The federal Centers for Medicare & Medicaid Services (CMS) sent a letter to state Medicaid directors on January 11 announcing a policy change that allows states to experiment with how they deliver the public health insurance for low-income residents of their states. The provision that prompted headlines was its suggestion that state officials seek a waiver to Medicaid regulations allowing them to attach work requirements, or what CMS calls “community engagement,” for eligibility among able-bodied adults.

CMS Administrator Seema Verma said the work requirement among eligible adults would “make a positive and lasting difference in the health and wellness of our beneficiaries.”

In a speech to Medicaid officials in November, Verma criticized the Obama administration for focusing on expanding Medicaid enrollment under the Affordable Care Act, rather than helping the poor move out of poverty and into jobs that provide health insurance.

“Believing that community engagement does not support or promote the objectives of Medicaid is a tragic example of the soft bigotry of low expectations consistently espoused by the prior administration,” she said. “Those days are over.”

So far, the states that have applied for the Medicaid waiver that would allow them to impose the work requirement are Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin. The Kentucky waiver application said it would require most nondisabled Medicaid beneficiaries age 19 to 64 to work at least 20 hours a week.

Medicaid was created in 1965 for families on public assistance and low-income seniors. It is now the nation’s largest health-insurance program and covers 70 million people, or about one in five Americans, and includes pregnant women and newborns, the elderly in nursing homes and people with disabilities.

Opponents of the work requirement say it demonizes the poor and that low-income people will fall through the cracks and could be denied coverage because of technicalities or errors in their paperwork.

We asked FSI senior fellow and Stanford Health Policy faculty member Jay Bhattacharya — a professor of medicine and health economist who is an expert on government policies designed to benefit vulnerable populations — a few questions about the new policy.

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Stanford Health Policy: A study by the Kaiser Family Foundation found that among nonelderly adults with Medicaid coverage — the group of enrollees most likely to be in the workforce — nearly 8 in 10 live in a working family and a majority are working themselves. They also found most Medicaid enrollees who work are working full time but their annual incomes are still low enough to qualify for Medicaid. So who are the Medicaid recipients that the Trump administration is targeting — and to what end?

Bhattacharya: The CMS decision permits states to experiment with work requirements for able-bodied Medicaid enrollees. That is, it does not permit state experiments with work requirements for Medicaid enrollees who qualify because of a disability, or qualify because they are pregnant, or otherwise qualify because of physical or medical incapacity to work. At least as a first cut, the CMS decision permits states to impose work requirements for Medicaid enrollees who qualify through the expansion in Medicaid induced by the Affordable Care Act and does not permit work requirements on traditional Medicaid population who qualified in ways permitted before the ACA. States can also require alternatives to work, including volunteering, caregiving, education, job training and even treatment for a substance abuse problem.

The end goal as stated in the CMS letter is to improve the health and well-being of the able-bodied poor. The logic is that (1) for able-bodied individuals, regular work is an important component of overall health, and (2) all income-linked welfare programs (Medicaid included) induce incentives not to work, or to work less. There is a literature in economics that documents this incentive (see this paper by Aaron Yelowitz.) The mid-1990s welfare reform law required this sort of linking of work and welfare, and CMS argues this decision permits states to align Medicaid with other income-linked welfare programs. If the KFF study is right, the decision will have an effect on a minority (perhaps a substantial minority) of able-bodied Medicaid recipients, since the majority are already working.

Stanford Health Policy: Under current law, can states impose a work requirement as a condition of Medicaid eligibility?

Bhattacharya: For a state to impose a work requirement, they must request a waiver from the Social Security Act to conduct a demonstration project. These waivers are permitted under current law, but are provided at the discretion of the appropriate executive agencies, in this case, CMS. A different administration might decide not to permit these waivers, and I think in general the Obama administration was more reluctant to permit this kind of state experimentation. The main substance of the CMS decision is to broadly signal to states that they will now be willing to provide such waivers.

Stanford Health Policy: Do critics of the work-requirement waiver have valid fears that low-income elderly or disabled people will fall through the cracks on technicalities or challenging paperwork?

Bhattacharya: Paperwork mistakes and problems caused by bureaucratic indifference are always possible when it comes to a program like Medicaid, which has such a complicated variety of paths to qualify. It is an empirical question whether such considerations would be more salient were a state to impose work requirements for a subset of Medicaid enrollees on top of the existing requirements.  Every state has experience with similar work requirements for qualification for other welfare programs, such as temporary assistance for needy families (TANF). Given that, it seems unlikely to me that — because of technicalities or paperwork — additional work requirements would be incorrectly applied to many elderly or disabled people applying for Medicaid.

Stanford Health Policy: Some states have proposed tying Medicaid eligibility to work requirements using waiver authority that may be approved by the Trump administration. What could this mean for Medicaid recipients in those states? In Kentucky, which expanded Medicaid, some state officials have said work requirements could lessen the program’s impact on the state budget.

Bhattacharya: I suppose it could have some effect on state budgets by reducing the number of people who qualify for Medicaid. I anticipate only a small effect on state budgets, though, because through the ACA, the Feds pay 100 percent of Medicaid costs for people who qualify via the ACA’s income provision, although that gradually phases down to 90 percent in 2020 and remains at that level.

Stanford Health Policy: How will the states that do not apply for the waiver, such as the large-population states of California and New York, be impacted by this change in Medicaid policy?

Bhattacharya: States that do not apply for a waiver will maintain their existing requirement for Medicaid qualification, including no work requirements for able-bodied Medicaid enrollees who qualify through the ACA’s Medicaid provisions.

Paul Wise watched as children ran around a playground attached to a health clinic at a displaced persons camp on the outskirts of Mosul — the northern city in Iraq once controlled by the Islamic State but now back in the hands of the Iraqi government.

The children had survived the Battle of Mosul, which had fallen to ISIS in 2014 but was retaken by the government forces and allied militias during a nine-month military campaign that ended in July. Many of the children suffer from physical and mental wounds and Wise wondered how they would recover with so little medical infrastructure.

Wise was part of a small delegation of physician-academics asked to evaluate a World Health Organization-led system to treat civilians injured in the Mosul fighting. Wise and his colleagues recently slipped into Mosul to visit field hospitals, review health care on the ground and determine whether there is a better way to distribute medical aid during armed conflict.

The visit left the Stanford Medicine professor of pediatrics and senior fellow at the Freeman Spogli Institute for International Studies with questions about health care, humanitarian ethics, and conduct of war: Are there better ways to deliver emergency medical care during the height of battle? How do relief workers maintain neutrality when embedded with government security forces? Has the system of financing humanitarian interventions — one that was essentially created during the Cold War — become dangerously outdated?

Answering these questions is the mission of a new health-and-security initiative at Stanford led by Wise, a core faculty member at Stanford Health Policy who has spent 40 years working to improve the health of children impacted by conflict. Much of his work has been in Guatemala through his Children in Crisis project, the first university-based program to address the needs of children in areas of unstable governance and civil war.

“In talking with the groups that are running these humanitarian efforts in Mosul, there was this uneasiness, this kind of disorientation with the way things are now,” said Wise. “It was a kind of recognition that humanitarian norms are changing, the health personnel and facilities are at greater risk; the financial gap between humanitarian need and humanitarian capability is growing; and the old way of financing humanitarian intervention is inadequate, archaic.”

An Interdisciplinary Approach

Wise believes academics are well suited to help resolve these humanitarian conundrums.

“So we are going to move ahead and try to bring all the players together to reconsider this global challenge. Here at Stanford, we have the capacity to draw upon remarkable resources,” he said.

The new biosecurity initiative led by Stanford Medicine physician and FSI senior fellow, David Relman, together with world-renowned political scientists, security specialists, computer scientists and health policy experts will “attempt to craft new strategies for the provision of critical services to populations affected by conflict and political stability.”

The initiative will collaborate with other institutions such as Johns Hopkins, UCSF, Harvard, and the American Academy of Arts and Sciences. It will also seek the engagement of partners committed to providing humanitarian services, including WHO, the U.N. High Commissioner for Refugees, Doctors Without Borders and the International Committee of the Red Cross.

“The voice of communities impacted by war should also be an essential element in this ambitious effort,” Wise said. “To break new ground, we’re going to have to do things differently; the health strategies need to take into consideration fundamental understanding of the political dynamics. But we have a special opportunity here at Stanford because we take an interdisciplinary approach.”

Children of War

Most of the children Wise saw will never be the same, he said, nor the humanitarian workers who risked their lives to treat them, their families, and fighters from all sides of the battle to oust the Islamic extremists from the city on the Tigris River.

“I look at these little kids with horrendous emotional trauma and PTSD, and I think to myself, it’s the collision of all these questions playing out within a 50-square-meter little playground,” he said. “It’s these broader, strategic and ethical questions that are really profound. And as a pediatrician who is dedicating the last phase of my career to these questions of security and the political dimensions — I have to engage on all of these levels. That’s not easy.”

Wise traveled with WHO officials, as well as Paul Spiegel, a physician who leads the Center for Humanitarian Health at Johns Hopkins Bloomberg School of Public Health; Adam Kushner, a trauma surgeon affiliated with Johns Hopkins; and Kent Garber, a surgical resident at UCLA and research associate at Johns Hopkins.

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Spiegel also believes academics are uniquely positioned to help assess the current system of responding to medical crises during conflict.

“I believe that we can bring objectivity and rigor to analyzing and evaluating important and innovative responses, such as the trauma response by WHO and others in Mosul,” Spiegel said. “Humanitarian organizations are often busy responding quickly to rapidly changing situations; they don’t always have the luxury of time to do what academic humanitarians can do.”

Making the two-hour drive from Erbil to Mosul in armored, bulletproof SUVs provided by the United Nations, they slipped into field hospitals to meet with Iraqi physicians and medical teams with the humanitarian agencies.

Wise, who was able to take a few photos and video on his smartphone, described the devastation on the ground, noting that not since the siege of Leningrad has a city of this size experienced such street-by-street fighting. In large parts of the city, virtually every building was bombed or bulleted. It will take years to clear the rubble and rebuild.

“It’s just a remarkable story of tragedy and resilience,” he said.

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Since the city was not long ago controlled by ISIS, the field hospitals are still surrounded by massive concrete barricades and tactical trucks stationed outside with mounted machine guns.

The team found that at the height of the battle for Mosul, there was tremendous pressure to treat injured civilians and discharge patients very quickly, due to the lack of medical infrastructure and personnel and the continuous wave of new injuries coming in.

“The charge for us was to evaluate the system and how well it worked, what ways could it be improved, how many lives that it saved,” Wise said. “One of the concerns, for example, was that in order to put in medical people that close to the frontline, you have to give them some kind of security. This raised issues among the humanitarians about their need for independence and neutrality, since you’re essentially embedding them with Iraqi security forces.”

Epidemiology and Ethics

“We are looking at the technical issues and the epidemiologic issues, but also dealing with the ethical issues and their implications,” he said.

They intend to write an internal report and then publish their findings in a major medical journal, to get the word out about the issue and gain support for ongoing collaborative work. They’re looking to partners like the American Academy of Arts and Sciences, which recently devoted an entire issue of its journal, Daedalus, to the factors and influences of contemporary civil war. One of the essays in that issue by Wise and his Stanford colleague, Dr. Michele Barry, who directs the Center for Innovation in Global Health, talks about the threat of a global pandemic as a potential byproduct of the 30 ongoing civil wars around the world.

“We’re trying to get the report completed quickly because the model of trauma care for civilians in Mosul is a new model and could be implemented in other combat areas, like the fighting in Syria and other places in Iraq,” Wise said.

Wise worries some see Stanford University as an insulated Silicon Valley institution in a beautiful setting and not always engaged in the real world.

“Well, this is about as engaged in the real world as you can get — this is Stanford moving and doing things out there, not just sitting around in seminar rooms. Sometimes you need to get close to the front lines to save lives,” he said.

When asked what surprised him during this trip to Mosul, Wise smiled.

“I’m sort of old and I’ve seen a lot of the world and not a lot surprises me anymore,” he said. “But it was a reminder of how desperate are the lives of millions of people — that we could do so much more. It’s a reminder of just how fragile physical security really is in this world."

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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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Stanford Health Policy’s newest faculty member, Joshua Salomon, believes that one urgent need in global health research is to improve forecasts of the patterns and trends that are the major causes of death and disease.

Salomon, who is leaving leaving his position as professor of global health at the Harvard T.H. Chan School of Public Health to join Stanford on Aug. 1, works on modeling of infectious and chronic diseases and their associated intervention strategies, as well as methods for economic evaluation of public health programs and ways to measure the global burden of disease.

And he looks at the potential impact and cost effectiveness of new health technologies.

“Projections of future trends in health are crucial to formulating policy,” said Salomon, who has a PhD from Harvard. “To think strategically about the technologies and policies that would make the biggest impact on health over the next 20 to 50 years, we really need to start by understanding the range of likely trends in major health challenges over the coming decades.”

Stanford, he said, offers him a “rich collaborative environment” to better learn from advances in forecasting across a range of other disciplines, such as economics, political science, and environmental science.

“With a better picture of what the world is likely to look like over the next 50 years — and what are going to be the most pressing health problems — we can invest wisely and put ourselves in a position to respond more effectively.”

Salomon is also the director of the Prevention Policy Modeling Lab, which is funded by a five-year award from the Centers for Disease Control and Prevention. The consortium represents the collaborative research of experts from Massachusetts General Hospital, Boston Medical Center, Dana Farber Cancer Institute, Yale School of Public Health, Brown University School of Public Health, and the Massachusetts Department of Public Health and.

He will continue directing the lab from Stanford and intends to bring in new research threads from his colleagues here on the Farm. The lab works on a wide range of projects dealing with policy analysis for hepatitis, sexually transmitted infections and diseases such as HIV, and tuberculosis.

“It’s a rewarding grant for me to work on because, unlike a lot of modeling projects, the work that we do really starts from urgent public health questions that policymakers have,” he said. “All of the questions that we are working on are questions that originated directly from discussions with CDC and other public health partners.”

With Salomon’s move to Stanford, the university gains a dynamic duo.

Grace Lee joins Stanford as the Associate Chief Medical Officer at Lucile Packard Children's Hospital in the fall, 2017.

His wife, Grace Lee, MD, MPH, joins in the fall as the Associate Chief Medical Officer at Lucile Packard Children’s Hospital. As a professor of population medicine at Harvard Pilgrim Health Care Institute & Harvard Medical School, Lee has led research in vaccine safety in the FDA-funded Post-licensure Rapid Immunization Safety Monitoring (PRISM) program and the CDC-funded Vaccine Safety Datalink, which monitors the safety of vaccines and studies rare and adverse reactions from immunizations.

She has also examined the impact of financial penalties on rates of healthcare-associated infections, as the principal investigator of an AHRQ-funded study, as well as developed novel surveillance definitions for ventilator-related events in neonates and children.

While at Stanford, Lee said, she intends “to find opportunities to enhance the learning health system approach to improve patient outcomes and population health.”

Salomon has spent his entire career as a collaborator on the Global Burden of Disease project, the world’s most comprehensive epidemiological study commissioned by the World Bank in 1990, which tracks mortality and morbidity from major diseases, injuries and risks factors.

“The study has made a major contribution to global public health because before this study we just didn’t have a comprehensive, systematic understanding of the things that cause death and disability in low- and middle-income countries. But now we do,” he said. “It’s hugely ambitious and very sweeping in scope — and a lot of my work is around providing the evidence we need to inform policy.”

Much of Salomon’s work is global in nature. He’s most recently focused on older adults in one rural South African community, which has a high prevalence of HIV and one of the world’s highest levels of hypertension. His research there aims to inform urgent prevention initiatives tailored to older adults where HIV and cardiovascular risks are moderate or high, as in similar communities in sub-Saharan Africa.

“People don’t expect a high level of ongoing HIV transmission in older adults,” he said. “The double burden that we find, with a very high level of HIV, as well as the high prevalence of diabetes and heart disease, creates enormous strains on the health-care system.”

Stanford Health Policy’s Michelle Mello is calling for reforms to the practice of overlapping surgery, a practice in which surgeons juggle multiple operations at the same time.

Primary surgeons who run multiple operating rooms delegate “non-critical” parts of the operations to trainees or physician assistants. Overlapping scheduling is considered an important means of giving surgical trainees hands-on experience before they enter the profession with a license to operate. But patients are often unaware about the prospect that their surgeon may be double-booked.

“As patients at a teaching hospital, we know that surgery is a team sport and trainees will be involved,” Mello said in an interview. “But learning that the surgeon we’ve entrusted ourselves to may be out of the room for extended periods while we’re under anesthesia comes as a surprise to many patients. Like other aspects of surgical care, policies and procedures need to be in place to make sure this can be done safely.”

Mello, who is a professor of health research and policy at Stanford Medicine and a professor of law at Stanford Law School, wrote in this JAMA editorial that the practice has dented patient trust in the surgical profession and that better research is needed to determine how patients are impacted by double booking. Mello wrote with co-author Edward H. Livingston, MD, of the Department of Surgery at the UT Southwestern School of Medicine in Dallas. Livingston is also deputy editor of JAMA.

For example, Mello and Livingston noted that The Seattle Times reported in February about the unusually high volume of neurosurgical operations “and reportedly poor outcomes” at the Swedish Neuroscience Institute. The top two neurosurgeons each billed more than $75 million in 2015, and clinical staffers who raised concerns were ignored. The news reports prompted federal and state investigations and the resignations of the hospital’s neurosurgery chief and chief executive officer.

Medicare regulations applicable to teaching hospitals allow surgeries to overlap, but primary surgeons can’t bill the government for an operation unless they personally perform the “critical or key portions.”

The Senate Committee on Finance, which oversees Medicare, issued a report last year that said patient safety and informed consent were key concerns raised by overlapping surgery. But they also found scant research on the consequences for patients.

Mello and Livingston write that six peer-reviewed studies have been published about the safety of overlaps, but note that they were all retrospective, single-institution studies.

“These studies suggest that overlapping surgery is not associated with increased risk of patient harm, but these observational studies have important limitations,” they said. 

For example, some studies lumped cases with just one second of overlap together with cases that overlapped significantly longer, making it hard to measure the relationship between the amount of overlap and surgical outcomes. They added that the generalizability of findings beyond the small number of institutions and surgeons studied is unknown.

In ongoing work with other Stanford Health Policy faculty, Mello plans to examine data from a large number of teaching hospitals. One issue requiring further investigation, she said, is whether the longer procedure times documented for overlapping cases mean more time under anesthesia, which elevates the risk of postoperative complications.

Citing a public opinion survey showing that 69 percent of Americans oppose the practice, the JAMA authors concluded, “Overall, the modest evidence base does not suggest that overlapping surgery is unsafe, but rather that the practice is not trusted.”

They believe patients and regulators may distrust it because of the possibility of harm to patients, lack of transparency about what is going on, and surgeons’ conflict of interest in determining on their own what aspects of operations they must personally perform.

Mello and Livingston believe restoring public trust in the surgical system requires stronger proof that overlapping scheduling is safe, including evidence from randomized studies, and better informed consent practices which ensure that patients are given full information about scheduling practices well ahead of surgery.

“The disclosure should include the likelihood that the operation will involve an overlap, a description of who will perform which parts of the operation and what their qualifications are, and the patient’s option if he or she objects to the scheduling,” they said.

Finally, hospitals have an obligation to ensure that their surgeons are performing the critical parts of an operation.

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