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Jeffrey M Cochran,1 Hui Fang,1 John G Sonnenberg,2,3 Elan A Cohen,4 Jean-Pierre Lindenmayer,5 J Corey Reuteman-Fowler1 1Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA; 2Uptown Research Institute, Chicago, IL, USA; 3Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; 4Hassman Research Institute, Marlton, NJ, USA; 5Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USACorrespondence: Jeffrey M Cochran, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, USA, Tel +1 609 535 9035, Email Jeffrey.Cochran@otsuka-us.comPurpose: 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.Keywords: digital medicine system, clinical decision-making, clinical decision support, patient–provider communication, schizophrenia |
