20 Functionality Study of the Pill-SafeTM Digital Health System to Assess Real Time Mechanical, Clinical Practicality, and Utility including Instantaneous Analytical Data on Drug Abuse Tendencies and Adherence: Alpha Usability Test Jeffrey Fudin1, Michael Schatman2, Jeffrey Bettinger3, Jacqueline Cleary1, Ronald Kulich4, David Zuleta5, David DiBenedetto6,7, Kelly Wawrzyniak6,8, Hannah Shapiro9 Albany College of Pharmacy and Health Sciences, Albany, NY, USA. 2Tufts University School of Medicine, Boston, MA, USA. Saratoga Hospital Medical Group, Saratoga, NY, USA. 4Massachusetts General Hospital, Boston, MA, USA. 5ModoScript, Boston, MA, USA. 6Boston PainCare, Waltham, MA, USA. 7Tufts School of Dental Medicine, Boston, MA, USA. 8Tufts School of Medicine, Boston, MA, USA. 9Tufts University, Boston, MA, USA 1
3
Purpose Recent data trends from 2012 to 2017 show overall reductions in national opioid prescribing rates, but overdose death rates involving any opioid continues to increase, with specific peaks in deaths involving non-methadone synthetic opioids (heroin, illicit fentanyl analogues, etc) and heroin. Notwithstanding, opioid deaths associated with heroin and illicit synthetics, also include prescription medications that have been diverted to persons to whom they were not prescribed. Furthermore, studies continue to show extremely high rates of non-medical use of prescription pain relievers, indicating that there are still problems with non-adherence, misuse, and abuse of prescription opioids. able Pill-edge technology to provide patients with mobile/online personalized multilingual general and prescription treatment plans (initially in English, and Spanish). This system involves the use of a locking-dispensing cap that requires fingerprint biometrics to dispense caplets inside, AI-enabled multilingual treatment voice and visual interaction, and color-coded LED strip for medication differentiation. The device is also designed with a novel platform that integrates hardware, AI, and block chain security to provide real-time treatment adherence, prescription flow, and behavioral data to relevant stakeholders (prescribers, pharmacists, government entities, etc) via backend data gathering dashboard (EMR integrable) compatible with smart phones. The platform has the ability to significantly increase system-wide efficiency and reduce short term and long term health costs associated with patient non-adherence, prescription drug abuse, overdose, under-dose, drug adverse reactions, and prescription drug trafficking. As the healthcare industry shifts into valuetechnological shift that the industry is undergoing, providing a high-end system wide solution to ensure prescription opioid compliance in a multilingual setting. The ultimate goal of this alpha-usability test is to ensure that the software is working completely and accurately, and to increase awareness of this technology as a potential new, innovative way to combat the opioid epidemic and overall medication non-adherence by becoming the next generation of remote treatment care delivery. Methods We intend to recruit up to 28-volunteers of students and separate them into 3 fictitious groups: 20-prescription users, 4prescribers, and 4-dispensing pharmacists. Our investigators will train all three groups on how to use the dispensing cap and he medication used with be lactose caplets, however the patient group will be instructed NOT to ingest them. Once trained, they will go about their daily routines, and our group will collect real time, analytical data on patient, prescriber, and pharmacist behaviors over a period of 1 or more months to ensure platforms and data collection are working. During this time, the e asked to complete a system usability scale to assess overall usability of both the dispensing cap and dashboard technology.
The following outcomes will be assessed: