Clever Firm Predicts Patients Most at Risk, Then Tries to Intervene Before They Get Sicker
The diabetic patient hit the danger zone.
Ideally, blood sugar, measured by an A1C test, rests at 5.9 or less. A 7 is elevated, according to the Diabetes Council. Over 10, and you're into the extreme danger zone, at risk of every diabetic crisis from kidney failure to blindness.
In three months of working with a case manager, Jen's blood sugar had dropped to 7.2, a much safer range.
This patient's A1C was 10. Let's call her Jen for the sake of this story. (Although the facts of her case are real, the patient's actual name wasn't released due to privacy laws.).
Jen happens to live in Pennsylvania's Lehigh Valley, home of the nonprofit Lehigh Valley Health Network, which has eight hospital campuses and various clinics and other services. This network has invested more than $1 billion in IT infrastructure and founded Populytics, a spin-off firm that tracks and analyzes patient data, and makes care suggestions based on that data.
When Jen left the doctor's office, the Populytics data machine started churning, analyzing her data compared to a wealth of information about future likely hospital visits if she did not comply with recommendations, as well as the potential positive impacts of outreach and early intervention.
About a month after Jen received the dangerous blood test results, a community outreach specialist with psychological training called her. She was on a list generated by Populytics of follow-up patients to contact.
"It's a very gentle conversation," says Cathryn Kelly, who manages a care coordination team at Populytics. "The case manager provides them understanding and support and coaching." The goal, in this case, was small behavioral changes that would actually stick, like dietary ones.
In three months of working with a case manager, Jen's blood sugar had dropped to 7.2, a much safer range. The odds of her cycling back to the hospital ER or veering into kidney failure, or worse, had dropped significantly.
While the health network is extremely localized to one area of one state, using data to inform precise medical decision-making appears to be the wave of the future, says Ann Mongovern, the associate director of Health Care Ethics at the Markkula Center for Applied Ethics at Santa Clara University in California.
"Many hospitals and hospital systems don't yet try to do this at all, which is striking given where we're at in terms of our general technical ability in this society," Mongovern says.
How It Happened
While many hospitals make money by filling beds, the Lehigh Valley Health Network, as a nonprofit, accepts many patients on Medicaid and other government insurances that don't cover some of the costs of a hospitalization. The area's population is both poorer and older than national averages, according to the U.S. Census data, meaning more people with higher medical needs that may not have the support to care for themselves. They end up in the ER, or worse, again and again.
In the early 2000s, LVHN CEO Dr. Brian Nester started wondering if his health network could develop a way to predict who is most likely to land themselves a pricey ICU stay -- and offer support before those people end up needing serious care.
Embracing data use in such specific ways also brings up issues of data security and patient safety.
"There was an early understanding, even if you go back to the (federal) balanced budget act of 1997, that we were just kicking the can down the road to having a functional financial model to deliver healthcare to everyone with a reasonable price," Nester says. "We've got a lot of people living longer without more of an investment in the healthcare trust."
Popultyics, founded in 2013, was the result of years of planning and agonizing over those population numbers and cost concerns.
"We looked at our own health plan," Nester says. Out of all the employees and dependants on the LVHN's own insurance network, "roughly 1.5 percent of our 25,000 people — under 400 people — drove $30 million of our $130 million on insurance costs -- about 25 percent."
"You don't have to boil the ocean to take cost out of the system," he says. "You just have to focus on that 1.5%."
Take Jen, the diabetic patient. High blood sugar can lead to kidney failure, which can mean weekly expensive dialysis for 20 years. Investing in the data and staff to reach patients, he says, is "pennies compared to $100 bills."
For most doctors, "there's no awareness for providers to know who they should be seeing vs. who they are seeing. There's no incentive, because the incentive is to see as many patients as you can," he says.
To change that, first the LVHN invested in the popular medical management system, Epic. Then, they negotiated with the top 18 insurance companies that cover patients in the region to allow access to their patient care data, which means they have reams of patient history to feed the analytics machine in order to make predictions about outcomes. Nester admits not every hospital could do that -- with 52 percent of the market share, LVHN had a very strong negotiating position.
Third party services take that data and churn out analytics that feeds models and care management plans. All identifying information is stripped from the data.
"We can do predictive modeling in patients," says Populytics President and CEO Gregory Kile. "We can identify care gaps. Those care gaps are noted as alerts when the patient presents at the office."
Kile uses himself as a hypothetical patient.
"I pull up Gregory Kile, and boom, I see a flag or an alert. I see he hasn't been in for his last blood test. There is a care gap there we need to complete."
"There's just so much more you can do with that information," he says, envisioning a future where follow-up for, say, knee replacement surgery and outcomes could be tracked, and either validated or changed.
Ethical Issues at the Forefront
Of course, embracing data use in such specific ways also brings up issues of security and patient safety. For example, says medical ethicist Mongovern, there are many touchpoints where breaches could occur. The public has a growing awareness of how data used to personalize their experiences, such as social media analytics, can also be monetized and sold in ways that benefit a company, but not the user. That's not to say data supporting medical decisions is a bad thing, she says, just one with potential for public distrust if not handled thoughtfully.
"You're going to need to do this to stay competitive," she says. "But there's obviously big challenges, not the least of which is patient trust."
So far, a majority of the patients targeted – 62 percent -- appear to embrace the effort.
Among the ways the LVHN uses the data is monthly reports they call registries, which include patients who have just come in contact with the health network, either through the hospital or a doctor that works with them. The community outreach team members at Populytics take the names from the list, pull their records, and start calling. So far, a majority of the patients targeted – 62 percent -- appear to embrace the effort.
Says Nester: "Most of these are vulnerable people who are thrilled to have someone care about them. So they engage, and when a person engages in their care, they take their insulin shots. It's not rocket science. The rocket science is in identifying who the people are — the delivery of care is easy."
If any malady proves the fragile grace of the human genome, it is sickle cell disease.
If experimental treatments receive regulatory approval, it would be a watershed breakthrough for tens of thousands of Americans.
It occurs because of a single "misspelled" letter of DNA, causing red blood cells to run low on oxygen and transforming the hemoglobin in each cell into a stiff rod. Normally round cells become rigid crescents that hamper the flow of blood throughout the body, like leaves clumping in a drain.
Strokes in toddlers are merely the beginning of the circulatory calamities this disease may inflict. Most sickled cells cannot carry oxygen through the body, causing anemia as well as excruciating chronic pain. Older patients are at risk of kidney failure, heart disease and all the other collateral damage caused by poor circulation. Few live beyond middle age.
The only way to cure it has been through a bone marrow transplant from a donor, which requires not only a closely matching volunteer, but bouts of chemotherapy to allow new stem cells to take root, as well as rounds of immunosuppressive drugs that may last for years.
Recent advances in genomic medicine may soon alter the disease's outlook, although many obstacles remain.
In one treatment under development, patient's skin cells are converted into stem cells, allowing them to be inserted into the bone marrow without the need for a donor. Another treatment known as gene therapy involves replacing the aberrant gene in the patient's body with new genetic material.
Although both remain in clinical trials -- and also require at least chemotherapy -- they have shown promise. Matthew Hsieh, a hematologist and staff scientist with the National Heart Lung and Blood Institute in Maryland, has performed about 10 gene therapy procedures over the past three years as part of a clinical trial. Ongoing tweaks in the procedure have led to the blood in more recent patients showing sickle cell trait -- not a perfect outcome, but one that leaves patients with far fewer symptoms than if they have the full-blown disease.
If one or both treatments receive regulatory approval, it would be a watershed breakthrough for the tens of thousands of Americans who suffer from the disease.
Yet it is entirely possible many patients may decline the cure.
A Painful History
The vast majority of sickle cell sufferers in the U.S. -- well beyond 90 percent -- are African-American, a population with a historically uneasy relationship toward healthcare.
"There is a lot of data on distrust between African-Americans and American medical institutions," says J. Corey Williams, a psychiatrist with the Children's Hospital of Philadelphia who has written extensively on racial disparities in healthcare. "It comes from a long legacy of feeling victimized by medicine."
"What you hear from many patients is 'I am not going to be your guinea pig, and I am not going to be experimented on.'"
As a result, Williams is among several clinicians interviewed for this story who believe a cure for sickle cell disease would be embraced reluctantly.
"What you hear from many patients is 'I am not going to be your guinea pig, and I am not going to be experimented on.' And so the history of African-Americans and research will manifest as we develop gene therapies for [these] patients," says Christopher L. Edwards, a clinical psychologist and researcher with the Maya Angelou Center for Health Equity at the Wake Forest University School of Medicine.
Fear among African-Americans of becoming guinea pigs is well-founded. The first c-sections and fistula repairs occurring in North America were performed on enslaved women -- all without consent and virtually none with anesthesia.
Modern 20th century medicine led to the Tuskegee syphilis experiments conducted by the U.S. Public Health Service. Researchers withheld treatment from some 400 African-American men from the 1930s well into the 1970s to observe how they reacted to the disease -- even though curative antibiotics had been around for decades. Only news reports ended the experiment.
The long-standing distrust of American healthcare in the African-American community is also baked into the care provided to sickle cell patients. Despite affecting one in 365 African-Americans, there is no disease registry to assist clinical trials, according to Mary Hulihan, a blood disorders epidemiologist with the Centers for Disease Control and Prevention. Edwards says many sufferers are suspicious of being monitored.
Meanwhile, only two drugs are available to alleviate the worst symptoms. The first one, hydroxyurea, received FDA approval only in 1998 -- nearly 90 years after the disease was first diagnosed. Moreover, Edwards says that some sufferers shy away from using hydroxyurea because it is also used to treat cancer. It's part of what he calls the "myth and folklore" in the African-American community about sickle cell disease.
Economics plays a role as well in the often-fragmented care such patients receive. According to CDC data, many patients rely extensively on public insurance programs such as Medicaid, whose coverage varies from state to state.
A Tough Transition
Edwards notes that sickle cell sufferers usually receive good care when they're children because of support provided by family members. But that often breaks down in adulthood. According to CDC data, an adult sickle cell patient visits a hospital emergency room three times as often as a child patient.
The consensus is that the path to a medical cure for sickle cell will first need to be smoothed over with a talk cure.
Modupe Idowu, a hematologist with the University of Texas Health system, estimates that there are perhaps a dozen comprehensive care centers for the estimated 100,000 sickle cell patients in the U.S., including the one she operates in Houston. That means a significant proportion of those afflicted are on their own to procure care.
And since many patients are on Medicaid, "a lot of hematologists that train to take care of blood disorders, many are not interested in treating [sickle cell disease] because the reimbursement for providers is not great," Idowu says.
Hsieh acknowledges that many of his patients can be suspicious about the care they are receiving. Frustration with fragmented care is usually the biggest driver, he adds.
Meanwhile, the skepticism that patients have about the treatments they seek is often reciprocated by their caregivers.
"The patients have experiences with medication and know what works at a very young age (for their pain)," Edwards says. Such expertise demonstrated by an African-American patient often leads to them being labeled as narcotics seekers.
The Correct Path
This all begs the question of how to deploy a cure. Idowu, who regularly holds town hall-style meetings with Houston-area patients, often must allay anxieties. For example, the gene therapy approach uses a harmless virus to transport new genetic material into cells. That virus happens to be a benign version of HIV, and convincing patients they won't be infected with HIV is a fraught issue.
The consensus is that the path to a medical cure for sickle cell will first need to be smoothed over with a talk cure.
Idowu tries to hammer home the fact that patients are afforded vastly more protections than in the past. "There are a lot of committees and investigational review boards that keep track of clinical trials; things just don't happen anymore as they did in the past," she says. She also believes it helps if more providers of color communicate to patients.
Hsieh is very straightforward with his patients. He informs them about the HIV vector but assures them no one has ever tested positive for the virus as a result of its use.
Edwards notes that since many patients suffer psychosocial trauma as a result of their chronic pain, there already is some counseling infrastructure in place to help them cope. He believes such resources will have to be stretched further as a cure looms closer.
In the absence of formal mental health services, straight talk may be the best way to overcome wariness.
"If patients have misgivings, we try our best to address them, and let them know at the end of the day it is their decision to make," Hsieh says. "And even the patients who have gone through the gene therapy and it didn't work well -- they're still glad they took the chance."
Probiotics seem to be everywhere these days. They are marketed for numerous health issues, from irritable bowel syndrome and vaginal yeast infections to life-threatening disorders like the bacterial infection Clostridium difficile.
The new probiotic drink is made of genetically engineered bacteria meant to help people feel better the day after drinking.
While the probiotic gummies that you'll find in supermarkets may not do much for you, good clinical evidence does support the C. difficile treatment, known as a fecal transplant, despite a recent setback, and there are always new probiotic regimens entering the scene. One emerging such treatment targets the hangover.
The Lowdown
You read that right – although "hangover" is a loaded term, according to ZBiotics, the company that's developing the product. The popular understanding of a hangover implies a collection of symptoms like a headache and fatigue, many of which result simply from dehydration and low-quality sleep. But those aren't the problems that the new product, a genetically engineered form of a common bacterial species, was developed to confront.
"Dehydration and poor sleep have actually always been pretty simple to deal with by having a good breakfast and some caffeine," notes ZBiotics founder and microbiologist Zack Abbott. Instead, the product targets acetaldehyde, a chemical that accumulates in the body if more than small amounts of alcohol are consumed.
Normally, body cells produce an enzyme that converts acetaldehyde into harmless acetic acid. But the enzyme becomes overwhelmed if you drink more than a little alcohol, or if you have a certain genetic deficiency.
A new probiotic drink aims to neutralize a chemical that builds up in the body after drinking alcohol.
(Zbiotics)
"I started ZBiotics with the hypothesis that if we used edible probiotic bacteria to make enzymes, and chose applications in which the enzymes these microbes make would be useful directly in the gut after you eat them, we could create all sorts of beneficial products," says Abbott. "I started with alcohol with the idea that we can augment the body's natural ability to digest its nasty byproduct, acetaldehyde, helping people feel better the day after drinking."
Next Steps
Based on the premise that the engineered bacteria augments a natural body function, ZBiotics had the product "sampled by thousands of beta-testers," including ZBiotics personnel, with "almost unanimously positive feedback," says Abbott.
"We are working on future scientifically controlled testing for publication."
ZBiotics is to set to launch on the market next week as a probiotic supplement, a category that does not require FDA approval. But some observers are troubled over whether the new product is attempting to serve a medical function without going through the standard drug testing process.
"I am skeptical of any new alternative product that is not FDA approved, has not undergone rigorous double-blind placebo control testing and adverse effects evaluation, and cites anecdotes as evidence of its efficacy," warns Heather Berlin, a cognitive neuroscientist and assistant professor of psychiatry at Icahn School of Medicine at Mount Sinai, in New York.
Abbott acknowledges that his product still needs to undergo rigorous study. "We are working on future scientifically controlled testing for publication," he says, noting that the company was "founded and [is] run by people with backgrounds in academic research."
Open Questions
Moving beyond the need for proper testing, Berlin has an additional concern: will a "hangover"-blocking substance cause people to drink more alcohol, or mask important physiological sensations like thirst?
"If that negative feeling is obscured, they may not [rehydrate], which can cause numerous adverse effects," Berlin says.
As for excessive drinking, there is a treatment on the market that does the opposite of Zbiotics. Disulfiram, commonly given to alcohol abusers, inhibits the very enzyme that ZBiotics supplements, causing acetaldehyde to accumulate especially fast. This makes drinking a pretty miserable experience.
But Abbott says his product would not interfere with disulfiram.
"[Zbiotics] is about enjoying the special moments in life where alcohol happens to be involved, but isn't the main focus."
"Disulfiram globally inhibits the enzyme throughout the entire body, including the liver, creating a massive amount of acetaldehyde at once, making the person ill immediately and forcing them to stop drinking right away," Abbott explains, whereas his product exerts its effects in the gut, and is really only helpful the next day. Thus, timing is everything; the probiotic would not change the experience at the moment of drinking.
"ZBiotics isn't about going out and ripping shots all night," Abbott says. "It's about enjoying the special moments in life where alcohol happens to be involved, but isn't the main focus. Weddings, celebrations, weekends with friends. And wanting to do that enjoyably while being safe and responsible at the same time."