A new journal article highlights three challenges in accounting for coronavirus deaths and offers solutions.
The number of deaths directly and indirectly associated with the coronavirus disease 2019 (COVID-19) pandemic is probably higher than has been reported, a new journal article says.
The United States has had the highest number of reported COVID-19 cases and deaths. As of Sept. 18, there were more than 6.8 million COVID-19 cases and more than 202,000 deaths reported in the United States, according to worldometer.
The co-authors of the new journal article, which was published in Annals of Internal Medicine, wrote that it is essential to have an accurate count of COVID-19 deaths. "Estimates of direct, indirect, and excess deaths are critical to our understanding of the pandemic and its effect on human life. They also illuminate the weaknesses in our health system and societal structures. It is imperative to get them right."
The journal article focuses on three challenges to determining COVID-19 mortality and offers solutions for each.
1. Direct deaths
For a death to be directly associated with a disaster, the cause of death must be listed on the deceased person's death certificate. However, the new journal article points out that the Council of State and Territorial Epidemiologists did not set a case definition for COVID-19 until April 5, which was nearly three months after the first reported coronavirus case in the United States.
"Early in the pandemic, when the understanding of the clinical presentation of COVID-19 was still developing and testing rates were very low, it is likely that practitioners in the United States and elsewhere did not attribute all deaths in patients infected with SARS-CoV-2 to COVID-19," the journal article's co-authors wrote.
The Centers for Disease Control and Prevention (CDC) took action to avoid under-counting COVID-19 deaths, the journal article's co-authors wrote. "To account for possible underestimation from underdiagnosis of deaths attributable to COVID-19, the CDC began counting all deaths from pneumonia, influenza-like illness, and COVID-19 and subtracting the expected seasonal number of cases of pneumonia and influenza computed from trends in the previous 5 years."
To achieve a more accurate count of deaths directly associated with COVID-19, the journal article calls for stepping up efforts to educate physicians about CDC guidelines—particularly for documenting presumed cases.
2. Indirect deaths
There are several forms of indirect causes of death associated with COVID-19, including psychological distress prompting suicides, the journal article's co-authors wrote.
"In the context of the COVID-19 pandemic, this would include loss of wages or housing, disruption to medical care from temporary suspension of outpatient facilities, hospital or emergency department avoidance, postponement of surgeries or chemotherapy, and loss of health insurance, all of which could result in premature deaths," they wrote.
There are three challenges in accounting for indirect deaths associated with COVID-19, according to the journal article.
The complexity of the intersection between economic and social disruptions
Lack of consensus about the timescale for measuring deaths after a disaster
Interpreting the CDC's "but for" principle, which in this instance holds that "but for the [pandemic], would the person have died when he/she did?"
To account for indirect deaths associated with COVID-19, the journal article calls for improving death certificate reporting at the institutional, city, and state levels. "Applying the CDC's 'but for' test to include 'COVID-19' in part II or question 43 [of death certificates] is therefore a simple and feasible intervention that may greatly improve the reporting of indirect death," the journal article's co-authors wrote.
They also call for physicians to receive "refresher training" on how to fill out death certificates.
3. Excess deaths
In addition to accounting for direct and indirect deaths associated with a disaster such as the coronavirus pandemic, disaster mortality can estimated by comparing observed deaths with the expected mortality rate based on the experience in prior years, the journal article says.
Calculating excess deaths is an imprecise science and should be set in a range, the co-authors wrote. "The estimation of excess mortality requires both modeling and timely data from reliable civil registries and vital statistics records, and it may be associated with significant margins of uncertainty."
To rise to this challenge, timely access to baseline and mortality-range data is essential, the co-authors wrote. "These data would ideally be available in near real time from the states before being sent to the CDC or Department of Health and Human Services for further coding or analysis, allowing scientists prompt access to the most up-to-date information from each state."
Accounting for COVID-19 deaths
At this point in the coronavirus pandemic, it is difficult to determine the extent of the understatement of COVID-19 deaths, a co-author of the journal article told HealthLeaders.
"Given the pandemic is still raging across the United States, testing continues to vary widely, and because the impact of indirect deaths will not be immediately obvious, it is not yet possible to estimate how high the true mortality will be," said Satchit Balsari, MD, MPH, an assistant professor of emergency medicine at Harvard Medical School and Beth Israel Lahey Health in Boston.
Balsari discounted media reports that have claimed the number of COVID-19 deaths have been overestimated.
"The reports make this claim on the basis that some deaths may be wrongly attributed to COVID-19 when the patient died of something else just because they also had COVID-19. There is no evidence so far that the number of such cases is statistically significant. In fact, there are peer-reviewed research articles that demonstrate how mortality rates reported early in the pandemic are lower from a combination of decreased testing, evolving understanding of the disease (missed diagnoses), and sometimes simply delays in reporting," he said.
Photo: The bodies of deceased COVID-19 patients are moved into a temporary morgue in New York City. Lev Radin/Shutterstock
Tait Shanafelt, MD, has written more than 150 peer-reviewed articles on the topic of physician burnout.
One of the top physician burnout researchers in the country is expecting a new national survey will show a significant uptick in clinician burnout due to the coronavirus pandemic.
Burnout is one of the most vexing challenges facing physicians and other healthcare workers nationwide. Research published in September 2018 indicates that nearly half of physicians nationwide are experiencing burnout symptoms, and a study published in October 2018 found burnout increases the odds of physician involvement in patient safety incidents, unprofessionalism, and lower patient satisfaction.
Tait Shanafelt, MD, who is the chief wellness officer at Stanford Medicine and a professor of medicine at Stanford University in Palo Alto, California, has written more than 150 peer-reviewed articles on physician burnout.
He has helped lead several national surveys of physicians to gauge the level of clinician burnout across the country—most recently in 2017 and the latest survey is being conducted this month. In 2008, Shanafelt became the first director of Mayo Clinic's Department of Medicine Program on Physician Well-Being, where he launched an effort to address physician burnout through programs focused on physician autonomy, efficiency, collegiality, and a sense of community.
He earned his medical degree at the University of Colorado and performed his residency in internal medicine at the University of Washington Medical Center.
Shanafelt recently talked with HealthLeaders about a range of issues related to physician burnout. The following is a lightly edited transcript of that conversation.
HealthLeaders:Gauge the extent of physician burnout during the coronavirus pandemic.
Tait Shanafelt, MD: Overall, we are probably higher in physician burnout than we have been in the past. In addition to the challenges in healthcare settings, society is dealing with challenges linked to sheltering in place and a lack of outlets for relieving stress such as connections with friends or family, going to the gym, or going to the theater. Whatever your main stress reliever was, you probably can't do it now.
In healthcare settings, there have been many challenges, including susceptibility to becoming infected, being a portal of transmission to your family, and a lack of answers for caring for patients with this disease. I am anticipating that we may see higher prevalence of physician burnout in the survey this month compared to 2017, which showed a slight improvement compared to 2014.
Although burnout has been the dominant occupational form of distress over the past decade, with other dimensions such as fatigue and problems with work-life integration, the pandemic has also caused an uptick in PTSD-like phenomena for physicians who went through events such as what happened in New York. There has been depression, anxiety, and sleep disorders. So, the pandemic is associated with a category of more traditional mental health disorders that probably have been exacerbated more than burnout has been exacerbated.
HL: What has inspired you to devote much of your professional career to studying and addressing physician burnout?
Shanafelt: It has been the witnessed suffering of colleagues. I have watched a dedicated and altruistic group of people become discouraged, demoralized, and sometimes worse. I have had colleagues consider leaving the profession or experience personal life repercussions because of some of the challenges in the work environment and healthcare delivery system. Witnessing these things made me care and want to drive change. We can certainly do better.
HL: When it comes to addressing physician burnout, which is more important—organizational approaches such as improving the work environment or individual approaches such as resilience training?
Shanafelt: First, we know that burnout is an occupational syndrome caused mainly by characteristics and stressors in the work environment, not deficits in individual resilience. About 80% of the burnout challenge is triggered by characteristics of the work environment, organizational culture, and professional culture. So, we certainly need to focus a lot of effort as a healthcare delivery system and healthcare organizations on addressing the primary problems.
That said, I encourage individual physicians that we are not victims and there is a component of burnout that includes choices we can make about integrating our personal and professional priorities, optimizing our own sense of meaning and purpose in work by shaping our career, and making sure that we are attending to personal things around self-care that we can control.
HL: In the United States, how does the culture of medicine impact physician burnout?
Shanafelt: It is a huge factor.
It is easy for us to point to some of the tangible manifestations of inefficiency, administrative burden, loss of control and flexibility, and a productivity-based reimbursement system, then say, "These are the problems." Those are problems; but in many ways, those problems are really manifestations of much deeper issues in the culture of our healthcare delivery systems and the view of the role of the physician in healthcare organizations.
In that sense, we often have incongruities between what we claim and our actions. We claim that physicians are professionals who are highly trained, and we want to minimize administrative burden. We claim that quality of care is our top priority, along with serving our communities. But oftentimes, we have a healthcare delivery system that operates in a way that is the antithesis of those things.
We have preauthorization and a whole bunch of documentation that is required to support billing, which says, "We do not trust you as a physician." We have administrative burdens that say, "We do not value your time." We have short visits that may not allow physicians to deliver optimal care. In a sense, we are suggesting that our economic priorities are more important than our quality priorities, our social justice priorities, or treating our physicians as professionals.
HL: If there were two causes of physician burnout that could be eliminated, which ones would you choose?
Shanafelt: For organizations, one of the most important things to think about initially is to address the loss of control and lack of flexibility. These are things that show up in many ways—physicians feel that they have no control and that they have no input in the way that their practices run.
Restoring a sense of control brings about the sense that physicians can drive change. When change seems possible, it brings a sense of hope, which can be a powerful first step on the journey to improvement.
At the level of individual doctors, we need to get rid of the mindsets of perfectionism and harsh self-criticism. What we find is that physicians are very compassionate with others but very critical and harsh in the way they treat themselves. They expect nothing but perfection in themselves.
For physicians, being compassionate with themselves is a skill that can be learned. Instead of a mindset of being perfect, there needs to be a mindset of always learning and getting better, and that is how we can get to being a better physician a year from now than we are today. It is a commitment to excellence and a growth mindset, rather than a self-critical mindset.
A national push involving more than two dozen organizations is seeking to ramp up patient safety efforts.
A coalition of 27 organizations convened by the Institute for Healthcare Improvement has launched an initiative to improve coordination of patient safety work nationwide.
Patient safety has been a pressing issue in healthcare since 1999, with the publication of the landmark reportTo Err Is Human: Building a Safer Health System. Despite two decades of attention, estimates of annual patient deaths due to medical errors have risen steadily to as many as 440,000 lives, a figure that was reported in the Journal of Patient Safety in 2013.
The new initiative is detailed in an "action plan" published on Sept. 14. The document was crafted by the National Steering Committee for Patient Safety, which was formed in May 2018. There were 27 organizations represented on the steering committee from the following groups: healthcare organizations and healthcare systems; patients, families, and care partners; professional societies; safety and quality organizations; regulatory and accrediting bodies; and federal agencies.
The action plan has four focal points and 17 recommendations.
1. Culture, leadership, and governance
The action plan calls on healthcare leaders, governance bodies, and policymakers to demonstrate a commitment to safety as a core value and to foster cultures of safety. There are four recommendations related to culture, leadership, and governance.
Healthcare leaders and governance bodies must demonstrate that safety is a top priority and part of their organization's mission and values. Organizational cultures should embrace trust and transparency, ensure physical and psychological safety for healthcare workers, and promote joy in work.
Healthcare leaders and governance bodies must regularly assess capabilities and devote resources to promote safety at the personal and organizational level. Assessments should include the core competencies of every employee in the organization.
Healthcare leaders and governance bodies must encourage sharing of information about safety such as near misses and harm incidents. This transparency should include timely sharing of information across organizations as well as with patients, families, and care partners.
The quality and patient safety competencies of healthcare leaders and governance bodies should be assessed during onboarding and throughout their tenure. These competencies include knowledge, skills, and characteristics needed to promote patient safety.
2. Patient and family engagement
The action plan calls for propagation of effective patient and family engagement. Specifically, healthcare organizations should include patients, families, and care partners in the design and delivery of care. There are five recommendations related to patient and family engagement.
Healthcare organizations should set competencies for all healthcare workers to engage patients, families, and care partners. All healthcare workers should be capable of forming equitable and effective partnerships with patients, families, and care partners.
Healthcare leaders and workers must enlist patients, families, and care partners in the design and delivery of care.
Patients, families, and care partners should be included in leadership and governance of safety and improvement initiatives.
In their engagement efforts, healthcare leaders should actively and equitably work with patients, families, care partners, and community organizations.
Healthcare leaders must ensure that all healthcare workers are respectful and transparent in their interactions with patients, families, care partners, and each other.
3. Workforce safety
The action plan says patient safety and workforce safety are linked closely. To boost workforce safety, healthcare organizations should take a unified and total-systems approach. There are three recommendations related to workforce safety.
In a systems approach to workforce safety, all healthcare organizations should have comprehensive workforce safety programs. A systems approach includes leadership and engagement, safety management systems, risk reduction, and performance analytics.
Healthcare organizations should hold themselves accountable for the physical and psychological safety of healthcare workers as well joy in the workplace.
Healthcare leaders should create and implement programs to prevent healthcare worker injuries.
4. Learning system
The action plan calls on healthcare organizations to foster networked and continuous learning such as promoting the sharing of information and improvement efforts. There are five recommendations related to a learning system.
Learning should be promoted inside and between healthcare organizations. Methods to achieve collaborative learning include using high-reliability principles as well as creating local, regional, state, and national learning systems.
Promote safety learning networks and adoption of best practices.
Improve safety education and training for all healthcare workers.
Healthcare leaders should develop shared goals for safety in all healthcare settings and disseminate these goals widely.
Promote coordination, collaboration, and cooperation on safety across the healthcare sector. "Modelling leaders in civil aviation, healthcare leaders representing all stakeholders must actively develop a public-private partnership to use the power of data sharing and cooperative learning to identify and solve the most urgent and emerging patient safety problems," the action plan says.
Call to action
During a press conference yesterday, the co-chairs of the National Steering Committee for Patient Safety urged healthcare organizations to redouble their patient safety efforts.
Coordinated work is required to re-energize patient safety improvement and accelerate change, said Tejal Ghandi, MD, MPH, senior fellow at the Institute for Healthcare Improvement.
"In the United States, there are many organizations that work on patient safety—multiple federal agencies, hospitals and health systems, accreditation groups, associations, foundations, patient advocacy groups—the list goes on and on. But we don't tend to work together in a coordinated and collaborative way, which often results in the frontline getting recommendations and advice coming at them from many different directions. We believe that if we all work together and are synergistic rather than uncoordinated, we can go further faster," she said.
Even the safest healthcare organizations in the country can benefit from following the action plan's recommendations, said Jeffrey Brady, MD, MPH, director of the Center for Quality Improvement and Patient Safety at the Agency for Healthcare Research and Quality.
"In these high-performing organizations, delivering care is a team effort and safety is a shared value. When it comes to safety, no one sits on the sidelines. People who work in these organizations also trust that their own safety is important to leadership. Clinicians feel safe, and they work with patients and families to keep them safe. That is the kind of care that we want for ourselves and our families, but we all know that many obstacles stand in the way. Even the best organizations in the country struggle with these barriers, and they know the job of ensuring safety is never done."
Reduction in the number of days seriously ill coronavirus patients are on mechanical ventilation can reduce respiratory complications.
Dexamethasone treatment for coronavirus disease 2019 (COVID-19) patients with moderate or severe acute respiratory distress syndrome (ARDS) reduces the number of days patients spend on mechanical ventilation, a recent research article shows.
Earlier research has found that as many as 12% of hospitalized COVID-19 patients require invasive mechanical ventilation, with most of those patients developing ARDS. Mechanical ventilation is associated with several respiratory complications such as barotrauma, ventilator-associated lung injury, and ventilator-associated pneumonia.
The recent research, which was published by JAMA Network Open, gathered data from 41 ICUs in Brazil. There were nearly 300 COVID-19 patients in the study, with 151 randomly assigned to receive intravenous dexamethasone and standard care, and 148 in a control group that only received standard care. For the treatment group, patients received 20 mg of dexamethasone intravenously daily for five days, then 10 mg of dexamethasone daily for five days or until ICU discharge.
The study generated several key data points:
Patients in the dexamethasone group had a mean of 6.6 ventilator-free days during their first 28 days of hospitalization, compared to a mean of 4.0 ventilator-free days in the standard care group.
Sequential Organ Failure Assessment (SOFA) mean scores, which range from 0 to 24 with higher scores indicating greater organ dysfunction, were lower in the dexamethasone group (6.1) than in the standard care group (7.5) at seven days.
There was no significant difference between the two groups in all-cause mortality at 28 days, ICU-free days during the first 28 days of hospitalization, or a six-point ordinal scale measuring clinical status.
"Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days," the recent research article's co-authors wrote.
The decrease in ventilator days for seriously ill COVID-19 patients is a significant benefit for patients and healthcare providers, they wrote. "This reduction is relevant in the context of a pandemic, in which an inexpensive, safe, and widely available intervention like dexamethasone increases even modestly the number of ventilator-free days and may reduce the risk of ventilatory complications, ICU length of stay, and burden to the healthcare system."
Remdesivir is the only other drug that has been shown to generate improved clinical outcomes in seriously ill COVID-19 patients.
Photobiomodulation therapy has been an FDA-approved treatment for inflammation and pain since 2011.
The first U.S. patient to receive photobiomodulation therapy for severe coronavirus disease 2019 (COVID-19) pneumonia responded positively to the treatment, according to the principal investigator of the pilot study.
Pneumonia and acute respiratory distress syndrome in COVID-19 patients are potentially deadly conditions. As of Sept. 10 in the United States, there had been more than 6.5 million confirmed cases of COVID-19, with more than 195,000 associated deaths, according to worldometer.
Details about the first treatment of a COVID-19 patient with photobiomodulation therapy (PBMT) was published last month in the American Journal of Case Reports.
The patient was a 57-year-old African American man presenting with a serious case of COVID-19 pneumonia at Lowell General Hospital in Massachusetts. The patient was placed in a prone position during the laser therapy for 28 minutes once a day for four consecutive days.
After the treatment, the patient's oxygen saturation increased from 93%-94% to 97%-100%, oxygen support was decreased from 2-4 liters per minute to 1 liter per minute, and the radiological assessment of lung edema score improved from 8 to 5. The patient also reported significant improvement in the Community-Acquired Pneumonia assessment tool. "Respiratory indices, radiological findings, oxygen requirements, and patient outcomes improved over several days and without need for a ventilator," the case report says.
The principal investigator for the PBMT pilot study, which features 10 patients, says the laser therapy had a significant impact on the first patient to receive the treatment. "It was remarkable watching him going through these four treatments and being discharged to a rehab facility the day after his last treatment," says Scott Sigman, MD, a practicing orthopedic surgeon at Orthopedic Surgical Associates of Lowell and team orthopedic physician at UMass Lowell.
Healthy dose of skepticism
A pair of critical care experts told HealthLeaders that much more research needs to be done before PBMT can be viewed as a viable treatment option for COVID-19 patients.
The improvements in the first patient to undergo PBMT may be related to the prone positioning during the treatment, says Abhijit Duggal, MD, assistant professor, Department of Pulmonary Critical Care and Allergy, Respiratory Institute, Cleveland Clinic, Cleveland.
"The data should be presented in terms of what the oxygen levels of patients were at four- to six-hour intervals after the photobiomodulation therapy. The improved oxygenation that was reported could have been a result of the therapy, but it is more likely that the improvement is associated with the prone positioning. What you need to know is what happened to the patient's oxygenation four hours later, eight hours later, or 12 hours later. If there was a trend in improved oxygenation without proning, that would be interesting to see. But that is not being reported in the case study."
The overall trajectory of COVID-19 patients with pneumonia or acute respiratory distress syndrome also must be considered, Duggal says. "We know that COVID-19 patients who are on 1 to 6 liters of oxygen usually have trajectories that improve around day three or four. Looking at the data in the case report, I did not see anything that I can say, 'Yes, this therapy by itself is showing a direct correlation with patient outcomes.'"
Until there are randomized controlled trials involving many patients, any new treatment for COVID-19 acute respiratory distress syndrome (ARDS) should be viewed skeptically, says David Kirk, MD, director of Pulmonary and Critical Care Medicine and director of eICU Service at WakeMed Health & Hospitals in Raleigh, North Carolina.
"At WakeMed, we believe that unproven therapies like hydroxychloroquine may have led to worse outcomes based on our internal data. Because of these facts, we have been very conservative to not jump on any unproven novel therapies unless they are done under research protocols. So, in general, we are skeptical of ARDS therapies, and we are worried that unproven therapies may make things worse instead of better."
Journey of discovery
So, how does an orthopedic surgeon with no experience treating lung injury become the principal investigator of a study on the use of laser technology in the treatment of COVID-19 pneumonia?
PBMT has been an FDA-approved treatment for inflammation and pain since 2011. Sigman has been using PBMT to treat inflammation and pain associated with acute joint injuries and chronic joint pain for nearly three years, with a success rate of about 78% in improvement of patient pain and inflammation.
"I wondered whether we could try the laser for the acute lung inflammation associated with COVID-19. I wondered whether it could work because it works well in orthopedic conditions," Sigman says.
Sigman's next step was to consult with his PBMT mentor, Professor Monica Monici of the University of Florence in Italy, one of the world's leading authorities in the study of the biology of laser treatment.
"She educated me on the process of the laser treatment, so I became much more comfortable using it for my patients. I called her in March and went over the details of what I was thinking about doing. She thought it was a good idea, and she gave me some initial parameters. But she is a molecular biologist, not a clinician, and she did not have experience in laser treatment of the lung fields," Sigman says.
The second step was finding clinicians who were familiar with the concept of using PBMT in the treatment of injured lungs. Sigman used a common research tool when doctors are unsure of their direction—Google.
"I was able to identify that there were two doctors—Soheila Mokmeli and Mariana Vetrici—who were MD-PhDs in Canada who were in the process of writing a paper about the theoretical use of laser treatment for COVID-19. I direct messaged Dr. Mokmeli, and she got back to me within an hour. I told her my idea and she said it was amazing," he says.
After consulting with Mokmeil, Sigman was able to determine the laser wavelength dose and duration of the laser treatment for COVID-19 patients with pneumonia or ARDS.
The next step was to convince the institutional review board at Lowell General Hospital to approve a pilot study. While the local IRB members were intrigued, they wanted to know whether the Food and Drug Administration would designate PBMT as a nonsignificant risk in the treatment of lung injury in COVID-19 patients, Sigman says. "I picked up the phone and called the FDA. Six hours later, the FDA called me back."
After several days of sending email back-and-forth with the FDA, Sigman got the greenlight. "The FDA was able to provide us with the documentation that my laser was a nonsignificant-risk device, which then allowed the IRB to give us permission to use this laser in a randomized trial."
Sigman and his colleagues at Lowell General Hospital are poised to publish results from a second COVID-19 patient in the Canadian Journal of Respiratory Therapy. "The case has been accepted for peer review—we are putting together the galley at this point. We will be able to announce the findings for that patient soon. The laser had a profound positive impact on that patient," he says.
The research team is compiling data from the pilot study and plans to submit that data to the New England Journal of Medicine, Sigman says.
Tower Health's flagship hospital promotes executive with cardiovascular and thoracic surgery background to top clinical leadership role.
The new chief medical officer of Reading Hospital is confident that the expansion of telemedicine services will continue after the coronavirus disease 2019 (COVID-19) pandemic passes.
Reading Hospital is the flagship hospital of West Reading, Pennsylvania–based Tower Health. Ron Nutting, MD, was appointed CMO of Reading Hospital in July. He succeeded Gregory Sorensen, MD, who had been serving in a dual role as CMO of Reading Hospital and Tower Health. Sorensen remains as the CMO of the eight-hospital health system.
Nutting, who is also serving as vice president for medical staff services at Tower Health, started his medical career as a cardiovascular and thoracic surgeon at Reading Hospital in 1992. He transitioned from clinical care to medical staff administration in 2013, when he became director of medical affairs at Reading Hospital.
Nutting shared his perspectives on telemedicine, patient safety, and other healthcare topics in a recent interview with HealthLeaders. The following is a lightly edited transcript of that conversation.
HealthLeaders: Telemedicine has experienced explosive growth during the coronavirus pandemic. Which telemedicine services has Reading Hospital adopted or expanded recently?
Nutting: Telemedicine areas where we have had success include outpatient screening—particularly individuals suspected of respiratory illnesses that could possibly be COVID-19. The telemedicine screening has allowed us to direct these patients to locations where they can be safely and effectively evaluated.
With telemedicine, we have also been in a better position to monitor our COVID-19 patients who have been staying at home. We have been doing remote monitoring utilizing pulse oximetry and screening questions. In the past, we have done telemonitoring of congestive heart failure and chronic obstructive pulmonary disease patients as part of our population health management strategy. The onset of the pandemic allowed us to amplify many of those activities.
We have done a lot of ongoing patient care with telemedicine—particularly for patients who need continued monitoring for chronic illnesses during the pandemic when they are concerned about coming in for office visits. For example, we have used telemedicine to monitor patients with diabetes and anticoagulation needs.
Perioperatively, we have been able to conduct pre-operative screening via electronic means to a larger extent than we have before. And we have taken advantage of being able to monitor our postoperative patients with telemedicine. This is an area of telemedicine that is likely to continue after the pandemic—it is a significant patient satisfier. If we have a patient who travels from the next county to undergo a surgical procedure, we can have a postoperative visit and our ability to evaluate a wound electronically can save the patient a car ride that can be uncomfortable. We can screen the patients to determine which ones we need to see in person.
We have been able to set up virtual ICU care with our sister facilities. We are a hospital system with eight acute care hospitals, and several of the hospitals have adult ICUs that have relatively small critical care teams compared to Reading Hospital. We have been able to utilize Reading Hospital's ICU team to render virtual ICU monitoring to help several of our sister facilities with coverage of acutely ill patients. This has helped us standardize some protocols and to identify patients earlier in the phase of decompensation.
Telemedicine has been available for many years; but, as a society, we had allowed the strategies around what was allowable for billing to prevent us from doing things that patients would prefer us to do remotely. It is nice to see this logjam open up, and I am very optimistic that many of these telemedicine advantages that have been gained will be maintained in the future.
HL: Since the publication of To Err Is Human two decades ago, where have healthcare organizations made the greatest strides in patient safety?
Nutting: This is an interesting issue, and it serves to highlight how complicated healthcare delivery is.
Unlike many manufacturing processes, healthcare is extraordinarily variable at the biologic level, both in terms of the individual variability of our patients and the wide array of maladies that they are presenting with that require us to discover the underlying ills and make an accurate diagnosis.
The strides that we have made in patient safety are around elements that reduce variability such as universal protocols like central line protocols, how we don gowns, and rituals for handwashing.
Medication safety is another area that stands out. This is one area where we have reaped some gains from information technology in terms of being able to track what medications we are giving patients in the inpatient environment and ensure we are giving medications safely through methods such as barcodes and multiple forms of identification.
We also have made progress in the engagement of patients and family members in care—they are participating at the level of decision-making and timeouts to verify that we are operating on the right site and performing the correct procedure.
Infection control through various bundles has also been a big win.
HL: How can health systems and hospitals help address physician burnout?
For physicians and clinicians of all stripes including allied health professionals and nurses, burnout is one of the big issues of our time.
Addressing burnout is not about making clinicians more resilient—it is about looking at the root causes of the burnout problem. Physicians feel overworked. Sometimes, they feel underappreciated. They are mourning the loss of autonomy. They feel they spend too much of their time on activities that are not aligned with their sense of purpose such as the impact of the electronic medical record.
When we look at the EMR, many of them are designed to limit the variability of care, but limiting variability of care drives a sense of loss of autonomy if the clinicians have not been involved in the process of standardizing care at the outset. There also are ways that clinicians must work through the EMR interface that are primary drivers of career dissatisfaction. Those drivers include the diminishing time of eye-to-eye contact with patients because of the distraction of needing to click fields in the EMR. Overall, interface optimization is going to be important in moving forward and reducing those distractions.
The inefficiencies of EMRs contribute to causing work hours beyond clinic time and into the evening for many medical professionals. As a result, there is diminished access to outside interests, which can cause hopelessness and a sense of depersonalization, which are hallmarks of burnout.
Other clinical inefficiencies are created by nonclinical agents that are mandating requirements for data input from clinicians that may be important but really are not good uses of clinician time. Clinicians feel they are not creating value in the clinic because they are working more in the role of a clerk. This is related to requirements from government regulators, insurers, and health system management. My colleagues and I need to be careful about what we are asking clinicians to do.
The antidote to burnout is to engage physicians and enlarge their sense of joy in work by involving them in clinical redesign that leads to performance improvement through lean-process improvement efforts and lean management. That approach will allow clinicians to have a sense of autonomy and to make sure a greater fraction of their time is spent on higher-value activities such as interacting with patients.
Influenza vaccination is more important than ever because of the overlapping threat of the coronavirus pandemic this fall and winter.
With the coronavirus disease 2019 (COVID-19) pandemic showing no signs of going away, influenza vaccination has taken on increased gravity.
There is widespread concern among healthcare professionals that the United States could be facing two infectious disease emergencies this flu season. For example, the California Immunization Coalition and the California Chronic Care Coalition are urging Americans to get flu vaccination to avoid a deadly "twindemic" this fall and winter.
"We are facing a dangerous double whammy in the coming months. Contracting the flu and getting COVID-19 on top of it can be deadly, so don't wait—vaccinate. Make plans to get a flu shot now to keep you and your family protected from influenza during the pandemic," says Catherine Flores Martin, executive director of the California Immunization Coalition.
Niket Sonpal, MD, a board-certified gastroenterologist and an assistant professor at Touro College of Osteopathic Medicine in Harlem, New York, says there are two pressing reasons to promote flu vaccination.
"The first and foremost reason is because the flu is a deadly disease. So, we want to protect everyone from flu regardless of COVID-19. The second most pressing issue is the coronavirus pandemic. I was in the forefront here in New York City for 43 days straight treating COVID-19 patients when we were bombarded by the pandemic. We were overwhelmed. And if you consider a COVID-19 resurgence in the winter along with a flu resurgence, we could not only overwhelm physicians and other healthcare workers but also resources and hospitals."
Just as in past years, health systems, hospitals, physician practices, and healthcare workers should actively encourage flu vaccination, he says. "Healthcare organizations do a great job of promoting flu vaccination to begin with. There are vaccination drives. Healthcare workers post on social media that flu vaccination is the right thing to do."
Government leaders also have a role to play, Sonpal says. "What is equally important is to see leaders of the country promote flu vaccination as well. Part of the reason masks have become political, part of the reason masks have been flouted, and part of the reason why some people think COVID-19 is a hoax is because the coronavirus was not taken seriously by the Trump administration to begin with."
People should not be concerned about contracting influenza from a flu shot, he says.
"The flu vaccine absolutely—without a doubt—does not cause the flu. It is a very common mistake to think the vaccine causes the flu, which is why some people do not get it. You may feel a little something, but that is your body accommodating the vaccine and building antibodies. You may feel a little achy, feel some pain in your shoulder where you got the shot, or feel a little warm for a day, but there will be nothing that a little bit of Tylenol can't fix."
Diagnosis challenge
Distinguishing between influenza and COVID-19 symptoms is difficult, Sonpal said.
"We don't know how people are going to present when they have both the flu and COVID-19. But what we can say is that the symptoms for both conditions are essentially similar. What we are telling people to do in the fall is to take the flu vaccine to take it out of the equation and to consult with their doctors if they are feeling unwell. Clinicians will go through your travel history, your contacts, and whether you have been exposed to people with COVID-19. Then, it comes down to testing."
Most flu and COVID-19 symptoms such as fever, aches, sniffles, and cough are common to both conditions. The only symptoms that are unique to COVID-19 and not unique to flu are the loss of taste and the loss of smell, he says.
A nonpunitive safety event reporting regime is likely to encourage staff to participate in reporting and to focus on systemic deficiencies.
A punitive approach to safety event reporting at healthcare organizations is counterproductive, a recent research article concludes.
Two decades after the dawn of the patient safety movement in healthcare with the publication of "To Err Is Human: Building a Safer Health System," medical errors remain a vexing challenge at healthcare settings. Encouraging staff to participate in safety event reporting is a primary strategy in fixing systemic problems that jeopardize patient safety.
The co-authors of the recent research article, which was published in Annals of Emergency Medicine, conclude that safety event reporting regimes that focus on punishing individuals are self-defeating.
"Punitive reports have important implications for reporting systems because they may reflect a culture of blame and a failure to recognize system influences on behaviors. Nonpunitive wording better identifies factors contributing to safety concerns. Reporting systems should focus on patient outcomes and learning from systems issues, not blaming individuals," the co-authors wrote.
The research, which was conducted at Richmond, Virginia-based VCU Health, examined more than 500 safety event reports from January to June 2019. The study includes several key data points.
25% of the safety event reports were designated as punitive and 68% of the reports were designated as nonpunitive
Punitive safety event reports compared to nonpunitive reports were more likely focused on communication (41% vs. 13%), employee behavior (38% vs. 2%), and patient assessment (17% vs. 4%)
Nonpunitive safety event reports compared to punitive reports were more likely focused on equipment (19% vs. 4%) and patient or family behavior (8% vs. 2%)
More nonpunitive safety event reports involved patient harm than not (5% vs. 2%)
"A high frequency of punitive reports may reflect a culture of blame and retribution, rather than a just culture focused on learning and improvement," the research article's co-authors wrote.
They wrote that there are two primary strategies to promote a nonpunitive safety event reporting regime. First, training staff to use safety event reporting to focus on creating a high-reliability organization and a just culture. Second, using alternative resources or tools rather than safety event reporting to disclose problematic behavior by colleagues such as intimidation.
Crafting an effective safety event reporting regime
One of the co-authors of the research article—Robin Hemphill, MD, chief quality and safety officer at VCU Health—told HealthLeaders that an effective safety event reporting system has five components.
1. Leadership: A good safety reporting system is supported by leadership. There needs to be an expressed desire from leadership that they do not want to punish people—they want to understand vulnerabilities in the healthcare organization's system.
2. Accessibility: A good safety reporting system is easy to access. If you must go searching on the intranet of your healthcare organization to find the patient safety reporting system, people are not going to use it. There should be a desktop icon that makes it easy to find—you log on to your computer and there it is.
3. Ease: Safety reporting should not be lengthy and onerous when people want to report. You may offer a lot of detail that people can report, but you must limit the computer system fields in a required reporting form to the bare elements. A busy healthcare worker should be able to get into the safety report and give enough information in the report so someone can understand the concern. The safety report should include the location of the safety event, a brief description of the event, and the perceived level of seriousness of the event.
4. Receptivity: Management needs to be responsive to safety event reports. If people put safety event reports into the system and it feels like a black hole, then few people will use the reporting system.
5. Training: Healthcare organizations need to train staff on how to use a safety reporting system and help them understand why the safety reporting system is important. Management should remind staff that safety reporting is about fixing systemic problems.
When to focus on individuals
There are circumstances when focusing on an individual's actions related to a safety event is appropriate, Hemphill said.
"There are times when you must look at the individual. But what we try to do before we leap to whodunit is to try to find out why it happened. Most errors, adverse events, and near misses have an individual at the sharp end of the processes that lead up to that moment in time. So, it is uncommon that people are not involved in these events. But, if you fundamentally believe that people don't go to work to hurt patients, then you need to understand everything around a healthcare worker that may have contributed to a bad choice or a wrong decision," she said.
When a patient safety event occurs, managers should conduct a rigorous investigation before laying blame on an individual, Hemphill said. Four key questions should be addressed, she said.
What is the action that we see? The patient safety event could be an innocent mistake.
Was there a low or moderate level of risk involved? For example, a nurse could have given a medication without using the barcode scanner, but there could be extenuating circumstances. If the barcode scanner is wireless and unreliable, then it could be rational behavior to not use the device, particularly if management has been alerted to the problem and failed to fix it.
Was there an unacceptable level of risk involved? To use the barcode example, if the nurse says the barcode scanner works fine but she just decided not to use it because she is smart enough to know which medication to administer, that would be an example of the kind of overly risky behavior that is inappropriate.
What is the performance of the individual? A just culture cannot tolerate repeated errors. If someone is making the same error week after week, maybe they are just bad at their job and maybe they need to be fired or reassigned to a different area where they can be more successful. Eventually, the competency of the individual must be questioned, but it is not the first step in a just culture.
"Safety reporting that is designed to detect systems deficiencies is complicated and very difficult to conduct. Situations must be managed fairly. You must make sure that you have a complete picture of what is going on if someone is being singled out for a behavioral problem," Hemphill said.
In the health system of the future, there are multiple opportunities for clinical care improvement and reform such as patient safety and quality improvement.
Clinical care is a hotbed of innovation in the healthcare sector. There are not only opportunities for improvement and reform, but also a shift in the delivery of care from the inpatient setting to the outpatient setting.
Quality improvement and boosting patient safety are primary objectives for clinical leaders, says Julian Schink, MD, chief medical officer of Boca Raton, Florida-based Cancer Treatment Centers of America. "This is our day-to-day job. This is our No. 1 priority: quality and safety within our workspace. I look at it as three spheres. There are the tools that make it easier for us to be safe and practice quality medicine. There are the incentives to practice quality medicine. Then there are the barriers."
At healthcare organizations, establishing a just culture is foundational for patient safety, says Sarah Garber, MD, chief medical officer of the Swedish Medical Center Ballard Campus in Seattle.
"Part of a just culture is reporting problems. Physicians and other caregivers need to be able to report on themselves, and they need to feel that they will be supported by colleagues and the organization. We are all human and we all make mistakes—we all need to be able to step back together to acknowledge that. If caregivers feel that they can raise their hands in the moment and say, 'I see a problem,' that would be a huge opportunity and a place to improve before bad things happen to patients," she says.
With the rapid expansion of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, healthcare leaders need to be cognizant of patient safety and quality challenges, says Joe Kimura, MD, MPH, chief medical officer of Newton, Massachusetts–based Atrius Health.
"We do need to understand where telemedicine strategies could raise patient safety or quality of care issues. The recent Sciencepublication highlighting racial bias in risk stratification algorithms shows where unintended care disparities may be propagated as we funnel more and more care through digital platforms. For the broad use of telehealth during the COVID-19 pandemic, there are questions about the quality of communication and the interaction between clinicians and patients. While it may seem natural and easy, it may take people time to learn how to best use this mode of care appropriately," he says.
The ongoing shift of care delivery from the inpatient setting to the outpatient setting also raises patient safety concerns. Patient ownership of care is a significant factor in outpatient care safety, says Donald Whiting, MD, chief medical officer of Pittsburgh-based Allegheny Health Network. "In the outpatient setting, safety is much more about the patient and their family's ownership of safety. You aren't watching them as inpatients, and patients are just starting to really want to own their own health, particularly the younger generation."
Chicago-based CommonSpirit Health has established a partnership with a direct primary care provider that will eventually be rolled out in several states.
Primary care services boost health condition prevention and improve clinical outcomes. A 2007 study published by the International Journal of Health Services found increasing the primary care physician supply reduced mortality for cancer, heart disease and stroke; decreased the incidence of low birth weight; and improved life expectancy.
CommonSpirit, which operates more than 700 care centers in 21 states, has established a partnership with direct primary care provider Paladina Health. Paladina, which is based in Denver, has more than 130 clinics that operate under value-based contracts with employers, unions, and other organizations. The partnership is launching in the Las Vegas area.
Paladina clinics are financed through per-member-per-month (PMPM) fees paid by employers and other organizations, says Paladina Chief Revenue Officer Kirk Rosin.
"We can tailor the financial arrangement based on several factors. Those factors include the hours of operation of the primary care center, the staffing that an organization wants to have in the primary care center, and the scope of clinical services. We have expanded the clinical scope in our primary care centers to include behavioral health, physical therapy, occupational therapy, dental, and vision," Rosin says.
The range of the PMPM fee is also linked to whether an organization contracts primary care services for an entire population of employees or members, or just contracts for the employees or members who utilize a Paladina primary care clinic. For contracts that cover an entire population of employees or members, the PMPM fee ranges from $40 to $55, and the fee is higher for the walk-in model, he says.
CommonSpirit has teamed up with Paladina to boost population health and lower total cost of care, says Rich Roth, MHA, senior vice president and chief strategic innovation officer at the health system.
"The opportunity for direct primary care is for an employer, a union, or any organized group to pay for primary care for all of their employees or members to effectively engage individuals in better preventive care and high-access services that avoid complications down the line. The uniqueness of the model is the business approach, which is having employers, unions, and other organizations invest in their employees or members through dedicated payment for primary care services. The goal of these organizations is to keep their employees or members healthy and avoid unnecessary healthcare service utilization," Roth says.
From the patient perspective, direct primary care is free, Roth says. "Patients do not have extraneous costs for the use of primary care services because the employer, union, or organization is invested in the health of patients. In theory, there are greater primary care interventions, which results in lower costs down the line for specialty care and other avoidable care costs."
For example, employers and other organizations contracted with Paladina reduce total cost of care by about 25% and decrease specialty care costs by about 50%, Rosin says. "We avoid exorbitant specialist visits, emergency room visits, and urgent care visits. We have seen a reduction in inpatient admissions over time because what we are able to do is meaningfully move the health risk of our patient populations in a positive way."
How Paladina's direct primary care clinics work
Rosin says there are five key elements of a Paladina direct primary care clinic.
1. Data: "What we have seen is that when 80%–85% of the employees and their family members start to use our centralized health service, the information on that population becomes a lot richer. So, we bring individuals into our clinics who typically would not have pursued any kind of primary care relationship. We can uncover clinical conditions that would have gone unchecked or undetected, then intervene at a point where the conditions are not severe," he says.
2. Small patient panels: Paladina primary care physicians typically see no more than a dozen patients per day, Rosin says. "When you think about the quality of the discussion that can happen in 90 minutes versus the seven to 10 minutes that is allotted for a fee-for-service visit, our physicians are able to get much deeper into not only a health concern on a specific day but also have conversations about closing gaps in care and healthy lifestyle coaching. We have the luxury of time because we are maintaining smaller patient panels."
3. Tight referral network: With a concentrated patient population, Paladina can work with employers and other organizations to establish and direct a referral network that is often "tighter" than the traditional insurance network, he says. "With that referral network, we can co-manage the patient within the specialty realm, so that once a patient has been diagnosed and has an established treatment protocol, we are able to perform ongoing care in our health center with a primary care physician."
4. Individualized care: Largely through examining claims data, Paladina primary care clinics can take an advanced approach to patient engagement, Rosin says. "It is a matter of absorbing claims data from every employer we work with and running that claims data through technology such as predictive analytics, which helps identify preventive care gaps. … We tailor every message to the individual. We account for demographic factors, health factors, and attitudinal segmentation, so that the messages and reminders that each individual receives are put into language they understand and reflect their views on health and healthcare."
5. Access: Paladina patients have 24/7 urgent care access to primary care physicians, including video visits and text messaging. "If something comes up and the primary care center is not open, that allows patients the leeway to always get ahold of one of our primary care physicians. Patients have a trusted resource they can go to and have a meaningful conversation," he says.
