The problem we solve: Tardive dyskinesia is the most common debilitating side effect of antipsychotic use. Tardive dyskinesia (TD) is a neurological syndrome most often caused by long-term antipsychotic medication use (as short as 6 weeks). Characterized by involuntary movements of the tongue, lips, eyes, face, trunk, and extremities, TD is difficult to treat and potentially irreversible. TD is a serious side effect of taking needed psychiatric medications involving presumed structural brain changes that cause considerable distress for affected individuals, reducing quality of life, exacerbating cognitive impairment, and raising the risk of non-adherence. FDA warnings for anti-psychotic Reglan (metoclopramide) state 20% will get TD and for many of these patients TD will be irreversible. In 2014 6.8 million people were taking antipsychotic medications.
About our solution: We are proposing the development and field testing of a smartphone-based AI platform for assessing TD in patients treated using antipsychotic medication. Our working title for this platform is TDtect™. TDtect will use self-administered, smartphone–recorded video interviews to yield data that can be scored with algorithms produced using our highly discriminating machine learning software. The video capture and analytics engine is similar to interviewing and hiring software (e.g., Apple, GE, Nike) and has been used with more than 16 million interviews, demonstrating a robust, scalable platform for the reliable collection of video interview data for analysis. The platform is enhanced by using iRxReminder's IoT pill dispensing pod with smart alerting and effortless data recording when the medication is dispensed. The platform is basis for following other chronic conditions and would become a very useful cognitive and behavioral science diagnostic and monitoring software tool.Progress to date:
App improves adherence Sterns et al. (NIH Grant No. 1R43AG033500) conducted a pilot to improve medication compliance using smartphones for older adults (Mean Age = 65) recovering from stroke. Participants used the iRxReminder system or kept paper diaries for 2 months. Overall, participants using iRxReminder complied with 83% of medication events. No additional interventions, such as calls from the research team, or behavioral reinforcements, such as display of counts of successful events, were provided. Patient recall of medication adherence was poor: the smartphone group underestimated their adherence and the diary group overestimated their adherence, showing the value of providing accurate data to the healthcare team. No one misplaced a smartphone, and half of the participants asked to keep the smartphone, demonstrating that even older adults will accept this technology.
mHealth meets telepsychiatry. The TDtect platform can be conceptualized as an advance in telepsychiatry that uses mHealth. As such, all of the advantages of telepsychiatry apply, such as cost effectiveness (e.g., reduced travel for follow-up meetings), increased access for patients in rural or hard-to-reach areas (e.g., prison, detox units), improved coverage of underserved groups (e.g., minorities), and improved efficiency. With respect to efficiency, TDtect can be used to interview large numbers of people quickly, and videos are securely stored for later access for second opinion for complex or subtle cases. TDtect will also provide a quantitative assessment that may improve sensitivity and thus early detection of TD that is currently a challenge. Currently, there is no technological solution for assessing, monitoring, and detecting TD in patients taking antipsychotics.
Cognitive prosthetic. The platform when fully developed will act as a cognitive prosthetic to support successful self-management of patients living with chronic mental health issues. The system provides an effective monitoring system that can trigger early interventions, alerting and bringing to bear available resources just when needed. The platform can be right sized so that those who use the system successfully are matched to the available healthcare professional team. The system will provide the quantitative information required to improve the quality of care and ensure that best practices are being added to the system as developed. The envisioned platform provides exactly the patient centered care one imagines is possible with technology supported care coordination but has yet to be realized.
Creator: Anthony Sterns
Education: CUNY SPS, UMUC, University of Akron
Bio: Anthony Sterns founded iRxReminder after 10-years of research on caring for people living with dementia. The key lesson gained from this work is that people lose their independence due to failing to take their medications correctly. In addition, healthcare professionals are disconnected from what their patients are experiencing and cannot share their expertise and help. iRxReminder's core purpose is to empower patients and healthcare professionals to manage medications together, to achieve high adherence, lower ER visits, and improve health outcomes.
Hospital Affiliation: Kent State University College of Nursing
Title: Chief Executive Officer
Advanced Degree(s): Ph.D.
Chief Technology Officer, MBA
Biography: I serve as the Chief Technology Officer for Creative Action LLC and for iRxReminder LLC. I have worked with Drs. Anthony Sterns on previous grant-funded projects related to developing mobile applications to provide cognitive intervention therapies with older adults living with heart failure (NIH 1R43AG042230), living with dementia, and recovering from transient ischemic attack (NIH 1R43AG033500). I have spent my career helping users identify their goals and achieve the IT results they want. I am an Agile practitioner (software always internally tested and in a running state), and am comfortable working with both technical and non-technical people in an iterative design process that helps involve and engage project stakeholders. I have extensive full software life cycle experience in online media and mobile products (including 3 games specifically for Apple’s iPad and development of the iRxReminder, iRxCapture, and ESmCapture smartphone applications). In addition, my diverse academic background has provided a toolbox that is well stocked to handle a full range of software systems development projects. Lastly, I bring proven leadership of cross-functional software and product development teams.
Title: Chief Technology Officer
Advanced Degree(s): MBA
Professor, Department of Psychology, PhD
Biography: The proposed study will test a novel and practical approach to improving management of patients treated using antipsychotic medication by improving detection of problematic side effects; specifically tardive dyskinesia. This smartphone-based platform for assessing Tardive Dyskinesia in patients treated using antipsychotic medication will be a practical solution for helping people taking antipsychotics improve their communication with care providers, adherence to medication, and manage medication side effects. This project is a natural continuation of my work in patient self-management and my growing interest in telehealth and mHealth. That is, I am a licensed clinical health psychologist and researcher. I was PI of an R01 designed to investigate the implications of cognitive impairment in patient self-management in heart failure . I have worked with Anthony Sterns for over 6 years and we had NIH-sponsored research as well as Ohio Third Frontier funding. We have already used much of the technology and some of the measures in NIH-funded studies. In addition to our study of mHealth in heart failure. I have extensive experience with several telehealth and mHealth technologies (e.g., MedSignals, IdealLife, iRxReminder) and even share a provisional patent for a monitored medication delivery system that interoperates with reminding software.
Title: Professor, Department of Psychology
Advanced Degree(s): PhD
Potential Benefits of the Proposed Research to Human Subjects and Others
Participating in the study does not provide direct benefit. However, the risks to participants, in view of the safeguards described above are very minimal and reasonable in relation to the potential scientific benefit and potential benefits to future patients treated with antipsychotics if the findings of the proposed research support the clinical meaningfulness of the proposed mHealth tool for future use.
This research will, if successful, provide a novel approach to detecting and monitoring TD, a potentially irreversible side effect of antipsychotic medication. This could improve treatment of individuals with psychotic disorders or who are prescribed antipsychotics for off-label uses. A case study illustrates the importance of this knowledge.
Recently, we interviewed a young woman with a strong family history of schizophrenia. Her mother and uncle are not well controlled and have had serious complications from their disease. She began to experience auditory and visual hallucinations about a year ago. She currently has relatively intact reality testing, but has succumbed to the insistent voices commanding her to cut herself. She knows that she is developing a psychotic disorder, and is very frightened. Although Northeast Ohio has resources for state of the art treatment of the onset of psychotic disorders, she likely faces a lifetime of antipsychotic medication use and other assistance. Currently attractive, intelligent, energetic and successful, her quality of life would be harmed by developing TD or by poor treatment adherence. If a smartphone-based approach for detecting TD were available, she would be an ideal candidate. She would be connected to her care team and could receive medication reminders, education, and periodic self-administered assessments. With improved care, she could potentially avoid the non-adherence that led to further decompensation in her mother and uncle.
Thus, the project described here addresses a clinical problem of considerable interest to the individuals affected, their families, and their care providers. The importance of this knowledge outweighs the small risks involved in this research project.
Demand potential for the iRxReminder research product has already yielded 21 customers following previous development including researchers at leading research institutions. The proposed self-management platform with unique features like TDtect provides a substantially larger usefulness for many patient populations.
At the end of this project the iRxReminder platform, consisting of the iRxControl center and smartphone app, will provide a new tool ready to support research and intervention efforts related to TD as well as to improve treatment of mental health disorders in general. Uniquely, the platform will be able to connect wirelessly to patient’s healthcare professionals (HCPs). Linkage to the EMR is ensured by iRxReminder’s development partnership with InterSystems, Inc., the global leader in health information exchange and their product HealthShare. This platform has the potential to raise the bar for state-of-the-art, evidence-based research and practice; improving physician/patient interactions, patient self-management, and health outcomes. Because communication is via cellular technology, there is no need for the patient to have a computer or Internet access. The system works equally well on computers for those needing them for specific adaptations. The commercial system will consist of the cloud-based control center, smartphone app, and integration with the TDtect video analytic engine.
Many at risk for TD. In 2014, 6.8 million people were taking antipsychotic medications chronically. All patients must be actively monitored for TD, as the incidence with even second generation antipsychotics is estimated to be about 4% per year of treatment with a prevalence of about 13%. Risk is even higher with advancing age, off-label uses, and chronic exposure to antipsychotic medications. For example, a recent study reported that TD rates among newly treated elderly ranged from 7.2% for those taking risperidone to 11.1% for those taking olanzapine after 2 years of treatment. TD only remits in a minority of cases and will otherwise be permanent. There are likely over 1 million patients living with TD and the number of patients with TD is expected to grow with the aging population and increasing off-label use of antipsychotics.
We welcome industry collaborators to support this application and other future applications. Please contact us to discuss this opportunity and others. We are excited to build collaborations with industry partners.
The TDtect platform will translate easily from a research tool to the personal prescription management market, with FDA clearance; defined as a 510(k) Class II “remote medication management system.” The human factors testing in this proposal and the additional future clinical trials (Stage 2 and 3) will aid FDA clearance. Markets include pharmaceutical corporations, academic medical centers, psychiatrist practices, insurance companies, health systems, accountable care organizations, and consumers.
Products such as the initial public offering of Epocrates, makers of a drug formulary app, at over $85 million, and sale of the company producing GlowCaps, demonstrates that the market is ready for well-designed healthcare technologies for physicians and patients. Supporting our argument, our Technology Niche Analysis® prepared by Foresight Science and Technology (Providence, RI) for iRxReminder reported that: “The application of smartphone technology to healthcare, defined as mobile health or mHealth is increasing. That market is projected to reach US$1.3B in revenue.” (p. 1). Furthermore, the competitive technologies section of the report concluded “most of the products researched share some capabilities with the iRxReminder solution, but none currently seems to be a direct competitor across all capabilities.” (p. 12).
Therefore, a smartphone-based app for supporting collaborative care of patients with TD based on the iRxReminder platform would be well positioned as a first mover and be broadly adopted in the healthcare marketplace. Finally, 40 million Americans are affected by movement disorders caused by over 30 neurological conditions. The focus of this project is on TD, but the platform created can be further developed for use with other conditions, greatly expanding the potential market.
Projected 3 Year Growth
We want to further validate, optimize, and scale our business model in the research and personal prescription management markets. We are seeking collaborators who can help us gain access to medical coding and billing expertise to implement and test our reimbursement business model to support the key elements of our "revenue plus cost savings for our customers" marketing approach.
Our goal in 2018 is to build relationships with five new patient pre-post procedure monitoring validation opportunities (e.g. taking anti-psychotics at 100% adherence for 3-weeks following discharge from hospitalization) to expand our target patient populations.
With these manufacturing plans and validation collaborations complete, we want to complete a $3 million 2nd Seed round. The funding will be used to expand our sales and programming teams in-house, create inventory, and support direct and digital marketing and sales to drive revenues above $10 million.
How We Will Make Money
There is a $15 billion personal prescription management market based on the potential return utilizing a reimbursement model. There are 22 ICD-10 codes that apply to personal medication management support.
There are 10 million people in North America taking 8 or more medications daily and qualify for personal medication management support. These 10 million people have between a 26% and 59% adherence rate meaning that a majority of them would benefit from better adherence and healthcare team support. iRxReminder's technology provides the means to deliver and invoice payors for the support required to achieve positive health outcomes and improved care. Initially, we have focused on oral oncological drugs as our initial market. The oral cancer therapy treatments are generally short (e.g. 2 weeks) and most centers have an on-site pharmacy with a staff to manage and support the filling, programming, and training of the patients to use the pods.
The research market, specifically new drug studies, offers the opportunity to demonstrate the technology by lowering study costs by up to 20%. There are annually 43,000 studies world-wide (a $2.5 billion market) with 5,000 studies in North America ( $500 million market). This market has the advantage of an incentivized, well-funded payer. Globally, there are about 4.9 million participants in research studies.
About our Competition
We see three kinds of direct competitors: 1) pill packing technologies, 2) wireless pill bottles, and 3) wired pillboxes. The first type of competitors are pill packing technologies such as PilPak and ExactCare. These companies bring daily medication dosing together in a single bag or blister pack. The problem with these technologies is that when you skip a day you have a large number of pills now around which can be dangerous as well as confusing. Our technology always contains the medication, so you can only dispense it at the right time and in the right amount. Pill packing also has a serious problem when regimens change. Patients are required to remove the old pills and add the new pills. This is risky for many patients with cognitive impairment. They are at risk of taking both the old and new medications which may lead to serious and life threatening situations.
The second type of competitor are wireless pill bottle technologies such as MEMSCaps, GlowCaps, and AdhereTech bottles. These technologies can count the opening of the bottle, but they cannot stop a person from taking too many pills at once, or taking medications too many times in a day. These technologies are also either passive (no alert) or nagging, sounding an alarm even if you take the pill on-time. iRxReminder's platform knows when you dispensed the pill, so you only get an alert if you forget, so its supportive and never nagging. Also, you can only take the right amount at the right time,
Progress with Customers to date
We are development partners with InterSystems, we participate in the Burton Mortan Mentoring program through JumpStart, we are a BioEnterprise portfolio company, and we are housed in the MAGNET Incubator in Cleveland, OH. This has helped support our fundraising efforts as well as provide in-roads into major research and healthcare centers.
We have research collaborations with Harvard University, The University of Wisconsin School of Medicine, Case Western Reserve University, Cleveland MetroHealth Hospital, George Mason University, Kent State University, and The University of Michigan College of Pharmacy and The University of Michigan Cancer Center. All these partners are paying customers.
New Orleans and Our Company
We have collaborated with the State of Louisiana Department of Corrections in the past and provided state-of-the-art computer-based training on better management of older offenders. During this collaboration we worked with corrections officers and staff including mental health experts that work with offenders during and after incarceration. We believe we had an impact on the culture and understanding by professionals for the issues related to mental health and aging. We want to again apply a technology supported solution to enhance and extend the reach of mental health professionals to improve the quality of life for the people of New Orleans and throughout Louisana.
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