There is no denying the Affordable Care Act has significantly increased the number of Americans with health insurance. Yet many policymakers and consumers question the value of Marketplace plan coverage under the ACA because cost-sharing can get pretty high.

A survey by the Kaiser Family Foundation and The New York Times last year found that 22 percent of people who purchased health insurance through an ACA Marketplace plan had trouble paying their medical bills due to copayments, high deductibles, and co-insurance payments.

Out-of-pocket costs under a typical silver plan, for example, can be twice as high as they are in the average plan provided by employers.

So Stanford health policy researchers conducted a study, published online in Health Affairs, in which they simulated out-of-pocket spending for bronze, silver and gold Marketplace plans — those having actuarial values of 60 percent, 70 percent and 80 percent, respectively.

They found that while Marketplace plans significantly reduce exposure to the financial risk of a catastrophic illness, the use of actuarial values can be misleading. For the vast majority of consumers, the proportion of covered spending is likely to be far less than their actuarial values.

“Many Americans may find themselves not using their health insurance plan in a given year because they didn't get sick,” said Maria Polyakova, an assistant professor of health research and policy at Stanford Medicine and lead author of the paper.

In fact, only when annual health-care spending exceeds $16,500 for bronze plans, $19,500 for silver plans, and $21,500 for gold plans do plans in these metal tiers cover the proportion of costs matching their actuarial values. These metal levels are intended to provide standardized information on coverage generosity to help consumers choose among plans.

Marketplace plans provide relatively comprehensive coverage for the small proportion of people who experience extremely high health-care spending, the authors wrote. But the vast majority of enrollees experience relatively little direct benefit from their coverage in any given year because most of their services out of pocket because their expenses fall below the deductible limits.

But Polyakova, who is also a faculty research fellow at the National Bureau of Economic Research, said it’s important not to conclude that purchasing health insurance is a waste of money for the young and healthy.

“Indeed, most working-age adults do not use much health care,” she said. “The idea of health insurance, however, is to protect household finances in those cases when someone does get sick and needs expensive care. In this paper, we find that for many consumers, Marketplace plans are likely to provide valuable risk protection.”

The mismatch between expected and experienced coverage for the majority of people who have low health-care expenditures is one factor that may have inhibited enrollment in Marketplace plans among relatively healthy people, the authors wrote, a phenomenon that could have contributed to Marketplace instability.

“More generally, a weakness of using actuarial value is that doing so distracts consumers from the key purpose of insurance, which is financial risk protection,” said Polyakova and co-author Kate Bundorf, an associate professor of health research and policy and chief of the Division of Health Services Research at the Stanford School of Medicine.

“Policymakers should consider alternative ways of communicating plan generosity that more accurately convey to consumers their likely out-of-pocket spending in a plan and how much risk protection plans provide,” they wrote. “Moreover, it may be important and valuable to emphasize the risk protection value of plans in the public debate.”

One fairly easy fix, Polyakova said, would be for healthcare.gov to show consumers their expected spending under different “sick” and “healthy” scenarios. Currently, the health site asks consumers whether they expect to be sick or healthy and then shows which out-of-pocket costs would result. But it doesn't show people who expect to be healthy what would happen to their spending if they did get sick.

The high cost of prescription drugs in the United States came under scrutiny in a new report from the National Academies of Sciences, Engineering, and Medicine, “Making Medicines Affordable: A National Imperative,” co-authored by Stanford Law Professor Michelle Mello, who is also a professor of health policy and a core faculty member at Stanford Health Policy. Published on November 30, the report aims to increase both affordability and accessibility to crucial—often lifesaving—drugs for Americans, with recommendations such as better government negotiated prices, quicker turnaround for generic drugs, and increased financial transparency for biopharmaceutical companies.

In the discussion that follows, Mello explains some of the key challenges facing Americans in need of prescription drugs and key recommendations in the report.

You note in the report that Americans are paying significantly more for their healthcare but are significantly less healthy when compared to developed countries. Do we also pay more for prescription drugs?

Yes. In fact, many countries use “reference pricing” schemes, through which the price that their national health programs pay for prescription drugs is actually calculated as a percentage of what we pay!  One of the ethical issues that weighed on the Committee as we deliberated was that interventions that tamp down prices in the U.S. could have ripple effects in other, less wealthy countries if drug makers seek to recoup their losses by giving fewer price concessions elsewhere.

What is the most important factor leading to higher prescription drug costs in the U.S.? 

The old adage that “every system is perfectly designed to get the result it gets” really came to mind as we investigated why drugs cost so much.  It’s not just one factor, but a whole ecosystem in which multiple actors and factors are contributing.  At the root of it, though, is that there are distortions in the market for drugs that permit things to happen that wouldn’t occur in a truly competitive market.

Which of the 27 action points recommended in the report stand out to you as a priority—and achievable? 

We view our recommendations as a package that should be implemented together, but there are three that we think are especially promising. First, the federal government should directly negotiate drug prices on behalf of all federal programs (and any state programs that want to join in). To create leverage in these negotiations, federal programs should have the flexibility to exclude certain drugs, such as when less costly drugs provide similar clinical benefit.  Second, to improve transparency about where the money is going and where opportunities exist to recapture some of it, biopharmaceutical companies and insurance plans should make public information about the net prices they receive and pay for drugs, including discounts and rebates. Third, insurance plans—especially Medicare plans— should provide better protection against out-of-pocket drug costs. There should be limits on total out-of-pocket costs, and patients’ deductibles and coinsurance payments should be based on the net price of the drug, not the list price.

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A number of the recommendations seem quite procedural, such as eliminating misapplication of funds and inefficiencies in federal discount programs, ensuring financial incentives are not extended to widely sold drugs, and increasing information sharing about reimbursement incentives. Is part of the high cost we pay due to bureaucracy and inefficiency?  

We identified ways in which federal programs are being misused, to the detriment of consumers. One example is what is known as the “340B program,” which was intended to ensure that hospitals and other facilities that serve low-income populations receive deep discounts on drug prices, but is being used by a broad range of facilities that don’t necessarily pass those savings on to patients. Another example is the orphan drug program, which provides very valuable financial incentives for manufacturers to develop drugs for rare diseases.  Companies have obtained these rewards even when they also sell their drug for other indications for which there is a huge market, and in some cases have gotten the rewards multiple times for the same drug.  These problems aren’t about bureaucracy, they’re about gaming the system.  These programs were good ideas that have been very successful in achieving their goals, but have had unintended effects that need to be addressed.

Biopharmaceutical companies have gotten a bad rap in the press, but you note that the cost of developing drugs is very high, and success rates low, with 9 out of 10 investigational products never making it to market. So there is an acknowledgment of the high stakes, high-cost nature of the sector. The report recommends accelerating market entry and use of generic and biosimilar drugs. How can this be implemented without discouraging development of new drugs?

Ensuring affordability of drugs while not discouraging innovation is the central tension that our committee had to grapple with. It’s not easy.  The recommendations in the report strike a balance between these two important objectives.  With regard to generics, our patent system creates a workable deal with drug innovators: create a useful new product, and we’ll give you a period of market exclusivity; generics can’t enter until after that period is up. One problem that our report addresses, though, is that companies have developed ways to extend that period of exclusivity. One is to pay generic companies to delay market entry. Another is to seek follow-on patents on incremental changes to their drug. For example, one company got a new patent by demonstrating their drug could be administered by crushing it up and mixing it with applesauce. The use of this tactic, called “evergreening”, should be curbed.

One recommendation in the report is that the federal government consolidate and apply its purchasing power to directly negotiate prices with the producers and suppliers of medicine, and strengthen formulary design and management. Do government-sponsored medical plans, such as Medicaid and Medicare, already do this? 

By law, the federal agency that runs these programs isn’t allowed to negotiate directly for drug prices for Medicare patients. Instead, all the individual, private plans that provide drug coverage under Medicare Part D do the negotiating. They get discounts, but we think the discounts would be deeper if the bargaining was consolidated in one mighty purchaser.

You noted that private investment is increasingly important to drug development. How much of drug development is supported by public funding, via grants to universities, etc., that then go on to become small startups with private investment? If it is significant, does the public get a good deal on its seed investments?

American taxpayers foot the lion’s share of the bill for the basic-science research that generates information about which molecules are promising to pursue. Private companies pay most of the development costs—that is, testing the molecule in clinical trials to see if it’s safe and effective. The public has gotten a great return on investment in the sense that the industry, particularly in the last decade or so, has been turning out a lot of very innovative, useful products. The work that remains to be done is ensuring that those products are financially accessible to everyone who needs them.

One recommendation is that biopharmaceutical companies and insurance plans disclose net prices received and paid, including all discounts and rebates, at a National Drug Code level. Would this cover all international transactions too, so that we could see costs/prices in other countries? 

No, our recommendation relates to the drug supply chain in the U.S., which is highly complex and highly opaque.

Can you talk about this a bit—why this transparency is important?

One of the things that was frustrating about studying drug affordability is that the various players in our system—such as drug manufacturers, health insurance plans, and intermediary organizations called pharmacy benefit managers, or PBMs—all point fingers at one another when you ask them who is responsible for consumers’ high drug costs.  Yet, there’s very little information available by which to assess their claims. Is the problem that drug makers launch their products at excessive list prices? Or that PBMs buy them at a discounted price, which is kept confidential, and don’t pass those savings along to health plans? Or that health plans get drugs at a deep discount but make subscribers pay cost-sharing (for example, the 20% coinsurance you pay at the pharmacy) as though the drug’s cost was the list price?  Nobody will cough up the data necessary to make these judgments.  Our recommendation addresses that problem.

Are there any next steps for you and the authors of this report? Will there be subsequent research by the group—or coordination with policy makers?

We are working hard to make sure policy makers, journalists, and key stakeholders understand our recommendations and the evidence behind them.  This week, for example, our report was presented to a packed room of Senate staffers.  We have also identified some areas where additional research is needed, and hope that research sponsors will respond to that need.  There is a lot of work to be done.

Maya Rossin-Slater uses her PhD in economics to analyze large-scale data on population health and socioeconomic outcomes to help inform policies targeting families with children, especially those who are disadvantaged or poor.

Rossin-Slater, an assistant professor at the Department of Health Research and Policy at Stanford Medicine, is the newest core faculty member at Stanford Health Policy. Prior to coming to Stanford this summer, she was an assistant professor of economics at the University of California, Santa Barbara for four years after receiving her PhD at Columbia University. Her research centers on public policies and their impacts on the health and well-being of families.She asks complex questions, often finding the answers in large administrative databases. Specializing in using “natural experiment” methods, Rossin-Slater tries to separate causation from correlation.

How do child-support mandates impact the relationship between parents and children? Does high-quality preschool compensate for early life health disadvantages? What are the long-term impacts of early childhood exposure to air pollution once they become adults?

“To me, it’s important to do this kind of research that can inform real-world policies, particularly for less advantaged families,” said Rossin-Slater, who is also a faculty fellow at the Stanford Institute for Economic and Policy Research (SIEPR) and a faculty research fellow at the National Bureau of Economic Research.

“We live in a world with limited resources and we need to understand how to best allocate them,” she said. “So I think there is value in providing rigorous causal evidence on the effectiveness of various tools and policies that impact the less advantaged so that we can get the highest return on public spending as well as the highest potential for improving the outcomes of those at the very bottom.”

In a paper published in the Journal of Public Economics, Rossin-Slater talks about the growing body of evidence that suggests in-utero conditions and health at birth make a difference in later-life well-being. She found that the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) is one of the most cost-effective and successful programs to improve health at birth for children of disadvantaged mothers.

“The estimated effects are the strongest for mothers with a high school education or less, who are most likely eligible for WIC services,” she wrote in the paper, which was cited by the White House blog under President Barack Obama.

Paid Family Leave

When Mark Zuckerberg announced he would take a two-month paternity leave when his daughter was born in 2015, the Facebook co-founder was taking advantage of his own company’s policy, which grants employees up to four months leave for all new parents.

“Studies show that when working parents take time to be with their newborns, outcomes are better for the children and families,” Zuckerberg wrote on his Facebook page.

This prompted many media outlets to turn to a co-authored study with Rossin-Slater, which found that 46 percent more men have taken time off to help take care of their newborns since California made paid family leave (PFL) law in 2004.

“The increase in paternal leave-taking may also have important implications for addressing the gender wage gap,” the authors wrote. “Our results suggest that a gender-neutral PFL policy can increase the amount of time fathers of newborns spend at home—including the time they spend at home while the mothers work—and may therefore be seen as one way to promote gender equality.”

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Here at Stanford, Rossin-Slater is using databases in the United States, Denmark and Sweden to continue her research on public policies (including paid family leave), as well as looking at how prenatal and early childhood factors impact lifelong outcomes. Does inequality and the stress of poverty in pregnancy, for example, get transmitted across generations?

In a forthcoming paper in the American Economic Review Rossin-Slater and her co-author, Stanford economist Petra Persson, found that prenatal exposure to maternal stress due to deaths in the family could have lasting consequences for the mental health of the children.

They examined nearly 300,000 births in Sweden between 1973 and 2011, in which a relative of the mother died either before her due date or in her child’s first year of life. They found that children who were in the womb when a relative died were 25 percent more likely to take medication for ADHD than those who were infants when the relative died. And those children were 13 percent more likely to take prescription drugs for anxiety once they became adults.

Take those results and one can imagine that the stress of living in poverty during pregnancy might be compounded over generations in that same disadvantaged family.

“This would imply that policies aiming to alleviate stress associated with economic disadvantage may help break the cycle of poverty,” Rossin-Slater and Persson told The Washington Post for a story on their research.

In new projects, Rossin-Slater is now studying the effects of reforms in the WIC program in California on maternal and child health, as well as the impacts of paternity leave on maternal mental health and child outcomes in Sweden. She continues using research designs that pay careful attention to establishing causality and working with large administrative databases.

“I believe in and enjoy working with data because it provides an opportunity to learn about how real-world policies actually work,” she said. “I have the privilege of being able to set my own research questions and to use my economic training and newly available data to try to find at least some answers. My hope is that these answers can be useful for creating better and more effective policies.”

Sometimes a straightforward explanation and an apology for what went wrong in the hospital goes a long way toward preventing medical malpractice litigation and improving patient safety.

That’s what Michelle Mello, JD, PhD, and her colleagues found in a study published Oct. 2 in Health Affairs.

Mello, a professor of health research and policy and of law at Stanford University, is the lead author of the study. The senior author is Kenneth Sands, former senior vice president at Beth Israel Deaconess Medical Center.

Medical injuries are a leading cause of death in the United States. The lawsuits they spawn are also a major concern for physicians and health-care facilities. So hospital risk managers and liability insurers are experimenting with new approaches to resolving these disputes that channel them away from litigation.

The focus is on meeting patients’ needs without requiring them to sue. Hospitals disclose accidents to patients, investigate and explain why they occurred, apologize and, in cases in which the harm was due to a medical error, offer compensation and reassurance that steps will be taken to keep it from happening again.

Positive results

The study reports on the outcome of a so-called communication-and-resolution program at two large Massachusetts hospital systems. Mello and her co-authors found that the program not only yielded positive results in terms of liability costs but also led to significant patient safety improvements.

“In these programs, hospitals scrutinize every serious harm event to answer the question, ‘What can we learn?’” Mello said. “Traditionally, a risk manager’s focus has been on the patients who complain about the care or threaten to sue. But every patient deserves to know that what happened to them is being taken seriously.”

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Despite concerns that telling patients about errors and proactively offering compensation could cause liability costs to skyrocket, of the 989 adverse events reviewed for the study from 2013 to 2015, only 5 percent led to malpractice claims or lawsuits. And when the program did lead to compensation, the median payment was $75,000. By comparison, the median payment nationwide in 2015 when plaintiffs prevailed in malpractice lawsuits was about $225,000, Mello noted.

“Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively,” the authors wrote.

Pilot program

The authors focused on a program called CARe — Communication, Apology and Resolution — at six Massachusetts hospitals: Beth Israel Deaconess Medical Center and Baystate Medical Center, and two of each center’s community hospitals.

The hospitals demonstrated good adherence to the program protocol, the authors found. Physicians were supportive of the approach but did ask for better communication about the program and what was happening with their patients.

The low percentage of events that led to litigation should reassure hospitals concerned about the risks of being honest with patients, the authors wrote. A likely explanation, according to Mello, is that explaining why adverse events occurred defused patients’ anger. About three-quarters of the time, adverse events were not actually due to error, the study said. Rather, malpractice claims frequently arise when plaintiffs perceive that the health care providers communicated poorly or attempted to cover up negligence, the authors noted.

“Given the rarity with which communication-and-resolution events resulted in settlements, it is reasonable to wonder whether the programs are worth the time they require,” the authors wrote, “but risk managers in our study thought they were. By providing explanations and expressions of sympathy for harms not arising from negligence, communication-and-resolution programs may avert lawsuits springing from misunderstanding.”

Objectives and improved safety

The CARe objectives are to improve transparency surrounding events, improve patient safety, reduce lawsuits and support clinicians in disclosing error or injury.

Medical events were bumped to a CARe evaluation if they met a severity threshold of either causing permanent or temporary harm that led to an extended hospitalization, required an invasive procedure or led to at least three outpatient visits.

Of the 989 total events studied by the authors, 60 of them entered the CARe program because the hospital received notice that the patient intended to sue. Another 929 entered the program when an adverse event was reported that allegedly exceeded the severity threshold, or that met other criteria.

The protocol called for compensation to be proactively offered whenever a violation of the standard of care caused serious harm. Only 9 percent of cases met these criteria. The largest payment made was $2 million. In 181 events, in which compensation criteria weren’t met, hospitals offered to waive medical bills or made other modest gestures, like giving the patients meal vouchers and gift cards. About three-quarters of injuries didn’t qualify for compensation because the standard of care was judged to have been met — a proportion that is consistent with prior studies of medical injuries. About a third of the injuries weren’t caused by the medical care: For example, a patient contracted an infection in the hospital but died from other causes.

“These programs are usually talked about as a way to resolve cases of medical error, but what they do more often is encourage communication with patients about non-error events — as well as systematic evaluation of each event for patient-safety lessons,” Mello said.

The authors also noted that communication-and-resolution programs “can help hospitals foster a culture of transparency by supporting clinicians in making disclosures.”

The safety interventions identified in the CARe investigations included new labeling for high-risk medications, color-coded socks for patients at risk for falls, radio frequency identification tags for surgical sponges, improved interpreter services, improvements for managing the selection of implantables after surgery, and a multidisciplinary checklist for breech deliveries.

Other authors of the study are affiliated with Harvard, Tufts, Baystate Medical Center, and Beth Israel Deaconess Medical Center.

Women now have the option of getting screened every three or five years for cervical cancer, depending on which type of test they use, according to new draft recommendations from the U.S. Preventive Services Task Force.

The group of independent medical experts is recommending that women 21 to 29 years old get a cervical cytology (PAP test) every three years, while women aged 30 to 65 should either continue to get screened with a Pap every three years, or opt to be tested for the high-risk human papillomavirus (HPV) every five years.

“Cervical cancer is highly curable when found and treated early,” task force member Carol Mangione, MD, MSPH, said in a release on Monday. “Most cases of cervical cancer occur in women who have not been regularly screened or treated. Therefore, making sure all women are adequately screened and treated is critical to reducing deaths from cervical cancer.”

Despite the dramatic reduction of cervical cancer by half since the Pap test was introduced 40 years ago, nearly 13,000 American women are expected to contract this type of cancer this year. Of those, 4,200 are likely to die, according to the American Cancer Society. African-American and Hispanic women are at even greater risk.

The task force is an independent, volunteer panel of national experts in prevention and evidence-based medicine whose recommendations are widely followed by physicians and policymakers. They assign each recommendation a letter grade based on the strength of the evidence — and this recommendation comes with an A.

“We now have two effective screening strategies for women over 30, either cervical cytology every three years or HPV testing every five years,” said Douglas K. Owens, vice-chairperson of the task force.

Owens, a physician, professor of Stanford Medicine and director of the Center for Health Policy and Center for Primary Care and Outcomes Research, said that in women ages 21 to 29, a substantial portion of HPV infections resolve on their own. Cervical cytology, or Pap tests, remains the recommended screening strategy in this age group.

The advisory panel recommended against screening in women younger than 21 and older than age 65 years who have been adequately screened and don’t have a history of high-risk lesions.

The task force emphasized that cervical cytology tests remain an effective method of screening for cervical cancer, but that evidence published since its 2012 found that both Pap tests and HPV testing alone are effective ways to screen for cervical cancer in women aged 30 to 65.

“So women should discuss with their health-care provider which testing strategy is best for them,” Owens said. “What’s most important is that women get screened regularly.”

The Food and Drug Administration in 2011 approved the first test for HPV screening, a DNA test that looks for 14 types of the HPV virus, including types 16 and 18, which cause about 70 percent of all cervical cancers. In 2014, the FDA determined that the HPV test could be used alone instead of alongside the Pap test, which looks for changes in cervical cells.

The task force’s draft recommendation and evidence review have been posted for public comment on its website. Public comments can be submitted through October 9.

Design learning and journey maps are all the rage here at Stanford University and in Silicon Valley. So why not apply it to health systems to reduce diagnostic errors?

That’s what Stanford Health Policy’s Kathryn M. McDonald is trying to do: Map the journey of worrisome scenarios that keep clinicians up at night, and then plant design seeds that might just help those clinicians get back to sleep.

One of those real-world scenarios involves a preventable diagnostic error made as a high-risk condition unfolds across multiple visits to the doctor. Missed cancer diagnoses, for example, are the leading cause for paid medical malpractice claims in the ambulatory setting, with one in 20 patients experiencing potentially preventable diagnostic errors each year.

“For example, a patient who has a positive fecal blood test, but no follow-up colonoscopy within a reasonable period may experience a missed opportunity to detect and successfully treat colon cancer,” McDonald said.

McDonald and her team worked with San Francisco public health clinics that cater to low-income patients to investigate this key problem — missed diagnosis and prevention activities during outpatient care — then came up with design seeds to plant possible solutions.

She and her co-authors published their research in the journal Implementation Science. The project was conducted at the Ambulatory Safety Center for Innovation (ASCENT), a patient safety learning laboratory led by Dr. Urmimala Sarkar at University of California San Francisco, and funded by the federal Agency for Healthcare Research and Quality.

The team used a research design approach called “journey mapping,” a tool that tells the story of a customer’s experience through his own viewpoint. They constructed maps for each pathway used by doctors to monitor patients with sinister findings, starting with the initial diagnostic assessment during an initial clinic visit and continuing through ongoing follow-up visits.

“Whenever participants in the study verbalized elements of the pathway that were particularly vulnerable to error or poor monitoring, we marked the activity with a bullseye target, also referred to by clinicians as a ‘pain point,’” the authors wrote. “To our knowledge, this technique has seldom been applied to the ambulatory setting, and has not been targeted to clinic workflow efficiency or patient safety intervention development.”

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“A design seed gives the specs for what a solution needs to do,” said McDonald, who is the executive director of Stanford Health Policy’s Center for Health Policy and Center for Primary Care and Outcomes Research. “Once you know the vulnerabilities through journey mapping, you create all the design seeds that are tied to the problem, then the implementation stage becomes much more straightforward and more likely to assure that all the key goals are met.”

To test out this theory, McDonald’s team spent the last two years working with doctors, residents, nurse practitioners and registered nurses with the San Francisco Health Network. The publicly funded integrated health network operates under the auspices of the San Francisco Department of Public Health and includes 14 primary care clinics, as well as urgent and specialty care at Zuckerberg San Francisco General hospital.

“The health system serves many of the most medically and socially vulnerable patients in San Francisco,” the authors wrote in their research paper. “Like many safety-net systems and ambulatory practices, the health system does not have a comprehensive electronic health record system and struggles with information transfer as well as fragmentation of health information across over 50 electronic platforms.”

The health system had more than half a million outpatient visits last year by people who could not afford care. Patients at the network’s main clinics and hospital are diverse: 35 percent are Latino, 21 percent are white, another 21 percent are Asians, and 17 percent are African-American.

Only 1 percent of the network population has commercial insurance; 10 percent were uninsured; 57 percent were on Medi-Cal — California’s Medicaid program — 21 percent were on Medicare and the remaining 11 percent were covered by other, mostly public sources.

This type of ambulatory health care is complex, requiring constant tracking and reconciliation of individual patient activities, patient data, and the unique evolution of each clinical case.

"Human factors and industrial design methodologies have tremendous potential to help unravel these complexities and provide fundamental insights that can drive the development of novel solutions," said co-author George Su of the University of California San Francisco School of Medicine.

McDonald said that journey mapping helped frontline clinic members see their workflow for a specific task, which in this case was monitoring this diverse population for follow-up visits after a potentially sinister finding. The system challenge is population management of an ill-defined problem.

“Lots of ambulatory care work is done one patient interaction at a time, but robust monitoring requires a view from a higher plane,” she said in an interview. “Journey mapping makes the aerial view more tangible and realistic for clinic team input.”

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McDonald’s team selected high-risk cancer situations: incidentally discovered pulmonary nodules; monitoring for breast, colorectal and prostate cancers; and ear, nose and throat cancers. These high-risk cancers require recurring and timely follow-up care to assure intervention whenever the disease takes hold.

The team interviewed clinicians from each of five specialty clinics responsible for these high-risk patients in pulmonary medicine, breast cancer, gastroenterology, urology, and otolaryngology. They asked the frontline clinicians: “What keeps you up and night? And what are your clinical hunches about who might fall through the cracks?”

While the providers talked about the types of patients who become lost to follow-up visits, the researchers found, none of the clinics had a standardized and efficient method of quantifying how many patients were lost to follow-up care and, perhaps more importantly, why.

“Many other health networks share similar struggles with incomplete documentation and measuring the real-time scope of patient safety problems,” wrote McDonald and co-authors Sarkar, Su and Sarah Lisker of the University of California San Francisco School of Medicine; and Emily S. Patterson of Ohio State University College of Medicine.

“When a patient has a warning signal for a serious condition that has yet to materialize but may in the future, the ability of a clinical team to watch the patient closely over time hinges on incredible vigilance on the part of individual clinicians — hardly an ideal solution,” McDonald said.

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This is the crux of the problem, she said, and where so-called “design seeds” are planted.

“The design seeds lay the groundwork in a very specific fashion. Journey mapping and process tracing figure out the problem, in our case, vulnerabilities, and then the design seeds are the first-stage of the solution,” McDonald said. “It’s very user-focused, learning directly from those who are on the frontlines of the work, and making sure that the problem is specified in a way that allows for the developments of solutions that can scale more flexibly during implementation.”

The team identified 45 vulnerabilities within San Francisco’s publicly funded health clinics.

“Repeatedly, we heard that clinicians worry about properly tracking these patients, and are troubled by the significant personnel time required in carrying out patient-level monitoring activities without tools and organization approaches for population-level monitoring,” they wrote.

But even then, the team did not jump straight to solutions. That’s the next step.

The team will launch a pilot project to test possible solutions that will grow from the design seeds, such as whether new digital technology, workflow arrangements, and structured data collection could help find those patients lost in the cracks of an overloaded system.

“Such focused and potentially scalable work is particularly needed for patients who may be lost to follow-up in systems that are stretched for dollars and time,” the authors concluded. “Providers will often create informal workarounds in response to the lack of comprehensive and coordinated record-keeping systems, which can result in errors as well as redundant efforts.”

The ASCENT team is already implementing a monitoring solution informed by the journey mapping activities, in subspecialty care clinics at Zuckerberg San Francisco General, by testing technical and workflow models.

“We determined the need for a registry for high-risk patients in the otolaryngology clinic to help us monitor the entire process,” said Sarkar, a primary care physician and head of the ASCENT lab at UCSF. “This means the final diagnosis, workup and treatment planning, the actual treatment itself and then surveillance and follow-up.”

After going in for a routine procedure, a man ends up with a punctured lung and a medical emergency. A woman's surgery goes well until her stomach is stitched up with a sponge inside. Most of us feel safe going to the doctor, but the road to high-quality care was not straightforward. In this FSI World Class Podcast, Stanford Health Policy's Kathryn McDonald tells us how the safe, high-quality care we expect got where it is today and what we can do to maintain it. Kathryn McDonald is the Executive Director of the Center for Health Policy/Primary Care and Outcomes Research at Stanford University.

And in this Q&A posted on Medium, McDonald responds to the age-old question: How can we improve the quality of health care?

"One of the lead agencies that’s responsible for generating evidence and moving it into practice is the Agency for Healthcare Research and Quality (AHRQ). They’re under Health and Human Services. They have a major program called AHRQ’s Evidence Now aimed at improving heart health in America. Lots of people are on aspirin to prevent heart attacks, but there are also lots of people who could benefit from it who aren’t on it. They’re working with the health-care delivery system to figure out how to get patients who need to be on aspirin to use it. These are driven by reforms to make the delivery system accountable for patients’ health. If you can change behavior — either of patients or of physicians — you can save more lives."

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