Clinical Drug Trials
Chronic Disease Management
Home Infusion
Cardiac Diseases
Family Health and Wellness
ArioTech’s Medical Digital Assistance (MDA) Interactive Wireless Health Monitoring system helps solve many of the challenges now faced by pharmaceutical companies, healthcare providers, health plan providers and patients, themselves. Here are some sample applications and solutions that address these challenges.
Clinical Drug Trials
Clinical trials are a massive and expensive logistical feat. Of the $500 to $800 million spent by pharmaceutical companies to bring a new drug to market, it’s estimated that 30% of that price tag is the cost of handling patient records. Additionally, over half the time needed for phases I, II, and III of drug trials is spent collecting data and managing the program. Therefore, technology that can expedite and simplify these processes is worth millions, even billions of dollars to the pharmaceutical industry.
The MDA system supports both subjective and objective methods of data collection, which broadens both the scope and accuracy of information gathered during a trial. Traditionally, data has been collected via paper and/or electonic-based diaries, phone or office interviews. ArioTech MDA next-generation system solutions can speed these collection methods and enhance their accuracy. Additionally, they enable researchers to use objective methods to capture data with greater sensitivity and precision by interfacing with third-party point-of-care devices and/or sensors such as a spirometer, pulse oximeter, glucometer, dermal temperature patch, blood analyzer, infusion pump, physical activity monitor or blood pressure monitor.
It’s been reported that average adherence rates among patients receiving treatment for chronic conditions during clinical trials were only 43% to 78% (New England Journal of Medicine; 353). This contributes to uncertainty concerning efficacy, and drastically extends the time and budget needed to complete the trials due to re-recruitment costs and delays. These costs have forced many top pharmaceutical companies to look for ways to reduce the duration and management of trials.
Today, electronic data collection is becoming the new norm in clinical drug trials, to improve data accuracy and to gather those findings in less time. It also makes it easier to communicate among parties (subject / physician / pharmaceutical company), thus improving patient compliance and safety during the process:
- Improved data accuracy - Studies show that electronic monitoring increases the validity of data collected, due to reduced data variance, improved compliance and more complete patient feedback across all subjects. This means studies can contain smaller cohorts, saving significant time and cost of drug trials.
- Better patient compliance - Patients can receive reminders to take medication and are contacted if results are not received, ensuring that recommended regimes are adhered to and that resulting data is accurate.
- Patient safety - A real-time connection with out-patients improves safety, providing the ability to intervene quickly if adverse events occur.
- Preferred choice - Multiple studies show that patients prefer this technology over paper questionnaires for studies and trials (Crawley, Kleinman & Dominitz, 2000), contributing to improved compliance.
- Increased efficiency - Time is not lost waiting for paper to arrive or for data to be entered. Patient responses can be stored and accessed in seconds. Paperwork is minimized and analysis is quicker.
- Increased revenue - Each day a new drug is delayed getting to market can cost $1-3 million in lost revenue opportunity. By shortening the trial time, not only is money saved, but revenue is generated sooner.
- Reduced recall bias - With real-time data collection and time-stamp accuracy, issues such as recall bias are greatly reduced.
- 24/7 data availability - A client portal suite allows all authorized sponsors, vendors, and study site staff to exchange documents and messages in a highly secure environment, 24 hours a day, from any location.
- Objective and subjective monitoring – Individual’s subjective response and objective monitoring data can be continuously captured and monitored within a trial at any given study site in real time.
- Secure and safe patient data – Patient data is immediately deposited from MDA Mobile device onto a secure backend server, so if a device crashes data integrity is safe. This data is securely stored in compliance with FDA controls and auditing guidelines. Design tools allow clinical researchers to structure the database so that it is consistent with individual trial design, query and reporting requirements.
Chronic Disease Management
Management of acute and chronic diseases—including congestive heart failure, pulmonary disease, diabetes, osteoporosis, cerebral vascular accident, progressive neurological disorders, dementia and incontinence—places a huge burden on both medical staff and healthcare resources. As our population ages, the incidence of chronic disease will rise and the cost of managing the many sufferers will increase (Evans, 2009). 2008 statistics estimate that almost half the expenditure of chronic diseases occurs through the use of office services, followed by hospitalizations (Santamour, 2008).
The ArioTech MDA system can contribute greatly to both the quality of care and cost reduction of chronic disease management. Healthcare providers survey patient data from the office, in real-time, while patients maintain a healthy regime without constant visits to the office or hospital. A 2009 study reported that home telemonitoring of chronic respiratory disease symptoms helped prevent or detect worsening of conditions, and consequently saved money for both patients and healthcare providers. It also found that patient compliance with medication regimes increased with the use of telemonitoring (Jaana, Pare & Sicotte, 2009). It is calculated that an estimated 10 billion dollars could be saved if congestive heart failure patients were monitored from home (Better Healthcare Together).
An emerging trend in management of chronic diseases in America has been towards self- management (Bland, 2009), with instantaneous exchanges of information between patient and provider.
- The ArioTech MDA system helps manage chronic disease more efficiently by preventing exacerbations that often result in more frequent office visits and hospitalizations.
- When unnecessary office visits are reduced, physicians can improve their productivity and efficiency and increase revenue over time, even while reducing patient discomfort (Jana, Pare & Sicotte, 2009).
- In response to an overburdened healthcare system, early detection and treatment is the current trend in the U.S. (Bland, 2009). ArioTech’s MDA system technology is a part of that solution.
- Patients are better able to cope when they feel supported through treatment of their chronic disease. This increases success rates, helps prevent exacerbation and promotes patient confidence throughout the process.
- Patient compliance increases with the use of an MDA system, which serves to improve disease management and reduce office visits. For example, patients can be reminded to take their medication or perform monitoring such as blood pressure or oxygenation.
Home Infusion
Home infusions occur for many reasons—courses of antibiotics, chemotherapy, insulin pumps, pain pumps, and the like—and treatment at home is almost always more appealing than an office visit or hospital admission. Using the ArioTech MDA system, titration management can occur remotely, from the office, and response data is reported real-time so that the patient is monitored closely from the comfort of home for any reactions or adverse events.
Medication error rates were found to be as high as 8% among outpatient cancer treatment patients, and half of these errors were potentially injurious (Walsh et al.,2009). Researchers suggested that better communication could reduce this error rate. The ArioTech MDA system provides a constant link of two-way communication to help alleviate errors in therapy and support patients through difficult treatments.
- Instant communication between patient and staff reduces errors and helps prevent potential patient injury.
- Constant, real-time monitoring can reduce patient discomfort or other adverse events. If a patient begins to have a reaction to the infusion, it can be stopped immediately until further staff assessment.
- When a patient is comfortable, it increases the efficacy of treatment and reduces stress.
- Patients no longer have to worry about driving or finding a ride to the physician’s office, hunting for a parking spot and fighting traffic!
- Electronic record management decreases data-entry errors and reduces the cost and manpower hours required for in-home and/or in-office infusion therapy.
Cardiac Diseases
When it comes to cardiac function, time is at the heart of the matter. Cardiovascular disease, particularly heart disease and stroke, kills more Americans per year than any other chronic disease (Santamour, 2008). The ArioTech MDA system allows for intelligent, remote workflow-enabled arrhythmia monitoring, data collection, database management, communication, and reporting of digital electrocardiography (ECG) data.
The system also helps create a more collaborative healthcare team. Instead of waiting to receive reports from busy office support staff, team members can access records immediately. Automated computer analysis streamlines the processing of test procedures, while seamlessly integrating results with the existing EMR system. This means better care for patients and increased productivity for physicians.
Often, patients’ vital signs are quite different when measured at home as compared to the clinical setting, and capturing this data aids in more appropriate diagnosis and treatment. When dealing with cardiac disease, every second can be precious, therefore remote, real-time alerting of abnormal values allows timely intervention while giving cardiac patients increased freedom to live normal lives.
Family Health and Wellness
In addition to managing chronic diseases, the versatile ArioTech MDA system supports applications in obstetrics, illness and accident recovery, fertility, and ageing independently.
The MDA system can give couples the best odds of conception by helping determine the exact time of ovulation. Through real-time transmission of temperatures and hormone levels, specialists can advise patients without an office visit. If ovulation is suspected, the device alerts patients to proceed directly to the clinic for procedures. Monitoring fetal heartbeat and maternal contraction patterns from home not only helps coordinate care, but prevents premature trips to the hospital. Early detection of complications can help prevent trauma to both mother and child, even save lives.
Elderly patients can be safely monitored from home rather than remaining indefinitely in expensive hospital beds. Precision applications control equipment such as CADD or morphine pumps to help palliative patients at home experience the most comfortable final days.
For general illness and accident recovery, ArioTech’s MDA system lets patients recover at home while transmitting the data needed by their healthcare professionals. This combines independence with a sense of security that the patient is not alone.
Interested in learning more? Contact ArioTech at 201-252-2880.
