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Antidepressant shows early promise for mild COVID-19
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.
In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.
“Most investigational treatments for COVID-19 have been aimed at the very sickest patients, but it’s also important to find therapies that prevent patients from getting sick enough to require supplemental oxygen or to have to go to the hospital,” study investigator Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University, St. Louis, said in a statement.
“Our study suggests fluvoxamine may help fill that niche,” Lenze added.
The study was published online Nov. 12 in the JAMA.
Antiviral effects?
The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.
Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.
The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).
Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
Hypothesis generating
The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”
However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.
Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.
“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.
“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.
She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”
The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”
However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.
This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.
Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.
A version of this article originally appeared on Medscape.com.
Pfizer files for FDA emergency use authorization of COVID vaccine
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
The pandemic experience through the eyes of APPs
The evolution of hospitalist advanced practice providers
Throughout the chaos of the COVID-19 pandemic, advanced practice providers (APPs) – physician assistants (PAs) and nurse practitioners (NPs) – have become an integral component of the hospitalist response. As many physicians began shifting into telemedicine and away from direct patient care, APPs have been eagerly jumping in to fill the gaps. Their work has been changing almost as dramatically and quickly as the pandemic itself, bringing with it expected challenges but bestowing hugely satisfying, often unanticipated, rewards.
APPs on the rise
As the coronavirus pandemic evolves, the role of APPs is evolving right alongside it. With the current relaxation of hospital bylaw restrictions on APPs, their utilization has increased, said Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner and vice president of advanced practice providers at Sound Physicians. “We have not really furloughed any advanced practice providers,” Ms. Cardin said. “In fact, I consider them to be, within hospital medicine, a key lever to finding more cost-effective care delivery models.”
Ms. Cardin said APPs have been working more independently since COVID-19 started, seeing patients on their own and using physician consultation and backup via telemedicine or telephone as needed. With the reduction in elective surgeries and patient volumes at many hospitals, APP-led care also saves money. Because one of the biggest costs is labor, Ms. Cardin said, offering this high-quality care delivery model using APPs in collaboration with physician providers helps defray some of that cost. “We’re hoping that advanced practice providers are really a solution to some of these financial pressures in a lot of different ways,” she said.
“COVID … forced us to expedite conversations about how to maximize caseloads using APPs,” said Alicia Sheffer, AGAC-AGPC NP, a nurse practitioner and Great Lakes regional director of advanced practice providers at Sound Physicians in Cincinnati. Some of those staffing model changes have included using APPs while transitioning ICUs and med-surg units to COVID cohort units, APP-led COVID cohorts, and APP-led ICUs.
“At first the hospital system had ideas about bringing in telemedicine as an alternative to seeing patients, rather than just putting APPs on the front lines and having them go in and see patients,” said Jessica Drane, APRN, PhD, DNP FNP-C, a nurse practitioner and regional director of advanced practice provider services and hospital medicine at Sound Physicians in San Antonio. In Texas at the beginning of the pandemic, hospital numbers were so low that Dr. Drane did not work at all in April. “We were all afraid we were going to lose our jobs,” she said. Then the state got slammed and APPs have been desperately needed.
Ilaria Gadalla, DMSc, PA-C, a PA at Treasure Coast Hospitalists in Port St. Lucie, Fla., and the PA program director at South University, West Palm Beach, Fla., noted that many of her APP colleagues have pivoted fluidly from other specialties to the hospitalist realm as the need for frontline workers has increased. “Hospitalists have shined through this and their value has been recognized even more than previously as a result of COVID-19,” Dr. Gadalla said.
“I don’t think it’s any surprise that hospitalists became a pillar of the COVID pandemic,” said Bridget McGrath, PA-C, a physician assistant and director of the NP/PAs service line for the section of hospital medicine at the University of Chicago. “There are just some innate traits that hospitalists have, such as the ability to be flexible, to problem solve, and to be the solution to the problem.”
Building team camaraderie
Ms. Cardin says that the need for APPs has led to an evolving integration between physicians and APPs. The growing teamwork and bonding between colleagues have been some of the most rewarding aspects of the pandemic for Dr. Gadalla. “We rely even more on each other and there isn’t really a line of, ‘I’m a physician versus an NP or PA or nurse.’ We’re all working together with the same goal,” she said.
Ms. McGrath said she has been learning what it means to lead a team during a challenging time. It has been gratifying for her to watch mentors get down to the bare bones of patient care and see everyone unify, putting aside roles and titles and coming together to care for their patients in innovative ways.
“This pandemic has really opened up a lot of doors for us because up until now, we were used almost like scribes for physicians,” Dr. Drane said. She has seen even the most resistant hospital systems beginning to rely on APPs as the pandemic has progressed. “They have become pleasantly surprised at what an APP can do.”
Work challenges
Obviously, challenges abound. Dr. Gadalla listed hers as visiting restrictions that invariably lead to slower patient visits thanks to obligatory phone calls, constantly fluctuating patient censuses, sporadic elective surgeries, watching colleagues become furloughed, and trying to balance external perceptions with what’s actually happening in the hospital.
Overall, though, “There have been a lot more rewards than barriers,” added Dr. Drane.
One of the biggest obstacles for health care workers navigating a pandemic is balancing work and home life, not to mention having time to unwind while working long hours. “Finding time for my family has been very limited. My kids feel really neglected,” said Dr. Gadalla. Some days, she gets up extra early to exercise to help clear her head, but other times she’s just too exhausted to even move.
Dr. Drane agreed that the work can get overwhelming. “We’re changing the way we practice almost every week, which can make you doubt yourself as an educator, as a practitioner. You constantly feel like you’re not sure what you’re doing, and people trust you to heal them,” she said. “Today is my first day off in 24 days. I only got it off because I said I needed a moment.”
Ms. Sheffer’s crazy days were at the beginning of the pandemic when she had to self-quarantine from her family and was working nonstop. “I would come home and sleep and work and wake up in the middle of the night and double check and triple check and go back to sleep and work, and that consumed me for several months,” she said.
The biggest challenge for Ms. Sheffer has been coping with public fear. “No matter how logical our medical approach has been, I think the constant feeling of the public threat of COVID has had this insidious effect on how patients approach their health,” she said. “We’re spending a lot more time shaping our approach to best address their fears first and not to politicize COVID so we can actually deal with the health issue at hand.”
Complications of COVID
With all the restrictions, caring for patients these days has meant learning to interact with them in different ways that aren’t as personal, Ms. McGrath said. It has been difficult to lose “that humanity of medicine, the usual ways that you interact with your patients that are going through a vulnerable time,” she noted.
Additionally, students in the medical field are being held back from graduation because they cannot participate in direct patient care. This is particularly problematic for PAs and medical students who must touch patients to graduate, Dr. Gadalla said. “All of this is slowing down future providers. We’re going to have trouble catching up. Who’s going to relieve us? That’s a huge problem and no one is finding solutions for that yet,” she said.
At the University of Chicago, Ms. McGrath explained, they created virtual rotations so that PA students could continue to do them at the university. Not only has the experience reminded Ms. McGrath how much she loves being a medical educator and fighting for the education of PA students, but she was surprised to find that her patients came to appreciate the time they spent with her students on the virtual platform as well.
“It’s isolating for patients to be in the hospital in a vulnerable state and with no support system,” she said. “I think being a part of [the PA students’] education gave some meaning to their hospitalization and highlighted that collaboration and connection is a human need.”
Despite everything, there’s a noticeable emphasis on the flowering buds of hope, unity, compassion, and pride that have been quietly blooming from the daily hardships. As Ms. Cardin puts it, “It’s so cliché to say that there’s a crisis. The other word is ‘opportunity,’ and it’s true, there are opportunities here.”
Taking care of each other
Creating resources for providers has been a priority at the University of Chicago, according to Ms. McGrath. “As hospitalists, we’re used to taking care of a variety of patients, but our section leadership and providers on the front lines quickly realized that COVID patients are more akin to trauma patients with their quick changes in health, as well as their isolation, fear, and unexpected deterioration,” she said. Her facility has implemented wellness initiatives to help prevent burnout and mental health problems in COVID providers so they can continue to give the best care to their patients.
Both Ms. Sheffer and Dr. Drane say that they have a peer network of APPs at Sound Physicians to call on for questions and support. And it’s encouraging to know you’re not alone and to keep tabs on how colleagues in other states are doing, Ms. Sheffer noted.
“The peer support system has been helpful,” Dr. Drane said. “This job, right now, takes pieces of you every day. Sometimes it’s so emotional that you can’t put it into words. You just have to cry and get it out so that you can go be with your family.”
Getting back to basics
The changes in patient care have turned into something Ms. McGrath said she appreciates. “This pandemic has really stripped away the extra fluff of medicine and brought us back to the reason why many of us have gotten into the field, because it became about the patients again,” she says. “You quickly learn your strengths and weaknesses as a provider and as a leader, and that flows into the decisions you’re making for your team and for your patients.”
Ms. Sheffer acknowledged that it is difficult to deal with patients’ family members who don’t understand that they can’t visit their sick relatives, but she said the flip side is that frontline workers become surrogate family members, an outcome she considers to be an honor.
“You step into the emotion with the family or with the patient because you’re all they have. That is a beautiful, honorable role, but it’s also tremendously emotional and sometimes devastating,” she said. “But to me, it’s one of the most beautiful things I’ve been able to offer in a time where we don’t even know what to do with COVID.”
Limited resources mixed with a healthy dose of fear can stifle creativity, Dr. Drane said. Right away, she noticed that despite the abundance of incentive spirometers at her hospital, they were not being utilized. She came in 2 hours early for 3 days to pass one out to every patient under investigation or COVID-positive patient and enlisted the help of her chief nursing officer, CEO, and regional medical director to get everyone on board.
Dr. Drane’s out-of-the-box thinking has enabled people to go home without oxygen 2 days earlier and cut the hospital’s length of stay by 5%. “It’s something so small, but it has such a great end reward,” she said. “I’m proud of this project because it didn’t take money; it was getting creative with what we already have.”
Renewed pride and passion
Dr. Drane is intensely proud of being an NP and working on the front lines. She sees that the pandemic has encouraged her and other APPs to expand their horizons.
“For me, it’s made me work to get dual certified,” she said. “APPs can be all-inclusive. I feel like I’m doing what I was meant to do and it’s not just a job anymore.”
Ms. McGrath is even more passionate about being a hospitalist now, as she has realized how valuable their unique skill sets are. “I think other people have also been able to realize that our ability to see the patient as a whole has allowed us to take care of this pandemic, because this disease impacts all organ systems and has a trickle-down effect that we as hospitalists are well versed to manage,” she said.
Ms. Cardin’s work involves communicating with APPs all around the country. Recently she had a phone exchange with an APP who needed to vent.
“She was weeping, and I thought she was going to say, ‘I can’t do this anymore, I need to go home,’ ” said Ms. Cardin. “Instead, she said, ‘I just want to make a difference in one of these people’s lives.’ And that is who the advanced practice providers are. They’re willing to go into those COVID units. They’re willing to be in the front lines. They are dedicated. They’re just intensely inspirational to me.”
The evolution of hospitalist advanced practice providers
The evolution of hospitalist advanced practice providers
Throughout the chaos of the COVID-19 pandemic, advanced practice providers (APPs) – physician assistants (PAs) and nurse practitioners (NPs) – have become an integral component of the hospitalist response. As many physicians began shifting into telemedicine and away from direct patient care, APPs have been eagerly jumping in to fill the gaps. Their work has been changing almost as dramatically and quickly as the pandemic itself, bringing with it expected challenges but bestowing hugely satisfying, often unanticipated, rewards.
APPs on the rise
As the coronavirus pandemic evolves, the role of APPs is evolving right alongside it. With the current relaxation of hospital bylaw restrictions on APPs, their utilization has increased, said Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner and vice president of advanced practice providers at Sound Physicians. “We have not really furloughed any advanced practice providers,” Ms. Cardin said. “In fact, I consider them to be, within hospital medicine, a key lever to finding more cost-effective care delivery models.”
Ms. Cardin said APPs have been working more independently since COVID-19 started, seeing patients on their own and using physician consultation and backup via telemedicine or telephone as needed. With the reduction in elective surgeries and patient volumes at many hospitals, APP-led care also saves money. Because one of the biggest costs is labor, Ms. Cardin said, offering this high-quality care delivery model using APPs in collaboration with physician providers helps defray some of that cost. “We’re hoping that advanced practice providers are really a solution to some of these financial pressures in a lot of different ways,” she said.
“COVID … forced us to expedite conversations about how to maximize caseloads using APPs,” said Alicia Sheffer, AGAC-AGPC NP, a nurse practitioner and Great Lakes regional director of advanced practice providers at Sound Physicians in Cincinnati. Some of those staffing model changes have included using APPs while transitioning ICUs and med-surg units to COVID cohort units, APP-led COVID cohorts, and APP-led ICUs.
“At first the hospital system had ideas about bringing in telemedicine as an alternative to seeing patients, rather than just putting APPs on the front lines and having them go in and see patients,” said Jessica Drane, APRN, PhD, DNP FNP-C, a nurse practitioner and regional director of advanced practice provider services and hospital medicine at Sound Physicians in San Antonio. In Texas at the beginning of the pandemic, hospital numbers were so low that Dr. Drane did not work at all in April. “We were all afraid we were going to lose our jobs,” she said. Then the state got slammed and APPs have been desperately needed.
Ilaria Gadalla, DMSc, PA-C, a PA at Treasure Coast Hospitalists in Port St. Lucie, Fla., and the PA program director at South University, West Palm Beach, Fla., noted that many of her APP colleagues have pivoted fluidly from other specialties to the hospitalist realm as the need for frontline workers has increased. “Hospitalists have shined through this and their value has been recognized even more than previously as a result of COVID-19,” Dr. Gadalla said.
“I don’t think it’s any surprise that hospitalists became a pillar of the COVID pandemic,” said Bridget McGrath, PA-C, a physician assistant and director of the NP/PAs service line for the section of hospital medicine at the University of Chicago. “There are just some innate traits that hospitalists have, such as the ability to be flexible, to problem solve, and to be the solution to the problem.”
Building team camaraderie
Ms. Cardin says that the need for APPs has led to an evolving integration between physicians and APPs. The growing teamwork and bonding between colleagues have been some of the most rewarding aspects of the pandemic for Dr. Gadalla. “We rely even more on each other and there isn’t really a line of, ‘I’m a physician versus an NP or PA or nurse.’ We’re all working together with the same goal,” she said.
Ms. McGrath said she has been learning what it means to lead a team during a challenging time. It has been gratifying for her to watch mentors get down to the bare bones of patient care and see everyone unify, putting aside roles and titles and coming together to care for their patients in innovative ways.
“This pandemic has really opened up a lot of doors for us because up until now, we were used almost like scribes for physicians,” Dr. Drane said. She has seen even the most resistant hospital systems beginning to rely on APPs as the pandemic has progressed. “They have become pleasantly surprised at what an APP can do.”
Work challenges
Obviously, challenges abound. Dr. Gadalla listed hers as visiting restrictions that invariably lead to slower patient visits thanks to obligatory phone calls, constantly fluctuating patient censuses, sporadic elective surgeries, watching colleagues become furloughed, and trying to balance external perceptions with what’s actually happening in the hospital.
Overall, though, “There have been a lot more rewards than barriers,” added Dr. Drane.
One of the biggest obstacles for health care workers navigating a pandemic is balancing work and home life, not to mention having time to unwind while working long hours. “Finding time for my family has been very limited. My kids feel really neglected,” said Dr. Gadalla. Some days, she gets up extra early to exercise to help clear her head, but other times she’s just too exhausted to even move.
Dr. Drane agreed that the work can get overwhelming. “We’re changing the way we practice almost every week, which can make you doubt yourself as an educator, as a practitioner. You constantly feel like you’re not sure what you’re doing, and people trust you to heal them,” she said. “Today is my first day off in 24 days. I only got it off because I said I needed a moment.”
Ms. Sheffer’s crazy days were at the beginning of the pandemic when she had to self-quarantine from her family and was working nonstop. “I would come home and sleep and work and wake up in the middle of the night and double check and triple check and go back to sleep and work, and that consumed me for several months,” she said.
The biggest challenge for Ms. Sheffer has been coping with public fear. “No matter how logical our medical approach has been, I think the constant feeling of the public threat of COVID has had this insidious effect on how patients approach their health,” she said. “We’re spending a lot more time shaping our approach to best address their fears first and not to politicize COVID so we can actually deal with the health issue at hand.”
Complications of COVID
With all the restrictions, caring for patients these days has meant learning to interact with them in different ways that aren’t as personal, Ms. McGrath said. It has been difficult to lose “that humanity of medicine, the usual ways that you interact with your patients that are going through a vulnerable time,” she noted.
Additionally, students in the medical field are being held back from graduation because they cannot participate in direct patient care. This is particularly problematic for PAs and medical students who must touch patients to graduate, Dr. Gadalla said. “All of this is slowing down future providers. We’re going to have trouble catching up. Who’s going to relieve us? That’s a huge problem and no one is finding solutions for that yet,” she said.
At the University of Chicago, Ms. McGrath explained, they created virtual rotations so that PA students could continue to do them at the university. Not only has the experience reminded Ms. McGrath how much she loves being a medical educator and fighting for the education of PA students, but she was surprised to find that her patients came to appreciate the time they spent with her students on the virtual platform as well.
“It’s isolating for patients to be in the hospital in a vulnerable state and with no support system,” she said. “I think being a part of [the PA students’] education gave some meaning to their hospitalization and highlighted that collaboration and connection is a human need.”
Despite everything, there’s a noticeable emphasis on the flowering buds of hope, unity, compassion, and pride that have been quietly blooming from the daily hardships. As Ms. Cardin puts it, “It’s so cliché to say that there’s a crisis. The other word is ‘opportunity,’ and it’s true, there are opportunities here.”
Taking care of each other
Creating resources for providers has been a priority at the University of Chicago, according to Ms. McGrath. “As hospitalists, we’re used to taking care of a variety of patients, but our section leadership and providers on the front lines quickly realized that COVID patients are more akin to trauma patients with their quick changes in health, as well as their isolation, fear, and unexpected deterioration,” she said. Her facility has implemented wellness initiatives to help prevent burnout and mental health problems in COVID providers so they can continue to give the best care to their patients.
Both Ms. Sheffer and Dr. Drane say that they have a peer network of APPs at Sound Physicians to call on for questions and support. And it’s encouraging to know you’re not alone and to keep tabs on how colleagues in other states are doing, Ms. Sheffer noted.
“The peer support system has been helpful,” Dr. Drane said. “This job, right now, takes pieces of you every day. Sometimes it’s so emotional that you can’t put it into words. You just have to cry and get it out so that you can go be with your family.”
Getting back to basics
The changes in patient care have turned into something Ms. McGrath said she appreciates. “This pandemic has really stripped away the extra fluff of medicine and brought us back to the reason why many of us have gotten into the field, because it became about the patients again,” she says. “You quickly learn your strengths and weaknesses as a provider and as a leader, and that flows into the decisions you’re making for your team and for your patients.”
Ms. Sheffer acknowledged that it is difficult to deal with patients’ family members who don’t understand that they can’t visit their sick relatives, but she said the flip side is that frontline workers become surrogate family members, an outcome she considers to be an honor.
“You step into the emotion with the family or with the patient because you’re all they have. That is a beautiful, honorable role, but it’s also tremendously emotional and sometimes devastating,” she said. “But to me, it’s one of the most beautiful things I’ve been able to offer in a time where we don’t even know what to do with COVID.”
Limited resources mixed with a healthy dose of fear can stifle creativity, Dr. Drane said. Right away, she noticed that despite the abundance of incentive spirometers at her hospital, they were not being utilized. She came in 2 hours early for 3 days to pass one out to every patient under investigation or COVID-positive patient and enlisted the help of her chief nursing officer, CEO, and regional medical director to get everyone on board.
Dr. Drane’s out-of-the-box thinking has enabled people to go home without oxygen 2 days earlier and cut the hospital’s length of stay by 5%. “It’s something so small, but it has such a great end reward,” she said. “I’m proud of this project because it didn’t take money; it was getting creative with what we already have.”
Renewed pride and passion
Dr. Drane is intensely proud of being an NP and working on the front lines. She sees that the pandemic has encouraged her and other APPs to expand their horizons.
“For me, it’s made me work to get dual certified,” she said. “APPs can be all-inclusive. I feel like I’m doing what I was meant to do and it’s not just a job anymore.”
Ms. McGrath is even more passionate about being a hospitalist now, as she has realized how valuable their unique skill sets are. “I think other people have also been able to realize that our ability to see the patient as a whole has allowed us to take care of this pandemic, because this disease impacts all organ systems and has a trickle-down effect that we as hospitalists are well versed to manage,” she said.
Ms. Cardin’s work involves communicating with APPs all around the country. Recently she had a phone exchange with an APP who needed to vent.
“She was weeping, and I thought she was going to say, ‘I can’t do this anymore, I need to go home,’ ” said Ms. Cardin. “Instead, she said, ‘I just want to make a difference in one of these people’s lives.’ And that is who the advanced practice providers are. They’re willing to go into those COVID units. They’re willing to be in the front lines. They are dedicated. They’re just intensely inspirational to me.”
Throughout the chaos of the COVID-19 pandemic, advanced practice providers (APPs) – physician assistants (PAs) and nurse practitioners (NPs) – have become an integral component of the hospitalist response. As many physicians began shifting into telemedicine and away from direct patient care, APPs have been eagerly jumping in to fill the gaps. Their work has been changing almost as dramatically and quickly as the pandemic itself, bringing with it expected challenges but bestowing hugely satisfying, often unanticipated, rewards.
APPs on the rise
As the coronavirus pandemic evolves, the role of APPs is evolving right alongside it. With the current relaxation of hospital bylaw restrictions on APPs, their utilization has increased, said Tracy Cardin, ACNP-BC, SFHM, a nurse practitioner and vice president of advanced practice providers at Sound Physicians. “We have not really furloughed any advanced practice providers,” Ms. Cardin said. “In fact, I consider them to be, within hospital medicine, a key lever to finding more cost-effective care delivery models.”
Ms. Cardin said APPs have been working more independently since COVID-19 started, seeing patients on their own and using physician consultation and backup via telemedicine or telephone as needed. With the reduction in elective surgeries and patient volumes at many hospitals, APP-led care also saves money. Because one of the biggest costs is labor, Ms. Cardin said, offering this high-quality care delivery model using APPs in collaboration with physician providers helps defray some of that cost. “We’re hoping that advanced practice providers are really a solution to some of these financial pressures in a lot of different ways,” she said.
“COVID … forced us to expedite conversations about how to maximize caseloads using APPs,” said Alicia Sheffer, AGAC-AGPC NP, a nurse practitioner and Great Lakes regional director of advanced practice providers at Sound Physicians in Cincinnati. Some of those staffing model changes have included using APPs while transitioning ICUs and med-surg units to COVID cohort units, APP-led COVID cohorts, and APP-led ICUs.
“At first the hospital system had ideas about bringing in telemedicine as an alternative to seeing patients, rather than just putting APPs on the front lines and having them go in and see patients,” said Jessica Drane, APRN, PhD, DNP FNP-C, a nurse practitioner and regional director of advanced practice provider services and hospital medicine at Sound Physicians in San Antonio. In Texas at the beginning of the pandemic, hospital numbers were so low that Dr. Drane did not work at all in April. “We were all afraid we were going to lose our jobs,” she said. Then the state got slammed and APPs have been desperately needed.
Ilaria Gadalla, DMSc, PA-C, a PA at Treasure Coast Hospitalists in Port St. Lucie, Fla., and the PA program director at South University, West Palm Beach, Fla., noted that many of her APP colleagues have pivoted fluidly from other specialties to the hospitalist realm as the need for frontline workers has increased. “Hospitalists have shined through this and their value has been recognized even more than previously as a result of COVID-19,” Dr. Gadalla said.
“I don’t think it’s any surprise that hospitalists became a pillar of the COVID pandemic,” said Bridget McGrath, PA-C, a physician assistant and director of the NP/PAs service line for the section of hospital medicine at the University of Chicago. “There are just some innate traits that hospitalists have, such as the ability to be flexible, to problem solve, and to be the solution to the problem.”
Building team camaraderie
Ms. Cardin says that the need for APPs has led to an evolving integration between physicians and APPs. The growing teamwork and bonding between colleagues have been some of the most rewarding aspects of the pandemic for Dr. Gadalla. “We rely even more on each other and there isn’t really a line of, ‘I’m a physician versus an NP or PA or nurse.’ We’re all working together with the same goal,” she said.
Ms. McGrath said she has been learning what it means to lead a team during a challenging time. It has been gratifying for her to watch mentors get down to the bare bones of patient care and see everyone unify, putting aside roles and titles and coming together to care for their patients in innovative ways.
“This pandemic has really opened up a lot of doors for us because up until now, we were used almost like scribes for physicians,” Dr. Drane said. She has seen even the most resistant hospital systems beginning to rely on APPs as the pandemic has progressed. “They have become pleasantly surprised at what an APP can do.”
Work challenges
Obviously, challenges abound. Dr. Gadalla listed hers as visiting restrictions that invariably lead to slower patient visits thanks to obligatory phone calls, constantly fluctuating patient censuses, sporadic elective surgeries, watching colleagues become furloughed, and trying to balance external perceptions with what’s actually happening in the hospital.
Overall, though, “There have been a lot more rewards than barriers,” added Dr. Drane.
One of the biggest obstacles for health care workers navigating a pandemic is balancing work and home life, not to mention having time to unwind while working long hours. “Finding time for my family has been very limited. My kids feel really neglected,” said Dr. Gadalla. Some days, she gets up extra early to exercise to help clear her head, but other times she’s just too exhausted to even move.
Dr. Drane agreed that the work can get overwhelming. “We’re changing the way we practice almost every week, which can make you doubt yourself as an educator, as a practitioner. You constantly feel like you’re not sure what you’re doing, and people trust you to heal them,” she said. “Today is my first day off in 24 days. I only got it off because I said I needed a moment.”
Ms. Sheffer’s crazy days were at the beginning of the pandemic when she had to self-quarantine from her family and was working nonstop. “I would come home and sleep and work and wake up in the middle of the night and double check and triple check and go back to sleep and work, and that consumed me for several months,” she said.
The biggest challenge for Ms. Sheffer has been coping with public fear. “No matter how logical our medical approach has been, I think the constant feeling of the public threat of COVID has had this insidious effect on how patients approach their health,” she said. “We’re spending a lot more time shaping our approach to best address their fears first and not to politicize COVID so we can actually deal with the health issue at hand.”
Complications of COVID
With all the restrictions, caring for patients these days has meant learning to interact with them in different ways that aren’t as personal, Ms. McGrath said. It has been difficult to lose “that humanity of medicine, the usual ways that you interact with your patients that are going through a vulnerable time,” she noted.
Additionally, students in the medical field are being held back from graduation because they cannot participate in direct patient care. This is particularly problematic for PAs and medical students who must touch patients to graduate, Dr. Gadalla said. “All of this is slowing down future providers. We’re going to have trouble catching up. Who’s going to relieve us? That’s a huge problem and no one is finding solutions for that yet,” she said.
At the University of Chicago, Ms. McGrath explained, they created virtual rotations so that PA students could continue to do them at the university. Not only has the experience reminded Ms. McGrath how much she loves being a medical educator and fighting for the education of PA students, but she was surprised to find that her patients came to appreciate the time they spent with her students on the virtual platform as well.
“It’s isolating for patients to be in the hospital in a vulnerable state and with no support system,” she said. “I think being a part of [the PA students’] education gave some meaning to their hospitalization and highlighted that collaboration and connection is a human need.”
Despite everything, there’s a noticeable emphasis on the flowering buds of hope, unity, compassion, and pride that have been quietly blooming from the daily hardships. As Ms. Cardin puts it, “It’s so cliché to say that there’s a crisis. The other word is ‘opportunity,’ and it’s true, there are opportunities here.”
Taking care of each other
Creating resources for providers has been a priority at the University of Chicago, according to Ms. McGrath. “As hospitalists, we’re used to taking care of a variety of patients, but our section leadership and providers on the front lines quickly realized that COVID patients are more akin to trauma patients with their quick changes in health, as well as their isolation, fear, and unexpected deterioration,” she said. Her facility has implemented wellness initiatives to help prevent burnout and mental health problems in COVID providers so they can continue to give the best care to their patients.
Both Ms. Sheffer and Dr. Drane say that they have a peer network of APPs at Sound Physicians to call on for questions and support. And it’s encouraging to know you’re not alone and to keep tabs on how colleagues in other states are doing, Ms. Sheffer noted.
“The peer support system has been helpful,” Dr. Drane said. “This job, right now, takes pieces of you every day. Sometimes it’s so emotional that you can’t put it into words. You just have to cry and get it out so that you can go be with your family.”
Getting back to basics
The changes in patient care have turned into something Ms. McGrath said she appreciates. “This pandemic has really stripped away the extra fluff of medicine and brought us back to the reason why many of us have gotten into the field, because it became about the patients again,” she says. “You quickly learn your strengths and weaknesses as a provider and as a leader, and that flows into the decisions you’re making for your team and for your patients.”
Ms. Sheffer acknowledged that it is difficult to deal with patients’ family members who don’t understand that they can’t visit their sick relatives, but she said the flip side is that frontline workers become surrogate family members, an outcome she considers to be an honor.
“You step into the emotion with the family or with the patient because you’re all they have. That is a beautiful, honorable role, but it’s also tremendously emotional and sometimes devastating,” she said. “But to me, it’s one of the most beautiful things I’ve been able to offer in a time where we don’t even know what to do with COVID.”
Limited resources mixed with a healthy dose of fear can stifle creativity, Dr. Drane said. Right away, she noticed that despite the abundance of incentive spirometers at her hospital, they were not being utilized. She came in 2 hours early for 3 days to pass one out to every patient under investigation or COVID-positive patient and enlisted the help of her chief nursing officer, CEO, and regional medical director to get everyone on board.
Dr. Drane’s out-of-the-box thinking has enabled people to go home without oxygen 2 days earlier and cut the hospital’s length of stay by 5%. “It’s something so small, but it has such a great end reward,” she said. “I’m proud of this project because it didn’t take money; it was getting creative with what we already have.”
Renewed pride and passion
Dr. Drane is intensely proud of being an NP and working on the front lines. She sees that the pandemic has encouraged her and other APPs to expand their horizons.
“For me, it’s made me work to get dual certified,” she said. “APPs can be all-inclusive. I feel like I’m doing what I was meant to do and it’s not just a job anymore.”
Ms. McGrath is even more passionate about being a hospitalist now, as she has realized how valuable their unique skill sets are. “I think other people have also been able to realize that our ability to see the patient as a whole has allowed us to take care of this pandemic, because this disease impacts all organ systems and has a trickle-down effect that we as hospitalists are well versed to manage,” she said.
Ms. Cardin’s work involves communicating with APPs all around the country. Recently she had a phone exchange with an APP who needed to vent.
“She was weeping, and I thought she was going to say, ‘I can’t do this anymore, I need to go home,’ ” said Ms. Cardin. “Instead, she said, ‘I just want to make a difference in one of these people’s lives.’ And that is who the advanced practice providers are. They’re willing to go into those COVID units. They’re willing to be in the front lines. They are dedicated. They’re just intensely inspirational to me.”
Pfizer’s COVID-19 vaccine 95% effective in final phase 3 results
After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.
Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.
Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.
The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.
Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.
The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.
The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.
As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.
The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
‘Historic 8-month journey’
The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”
The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.
The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.
This article first appeared on Medscape.com.
After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.
Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.
Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.
The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.
Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.
The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.
The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.
As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.
The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
‘Historic 8-month journey’
The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”
The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.
The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.
This article first appeared on Medscape.com.
After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.
Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.
Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.
The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.
Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.
The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.
The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.
As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.
The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
‘Historic 8-month journey’
The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”
The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.
The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.
This article first appeared on Medscape.com.
‘Hospital at home’ increases COVID capacity in large study
A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.
“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.
Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.
The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).
Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
Patients hop onboard
Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.
Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.
Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.
Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
Few patients go to hospital
Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.
A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.
Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
Augmenting hospital capacity
The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.
Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”
How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”
If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.
For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.
The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
Prior planning paid off
Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.
While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.
Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
COVID vs. non-COVID patients
Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)
Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.
Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”
Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”
The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.
Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”
Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.
A version of this article originally appeared on Medscape.com.
A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.
“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.
Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.
The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).
Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
Patients hop onboard
Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.
Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.
Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.
Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
Few patients go to hospital
Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.
A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.
Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
Augmenting hospital capacity
The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.
Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”
How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”
If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.
For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.
The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
Prior planning paid off
Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.
While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.
Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
COVID vs. non-COVID patients
Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)
Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.
Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”
Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”
The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.
Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”
Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.
A version of this article originally appeared on Medscape.com.
A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.
“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.
Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.
The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).
Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
Patients hop onboard
Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.
Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.
Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.
Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
Few patients go to hospital
Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.
A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.
Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
Augmenting hospital capacity
The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.
Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”
How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”
If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.
For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.
The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
Prior planning paid off
Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.
While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.
Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
COVID vs. non-COVID patients
Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)
Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.
Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”
Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”
The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.
Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”
Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.
A version of this article originally appeared on Medscape.com.
Predicting patient risk of medication-related harm
A new tool is the first of its kind
“An increasing number of older adults are using multiple medicines, and it is important that the benefits are outweighing the risks,” said Nikesh Parekh, MBBS, MPH, lead author of a recent study of a new predictive tool. The study was done in the context of the World Health Organization campaign to halve the incidence of medication-related harm (MRH) by 2022 – reducing MRH following hospital discharge was identified as a priority area.
This works allows clinicians to calculate the risk of a patient suffering MRH post-discharge requiring health care, said Dr. Parekh, a research fellow at Brighton and Sussex Medical School in Great Britain. “This enables practitioners and policy makers to target interventions to reduce MRH at those with highest risk. This should support the delivery of cost-effective care. The knowledge of individual risk can also prompt clinicians to reconsider any high-risk medicines that they intend on prescribing at discharge.”
This is the first prediction tool to calculate individual patient risk of serious MRH post-discharge, he added.The high readmission rate for older adults is often an avoidable pressure for hospitalists, particularly where MRH is the underlying cause. “The prediction tool has the potential to significantly reduce this burden for hospitalists/patients by identifying those individuals at high risk upon discharge and ensuring that monitoring and additional support is provided to them in the community with their medications,” Dr. Parekh said.
This electronic tool could be integrated into the electronic discharge summaries so that the information can be shared with primary care clinicians in a straightforward way. “The risk score should be calculated automatically by a self-population of the tool’s fields from information that exists on the patient within the electronic discharge system.”The tool now needs to be externally validated through testing in new settings to assess its validity and reliability in new populations. “If the tool is found to be usable by hospitalists and demonstrates reasonable predictive accuracy, then it should be implemented widely to reduce the incidence of MRH,” Dr. Parekh said.
Reference
1. Parekh N, et al. Medication-related harm in older adults following hospital discharge: development and validation of a prediction tool. BMJ Qual Saf. Published Online First 2019 Sept 16. doi: 10.1136/bmjqs-2019-009587.
A new tool is the first of its kind
A new tool is the first of its kind
“An increasing number of older adults are using multiple medicines, and it is important that the benefits are outweighing the risks,” said Nikesh Parekh, MBBS, MPH, lead author of a recent study of a new predictive tool. The study was done in the context of the World Health Organization campaign to halve the incidence of medication-related harm (MRH) by 2022 – reducing MRH following hospital discharge was identified as a priority area.
This works allows clinicians to calculate the risk of a patient suffering MRH post-discharge requiring health care, said Dr. Parekh, a research fellow at Brighton and Sussex Medical School in Great Britain. “This enables practitioners and policy makers to target interventions to reduce MRH at those with highest risk. This should support the delivery of cost-effective care. The knowledge of individual risk can also prompt clinicians to reconsider any high-risk medicines that they intend on prescribing at discharge.”
This is the first prediction tool to calculate individual patient risk of serious MRH post-discharge, he added.The high readmission rate for older adults is often an avoidable pressure for hospitalists, particularly where MRH is the underlying cause. “The prediction tool has the potential to significantly reduce this burden for hospitalists/patients by identifying those individuals at high risk upon discharge and ensuring that monitoring and additional support is provided to them in the community with their medications,” Dr. Parekh said.
This electronic tool could be integrated into the electronic discharge summaries so that the information can be shared with primary care clinicians in a straightforward way. “The risk score should be calculated automatically by a self-population of the tool’s fields from information that exists on the patient within the electronic discharge system.”The tool now needs to be externally validated through testing in new settings to assess its validity and reliability in new populations. “If the tool is found to be usable by hospitalists and demonstrates reasonable predictive accuracy, then it should be implemented widely to reduce the incidence of MRH,” Dr. Parekh said.
Reference
1. Parekh N, et al. Medication-related harm in older adults following hospital discharge: development and validation of a prediction tool. BMJ Qual Saf. Published Online First 2019 Sept 16. doi: 10.1136/bmjqs-2019-009587.
“An increasing number of older adults are using multiple medicines, and it is important that the benefits are outweighing the risks,” said Nikesh Parekh, MBBS, MPH, lead author of a recent study of a new predictive tool. The study was done in the context of the World Health Organization campaign to halve the incidence of medication-related harm (MRH) by 2022 – reducing MRH following hospital discharge was identified as a priority area.
This works allows clinicians to calculate the risk of a patient suffering MRH post-discharge requiring health care, said Dr. Parekh, a research fellow at Brighton and Sussex Medical School in Great Britain. “This enables practitioners and policy makers to target interventions to reduce MRH at those with highest risk. This should support the delivery of cost-effective care. The knowledge of individual risk can also prompt clinicians to reconsider any high-risk medicines that they intend on prescribing at discharge.”
This is the first prediction tool to calculate individual patient risk of serious MRH post-discharge, he added.The high readmission rate for older adults is often an avoidable pressure for hospitalists, particularly where MRH is the underlying cause. “The prediction tool has the potential to significantly reduce this burden for hospitalists/patients by identifying those individuals at high risk upon discharge and ensuring that monitoring and additional support is provided to them in the community with their medications,” Dr. Parekh said.
This electronic tool could be integrated into the electronic discharge summaries so that the information can be shared with primary care clinicians in a straightforward way. “The risk score should be calculated automatically by a self-population of the tool’s fields from information that exists on the patient within the electronic discharge system.”The tool now needs to be externally validated through testing in new settings to assess its validity and reliability in new populations. “If the tool is found to be usable by hospitalists and demonstrates reasonable predictive accuracy, then it should be implemented widely to reduce the incidence of MRH,” Dr. Parekh said.
Reference
1. Parekh N, et al. Medication-related harm in older adults following hospital discharge: development and validation of a prediction tool. BMJ Qual Saf. Published Online First 2019 Sept 16. doi: 10.1136/bmjqs-2019-009587.
Myocarditis rare, macrophage infiltration common at COVID autopsy
An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.
However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.
“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.
Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.
Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).
The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.
“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.
“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.
For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.
A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.
Macrophage infiltration rather than myocarditis, myocardial injury?
The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.
“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.
“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.
In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.
Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.
Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.
“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.
“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.
Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
A version of this article originally appeared on Medscape.com.
An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.
However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.
“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.
Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.
Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).
The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.
“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.
“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.
For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.
A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.
Macrophage infiltration rather than myocarditis, myocardial injury?
The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.
“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.
“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.
In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.
Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.
Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.
“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.
“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.
Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
A version of this article originally appeared on Medscape.com.
An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.
However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.
“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.
Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.
Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).
The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.
“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.
“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.
For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.
A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.
Macrophage infiltration rather than myocarditis, myocardial injury?
The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.
“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.
“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.
In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.
Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.
Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.
“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.
“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.
Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
A version of this article originally appeared on Medscape.com.
Liver injury linked to COVID-19–related coagulopathy
There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.
Cells that line the liver’s blood vessels produce high levels of factor VIII, a coagulation factor, when they are exposed to interleukin-6, an inflammatory molecule associated with COVID-19.
These findings “center the liver in global coagulopathy of COVID-19 and define a mechanism for increased coagulation factor levels that may be treatment targets,” said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.
The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said Dr. McConnell, who presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.
These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.
For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.
The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”
Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).
Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.
“As we learn more about COVID-19, we find that it is as much a coagulatory as a respiratory disease,” said Tien Dong, MD, PhD, from the University of California, Los Angeles, who was not involved in the study.
These findings are in line with a lot of other COVID-19-related research that suggests a link between hepatocyte injury and clotting disorders, he added.
One important factor is existing liver disease, said Dr. Dong. “If you have COVID-19 on top of that, you’re probably at risk of developing acute liver injury from the infection itself.”
That said, it’s still a good idea to check liver function in patients with COVID-19 and no known liver disease, he advised. Staying on top of these measures will keep the odds of long-term problems “a lot lower.”
There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.
Dr. McConnell and Dr. Dong have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.
Cells that line the liver’s blood vessels produce high levels of factor VIII, a coagulation factor, when they are exposed to interleukin-6, an inflammatory molecule associated with COVID-19.
These findings “center the liver in global coagulopathy of COVID-19 and define a mechanism for increased coagulation factor levels that may be treatment targets,” said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.
The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said Dr. McConnell, who presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.
These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.
For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.
The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”
Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).
Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.
“As we learn more about COVID-19, we find that it is as much a coagulatory as a respiratory disease,” said Tien Dong, MD, PhD, from the University of California, Los Angeles, who was not involved in the study.
These findings are in line with a lot of other COVID-19-related research that suggests a link between hepatocyte injury and clotting disorders, he added.
One important factor is existing liver disease, said Dr. Dong. “If you have COVID-19 on top of that, you’re probably at risk of developing acute liver injury from the infection itself.”
That said, it’s still a good idea to check liver function in patients with COVID-19 and no known liver disease, he advised. Staying on top of these measures will keep the odds of long-term problems “a lot lower.”
There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.
Dr. McConnell and Dr. Dong have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.
Cells that line the liver’s blood vessels produce high levels of factor VIII, a coagulation factor, when they are exposed to interleukin-6, an inflammatory molecule associated with COVID-19.
These findings “center the liver in global coagulopathy of COVID-19 and define a mechanism for increased coagulation factor levels that may be treatment targets,” said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.
The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said Dr. McConnell, who presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.
These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.
For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.
The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”
Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).
Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.
“As we learn more about COVID-19, we find that it is as much a coagulatory as a respiratory disease,” said Tien Dong, MD, PhD, from the University of California, Los Angeles, who was not involved in the study.
These findings are in line with a lot of other COVID-19-related research that suggests a link between hepatocyte injury and clotting disorders, he added.
One important factor is existing liver disease, said Dr. Dong. “If you have COVID-19 on top of that, you’re probably at risk of developing acute liver injury from the infection itself.”
That said, it’s still a good idea to check liver function in patients with COVID-19 and no known liver disease, he advised. Staying on top of these measures will keep the odds of long-term problems “a lot lower.”
There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.
Dr. McConnell and Dr. Dong have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
One-third of critical illness survivors emerge from ICU with functional deterioration
More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.
Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.
Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.
“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”
To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.
The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.
The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.
Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.
“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.
Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.
Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).
“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”
According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.
“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”
Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.
“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”
Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.
“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.
The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.
SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.
More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.
Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.
Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.
“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”
To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.
The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.
The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.
Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.
“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.
Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.
Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).
“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”
According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.
“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”
Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.
“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”
Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.
“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.
The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.
SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.
More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.
Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.
Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.
“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”
To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.
The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.
The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.
Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.
“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.
Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.
Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).
“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”
According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.
“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”
Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.
“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”
Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.
“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.
The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.
SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.
FROM CRITICAL CARE MEDICINE
COVID-19 burdens follow patients after discharge
COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.
“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)
The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.
The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.
Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.
While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.
“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”
The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).
Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.
The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.
Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.
The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.
The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”
He echoed the study authors’ call for better postdischarge support for COVID-19 patients. “There’s typically, although not at every hospital, a one-size-fits-all discharge planning process,” Dr. Gupta said. “For older patients, particularly with comorbid conditions, close follow-up after discharge is important.”
Dr. Farmer noted that one challenge in discharge support may be a matter of personnel. “The providers of this care might be fearful of patients who have had COVID-19 – Do the patients remain contagious? What if symptoms of COVID-19 return such as dry cough, fever? – and of contracting the disease themselves,” she said.
The findings regarding the emotional status of discharged patients should factor into discharge planning, she added. “Providers of posthospital care need to be educated in the emotional impact of this disease (e.g., the patients may feel ostracized or that no one wants to be around them) to assist in their recovery.”
Dr. Chopra and Dr. Farmer have no financial relationships to disclose. Dr. Gupta is an employee and shareholder of Genentech.
SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.
COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.
“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)
The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.
The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.
Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.
While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.
“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”
The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).
Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.
The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.
Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.
The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.
The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”
He echoed the study authors’ call for better postdischarge support for COVID-19 patients. “There’s typically, although not at every hospital, a one-size-fits-all discharge planning process,” Dr. Gupta said. “For older patients, particularly with comorbid conditions, close follow-up after discharge is important.”
Dr. Farmer noted that one challenge in discharge support may be a matter of personnel. “The providers of this care might be fearful of patients who have had COVID-19 – Do the patients remain contagious? What if symptoms of COVID-19 return such as dry cough, fever? – and of contracting the disease themselves,” she said.
The findings regarding the emotional status of discharged patients should factor into discharge planning, she added. “Providers of posthospital care need to be educated in the emotional impact of this disease (e.g., the patients may feel ostracized or that no one wants to be around them) to assist in their recovery.”
Dr. Chopra and Dr. Farmer have no financial relationships to disclose. Dr. Gupta is an employee and shareholder of Genentech.
SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.
COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.
“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)
The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.
The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.
Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.
While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.
“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”
The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).
Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.
The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.
Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.
The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.
The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”
He echoed the study authors’ call for better postdischarge support for COVID-19 patients. “There’s typically, although not at every hospital, a one-size-fits-all discharge planning process,” Dr. Gupta said. “For older patients, particularly with comorbid conditions, close follow-up after discharge is important.”
Dr. Farmer noted that one challenge in discharge support may be a matter of personnel. “The providers of this care might be fearful of patients who have had COVID-19 – Do the patients remain contagious? What if symptoms of COVID-19 return such as dry cough, fever? – and of contracting the disease themselves,” she said.
The findings regarding the emotional status of discharged patients should factor into discharge planning, she added. “Providers of posthospital care need to be educated in the emotional impact of this disease (e.g., the patients may feel ostracized or that no one wants to be around them) to assist in their recovery.”
Dr. Chopra and Dr. Farmer have no financial relationships to disclose. Dr. Gupta is an employee and shareholder of Genentech.
SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.
FROM ANNALS OF INTERNAL MEDICINE