A new study published in the Journal of Health Affairs shows more patients are receiving timely sepsis interventions in New York State, resulting in lowered mortality rates–but uncovers concerning racial disparities in quality of care.
New research found that hospitals with more black patients saw much smaller increases in compliance with new sepsis protocols than hospitals that treat mainly white patients, highlighting a need to evaluate the effects of quality improvement projects for minority groups.
PROVIDENCE, R.I.[Brown University] – The New York Sepsis Initiative was launched in 2014 with the goal of improving the prompt identification and treatment of sepsis. A new study has found that while the program has improved care over all, there were racial and ethnic disparities in the implementation of the best-practice protocols.
Sepsis is a life-threatening condition that occurs when the body’s extreme response to an infection triggers a chain reaction, said Dr. Mitchell Levy, a professor of medicine and chief of the division of Pulmonary, Critical Care and Sleep Medicine at Brown University’s Warren Alpert Medical School. “Even with the best care, the mortality rate is between 15 and 25 percent.”
Early identification and treatment of sepsis is essential for saving lives, and the multi-stage best practices for sepsis identification and treatment were codified in the New York Sepsis Initiative’s protocols. The new research, published Monday, July 1 in the July issue of the journal Health Affairs, found that during the first 27 months of the initiative, the percent of patients who received the complete 3-hour-long, best-practice protocol increased from 60.7 percent to 72.1 percent. At the same time, the in-hospital mortality rates for sepsis patients decreased from 25.4 percent to 21.3 percent, which aligned with prior research by Levy, who is also the medical director of the Medical Intensive Care Unit at Rhode Island Hospital.
However, the paper highlights a disparity in sepsis care between black and white patients.
Specifically, during the first 27 months of the initiative, black patients only experienced an increase of 5.3 percentage points in the completion of the best-practice protocol, while white patients experienced an increase of 14 percentage points. Hispanic and Asian patients experienced an increase of 6.7 and 8.4 percentage points respectively.
Being aware of these disparities is critical because the Centers for Medicare and Medicaid Services is considering trying sepsis protocol completion rates to hospital reimbursement, said Dr. Amal Trivedi, senior author on the paper and a professor at Brown’s School of Public Health and medical school. “If our study findings extend beyond New York, it raises concerns about the possibility of these quality improvement initiatives for sepsis exacerbating racial disparities in care.”
The researchers found that hospitals that serve higher proportions of black patients had smaller improvements in protocol completion. Within the same hospital, white and black patients received similar care, in terms of protocol completion rates, Trivedi said.
Prior research found that minority-serving hospitals tend to have more financial stress, fewer resources and less infrastructure to devote toward quality improvement measures, which is likely the reason why minority-serving hospitals had smaller improvements in sepsis protocol completion, Trivedi said. These hospitals also tend to treat more uninsured patients and those on Medicaid.
After adjusting for risks, such as type of infection, age and other chronic health conditions, the team did not find a statistically significant change in hospital mortality rates between racial and ethnic groups, despite the disparities in care delivery. During the first three months of the initiative, 25.8 percent of white sepsis patients and 25.4 percent of black sepsis patients died while in the hospital. Two years into the initiative, 21.3 percent of white sepsis patients and 23.1 percent of black sepsis patients died while in the hospital.
“Our work highlights the need for state and federal policy makers to anticipate and monitor the effects that quality improvement projects, such as the New York State Sepsis Initiative, have on racial and ethnic minority groups,” said Dr. Keith Corl, first author on the paper and an assistant professor of medicine in the division of Pulmonary, Critical Care and Sleep Medicineat Warren Alpert Medical School. “Racial and ethnic minority groups can get left behind. Knowing this, it is our job to better design and monitor these programs to ensure racial and ethnic minority patients realize the same benefits as white patients.”
Trivedi added that in order to improve health equity, policymakers may need to devote additional funding to under-resourced hospitals that experience challenges in improving sepsis care so that their performances can match that of other hospitals.
Other authors on the paper include Gary Phillips, a statistical consultant who is retired from Ohio State University; Kathleen Terry, a senior director at IPRO, a non-profit health care improvement organization; and Dr. Marcus Friedrich, the chief medical officer of the Office of Quality and Patient Safety at the New York State Department of Health. The research was approved by the New York State Department of Health’s Institutional Review Board.
The research was supported by a fellowship from the Department of Veterans Affairs as well as internal Warren Alpert Medical School funding.
There are bad days and there are better days and there are days when I plead to God to give me a break when memories are too painful to bear. And there are days when I lean into life in a way I never thought I could and find joy once again in a life which will always have you with us in spirit.
Your little sister made her way to college orientation this week, hard to believe she is now seventeen and soon beginning a new chapter in her life. We got to join her for orientation and so many conversations with other parents began with “Is this your first child going to college?” innocent, friendly conversations from one parent to another but each time a knife to my heart and a new dread thinking how many more times in my life do I have to answer this question, each answer a reminder of how you could have been saved.
You are not here and you will not be here. You did not make it to college and oh the world is a sadder place because of that.
She is great, that sister of yours…Kathleen. She is smart and she is brave and she is strong and she is kind… but she hurts and I saw that in all its glory this week at college. Her ice-breaker questions at orientation were about siblings too, how many, how few…
And so Rory when you left, no matter how many times we screamed your name and wanted you back, the world kept turning. We try to find the courage to live a meaningful life where sadness and joy can co-exist, we fight for a future, one lost to you, a future never guaranteed to anyone. A future noone can take for granted.
An exciting new report from our friends at the University of Pittsburgh Medical Center shows that sepsis is in fact several distinct conditions requiring different treatment approaches. This important research could be a powerful breakthrough in sepsis care. Read the full release below:
PITTSBURGH, May 19, 2019 – Much like cancer, sepsis isn’t simply one condition but rather many conditions that could benefit from different treatments, according to the results of a University of Pittsburgh School of Medicine study involving more than 60,000 patients.
These findings, announced today in JAMA and presented at the American Thoracic Society’s Annual Meeting, could explain why several recent clinical trials of treatments for sepsis, the No. 1 killer of hospitalized patients, have failed. Sepsis is a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.
“For over a decade, there have been no major breakthroughs in the treatment of sepsis; the largest improvements we’ve seen involve the enforcing of ‘one-size fits all’ protocols for prompt treatment,” said lead author Christopher Seymour, M.D., M.Sc., associate professor in Pitt’s Department of Critical Care Medicine and member of Pitt’s Clinical Research Investigation and Systems Modeling of Acute Illness Center. “But these protocols ignore that sepsis patients are not all the same. For a condition that kills more than 6 million people annually, that’s unacceptable. Hopefully, by seeing sepsis as several distinct conditions with varying clinical characteristics, we can discover and test therapies precisely tailored to the type of sepsis each patient has.”
In the “Sepsis ENdotyping in Emergency Care” (SENECA) project, funded by the National Institutes of Health (NIH), Seymour and his team used computer algorithms to analyze 29 clinical variables found in the electronic health records of more than 20,000 UPMC patients recognized to have sepsis within six hours of hospital arrival from 2010 to 2012.
The algorithm clustered the patients into four distinct sepsis types, described as:
Alpha: most common type (33%), patients with the fewest abnormal laboratory test results, least organ dysfunction and lowest in-hospital death rate at 2%;
Beta: older patients, comprising 27%, with the most chronic illnesses and kidney dysfunction;
Gamma: similar frequency as beta, but with elevated measures of inflammation and primarily pulmonary dysfunction;
Delta: least common (13%), but most deadly type, often with liver dysfunction and shock, and the highest in-hospital death rate at 32%.
The team then studied the electronic health records of another 43,000 UPMC sepsis patients from 2013 to 2014. The findings held. And they held again when the team studied rich clinical data and immune response biomarkers from nearly 500 pneumonia patients enrolled at 28 hospitals in the U.S.
In the next part of the study, Seymour and his team applied their findings to several recently completed international clinical trials that tested different promising therapies for sepsis–all of which had ended with unremarkable results.
When trial participants were classified by the four sepsis types, some trials might not have been failures. For example, early goal-directed therapy (EGDT), an aggressive resuscitation protocol that includes placing a catheter to monitor blood pressure and oxygen levels, delivery of drugs, fluids and blood transfusions was found in 2014 to have no benefit following a five-year, $8.4 million study. But when Seymour’s team re-examined the results, they found that EGDT was beneficial for the Alpha type of sepsis patients. Conversely, it resulted in worse outcomes for the Delta subtype.
“Intuitively, this makes sense–you wouldn’t give all breast cancer patients the same treatment. Some breast cancers are more invasive and must be treated aggressively. Some are positive or negative for different biomarkers and respond to different medications,” said senior author Derek Angus, M.D., M.P.H., professor and chair of Pitt’s Department of Critical Care Medicine. “The next step is to do the same for sepsis that we have for cancer–find therapies that apply to the specific types of sepsis and then design new clinical trials to test them.”
Additional authors on this research publication are Jason N. Kennedy, M.S., Shu Wang, M.S., Chung-Chou H. Chang, Ph.D., Zhongying Xu, M.S., Gilles Clermont, M.D., M.Sc., Hernando Gomez, M.D., M.P.H., David Huang, M.D., John A. Kellum, M.D., Qi Mi, Ph.D., Victor Talisa, M.S., Shyam Visweswaran, M.D., Ph.D., Yoram Vodovotz, Ph.D., and Donald M. Yealy, M.D., all of Pitt; Corrine F. Elliott, M.S., and Scott Berry, Ph.D., both of Berry Consultants in Texas; Steven M. Opal, M.D., of Rhode Island Hospital; Tom van der Poll, M.D., Ph.D., of Pitt and the University of Amsterdam; Jeremy C. Weiss, M.D., Ph.D., of Carnegie Mellon University; and Sachin Yende, M.D., M.S., of Pitt and the VA Pittsburgh Healthcare System.
This research was funded by NIH grants R35GM119519, P50GM076659, R34GM102696, R01GM101197, GM107231, R01LM012095, K08GM117310-01A1 and GM61992.
Read the release online: https://www.upmc.com/media/news/051919-seymour-seneca.
Here at the Foundation, we are guided every day by our memories of Rory. Rory was a leader, an advocate, a believer in the ability of the individual to make a difference. That’s why we are always especially delighted to recognize the work that young people–the leaders of tomorrow (and in some cases, today!)–are doing to further sepsis awareness.
In honor of World Hand Hygiene Day, we’d like to recognize several young people whose dedication to educating their communities about sepsis fills is with hope:
1. Caroline Robitaille of Union Township, New Jersey, is a Girl Scout Cadette in the eighth grade. After reading an article about Rory and the work of our Foundation, Caroline dedicated herself to raising awareness of sepsis ahead of World Sepsis Day. Caroline developed the “Pink Day Out” campaign and persuaded the Union Township PTA and School Board to support it and to supply the elementary school classes in her district with copies of Ouch! I Got a Cut!, the Foundation’s book for young readers. She was able to take a day off school to read the book to all five elementary school classes and educate them further about sepsis. According to Caroline, “The week after my talk at the elementary school, my family and I were out in town and we saw the parents of one of the students I read to. The mom came up to me and thanked me for teaching her daughter about proper wound care as she was so impressed what she learned about sepsis and what her daughter taught her family. That made me very proud.” We’re proud of you too, Caroline! Caroline is now in the running the receive the Girl Scout Silver Award for her work raising awareness of sepsis.
2. Talia Coopersmith is a high school junior in Atlanta, Georgia. Talia chose to implement sepsis education in her school district for her Girl Scout Gold Award project after being inspired by the Foundation’s work. She designed presentations for elementary and middle school students in her district and thoughtfully took note of the different levels of knowledge she encountered at different schools. “This disparity helped me to understand the importance of the foundation’s lesson plans. They are very accessible to their targeted age group and do a very good job of building up information,” she said. Talia deserves our sincere thanks and appreciation for teaching hundreds of children a potentially lifesaving lesson!
3. Many of you know Kathleen Staunton, Rory’s younger sister. Kathleen adored her big brother and her life will never be the same after losing him. Kathleen was inspired to write Ouch! I Got a Cut! with her mother after watching a wound on a basketball court go untreated–exactly as Rory’s was. The read-along book for young children teaches the importance of caring for cuts and scrapes to prevent infection. Kathleen led a reading of the book with elementary classes at her school. “I’m glad I got to share the three C’s with the Lower School: If you get a cut, clean and cover it. Our three C’s campaign can protect everyone from dirt and germs that cause infection and help them stay healthy and strong!”
Dr. Martin Doerfler, senior vice president of clinical strategy and development and associate chief medical officer at Northwell Health and Medical Advisor to the Rory Staunton Foundation has co-authored a new study that assesses the differences between hospital-presenting sepsis (HPS) and emergency department-presenting sepsis (EDPS). “In an effort to continue finding solutions that curtail the concerning numbers of fatalities as a result of sepsis, we set out to explore how this condition manifests itself both in the in-patient and emergency room locales, and the various challenges associated with recognition, treatment and monitoring,” said Dr. Doerfler. “As clinicians, we need to better to understand this knowledge gap so that we can correct the origins of the disparities.”
The findings appeared on April 8 in the Journal of Hospital Medicine, the official peer-reviewed journal of the Society of Hospital Medicine. The study finds the HPS disproportionately results in adverse patient outcomes, concluding that increased efforts were needed to improve recognition of sepsis during hospitalization. Read the full journal article here.
As Rhode Island moves ever closer to adopting statewide sepsis regulations, we’re bringing you the stories of the children who inspired them. Below is the story of Lucas, a beautiful, bright-eyed little boy who tragically lost his young life to sepsis. His parents have played a large role in the successful campaign for regulations in their state.
LUCAS, by Courtney Dewar, Lucas’ Mom
“Our sweet Lucas blessed us with his happy, little face for 13 months and 8 days before he gained his angel wings. Never, ever did I expect to lose a child and certainly not as suddenly and unexpectedly as I lost my sweet baby.
Lucas was admitted to the hospital in the early morning hours of Sunday, April 29th, 2018. In the days prior he had some minor cold symptoms, but nothing alarming. I took him to his pediatrician on the morning of April 28th and although his fever had spiked to 105 degrees, she wasn’t alarmed. She said he looked like he might be developing an ear infection and sent us on our way with antibiotics. I am haunted by that interaction and wish I had questioned that diagnoses, but as a mother of two young boys who have had countless colds, stomach bugs, ear infections, etc., I simply figured a round of antibiotics and some rest would do the trick.
By the time Lucas was admitted on Sunday morning, he was deteriorating quickly. His breathing was labored and he wasn’t responding well to breathing treatments. A chest x-ray confirmed pneumonia and several types of antibiotics and fluids were given intravenously. After several hours without improvement, his lungs were filling with fluid, his oxygen levels were low, as was his blood pressure, and his heart rate was dangerously high. This was all happening so quickly, my husband and I simply could not grasp how our healthy boy was suddenly so dangerously ill. We had no idea that when he was sedated to insert a breathing tube and a tube to drain his lungs, that he would never again wake up. The drainage was unsuccessful, and he was still failing.
By Monday morning, the doctors were educating us about sepsis and discussing a very risky, yet possibly life-saving procedure. He would be put on an ECMO machine, or a heart-lung bypass machine, which would allow his lungs and heart to heal and ultimately “buy some time” so his little body could fight this infection. The procedure came with many risks, mainly kidney failure, internal bleeding, blood clots and stroke. My husband and I were terrified but without it, we were told Lucas wouldn’t survive another 24 hours. After two days of being on the ECMO machine, he was showing great progress. I thought, just maybe, that the odds had turned in our favor and that we’d walk out of the hospital with our sweet boy.
On Thursday, May 3rd, 2018, my husband and I returned from the hospital cafeteria to see a group of doctors and nurses outside Lucas’ room. We knew this wasn’t good. We were told that they suspected bleeding on his brain and immediately ordered a CAT scan. We dropped to the floor. Although we were hyper-aware of complications, we were cautiously optimistic about his progress. Shortly after, while my husband and I prayed fiercely in the hospital’s chapel, we were given the news. Our sweet Lucas suffered a massive stroke and there was nothing more that they could do.
That afternoon, I crawled into the hospital bed with my sweet baby and held him as they disconnected the machines. That is something no mother, no parent, should ever have to do. The cause of Lucas’ death was technically a stroke, with the secondary causes being sepsis and pneumonia. However, sepsis is the true cause of death in my mind. The infection ravaged his body, making it too weak to fight the bacterial pneumonia and causing him to have to be put on the ECMO machine, resulting in his stroke. I will spend my life remembering Lucas and educating others about his brief battle with this devastating illness. No parent should have to witness their child go through that, ever.”
Looking for something fun and educational for the kids to do over the Easter/Passover break? How about a coloring book that teaches kids about the importance of infection prevention and caring for cuts and scrapes with the help of some wacky characters? Teach your kids “the three ‘C’s” of effective wound care–Cut, Clean, Cover!
Please send us photos of your completed pages (or pictures of the coloring process!) to email@example.com. We’d love to see them (and will post to Facebook)!
This coloring book comes to us from Judy Brohm, a registered nurse and Sepsis Champion at Clark Memorial Hospital in Indiana. With the creative help of a colleague, Bill Greene, Judy created this coloring book for Child Safety Day after meeting Ciaran and hearing his story at a conference of the Indiana Hospital Association. We love the concept, which shows that we can ALL do our part to protect families from sepsis.
We are often asked how Rory’s Regulations, adopted in New York State to facilitate the rapid identification and treatment of sepsis, differ from the CMS sepsis regulations, known as SEP-1. Our answer is that the differences are major and important, leading us to believe that CMS’s guidelines are far from the best means of ensuring a positive outcome for sepsis patients.
Here are a few of the most important differences between Rory’s Regulations and the CMS guidelines:
Finally, it is important to note that while the SEP-1 and its impact remain controversial in hospitals, the data yielded thus far from Rory’s Regulations have clearly shown their effectiveness:
We strongly recommend that states adopt the New York sepsis protocol model in which clear protocols are developed, hospitals are help accountable, and data is collected and analyzed to improve care and reduce sepsis mortality.
Karen McEvoy died as a result of “multiorgan failure with septicemia” a coroner in Ireland reported. Karen had given birth to a baby girl on December 18th, her third baby. She visited a primary care clinic on December 21st because she was experiencing flu-like symptoms, severe back and pelvic pain, and sweats, she visited a hospital on December 23rd. On Christmas Day, she died. At no point did anyone ask: Could this be sepsis?
Sepsis is a leading cause of maternal death. Maternal sepsis usually occurs due to a severe bacterial infection of the uterus during pregnancy or immediately after childbirth. Though more common in developing countries, maternal sepsis is also prominent in developed countries, including the United States. According to the Centers for Disease Control and Prevention, maternal sepsis causes 12.7% of pregnancy-related deaths in the United States. Despite being highly preventable, maternal sepsis continues to be a major cause of death and morbidity for pregnant or recently pregnant women.