A cacophony of alarms began to beep simultaneously just as 5-year old Riley Kinman was finishing her dinner of chicken nuggets. Her parents, Terry Kinman and Nicole White, rushed from the dining room table to grab a large bag of pills from the kitchen.
Riley had a kidney transplant last year and takes multiple medications on a strict schedule. If she misses too many, the kidney she received from her dad could fail, leaving her in need of dialysis and on the waiting list for a replacement organ. The multitude of alarms helps her parents to stay on track.
Anyone who has ever needed to take several prescriptions at different times of day can understand how hard it can be to stick to the routine. But it’s a particular concern for patients with chronic illnesses, for whom medication is necessary to survive.
In June, Children's Health in Dallas began testing an emerging innovation known as "digitized medicine." They hope the technology will track how well patients stick to complex medication schedules in real time, from inside the patient's body, and allow immediate feedback from the patient to the provider.
How it works
A digitized pill looks like a regular pill, but it contains no medication and carries a small sensor about the size of a grain of sand.
From inside the stomach, the sensor documents if a medication has been taken, which it communicates to a patch worn on the patient's side. The system can identify spikes or dips in blood pressure or heart rate, and track physical activity and sleep patterns, for example.
The information is transmitted from the patch to a cloud-based server, and within a matter of minutes downloaded onto a web interface at the hospital, which the clinical staff can see.
Each patient is also provided an iPad, so they can see the same information. If a medication has (or has not) been taken at the scheduled time, or if too much (or too little) has been ingested, both the patient and their medical team can tell.
The technology has mostly been tested in adults with chronic conditions such as uncontrolled hypertension, diabetes and tuberculosis.
Children's Dallas is perhaps the first to extensively test it using pediatric patients. Riley, who takes a daily combo of vitamins, steroids, blood pressure, urinary tract and immunosuppressive drugs, was the first patient to enroll in the pilot.
She's too young to understand the health information that populates each day on the iPad; her current interests are swimming class and a princess from the animated movie Frozen.
But her parents, hope that by familiarizing her with the technology at an early age, they can better prepare her for the lifetime routine she will have to maintain to keep her kidney functioning. "Right now we're in charge," said her mom Nicole White. "But we're going to like this when she gets older and can start to monitor herself."
The trial is part of a broader initiative focused on population health, an area of study that looks beyond medical care and delves into the social determinants and personal behaviors that impact health care outcomes.
A $289 billion problem
Not taking medications as recommended is one of the main behaviors that causes adolescents and young adults to ultimately lose their transplant.
"Even if they don't lose the organ, there can be permanent loss of function that will not recover," explained Dr. Dev Desai, head of pediatric abdominal transplantation at the Children's Medical Center in Dallas.
"It's a major challenge for pediatric transplant centers," explained the transplant surgeon. He's spearheading the effort at the hospital.
In the general population, poor medication adherence is estimated to be a $289 billion national problem, one that frequently results in preventable tests, procedures, doctor's visits and hospitalizations.
Stakeholders in the health care business have been encouraged to address the issue as a means of improving poor outcomes in patients with chronic diseases and driving down costs. But it has been a challenge to research.
Some studies depend on patient self-reports and memory, which can be unreliable.
More frequently, pharmacy claims data is pulled to show whether prescriptions have been filled. However, just because a patient has picked up their medications, doesn’t mean they actually took them as instructed.
About half of the time consumers do not take prescription drugs as recommended, and rates tend to drop the longer the patient is on them.
Another option to study the problem, especially in child patients whose medications are based on dose, has been to look at changes in blood levels from one doctor's visit to the next.
But visits can happen weeks or months apart, thus delaying the opportunity to spot lapses in the medication schedule.
Use of a digital sensor to provide data in real time from inside the patient's gut, is one way some groups are trying to get around the challenges.
The digitized drug is manufactured by a Redwood, Ca.-based digital health company named Proteus. The product gained Food and Drug Administration approval in 2012, under a classification meant for "novel devices of low to moderate risk." It has steadily been gaining industry attention.
In 2014, the device landed on a top 10 list of trends to watch in a report from the ECRI Institute, an organization that evaluates emerging health care technology for hospitals and health systems, insurers, health policy and other industry groups.
It's a "promising innovation," and with additional research may offer new insight into the issue, says Diane Robertson, director of health technology assessment for the ECRI Institute.
In April, the group released a report that summarized all the existing studies on the Proteus device. ECRI concluded it is safe, but said the best use for it in clinical practice needs further evaluation.
The partnership with Children's Medical Center in Dallas falls in line with a greater trend among pediatric hospitals that are actively seeking ways to connect with young patients and their millennial parents.
"Think about the impact of Pokemon Go," explained Amy Wimpey Knight, chief operating officer for the Children's Hospital Association. "Technology can be a game changer," and pediatric hospitals are investing in it at a rapid rate in high-cost areas of care, like transplant and heart care.
"There is still a lot of basic science," she said. "But more and more, the investment is in innovative ways of delivering care and engaging and interacting with parents from their home environment."
Riley's parents both work in the technology field, one is a software developer and the other an engineer. Their tech-savvy helps keep Riley on schedule in their home.
"I don't trust myself sometimes," says father Terry Kinman, who admits that he sets one alarm five minutes before it's time for the round of medications to begin.
That’s one of the reasons she was selected for the pilot at Children's of Dallas. Her active lifestyle also allows researchers to test the product in the real-world setting of an active 5-year old.
So far about 15 pediatric transplant patients' are participating in the trial, and the hospital says it has already proven to been useful. For example, when one preteen had not doubled up on a blood pressure medicine as recommended, the care team intervened within a matter of days.
“It turns out they had simply forgot,” Desai said. "Our phone call had an immediate impact on that patient's care."
They also get immediate feedback from participants, which can be shared with the manufacturer as they continue to develop the technology.
For example, in order for the tiny sensor to transmit information, patients must wear a waterproof patch just below their rib cage. As Riley's parents noted, that patch sometimes irritates the skin.
The medical center staff has also noticed that the patch needs to be replaced more frequently in active pediatric patients, than it did in trials by the manufacturer, which focused adults with more sedentary lifestyles.
The technology is promising, but experts say there is still much to learn. Right now, patients have to take the digital drug at the same time as they take their regular medications. The goal is to one day have the sensors placed inside of FDA-approved commercial medications.
That plan suffered a setback in April, when the FDA rejected a request by Otsuka Pharmaceutical to place the sensor inside the antipsychotic drug Abilify. The federal agency requested more data about the product's performance and effectiveness in real-life settings before moving forward.
Molly O'Neill, chief commercial officer for Proteus remains optimistic. "This is a first of a new pathway,"she noted. "There's been a lot of interest, and we're going through each step of the process faster than we had ever envisioned. We have every reason to believe this will be approved."
While supportive of health care innovation, Wimpey Knight cautions that the urgency to problem-solve should not preclude the careful testing and regulatory approval needed to make medical technology safe.
"That's the natural tension with innovation," she said. "It's worth stepping out there and doing it, but it's a balancing act...between the need for a solution and making sure you don't negatively impact the quality of patient care."
The health technology group at ECRI supports more studies on digital drugs, especially from groups other than the manufacturer. Clients are curious, Robertson said. "Payers want to know if they should invest, and researchers if they should use it in trials."
Children's Health in Dallas plans to enroll about 75 pediatric transplant patients that take multiple medications daily in its study. They hope to release preliminary data in a white paper by late next year.
Right now the medical center says it has only paid for the cost of the software, but has made no other investment in Proteus. The manufacturer provides the iPad at no cost to each of the families, so they can see the same information as the doctor and share feedback to enhance the product.
The big costs, however, would come in the future. If successful, the medical center says its compounding pharmacy would need to seek approval to encapsulate the digital sensor into some medications taken by pediatric patients. A worthy investment, Desai says.
“If our trial shows that we can reduce the rates of organ rejection due to nonadherence, it would easily help reduce health care costs long term," he said. "One patient that we can keep from losing a transplanted organ would justify the initial cost.”