Pulmonology

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; [email protected].

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; [email protected].

CASE 

Mr. A is a 30-year-old man with neurofibromatosis and myelopathy with associated quadriplegia, complicated by dysphasia and chronic hypercapnic respiratory failure requiring a tracheostomy. He is cared for at home by his very competent mother but requires regular visits with his medical providers for assistance with his complex care needs. Due to logistical challenges, he had been receiving regular home visits even before the ­COVID-19 pandemic.

After estimating the risk of exposure to the patient, Mr. A’s family and his physician’s office staff scheduled a home visit. Before the appointment, the doctor conducted a virtual visit with the patient and family members to screen for COVID-19 infection, which proved negative. The doctor arranged a visit to coincide with Mr. A’s regular appointment with the home health nurse. He invited the patient’s social worker to attend, as well.

The providers donned masks, face shields, and gloves before entering the home. Mr. A’s temperature was checked and was normal. The team completed a physical exam, assessed the patient’s current needs, and refilled prescriptions. The doctor, nurse, and social worker met afterward in the family’s driveway to coordinate plans for the patient’s future care.

This encounter allowed a vulnerable patient with special needs to have access to care while reducing his risk of undesirable exposure. Also, his health care team’s provision of care in the home setting reduced Mr. A’s anxiety and that of his family members.

Home visits have long been an integral part of what it means to be a family physician. In 1930, roughly 40% of all patient-physician encounters in the United States occurred in patients’ homes. By 1980, this number had dropped to < 1%.¹ Still, a 1994 survey of American doctors in 3 primary care specialties revealed that 63% of family physicians, more than the other 2 specialties, still made house calls.² A 2016 analysis of Medicare claims data showed that between 2006 and 2011, only 5% of American doctors overall made house calls on Medicare recipients, but interestingly, the total number of home visits was increasing.³

This resurgence of interest in home health care is due in part to the increasing number of homebound patients in America, which exceeds the number of those in nursing homes.⁴ Further, a growing body of evidence indicates that home visits improve patient outcomes. And finally, many family physicians whose work lives have been centered around a busy office or hospital practice have found satisfaction in once again seeing patients in their own homes.

The COVID-19 pandemic has of course presented unique challenges—and opportunities, too—for home visits, which we discuss at the end of the article.

In the elderly, home visits have reduced functional decline, nursing home admissions, and mortality by 25% to 33%.

Why aren’t more of us making home visits?

For most of us, the decision not to make home visits is simply a matter of time and money. Although Medicare reimbursement for a home visit is typically about 150% that of a comparable office visit,⁵ it’s difficult, if not impossible, to make 2 home visits in the time you could see 3 patients in the office. So, economically it’s a net loss. Furthermore, we tend to feel less comfortable in our patients’ homes than in our offices. We have less control outside our own environment, and what happens away from our office is often less predictable—sometimes to the point that we may be concerned for our safety.

Continue to: So why make home visits at all?

So why make home visits at all?

First and foremost, home visits improve patient outcomes. This is most evident in our more vulnerable patients: newborns and the elderly, those who have been recently hospitalized, and those at risk because of their particular home situation. Multiple studies have shown that, for elders, home visits reduce functional decline, nursing home admissions, and mortality by around 25% to 33%.^6-8 For those at risk of abuse, a recent systematic review showed that home visits reduce intimate partner violence and child abuse.⁹ Another systematic review demonstrated that patients with diabetes who received home visits vs usual care were more likely to show improvements in quality of life.¹⁰ These patients were also more likely to have lower HbA1c levels and lower systolic blood pressure readings.¹⁰ A few caveats apply to these studies:

• all of them targeted “vulnerable” patients
• most studies enlisted interdisciplinary teams and had regular team meetings
• most findings reached significance only after multiple home visits.

A further reason for choosing to become involved in home care is that it builds relationships, understanding, and empathy with our patients. “There is deep symbolism in the home visit.... It says, ‘I care enough about you to leave my power base … to come and see you on your own ground.’”¹¹ And this benefit is 2-way; we also grow to understand and appreciate our patients better, especially if they are different from us culturally or socioeconomically.

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention. For the patient, home visits foster a strong sense of trust with the individual doctor and our health delivery network, and they decrease the need to seek emergency services. Finally, it has been demonstrated that provider satisfaction improves when home visits are incorporated into the work week.¹²

What is the role of community health workers in home-based care?

Community health workers (CHWs), defined as “frontline public health workers who are trusted members of and/or have an unusually close understanding of the community they serve,”¹³ can be an integral part of the home-based care team. Although CHWs have variable amounts of formal training, they have a unique perspective on local health beliefs and practices, which can assist the home-care team in providing culturally competent health care services and reduce health care costs.

In a study of children with asthma in Seattle, Washington, patients were randomized to a group that had 4 home visits by CHWs and a group that received usual care. The group that received home visits demonstrated more asthma symptom–free days, improved quality-of-life scores, and fewer urgent care visits.¹⁴ Furthermore, the intervention was estimated to save approximately $1300 per patient, resulting in a return on investment of 190%. Similarly, in a study comparing inappropriate emergency department (ED) visits between children who received CHW visits and those who did not, patients in the intervention group were significantly less likely to visit the ED for ambulatory complaints (18.2% vs 35.1%; P = .004).¹⁵

Continue to: What is the role of social workersin home-based care?

What is the role of social workersin home-based care?

Social workers can help meet the complex medical and biopsychosocial needs of the homebound population.¹⁶ A study by Cohen et al based in Israel concluded that homebound participants had a significantly higher risk for mortality, higher rates of depression, and difficulty completing instrumental activities of daily living when compared with their non-homebound counterparts.¹⁷

The Mount Sinai (New York) Visiting Doctors Program (MSVD) is a home-based care team that uses social workers to meet the needs of their complex patients.¹⁸ The social workers in the MSVD program provide direct counseling, make referrals to government and community resources, and monitor caregiver burden. Using a combination of measurement tools to assess caregiver burden, Ornstein et al demonstrated that the MSVD program led to a decrease in unmet needs and in caregiver burden.^19,20 Caregiver burnout can be assessed using the Caregiver Burden Inventory, a validated 24-item questionnaire.²¹

What electronic tools are availableto monitor patients at home?

Although expensive in terms of both dollars and personnel time, telemonitoring allows home care providers to receive real-time, updated information regarding their patients.

Chronic obstructive pulmonary disease (COPD). One systematic review showed that although telemonitoring of patients with COPD improved quality of life and decreased COPD exacerbations, it did not reduce the risk of hospitalization and, therefore, did not reduce health care costs.²² Telemonitoring in COPD can include transmission of data about spirometry parameters, weight, temperature, blood pressure, sputum color, and 6-minute walk distance.^23,24

Congestive heart failure (CHF). A 2010 Cochrane review found that telemonitoring of patients with CHF reduced all-cause mortality (risk ratio [RR] = 0.66; P < .0001).²⁵ The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial,conducted from 2013 to 2017, compared usual care for CHF patients with care incorporating daily transmission of body weight, blood pressure, heart rate, electrocardiogram tracings, pulse oximetry, and self-rated health status.²⁶ This study showed that the average number of days lost per year due to hospital admission was less in the telemonitoring group than in the usual care group (17.8 days vs. 24.2 days; P = .046). All-cause mortality was also reduced in the telemonitoring group (hazard ratio = 0.70; P = .028).

Home visits allow the medical team to see challenges the patient has grown accustomed to, and perhaps ones that the patient has deemed too insignificant to mention.

Continue to: What role do “home hospitals” play?

What role do “home hospitals” play?

Home hospitals provide acute or subacute treatment in a patient’s home for a condition that would normally require hospitalization.²⁷ In a meta-analysis of 61 studies evaluating the effectiveness of home hospitals, this option was more likely to reduce mortality (odds ratio [OR] = 0.81; P = .008) and to reduce readmission rates (OR = 0.75; P = .02).²⁸ In a study of 455 older adults, Leff et al found that hospital-at-home was associated with a shorter length of stay (3.2 vs. 4.9 days; P = .004) and that the mean cost was lower for hospital-at-home vs traditional hospital care.²⁹

However, a 2016 Cochrane review of 16 randomized controlled trials comparing hospital-at-home with traditional hospital care showed that while care in a hospital-­at-home may decrease formal costs, if costs for caregivers are taken into account, any difference in cost may disappear.³⁰

Although the evidence for cost saving is variable, hospital-at-home admission has been shown to reduce the likelihood of living in a residential care facility at 6 months (RR = 0.35; P < .0001).³⁰ Further, the same Cochrane review showed that admission avoidance may increase patient satisfaction with the care provided.³⁰

Finally, a recent randomized trial in a Boston-area hospital system showed that patients cared for in hospital-at-home were significantly less likely to be readmitted within 30 days and that adjusted cost was about two-thirds the cost of traditional hospital care.³¹

What is the physician’s rolein home health care?

While home health care is a team effort, the physician has several crucial roles. First, he or she must make the determination that home care is appropriate and feasible for a particular patient. Appropriate, meaning there is evidence that this patient is likely to benefit from home care. Feasible, meaning there are resources available in the community and family to safely care for the patient at home. “Often a house call will serve as the first step in developing a home-based-management plan.”³²

Patients with diabetes receiving home care are more likely to have improved quality of life, lower HbA1c levels, and lower systolic BP readings.

Continue to: Second, the physician serves...

Second, the physician serves an important role in directing and coordinating the team of professionals involved. This primarily means helping the team to communicate with one another. Before home visits begin, the physician’s office should reach out not only to the patient and family, but also to any other health care personnel involved in the patient’s home care. Otherwise, many of the health care providers involved will never have face-to-face interaction with the physician. Creation of the coordinated health team minimizes duplication and miscommunication; it also builds a valuable bond.

How does one go about making a home visit?

Scheduling. What often works best in a busy practice is to schedule home visits for the end of the workday or to devote an entire afternoon to making home visits to several patients in one locale. Also important is scheduling times, if possible, when important family members or other caregivers are at home or when other members of the home care team can accompany you.

What to bring along. Carry a “home visit bag” that includes equipment you’re likely to need and that is not available away from your office. A minimally equipped visit bag would include different-sized blood pressure cuffs, a glucometer, a pulse oximeter, thermometers, and patient education materials. Other suggested contents are listed in TABLE 1. Due to the COVID-19 pandemic, providers should also carry adequate personal protective equipment (PPE), including an N-95 mask.

Dos and don’ts. Take a few minutes when you first arrive to simply visit with the patient. Sit down and introduce yourself and any members of the home care team that the patient has not met. Take an interim history. While you’re doing this, be observant: Is the home neat or cluttered? Is the indoor temperature comfortable? Are there fall hazards? Is there a smell of cigarette smoke? Are there any indoor combustion sources (eg, wood stove or kerosene heater)? Ask questions such as: Who lives here with you? Can you show me where you keep your medicines? (If the patient keeps insulin or any other medicines in the refrigerator, ask to see it. Note any apparent food scarcity.)

During your exam, pay particular attention to whether vital signs are appreciably different than those measured in the office or hospital. Pay special attention to the patient’s functional abilities. “A subtle, but critical distinction between medical management in the home and medical management in the hospital, clinic, or office is the emphasis on the patient’s functional abilities, family assistance, and environmental factors.”³³

Observe the patient’s use of any home technology, if possible; this can be as simple as home oxygenation or as complex as home hemodialysis. Assess for any apparent caregiver stress. Finally, don’t neglect to offer appropriate emotional and spiritual support to the patient and family and to schedule the next follow-up visit before you leave.

Continue to:  Documentation and reimbursement.

Not all assessments will be able to be done at each visit but seeing them listed in the template can be helpful. Billing follows the same principles as for office visits and has similar requirements for documentation. Codes for the most common types of home visits are listed in TABLE 3.

Where can I get help?

Graduates of family medicine residency programs are required to receive training in home visits by the Accreditation Council for Graduate Medical Education (ACGME). Current ACGME program requirements stipulate that “residents must demonstrate competence to independently diagnose, manage, and integrate the care of patients of all ages in various outpatient settings, including the FMP [family medicine practice] site and home environment,” and “residents must be primarily responsible for a panel of continuity patients, integrating each patient’s care across all settings, including the home ...” [emphasis added].³⁴

For those already in practice, one of the hardest parts of doing home visits is feeling alone, especially if few other providers in your community engage in home care. As you run into questions and challenges with incorporating home care of patients into your practice, one excellent resource is the American Academy of Home Care Medicine (www.aahcm.org/). Founded in 1988 and headquartered in Chicago, it not only provides numerous helpful resources, but serves as a networking tool for physicians involved in home care.

Using a home visit template can help with documentation and reimbursement.

This unprecedented pandemichas allowed home visits to shine

As depicted in our opening patient case, patients who have high-risk conditions and those who are older than 65 years of age may be cared for more appropriately in a home visit rather than having them come to the office. Home visits may also be a way for providers to “lay eyes” on patients who do not have technology available to participate in virtual visits.

Before performing a home visit, inquire as to whether the patient has symptoms of COVID-19. Adequate PPE should be donned at all times and social distancing should be practiced when appropriate. With adequate PPE, home visits may also allow providers to care for low-risk patients known to have ­COVID-19 and thereby minimize risks to staff and other patients in the office. JFP

CORRESPONDENCE
Curt Elliott, MD, Prisma Health USC Family Medicine Center, 3209 Colonial Drive, Columbia, SC 29203; [email protected].

Background: Venous thromboembolism and pulmonary embolism are common after major trauma. Anticoagulant prophylaxis usually is not considered because of the increased risk of bleeding. Despite the limited data, many trauma centers use inferior vena cava (IVC) filters as a primary means to prevent pulmonary embolism.

Study design: Randomized, controlled, and multicenter trial.

Setting: Four tertiary hospitals in Australia.

Synopsis: 240 major trauma patients were randomly assigned to receive either IVC filter or no IVC filter within 72 hours after admission. The primary endpoint was a composite of 90-day mortality or symptomatic pulmonary embolism confirmed on imaging. There was no difference in the rate of composite outcome in those with IVC filter, compared with those with no IVC filter.

Bottom line: After major trauma, early prophylactic placement of IVC filter did not reduce the 90-day mortality or incidence of symptomatic pulmonary embolism.

Citation: Ho KM et al. A multicenter trial of vena cava filters in severely injured patients. N Engl J Med. 2019 Jul 25;381:328-37.

Dr. Hoque Sharmy is a hospitalist and assistant professor of medicine in the division of hospital medicine at St. Louis University School of Medicine.

Background: Venous thromboembolism and pulmonary embolism are common after major trauma. Anticoagulant prophylaxis usually is not considered because of the increased risk of bleeding. Despite the limited data, many trauma centers use inferior vena cava (IVC) filters as a primary means to prevent pulmonary embolism.

Study design: Randomized, controlled, and multicenter trial.

Setting: Four tertiary hospitals in Australia.

Synopsis: 240 major trauma patients were randomly assigned to receive either IVC filter or no IVC filter within 72 hours after admission. The primary endpoint was a composite of 90-day mortality or symptomatic pulmonary embolism confirmed on imaging. There was no difference in the rate of composite outcome in those with IVC filter, compared with those with no IVC filter.

Bottom line: After major trauma, early prophylactic placement of IVC filter did not reduce the 90-day mortality or incidence of symptomatic pulmonary embolism.

Citation: Ho KM et al. A multicenter trial of vena cava filters in severely injured patients. N Engl J Med. 2019 Jul 25;381:328-37.

Dr. Hoque Sharmy is a hospitalist and assistant professor of medicine in the division of hospital medicine at St. Louis University School of Medicine.

Background: Venous thromboembolism and pulmonary embolism are common after major trauma. Anticoagulant prophylaxis usually is not considered because of the increased risk of bleeding. Despite the limited data, many trauma centers use inferior vena cava (IVC) filters as a primary means to prevent pulmonary embolism.

Study design: Randomized, controlled, and multicenter trial.

Setting: Four tertiary hospitals in Australia.

Synopsis: 240 major trauma patients were randomly assigned to receive either IVC filter or no IVC filter within 72 hours after admission. The primary endpoint was a composite of 90-day mortality or symptomatic pulmonary embolism confirmed on imaging. There was no difference in the rate of composite outcome in those with IVC filter, compared with those with no IVC filter.

Bottom line: After major trauma, early prophylactic placement of IVC filter did not reduce the 90-day mortality or incidence of symptomatic pulmonary embolism.

Citation: Ho KM et al. A multicenter trial of vena cava filters in severely injured patients. N Engl J Med. 2019 Jul 25;381:328-37.

Dr. Hoque Sharmy is a hospitalist and assistant professor of medicine in the division of hospital medicine at St. Louis University School of Medicine.

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

Background: Past surveys of providers revealed a tendency to select longer durations of antibiotics to reduce disease recurrence, but recent studies have shown that shorter courses of antibiotics are safe and equally effective in treatment for pneumonia. In addition, there has been a renewed focus on reducing unnecessary use of antibiotics to decrease adverse effects.

Study design: Retrospective cohort study.

Setting: 43 hospitals in the Michigan Hospital Medicine Safety Consortium.

Synopsis: A retrospective chart review of 6,481 patients hospitalized with pneumonia revealed that 67.8% of patients received excessive days of antibiotic treatment. On average, patients received 2 days of excessive treatment and 93.2% of the additional days came in the form of antibiotics prescribed at discharge.

Excessive treatment was defined as more than 5 days for community-acquired pneumonia (CAP) and more than 7 days for health care–associated pneumonia, methicillin-resistant Staphylococcus aureus, or gram-negative organisms. The authors adjusted for time to clinical stability when defining the expected duration of treatment.

After statistical adjustment, excess antibiotic days were not associated with increased rates of C. diff infection, emergency department visits, readmission, or 30-day mortality. Additional treatment was associated with increased patient-reported adverse effects including diarrhea, gastrointestinal distress, and mucosal candidiasis.

The impact of this study is limited by a few factors. The study was observational and relied on provider documentation and patient reporting of adverse events. Also, it was published prior to updates to the Infectious Diseases Society of America CAP guidelines, which may affect how it will be interpreted once those guidelines are released.

Bottom line: Adherence to the shortest effective duration of antibiotic treatment for pneumonia may lead to a reduction in the rates of patient reported adverse effects while not impacting treatment success.

Citation: Vaughn VM et al. Excess antibiotic treatment duration and adverse events in patients hospitalized with pneumonia: A multihospital cohort study. Ann Intern Med. 2019 Aug 6;171(3):153-63.

Dr. Purdy is a hospitalist and assistant professor of internal medicine at St. Louis University School of Medicine.

Background: Past surveys of providers revealed a tendency to select longer durations of antibiotics to reduce disease recurrence, but recent studies have shown that shorter courses of antibiotics are safe and equally effective in treatment for pneumonia. In addition, there has been a renewed focus on reducing unnecessary use of antibiotics to decrease adverse effects.

Study design: Retrospective cohort study.

Setting: 43 hospitals in the Michigan Hospital Medicine Safety Consortium.

Synopsis: A retrospective chart review of 6,481 patients hospitalized with pneumonia revealed that 67.8% of patients received excessive days of antibiotic treatment. On average, patients received 2 days of excessive treatment and 93.2% of the additional days came in the form of antibiotics prescribed at discharge.

Excessive treatment was defined as more than 5 days for community-acquired pneumonia (CAP) and more than 7 days for health care–associated pneumonia, methicillin-resistant Staphylococcus aureus, or gram-negative organisms. The authors adjusted for time to clinical stability when defining the expected duration of treatment.

After statistical adjustment, excess antibiotic days were not associated with increased rates of C. diff infection, emergency department visits, readmission, or 30-day mortality. Additional treatment was associated with increased patient-reported adverse effects including diarrhea, gastrointestinal distress, and mucosal candidiasis.

The impact of this study is limited by a few factors. The study was observational and relied on provider documentation and patient reporting of adverse events. Also, it was published prior to updates to the Infectious Diseases Society of America CAP guidelines, which may affect how it will be interpreted once those guidelines are released.

Bottom line: Adherence to the shortest effective duration of antibiotic treatment for pneumonia may lead to a reduction in the rates of patient reported adverse effects while not impacting treatment success.

Citation: Vaughn VM et al. Excess antibiotic treatment duration and adverse events in patients hospitalized with pneumonia: A multihospital cohort study. Ann Intern Med. 2019 Aug 6;171(3):153-63.

Dr. Purdy is a hospitalist and assistant professor of internal medicine at St. Louis University School of Medicine.

Background: Past surveys of providers revealed a tendency to select longer durations of antibiotics to reduce disease recurrence, but recent studies have shown that shorter courses of antibiotics are safe and equally effective in treatment for pneumonia. In addition, there has been a renewed focus on reducing unnecessary use of antibiotics to decrease adverse effects.

Study design: Retrospective cohort study.

Setting: 43 hospitals in the Michigan Hospital Medicine Safety Consortium.

Synopsis: A retrospective chart review of 6,481 patients hospitalized with pneumonia revealed that 67.8% of patients received excessive days of antibiotic treatment. On average, patients received 2 days of excessive treatment and 93.2% of the additional days came in the form of antibiotics prescribed at discharge.

Excessive treatment was defined as more than 5 days for community-acquired pneumonia (CAP) and more than 7 days for health care–associated pneumonia, methicillin-resistant Staphylococcus aureus, or gram-negative organisms. The authors adjusted for time to clinical stability when defining the expected duration of treatment.

After statistical adjustment, excess antibiotic days were not associated with increased rates of C. diff infection, emergency department visits, readmission, or 30-day mortality. Additional treatment was associated with increased patient-reported adverse effects including diarrhea, gastrointestinal distress, and mucosal candidiasis.

The impact of this study is limited by a few factors. The study was observational and relied on provider documentation and patient reporting of adverse events. Also, it was published prior to updates to the Infectious Diseases Society of America CAP guidelines, which may affect how it will be interpreted once those guidelines are released.

Bottom line: Adherence to the shortest effective duration of antibiotic treatment for pneumonia may lead to a reduction in the rates of patient reported adverse effects while not impacting treatment success.

Citation: Vaughn VM et al. Excess antibiotic treatment duration and adverse events in patients hospitalized with pneumonia: A multihospital cohort study. Ann Intern Med. 2019 Aug 6;171(3):153-63.

Dr. Purdy is a hospitalist and assistant professor of internal medicine at St. Louis University School of Medicine.

Clinical question: Is early glucocorticoid therapy associated with reduced mortality or need for mechanical ventilation in hospitalized patients with SARS-CoV-2 infection?

Background: Glucocorticoids have been used as adjunctive treatment in some infections with inflammatory responses, but their efficacy in COVID-19 infections had not been entirely clear. The RECOVERY trial found a subset of patients with COVID-19 who may benefit from treatment with glucocorticoids. The ideal role of steroids in this infection, and who the subset of patients might be for whom they would benefit, is so far unclear.

Study design: Retrospective cohort analysis.

Setting: Large academic health center in New York.

Synopsis: Researchers analyzed admissions of COVID-19 positive patients hospitalized between March 11, 2020 and April 13, 2020 who did not die or become mechanically ventilated within the first 48 hours of admission. Patients treated with glucocorticoids within 48 hours of admission were compared with patients who were not treated with glucocorticoids during this time frame. In total, 2,998 patients were examined, of whom 1,806 met inclusion criteria, and 140 (7.7%) were treated with glucocorticoids within 48 hours of admission. These treated patients were more likely to have an underlying pulmonary or rheumatologic comorbidity. Early use of glucocorticoids was not associated with in-hospital mortality or mechanical ventilation in either adjusted or unadjusted models. However, if the initial C-reactive protein (CRP) was >20mg/dL, this was associated with a reduced risk of mortality or mechanical ventilation in unadjusted (odds ratio, 0.23; 95% confidence interval, 0.08-0.70) and adjusted analyses for clinical characteristics (adjusted OR, 0.20; 95% CI, 0.06-0.67). Conversely, treatment in patients with CRP <10mg/dL was associated with significantly increased risk of mortality or ventilation during analysis.

Bottom line: Glucocorticoids can benefit patients with significantly elevated CRP but may be harmful to those with lower CRPs.

Citation: Keller MJ et al. Effect of systemic glucocorticoids on mortality or mechanical ventilation in patients with COVID-19. J Hosp Med. 2020;8;489-493. Published online first. 2020 Jul 22. doi:10.12788/jhm.3497.
 

Dr. Halpern is a med-peds hospitalist at Brigham and Women’s Hospital in Boston.

Clinical question: Is early glucocorticoid therapy associated with reduced mortality or need for mechanical ventilation in hospitalized patients with SARS-CoV-2 infection?

Background: Glucocorticoids have been used as adjunctive treatment in some infections with inflammatory responses, but their efficacy in COVID-19 infections had not been entirely clear. The RECOVERY trial found a subset of patients with COVID-19 who may benefit from treatment with glucocorticoids. The ideal role of steroids in this infection, and who the subset of patients might be for whom they would benefit, is so far unclear.

Study design: Retrospective cohort analysis.

Setting: Large academic health center in New York.

Synopsis: Researchers analyzed admissions of COVID-19 positive patients hospitalized between March 11, 2020 and April 13, 2020 who did not die or become mechanically ventilated within the first 48 hours of admission. Patients treated with glucocorticoids within 48 hours of admission were compared with patients who were not treated with glucocorticoids during this time frame. In total, 2,998 patients were examined, of whom 1,806 met inclusion criteria, and 140 (7.7%) were treated with glucocorticoids within 48 hours of admission. These treated patients were more likely to have an underlying pulmonary or rheumatologic comorbidity. Early use of glucocorticoids was not associated with in-hospital mortality or mechanical ventilation in either adjusted or unadjusted models. However, if the initial C-reactive protein (CRP) was >20mg/dL, this was associated with a reduced risk of mortality or mechanical ventilation in unadjusted (odds ratio, 0.23; 95% confidence interval, 0.08-0.70) and adjusted analyses for clinical characteristics (adjusted OR, 0.20; 95% CI, 0.06-0.67). Conversely, treatment in patients with CRP <10mg/dL was associated with significantly increased risk of mortality or ventilation during analysis.

Bottom line: Glucocorticoids can benefit patients with significantly elevated CRP but may be harmful to those with lower CRPs.

Citation: Keller MJ et al. Effect of systemic glucocorticoids on mortality or mechanical ventilation in patients with COVID-19. J Hosp Med. 2020;8;489-493. Published online first. 2020 Jul 22. doi:10.12788/jhm.3497.
 

Dr. Halpern is a med-peds hospitalist at Brigham and Women’s Hospital in Boston.

Clinical question: Is early glucocorticoid therapy associated with reduced mortality or need for mechanical ventilation in hospitalized patients with SARS-CoV-2 infection?

Background: Glucocorticoids have been used as adjunctive treatment in some infections with inflammatory responses, but their efficacy in COVID-19 infections had not been entirely clear. The RECOVERY trial found a subset of patients with COVID-19 who may benefit from treatment with glucocorticoids. The ideal role of steroids in this infection, and who the subset of patients might be for whom they would benefit, is so far unclear.

Study design: Retrospective cohort analysis.

Setting: Large academic health center in New York.

Synopsis: Researchers analyzed admissions of COVID-19 positive patients hospitalized between March 11, 2020 and April 13, 2020 who did not die or become mechanically ventilated within the first 48 hours of admission. Patients treated with glucocorticoids within 48 hours of admission were compared with patients who were not treated with glucocorticoids during this time frame. In total, 2,998 patients were examined, of whom 1,806 met inclusion criteria, and 140 (7.7%) were treated with glucocorticoids within 48 hours of admission. These treated patients were more likely to have an underlying pulmonary or rheumatologic comorbidity. Early use of glucocorticoids was not associated with in-hospital mortality or mechanical ventilation in either adjusted or unadjusted models. However, if the initial C-reactive protein (CRP) was >20mg/dL, this was associated with a reduced risk of mortality or mechanical ventilation in unadjusted (odds ratio, 0.23; 95% confidence interval, 0.08-0.70) and adjusted analyses for clinical characteristics (adjusted OR, 0.20; 95% CI, 0.06-0.67). Conversely, treatment in patients with CRP <10mg/dL was associated with significantly increased risk of mortality or ventilation during analysis.

Bottom line: Glucocorticoids can benefit patients with significantly elevated CRP but may be harmful to those with lower CRPs.

Citation: Keller MJ et al. Effect of systemic glucocorticoids on mortality or mechanical ventilation in patients with COVID-19. J Hosp Med. 2020;8;489-493. Published online first. 2020 Jul 22. doi:10.12788/jhm.3497.
 

Dr. Halpern is a med-peds hospitalist at Brigham and Women’s Hospital in Boston.

Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 10⁹ cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 10⁹ cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 10⁹ cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

Background: A previous study has shown that patients with acute COPD exacerbations had little difference in rate of clinical cure with placebo or antibiotics when CRP is less than 40 mg/L.

Setting: 86 general medical practices in the United Kingdom from January 2015 through September 2017.

Synopsis: More than 600 patients who presented to a primary care physician with an acute COPD exacerbation were randomized to point of care CRP testing vs. usual care. Clinicians in the CRP testing group were provided with a point-of-care testing unit along with an algorithm for results. If the CRP was greater than 40 mg/L, antibiotics were thought to be beneficial; but they were urged not to prescribe antibiotics if the level was less than 20 mg/L. For levels between 20 mg/L and 40 mg/L, it was suggested that antibiotics might be beneficial if the sputum is purulent.

The primary outcomes were patient-reported use of antibiotics for an acute COPD exacerbation within 4 weeks of randomization along with measurement of COPD-related health status on the Clinical COPD Questionnaire at 2 weeks of randomization. Fewer antibiotics were prescribed in the CRP testing group over the usual care group (57% vs. 77%). The adjusted mean difference in the Clinical COPD Questionnaire total score at 2 weeks was –0.19 points, in favor of the CRP-guided group.

Bottom line: The use of point-of-care testing CRP as an adjunctive guide to antibiotic use in acute COPD exacerbations may lower the amount of antibiotic prescribing without compromising clinical outcomes.

Citation: Butler CC et al. C-reactive protein testing to guide antibiotics prescribing for COPD exacerbations. N Engl J Med. 2019 Jul 11; 381:111-120.

Dr. Choksi is a hospitalist and associate professor of internal medicine at Saint Louis University, where she is assistant dean of admissions. She is president of the SHM St. Louis Chapter.

Background: A previous study has shown that patients with acute COPD exacerbations had little difference in rate of clinical cure with placebo or antibiotics when CRP is less than 40 mg/L.

Setting: 86 general medical practices in the United Kingdom from January 2015 through September 2017.

Synopsis: More than 600 patients who presented to a primary care physician with an acute COPD exacerbation were randomized to point of care CRP testing vs. usual care. Clinicians in the CRP testing group were provided with a point-of-care testing unit along with an algorithm for results. If the CRP was greater than 40 mg/L, antibiotics were thought to be beneficial; but they were urged not to prescribe antibiotics if the level was less than 20 mg/L. For levels between 20 mg/L and 40 mg/L, it was suggested that antibiotics might be beneficial if the sputum is purulent.

The primary outcomes were patient-reported use of antibiotics for an acute COPD exacerbation within 4 weeks of randomization along with measurement of COPD-related health status on the Clinical COPD Questionnaire at 2 weeks of randomization. Fewer antibiotics were prescribed in the CRP testing group over the usual care group (57% vs. 77%). The adjusted mean difference in the Clinical COPD Questionnaire total score at 2 weeks was –0.19 points, in favor of the CRP-guided group.

Bottom line: The use of point-of-care testing CRP as an adjunctive guide to antibiotic use in acute COPD exacerbations may lower the amount of antibiotic prescribing without compromising clinical outcomes.

Citation: Butler CC et al. C-reactive protein testing to guide antibiotics prescribing for COPD exacerbations. N Engl J Med. 2019 Jul 11; 381:111-120.

Dr. Choksi is a hospitalist and associate professor of internal medicine at Saint Louis University, where she is assistant dean of admissions. She is president of the SHM St. Louis Chapter.

Background: A previous study has shown that patients with acute COPD exacerbations had little difference in rate of clinical cure with placebo or antibiotics when CRP is less than 40 mg/L.

Setting: 86 general medical practices in the United Kingdom from January 2015 through September 2017.

Synopsis: More than 600 patients who presented to a primary care physician with an acute COPD exacerbation were randomized to point of care CRP testing vs. usual care. Clinicians in the CRP testing group were provided with a point-of-care testing unit along with an algorithm for results. If the CRP was greater than 40 mg/L, antibiotics were thought to be beneficial; but they were urged not to prescribe antibiotics if the level was less than 20 mg/L. For levels between 20 mg/L and 40 mg/L, it was suggested that antibiotics might be beneficial if the sputum is purulent.

The primary outcomes were patient-reported use of antibiotics for an acute COPD exacerbation within 4 weeks of randomization along with measurement of COPD-related health status on the Clinical COPD Questionnaire at 2 weeks of randomization. Fewer antibiotics were prescribed in the CRP testing group over the usual care group (57% vs. 77%). The adjusted mean difference in the Clinical COPD Questionnaire total score at 2 weeks was –0.19 points, in favor of the CRP-guided group.

Bottom line: The use of point-of-care testing CRP as an adjunctive guide to antibiotic use in acute COPD exacerbations may lower the amount of antibiotic prescribing without compromising clinical outcomes.

Citation: Butler CC et al. C-reactive protein testing to guide antibiotics prescribing for COPD exacerbations. N Engl J Med. 2019 Jul 11; 381:111-120.

Dr. Choksi is a hospitalist and associate professor of internal medicine at Saint Louis University, where she is assistant dean of admissions. She is president of the SHM St. Louis Chapter.

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the antiviral baloxavir marboxil (Xofluza) to include postexposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, said in a press release.

In addition, Xofluza, which was previously available only in tablet form, is also now available as granules for mixing in water, the FDA said.

The agency first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours.

A year later, the FDA expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

The safety and efficacy of Xofluza for influenza postexposure prophylaxis is supported by a randomized, double-blind, controlled trial involving 607 people aged 12 years and older. After exposure to a person with influenza in their household, they received a single dose of Xofluza or placebo.

The primary endpoint was the proportion of individuals who became infected with influenza and presented with fever and at least one respiratory symptom from day 1 to day 10.

Of the 303 people who received Xofluza, 1% of individuals met these criteria, compared with 13% of those who received placebo.

The most common adverse effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.

Hypersensitivity, including anaphylaxis, can occur in patients taking Xofluza. The antiviral is contraindicated in people with a known hypersensitivity reaction to Xofluza.

Xofluza should not be coadministered with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminium, or zinc.

Full prescribing information is available online.

This article first appeared on Medscape.com.

Cigarettes are still the product of choice among U.S. adults who use tobacco, but the youngest adults are more likely to use e-cigarettes than any other product, according to data from the 2019 National Health Interview Survey.

Just under 21% of all adults (an estimated 50.6 million individuals) said they used tobacco products “every day” or “some days,” with cigarette use reported by the largest share of respondents (14.0%) and e-cigarettes next at 4.5%, Monica E. Cornelius, PhD, and associates said in the Morbidity and Mortality Weekly Report.

Among adults aged 18-24 years, however, e-cigarettes were used by 9.3% of respondents in 2019, compared with 8.0% who used cigarettes every day or some days. Current e-cigarette use was 6.4% in 25- to 44-year-olds and continued to diminish with increasing age, said Dr. Cornelius and associates at the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion.

Men were more likely than women to use e-cigarettes (5.5% vs. 3.5%), and to use any tobacco product (26.2% vs. 15.7%). Use of other products, including cigarettes (15.3% for men vs. 12.7% for women), followed the same pattern to varying degrees, the national survey data show.

“Differences in prevalence of tobacco use also were also seen across population groups, with higher prevalence among those with a [high school equivalency degree], American Indian/Alaska Natives, uninsured adults and adults with Medicaid, and [lesbian, gay, or bisexual] adults,” the investigators said.

Among those groups, overall tobacco use and cigarette use were highest in those with an equivalency degree (43.8%, 37.1%), while lesbian/gay/bisexual individuals had the highest prevalence of e-cigarette use at 11.5%, they reported.

“As part of a comprehensive approach” to reduce tobacco-related disease and death, Dr. Cornelius and associates suggested, “targeted interventions are also warranted to reach subpopulations with the highest prevalence of use, which might vary by tobacco product type.”

[email protected]

SOURCE: Cornelius ME et al. MMWR. 2020 Nov 20;69(46);1736-42.

Cigarettes are still the product of choice among U.S. adults who use tobacco, but the youngest adults are more likely to use e-cigarettes than any other product, according to data from the 2019 National Health Interview Survey.

Just under 21% of all adults (an estimated 50.6 million individuals) said they used tobacco products “every day” or “some days,” with cigarette use reported by the largest share of respondents (14.0%) and e-cigarettes next at 4.5%, Monica E. Cornelius, PhD, and associates said in the Morbidity and Mortality Weekly Report.

Among adults aged 18-24 years, however, e-cigarettes were used by 9.3% of respondents in 2019, compared with 8.0% who used cigarettes every day or some days. Current e-cigarette use was 6.4% in 25- to 44-year-olds and continued to diminish with increasing age, said Dr. Cornelius and associates at the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion.

Men were more likely than women to use e-cigarettes (5.5% vs. 3.5%), and to use any tobacco product (26.2% vs. 15.7%). Use of other products, including cigarettes (15.3% for men vs. 12.7% for women), followed the same pattern to varying degrees, the national survey data show.

“Differences in prevalence of tobacco use also were also seen across population groups, with higher prevalence among those with a [high school equivalency degree], American Indian/Alaska Natives, uninsured adults and adults with Medicaid, and [lesbian, gay, or bisexual] adults,” the investigators said.

Among those groups, overall tobacco use and cigarette use were highest in those with an equivalency degree (43.8%, 37.1%), while lesbian/gay/bisexual individuals had the highest prevalence of e-cigarette use at 11.5%, they reported.

“As part of a comprehensive approach” to reduce tobacco-related disease and death, Dr. Cornelius and associates suggested, “targeted interventions are also warranted to reach subpopulations with the highest prevalence of use, which might vary by tobacco product type.”

[email protected]

SOURCE: Cornelius ME et al. MMWR. 2020 Nov 20;69(46);1736-42.

Cigarettes are still the product of choice among U.S. adults who use tobacco, but the youngest adults are more likely to use e-cigarettes than any other product, according to data from the 2019 National Health Interview Survey.

Just under 21% of all adults (an estimated 50.6 million individuals) said they used tobacco products “every day” or “some days,” with cigarette use reported by the largest share of respondents (14.0%) and e-cigarettes next at 4.5%, Monica E. Cornelius, PhD, and associates said in the Morbidity and Mortality Weekly Report.

Among adults aged 18-24 years, however, e-cigarettes were used by 9.3% of respondents in 2019, compared with 8.0% who used cigarettes every day or some days. Current e-cigarette use was 6.4% in 25- to 44-year-olds and continued to diminish with increasing age, said Dr. Cornelius and associates at the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion.

Men were more likely than women to use e-cigarettes (5.5% vs. 3.5%), and to use any tobacco product (26.2% vs. 15.7%). Use of other products, including cigarettes (15.3% for men vs. 12.7% for women), followed the same pattern to varying degrees, the national survey data show.

“Differences in prevalence of tobacco use also were also seen across population groups, with higher prevalence among those with a [high school equivalency degree], American Indian/Alaska Natives, uninsured adults and adults with Medicaid, and [lesbian, gay, or bisexual] adults,” the investigators said.

Among those groups, overall tobacco use and cigarette use were highest in those with an equivalency degree (43.8%, 37.1%), while lesbian/gay/bisexual individuals had the highest prevalence of e-cigarette use at 11.5%, they reported.

“As part of a comprehensive approach” to reduce tobacco-related disease and death, Dr. Cornelius and associates suggested, “targeted interventions are also warranted to reach subpopulations with the highest prevalence of use, which might vary by tobacco product type.”

[email protected]

SOURCE: Cornelius ME et al. MMWR. 2020 Nov 20;69(46);1736-42.