with schizophrenia or bipolar I disorder, and as adjunct treatment for adults with major depressive disorder. 47 In the AS system, clinicians can review patient medication ingestion data via a web-based dashboard, and patients can access their data via the smartphone application.…”

Section: Dovepressmentioning

confidence: 99%

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

Cochran¹,

Fang²,

Sonnenberg³

et al. 2022

NDT

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Schizophrenia is a severe, chronic condition accounting for disproportionate healthcare utilization. Antipsychotics can reduce relapse rates, but the characteristics of schizophrenia may hinder medication adherence. A phase 3b open-label clinical trial used aripiprazole tablets with sensor (AS; includes pills with ingestible event-marker, wearable sensor patches and smartphone application) in adults with schizophrenia. This post hoc analysis explored how healthcare providers' (HCPs) usage of a dashboard that provided medication ingestion information impacted treatment decisions and clinical assessments. Patients and Methods: Participants used AS for 3-6 months. HCPs were instructed to check the dashboard regularly, identify features used, and report impact on treatment decisions. After stratifying HCPs by frequency of dashboard checks and resulting treatment decisions, changes from baseline were calculated for Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI)-Severity of Illness and CGI-Improvement (CGI-I), and Personal and Social Performance (PSP), and compared using Mann-Whitney U-tests and rank-biserial correlation coefficient (r) effect sizes. Results: To ensure sufficient opportunity for AS engagement, 113 participants who completed ≥3 months on study were analyzed. HCPs most often accessed dashboard data regarding medication ingestion and missed doses. HCPs recommended adherence counseling and participant education most often. Participants whose HCPs used the dashboard more and recommended adherence counseling and participant education (n=61) improved significantly more than participants with less dashboard-active HCPs (n=49) in CGI-I mean score (2.9 versus 3.4 [p=0.004]), total PANSS (mean change: −9.2 versus −3.1 [p=0.0002]), PANSS positive subscale (−3.2 versus −1.5 [p=0.003]), PANSS general subscale (−4.3 versus −1.2 [p=0.02]), and Marder factor for negative symptoms (−1.9 versus 0.0 [p=0.03]). Most HCPs found the dashboard easy to use (74%) and helpful for improving conversations with participants about their treatment plan and progress (78%). Conclusion: This provider dashboard may facilitate discussions with patients about regular medication-taking, which can improve patient outcomes.

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Section: Dovepressmentioning

confidence: 99%

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

Cochran¹,

Fang²,

Sonnenberg³

et al. 2022

NDT

Self Cite

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“…Lack of insight usually complicates psychiatric presentations, requiring the assistance of a qualified medical professional, usually a psychiatrist, to determine the best plan of care. Lack of insight has been defined in various models but generally refers to the inability of a patient to understand and perceive the actual and accurate purpose behind his disease process or plan of care [5][6][7]. Lack of insight is seen as an obstacle to adequate medication administration and treatment because people with a lack of insight do not show responsible healthy behavior [6].…”

Section: Introductionmentioning

confidence: 99%

“…Lack of insight has been defined in various models but generally refers to the inability of a patient to understand and perceive the actual and accurate purpose behind his disease process or plan of care [5][6][7]. Lack of insight is seen as an obstacle to adequate medication administration and treatment because people with a lack of insight do not show responsible healthy behavior [6]. They may miss their medication, or appointments, show non-adherence to medicines, or [7] completely refuse pharmacotherapy [3].…”

Section: Introductionmentioning

confidence: 99%

“…They may miss their medication, or appointments, show non-adherence to medicines, or [7] completely refuse pharmacotherapy [3]. Cohen et al (2022) found that people with chronic mental health problems, chronic diseases that go along with mental health problems, disorders of cognition in children, and a cultural or low educational background often lack insight [6]. In accordance with the ethical principles of medicine, beneficence provides the obligation for healthcare professionals to provide the most effective medical treatments [8].…”

Section: Introductionmentioning

confidence: 99%

“…Even when a lack of insight is diagnosed, medication services should be provided to patients who lack insight, in addition to other treatment modalities like insight-oriented psychotherapy aimed at educating them regarding, the nature of their illness, the need for treatment, the medications, treatment modalities for their diseases, and the consequences of non-treatment [5,[9][10]. The ultimate short-term goal, therefore, in managing patients with a lack of insight is to provide therapeutic benefit and overcome the lack of insight barrier as quickly as possible [5][6][7][9][10]. Therefore, it is important to choose practical and appropriate medication administration techniques for people lacking the insight to achieve maximum medication benefits.…”

Section: Introductionmentioning

confidence: 99%

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Approaches to Medication Administration in Patients With Lack of Insight

Okobi¹,

Agazie²,

Ayisire³

et al. 2022

Cureus

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Lack of insight typically complicates psychiatric presentations, necessitating careful thought and planning to choose the best course of treatment. Exploring methods of medication administration techniques in the context of a lack of insight is crucial to achieving the ultimate goal of overcoming the insight barrier as rapidly as possible, which will result in therapeutic benefit. This study's objective was to systematically review the evidence on medication administration techniques in a backdrop of lack of insight and how that evidence was curated in the scientific literature. This study used the literature search strategy, which entails retrieving and analyzing the existing scientific literature pertinent to medication administration techniques for individuals with no insight between 2010 and 2022. Accessing online databases, such as PubMed, Google Scholar, and Medline was utilized in this study's literature search strategy. In our findings, in the primary evidence search, no randomized control trial (RCT) comparing the various models of medication administration with a lack of insight was found. No study provided data on the superiority of utility, quality of life, or efficacy outcome. Some 17 scientific papers were identified that cited various trials about lack of insight and medication use and met the inclusion criteria. We concluded that it could be challenging to administer medication to patients who lack insight.Nonetheless, progress has been made to mitigate this obstacle. Common moral values, common sense, medicolegal support, person-centered integrated care, and cutting-edge medication techniques may play a role. However, these models of medication administration are still evolving, along with the ethical concerns accompanying them. Hopefully, the available models discussed in this analysis will serve as a foundation for future developments. Nonetheless, much remains to be done. We encourage contemporary research to investigate safer and more dynamic methods that can alleviate this condition.

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Digital Interventions for Relapse Prevention, Illness Self-Management, and Health Promotion In Schizophrenia: Recent Advances, Continued Challenges, and Future Opportunities

Chukka,

Choudhary,

Dutt

et al. 2023

Curr Treat Options Psych

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Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia

Cited by 10 publications

References 0 publications

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia

Approaches to Medication Administration in Patients With Lack of Insight

Digital Interventions for Relapse Prevention, Illness Self-Management, and Health Promotion In Schizophrenia: Recent Advances, Continued Challenges, and Future Opportunities

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