Clinical

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.

The first cases of large vessel arterial occlusion strokes linked to the AstraZeneca COVID-19 vaccine have been described in the United Kingdom. The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.  

They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry

“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.

“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.

“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.  

Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.

Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.

“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.  
 

Three cases

The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.

Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.

The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.  

Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.

The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
 

High index of suspicion required

In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.

“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
 

Risk/benefit unaltered

Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.

Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”  

“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.

“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.

“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”

Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”

Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.

A version of this article first appeared on Medscape.com.

The first cases of large vessel arterial occlusion strokes linked to the AstraZeneca COVID-19 vaccine have been described in the United Kingdom. The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.  

They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry

“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.

“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.

“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.  

Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.

Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.

“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.  
 

Three cases

The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.

Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.

The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.  

Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.

The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
 

High index of suspicion required

In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.

“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
 

Risk/benefit unaltered

Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.

Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”  

“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.

“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.

“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”

Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”

Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.

A version of this article first appeared on Medscape.com.

The first cases of large vessel arterial occlusion strokes linked to the AstraZeneca COVID-19 vaccine have been described in the United Kingdom. The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.  

They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry

“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.

“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.

“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.  

Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.

Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.

“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.  
 

Three cases

The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.

Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.

The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.  

Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.

The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
 

High index of suspicion required

In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.

“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
 

Risk/benefit unaltered

Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.

Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”  

“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.

“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.

“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”

Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”

Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.

A version of this article first appeared on Medscape.com.

The COVID-19 pandemic upended the U.S. health care market and disrupted much of what was thought to be consistent and necessary hospital-based care for children. Early in the pandemic, clinics closed, elective surgeries were delayed, and well visits were postponed. Mitigation strategies were launched nationwide to limit the spread of SARS-CoV-2 including mask mandates, social distancing, shelter-in-place orders, and school closures. While these measures were enacted to target COVID-19, a potential off-target effect was reductions in transmission of other respiratory illness, and potentially nonrespiratory infectious illnesses and conditions exacerbated by acute infections.¹ These measures have heavily impacted the pediatric population, wherein respiratory infections are common, and also because daycares and school can be hubs for disease transmission.²

To evaluate the effect of the COVID-19 pandemic on pediatric health care utilization, we performed a multicenter, cross-sectional study of 44 children’s hospitals using the Pediatric Health Information System (PHIS) database.³ Children aged 2 months to 18 years discharged from a PHIS hospital with nonsurgical diagnoses from Jan. 1 to Sept. 30 over a 4-year period (2017-2020) were included in the study. The primary exposure was the 2020 COVID-19 pandemic, which was divided into three study periods: pre–COVID-19 (January–February 2020), early COVID-19 (March-April 2020), and COVID-19 (May-September 2020). The primary outcomes were the observed-to-expected ratio of respiratory and nonrespiratory illness encounters of the study period, compared with the 3 years prior to the pandemic. For these calculations, the expected encounters for each period was derived from the same calendar periods from prepandemic years (2017-2019).

A total of 9,051,980 pediatric encounters were included in the analyses: 6,811,799 with nonrespiratory illnesses and 2,240,181 with respiratory illnesses. We found a 42% reduction in overall encounters during the COVID-19 period, compared with the 3 years prior to the pandemic, with a greater reduction in respiratory, compared with nonrespiratory illnesses, which decreased 62% and 38%, respectively. These reductions were consistent across geographic and encounter type (ED vs. hospitalization). The frequency of hospital-based encounters for common pediatric respiratory illnesses was substantially reduced, with reductions in asthma exacerbations (down 76%), pneumonia (down 81%), croup (down 84%), influenza (down 87%) and bronchiolitis (down 91%). Differences in both respiratory and nonrespiratory illnesses varied by age, with larger reductions found in children aged less than 12 years. While adolescent (children aged over 12 years) encounters diminished during the early COVID period for both respiratory and nonrespiratory illnesses, their encounters returned to previous levels faster than those from younger children. For respiratory illnesses, hospital-based adolescents encounters had returned to prepandemic levels by the end of the study period (September 2020).

These findings warrant consideration as relaxation of SARS-CoV-2 mitigation are contemplated. Encounters for respiratory and nonrespiratory illnesses declined less and recovered faster in adolescents, compared with younger children. The underlying contributors to this trend are likely multifactorial. For example, respiratory illnesses such as croup and bronchiolitis are more common in younger children and adolescents may be more likely to transmit SARS-CoV-2, compared with younger age groups.^4,5 However, adolescents may have had less strict adherence to social distancing measures.⁶ Future efforts to halt transmission of SARS-CoV-2, as well as other respiratory pathogens, should inform mitigation efforts in the adolescent population with considerations of the intensity of social mixing in different pediatric age groups.

While reductions in encounters caused by respiratory illnesses were substantial, more modest but similar age-based trends were seen in nonrespiratory illnesses. Yet, reduced transmission of infectious agents may not fully explain these findings. For example, it is possible that families sought care for mild to moderate nonrespiratory illness in clinics or via telehealth rather than the EDs.⁷ Provided there were no unintended negative consequences, such transition of care to non-ED settings would suggest there was overutilization of hospital resources prior to the pandemic. Additional assessments would be helpful to examine this more closely and to clarify the long-term impact of those transitions.

It is also possible that the pandemic effects on financial, social, and family stress may have led to increases in some pediatric health care encounters, such as those for mental health conditions,⁸ nonaccidental trauma or inability to adhere to treatment because of lack of resources.^9,10 Additional study on the evolution and distribution of social and stress-related illnesses is critical to maintain and improve the health of children and adolescents.

The COVID-19 pandemic resulted in rapid and marked changes to both communicable and noncommunicable illnesses and care-seeking behaviors. Some of these findings are encouraging, such as large reductions in respiratory and nonrespiratory illnesses. However, other trends may be harbingers of negative health consequences of the pandemic, such as increases in health care utilization later in the pandemic. Further study of the evolving pandemic’s effects on disease and health care utilization is needed to benefit our children now and during the next pandemic.

Dr. Antoon is an assistant professor of pediatrics at Vanderbilt University and a pediatric hospitalist at the Monroe Carroll Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn.

References

1. Kenyon CC et al. Initial effects of the COVID-19 pandemic on pediatric asthma emergency department utilization. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2774-6.e1. doi: 10.1016/j.jaip.2020.05.045.

2. Luca G et al. The impact of regular school closure on seasonal influenza epidemics: A data-driven spatial transmission model for Belgium. BMC Infect Dis. 2018;18(1):29. doi: 10.1186/s12879-017-2934-3.

3. Antoon JW et al. The COVID-19 Pandemic and changes in healthcare utilization for pediatric respiratory and nonrespiratory illnesses in the United States. J Hosp Med. 2021 Mar 8. doi: 10.12788/jhm.3608.

4. Park YJ et al. Contact tracing during coronavirus disease outbreak, South Korea, 2020. Emerg Infect Dis. 2020 Oct;26(10):2465-8. doi: 10.3201/eid2610.201315.

5. Davies NG et al. Age-dependent effects in the transmission and control of COVID-19 epidemics. Nat Med. 2020 Aug;26(8):1205-11. doi: 10.1038/s41591-020-0962-9.

6. Andrews JL et al. Peer influence in adolescence: Public health implications for COVID-19. Trends Cogn Sci. 2020;24(8):585-7. doi: 10.1016/j.tics.2020.05.001.

7. Taquechel K et al. Pediatric asthma healthcare utilization, viral testing, and air pollution changes during the COVID-19 pandemic. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3378-87.e11. doi: 10.1016/j.jaip.2020.07.057.

8. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and during COVID-19. Pediatrics. 2021;147(3):e2020029280. doi: 10.1542/peds.2020-029280.

9. Sharma S et al. COVID-19: Differences in sentinel injury and child abuse reporting during a pandemic. Child Abuse Negl. 2020 Dec;110:104709. doi: 10.1016/j.chiabu.2020.104709.

10. Lauren BN et al. Predictors of households at risk for food insecurity in the United States during the COVID-19 pandemic. Public Health Nutr. 2021 Jan 27. doi: 10.1017/S1368980021000355.

The COVID-19 pandemic upended the U.S. health care market and disrupted much of what was thought to be consistent and necessary hospital-based care for children. Early in the pandemic, clinics closed, elective surgeries were delayed, and well visits were postponed. Mitigation strategies were launched nationwide to limit the spread of SARS-CoV-2 including mask mandates, social distancing, shelter-in-place orders, and school closures. While these measures were enacted to target COVID-19, a potential off-target effect was reductions in transmission of other respiratory illness, and potentially nonrespiratory infectious illnesses and conditions exacerbated by acute infections.¹ These measures have heavily impacted the pediatric population, wherein respiratory infections are common, and also because daycares and school can be hubs for disease transmission.²

To evaluate the effect of the COVID-19 pandemic on pediatric health care utilization, we performed a multicenter, cross-sectional study of 44 children’s hospitals using the Pediatric Health Information System (PHIS) database.³ Children aged 2 months to 18 years discharged from a PHIS hospital with nonsurgical diagnoses from Jan. 1 to Sept. 30 over a 4-year period (2017-2020) were included in the study. The primary exposure was the 2020 COVID-19 pandemic, which was divided into three study periods: pre–COVID-19 (January–February 2020), early COVID-19 (March-April 2020), and COVID-19 (May-September 2020). The primary outcomes were the observed-to-expected ratio of respiratory and nonrespiratory illness encounters of the study period, compared with the 3 years prior to the pandemic. For these calculations, the expected encounters for each period was derived from the same calendar periods from prepandemic years (2017-2019).

A total of 9,051,980 pediatric encounters were included in the analyses: 6,811,799 with nonrespiratory illnesses and 2,240,181 with respiratory illnesses. We found a 42% reduction in overall encounters during the COVID-19 period, compared with the 3 years prior to the pandemic, with a greater reduction in respiratory, compared with nonrespiratory illnesses, which decreased 62% and 38%, respectively. These reductions were consistent across geographic and encounter type (ED vs. hospitalization). The frequency of hospital-based encounters for common pediatric respiratory illnesses was substantially reduced, with reductions in asthma exacerbations (down 76%), pneumonia (down 81%), croup (down 84%), influenza (down 87%) and bronchiolitis (down 91%). Differences in both respiratory and nonrespiratory illnesses varied by age, with larger reductions found in children aged less than 12 years. While adolescent (children aged over 12 years) encounters diminished during the early COVID period for both respiratory and nonrespiratory illnesses, their encounters returned to previous levels faster than those from younger children. For respiratory illnesses, hospital-based adolescents encounters had returned to prepandemic levels by the end of the study period (September 2020).

These findings warrant consideration as relaxation of SARS-CoV-2 mitigation are contemplated. Encounters for respiratory and nonrespiratory illnesses declined less and recovered faster in adolescents, compared with younger children. The underlying contributors to this trend are likely multifactorial. For example, respiratory illnesses such as croup and bronchiolitis are more common in younger children and adolescents may be more likely to transmit SARS-CoV-2, compared with younger age groups.^4,5 However, adolescents may have had less strict adherence to social distancing measures.⁶ Future efforts to halt transmission of SARS-CoV-2, as well as other respiratory pathogens, should inform mitigation efforts in the adolescent population with considerations of the intensity of social mixing in different pediatric age groups.

While reductions in encounters caused by respiratory illnesses were substantial, more modest but similar age-based trends were seen in nonrespiratory illnesses. Yet, reduced transmission of infectious agents may not fully explain these findings. For example, it is possible that families sought care for mild to moderate nonrespiratory illness in clinics or via telehealth rather than the EDs.⁷ Provided there were no unintended negative consequences, such transition of care to non-ED settings would suggest there was overutilization of hospital resources prior to the pandemic. Additional assessments would be helpful to examine this more closely and to clarify the long-term impact of those transitions.

It is also possible that the pandemic effects on financial, social, and family stress may have led to increases in some pediatric health care encounters, such as those for mental health conditions,⁸ nonaccidental trauma or inability to adhere to treatment because of lack of resources.^9,10 Additional study on the evolution and distribution of social and stress-related illnesses is critical to maintain and improve the health of children and adolescents.

The COVID-19 pandemic resulted in rapid and marked changes to both communicable and noncommunicable illnesses and care-seeking behaviors. Some of these findings are encouraging, such as large reductions in respiratory and nonrespiratory illnesses. However, other trends may be harbingers of negative health consequences of the pandemic, such as increases in health care utilization later in the pandemic. Further study of the evolving pandemic’s effects on disease and health care utilization is needed to benefit our children now and during the next pandemic.

Dr. Antoon is an assistant professor of pediatrics at Vanderbilt University and a pediatric hospitalist at the Monroe Carroll Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn.

References

1. Kenyon CC et al. Initial effects of the COVID-19 pandemic on pediatric asthma emergency department utilization. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2774-6.e1. doi: 10.1016/j.jaip.2020.05.045.

2. Luca G et al. The impact of regular school closure on seasonal influenza epidemics: A data-driven spatial transmission model for Belgium. BMC Infect Dis. 2018;18(1):29. doi: 10.1186/s12879-017-2934-3.

3. Antoon JW et al. The COVID-19 Pandemic and changes in healthcare utilization for pediatric respiratory and nonrespiratory illnesses in the United States. J Hosp Med. 2021 Mar 8. doi: 10.12788/jhm.3608.

4. Park YJ et al. Contact tracing during coronavirus disease outbreak, South Korea, 2020. Emerg Infect Dis. 2020 Oct;26(10):2465-8. doi: 10.3201/eid2610.201315.

5. Davies NG et al. Age-dependent effects in the transmission and control of COVID-19 epidemics. Nat Med. 2020 Aug;26(8):1205-11. doi: 10.1038/s41591-020-0962-9.

6. Andrews JL et al. Peer influence in adolescence: Public health implications for COVID-19. Trends Cogn Sci. 2020;24(8):585-7. doi: 10.1016/j.tics.2020.05.001.

7. Taquechel K et al. Pediatric asthma healthcare utilization, viral testing, and air pollution changes during the COVID-19 pandemic. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3378-87.e11. doi: 10.1016/j.jaip.2020.07.057.

8. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and during COVID-19. Pediatrics. 2021;147(3):e2020029280. doi: 10.1542/peds.2020-029280.

9. Sharma S et al. COVID-19: Differences in sentinel injury and child abuse reporting during a pandemic. Child Abuse Negl. 2020 Dec;110:104709. doi: 10.1016/j.chiabu.2020.104709.

10. Lauren BN et al. Predictors of households at risk for food insecurity in the United States during the COVID-19 pandemic. Public Health Nutr. 2021 Jan 27. doi: 10.1017/S1368980021000355.

The COVID-19 pandemic upended the U.S. health care market and disrupted much of what was thought to be consistent and necessary hospital-based care for children. Early in the pandemic, clinics closed, elective surgeries were delayed, and well visits were postponed. Mitigation strategies were launched nationwide to limit the spread of SARS-CoV-2 including mask mandates, social distancing, shelter-in-place orders, and school closures. While these measures were enacted to target COVID-19, a potential off-target effect was reductions in transmission of other respiratory illness, and potentially nonrespiratory infectious illnesses and conditions exacerbated by acute infections.¹ These measures have heavily impacted the pediatric population, wherein respiratory infections are common, and also because daycares and school can be hubs for disease transmission.²

To evaluate the effect of the COVID-19 pandemic on pediatric health care utilization, we performed a multicenter, cross-sectional study of 44 children’s hospitals using the Pediatric Health Information System (PHIS) database.³ Children aged 2 months to 18 years discharged from a PHIS hospital with nonsurgical diagnoses from Jan. 1 to Sept. 30 over a 4-year period (2017-2020) were included in the study. The primary exposure was the 2020 COVID-19 pandemic, which was divided into three study periods: pre–COVID-19 (January–February 2020), early COVID-19 (March-April 2020), and COVID-19 (May-September 2020). The primary outcomes were the observed-to-expected ratio of respiratory and nonrespiratory illness encounters of the study period, compared with the 3 years prior to the pandemic. For these calculations, the expected encounters for each period was derived from the same calendar periods from prepandemic years (2017-2019).

A total of 9,051,980 pediatric encounters were included in the analyses: 6,811,799 with nonrespiratory illnesses and 2,240,181 with respiratory illnesses. We found a 42% reduction in overall encounters during the COVID-19 period, compared with the 3 years prior to the pandemic, with a greater reduction in respiratory, compared with nonrespiratory illnesses, which decreased 62% and 38%, respectively. These reductions were consistent across geographic and encounter type (ED vs. hospitalization). The frequency of hospital-based encounters for common pediatric respiratory illnesses was substantially reduced, with reductions in asthma exacerbations (down 76%), pneumonia (down 81%), croup (down 84%), influenza (down 87%) and bronchiolitis (down 91%). Differences in both respiratory and nonrespiratory illnesses varied by age, with larger reductions found in children aged less than 12 years. While adolescent (children aged over 12 years) encounters diminished during the early COVID period for both respiratory and nonrespiratory illnesses, their encounters returned to previous levels faster than those from younger children. For respiratory illnesses, hospital-based adolescents encounters had returned to prepandemic levels by the end of the study period (September 2020).

These findings warrant consideration as relaxation of SARS-CoV-2 mitigation are contemplated. Encounters for respiratory and nonrespiratory illnesses declined less and recovered faster in adolescents, compared with younger children. The underlying contributors to this trend are likely multifactorial. For example, respiratory illnesses such as croup and bronchiolitis are more common in younger children and adolescents may be more likely to transmit SARS-CoV-2, compared with younger age groups.^4,5 However, adolescents may have had less strict adherence to social distancing measures.⁶ Future efforts to halt transmission of SARS-CoV-2, as well as other respiratory pathogens, should inform mitigation efforts in the adolescent population with considerations of the intensity of social mixing in different pediatric age groups.

While reductions in encounters caused by respiratory illnesses were substantial, more modest but similar age-based trends were seen in nonrespiratory illnesses. Yet, reduced transmission of infectious agents may not fully explain these findings. For example, it is possible that families sought care for mild to moderate nonrespiratory illness in clinics or via telehealth rather than the EDs.⁷ Provided there were no unintended negative consequences, such transition of care to non-ED settings would suggest there was overutilization of hospital resources prior to the pandemic. Additional assessments would be helpful to examine this more closely and to clarify the long-term impact of those transitions.

It is also possible that the pandemic effects on financial, social, and family stress may have led to increases in some pediatric health care encounters, such as those for mental health conditions,⁸ nonaccidental trauma or inability to adhere to treatment because of lack of resources.^9,10 Additional study on the evolution and distribution of social and stress-related illnesses is critical to maintain and improve the health of children and adolescents.

The COVID-19 pandemic resulted in rapid and marked changes to both communicable and noncommunicable illnesses and care-seeking behaviors. Some of these findings are encouraging, such as large reductions in respiratory and nonrespiratory illnesses. However, other trends may be harbingers of negative health consequences of the pandemic, such as increases in health care utilization later in the pandemic. Further study of the evolving pandemic’s effects on disease and health care utilization is needed to benefit our children now and during the next pandemic.

Dr. Antoon is an assistant professor of pediatrics at Vanderbilt University and a pediatric hospitalist at the Monroe Carroll Jr. Children’s Hospital at Vanderbilt, both in Nashville, Tenn.

References

1. Kenyon CC et al. Initial effects of the COVID-19 pandemic on pediatric asthma emergency department utilization. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2774-6.e1. doi: 10.1016/j.jaip.2020.05.045.

2. Luca G et al. The impact of regular school closure on seasonal influenza epidemics: A data-driven spatial transmission model for Belgium. BMC Infect Dis. 2018;18(1):29. doi: 10.1186/s12879-017-2934-3.

3. Antoon JW et al. The COVID-19 Pandemic and changes in healthcare utilization for pediatric respiratory and nonrespiratory illnesses in the United States. J Hosp Med. 2021 Mar 8. doi: 10.12788/jhm.3608.

4. Park YJ et al. Contact tracing during coronavirus disease outbreak, South Korea, 2020. Emerg Infect Dis. 2020 Oct;26(10):2465-8. doi: 10.3201/eid2610.201315.

5. Davies NG et al. Age-dependent effects in the transmission and control of COVID-19 epidemics. Nat Med. 2020 Aug;26(8):1205-11. doi: 10.1038/s41591-020-0962-9.

6. Andrews JL et al. Peer influence in adolescence: Public health implications for COVID-19. Trends Cogn Sci. 2020;24(8):585-7. doi: 10.1016/j.tics.2020.05.001.

7. Taquechel K et al. Pediatric asthma healthcare utilization, viral testing, and air pollution changes during the COVID-19 pandemic. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3378-87.e11. doi: 10.1016/j.jaip.2020.07.057.

8. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and during COVID-19. Pediatrics. 2021;147(3):e2020029280. doi: 10.1542/peds.2020-029280.

9. Sharma S et al. COVID-19: Differences in sentinel injury and child abuse reporting during a pandemic. Child Abuse Negl. 2020 Dec;110:104709. doi: 10.1016/j.chiabu.2020.104709.

10. Lauren BN et al. Predictors of households at risk for food insecurity in the United States during the COVID-19 pandemic. Public Health Nutr. 2021 Jan 27. doi: 10.1017/S1368980021000355.

The United States spends one-third of the nation’s health dollars on hospital care, amounting to $1.2 trillion in 2018.¹ U.S. hospital beds are prevalent², and expensive to build and operate, with most hospital services costs related to buildings, equipment, salaried labor, and overhead.³

Despite their mission to heal, hospitals can be harmful, especially for frail and elderly patients. A study completed by the Office of the Inspector General (OIG) found that 13.5% of hospitalized Medicare patients experienced an adverse event that resulted in a prolonged hospital stay, permanent harm, a life-sustaining intervention or death.⁴ In addition, there is growing concern about acquired post-hospitalization syndrome caused by the physiological stress that patients experience in the hospital, leaving them vulnerable to clinical adverse events such as falls and infections.⁵

In the mid-1990s, driven by a goal to “avoid the harm of inpatient care and honor the wishes of older adults who refused to go to the hospital”, Dr. Bruce Leff, director of the Center for Transformative Geriatric Research and professor of medicine at Johns Hopkins University in Baltimore, and his team set out to develop and test Hospital at Home (HaH) – an innovative model for delivering hospital-level care to selected patients in the safety of their homes.

More than 20 years later, despite extensive evidence supporting HaH safety and efficacy, and its successful rollout in other countries, the model has not been widely adopted in the U.S. However, the COVID-19 pandemic amplified interest in HaH by creating an urgent need for flexible hospital bed capacity and heightening concerns about hospital care safety, especially for vulnerable adults.

In this article, we will introduce HaH history and efficacy, and then discuss what it takes to successfully implement HaH.
 

Hospital at Home: History, efficacy, and early adoption

The earliest HaH study, a 17-patient pilot conducted by Dr. Leff’s team from 1996 to 1998, proved that HaH was feasible, safe, highly satisfactory and cost-effective for selected acutely ill older patients with community-acquired pneumonia, chronic heart failure, chronic obstructive pulmonary disease or cellulitis.⁶ In 2000 to 2002, a National Demonstration and Evaluation Study of 455 patients across three sites determined that patients treated in Hospital at Home had statistically significant shorter length of stay (3.2 vs 4.9 days), lower cost ($5,081 vs. $7,480) and complications.⁷ Equipped with evidence, Dr. Leff and his team focused on HaH dissemination and implementation across several health care systems.⁸

Presbyterian Healthcare Services in Albuquerque, N.M., was one of the earliest adopters of HaH and launched the program in 2008. The integrated system serves one-third of New Mexicans and includes nine hospitals, more than 100 clinics and the state’s largest health plan. According to Nancy Guinn, MD, a medical director of Presbyterian Healthcare at Home, “Innovation is key to survive in a lean environment like New Mexico, which has the lowest percentage of residents with insurance from their employer and a high rate of government payers.”

Presbyterian selected nine diagnoses for HaH focus: congestive heart failure, chronic obstructive pulmonary disease, community-acquired pneumonia, cellulitis, deep venous thrombosis, pulmonary embolism, complicated urinary tract infection or urosepsis, nausea and vomiting, and dehydration. The HaH care, including physician services, is reimbursed via a partial DRG (diagnosis-related group) payment that was negotiated internally between the health system and Presbyterian Health Plan.

The results demonstrated that, compared to hospitalized patients with similar conditions, patients in HaH had a lower rate of falls (0% vs. .8%), lower mortality (.93% vs. 3.4%), higher satisfaction (mean score 90.7 vs. 83.9) and 19% lower cost.⁹ According to Dr. Guinn, more recent results showed even larger cost savings of 42%.¹⁰ After starting the HaH model, Presbyterian has launched other programs that work closely with HaH to provide a seamless experience for patients. That includes the Complete Care Program, which offers home-based primary, urgent, and acute care to members covered through Presbyterian Health Plan and has a daily census of 600-700 patients.

Another important milestone came in 2014 when Icahn School of Medicine at Mount Sinai in New York was awarded $9.6 million by the Center for Medicare and Medicaid Innovation (CMMI) to test the HaH model during acute illness and for 30 days after admission. A case study of 507 patients enrolled in the program in 2014 through 2017 revealed that HaH patients had statistically significant shorter length of stay (3.2 days vs. 5.5 days), and lower rates of all-cause 30-day hospital readmissions (8.6% vs. 15.6%), 30-day ED revisits (5.8% vs. 11.7%), and SNF admissions (1.7% vs. 10.4%), and were also more likely to rate their hospital care highly (68.8% vs. 45.3%).¹¹

In 2017, using data from their CMMI study, Mount Sinai submitted an application to the Physician-Focused Payment Model Technical Advisory Committee (PTAC) to implement Hospital at Home as an alternative payment model that bundles the acute episode with 30 days of post‐acute transitional care. The PTAC unanimously approved the proposal and submitted their recommendations to the Secretary of Health and Human Services (HHS) to implement HaH as an alternative payment model that included two parts:

1. A bundled payment equal to a percentage of the prospective DRG (diagnosis-related group) payment that would have been paid to a hospital.

2. A performance-based payment (shared savings/losses) based on (a) total spending during the acute care phase and 30 days afterward relative to a target price, and (b) performance on quality measures.¹²

In June 2018, the HHS secretary announced that he was not approving the proposal as written, citing, among other things, concerns about proposed payment methodology and patient safety.¹³
 

Hospital at Home: Present state

Despite additional evidence of HaH’s impact on lowering cost, decreasing 30-day readmissions, improving patient satisfaction and functional outcomes without an adverse effect on mortality,^{14, 15} the model has not been widely adopted, largely due to lack of fee-for-service reimbursement from the public payers (Medicare and Medicaid) and complex logistics to implement it.

However, the COVID-19 pandemic created an urgent need for flexible hospital bed capacity and amplified concerns about hospital care safety for vulnerable populations. In response, the Centers for Medicare and Medicaid Services (CMS) introduced its Hospitals without Walls initiative that allowed hospitals to provide services in other health care facilities and sites that are not part of the existing hospital.¹⁶ On November 25, 2020, CMS announced expansion of the Hospital without Walls initiatives to include a Hospital Care at Home program that allows eligible hospitals to treat eligible patients at home.¹⁷

With significant evidence supporting HaH’s safety and efficacy, and long overdue support from CMS, it’s now a matter of how to successfully implement it. Let’s explore what it takes to select and enroll patients, deliver acute care at home, and ensure a smooth post-acute transition within the HaH model.

Successfully implementing Hospital at Home

HaH implementation requires five key components – people, processes, technology, supply chain, and analytics – to select and enroll patients, deliver acute care at home, and ensure a smooth postacute transition. Let’s discuss each of them in more detail below.

Selecting and enrolling patients

Patients eligible for HaH are identified based on their insurance, as well as clinical and social criteria. Despite a lack of public payer support, several commercial payers embraced the model for selected patients who consented to receive acute hospital care at home. The patients must meet criteria for an inpatient admission, be medically stable and have a low level of diagnostic uncertainty. Advances in home monitoring technology expanded clinical criteria to include acutely ill patients with multiple comorbidities, including cancer. It is important that patients reside in a safe home environment and live within a reasonable distance from the hospital.

CareMore Health, an integrated health care delivery system serving more than 180,000 Medicare Advantage and Medicaid patients across nine states and Washington D.C., launched Hospital at Home in December 2018, and rapidly scaled from a few referrals to averaging more than 20 new patients per week.

Sashidaran Moodley, MD, medical director at CareMore Health and Aspire Health, in Cerritos, Calif., shared a valuable lesson regarding launching the program: “Do not presume that if you build it, they will come. This is a new model of care that requires physicians to change their behavior and health systems to modify their traditional admission work flows. Program designers should not limit their thinking around sourcing patients just from the emergency department.”

Dr. Moodley recommends moving upstream and bring awareness to the program to drive additional referrals from primary care providers, case managers, and remote patient monitoring programs (for example, heart failure).

Linda DeCherrie, MD, clinical director of Mount Sinai at Home, based in New York, says that “educating and involving hospitalists is key.” At Mount Sinai, patients eligible for HaH are initially evaluated by hospitalists in the ED who write initial orders and then transfer care to HaH hospitalists.

HaH also can enroll eligible patients who still require hospital-level care to complete the last few days of acute hospitalization at home. Early discharge programs have been implemented at CareMore, Presbyterian Healthcare Services in Albuquerque, N.M., and Mount Sinai. At Mount Sinai, a program called Completing Hospitalization at Home initially started with non-COVID patients and expanded to include COVID-19 early discharges, helping to free up much-needed hospital beds.
 

Delivering acute care at home

HaH requires a well-coordinated multidisciplinary team. Patient care is directed by a team of physicians and nurse practitioners who provide daily in-person or virtual visits. To enable provider work flow, an ambulatory version of electronic medical records (for example, Epic) must be customized to include specialized order sets that mimic inpatient orders and diagnoses-specific care delivery protocols. HaH physicians and nurse practitioners are available 24/7 to address acute patient issues.

In addition, patients receive at least daily visits from registered nurses (RNs) who carry out orders, administer medications, draw labs, and provide clinical assessment and patient education. Some organizations employ HaH nurses, while others contract with home health agencies.

Typically, patients are provided with a tablet to enable telehealth visits, as well as a blood pressure monitor, thermometer, pulse oximeter, and, if needed, scale and glucometer, that allow on-demand or continuous remote monitoring. Recent technology advances in home monitoring enhanced HaH’s capability to care for complex, high-acuity patients, and increased the potential volume of patients that can be safely treated at home.

Providence St. Joseph Health, a not-for-profit health care system operating 51 hospitals and 1,085 clinics across seven states, launched their HaH program earlier this year. Per Danielsson, MD, executive medical director for hospital medicine at Swedish Medical Center in Seattle, describes it as a “high-touch, high-tech program anchored by hospitalists.” The Providence HaH team utilizes a wearable medical device for patients that enables at-home continuous monitoring of vital signs such as temperature, blood pressure, heart rate, respirations, and pulse oximetry. Single-lead EKG monitoring is available for selected patients. Individual patient data is transmitted to a central command center, where a team of nurses and physicians remotely monitor HaH patients. According to Todd Czartoski, MD, chief medical technology officer at Providence, “Hospital at Home improves quality and access, and can substitute for 20%-30% of hospital admissions.”

In addition to patient monitoring and 24/7 provider access, some HaH programs partner with community paramedics for emergency responses. At Mount Sinai, HaH providers can trigger paramedic response, if needed. Paramedics can set up a video link with a doctor and, under the direction of a physician, will provide treatment at home or transport patients to the hospital.

HaH would be impossible without a partnership with local ancillary service providers that can promptly deliver services and goods to patient homes. Raphael Rakowski, CEO of Medically Home, a Boston-based company that partners with health care providers to build virtual hospitals at home, calls it an “acute rapid response supply chain.” The services, both clinical and nonclinical, consist of infusions; x-rays; bedside ultrasound; laboratory; transportation; and skilled physical, occupational, and speech therapy. If patients require services that are not available at home (for example, a CT scan), patients can be transported to and from a diagnostic center. Medical and nonmedical goods include medications, oxygen, durable medical equipment, and even meals.

Delivery of hospital-level services at home requires a seamless coordination between clinical teams and suppliers that relies on nursing care coordinators and supporting nonclinical staff, and is enabled by a secure text messaging platform to communicate within the care team, with suppliers, and with other providers (for example, primary care providers and specialists).
 

Ensuring smooth postacute transition

Thirty days after hospital discharge is the most critical period, especially for elderly patients. According to one study, 19% of patients experienced adverse events within 3 weeks after hospital discharge.18 Adverse drug events were the most common postdischarge complication, followed by procedural complications and hospital-acquired infections. Furthermore, 30-day all-cause hospital readmissions is a common occurrence. Per the Healthcare Cost and Utilization Project database, 17.1% of Medicare and 13.9% of all-payers patients were readmitted to the hospital within 30 days in 2016.¹⁹

It is not surprising that some organizations offer ongoing home care during the postacute period. At Mount Sinai, patients discharged from HaH continue to have access to the HaH team around the clock for 30 days to address emergencies and health concerns. Recovery Care Coordinators and social workers monitor patient health status, develop a follow-up plan, coordinate care, and answer questions. Medically Home provides 24/7 care to HaH patients for the entire duration of the acute care episode (34 days) to ensure maximum access to care and no gaps in care and communication. At Presbyterian, most HaH patients are transitioned into a Home Health episode of care to ensure continued high-quality care.

In addition to people, processes, technology, and the supply chain, HaH implementation requires capabilities to collect and analyze quality and cost data to measure program efficacy and, in some arrangements with payers, to reconcile clams data to determine shared savings or losses.
 

Partnering with third parties

Considering the resources and capabilities required for HaH program development and implementation, it is not surprising that health care providers are choosing to partner with third parties. For example, Mount Sinai partnered with Contessa Health, a Nashville, Tenn.–based company that offers hospitals a turn-key Home Recovery Care program, to assist with supply chain contracting and management, and claims data reconciliation.

Medically Home has partnered with seven health care systems, including the Mayo Clinic, Tufts Medical Center in Boston, and Adventist Health in southern California, to create virtual beds, and is expected to launch the program with 15 health care systems by the end of 2020.

Medically Home offers the following services to its partners to enable care for high-acuity patients at home:

• Assistance with hiring and training of clinical staff.
• Proprietary EMR-integrated orders, notes, and clinical protocols.
• Technology for patient monitoring by the 24/7 central command center; tablets that provide health status updates and daily schedules, and enable televisits; a video platform for video communication; and secure texting.
• Selection, contracting and monitoring the performance of supply chain vendors.
• Analytics.

The future of Hospital at Home

There is no question that HaH can offer a safe, high-quality, and lower-cost alternative to hospitalizations for select patients, which is aligned with the Centers for Medicare and Medicaid Services’ triple aim of better care for individuals, better health for populations, and lower cost.²⁰

The future of HaH depends on development of a common payment model that will be adopted beyond the pandemic by government and commercial payers. Current payment models vary and include capitated agreements, discounted diagnosis-related group payments for the acute episode, and discounted DRG payments plus shared losses or savings.

The COVID-19 pandemic has created, arguably, the biggest crisis that U.S. health care has ever experienced, and it is far from over. Short term, Hospital at Home offers a solution to create flexible hospital bed capacity and deliver safe hospital-level care for vulnerable populations. Long term, it may be the solution that helps achieve better care for individuals, better health for populations and lower health care costs.

Dr. Farah is a hospitalist, physician advisor, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of the Hospitalist’s editorial advisory board.

References

1. Source: www.cms.gov/files/document/nations-health-dollar-where-it-came-where-it-went.pdf

2. Source: www.aha.org/statistics/fast-facts-us-hospitals

3. Roberts RR, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999 Feb;281(7):644-9.

4. Levinson DR; US Department of Health and Human Services; HHS; Office of the Inspector General; OIG.

5. Krumholz HM. Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk. N Engl J Med. 2013 Jan;368:100-102.

6. Leff B, et al. Home hospital program: a pilot study. J Am Geriatr Soc. 1999 Jun;47(6):697-702.

7. Leff B, et al. Hospital at home: Feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec;143(11):798-808.

8. Source: www.johnshopkinssolutions.com/solution/hospital-at-home/

9. Cryer L, et al. Costs for ‘Hospital at Home’ Patients Were 19 Percent Lower, with Equal or Better Outcomes Compared to Similar Inpatients. Health Affairs. 2012 Jun;31(6):1237–43.

10. Personal communication with Presbyterian Health Services. May 20, 2020.

11. Federman A, et al. Association of a bundled hospital-at-home and 30-day postacute transitional care program with clinical outcomes and patient experiences. JAMA Intern Med. 2018 Aug;178(8):1033–40.

12. Source: aspe.hhs.gov/system/files/pdf/255906/MtSinaiHAHReportSecretary.pdf

13. Source: aspe.hhs.gov/system/files/pdf/255906/Secretarial_Responses_June_13_2018.508.pdf

14. Shepperd S, et al. Admission avoidance hospital at home. Cochrane Database Syst Rev. 2016;9(9):CD007491. DOI:10.1002/14651858.CD007491.pub2.

15. Levine DM, et al. Hospital-level care at home for acutely ill adults: a randomized controlled trial. Ann Intern Med. 2020 Jan;172(2);77-85.

16. Source: www.cms.gov/files/document/covid-hospitals.pdf

17. Centers for Medicare & Medicaid Services. CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge. 2020 Nov 20.

18. Forster AJ et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Mar;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.

19. Bailey MK et al. Characteristics of 30-Day All-Cause Hospital Readmissions, 2010-2016. Statistical Brief 248. Agency for Healthcare Research and Quality. 2019 Feb 12. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb248-Hospital-Readmissions-2010-2016.jsp.

20. Centers for Medicare & Medicaid Services. What are the value-based programs? 2020 Jan 6. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/Value-Based-Programs.

The United States spends one-third of the nation’s health dollars on hospital care, amounting to $1.2 trillion in 2018.¹ U.S. hospital beds are prevalent², and expensive to build and operate, with most hospital services costs related to buildings, equipment, salaried labor, and overhead.³

Despite their mission to heal, hospitals can be harmful, especially for frail and elderly patients. A study completed by the Office of the Inspector General (OIG) found that 13.5% of hospitalized Medicare patients experienced an adverse event that resulted in a prolonged hospital stay, permanent harm, a life-sustaining intervention or death.⁴ In addition, there is growing concern about acquired post-hospitalization syndrome caused by the physiological stress that patients experience in the hospital, leaving them vulnerable to clinical adverse events such as falls and infections.⁵

In the mid-1990s, driven by a goal to “avoid the harm of inpatient care and honor the wishes of older adults who refused to go to the hospital”, Dr. Bruce Leff, director of the Center for Transformative Geriatric Research and professor of medicine at Johns Hopkins University in Baltimore, and his team set out to develop and test Hospital at Home (HaH) – an innovative model for delivering hospital-level care to selected patients in the safety of their homes.

More than 20 years later, despite extensive evidence supporting HaH safety and efficacy, and its successful rollout in other countries, the model has not been widely adopted in the U.S. However, the COVID-19 pandemic amplified interest in HaH by creating an urgent need for flexible hospital bed capacity and heightening concerns about hospital care safety, especially for vulnerable adults.

In this article, we will introduce HaH history and efficacy, and then discuss what it takes to successfully implement HaH.
 

Hospital at Home: History, efficacy, and early adoption

The earliest HaH study, a 17-patient pilot conducted by Dr. Leff’s team from 1996 to 1998, proved that HaH was feasible, safe, highly satisfactory and cost-effective for selected acutely ill older patients with community-acquired pneumonia, chronic heart failure, chronic obstructive pulmonary disease or cellulitis.⁶ In 2000 to 2002, a National Demonstration and Evaluation Study of 455 patients across three sites determined that patients treated in Hospital at Home had statistically significant shorter length of stay (3.2 vs 4.9 days), lower cost ($5,081 vs. $7,480) and complications.⁷ Equipped with evidence, Dr. Leff and his team focused on HaH dissemination and implementation across several health care systems.⁸

Presbyterian Healthcare Services in Albuquerque, N.M., was one of the earliest adopters of HaH and launched the program in 2008. The integrated system serves one-third of New Mexicans and includes nine hospitals, more than 100 clinics and the state’s largest health plan. According to Nancy Guinn, MD, a medical director of Presbyterian Healthcare at Home, “Innovation is key to survive in a lean environment like New Mexico, which has the lowest percentage of residents with insurance from their employer and a high rate of government payers.”

Presbyterian selected nine diagnoses for HaH focus: congestive heart failure, chronic obstructive pulmonary disease, community-acquired pneumonia, cellulitis, deep venous thrombosis, pulmonary embolism, complicated urinary tract infection or urosepsis, nausea and vomiting, and dehydration. The HaH care, including physician services, is reimbursed via a partial DRG (diagnosis-related group) payment that was negotiated internally between the health system and Presbyterian Health Plan.

The results demonstrated that, compared to hospitalized patients with similar conditions, patients in HaH had a lower rate of falls (0% vs. .8%), lower mortality (.93% vs. 3.4%), higher satisfaction (mean score 90.7 vs. 83.9) and 19% lower cost.⁹ According to Dr. Guinn, more recent results showed even larger cost savings of 42%.¹⁰ After starting the HaH model, Presbyterian has launched other programs that work closely with HaH to provide a seamless experience for patients. That includes the Complete Care Program, which offers home-based primary, urgent, and acute care to members covered through Presbyterian Health Plan and has a daily census of 600-700 patients.

Another important milestone came in 2014 when Icahn School of Medicine at Mount Sinai in New York was awarded $9.6 million by the Center for Medicare and Medicaid Innovation (CMMI) to test the HaH model during acute illness and for 30 days after admission. A case study of 507 patients enrolled in the program in 2014 through 2017 revealed that HaH patients had statistically significant shorter length of stay (3.2 days vs. 5.5 days), and lower rates of all-cause 30-day hospital readmissions (8.6% vs. 15.6%), 30-day ED revisits (5.8% vs. 11.7%), and SNF admissions (1.7% vs. 10.4%), and were also more likely to rate their hospital care highly (68.8% vs. 45.3%).¹¹

In 2017, using data from their CMMI study, Mount Sinai submitted an application to the Physician-Focused Payment Model Technical Advisory Committee (PTAC) to implement Hospital at Home as an alternative payment model that bundles the acute episode with 30 days of post‐acute transitional care. The PTAC unanimously approved the proposal and submitted their recommendations to the Secretary of Health and Human Services (HHS) to implement HaH as an alternative payment model that included two parts:

1. A bundled payment equal to a percentage of the prospective DRG (diagnosis-related group) payment that would have been paid to a hospital.

2. A performance-based payment (shared savings/losses) based on (a) total spending during the acute care phase and 30 days afterward relative to a target price, and (b) performance on quality measures.¹²

In June 2018, the HHS secretary announced that he was not approving the proposal as written, citing, among other things, concerns about proposed payment methodology and patient safety.¹³
 

Hospital at Home: Present state

Despite additional evidence of HaH’s impact on lowering cost, decreasing 30-day readmissions, improving patient satisfaction and functional outcomes without an adverse effect on mortality,^{14, 15} the model has not been widely adopted, largely due to lack of fee-for-service reimbursement from the public payers (Medicare and Medicaid) and complex logistics to implement it.

However, the COVID-19 pandemic created an urgent need for flexible hospital bed capacity and amplified concerns about hospital care safety for vulnerable populations. In response, the Centers for Medicare and Medicaid Services (CMS) introduced its Hospitals without Walls initiative that allowed hospitals to provide services in other health care facilities and sites that are not part of the existing hospital.¹⁶ On November 25, 2020, CMS announced expansion of the Hospital without Walls initiatives to include a Hospital Care at Home program that allows eligible hospitals to treat eligible patients at home.¹⁷

With significant evidence supporting HaH’s safety and efficacy, and long overdue support from CMS, it’s now a matter of how to successfully implement it. Let’s explore what it takes to select and enroll patients, deliver acute care at home, and ensure a smooth post-acute transition within the HaH model.

Successfully implementing Hospital at Home

HaH implementation requires five key components – people, processes, technology, supply chain, and analytics – to select and enroll patients, deliver acute care at home, and ensure a smooth postacute transition. Let’s discuss each of them in more detail below.

Selecting and enrolling patients

Patients eligible for HaH are identified based on their insurance, as well as clinical and social criteria. Despite a lack of public payer support, several commercial payers embraced the model for selected patients who consented to receive acute hospital care at home. The patients must meet criteria for an inpatient admission, be medically stable and have a low level of diagnostic uncertainty. Advances in home monitoring technology expanded clinical criteria to include acutely ill patients with multiple comorbidities, including cancer. It is important that patients reside in a safe home environment and live within a reasonable distance from the hospital.

CareMore Health, an integrated health care delivery system serving more than 180,000 Medicare Advantage and Medicaid patients across nine states and Washington D.C., launched Hospital at Home in December 2018, and rapidly scaled from a few referrals to averaging more than 20 new patients per week.

Sashidaran Moodley, MD, medical director at CareMore Health and Aspire Health, in Cerritos, Calif., shared a valuable lesson regarding launching the program: “Do not presume that if you build it, they will come. This is a new model of care that requires physicians to change their behavior and health systems to modify their traditional admission work flows. Program designers should not limit their thinking around sourcing patients just from the emergency department.”

Dr. Moodley recommends moving upstream and bring awareness to the program to drive additional referrals from primary care providers, case managers, and remote patient monitoring programs (for example, heart failure).

Linda DeCherrie, MD, clinical director of Mount Sinai at Home, based in New York, says that “educating and involving hospitalists is key.” At Mount Sinai, patients eligible for HaH are initially evaluated by hospitalists in the ED who write initial orders and then transfer care to HaH hospitalists.

HaH also can enroll eligible patients who still require hospital-level care to complete the last few days of acute hospitalization at home. Early discharge programs have been implemented at CareMore, Presbyterian Healthcare Services in Albuquerque, N.M., and Mount Sinai. At Mount Sinai, a program called Completing Hospitalization at Home initially started with non-COVID patients and expanded to include COVID-19 early discharges, helping to free up much-needed hospital beds.
 

Delivering acute care at home

HaH requires a well-coordinated multidisciplinary team. Patient care is directed by a team of physicians and nurse practitioners who provide daily in-person or virtual visits. To enable provider work flow, an ambulatory version of electronic medical records (for example, Epic) must be customized to include specialized order sets that mimic inpatient orders and diagnoses-specific care delivery protocols. HaH physicians and nurse practitioners are available 24/7 to address acute patient issues.

In addition, patients receive at least daily visits from registered nurses (RNs) who carry out orders, administer medications, draw labs, and provide clinical assessment and patient education. Some organizations employ HaH nurses, while others contract with home health agencies.

Typically, patients are provided with a tablet to enable telehealth visits, as well as a blood pressure monitor, thermometer, pulse oximeter, and, if needed, scale and glucometer, that allow on-demand or continuous remote monitoring. Recent technology advances in home monitoring enhanced HaH’s capability to care for complex, high-acuity patients, and increased the potential volume of patients that can be safely treated at home.

Providence St. Joseph Health, a not-for-profit health care system operating 51 hospitals and 1,085 clinics across seven states, launched their HaH program earlier this year. Per Danielsson, MD, executive medical director for hospital medicine at Swedish Medical Center in Seattle, describes it as a “high-touch, high-tech program anchored by hospitalists.” The Providence HaH team utilizes a wearable medical device for patients that enables at-home continuous monitoring of vital signs such as temperature, blood pressure, heart rate, respirations, and pulse oximetry. Single-lead EKG monitoring is available for selected patients. Individual patient data is transmitted to a central command center, where a team of nurses and physicians remotely monitor HaH patients. According to Todd Czartoski, MD, chief medical technology officer at Providence, “Hospital at Home improves quality and access, and can substitute for 20%-30% of hospital admissions.”

In addition to patient monitoring and 24/7 provider access, some HaH programs partner with community paramedics for emergency responses. At Mount Sinai, HaH providers can trigger paramedic response, if needed. Paramedics can set up a video link with a doctor and, under the direction of a physician, will provide treatment at home or transport patients to the hospital.

HaH would be impossible without a partnership with local ancillary service providers that can promptly deliver services and goods to patient homes. Raphael Rakowski, CEO of Medically Home, a Boston-based company that partners with health care providers to build virtual hospitals at home, calls it an “acute rapid response supply chain.” The services, both clinical and nonclinical, consist of infusions; x-rays; bedside ultrasound; laboratory; transportation; and skilled physical, occupational, and speech therapy. If patients require services that are not available at home (for example, a CT scan), patients can be transported to and from a diagnostic center. Medical and nonmedical goods include medications, oxygen, durable medical equipment, and even meals.

Delivery of hospital-level services at home requires a seamless coordination between clinical teams and suppliers that relies on nursing care coordinators and supporting nonclinical staff, and is enabled by a secure text messaging platform to communicate within the care team, with suppliers, and with other providers (for example, primary care providers and specialists).
 

Ensuring smooth postacute transition

Thirty days after hospital discharge is the most critical period, especially for elderly patients. According to one study, 19% of patients experienced adverse events within 3 weeks after hospital discharge.18 Adverse drug events were the most common postdischarge complication, followed by procedural complications and hospital-acquired infections. Furthermore, 30-day all-cause hospital readmissions is a common occurrence. Per the Healthcare Cost and Utilization Project database, 17.1% of Medicare and 13.9% of all-payers patients were readmitted to the hospital within 30 days in 2016.¹⁹

It is not surprising that some organizations offer ongoing home care during the postacute period. At Mount Sinai, patients discharged from HaH continue to have access to the HaH team around the clock for 30 days to address emergencies and health concerns. Recovery Care Coordinators and social workers monitor patient health status, develop a follow-up plan, coordinate care, and answer questions. Medically Home provides 24/7 care to HaH patients for the entire duration of the acute care episode (34 days) to ensure maximum access to care and no gaps in care and communication. At Presbyterian, most HaH patients are transitioned into a Home Health episode of care to ensure continued high-quality care.

In addition to people, processes, technology, and the supply chain, HaH implementation requires capabilities to collect and analyze quality and cost data to measure program efficacy and, in some arrangements with payers, to reconcile clams data to determine shared savings or losses.
 

Partnering with third parties

Considering the resources and capabilities required for HaH program development and implementation, it is not surprising that health care providers are choosing to partner with third parties. For example, Mount Sinai partnered with Contessa Health, a Nashville, Tenn.–based company that offers hospitals a turn-key Home Recovery Care program, to assist with supply chain contracting and management, and claims data reconciliation.

Medically Home has partnered with seven health care systems, including the Mayo Clinic, Tufts Medical Center in Boston, and Adventist Health in southern California, to create virtual beds, and is expected to launch the program with 15 health care systems by the end of 2020.

Medically Home offers the following services to its partners to enable care for high-acuity patients at home:

• Assistance with hiring and training of clinical staff.
• Proprietary EMR-integrated orders, notes, and clinical protocols.
• Technology for patient monitoring by the 24/7 central command center; tablets that provide health status updates and daily schedules, and enable televisits; a video platform for video communication; and secure texting.
• Selection, contracting and monitoring the performance of supply chain vendors.
• Analytics.

The future of Hospital at Home

There is no question that HaH can offer a safe, high-quality, and lower-cost alternative to hospitalizations for select patients, which is aligned with the Centers for Medicare and Medicaid Services’ triple aim of better care for individuals, better health for populations, and lower cost.²⁰

The future of HaH depends on development of a common payment model that will be adopted beyond the pandemic by government and commercial payers. Current payment models vary and include capitated agreements, discounted diagnosis-related group payments for the acute episode, and discounted DRG payments plus shared losses or savings.

The COVID-19 pandemic has created, arguably, the biggest crisis that U.S. health care has ever experienced, and it is far from over. Short term, Hospital at Home offers a solution to create flexible hospital bed capacity and deliver safe hospital-level care for vulnerable populations. Long term, it may be the solution that helps achieve better care for individuals, better health for populations and lower health care costs.

Dr. Farah is a hospitalist, physician advisor, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of the Hospitalist’s editorial advisory board.

References

1. Source: www.cms.gov/files/document/nations-health-dollar-where-it-came-where-it-went.pdf

2. Source: www.aha.org/statistics/fast-facts-us-hospitals

3. Roberts RR, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999 Feb;281(7):644-9.

4. Levinson DR; US Department of Health and Human Services; HHS; Office of the Inspector General; OIG.

5. Krumholz HM. Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk. N Engl J Med. 2013 Jan;368:100-102.

6. Leff B, et al. Home hospital program: a pilot study. J Am Geriatr Soc. 1999 Jun;47(6):697-702.

7. Leff B, et al. Hospital at home: Feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec;143(11):798-808.

8. Source: www.johnshopkinssolutions.com/solution/hospital-at-home/

9. Cryer L, et al. Costs for ‘Hospital at Home’ Patients Were 19 Percent Lower, with Equal or Better Outcomes Compared to Similar Inpatients. Health Affairs. 2012 Jun;31(6):1237–43.

10. Personal communication with Presbyterian Health Services. May 20, 2020.

11. Federman A, et al. Association of a bundled hospital-at-home and 30-day postacute transitional care program with clinical outcomes and patient experiences. JAMA Intern Med. 2018 Aug;178(8):1033–40.

12. Source: aspe.hhs.gov/system/files/pdf/255906/MtSinaiHAHReportSecretary.pdf

13. Source: aspe.hhs.gov/system/files/pdf/255906/Secretarial_Responses_June_13_2018.508.pdf

14. Shepperd S, et al. Admission avoidance hospital at home. Cochrane Database Syst Rev. 2016;9(9):CD007491. DOI:10.1002/14651858.CD007491.pub2.

15. Levine DM, et al. Hospital-level care at home for acutely ill adults: a randomized controlled trial. Ann Intern Med. 2020 Jan;172(2);77-85.

16. Source: www.cms.gov/files/document/covid-hospitals.pdf

17. Centers for Medicare & Medicaid Services. CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge. 2020 Nov 20.

18. Forster AJ et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Mar;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.

19. Bailey MK et al. Characteristics of 30-Day All-Cause Hospital Readmissions, 2010-2016. Statistical Brief 248. Agency for Healthcare Research and Quality. 2019 Feb 12. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb248-Hospital-Readmissions-2010-2016.jsp.

20. Centers for Medicare & Medicaid Services. What are the value-based programs? 2020 Jan 6. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/Value-Based-Programs.

The United States spends one-third of the nation’s health dollars on hospital care, amounting to $1.2 trillion in 2018.¹ U.S. hospital beds are prevalent², and expensive to build and operate, with most hospital services costs related to buildings, equipment, salaried labor, and overhead.³

Despite their mission to heal, hospitals can be harmful, especially for frail and elderly patients. A study completed by the Office of the Inspector General (OIG) found that 13.5% of hospitalized Medicare patients experienced an adverse event that resulted in a prolonged hospital stay, permanent harm, a life-sustaining intervention or death.⁴ In addition, there is growing concern about acquired post-hospitalization syndrome caused by the physiological stress that patients experience in the hospital, leaving them vulnerable to clinical adverse events such as falls and infections.⁵

In the mid-1990s, driven by a goal to “avoid the harm of inpatient care and honor the wishes of older adults who refused to go to the hospital”, Dr. Bruce Leff, director of the Center for Transformative Geriatric Research and professor of medicine at Johns Hopkins University in Baltimore, and his team set out to develop and test Hospital at Home (HaH) – an innovative model for delivering hospital-level care to selected patients in the safety of their homes.

More than 20 years later, despite extensive evidence supporting HaH safety and efficacy, and its successful rollout in other countries, the model has not been widely adopted in the U.S. However, the COVID-19 pandemic amplified interest in HaH by creating an urgent need for flexible hospital bed capacity and heightening concerns about hospital care safety, especially for vulnerable adults.

In this article, we will introduce HaH history and efficacy, and then discuss what it takes to successfully implement HaH.
 

Hospital at Home: History, efficacy, and early adoption

The earliest HaH study, a 17-patient pilot conducted by Dr. Leff’s team from 1996 to 1998, proved that HaH was feasible, safe, highly satisfactory and cost-effective for selected acutely ill older patients with community-acquired pneumonia, chronic heart failure, chronic obstructive pulmonary disease or cellulitis.⁶ In 2000 to 2002, a National Demonstration and Evaluation Study of 455 patients across three sites determined that patients treated in Hospital at Home had statistically significant shorter length of stay (3.2 vs 4.9 days), lower cost ($5,081 vs. $7,480) and complications.⁷ Equipped with evidence, Dr. Leff and his team focused on HaH dissemination and implementation across several health care systems.⁸

Presbyterian Healthcare Services in Albuquerque, N.M., was one of the earliest adopters of HaH and launched the program in 2008. The integrated system serves one-third of New Mexicans and includes nine hospitals, more than 100 clinics and the state’s largest health plan. According to Nancy Guinn, MD, a medical director of Presbyterian Healthcare at Home, “Innovation is key to survive in a lean environment like New Mexico, which has the lowest percentage of residents with insurance from their employer and a high rate of government payers.”

Presbyterian selected nine diagnoses for HaH focus: congestive heart failure, chronic obstructive pulmonary disease, community-acquired pneumonia, cellulitis, deep venous thrombosis, pulmonary embolism, complicated urinary tract infection or urosepsis, nausea and vomiting, and dehydration. The HaH care, including physician services, is reimbursed via a partial DRG (diagnosis-related group) payment that was negotiated internally between the health system and Presbyterian Health Plan.

The results demonstrated that, compared to hospitalized patients with similar conditions, patients in HaH had a lower rate of falls (0% vs. .8%), lower mortality (.93% vs. 3.4%), higher satisfaction (mean score 90.7 vs. 83.9) and 19% lower cost.⁹ According to Dr. Guinn, more recent results showed even larger cost savings of 42%.¹⁰ After starting the HaH model, Presbyterian has launched other programs that work closely with HaH to provide a seamless experience for patients. That includes the Complete Care Program, which offers home-based primary, urgent, and acute care to members covered through Presbyterian Health Plan and has a daily census of 600-700 patients.

Another important milestone came in 2014 when Icahn School of Medicine at Mount Sinai in New York was awarded $9.6 million by the Center for Medicare and Medicaid Innovation (CMMI) to test the HaH model during acute illness and for 30 days after admission. A case study of 507 patients enrolled in the program in 2014 through 2017 revealed that HaH patients had statistically significant shorter length of stay (3.2 days vs. 5.5 days), and lower rates of all-cause 30-day hospital readmissions (8.6% vs. 15.6%), 30-day ED revisits (5.8% vs. 11.7%), and SNF admissions (1.7% vs. 10.4%), and were also more likely to rate their hospital care highly (68.8% vs. 45.3%).¹¹

In 2017, using data from their CMMI study, Mount Sinai submitted an application to the Physician-Focused Payment Model Technical Advisory Committee (PTAC) to implement Hospital at Home as an alternative payment model that bundles the acute episode with 30 days of post‐acute transitional care. The PTAC unanimously approved the proposal and submitted their recommendations to the Secretary of Health and Human Services (HHS) to implement HaH as an alternative payment model that included two parts:

1. A bundled payment equal to a percentage of the prospective DRG (diagnosis-related group) payment that would have been paid to a hospital.

2. A performance-based payment (shared savings/losses) based on (a) total spending during the acute care phase and 30 days afterward relative to a target price, and (b) performance on quality measures.¹²

In June 2018, the HHS secretary announced that he was not approving the proposal as written, citing, among other things, concerns about proposed payment methodology and patient safety.¹³
 

Hospital at Home: Present state

Despite additional evidence of HaH’s impact on lowering cost, decreasing 30-day readmissions, improving patient satisfaction and functional outcomes without an adverse effect on mortality,^{14, 15} the model has not been widely adopted, largely due to lack of fee-for-service reimbursement from the public payers (Medicare and Medicaid) and complex logistics to implement it.

However, the COVID-19 pandemic created an urgent need for flexible hospital bed capacity and amplified concerns about hospital care safety for vulnerable populations. In response, the Centers for Medicare and Medicaid Services (CMS) introduced its Hospitals without Walls initiative that allowed hospitals to provide services in other health care facilities and sites that are not part of the existing hospital.¹⁶ On November 25, 2020, CMS announced expansion of the Hospital without Walls initiatives to include a Hospital Care at Home program that allows eligible hospitals to treat eligible patients at home.¹⁷

With significant evidence supporting HaH’s safety and efficacy, and long overdue support from CMS, it’s now a matter of how to successfully implement it. Let’s explore what it takes to select and enroll patients, deliver acute care at home, and ensure a smooth post-acute transition within the HaH model.

Successfully implementing Hospital at Home

HaH implementation requires five key components – people, processes, technology, supply chain, and analytics – to select and enroll patients, deliver acute care at home, and ensure a smooth postacute transition. Let’s discuss each of them in more detail below.

Selecting and enrolling patients

Patients eligible for HaH are identified based on their insurance, as well as clinical and social criteria. Despite a lack of public payer support, several commercial payers embraced the model for selected patients who consented to receive acute hospital care at home. The patients must meet criteria for an inpatient admission, be medically stable and have a low level of diagnostic uncertainty. Advances in home monitoring technology expanded clinical criteria to include acutely ill patients with multiple comorbidities, including cancer. It is important that patients reside in a safe home environment and live within a reasonable distance from the hospital.

CareMore Health, an integrated health care delivery system serving more than 180,000 Medicare Advantage and Medicaid patients across nine states and Washington D.C., launched Hospital at Home in December 2018, and rapidly scaled from a few referrals to averaging more than 20 new patients per week.

Sashidaran Moodley, MD, medical director at CareMore Health and Aspire Health, in Cerritos, Calif., shared a valuable lesson regarding launching the program: “Do not presume that if you build it, they will come. This is a new model of care that requires physicians to change their behavior and health systems to modify their traditional admission work flows. Program designers should not limit their thinking around sourcing patients just from the emergency department.”

Dr. Moodley recommends moving upstream and bring awareness to the program to drive additional referrals from primary care providers, case managers, and remote patient monitoring programs (for example, heart failure).

Linda DeCherrie, MD, clinical director of Mount Sinai at Home, based in New York, says that “educating and involving hospitalists is key.” At Mount Sinai, patients eligible for HaH are initially evaluated by hospitalists in the ED who write initial orders and then transfer care to HaH hospitalists.

HaH also can enroll eligible patients who still require hospital-level care to complete the last few days of acute hospitalization at home. Early discharge programs have been implemented at CareMore, Presbyterian Healthcare Services in Albuquerque, N.M., and Mount Sinai. At Mount Sinai, a program called Completing Hospitalization at Home initially started with non-COVID patients and expanded to include COVID-19 early discharges, helping to free up much-needed hospital beds.
 

Delivering acute care at home

HaH requires a well-coordinated multidisciplinary team. Patient care is directed by a team of physicians and nurse practitioners who provide daily in-person or virtual visits. To enable provider work flow, an ambulatory version of electronic medical records (for example, Epic) must be customized to include specialized order sets that mimic inpatient orders and diagnoses-specific care delivery protocols. HaH physicians and nurse practitioners are available 24/7 to address acute patient issues.

In addition, patients receive at least daily visits from registered nurses (RNs) who carry out orders, administer medications, draw labs, and provide clinical assessment and patient education. Some organizations employ HaH nurses, while others contract with home health agencies.

Typically, patients are provided with a tablet to enable telehealth visits, as well as a blood pressure monitor, thermometer, pulse oximeter, and, if needed, scale and glucometer, that allow on-demand or continuous remote monitoring. Recent technology advances in home monitoring enhanced HaH’s capability to care for complex, high-acuity patients, and increased the potential volume of patients that can be safely treated at home.

Providence St. Joseph Health, a not-for-profit health care system operating 51 hospitals and 1,085 clinics across seven states, launched their HaH program earlier this year. Per Danielsson, MD, executive medical director for hospital medicine at Swedish Medical Center in Seattle, describes it as a “high-touch, high-tech program anchored by hospitalists.” The Providence HaH team utilizes a wearable medical device for patients that enables at-home continuous monitoring of vital signs such as temperature, blood pressure, heart rate, respirations, and pulse oximetry. Single-lead EKG monitoring is available for selected patients. Individual patient data is transmitted to a central command center, where a team of nurses and physicians remotely monitor HaH patients. According to Todd Czartoski, MD, chief medical technology officer at Providence, “Hospital at Home improves quality and access, and can substitute for 20%-30% of hospital admissions.”

In addition to patient monitoring and 24/7 provider access, some HaH programs partner with community paramedics for emergency responses. At Mount Sinai, HaH providers can trigger paramedic response, if needed. Paramedics can set up a video link with a doctor and, under the direction of a physician, will provide treatment at home or transport patients to the hospital.

HaH would be impossible without a partnership with local ancillary service providers that can promptly deliver services and goods to patient homes. Raphael Rakowski, CEO of Medically Home, a Boston-based company that partners with health care providers to build virtual hospitals at home, calls it an “acute rapid response supply chain.” The services, both clinical and nonclinical, consist of infusions; x-rays; bedside ultrasound; laboratory; transportation; and skilled physical, occupational, and speech therapy. If patients require services that are not available at home (for example, a CT scan), patients can be transported to and from a diagnostic center. Medical and nonmedical goods include medications, oxygen, durable medical equipment, and even meals.

Delivery of hospital-level services at home requires a seamless coordination between clinical teams and suppliers that relies on nursing care coordinators and supporting nonclinical staff, and is enabled by a secure text messaging platform to communicate within the care team, with suppliers, and with other providers (for example, primary care providers and specialists).
 

Ensuring smooth postacute transition

Thirty days after hospital discharge is the most critical period, especially for elderly patients. According to one study, 19% of patients experienced adverse events within 3 weeks after hospital discharge.18 Adverse drug events were the most common postdischarge complication, followed by procedural complications and hospital-acquired infections. Furthermore, 30-day all-cause hospital readmissions is a common occurrence. Per the Healthcare Cost and Utilization Project database, 17.1% of Medicare and 13.9% of all-payers patients were readmitted to the hospital within 30 days in 2016.¹⁹

It is not surprising that some organizations offer ongoing home care during the postacute period. At Mount Sinai, patients discharged from HaH continue to have access to the HaH team around the clock for 30 days to address emergencies and health concerns. Recovery Care Coordinators and social workers monitor patient health status, develop a follow-up plan, coordinate care, and answer questions. Medically Home provides 24/7 care to HaH patients for the entire duration of the acute care episode (34 days) to ensure maximum access to care and no gaps in care and communication. At Presbyterian, most HaH patients are transitioned into a Home Health episode of care to ensure continued high-quality care.

In addition to people, processes, technology, and the supply chain, HaH implementation requires capabilities to collect and analyze quality and cost data to measure program efficacy and, in some arrangements with payers, to reconcile clams data to determine shared savings or losses.
 

Partnering with third parties

Considering the resources and capabilities required for HaH program development and implementation, it is not surprising that health care providers are choosing to partner with third parties. For example, Mount Sinai partnered with Contessa Health, a Nashville, Tenn.–based company that offers hospitals a turn-key Home Recovery Care program, to assist with supply chain contracting and management, and claims data reconciliation.

Medically Home has partnered with seven health care systems, including the Mayo Clinic, Tufts Medical Center in Boston, and Adventist Health in southern California, to create virtual beds, and is expected to launch the program with 15 health care systems by the end of 2020.

Medically Home offers the following services to its partners to enable care for high-acuity patients at home:

• Assistance with hiring and training of clinical staff.
• Proprietary EMR-integrated orders, notes, and clinical protocols.
• Technology for patient monitoring by the 24/7 central command center; tablets that provide health status updates and daily schedules, and enable televisits; a video platform for video communication; and secure texting.
• Selection, contracting and monitoring the performance of supply chain vendors.
• Analytics.

The future of Hospital at Home

There is no question that HaH can offer a safe, high-quality, and lower-cost alternative to hospitalizations for select patients, which is aligned with the Centers for Medicare and Medicaid Services’ triple aim of better care for individuals, better health for populations, and lower cost.²⁰

The future of HaH depends on development of a common payment model that will be adopted beyond the pandemic by government and commercial payers. Current payment models vary and include capitated agreements, discounted diagnosis-related group payments for the acute episode, and discounted DRG payments plus shared losses or savings.

The COVID-19 pandemic has created, arguably, the biggest crisis that U.S. health care has ever experienced, and it is far from over. Short term, Hospital at Home offers a solution to create flexible hospital bed capacity and deliver safe hospital-level care for vulnerable populations. Long term, it may be the solution that helps achieve better care for individuals, better health for populations and lower health care costs.

Dr. Farah is a hospitalist, physician advisor, and Lean Six Sigma Black Belt. She is a performance improvement consultant based in Corvallis, Ore., and a member of the Hospitalist’s editorial advisory board.

References

1. Source: www.cms.gov/files/document/nations-health-dollar-where-it-came-where-it-went.pdf

2. Source: www.aha.org/statistics/fast-facts-us-hospitals

3. Roberts RR, et al. Distribution of variable vs fixed costs of hospital care. JAMA. 1999 Feb;281(7):644-9.

4. Levinson DR; US Department of Health and Human Services; HHS; Office of the Inspector General; OIG.

5. Krumholz HM. Post-Hospital Syndrome – An Acquired, Transient Condition of Generalized Risk. N Engl J Med. 2013 Jan;368:100-102.

6. Leff B, et al. Home hospital program: a pilot study. J Am Geriatr Soc. 1999 Jun;47(6):697-702.

7. Leff B, et al. Hospital at home: Feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec;143(11):798-808.

8. Source: www.johnshopkinssolutions.com/solution/hospital-at-home/

9. Cryer L, et al. Costs for ‘Hospital at Home’ Patients Were 19 Percent Lower, with Equal or Better Outcomes Compared to Similar Inpatients. Health Affairs. 2012 Jun;31(6):1237–43.

10. Personal communication with Presbyterian Health Services. May 20, 2020.

11. Federman A, et al. Association of a bundled hospital-at-home and 30-day postacute transitional care program with clinical outcomes and patient experiences. JAMA Intern Med. 2018 Aug;178(8):1033–40.

12. Source: aspe.hhs.gov/system/files/pdf/255906/MtSinaiHAHReportSecretary.pdf

13. Source: aspe.hhs.gov/system/files/pdf/255906/Secretarial_Responses_June_13_2018.508.pdf

14. Shepperd S, et al. Admission avoidance hospital at home. Cochrane Database Syst Rev. 2016;9(9):CD007491. DOI:10.1002/14651858.CD007491.pub2.

15. Levine DM, et al. Hospital-level care at home for acutely ill adults: a randomized controlled trial. Ann Intern Med. 2020 Jan;172(2);77-85.

16. Source: www.cms.gov/files/document/covid-hospitals.pdf

17. Centers for Medicare & Medicaid Services. CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge. 2020 Nov 20.

18. Forster AJ et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Mar;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.

19. Bailey MK et al. Characteristics of 30-Day All-Cause Hospital Readmissions, 2010-2016. Statistical Brief 248. Agency for Healthcare Research and Quality. 2019 Feb 12. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb248-Hospital-Readmissions-2010-2016.jsp.

20. Centers for Medicare & Medicaid Services. What are the value-based programs? 2020 Jan 6. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/Value-Based-Programs.

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

 A version of this article first appeared on Medscape.com.

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

 A version of this article first appeared on Medscape.com.

The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.

The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”

In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.

“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.

Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”

“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.

Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.

The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”

All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.

“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.

 A version of this article first appeared on Medscape.com.

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

The greatest relative benefit from omecamtiv mecarbil, a member of the novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The findings reinforce the potential for this drug to be helpful in the management of the most advanced stages of heart failure with reduced ejection fraction (HFrEF), reported John R. Teerlink, MD, director of heart failure at San Francisco Veterans Affairs Medical Center, at the annual scientific sessions of the American College of Cardiology.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure–related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Drilling down on ejection fraction

The new analysis divided participants into quartiles of baseline LVEF and then compared relative outcomes and safety.

In the lowest quartile, defined by a LVEF of 22% or lower, the reduction in risk of events reached 17% (hazard ratio, 0.83; 95% confidence interval, 0.73-0.95) for omecamtiv mecarbil relative to placebo. In the highest, defined by a LVEF of 33% or greater, the benefit fell short of significance (HR 0.99; 95% CI, 0.84-1.16). Across quartiles, LVEF was the “strongest modifier of the treatment effect,” emerging in this analysis as a statistically significant (P = .004) continuous variable.

The comparison by LVEF quartiles also provided an opportunity to show that omecamtiv mecarbil was as safe and well tolerated in those with the most advanced disease as in those less sick. At the lowest levels of LVEF, like the higher levels, omecamtiv mecarbil did not produce any adverse effects on blood pressure, heart rate, potassium homeostasis, or renal function.

In GALACTIC-HF, 8,256 HFrEF patients with LVEF 35% or less were randomized to omecamtiv mecarbil or placebo. The primary composite outcome of hospitalization or urgent visit for heart failure or death from cardiovascular causes was evaluated after a median of 21.8 months on therapy.

When incidence rate per 100 patient years was graphed against the range of LVEF, the relative advantage of omecamtiv mecarbil became visible just below an LVEF of 30%, climbing steadily even to the lowest LVEF, which reached 10%.

Perhaps relevant to the reduction in events, there were also greater relative reductions in NT-proBNP (NT-proB-type natriuretic peptide) for omecamtiv mecarbil at lower relative to higher LVEF. Although omecamtiv mecarbil is not associated with any direct vascular, electrophysiologic, or neurohormonal effects, according to Dr. Teerlink, the indirect effects of selective binding to cardiac myosin has been associated with lower NT-proBNP and other biomarkers of cardiac remodeling in prior clinical studies.

Although Dr. Teerlink acknowledged that relatively few patients in GALACTIC-HF received an angiotensin-receptor neprilysin inhibitor (ARNI) or a sodium glucose cotransporter-2 (SGLT2) inhibitor, he said there is “every reason to believe that omecamtiv mecarbil would be complementary to these therapies.” He said the mechanism of action of omecamtiv mecarbil, which improves systolic function, has no overlap with these drugs.

Importantly, there is a particular need for new treatment options in patients with advanced LVEF, according to Dr. Teerlink, who cited evidence, for example, that “the beneficial effect of [the ARNI] sacubitril valsartan, while still significant, decreases in patients with LVEF less than 35%.”

Overall, based on these results, “we believe that omecamtiv mecarbil represents a novel therapy that holds the promise of improving clinical outcomes in patients with severely reduced ejection fraction, which are the very patients that are most challenging for us to treat,” Dr. Teerlink said.
 

Omecamtiv mecarbil may ‘buy you some time’

Ileana Piña, MD, clinical professor of medicine, Central Michigan University, Mount Pleasant, Mich., agreed. She said that omecamtiv mecarbil, if approved, will be an option for the type of HFrEF patients who are being considered for heart transplant or mechanical-assist devices.

“We are very loath to use inotropes in this population, because we know that ultimately the inotrope is not going to do well,” said Dr. Piña, calling these therapies a “Band-Aid.” Based on the evidence from GALACTIC-HF, she thinks that omecamtiv mecarbil will be more versatile.

“This drug does not increase myocardial oxygen demand as do the inotropes, and it can be given in the outpatient setting if need be, so I see this as a real advance,” Dr. Piña said. Although Dr. Piña acknowledged that omecamtiv mecarbil did not reduce mortality in the GALACTIC-HF trial, “at least it will buy you some time.”

Dr. Teerlink has financial relationships with multiple pharmaceutical companies, including Amgen, Cytogenetics, and Servier, which provided funding for the GALACTIC-HF trial. Dr. Piña reports no potential conflicts of interest.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Approaching the nursing unit, I heard the anxiety in my masked colleagues’ voices. I was starting another rotation on our COVID unit; this week I was trying to develop my emotional awareness in an effort to help with the stress of the job and, just as importantly, take in the moments of positive emotions when they arose. I was making a conscious effort to take in all I saw and felt in the same way I approached my patient examinations: my mind quiet, receptive, and curious.

Seeing my nursing teammates covered with personal protective equipment, I felt a little reverence at the purpose they bring to work. Thinking of our patients, isolated and scared in noisy, ventilated rooms, there was compassion welling up in my chest. Thinking about my role on the team, I felt humbled by the challenges of treating this new disease and meeting the needs of staff and patient.

A few years ago, a period of frustration and disaffectedness had led me to apply my diagnostic eye to myself: I was burning out. Developing a mindfulness practice has transformed my experience at work. Now, the pandemic pushed me to go beyond a few minutes of quieting the mind before work. I was developing my emotional awareness. A growing body of research suggests that emotional awareness helps temper the negative experiences and savor the good. This week on the COVID unit was an opportunity to put this idea to the test.

Across the hall from the desk was Ms. A, 85-year-old woman who always clutched her rosary. My Spanish is not great, but I understood her prayer when I entered the room. She had tested positive for COVID about 7 days before – so had all the people in her multigenerational home. Over the din of the negative-pressure machine, with damp eyes she kept saying she wanted to go home. I felt my body soften and, in my chest, it felt as if my heart moved towards her which is the manifestation of compassion. “I will do my best to get you there soon,” I said in an effort to comfort her.

We often resist strong emotions, especially at work, because they can increase stress in situations where we need to be in control. In high-emotion situations, our brain’s warning centers alert both body and brain. This has helped our ancestors to action over the millennia, but in the hospital, these responses hurt more than help. Our bodies amplifying the emotion, our mind races for solutions and we can feel overwhelmed.

Simply recognizing the emotion and naming it puts the brakes on this process. fMRI data demonstrate that naming the emotions moves the brain activity away from the emotion centers to the appraisal centers in the frontal lobe. Just the perspective to see the emotional process calms it down.

Name it to tame it – this is what those in the field call this act. “This is sadness,” I said to myself as I left Ms. A’s room.

Down the hall was Mr. D; he was an 81-year-old former Vietnamese refugee. He had come in 3 days prior to my coming on service. While he didn’t talk, even with an interpreter, he ate well and had looked comfortable for days on 50% O₂.

Ms. A’s O₂ needs crept up each day as did her anxiety, the plaintive tenor of her prayers and inquiries about going home. I got a priest to visit, not for last rites but just for some support. Over the phone, I updated the family on the prognosis.

A couple of days later, she needed 95% O₂ and with PO₂ was only 70. I told her family it seemed she was losing her battle with the virus. I said we could see how she did on 60% – that’s the max she could get at home with hospice. I called them after 2 hours on 60% to tell them she was up eating and despite slight increased resp rate, she looked okay. “Can you guarantee that she would not make it if she stayed in the hospital? “

My body vibrating with uncertainty – an emotional mix of fear and sadness – I said, “I am sorry, but this is such a new disease, I can’t say that for certain.” On the call, family members voiced different opinions, but in the end, they were unable to give up hope, so we agreed to keep her in hospital.

Down the hall, Mr. D had stopped eating and his sats dropped as did his blood pressure. A nurse exited his room; despite the mask and steamed-up glasses, I could read her body language. “That poor man is dying,” she said. I told her I agreed and called the family with the news and to offer them a chance to visit and to talk about home hospice.

“He has not seen any of us in 10 months,” said his daughter over the phone, “We would love to visit and talk about bringing him home on hospice.” The next morning four of his nine kids showed up with a quart of jook, an Asian rice porridge, for him and pastries for the staff.

They left the room smiling an hour later. “He ate all the jook and he smiled! Yes, let’s work on home with hospice.” That night his blood pressure was better, and we were able to move him to 8 liters oxymizer; the staff was excited by his improvement, too.

The next day Ms. A was less responsive with sats in the 80’s on 100% FiO₂, but she still had this great sense of warmth and dignity about her. When I entered the room, Spanish Catholic hymns were playing, two of her kids stood leaning over the bed and on an iPod, there was a chorus of tears. 20 family members were all crying on a Zoom call. Together this made the most beautiful soundtrack to an end of life I have ever heard. I tried hard not to join the chorus as we talked about turning off the oxygen to help limit her suffering.

We added a bolus of morphine to her drip and removed the oxygen. She looked more beautiful and peaceful without it. Briefly, she closed her eyes then opened them, her breathing calmer. And with the hymns and the chorus of family crying she lived another 20 minutes in the loving presence of her big family.

Leaving the room, I was flooded with “woulda, coulda, shouldas” that accompany work with so much uncertainty and high stakes. “Maybe I should have tried convalescent plasma. Maybe I should have told them she must go home,” and so on my mind went on looking for solutions when there were none. I turned to my body – my chest ached, and I whispered to myself: “This is how sadness feels.”

By thinking about how the emotion feels in the body, we move the mind away from problem solving that can end up leading to unhealthy ruminations. Such thoughts in times of high emotions lead to that pressurized, tightness feeling we get when overwhelmed. Taking in the universal sensations of the emotions is calming and connects us with these deep human experiences in healthy ways. At the same time, the racing and ruminations stop.

Meanwhile, down the hall, Mr. D’s family arrived in great spirits armed with more food for patient and staff. He was to go home later that day with hospice. When they saw him up in the chair without the oxygen, they said: “It is a miracle, Dr. Hass! He is going home on hospice but having beat COVID! We can’t thank you enough!”

“Don’t thank me! He was cured by love and jook! What a lesson for us all. Sometimes there is no better medicine than food from home and love!” With the explosive expansiveness of joy, we shared some “elbow bumps” and took some pictures before he was wheeled home.

Back at the nurse’s station, there were tears. Sometimes life is so full of emotion that it is hard to give it a name – joy? grief? Our bodies almost pulsing, our minds searching for words, it is as if an ancient process is marking a time and place in our souls. “This is what it is to be a human being living with love and creating meaning,” the experience seems to be telling us.

This is awesome work. In fact, awe was what we were feeling then – that sense of wonder we have in the presence of something beautiful or vast that we cannot easily comprehend. Taking in these moments of awe at the power and depth of the human experience is critical to keep us humble, engaged, and emotionally involved.

Cultivating emotional awareness is a simple technique to maintain equanimity as we do the emotionally turbulent work of caring for vulnerable and seriously ill members of our community. It uses the same techniques of attention and diagnosis we use on those we care for. It is a practice that can be seamlessly incorporated into our workday with no time added. Recognizing it, naming it, and feeling it will give us the resilience to handle the challenges this amazing work inevitably brings.

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley–UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

It’s now official: The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST-WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions. A follow-up report during the annual scientific sessions of the American College of Cardiology fleshed out the evidence and firmed up their landmark conclusion.

The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure.

Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting.
 

Equally effective ‘across the full range of LVEFs.’

Perhaps as notable and unprecedented was the further finding that the clinical benefits seen with treatment of patients with type 2 diabetes with sotagliflozin was consistent regardless of the ejection fraction they had at entry. Enrolled patients with baseline LVEFs in the range of 25% received a relative benefit from sotagliflozin treatment that was statistically no different from the benefit seen in patients who entered with an LVEF in the neighborhood of 45%, 65%, or at any other level across the LVEF spectrum, a finding that Dr. Bhatt called “remarkable” during a press briefing. “The results show the benefit of sotagliflozin across the full range of LVEFs.”

“We are very excited in the heart failure world by the SGLT2 inhibitors; we’ve been impressed by their reduction in heart failure hospitalizations, but we wonder about the patients with HFpEF, where we haven’t had a blockbuster drug to give,” said Ileana L. Piña, MD, a heart failure specialist and medical officer with the Food and Drug Administration.

The new findings “look like they could pose a regulatory indication [for sotagliflozin] for patients with type 2 diabetes and heart failure across the entire spectrum of heart failure,” said Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart & Vascular institute in Falls Church, Va., and designated discussant for Dr. Bhatt’s report.

A significant on-treatment reduction in CV death

Other new, notable findings from the meta-analysis included the observation that while treatment with sotagliflozin failed to produce a significant reduction in cardiovascular death, compared with placebo, in the intent-to-treat analysis of all patients and of those with heart failure at baseline (it produced nonsignificant point-estimate reductions of 11% compared with placebo for all patients, and of 23% for patients who began the study with heart failure), it did result in a significant 23% relative risk reduction when the researchers focused on patients while they remained adherent to their sotagliflozin regimen (the on-treatment analysis). This 23% relative reduction appeared among all enrolled patients, as well as in the subgroup that started with diagnosed heart failure.

“Given the totality of data from the SGLT2 inhibitors, I think this is a real finding,” Dr. Bhatt said.

Additional analyses also showed that, among women, treatment with sotagliflozin was linked with significant relative reductions in the primary endpoint of roughly 30% compared with placebo among all patients, and also among those with heart failure at baseline. “HFpEF is a problem particularly in older women, and we showed that the benefit was consistent in men and women,” Dr. Bhatt said.

He acknowledged that results are expected soon from two pivotal trials that are examining two different SGLT2 inhibitors, dapagliflozin and empagliflozin, in patients with HFpEF. “I think there will be a class effect for both SGLT2 inhibitors and sotagliflozin for reducing heart failure events in patients with HFpEF, and I predict that the dapagliflozin and empagliflozin trials will have positive results,” Dr. Bhatt said.

Sotagliflozin differs from the SGLT2 inhibitors by also inhibiting SGLT1, an enzyme found in the gastrointestinal system that, when inhibited, results in increased glucose excretion from the gut and a cut in bloodstream levels of postprandial glucose levels. The Food and Drug Administration accepted data from SCORED and SOLOIST-WHF as part of the evidence the agency is now considering for granting a new drug approval to sotagliflozin.

SCORED and SOLOIST-WHF were initially sponsored by Sanofi, and later by Lexicon Pharmaceuticals. Dr. Bhatt’s institution, Brigham and Women’s Hospital, has received funding from Sanofi and Lexicon Pharmaceuticals. He has been a consultant to and received honoraria from K₂P, Level Ex, and MJH Life Sciences; he has been an adviser to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio, and PLx Pharma; and he has received research funding from numerous companies. Dr. Piña has no relevant disclosures. Dr. O’Connor has been a consultant to Arena, Bayer, Bristol-Myers Squibb, Merck, and Windtree, and he has an ownership interest in Biscardia.

[email protected]

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

A version of this article first appeared on Medscape.com.