Pulmonology

Schools without mask requirements were three-and-a-half times more likely to have COVID-19 outbreaks than those enforcing mask mandates, according to new Centers for Disease Control and Prevention research.

The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.

“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.

But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.

Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.

“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.

Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.

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

Schools without mask requirements were three-and-a-half times more likely to have COVID-19 outbreaks than those enforcing mask mandates, according to new Centers for Disease Control and Prevention research.

The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.

“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.

But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.

Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.

“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.

Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.

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

Schools without mask requirements were three-and-a-half times more likely to have COVID-19 outbreaks than those enforcing mask mandates, according to new Centers for Disease Control and Prevention research.

The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.

“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.

But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.

Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.

“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.

Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.

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

Patients with a baseline DLCO (diffusing capacity for carbon monoxide) of < 60% of predicted have more severe disease clinical expression with higher mortality risk, according to a long-term observational study of Global Initiative for Obstructive Lung Disease (GOLD) I chronic obstructive pulmonary disease (COPD) patients. Clarifying mechanisms of low DLCO may help clinicians direct interventions toward ameliorating the low capacity, Juan Pablo de Torres, MD, and colleagues wrote in the journal CHEST^®.

Defining increased risk

“Can a DLCO threshold help define an increased risk of death and a different clinical presentation in GOLD I patients?” the researchers questioned. For evaluation of COPD, the GOLD does not currently promote the use of DLCO, and the clinical and prognostic utility of a low DLCO has not been studied, the authors noted.

Several COPD studies, however, have shown associations between low DLCO values and reduced exercise capacity, increased symptoms, risk of severe exacerbations, and mortality. The patients included in these studies, however, have generally had moderate to severe airflow limitation, and have not had postbronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) < 0.70 and an FEV₁ ≥ 80%, defined by GOLD as COPD spirometric stage I. These mild obstruction GOLD I patients, in large epidemiological studies, do have increased risk of death. But it is often assumed, Dr. de Torres and colleagues noted, that “mild” suggests a good prognosis. They propose that a simple DLCO measurement could help identify those GOLD I patients with “worse overall COPD compromise and an increased risk of death.” Importantly, GOLD I represents the largest percentage of patients with airflow limitation that epidemiological studies have identified.

The researchers enrolled 360 GOLD stage I COPD patients, recording their age, sex, pack-years’ history, body mass index, dyspnea, lung function measurements, exercise capacity, BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, and history of exacerbations, and followed them for a mean of 109 months. They identified a cutoff DLCO value for all-cause mortality, compared the clinical and physiological characteristics of patients above and below the threshold, and explored the predictive power of that cutoff value.
 

All-cause mortality difference

The mean age in the overall population studied was 63 years (31% were women), with 43% active smokers, and pack-years history of 45. Overall mortality was 11% during the follow-up period. The predominantly male population was mildly overweight, had few comorbidities, normal FEV₁ values, mild dyspnea, normal 6-minute walk distance, and very few exacerbations.

Analysis showed a DLCO cutoff value of < 60% was associated with a significant all-cause mortality differential (DLCO ≥ 60%: 9% vs. DLCO < 60%: 23%, P = .01). At a same FEV₁% predicted and Charlson score, patients with DLCO < 60% had lower BMI, more dyspnea, lower inspiratory capacity (IC)/total lung capacity (TLC) ratio, lower 6-minute walk distance, and higher BODE index. Adjusted Cox multiple regression analysis confirmed that a DLCO < 60% was associated with an all-cause mortality hazard ratio [HR] of 3.37, (95% confidence interval, 1.35-8.39; P = .009).
 

Multiorgan loss of tissue

The researchers found that patients with baseline DLCO < 60% were more likely to be women (46% versus 28%), and to have a lower BMI (25 vs. 27), higher pack-year history (54 vs. 43), the same spirometric values but lower IC/TLC ratio (.37 vs. .40), a lower walk distance (443 vs. 485 meters), higher dyspnea (MRC score 1.1 vs. .7), similar exacerbation rate, higher BODE index (.5 vs. .2) and higher mortality than patients with higher DLCO % predicted values. This group, Dr. de Torres and colleagues suggest, represents a multiorgan loss of tissue, a phenotype associated with worse clinical outcomes and prognosis.

“Low DLCO in these patients,” Dr. de Torres said in an interview, “could mainly be secondary to coexistent emphysema, which is the most common cause of low DLCO in this population. Also possible, but less likely, is coexistent pulmonary hypertension.” He noted further that “This study opens the door to research specifically testing if such is the case, and if it is, for clinicians to use available therapies to prevent adverse outcomes.”
 

Comorbidity burden

Patients with GOLD I COPD die more often of cardiovascular disease instead of underlying lung disease, according to Richard H. Zou, MD, and Jessica Bon, MD, of the University of Pittsburgh, in an accompanying editorial in the journal CHEST.

Increased mortality rates, they suggest, may be related to higher comorbidity burden, particularly comorbidities associated with cardiovascular-related health. Subclinical cardiovascular disease is a common comorbidity in COPD, and concomitant endothelial dysfunction has been associated with both cardiovascular disease and early emphysema in smokers. They may have disproportionately reduced DLCO levels because of parenchymal destruction.

“This study suggests that DLCO can be used to identify patients with GOLD I COPD at increased death risk and that individuals with mild airflow obstruction with DLCO <60% predicted are a clinical phenotype distinct from those with higher DLCO levels,” Dr. Zhou and Dr. Bon concluded.

The researchers and the editorialists declared that they had no disclosures. One of the three cohorts assessed in the current study (CHAIN cohort in Spain) received funding from AstraZeneca.

Patients with a baseline DLCO (diffusing capacity for carbon monoxide) of < 60% of predicted have more severe disease clinical expression with higher mortality risk, according to a long-term observational study of Global Initiative for Obstructive Lung Disease (GOLD) I chronic obstructive pulmonary disease (COPD) patients. Clarifying mechanisms of low DLCO may help clinicians direct interventions toward ameliorating the low capacity, Juan Pablo de Torres, MD, and colleagues wrote in the journal CHEST^®.

Defining increased risk

“Can a DLCO threshold help define an increased risk of death and a different clinical presentation in GOLD I patients?” the researchers questioned. For evaluation of COPD, the GOLD does not currently promote the use of DLCO, and the clinical and prognostic utility of a low DLCO has not been studied, the authors noted.

Several COPD studies, however, have shown associations between low DLCO values and reduced exercise capacity, increased symptoms, risk of severe exacerbations, and mortality. The patients included in these studies, however, have generally had moderate to severe airflow limitation, and have not had postbronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) < 0.70 and an FEV₁ ≥ 80%, defined by GOLD as COPD spirometric stage I. These mild obstruction GOLD I patients, in large epidemiological studies, do have increased risk of death. But it is often assumed, Dr. de Torres and colleagues noted, that “mild” suggests a good prognosis. They propose that a simple DLCO measurement could help identify those GOLD I patients with “worse overall COPD compromise and an increased risk of death.” Importantly, GOLD I represents the largest percentage of patients with airflow limitation that epidemiological studies have identified.

The researchers enrolled 360 GOLD stage I COPD patients, recording their age, sex, pack-years’ history, body mass index, dyspnea, lung function measurements, exercise capacity, BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, and history of exacerbations, and followed them for a mean of 109 months. They identified a cutoff DLCO value for all-cause mortality, compared the clinical and physiological characteristics of patients above and below the threshold, and explored the predictive power of that cutoff value.
 

All-cause mortality difference

The mean age in the overall population studied was 63 years (31% were women), with 43% active smokers, and pack-years history of 45. Overall mortality was 11% during the follow-up period. The predominantly male population was mildly overweight, had few comorbidities, normal FEV₁ values, mild dyspnea, normal 6-minute walk distance, and very few exacerbations.

Analysis showed a DLCO cutoff value of < 60% was associated with a significant all-cause mortality differential (DLCO ≥ 60%: 9% vs. DLCO < 60%: 23%, P = .01). At a same FEV₁% predicted and Charlson score, patients with DLCO < 60% had lower BMI, more dyspnea, lower inspiratory capacity (IC)/total lung capacity (TLC) ratio, lower 6-minute walk distance, and higher BODE index. Adjusted Cox multiple regression analysis confirmed that a DLCO < 60% was associated with an all-cause mortality hazard ratio [HR] of 3.37, (95% confidence interval, 1.35-8.39; P = .009).
 

Multiorgan loss of tissue

The researchers found that patients with baseline DLCO < 60% were more likely to be women (46% versus 28%), and to have a lower BMI (25 vs. 27), higher pack-year history (54 vs. 43), the same spirometric values but lower IC/TLC ratio (.37 vs. .40), a lower walk distance (443 vs. 485 meters), higher dyspnea (MRC score 1.1 vs. .7), similar exacerbation rate, higher BODE index (.5 vs. .2) and higher mortality than patients with higher DLCO % predicted values. This group, Dr. de Torres and colleagues suggest, represents a multiorgan loss of tissue, a phenotype associated with worse clinical outcomes and prognosis.

“Low DLCO in these patients,” Dr. de Torres said in an interview, “could mainly be secondary to coexistent emphysema, which is the most common cause of low DLCO in this population. Also possible, but less likely, is coexistent pulmonary hypertension.” He noted further that “This study opens the door to research specifically testing if such is the case, and if it is, for clinicians to use available therapies to prevent adverse outcomes.”
 

Comorbidity burden

Patients with GOLD I COPD die more often of cardiovascular disease instead of underlying lung disease, according to Richard H. Zou, MD, and Jessica Bon, MD, of the University of Pittsburgh, in an accompanying editorial in the journal CHEST.

Increased mortality rates, they suggest, may be related to higher comorbidity burden, particularly comorbidities associated with cardiovascular-related health. Subclinical cardiovascular disease is a common comorbidity in COPD, and concomitant endothelial dysfunction has been associated with both cardiovascular disease and early emphysema in smokers. They may have disproportionately reduced DLCO levels because of parenchymal destruction.

“This study suggests that DLCO can be used to identify patients with GOLD I COPD at increased death risk and that individuals with mild airflow obstruction with DLCO <60% predicted are a clinical phenotype distinct from those with higher DLCO levels,” Dr. Zhou and Dr. Bon concluded.

The researchers and the editorialists declared that they had no disclosures. One of the three cohorts assessed in the current study (CHAIN cohort in Spain) received funding from AstraZeneca.

Patients with a baseline DLCO (diffusing capacity for carbon monoxide) of < 60% of predicted have more severe disease clinical expression with higher mortality risk, according to a long-term observational study of Global Initiative for Obstructive Lung Disease (GOLD) I chronic obstructive pulmonary disease (COPD) patients. Clarifying mechanisms of low DLCO may help clinicians direct interventions toward ameliorating the low capacity, Juan Pablo de Torres, MD, and colleagues wrote in the journal CHEST^®.

Defining increased risk

“Can a DLCO threshold help define an increased risk of death and a different clinical presentation in GOLD I patients?” the researchers questioned. For evaluation of COPD, the GOLD does not currently promote the use of DLCO, and the clinical and prognostic utility of a low DLCO has not been studied, the authors noted.

Several COPD studies, however, have shown associations between low DLCO values and reduced exercise capacity, increased symptoms, risk of severe exacerbations, and mortality. The patients included in these studies, however, have generally had moderate to severe airflow limitation, and have not had postbronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) < 0.70 and an FEV₁ ≥ 80%, defined by GOLD as COPD spirometric stage I. These mild obstruction GOLD I patients, in large epidemiological studies, do have increased risk of death. But it is often assumed, Dr. de Torres and colleagues noted, that “mild” suggests a good prognosis. They propose that a simple DLCO measurement could help identify those GOLD I patients with “worse overall COPD compromise and an increased risk of death.” Importantly, GOLD I represents the largest percentage of patients with airflow limitation that epidemiological studies have identified.

The researchers enrolled 360 GOLD stage I COPD patients, recording their age, sex, pack-years’ history, body mass index, dyspnea, lung function measurements, exercise capacity, BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, and history of exacerbations, and followed them for a mean of 109 months. They identified a cutoff DLCO value for all-cause mortality, compared the clinical and physiological characteristics of patients above and below the threshold, and explored the predictive power of that cutoff value.
 

All-cause mortality difference

The mean age in the overall population studied was 63 years (31% were women), with 43% active smokers, and pack-years history of 45. Overall mortality was 11% during the follow-up period. The predominantly male population was mildly overweight, had few comorbidities, normal FEV₁ values, mild dyspnea, normal 6-minute walk distance, and very few exacerbations.

Analysis showed a DLCO cutoff value of < 60% was associated with a significant all-cause mortality differential (DLCO ≥ 60%: 9% vs. DLCO < 60%: 23%, P = .01). At a same FEV₁% predicted and Charlson score, patients with DLCO < 60% had lower BMI, more dyspnea, lower inspiratory capacity (IC)/total lung capacity (TLC) ratio, lower 6-minute walk distance, and higher BODE index. Adjusted Cox multiple regression analysis confirmed that a DLCO < 60% was associated with an all-cause mortality hazard ratio [HR] of 3.37, (95% confidence interval, 1.35-8.39; P = .009).
 

Multiorgan loss of tissue

The researchers found that patients with baseline DLCO < 60% were more likely to be women (46% versus 28%), and to have a lower BMI (25 vs. 27), higher pack-year history (54 vs. 43), the same spirometric values but lower IC/TLC ratio (.37 vs. .40), a lower walk distance (443 vs. 485 meters), higher dyspnea (MRC score 1.1 vs. .7), similar exacerbation rate, higher BODE index (.5 vs. .2) and higher mortality than patients with higher DLCO % predicted values. This group, Dr. de Torres and colleagues suggest, represents a multiorgan loss of tissue, a phenotype associated with worse clinical outcomes and prognosis.

“Low DLCO in these patients,” Dr. de Torres said in an interview, “could mainly be secondary to coexistent emphysema, which is the most common cause of low DLCO in this population. Also possible, but less likely, is coexistent pulmonary hypertension.” He noted further that “This study opens the door to research specifically testing if such is the case, and if it is, for clinicians to use available therapies to prevent adverse outcomes.”
 

Comorbidity burden

Patients with GOLD I COPD die more often of cardiovascular disease instead of underlying lung disease, according to Richard H. Zou, MD, and Jessica Bon, MD, of the University of Pittsburgh, in an accompanying editorial in the journal CHEST.

Increased mortality rates, they suggest, may be related to higher comorbidity burden, particularly comorbidities associated with cardiovascular-related health. Subclinical cardiovascular disease is a common comorbidity in COPD, and concomitant endothelial dysfunction has been associated with both cardiovascular disease and early emphysema in smokers. They may have disproportionately reduced DLCO levels because of parenchymal destruction.

“This study suggests that DLCO can be used to identify patients with GOLD I COPD at increased death risk and that individuals with mild airflow obstruction with DLCO <60% predicted are a clinical phenotype distinct from those with higher DLCO levels,” Dr. Zhou and Dr. Bon concluded.

The researchers and the editorialists declared that they had no disclosures. One of the three cohorts assessed in the current study (CHAIN cohort in Spain) received funding from AstraZeneca.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

The likelihood that a child will survive a near-drowning without long-term damage is substantially greater if a bystander attempts a rescue, even if that person doesn’t perform cardiopulmonary resuscitation (CPR), according to new research presented October 10 at the American Academy of Pediatrics (AAP) 2021 National Conference.

“The extent to which bystander rescue is associated with reduced odds of unfavorable drowning outcomes was surprising,” said lead investigator Rohit P. Shenoi, MD, professor of pediatrics at Baylor College of Medicine and attending physician at Texas Children’s Hospital, Houston.

“While we do know that early rescue and resuscitation is helpful in preventing severe drowning injury, the degree of benefit from bystander rescue in all cases of pediatric drowning has not been described so far,” he told this news organization.

The fact that a bystander’s rescue attempt improves a child’s odds of a good outcome is not surprising on its own, but the magnitude of the finding really affirms the importance of bystander intervention, said Benjamin Hoffman, MD, professor of pediatrics at the Oregon Health & Science University School of Medicine and medical director of the Tom Sargent Safety Center at the Doernbecher Children’s Hospital, Portland.

“If an adult finds a child in the water, even if they don’t administer formal CPR, they’re going to be doing things” to try to help, Dr. Hoffman, who was not involved in this research but who specializes in child injury prevention, said in an interview. The act of intervening – whether it’s formal CPR or a CPR attempt or even just calling appropriate first responders – “likely impacts the duration of the submersion” and “clearly makes a difference.”

Drowning is the leading cause of death for children younger than 4 years, Dr. Hoffman noted, adding that the AAP recommends swimming lessons for children older than 1 year to reduce that risk.

In their cross-sectional study, Dr. Shenoi and his colleagues analyzed data on drownings and near-drownings in children and adolescents younger than 18 years using hospital, emergency medical services, and child fatality records from Harris County, Texas.

They analyzed 237 incidents from 2010 to 2013 in which the young person was submerged. Median age of the victims was 3.2 years, 60% were male, 64% were Black, Hispanic, or Native American, and 78% occurred in a swimming pool.

Unfavorable outcomes – defined as death or severe impairment after hospital discharge – were experienced by 38 victims (16%) and were significantly associated with being submerged for longer than 5 minutes (P < .001).

The odds of an unfavorable outcome dropped by 80% if a bystander attempted a rescue, whether or not they performed CPR (adjusted odds ratio, 0.2; P = .004). If the bystander performed CPR, the odds of an unfavorable outcome dropped by a similar amount, but the difference was not statistically significant (aOR, 0.22; P = .07).

However, previous research has shown a significant reduction in poor outcomes when CPR is administered to children who have been submerged, Dr. Hoffman explained.

The most important thing a bystander can do is simply get a submerged child out of the water. “Early rescue in drowning terminates what is initially a respiratory arrest from progressing to a full cardiopulmonary arrest with severe hypoxic brain injury and death,” Dr. Shenoi said.

“CPR is also very important, and rescue and resuscitation go hand in hand. We encourage all laypersons to be trained in CPR so that they can administer correct CPR techniques,” he added.

Both Dr. Shenoi and Dr. Hoffman emphasized the value of CPR training for adults, as the AAP recommends, and the importance of other precautions that reduce the risk of drowning.

“Drowning prevention should consist of multiple layers of prevention,” Dr. Shenoi said. These consist of “close, constant, and attentive supervision; isolation fencing for swimming pools; and water competency, including water-safety knowledge, basic swim skills, and the ability to recognize and respond to a swimmer in trouble, use of life jackets, and early bystander CPR.”

The relative importance of each of those layers depends on geography and circumstances, Dr. Hoffman said. Pools are the most common drowning sites in the United States overall, but they’re much more common in warmer states, such as California, Florida, and Texas, which have more pools. In contrast, drownings in Oregon are more likely to occur in rivers, so prevention is more about access to life jackets and increasing access to swim lessons.

The findings from this study drive home how important it is for physicians to provide anticipatory guidance to families on reducing the risk of drowning. Pediatricians should convey to families the need for different layers of protection, he added.

“If your family spends a lot of time around water, whether open water or swimming pools, the more layers you can provide, the better off you’re going to be,” Dr. Hoffman said.

Dr. Shenoi echoed this sentiment.

“The take-home message is to be observant if you are entrusted with the care of a child around water,” Dr. Shenoi said. “If you notice the child to be drowning, either attempt rescue yourself if it is safe to do so or enlist the help of others to save the victim as soon as possible. However, the rescuer should not place himself or herself in danger when attempting rescue.”

The five steps in the “drowning chain of survival” – preventing drowning, recognizing distress, providing flotation, removing the victim from the water, and providing care and CPR as needed – are key to reducing drowning deaths and injury, Dr. Shenoi emphasized.

Dr. Shenoi has disclosed no relevant financial relationships. Dr. Hoffman is a paid consultant on child drowning prevention for the nonprofit Anonymous Philanthropy.

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

The likelihood that a child will survive a near-drowning without long-term damage is substantially greater if a bystander attempts a rescue, even if that person doesn’t perform cardiopulmonary resuscitation (CPR), according to new research presented October 10 at the American Academy of Pediatrics (AAP) 2021 National Conference.

“The extent to which bystander rescue is associated with reduced odds of unfavorable drowning outcomes was surprising,” said lead investigator Rohit P. Shenoi, MD, professor of pediatrics at Baylor College of Medicine and attending physician at Texas Children’s Hospital, Houston.

“While we do know that early rescue and resuscitation is helpful in preventing severe drowning injury, the degree of benefit from bystander rescue in all cases of pediatric drowning has not been described so far,” he told this news organization.

The fact that a bystander’s rescue attempt improves a child’s odds of a good outcome is not surprising on its own, but the magnitude of the finding really affirms the importance of bystander intervention, said Benjamin Hoffman, MD, professor of pediatrics at the Oregon Health & Science University School of Medicine and medical director of the Tom Sargent Safety Center at the Doernbecher Children’s Hospital, Portland.

“If an adult finds a child in the water, even if they don’t administer formal CPR, they’re going to be doing things” to try to help, Dr. Hoffman, who was not involved in this research but who specializes in child injury prevention, said in an interview. The act of intervening – whether it’s formal CPR or a CPR attempt or even just calling appropriate first responders – “likely impacts the duration of the submersion” and “clearly makes a difference.”

Drowning is the leading cause of death for children younger than 4 years, Dr. Hoffman noted, adding that the AAP recommends swimming lessons for children older than 1 year to reduce that risk.

In their cross-sectional study, Dr. Shenoi and his colleagues analyzed data on drownings and near-drownings in children and adolescents younger than 18 years using hospital, emergency medical services, and child fatality records from Harris County, Texas.

They analyzed 237 incidents from 2010 to 2013 in which the young person was submerged. Median age of the victims was 3.2 years, 60% were male, 64% were Black, Hispanic, or Native American, and 78% occurred in a swimming pool.

Unfavorable outcomes – defined as death or severe impairment after hospital discharge – were experienced by 38 victims (16%) and were significantly associated with being submerged for longer than 5 minutes (P < .001).

The odds of an unfavorable outcome dropped by 80% if a bystander attempted a rescue, whether or not they performed CPR (adjusted odds ratio, 0.2; P = .004). If the bystander performed CPR, the odds of an unfavorable outcome dropped by a similar amount, but the difference was not statistically significant (aOR, 0.22; P = .07).

However, previous research has shown a significant reduction in poor outcomes when CPR is administered to children who have been submerged, Dr. Hoffman explained.

The most important thing a bystander can do is simply get a submerged child out of the water. “Early rescue in drowning terminates what is initially a respiratory arrest from progressing to a full cardiopulmonary arrest with severe hypoxic brain injury and death,” Dr. Shenoi said.

“CPR is also very important, and rescue and resuscitation go hand in hand. We encourage all laypersons to be trained in CPR so that they can administer correct CPR techniques,” he added.

Both Dr. Shenoi and Dr. Hoffman emphasized the value of CPR training for adults, as the AAP recommends, and the importance of other precautions that reduce the risk of drowning.

“Drowning prevention should consist of multiple layers of prevention,” Dr. Shenoi said. These consist of “close, constant, and attentive supervision; isolation fencing for swimming pools; and water competency, including water-safety knowledge, basic swim skills, and the ability to recognize and respond to a swimmer in trouble, use of life jackets, and early bystander CPR.”

The relative importance of each of those layers depends on geography and circumstances, Dr. Hoffman said. Pools are the most common drowning sites in the United States overall, but they’re much more common in warmer states, such as California, Florida, and Texas, which have more pools. In contrast, drownings in Oregon are more likely to occur in rivers, so prevention is more about access to life jackets and increasing access to swim lessons.

The findings from this study drive home how important it is for physicians to provide anticipatory guidance to families on reducing the risk of drowning. Pediatricians should convey to families the need for different layers of protection, he added.

“If your family spends a lot of time around water, whether open water or swimming pools, the more layers you can provide, the better off you’re going to be,” Dr. Hoffman said.

Dr. Shenoi echoed this sentiment.

“The take-home message is to be observant if you are entrusted with the care of a child around water,” Dr. Shenoi said. “If you notice the child to be drowning, either attempt rescue yourself if it is safe to do so or enlist the help of others to save the victim as soon as possible. However, the rescuer should not place himself or herself in danger when attempting rescue.”

The five steps in the “drowning chain of survival” – preventing drowning, recognizing distress, providing flotation, removing the victim from the water, and providing care and CPR as needed – are key to reducing drowning deaths and injury, Dr. Shenoi emphasized.

Dr. Shenoi has disclosed no relevant financial relationships. Dr. Hoffman is a paid consultant on child drowning prevention for the nonprofit Anonymous Philanthropy.

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

The likelihood that a child will survive a near-drowning without long-term damage is substantially greater if a bystander attempts a rescue, even if that person doesn’t perform cardiopulmonary resuscitation (CPR), according to new research presented October 10 at the American Academy of Pediatrics (AAP) 2021 National Conference.

“The extent to which bystander rescue is associated with reduced odds of unfavorable drowning outcomes was surprising,” said lead investigator Rohit P. Shenoi, MD, professor of pediatrics at Baylor College of Medicine and attending physician at Texas Children’s Hospital, Houston.

“While we do know that early rescue and resuscitation is helpful in preventing severe drowning injury, the degree of benefit from bystander rescue in all cases of pediatric drowning has not been described so far,” he told this news organization.

The fact that a bystander’s rescue attempt improves a child’s odds of a good outcome is not surprising on its own, but the magnitude of the finding really affirms the importance of bystander intervention, said Benjamin Hoffman, MD, professor of pediatrics at the Oregon Health & Science University School of Medicine and medical director of the Tom Sargent Safety Center at the Doernbecher Children’s Hospital, Portland.

“If an adult finds a child in the water, even if they don’t administer formal CPR, they’re going to be doing things” to try to help, Dr. Hoffman, who was not involved in this research but who specializes in child injury prevention, said in an interview. The act of intervening – whether it’s formal CPR or a CPR attempt or even just calling appropriate first responders – “likely impacts the duration of the submersion” and “clearly makes a difference.”

Drowning is the leading cause of death for children younger than 4 years, Dr. Hoffman noted, adding that the AAP recommends swimming lessons for children older than 1 year to reduce that risk.

In their cross-sectional study, Dr. Shenoi and his colleagues analyzed data on drownings and near-drownings in children and adolescents younger than 18 years using hospital, emergency medical services, and child fatality records from Harris County, Texas.

They analyzed 237 incidents from 2010 to 2013 in which the young person was submerged. Median age of the victims was 3.2 years, 60% were male, 64% were Black, Hispanic, or Native American, and 78% occurred in a swimming pool.

Unfavorable outcomes – defined as death or severe impairment after hospital discharge – were experienced by 38 victims (16%) and were significantly associated with being submerged for longer than 5 minutes (P < .001).

The odds of an unfavorable outcome dropped by 80% if a bystander attempted a rescue, whether or not they performed CPR (adjusted odds ratio, 0.2; P = .004). If the bystander performed CPR, the odds of an unfavorable outcome dropped by a similar amount, but the difference was not statistically significant (aOR, 0.22; P = .07).

However, previous research has shown a significant reduction in poor outcomes when CPR is administered to children who have been submerged, Dr. Hoffman explained.

The most important thing a bystander can do is simply get a submerged child out of the water. “Early rescue in drowning terminates what is initially a respiratory arrest from progressing to a full cardiopulmonary arrest with severe hypoxic brain injury and death,” Dr. Shenoi said.

“CPR is also very important, and rescue and resuscitation go hand in hand. We encourage all laypersons to be trained in CPR so that they can administer correct CPR techniques,” he added.

Both Dr. Shenoi and Dr. Hoffman emphasized the value of CPR training for adults, as the AAP recommends, and the importance of other precautions that reduce the risk of drowning.

“Drowning prevention should consist of multiple layers of prevention,” Dr. Shenoi said. These consist of “close, constant, and attentive supervision; isolation fencing for swimming pools; and water competency, including water-safety knowledge, basic swim skills, and the ability to recognize and respond to a swimmer in trouble, use of life jackets, and early bystander CPR.”

The relative importance of each of those layers depends on geography and circumstances, Dr. Hoffman said. Pools are the most common drowning sites in the United States overall, but they’re much more common in warmer states, such as California, Florida, and Texas, which have more pools. In contrast, drownings in Oregon are more likely to occur in rivers, so prevention is more about access to life jackets and increasing access to swim lessons.

The findings from this study drive home how important it is for physicians to provide anticipatory guidance to families on reducing the risk of drowning. Pediatricians should convey to families the need for different layers of protection, he added.

“If your family spends a lot of time around water, whether open water or swimming pools, the more layers you can provide, the better off you’re going to be,” Dr. Hoffman said.

Dr. Shenoi echoed this sentiment.

“The take-home message is to be observant if you are entrusted with the care of a child around water,” Dr. Shenoi said. “If you notice the child to be drowning, either attempt rescue yourself if it is safe to do so or enlist the help of others to save the victim as soon as possible. However, the rescuer should not place himself or herself in danger when attempting rescue.”

The five steps in the “drowning chain of survival” – preventing drowning, recognizing distress, providing flotation, removing the victim from the water, and providing care and CPR as needed – are key to reducing drowning deaths and injury, Dr. Shenoi emphasized.

Dr. Shenoi has disclosed no relevant financial relationships. Dr. Hoffman is a paid consultant on child drowning prevention for the nonprofit Anonymous Philanthropy.

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

A secondary consequence of public health measures to prevent the spread of SARS-CoV-2 included a concurrent reduction in risk for children to acquire and spread other respiratory viral infectious diseases. In the Rochester, N.Y., area, we had an ongoing prospective study in primary care pediatric practices that afforded an opportunity to assess the effect of the pandemic control measures on all infectious disease illness visits in young children. Specifically, in children aged 6-36 months old, our study was in place when the pandemic began with a primary objective to evaluate the changing epidemiology of acute otitis media (AOM) and nasopharyngeal colonization by potential bacterial respiratory pathogens in community-based primary care pediatric practices. As the public health measures mandated by New York State Department of Health were implemented, we prospectively quantified their effect on physician-diagnosed infectious disease illness visits. The incidence of infectious disease visits by a cohort of young children during the COVID-19 pandemic period March 15, 2020, through Dec. 31, 2020, was compared with the same time frame in the preceding year, 2019.¹

Recommendations of the New York State Department of Health for public health, changes in school and day care attendance, and clinical practice during the study time frame

On March 7, 2020, a state of emergency was declared in New York because of the COVID-19 pandemic. All schools were required to close. A mandated order for public use of masks in adults and children more than 2 years of age was enacted. In the Finger Lakes region of Upstate New York, where the two primary care pediatric practices reside, complete lockdown was partially lifted on May 15, 2020, and further lifted on June 26, 2020. Almost all regional school districts opened to at least hybrid learning models for all students starting Sept. 8, 2020. On March 6, 2020, video telehealth and telephone call visits were introduced as routine practice. Well-child visits were limited to those less than 2 years of age, then gradually expanded to all ages by late May 2020. During the “stay at home” phase of the New York State lockdown, day care services were considered an essential business. Day care child density was limited. All children less than 2 years old were required to wear a mask while in the facility. Upon arrival, children with any respiratory symptoms or fever were excluded. For the school year commencing September 2020, almost all regional school districts opened to virtual, hybrid, or in-person learning models. Exclusion occurred similar to that of the day care facilities.

Incidence of respiratory infectious disease illnesses

Clinical diagnoses and healthy visits of 144 children from March 15 to Dec. 31, 2020 (beginning of the pandemic) were compared to 215 children during the same months in 2019 (prepandemic). Pediatric SARS-CoV-2 positivity rates trended up alongside community spread. Pediatric practice positivity rates rose from 1.9% in October 2020 to 19% in December 2020.

The table shows the incidence of significantly different infectious disease illness visits in the two study cohorts.

Change in care practices

In the prepandemic period, virtual visits, leading to a diagnosis and treatment and referring children to an urgent care or hospital emergency department during regular office hours were rare. During the pandemic, this changed. Significantly increased use of telemedicine visits (P < .0001) and significantly decreased office and urgent care visits (P < .0001) occurred during the pandemic. Telehealth visits peaked the week of April 12, 2020, at 45% of all pediatric visits. In-person illness visits gradually returned to year-to-year volumes in August-September 2020 with school opening. Early in the pandemic, both pediatric offices limited patient encounters to well-child visits in the first 2 years of life to not miss opportunities for childhood vaccinations. However, some parents were reluctant to bring their children to those visits. There was no significant change in frequency of healthy child visits during the pandemic.

To our knowledge, this was the first study from primary care pediatric practices in the United States to analyze the effect on infectious diseases during the first 9 months of the pandemic, including the 6-month time period after the reopening from the first 3 months of lockdown. One prior study from a primary care network in Massachusetts reported significant decreases in respiratory infectious diseases for children aged 0-17 years during the first months of the pandemic during lockdown.² A study in Tennessee that included hospital emergency department, urgent care, primary care, and retail health clinics also reported respiratory infection diagnoses as well as antibiotic prescription were reduced in the early months of the pandemic.³

Our study shows an overall reduction in frequency of respiratory illness visits in children 6-36 months old during the first 9 months of the COVID-19 pandemic. We learned the value of using technology in the form of virtual visits to render care. Perhaps as the pandemic subsides, many of the hand-washing and sanitizing practices will remain in place and lead to less frequent illness in children in the future. However, there may be temporary negative consequences from the “immune debt” that has occurred from a prolonged time span when children were not becoming infected with respiratory pathogens.⁴ We will see what unfolds in the future.
 

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz is pediatric medical director at Rochester (N.Y.) Regional Health. Dr. Pichichero and Dr. Schulz have no conflicts of interest to disclose. This study was funded in part by the Centers for Disease Control and Prevention.

References

1. Kaur R et al. Front Pediatr. 2021;(9)722483:1-8.

2. Hatoun J et al. Pediatrics. 2020;146(4):e2020006460.

3. Katz SE et al. J Pediatric Infect Dis Soc. 2021;10(1):62-4.

4. Cohen R et al. Infect. Dis Now. 2021; 51(5)418-23.

A secondary consequence of public health measures to prevent the spread of SARS-CoV-2 included a concurrent reduction in risk for children to acquire and spread other respiratory viral infectious diseases. In the Rochester, N.Y., area, we had an ongoing prospective study in primary care pediatric practices that afforded an opportunity to assess the effect of the pandemic control measures on all infectious disease illness visits in young children. Specifically, in children aged 6-36 months old, our study was in place when the pandemic began with a primary objective to evaluate the changing epidemiology of acute otitis media (AOM) and nasopharyngeal colonization by potential bacterial respiratory pathogens in community-based primary care pediatric practices. As the public health measures mandated by New York State Department of Health were implemented, we prospectively quantified their effect on physician-diagnosed infectious disease illness visits. The incidence of infectious disease visits by a cohort of young children during the COVID-19 pandemic period March 15, 2020, through Dec. 31, 2020, was compared with the same time frame in the preceding year, 2019.¹

Recommendations of the New York State Department of Health for public health, changes in school and day care attendance, and clinical practice during the study time frame

On March 7, 2020, a state of emergency was declared in New York because of the COVID-19 pandemic. All schools were required to close. A mandated order for public use of masks in adults and children more than 2 years of age was enacted. In the Finger Lakes region of Upstate New York, where the two primary care pediatric practices reside, complete lockdown was partially lifted on May 15, 2020, and further lifted on June 26, 2020. Almost all regional school districts opened to at least hybrid learning models for all students starting Sept. 8, 2020. On March 6, 2020, video telehealth and telephone call visits were introduced as routine practice. Well-child visits were limited to those less than 2 years of age, then gradually expanded to all ages by late May 2020. During the “stay at home” phase of the New York State lockdown, day care services were considered an essential business. Day care child density was limited. All children less than 2 years old were required to wear a mask while in the facility. Upon arrival, children with any respiratory symptoms or fever were excluded. For the school year commencing September 2020, almost all regional school districts opened to virtual, hybrid, or in-person learning models. Exclusion occurred similar to that of the day care facilities.

Incidence of respiratory infectious disease illnesses

Clinical diagnoses and healthy visits of 144 children from March 15 to Dec. 31, 2020 (beginning of the pandemic) were compared to 215 children during the same months in 2019 (prepandemic). Pediatric SARS-CoV-2 positivity rates trended up alongside community spread. Pediatric practice positivity rates rose from 1.9% in October 2020 to 19% in December 2020.

The table shows the incidence of significantly different infectious disease illness visits in the two study cohorts.

Change in care practices

In the prepandemic period, virtual visits, leading to a diagnosis and treatment and referring children to an urgent care or hospital emergency department during regular office hours were rare. During the pandemic, this changed. Significantly increased use of telemedicine visits (P < .0001) and significantly decreased office and urgent care visits (P < .0001) occurred during the pandemic. Telehealth visits peaked the week of April 12, 2020, at 45% of all pediatric visits. In-person illness visits gradually returned to year-to-year volumes in August-September 2020 with school opening. Early in the pandemic, both pediatric offices limited patient encounters to well-child visits in the first 2 years of life to not miss opportunities for childhood vaccinations. However, some parents were reluctant to bring their children to those visits. There was no significant change in frequency of healthy child visits during the pandemic.

To our knowledge, this was the first study from primary care pediatric practices in the United States to analyze the effect on infectious diseases during the first 9 months of the pandemic, including the 6-month time period after the reopening from the first 3 months of lockdown. One prior study from a primary care network in Massachusetts reported significant decreases in respiratory infectious diseases for children aged 0-17 years during the first months of the pandemic during lockdown.² A study in Tennessee that included hospital emergency department, urgent care, primary care, and retail health clinics also reported respiratory infection diagnoses as well as antibiotic prescription were reduced in the early months of the pandemic.³

Our study shows an overall reduction in frequency of respiratory illness visits in children 6-36 months old during the first 9 months of the COVID-19 pandemic. We learned the value of using technology in the form of virtual visits to render care. Perhaps as the pandemic subsides, many of the hand-washing and sanitizing practices will remain in place and lead to less frequent illness in children in the future. However, there may be temporary negative consequences from the “immune debt” that has occurred from a prolonged time span when children were not becoming infected with respiratory pathogens.⁴ We will see what unfolds in the future.
 

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz is pediatric medical director at Rochester (N.Y.) Regional Health. Dr. Pichichero and Dr. Schulz have no conflicts of interest to disclose. This study was funded in part by the Centers for Disease Control and Prevention.

References

1. Kaur R et al. Front Pediatr. 2021;(9)722483:1-8.

2. Hatoun J et al. Pediatrics. 2020;146(4):e2020006460.

3. Katz SE et al. J Pediatric Infect Dis Soc. 2021;10(1):62-4.

4. Cohen R et al. Infect. Dis Now. 2021; 51(5)418-23.

A secondary consequence of public health measures to prevent the spread of SARS-CoV-2 included a concurrent reduction in risk for children to acquire and spread other respiratory viral infectious diseases. In the Rochester, N.Y., area, we had an ongoing prospective study in primary care pediatric practices that afforded an opportunity to assess the effect of the pandemic control measures on all infectious disease illness visits in young children. Specifically, in children aged 6-36 months old, our study was in place when the pandemic began with a primary objective to evaluate the changing epidemiology of acute otitis media (AOM) and nasopharyngeal colonization by potential bacterial respiratory pathogens in community-based primary care pediatric practices. As the public health measures mandated by New York State Department of Health were implemented, we prospectively quantified their effect on physician-diagnosed infectious disease illness visits. The incidence of infectious disease visits by a cohort of young children during the COVID-19 pandemic period March 15, 2020, through Dec. 31, 2020, was compared with the same time frame in the preceding year, 2019.¹

Recommendations of the New York State Department of Health for public health, changes in school and day care attendance, and clinical practice during the study time frame

On March 7, 2020, a state of emergency was declared in New York because of the COVID-19 pandemic. All schools were required to close. A mandated order for public use of masks in adults and children more than 2 years of age was enacted. In the Finger Lakes region of Upstate New York, where the two primary care pediatric practices reside, complete lockdown was partially lifted on May 15, 2020, and further lifted on June 26, 2020. Almost all regional school districts opened to at least hybrid learning models for all students starting Sept. 8, 2020. On March 6, 2020, video telehealth and telephone call visits were introduced as routine practice. Well-child visits were limited to those less than 2 years of age, then gradually expanded to all ages by late May 2020. During the “stay at home” phase of the New York State lockdown, day care services were considered an essential business. Day care child density was limited. All children less than 2 years old were required to wear a mask while in the facility. Upon arrival, children with any respiratory symptoms or fever were excluded. For the school year commencing September 2020, almost all regional school districts opened to virtual, hybrid, or in-person learning models. Exclusion occurred similar to that of the day care facilities.

Incidence of respiratory infectious disease illnesses

Clinical diagnoses and healthy visits of 144 children from March 15 to Dec. 31, 2020 (beginning of the pandemic) were compared to 215 children during the same months in 2019 (prepandemic). Pediatric SARS-CoV-2 positivity rates trended up alongside community spread. Pediatric practice positivity rates rose from 1.9% in October 2020 to 19% in December 2020.

The table shows the incidence of significantly different infectious disease illness visits in the two study cohorts.

Change in care practices

In the prepandemic period, virtual visits, leading to a diagnosis and treatment and referring children to an urgent care or hospital emergency department during regular office hours were rare. During the pandemic, this changed. Significantly increased use of telemedicine visits (P < .0001) and significantly decreased office and urgent care visits (P < .0001) occurred during the pandemic. Telehealth visits peaked the week of April 12, 2020, at 45% of all pediatric visits. In-person illness visits gradually returned to year-to-year volumes in August-September 2020 with school opening. Early in the pandemic, both pediatric offices limited patient encounters to well-child visits in the first 2 years of life to not miss opportunities for childhood vaccinations. However, some parents were reluctant to bring their children to those visits. There was no significant change in frequency of healthy child visits during the pandemic.

To our knowledge, this was the first study from primary care pediatric practices in the United States to analyze the effect on infectious diseases during the first 9 months of the pandemic, including the 6-month time period after the reopening from the first 3 months of lockdown. One prior study from a primary care network in Massachusetts reported significant decreases in respiratory infectious diseases for children aged 0-17 years during the first months of the pandemic during lockdown.² A study in Tennessee that included hospital emergency department, urgent care, primary care, and retail health clinics also reported respiratory infection diagnoses as well as antibiotic prescription were reduced in the early months of the pandemic.³

Our study shows an overall reduction in frequency of respiratory illness visits in children 6-36 months old during the first 9 months of the COVID-19 pandemic. We learned the value of using technology in the form of virtual visits to render care. Perhaps as the pandemic subsides, many of the hand-washing and sanitizing practices will remain in place and lead to less frequent illness in children in the future. However, there may be temporary negative consequences from the “immune debt” that has occurred from a prolonged time span when children were not becoming infected with respiratory pathogens.⁴ We will see what unfolds in the future.
 

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. Dr. Schulz is pediatric medical director at Rochester (N.Y.) Regional Health. Dr. Pichichero and Dr. Schulz have no conflicts of interest to disclose. This study was funded in part by the Centers for Disease Control and Prevention.

References

1. Kaur R et al. Front Pediatr. 2021;(9)722483:1-8.

2. Hatoun J et al. Pediatrics. 2020;146(4):e2020006460.

3. Katz SE et al. J Pediatric Infect Dis Soc. 2021;10(1):62-4.

4. Cohen R et al. Infect. Dis Now. 2021; 51(5)418-23.

As of September 2021, over 222 million people worldwide (WHO, 2021) and 40 million Americans (CDC, 2021) have been infected with the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The total number of infections in the United States began climbing again this summer with the persistence of vaccine reluctance among a significant proportion of the population and the emergence of the much more infectious B.1.617.2 (Delta) variant. While the clinical illness caused by the SARS-CoV-2 virus, referred to as the Coronavirus disease 2019 (COVID-19), is mostly mild, approximately 10% of cases develop acute respiratory distress syndrome (ARDS) (Remuzzi A, et al. Lancet. 2020;395[10231]:1225-8). A small but substantial proportion of patients with COVID-19 ARDS fails to respond to the various supportive measures and requires extracorporeal membrane oxygenation (ECMO) support. The overarching goal of the different support strategies, including ECMO, is to provide time for the lungs to recover from ARDS. ECMO has the theoretical advantage over other strategies in facilitating recovery by allowing the injured lungs to ‘rest’ as the oxygenation and ventilation needs are met in an extracorporeal fashion. Regardless, a small number of patients with COVID-19 ARDS will not recover enough pulmonary function to allow them to be weaned from the various respiratory support strategies.

For patients with irreversible lung injury, lung transplantation (LT) is a potential consideration. Earlier in the pandemic, older patients with significant comorbid illnesses were more vulnerable to severe COVID-19, often precluding consideration for transplantation. However, the emergence of the Delta variant may have altered this dynamic via a substantial increase in the incidence of COVID-19 ARDS among younger and healthier patients. A handful of patients with COVID-19 ARDS have already had successful transplantation. However, the overall number is still small (Bharat A, et al. Sci Translat Med. 2020 Dec 16;12[574]:eabe4282. doi: 10.1126/scitranslmed.abe4282. Epub 2020 Nov 30; and Hawkins R, et al. Transplantation. 2021;6:1381-7), and there is a lack of long-term outcomes data among these patients.

Dr. Quinn and Dr. Banga are with the Lung Transplant Program, Divisions of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas.

As of September 2021, over 222 million people worldwide (WHO, 2021) and 40 million Americans (CDC, 2021) have been infected with the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The total number of infections in the United States began climbing again this summer with the persistence of vaccine reluctance among a significant proportion of the population and the emergence of the much more infectious B.1.617.2 (Delta) variant. While the clinical illness caused by the SARS-CoV-2 virus, referred to as the Coronavirus disease 2019 (COVID-19), is mostly mild, approximately 10% of cases develop acute respiratory distress syndrome (ARDS) (Remuzzi A, et al. Lancet. 2020;395[10231]:1225-8). A small but substantial proportion of patients with COVID-19 ARDS fails to respond to the various supportive measures and requires extracorporeal membrane oxygenation (ECMO) support. The overarching goal of the different support strategies, including ECMO, is to provide time for the lungs to recover from ARDS. ECMO has the theoretical advantage over other strategies in facilitating recovery by allowing the injured lungs to ‘rest’ as the oxygenation and ventilation needs are met in an extracorporeal fashion. Regardless, a small number of patients with COVID-19 ARDS will not recover enough pulmonary function to allow them to be weaned from the various respiratory support strategies.

For patients with irreversible lung injury, lung transplantation (LT) is a potential consideration. Earlier in the pandemic, older patients with significant comorbid illnesses were more vulnerable to severe COVID-19, often precluding consideration for transplantation. However, the emergence of the Delta variant may have altered this dynamic via a substantial increase in the incidence of COVID-19 ARDS among younger and healthier patients. A handful of patients with COVID-19 ARDS have already had successful transplantation. However, the overall number is still small (Bharat A, et al. Sci Translat Med. 2020 Dec 16;12[574]:eabe4282. doi: 10.1126/scitranslmed.abe4282. Epub 2020 Nov 30; and Hawkins R, et al. Transplantation. 2021;6:1381-7), and there is a lack of long-term outcomes data among these patients.

Dr. Quinn and Dr. Banga are with the Lung Transplant Program, Divisions of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas.

As of September 2021, over 222 million people worldwide (WHO, 2021) and 40 million Americans (CDC, 2021) have been infected with the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The total number of infections in the United States began climbing again this summer with the persistence of vaccine reluctance among a significant proportion of the population and the emergence of the much more infectious B.1.617.2 (Delta) variant. While the clinical illness caused by the SARS-CoV-2 virus, referred to as the Coronavirus disease 2019 (COVID-19), is mostly mild, approximately 10% of cases develop acute respiratory distress syndrome (ARDS) (Remuzzi A, et al. Lancet. 2020;395[10231]:1225-8). A small but substantial proportion of patients with COVID-19 ARDS fails to respond to the various supportive measures and requires extracorporeal membrane oxygenation (ECMO) support. The overarching goal of the different support strategies, including ECMO, is to provide time for the lungs to recover from ARDS. ECMO has the theoretical advantage over other strategies in facilitating recovery by allowing the injured lungs to ‘rest’ as the oxygenation and ventilation needs are met in an extracorporeal fashion. Regardless, a small number of patients with COVID-19 ARDS will not recover enough pulmonary function to allow them to be weaned from the various respiratory support strategies.

For patients with irreversible lung injury, lung transplantation (LT) is a potential consideration. Earlier in the pandemic, older patients with significant comorbid illnesses were more vulnerable to severe COVID-19, often precluding consideration for transplantation. However, the emergence of the Delta variant may have altered this dynamic via a substantial increase in the incidence of COVID-19 ARDS among younger and healthier patients. A handful of patients with COVID-19 ARDS have already had successful transplantation. However, the overall number is still small (Bharat A, et al. Sci Translat Med. 2020 Dec 16;12[574]:eabe4282. doi: 10.1126/scitranslmed.abe4282. Epub 2020 Nov 30; and Hawkins R, et al. Transplantation. 2021;6:1381-7), and there is a lack of long-term outcomes data among these patients.

Dr. Quinn and Dr. Banga are with the Lung Transplant Program, Divisions of Pulmonary and Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas.

A patient with worsening chronic cough, shortness of breath, and hemoptysis tested negative for tuberculosis; but a chest computed tomography scan showed an upper left lobe cavitary lesion.

A 71-year-old, currently homeless male veteran with a 29 pack-year history of smoking and history of alcohol abuse presented to the emergency department at Washington DC Veterans Affairs Medical Center with worsening chronic cough and shortness of breath. He had no history of HIV or immunosuppressant medications. Four weeks prior, he was treated at an outpatient urgent care for community acquired pneumonia with a 10-day course of oral amoxicillin/clavulanic acid 875 mg twice daily and azithromycin 500 mg day 1, then 250 mg days 2 through 5. Despite antibiotic therapy, his symptoms continued to worsen, and he developed hemoptysis. He also reported weight loss of 20 lb in the past 3 months despite a strong appetite and adequate oral intake. He reported no fevers and night sweats. A review of the patient’s systems was otherwise unremarkable.

On examination, the patient was afebrile at 37.2 °C but tachycardic at 108 beats/min. He also was tachypneic at 22 breaths/min with an oxygen saturation of 89% on room air. Decreased breath sounds in the left upper lobe were noted on auscultation of the lung fields. Laboratory test results were notable for a leukocytosis of 14.3 k/μL (reference range, 4-11k/μL) and an elevated erythrocyte sedimentation rate (ESR) of 25.08 mm/h (reference range, 0-16 mm/h) and C-reactive protein (CRP) of 4.75 mg/L (reference range, 0.00-3.00 mg/L). Liver-associated enzymes and a coagulation panel were within normal limits. His QuantiFERON-TB Gold tuberculosis (TB) blood test was negative. A computed tomography (CT) scan of the chest was obtained, which showed an interval increase of a known upper left lobe cavitary lesion compared with that of prior imaging and the presence of a ball-shaped lesion in the cavity (Figures 1 and 2).

In addition to the imaging, the patient underwent bronchoscopy with bronchoalveolar lavage (BAL) to further evaluate the upper left lobe cavitary lesion. The differential diagnosis for pulmonary cavities is described in the Table. The BAL aspirates were negative for acid-fast bacteria; however, periodic acid–Schiff stain and Grocott methenamine silver stain showed fungal elements. He was diagnosed with chronic cavitary pulmonary aspergillosis (CCPA), confirmed with serum antigen (galactomannan assay) and serum immunoglobulin G (IgG) positive for Aspergillus fumigatus (A fumigatus). Mycologic cultures were positive for A fumigatus.

Discussion

Aspergillomas are accumulations of Aspergillus spp hyphae, fibrin, and other inflammatory components that typically occur in preexisting pulmonary cavities.¹ They are most frequently caused by A fumigatus, which is ubiquitous in the environment and acquired via inhalation of airborne spores in 90% of cases.² The typical ball-shaped appearance forms when hyphae growing along the inside walls of the cavity ultimately fall inward, usually leaving a surrounding pocket of air that can be seen on diagnostic imaging. CCPA falls within the chronic pulmonary aspergillosis (CPA) category, which includes a spectrum of other subtypes to include single aspergillomas, Aspergillus nodules, and chronic fibrosing pulmonary aspergillosis (CFPA). The prevalence of CPA and its subtypes are limited to case reports and case series in the literature, with reported rates differing up to 40-fold based on region, treatment, and diagnosis criteria.^3,4 Models developed by Denning and colleagues mirror those used by The World Health Organization and estimate 1.2 million people have CPA as a sequela to pulmonary TB globally.⁵

A single aspergilloma (simple aspergilloma) is typically not invasive, whereas CCPA (complex aspergilloma) is the most common CPA and can behave more invasively.^6,7 Both can occur in immunocompetent hosts. One study followed 140 individuals with aspergillomas for more than 7 years and found that 60.8% of aspergillomas remained stable in size, while 25.9% increased and 13.3% decreased in size. Half of cases were complicated by hemoptysis, but only 4.2% of cases became invasive.⁸ Roughly 70% of aspergillomas occur in individuals with a previous history of TB, but any pulmonary cavity can put a patient at increased risk.

Cases have been observed in patients with pulmonary cysts, emphysema/chronic obstructive pulmonary disease, bullae, lung cancer, sarcoidosis, other fungal cavities, and previous lung surgeries.⁹ Because of its association with CPA, TB testing should be completed as part of the workup as was the case in our patient. Although QuantiFERON-TB Gold has an estimated sensitivity of 92% per the manufacturer’s package insert, results can vary depending on the setting and extent of the TB.¹⁰

Clinical features of Aspergillus infection in immunocompetent individuals include weight loss, chronic nonproductive cough, hemoptysis of variable severity, fatigue, and/or shortness of breath.¹¹ CT is the imaging modality of choice and will typically show an upper-lobe cavitation with or without a fungal ball. For patients with suspicious imaging, laboratory testing with serum Aspergillus IgG antibodies should be performed. Aspergillus antigen testing is performed with galactomannan enzyme immunoassay, which detects galactomannan, a polysaccharide antigen that exists primarily in the cell walls of Aspergillus spp. This should be performed on BAL washings rather than serum, however, as serum testing has poor sensitivity.¹¹ Sputum culture is not very sensitive, and although the polymerase chain reaction of sputum and BAL fluid are more sensitive than culture, false-positive results can occur with transient colonization or contamination of samples.^11,12 Elevations of inflammatory markers, namely ESR and CRP, are commonly present but not specific for CPA.

Denning and colleagues propose the following criteria for diagnosing CCPA: one large cavity or 2 or more cavities on chest imaging with or without a fungal ball (aspergilloma) in one or more of the cavities (exclude patients with other chronic fungal cavitary lesions, eg, pulmonary histoplasmosis, coccidioidomycosis, and paracoccidioidomycosis); and at least one of the following symptoms for at least 3 months: fever, weight loss, fatigue, cough, sputum production, hemoptysis, or shortness of breath; and a positive Aspergillus IgG with or without culture of Aspergillus spp from the lungs.¹¹Our case fulfills the diagnostic criteria for CCPA. The ≥ 3 months of weight loss was useful in differentiating this case from a single aspergilloma in which the role of antifungal treatment remains unclear especially in those who are asymptomatic.² In those with single aspergillomas with significant hemoptysis, embolization may be required. In the management of localized CCPA, surgical excision is recommended and curative in many cases.^6,11 If left untreated, CCPA carries a 5-year mortality rate as high as 80% and often is accompanied with progression to CFPA, the terminal fibrosing evolution of CCPA, resulting in major fibrotic lung destruction.⁶ Oral azoles with or without surgical management also are useful in preventing clinical and radiologic progression.⁶

A multidisciplinary team, including infectious disease and surgery carefully discussed treatment options with the patient. Surgery was offered and the patient declined. We then decided on a trial of medical management alone based on shared decision making. In accordance with the recommendations from our infectious disease colleagues, the patient was started on a voriconazole 200 mg orally twice daily. Duration of therapy was planned for 6 months, with close monitoring of hepatic function, serum electrolytes, and visual function.¹³

Conclusions

This case highlights important differences among the CPA subtypes and how management differs based on etiology. Diagnostic criteria for CCPA were discussed, and in any patient with the constellation of the symptoms described with one or more cavitary lesions noted on imaging, CCPA should be considered regardless of immunocompetence. A multidisciplinary treatment approach with medical and surgical considerations is crucial to prevent progression to CFPA.

A patient with worsening chronic cough, shortness of breath, and hemoptysis tested negative for tuberculosis; but a chest computed tomography scan showed an upper left lobe cavitary lesion.

A 71-year-old, currently homeless male veteran with a 29 pack-year history of smoking and history of alcohol abuse presented to the emergency department at Washington DC Veterans Affairs Medical Center with worsening chronic cough and shortness of breath. He had no history of HIV or immunosuppressant medications. Four weeks prior, he was treated at an outpatient urgent care for community acquired pneumonia with a 10-day course of oral amoxicillin/clavulanic acid 875 mg twice daily and azithromycin 500 mg day 1, then 250 mg days 2 through 5. Despite antibiotic therapy, his symptoms continued to worsen, and he developed hemoptysis. He also reported weight loss of 20 lb in the past 3 months despite a strong appetite and adequate oral intake. He reported no fevers and night sweats. A review of the patient’s systems was otherwise unremarkable.

On examination, the patient was afebrile at 37.2 °C but tachycardic at 108 beats/min. He also was tachypneic at 22 breaths/min with an oxygen saturation of 89% on room air. Decreased breath sounds in the left upper lobe were noted on auscultation of the lung fields. Laboratory test results were notable for a leukocytosis of 14.3 k/μL (reference range, 4-11k/μL) and an elevated erythrocyte sedimentation rate (ESR) of 25.08 mm/h (reference range, 0-16 mm/h) and C-reactive protein (CRP) of 4.75 mg/L (reference range, 0.00-3.00 mg/L). Liver-associated enzymes and a coagulation panel were within normal limits. His QuantiFERON-TB Gold tuberculosis (TB) blood test was negative. A computed tomography (CT) scan of the chest was obtained, which showed an interval increase of a known upper left lobe cavitary lesion compared with that of prior imaging and the presence of a ball-shaped lesion in the cavity (Figures 1 and 2).

In addition to the imaging, the patient underwent bronchoscopy with bronchoalveolar lavage (BAL) to further evaluate the upper left lobe cavitary lesion. The differential diagnosis for pulmonary cavities is described in the Table. The BAL aspirates were negative for acid-fast bacteria; however, periodic acid–Schiff stain and Grocott methenamine silver stain showed fungal elements. He was diagnosed with chronic cavitary pulmonary aspergillosis (CCPA), confirmed with serum antigen (galactomannan assay) and serum immunoglobulin G (IgG) positive for Aspergillus fumigatus (A fumigatus). Mycologic cultures were positive for A fumigatus.

Discussion

Aspergillomas are accumulations of Aspergillus spp hyphae, fibrin, and other inflammatory components that typically occur in preexisting pulmonary cavities.¹ They are most frequently caused by A fumigatus, which is ubiquitous in the environment and acquired via inhalation of airborne spores in 90% of cases.² The typical ball-shaped appearance forms when hyphae growing along the inside walls of the cavity ultimately fall inward, usually leaving a surrounding pocket of air that can be seen on diagnostic imaging. CCPA falls within the chronic pulmonary aspergillosis (CPA) category, which includes a spectrum of other subtypes to include single aspergillomas, Aspergillus nodules, and chronic fibrosing pulmonary aspergillosis (CFPA). The prevalence of CPA and its subtypes are limited to case reports and case series in the literature, with reported rates differing up to 40-fold based on region, treatment, and diagnosis criteria.^3,4 Models developed by Denning and colleagues mirror those used by The World Health Organization and estimate 1.2 million people have CPA as a sequela to pulmonary TB globally.⁵

A single aspergilloma (simple aspergilloma) is typically not invasive, whereas CCPA (complex aspergilloma) is the most common CPA and can behave more invasively.^6,7 Both can occur in immunocompetent hosts. One study followed 140 individuals with aspergillomas for more than 7 years and found that 60.8% of aspergillomas remained stable in size, while 25.9% increased and 13.3% decreased in size. Half of cases were complicated by hemoptysis, but only 4.2% of cases became invasive.⁸ Roughly 70% of aspergillomas occur in individuals with a previous history of TB, but any pulmonary cavity can put a patient at increased risk.

Cases have been observed in patients with pulmonary cysts, emphysema/chronic obstructive pulmonary disease, bullae, lung cancer, sarcoidosis, other fungal cavities, and previous lung surgeries.⁹ Because of its association with CPA, TB testing should be completed as part of the workup as was the case in our patient. Although QuantiFERON-TB Gold has an estimated sensitivity of 92% per the manufacturer’s package insert, results can vary depending on the setting and extent of the TB.¹⁰

Clinical features of Aspergillus infection in immunocompetent individuals include weight loss, chronic nonproductive cough, hemoptysis of variable severity, fatigue, and/or shortness of breath.¹¹ CT is the imaging modality of choice and will typically show an upper-lobe cavitation with or without a fungal ball. For patients with suspicious imaging, laboratory testing with serum Aspergillus IgG antibodies should be performed. Aspergillus antigen testing is performed with galactomannan enzyme immunoassay, which detects galactomannan, a polysaccharide antigen that exists primarily in the cell walls of Aspergillus spp. This should be performed on BAL washings rather than serum, however, as serum testing has poor sensitivity.¹¹ Sputum culture is not very sensitive, and although the polymerase chain reaction of sputum and BAL fluid are more sensitive than culture, false-positive results can occur with transient colonization or contamination of samples.^11,12 Elevations of inflammatory markers, namely ESR and CRP, are commonly present but not specific for CPA.

Denning and colleagues propose the following criteria for diagnosing CCPA: one large cavity or 2 or more cavities on chest imaging with or without a fungal ball (aspergilloma) in one or more of the cavities (exclude patients with other chronic fungal cavitary lesions, eg, pulmonary histoplasmosis, coccidioidomycosis, and paracoccidioidomycosis); and at least one of the following symptoms for at least 3 months: fever, weight loss, fatigue, cough, sputum production, hemoptysis, or shortness of breath; and a positive Aspergillus IgG with or without culture of Aspergillus spp from the lungs.¹¹Our case fulfills the diagnostic criteria for CCPA. The ≥ 3 months of weight loss was useful in differentiating this case from a single aspergilloma in which the role of antifungal treatment remains unclear especially in those who are asymptomatic.² In those with single aspergillomas with significant hemoptysis, embolization may be required. In the management of localized CCPA, surgical excision is recommended and curative in many cases.^6,11 If left untreated, CCPA carries a 5-year mortality rate as high as 80% and often is accompanied with progression to CFPA, the terminal fibrosing evolution of CCPA, resulting in major fibrotic lung destruction.⁶ Oral azoles with or without surgical management also are useful in preventing clinical and radiologic progression.⁶

A multidisciplinary team, including infectious disease and surgery carefully discussed treatment options with the patient. Surgery was offered and the patient declined. We then decided on a trial of medical management alone based on shared decision making. In accordance with the recommendations from our infectious disease colleagues, the patient was started on a voriconazole 200 mg orally twice daily. Duration of therapy was planned for 6 months, with close monitoring of hepatic function, serum electrolytes, and visual function.¹³

Conclusions

This case highlights important differences among the CPA subtypes and how management differs based on etiology. Diagnostic criteria for CCPA were discussed, and in any patient with the constellation of the symptoms described with one or more cavitary lesions noted on imaging, CCPA should be considered regardless of immunocompetence. A multidisciplinary treatment approach with medical and surgical considerations is crucial to prevent progression to CFPA.

A patient with worsening chronic cough, shortness of breath, and hemoptysis tested negative for tuberculosis; but a chest computed tomography scan showed an upper left lobe cavitary lesion.

A 71-year-old, currently homeless male veteran with a 29 pack-year history of smoking and history of alcohol abuse presented to the emergency department at Washington DC Veterans Affairs Medical Center with worsening chronic cough and shortness of breath. He had no history of HIV or immunosuppressant medications. Four weeks prior, he was treated at an outpatient urgent care for community acquired pneumonia with a 10-day course of oral amoxicillin/clavulanic acid 875 mg twice daily and azithromycin 500 mg day 1, then 250 mg days 2 through 5. Despite antibiotic therapy, his symptoms continued to worsen, and he developed hemoptysis. He also reported weight loss of 20 lb in the past 3 months despite a strong appetite and adequate oral intake. He reported no fevers and night sweats. A review of the patient’s systems was otherwise unremarkable.

On examination, the patient was afebrile at 37.2 °C but tachycardic at 108 beats/min. He also was tachypneic at 22 breaths/min with an oxygen saturation of 89% on room air. Decreased breath sounds in the left upper lobe were noted on auscultation of the lung fields. Laboratory test results were notable for a leukocytosis of 14.3 k/μL (reference range, 4-11k/μL) and an elevated erythrocyte sedimentation rate (ESR) of 25.08 mm/h (reference range, 0-16 mm/h) and C-reactive protein (CRP) of 4.75 mg/L (reference range, 0.00-3.00 mg/L). Liver-associated enzymes and a coagulation panel were within normal limits. His QuantiFERON-TB Gold tuberculosis (TB) blood test was negative. A computed tomography (CT) scan of the chest was obtained, which showed an interval increase of a known upper left lobe cavitary lesion compared with that of prior imaging and the presence of a ball-shaped lesion in the cavity (Figures 1 and 2).

In addition to the imaging, the patient underwent bronchoscopy with bronchoalveolar lavage (BAL) to further evaluate the upper left lobe cavitary lesion. The differential diagnosis for pulmonary cavities is described in the Table. The BAL aspirates were negative for acid-fast bacteria; however, periodic acid–Schiff stain and Grocott methenamine silver stain showed fungal elements. He was diagnosed with chronic cavitary pulmonary aspergillosis (CCPA), confirmed with serum antigen (galactomannan assay) and serum immunoglobulin G (IgG) positive for Aspergillus fumigatus (A fumigatus). Mycologic cultures were positive for A fumigatus.

Discussion

Aspergillomas are accumulations of Aspergillus spp hyphae, fibrin, and other inflammatory components that typically occur in preexisting pulmonary cavities.¹ They are most frequently caused by A fumigatus, which is ubiquitous in the environment and acquired via inhalation of airborne spores in 90% of cases.² The typical ball-shaped appearance forms when hyphae growing along the inside walls of the cavity ultimately fall inward, usually leaving a surrounding pocket of air that can be seen on diagnostic imaging. CCPA falls within the chronic pulmonary aspergillosis (CPA) category, which includes a spectrum of other subtypes to include single aspergillomas, Aspergillus nodules, and chronic fibrosing pulmonary aspergillosis (CFPA). The prevalence of CPA and its subtypes are limited to case reports and case series in the literature, with reported rates differing up to 40-fold based on region, treatment, and diagnosis criteria.^3,4 Models developed by Denning and colleagues mirror those used by The World Health Organization and estimate 1.2 million people have CPA as a sequela to pulmonary TB globally.⁵

A single aspergilloma (simple aspergilloma) is typically not invasive, whereas CCPA (complex aspergilloma) is the most common CPA and can behave more invasively.^6,7 Both can occur in immunocompetent hosts. One study followed 140 individuals with aspergillomas for more than 7 years and found that 60.8% of aspergillomas remained stable in size, while 25.9% increased and 13.3% decreased in size. Half of cases were complicated by hemoptysis, but only 4.2% of cases became invasive.⁸ Roughly 70% of aspergillomas occur in individuals with a previous history of TB, but any pulmonary cavity can put a patient at increased risk.

Cases have been observed in patients with pulmonary cysts, emphysema/chronic obstructive pulmonary disease, bullae, lung cancer, sarcoidosis, other fungal cavities, and previous lung surgeries.⁹ Because of its association with CPA, TB testing should be completed as part of the workup as was the case in our patient. Although QuantiFERON-TB Gold has an estimated sensitivity of 92% per the manufacturer’s package insert, results can vary depending on the setting and extent of the TB.¹⁰

Clinical features of Aspergillus infection in immunocompetent individuals include weight loss, chronic nonproductive cough, hemoptysis of variable severity, fatigue, and/or shortness of breath.¹¹ CT is the imaging modality of choice and will typically show an upper-lobe cavitation with or without a fungal ball. For patients with suspicious imaging, laboratory testing with serum Aspergillus IgG antibodies should be performed. Aspergillus antigen testing is performed with galactomannan enzyme immunoassay, which detects galactomannan, a polysaccharide antigen that exists primarily in the cell walls of Aspergillus spp. This should be performed on BAL washings rather than serum, however, as serum testing has poor sensitivity.¹¹ Sputum culture is not very sensitive, and although the polymerase chain reaction of sputum and BAL fluid are more sensitive than culture, false-positive results can occur with transient colonization or contamination of samples.^11,12 Elevations of inflammatory markers, namely ESR and CRP, are commonly present but not specific for CPA.

Denning and colleagues propose the following criteria for diagnosing CCPA: one large cavity or 2 or more cavities on chest imaging with or without a fungal ball (aspergilloma) in one or more of the cavities (exclude patients with other chronic fungal cavitary lesions, eg, pulmonary histoplasmosis, coccidioidomycosis, and paracoccidioidomycosis); and at least one of the following symptoms for at least 3 months: fever, weight loss, fatigue, cough, sputum production, hemoptysis, or shortness of breath; and a positive Aspergillus IgG with or without culture of Aspergillus spp from the lungs.¹¹Our case fulfills the diagnostic criteria for CCPA. The ≥ 3 months of weight loss was useful in differentiating this case from a single aspergilloma in which the role of antifungal treatment remains unclear especially in those who are asymptomatic.² In those with single aspergillomas with significant hemoptysis, embolization may be required. In the management of localized CCPA, surgical excision is recommended and curative in many cases.^6,11 If left untreated, CCPA carries a 5-year mortality rate as high as 80% and often is accompanied with progression to CFPA, the terminal fibrosing evolution of CCPA, resulting in major fibrotic lung destruction.⁶ Oral azoles with or without surgical management also are useful in preventing clinical and radiologic progression.⁶

A multidisciplinary team, including infectious disease and surgery carefully discussed treatment options with the patient. Surgery was offered and the patient declined. We then decided on a trial of medical management alone based on shared decision making. In accordance with the recommendations from our infectious disease colleagues, the patient was started on a voriconazole 200 mg orally twice daily. Duration of therapy was planned for 6 months, with close monitoring of hepatic function, serum electrolytes, and visual function.¹³

Conclusions

This case highlights important differences among the CPA subtypes and how management differs based on etiology. Diagnostic criteria for CCPA were discussed, and in any patient with the constellation of the symptoms described with one or more cavitary lesions noted on imaging, CCPA should be considered regardless of immunocompetence. A multidisciplinary treatment approach with medical and surgical considerations is crucial to prevent progression to CFPA.

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

One week after reporting promising results from the trial of their COVID-19 vaccine in children ages 5-11, Pfizer and BioNTech announced they’d submitted the data to the Food and Drug Administration. But that hasn’t stopped some parents from discreetly getting their children under age 12 vaccinated.

“The FDA, you never want to get ahead of their judgment,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Sept. 28. “But I would imagine in the next few weeks, they will examine that data and hopefully they’ll give the okay so that we can start vaccinating children, hopefully before the end of October.”
 

Lying to vaccinate now

More than half of all parents with children under 12 say they plan to get their kids vaccinated, according to a Gallup poll. Among those who say they’re “very worried” or “somewhat worried” about their children catching COVID, that number goes up to 90% and 72%, respectively.

And although the FDA and the American Academy of Pediatrics have warned against it, some parents whose children can pass for 12 have lied to get them vaccinated already.

Dawn G. is a mom of two in southwest Missouri, where less than 45% of the population has been fully vaccinated. Her son turns 12 in early October, but in-person school started in mid-August.

“It was scary, thinking of him going to school for even 2 months,” she said. “Some parents thought their kid had a low chance of getting COVID, and their kid died. Nobody expects it to be them.”

In July, she and her husband took their son to a walk-in clinic and lied about his age.

“So many things can happen, from bullying to school shootings, and now this added pandemic risk,” she said. “I’ll do anything I can to protect my child, and a birthdate seems so arbitrary. He’ll be 12 in a matter of weeks. It seems ridiculous that that date would stop me from protecting him.”

In northern California, Carrie S. had a similar thought. When the vaccine was authorized for children ages 12-15 in May, the older of her two children got the shot right away. But her youngest doesn’t turn 12 until November.

“We were tempted to get the younger one vaccinated in May, but it didn’t seem like a rush. We were willing to wait to get the dosage right,” she ssaid. “But as Delta came through, there were no options for online school, the CDC was dropping mask expectations –it seemed like the world was ready to forget the pandemic was happening. It seemed like the least-bad option to get her vaccinated so she could go back to school, and we could find some balance of risk in our lives.”
 

Adult vs. pediatric doses

For now, experts advise against getting younger children vaccinated, even those who are the size of an adult, because of the way the human immune system develops.

“It’s not really about size,” said Anne Liu, MD, an immunologist and pediatrics professor at Stanford (Calif.) University. “The immune system behaves differently at different ages. Younger kids tend to have a more exuberant innate immune system, which is the part of the immune system that senses danger, even before it has developed a memory response.”

The adult Pfizer-BioNTech vaccine contains 30 mcg of mRNA, while the pediatric dose is just 10 mcg. That smaller dose produces an immune response similar to what’s seen in adults who receive 30 mcg, according to Pfizer.

“We were one of the sites that was involved in the phase 1 trial, a lot of times that’s called a dose-finding trial,” said Michael Smith, MD, a coinvestigator for the COVID vaccine trials done at Duke University. “And basically, if younger kids got a higher dose, they had more of a reaction, so it hurt more. They had fever, they had more redness and swelling at the site of the injection, and they just felt lousy, more than at the lower doses.”

At this point, with Pfizer’s data showing that younger children need a smaller dose, it doesn’t make sense to lie about your child’s age, said Dr. Smith.

“If my two options were having my child get the infection versus getting the vaccine, I’d get the vaccine. But we’re a few weeks away from getting the lower dose approved in kids,” he said. “It’s certainly safer. I don’t expect major, lifelong side effects from the higher dose, but it’s going to hurt, your kid’s going to have a fever, they’re going to feel lousy for a couple days, and they just don’t need that much antigen.”

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

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; [email protected].

Financial disclosures: None.

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; [email protected].

Financial disclosures: None.

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; [email protected].

Financial disclosures: None.