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Promising add-on therapy for neonatal seizures found active in safety study
WASHINGTON – presented at the annual meeting of the American Epilepsy Society.
“This is an early-phase trial, but it did associate bumetanide with an additional reduction in seizure burden relative to phenobarbital alone,” reported Janet S. Soul, MD, director of the fetal-neonatal neurology program at Boston Children’s Hospital. She added, “The adverse events observed were not substantially different in the group that received the experimental agent.”
Of the 111 neonates with documented seizures enrolled at four participating hospitals, 43 proceeded to randomization if their seizures proved to be refractory to standard doses of phenobarbital. After randomization, the next dose of phenobarbital was administered either with placebo or with 0.1, 0.2, or 0.3 mg/kg of bumetanide. Seizure burden was evaluated at 0-2, 2-4, and 0-4 hours after study-drug administration and compared with the burden during the 2 hours before treatment.
All three doses were active, reducing the seizure burden by a median of 41%-75% in a dose-dependent manner. Whether assessed in the first 2 hours or the first 4 hours, the efficacy of bumetanide was significantly greater in those with the greatest, relative to the least, baseline seizure burden (P = .01 for hours 0-2; P = .04 for hours 0-4). The median seizure burden during the baseline period was higher in the 27 children randomized to bumetanide (114 minutes) relative to those randomized to placebo (33 minutes), although researchers attributed this to random effects in a small study.
The evidence of antiseizure activity from bumetanide as an add-on to phenobarbital is consistent with its mechanism of action, which is blockading the chloride transporter NKCC1. In the immature neurons of neonates, NKCC1 is highly expressed, and there is basic scientific evidence that this impairs the efficacy of gamma-aminobutyric acid–receptor agonists like phenobarbital, according to Dr. Soul. The hypothesis driving the study of bumetanide is that blockading NKCC1 would improve the efficacy of phenobarbital while adding its own antiseizure effects, which together could potentially provide synergistic benefit.
The efficacy and the safety of this study are somewhat discordant with a previously published study evaluating bumetanide in 14 neonates with hypoxic-ischemic encephalopathy (HIE) seizures (Lancet Neurol 2015;14:469-77). Even though there were seizure reductions in five children in this other series, which did not include a control arm, there were three cases of hearing loss considered potentially related to bumetanide. The authors of that study concluded that efficacy was not shown.
There were also three cases of hearing loss in the randomized trial presented by Dr. Soul, but one occurred in the placebo group. Although the potential for ototoxicity “still needs to be addressed” in the next set of studies, Dr. Soul noted that hearing loss in children with epilepsy is common and has numerous potential etiologies. Based on these data, she concluded, “All serious adverse events were related to severe HIE with multiorgan dysfunction and/or withdrawal of care for poor prognosis.”
Among nonserious adverse events, diuresis was the only one found significantly more common in the bumetanide group (P = .02).
Phenobarbital has been a standard in the treatment of neonatal seizures for several decades despite the substantial proportion of children who do not achieve an adequate response, according to Dr. Soul. She noted that bumetanide is one of several agents being evaluated as an adjunctive agent. For example, a phase 2 crossover trial with levetiracetam is now underway. She suggested that there is reason for optimism about gaining new treatments for neonates in an area in which she believes there are unmet needs.
“I think we may see a phase 2 trial with bumetanide within a year or 2,” Dr. Soul said. If bumetanide moves forward, she expects its role to be primarily for the treatment of acute seizures caused by HIE, stroke, or hemorrhage. She is less optimistic about its benefit for seizures caused by other etiologies, such as brain malformations.
SOURCE: Soul J Abstract 2.426
WASHINGTON – presented at the annual meeting of the American Epilepsy Society.
“This is an early-phase trial, but it did associate bumetanide with an additional reduction in seizure burden relative to phenobarbital alone,” reported Janet S. Soul, MD, director of the fetal-neonatal neurology program at Boston Children’s Hospital. She added, “The adverse events observed were not substantially different in the group that received the experimental agent.”
Of the 111 neonates with documented seizures enrolled at four participating hospitals, 43 proceeded to randomization if their seizures proved to be refractory to standard doses of phenobarbital. After randomization, the next dose of phenobarbital was administered either with placebo or with 0.1, 0.2, or 0.3 mg/kg of bumetanide. Seizure burden was evaluated at 0-2, 2-4, and 0-4 hours after study-drug administration and compared with the burden during the 2 hours before treatment.
All three doses were active, reducing the seizure burden by a median of 41%-75% in a dose-dependent manner. Whether assessed in the first 2 hours or the first 4 hours, the efficacy of bumetanide was significantly greater in those with the greatest, relative to the least, baseline seizure burden (P = .01 for hours 0-2; P = .04 for hours 0-4). The median seizure burden during the baseline period was higher in the 27 children randomized to bumetanide (114 minutes) relative to those randomized to placebo (33 minutes), although researchers attributed this to random effects in a small study.
The evidence of antiseizure activity from bumetanide as an add-on to phenobarbital is consistent with its mechanism of action, which is blockading the chloride transporter NKCC1. In the immature neurons of neonates, NKCC1 is highly expressed, and there is basic scientific evidence that this impairs the efficacy of gamma-aminobutyric acid–receptor agonists like phenobarbital, according to Dr. Soul. The hypothesis driving the study of bumetanide is that blockading NKCC1 would improve the efficacy of phenobarbital while adding its own antiseizure effects, which together could potentially provide synergistic benefit.
The efficacy and the safety of this study are somewhat discordant with a previously published study evaluating bumetanide in 14 neonates with hypoxic-ischemic encephalopathy (HIE) seizures (Lancet Neurol 2015;14:469-77). Even though there were seizure reductions in five children in this other series, which did not include a control arm, there were three cases of hearing loss considered potentially related to bumetanide. The authors of that study concluded that efficacy was not shown.
There were also three cases of hearing loss in the randomized trial presented by Dr. Soul, but one occurred in the placebo group. Although the potential for ototoxicity “still needs to be addressed” in the next set of studies, Dr. Soul noted that hearing loss in children with epilepsy is common and has numerous potential etiologies. Based on these data, she concluded, “All serious adverse events were related to severe HIE with multiorgan dysfunction and/or withdrawal of care for poor prognosis.”
Among nonserious adverse events, diuresis was the only one found significantly more common in the bumetanide group (P = .02).
Phenobarbital has been a standard in the treatment of neonatal seizures for several decades despite the substantial proportion of children who do not achieve an adequate response, according to Dr. Soul. She noted that bumetanide is one of several agents being evaluated as an adjunctive agent. For example, a phase 2 crossover trial with levetiracetam is now underway. She suggested that there is reason for optimism about gaining new treatments for neonates in an area in which she believes there are unmet needs.
“I think we may see a phase 2 trial with bumetanide within a year or 2,” Dr. Soul said. If bumetanide moves forward, she expects its role to be primarily for the treatment of acute seizures caused by HIE, stroke, or hemorrhage. She is less optimistic about its benefit for seizures caused by other etiologies, such as brain malformations.
SOURCE: Soul J Abstract 2.426
WASHINGTON – presented at the annual meeting of the American Epilepsy Society.
“This is an early-phase trial, but it did associate bumetanide with an additional reduction in seizure burden relative to phenobarbital alone,” reported Janet S. Soul, MD, director of the fetal-neonatal neurology program at Boston Children’s Hospital. She added, “The adverse events observed were not substantially different in the group that received the experimental agent.”
Of the 111 neonates with documented seizures enrolled at four participating hospitals, 43 proceeded to randomization if their seizures proved to be refractory to standard doses of phenobarbital. After randomization, the next dose of phenobarbital was administered either with placebo or with 0.1, 0.2, or 0.3 mg/kg of bumetanide. Seizure burden was evaluated at 0-2, 2-4, and 0-4 hours after study-drug administration and compared with the burden during the 2 hours before treatment.
All three doses were active, reducing the seizure burden by a median of 41%-75% in a dose-dependent manner. Whether assessed in the first 2 hours or the first 4 hours, the efficacy of bumetanide was significantly greater in those with the greatest, relative to the least, baseline seizure burden (P = .01 for hours 0-2; P = .04 for hours 0-4). The median seizure burden during the baseline period was higher in the 27 children randomized to bumetanide (114 minutes) relative to those randomized to placebo (33 minutes), although researchers attributed this to random effects in a small study.
The evidence of antiseizure activity from bumetanide as an add-on to phenobarbital is consistent with its mechanism of action, which is blockading the chloride transporter NKCC1. In the immature neurons of neonates, NKCC1 is highly expressed, and there is basic scientific evidence that this impairs the efficacy of gamma-aminobutyric acid–receptor agonists like phenobarbital, according to Dr. Soul. The hypothesis driving the study of bumetanide is that blockading NKCC1 would improve the efficacy of phenobarbital while adding its own antiseizure effects, which together could potentially provide synergistic benefit.
The efficacy and the safety of this study are somewhat discordant with a previously published study evaluating bumetanide in 14 neonates with hypoxic-ischemic encephalopathy (HIE) seizures (Lancet Neurol 2015;14:469-77). Even though there were seizure reductions in five children in this other series, which did not include a control arm, there were three cases of hearing loss considered potentially related to bumetanide. The authors of that study concluded that efficacy was not shown.
There were also three cases of hearing loss in the randomized trial presented by Dr. Soul, but one occurred in the placebo group. Although the potential for ototoxicity “still needs to be addressed” in the next set of studies, Dr. Soul noted that hearing loss in children with epilepsy is common and has numerous potential etiologies. Based on these data, she concluded, “All serious adverse events were related to severe HIE with multiorgan dysfunction and/or withdrawal of care for poor prognosis.”
Among nonserious adverse events, diuresis was the only one found significantly more common in the bumetanide group (P = .02).
Phenobarbital has been a standard in the treatment of neonatal seizures for several decades despite the substantial proportion of children who do not achieve an adequate response, according to Dr. Soul. She noted that bumetanide is one of several agents being evaluated as an adjunctive agent. For example, a phase 2 crossover trial with levetiracetam is now underway. She suggested that there is reason for optimism about gaining new treatments for neonates in an area in which she believes there are unmet needs.
“I think we may see a phase 2 trial with bumetanide within a year or 2,” Dr. Soul said. If bumetanide moves forward, she expects its role to be primarily for the treatment of acute seizures caused by HIE, stroke, or hemorrhage. She is less optimistic about its benefit for seizures caused by other etiologies, such as brain malformations.
SOURCE: Soul J Abstract 2.426
REPORTING FROM AES 2017
Key clinical point: Bumetanide is associated with antiseizure activity as add-on therapy to phenobarbital for neonatal seizures.
Major finding: Relative to pretreatment, there was greater reduction in seizure burden (P = .01) at 4 hours in those with the highest seizure burden.
Data source: Randomized, double-blind phase 1/2 trial.
Disclosures: Dr. Soul reports no potential conflicts of interest related to this topic.
Source: Soul J et al. Abstract 2.426
Alcohol use, abuse rise after bariatric surgery
ORLANDO –
Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.
Her meta-analysis identified prospective, retrospective, and cross-sectional studies of alcohol use that included more than 100 bariatric surgery patients and that had follow-up beyond 1 year. Patients could have undergone Roux-en-Y gastric bypass, sleeve gastrectomy, or laparoscopic adjustable gastric banding. Comparator populations had to be either the surgery patients prior to the procedure or the controls matched by age and body mass index.
The 28 included studies enrolled 15,714 patients who averaged 43 years old, with more than three quarters women. Follow-up averaged 2.6 years. The most common surgery was Roux-en-Y, used in 23 studies, followed by banding in 12 studies, and sleeves in 8 studies (some studies used more than one type of surgery).
Nineteen of the studies examined the prevalence of “significant alcohol abuse” following surgery in a total of 4,552 patients, with 23% of patients overall showing this behavior. Five studies, involving 2,698 patients, documented the rate of new-onset alcohol abuse after surgery, with an overall rate of 8% that was statistically significant. All five studies individually showed increased incidence of alcohol abuse, with rates that ranged from 4% to 8%.
The analysis that showed a relative 50% higher rate of “significant” alcohol use after surgery, compared with the same patients before their surgery used data from 11 studies with 3,370 patients. Five of these 11 studies individually showed a statistically significant increase in alcohol use, 1 showed a significant, 34% relative decrease, and the remaining 5 studies did not show statistically significant changes, with 3 studies trending toward an increased rate and two trending toward a decreased rate after surgery.
None of the 28 included studies had a randomized control arm, and the studies collectively ran in six countries, including the United States, and hence involved different societal norms of alcohol use. Changes in alcohol absorption and metabolism following bariatric surgery may play roles in the observed effects, as might undiagnosed depression or substance use by patients who undergo this surgery, Dr. Wander suggested.
SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.
ORLANDO –
Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.
Her meta-analysis identified prospective, retrospective, and cross-sectional studies of alcohol use that included more than 100 bariatric surgery patients and that had follow-up beyond 1 year. Patients could have undergone Roux-en-Y gastric bypass, sleeve gastrectomy, or laparoscopic adjustable gastric banding. Comparator populations had to be either the surgery patients prior to the procedure or the controls matched by age and body mass index.
The 28 included studies enrolled 15,714 patients who averaged 43 years old, with more than three quarters women. Follow-up averaged 2.6 years. The most common surgery was Roux-en-Y, used in 23 studies, followed by banding in 12 studies, and sleeves in 8 studies (some studies used more than one type of surgery).
Nineteen of the studies examined the prevalence of “significant alcohol abuse” following surgery in a total of 4,552 patients, with 23% of patients overall showing this behavior. Five studies, involving 2,698 patients, documented the rate of new-onset alcohol abuse after surgery, with an overall rate of 8% that was statistically significant. All five studies individually showed increased incidence of alcohol abuse, with rates that ranged from 4% to 8%.
The analysis that showed a relative 50% higher rate of “significant” alcohol use after surgery, compared with the same patients before their surgery used data from 11 studies with 3,370 patients. Five of these 11 studies individually showed a statistically significant increase in alcohol use, 1 showed a significant, 34% relative decrease, and the remaining 5 studies did not show statistically significant changes, with 3 studies trending toward an increased rate and two trending toward a decreased rate after surgery.
None of the 28 included studies had a randomized control arm, and the studies collectively ran in six countries, including the United States, and hence involved different societal norms of alcohol use. Changes in alcohol absorption and metabolism following bariatric surgery may play roles in the observed effects, as might undiagnosed depression or substance use by patients who undergo this surgery, Dr. Wander suggested.
SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.
ORLANDO –
Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.
Her meta-analysis identified prospective, retrospective, and cross-sectional studies of alcohol use that included more than 100 bariatric surgery patients and that had follow-up beyond 1 year. Patients could have undergone Roux-en-Y gastric bypass, sleeve gastrectomy, or laparoscopic adjustable gastric banding. Comparator populations had to be either the surgery patients prior to the procedure or the controls matched by age and body mass index.
The 28 included studies enrolled 15,714 patients who averaged 43 years old, with more than three quarters women. Follow-up averaged 2.6 years. The most common surgery was Roux-en-Y, used in 23 studies, followed by banding in 12 studies, and sleeves in 8 studies (some studies used more than one type of surgery).
Nineteen of the studies examined the prevalence of “significant alcohol abuse” following surgery in a total of 4,552 patients, with 23% of patients overall showing this behavior. Five studies, involving 2,698 patients, documented the rate of new-onset alcohol abuse after surgery, with an overall rate of 8% that was statistically significant. All five studies individually showed increased incidence of alcohol abuse, with rates that ranged from 4% to 8%.
The analysis that showed a relative 50% higher rate of “significant” alcohol use after surgery, compared with the same patients before their surgery used data from 11 studies with 3,370 patients. Five of these 11 studies individually showed a statistically significant increase in alcohol use, 1 showed a significant, 34% relative decrease, and the remaining 5 studies did not show statistically significant changes, with 3 studies trending toward an increased rate and two trending toward a decreased rate after surgery.
None of the 28 included studies had a randomized control arm, and the studies collectively ran in six countries, including the United States, and hence involved different societal norms of alcohol use. Changes in alcohol absorption and metabolism following bariatric surgery may play roles in the observed effects, as might undiagnosed depression or substance use by patients who undergo this surgery, Dr. Wander suggested.
SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.
REPORTING FROM WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point: Following bariatric surgery patients have increased alcohol use and abuse.
Major finding: Alcohol abuse rose by 8%; significant alcohol use rose by a relative 50%.
Study details: Meta-analysis of 28 reports with 15,714 patients
Disclosures: Dr. Wander had no disclosures.
Source: Wander P et al. World Congress of Gastroenterology, abstract 10.
Elevated antiphospholipid antibodies in celiac disease unrelated to gluten
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Levels of antiphospholipid antibodies were significantly higher in adults with celiac disease compared with healthy controls, and gluten was not a factor, according to a study published in Digestive and Liver Disease (Dig Liver Dis. 2017. doi: 10.1016/j.dld.2017.11.018).
“In inflammatory bowel diseases active prophylaxis and treatment of thromboembolic complications is considered appropriate despite the increased risk of gastrointestinal bleeding,” wrote Outi Laine, MD, of Tampere University, Finland, and colleagues.
Results from previous studies suggest that thrombophilic autoantibodies are increased in celiac disease patients, but data are limited, the researchers wrote. In this study, the researchers measured antiphospholipid antibodies (cardiolipin IgG and M, prothrombin IgG, and aPS/PT IgG) in 179 adults with celiac disease (89 untreated, 90 on long-term gluten-free diets) and 91 nonceliac controls. Demographic characteristics were similar among the groups; the average age of the patients was 48 years in the untreated celiac disease group, 58 years in the treated group, and 45 years in the control group. In addition, the presentation of disease (gastrointestinal symptoms, malabsorption or anemia, and extraintestinal symptoms or screen-detected celiac disease) was similar among the groups.
Overall, the levels of antiphospholipid antibodies were significantly higher among celiac disease patients compared with controls 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin. All three were higher among the untreated celiac disease patients compared with the treated patients.
“Treated patients with the highest levels of cardiolipin IgG and prothrombin IgG antibodies and aPS/PT were older than the newly diagnosed, untreated patients. This observation suggests that the formation of antibodies is not triggered by gluten but is related to the autoimmune-based celiac disease itself,” the researchers wrote.
The study was not designed to assess the impact of antiphospholipid antibodies on thrombosis, the researchers noted. However, “To guide therapeutic decisions, the optimal predictive biomarkers for thromboembolic episodes in patients with celiac disease should be determined,” and future areas of research should include identifying patients at high risk for thromboembolic episodes, they said.
The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
FROM DIGESTIVE AND LIVER DISEASE
Key clinical point: Antiphospholipid antibodies are elevated in celiac patients, and highest in those on a gluten-free diet.
Major finding: Levels among celiac patients vs. controls were 4.9 U/mL vs. 2.2 U/mL respectively, for anticardiolipin; 2.9 U/mL vs. 2.1 U/mL for antiprothrombin IgG, and 6.9 U/mL vs. 2.3 U/mL for antiphosphatidylserine-prothrombin.
Data source: Study of 179 adults with confirmed celiac disease and 91 controls.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded in part by organizations including the Competitive State Research Financing of the Expert Responsibility Area of Tampere University Hospital, the Academy of Finland, and the Finnish Association of Hematology.
Managing mental health care at the hospital
The numbers tell a grim story. Nationwide, 43.7 million adult Americans experienced a mental health condition during 2016 – an increase of 1.2 million over the previous year. Mental health issues send almost 5.5 million people to emergency departments each year; nearly 60% of adults with a mental illness received no treatment at all.
If that massive – and growing – need is one side of the story, shrinking resources are the other. Mental health resources had already been diminishing for decades before the recession hit – and hit them especially hard. Between 2009 and 2012, states cut $5 billion in mental health services; during that time, at least 4,500 public psychiatric hospital beds nationwide disappeared – nearly 10% of the total supply. The bulk of those resources have never been restored.
Provider numbers also are falling. “Psychiatry is probably the top manpower shortage among all specialties,” said Joe Parks, MD, medical director of the National Council for Behavioral Health. “We have about a third the number of psychiatrists that most estimates say we need, and the number per capita is decreasing.” A significant percentage of psychiatrists – more than 50% – only accept cash, bypassing the low reimbursement rates even private insurance typically offers.
Hospitals, of course, feel those financial disincentives too, which discourage them from investments of their own. “It’s a difficult population to manage, and it’s difficult to manage the financial realities of mental health as well,” said John McHugh, PhD, assistant professor of health policy at Columbia University, New York. “If you were a hospital administrator looking to invest your last dollar and you have the option of investing it in a new heart institute or in behavioral health service, more likely than not, you’re going to invest it in the more profitable cardiovascular service line.”
Providers of last resort
But much of the burden of caring for this population ends up falling on hospitals by default. At Denver Health, Melanie Rylander, MD, medical director of the inpatient psychiatric unit, reports seeing this manifest in three categories of patients. First, there is an influx of people coming into the emergency department with primary mental health issues.
“We’re also seeing an influx of people coming in with physical problems, and upon assessment it becomes very clear very quickly that the real issue is an underlying mental health issue,” she said. Then there are the people coming in for the same physical problems over and over – maybe decompensated heart failure or COPD exacerbations – because mental health issues are impeding their ability to take care of themselves.
Some hospitalists say they feel ill equipped to care for these patients. “We don’t have the facility or the resources many times to properly care for their psychiatric needs when they’re in the hospital. It’s not really part of an internist’s training to be familiar with a lot of the medications,” said Atashi Mandal, MD, a hospitalist and pediatrician in Los Angeles. “Sometimes they get improperly medicated because we don’t know what else to do and the patient’s behavioral issues are escalating, so it’s really a difficult position.”
It’s a dispiriting experience for a hospitalist. “It really bothers me when I am trying to care for a patient who has psychiatric needs, and I feel I’m not able to do it, and I can’t find resources, and I feel that this patient’s needs are being neglected – not because we don’t care, and not because of a lack of effort by the staff. It’s just set up to fail,” Dr. Mandal said.
Ending the silo mentality
Encouraging a more holistic view of health across health care would be an important step to begin to address the problem – after all, the mind and the body are not separate.
“We work in silos, and we really have to stop doing that because these are intertwined,” said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “A schizophrenic will become worse when they’re medically ill. That illness will be harder to treat if their psychiatric illness is active.” This is starting to happen in the outpatient setting, evidenced by the expansion of the integrated care model, where a primary care doctor is the lead physician working in combination with psychologists, psychiatrists, and social workers. Communication among providers becomes simpler, and patients don’t fall through the cracks as often while trying to navigate the system.
That idea of integration is also making its way into the hospital setting in various ways. In their efforts to bring the care to the patient, rather than the other way around, Dr. Karlin-Zysman’s hospital embedded two hospitalists in the neighboring inpatient psychiatric hospital; when patients need medical treatment, they can receive it without interrupting their behavioral health treatment. As a result, patients who used to end up in their emergency department don’t anymore, and their 30-day readmission rate has fallen by 50%.
But at its foundation, care integration is more of an attitude than a system; it begins with a mindset.
“We talk so much today about system reform, integrated systems, blah, blah,” said Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston. “I don’t want to make it seem like it’s not going to work, but what does it mean for the patient who is psychotic and has 10 problems, with whom you have 15 minutes? Taking good care of these patients means you have to take a deep breath and put in a lot of time and deal with all these things that have nothing to do with the health system under which you practice. There’s this ‘only so much you can do’ feeling that is a problem in itself, because there’s actually a lot we can do.”
Hospitals and communities
It’s axiomatic to say that a better approach to mental health would be based around prevention and early intervention, rather than the less crisis-oriented system we have now. Some efforts are being made in that direction, and they involve, and require, outreach outside the hospital.
“The best hospitals doing work in mental health are going beyond the hospital walls; they’re really looking at their community,” Dr. Nguyen said. “You have hospitals, like Accountable Care Organizations, who are trying to move earlier and think about mental health from a pediatric standpoint: How can we support parents and children during critical phases of brain growth? How can we provide prevention services?” Ultimately, those efforts should help lower future admission rates to EDs and hospitals.
That forward-looking approach may be necessary, but it’s also a challenge. “As a hospital administrator, I would think that you look out at the community and see this problem is not going away – in fact, it is likely going to get worse,” Dr. McHugh said. “A health system may look at themselves and say we have to take the lead on this.” The difficulty is that thinking of it in a sense of value to the community, and making the requisite investments, will have a very long period of payout; a health system that’s struggling may not be able to do it. “It’s the large [health systems] that tend to be more integrated … that are thinking about this much differently,” he said.
Still, the reality is that’s where the root of the problem lies, Dr. Rylander said – not in the hospital, but in the larger community. “In the absence of very basic needs – stable housing, food, heating – it’s really not reasonable to expect that people are going to take care of their physical needs,” she said. “It’s a much larger social issue: how to get resources so that these people can have stable places to live, they can get to and from appointments, that type of thing.”
Those needs are ongoing, of course. Many of these patients suffer from chronic conditions, meaning people will continue to need services and support, said Ron Honberg, JD, senior policy adviser for the National Alliance on Mental Illness. Often, people need services from different systems. “There are complexities in terms of navigating those systems and getting those systems to work well together. Until we make inroads in solving those things, or at least improving those things, the burdens are going to fall on the providers of last resort, and that includes hospitals,” he said.
A collaborative effort may be needed, but hospitals can still be active participants and even leaders.
“If hospitals really want to address these problems, they need to be part of the discussions taking place in communities among the various systems and providers and advocates,” Mr. Honberg said. “Ultimately, we need to develop a better community-based system of care, and a better way of handing people off from inpatient to community-based treatment, and some accountability in terms of requiring that people get services, so they don’t get rehospitalized quickly. You’re increasingly seeing accountability now with other health conditions; we’re measuring things in Medicare like rehospitalization rates and the like. We need to be doing that with mental health treatment as well.”
What a hospitalist can do
One thing hospitalists might consider is starting that practice at their own hospitals, measuring, recording, and sharing that kind of information.
“Hospitalists should measure systematically, and in a very neutral manner, the total burden and frequency of the problem and report it consistently to management, along with their assessment that this impairs the quality of care and creates patient risk,” Dr. Parks said. That information can help hospitalists lobby for access to psychiatric personnel, be that in person or through telemedicine. “We don’t have to lay hands on you. There’s no excuse for any hospital not having a contract in place for on-demand consultation in the ER and on the floors.”
Track outcomes, too, Dr. Mandal suggests. With access to the right personnel, are you getting patients out of the ED faster? Are you having fewer negative outcomes while these patients are in the hospital, such as having to use restraints or get security involved? “Hopefully you can get some data in terms of how much money you’ve saved by decreasing the length of stays and decreasing inadvertent adverse effects because the patients weren’t receiving the proper care,” he said.
As this challenge seems likely to continue to grow, hospitalists might consider finding more training in mental health issues themselves so they are more comfortable handling these issues, Dr. Parks said. “The average mini-psych rotation from medical school is only 4 weeks,” he noted. “The ob.gyn. is at least 8 weeks and often 12 weeks, and if you don’t go into ob.gyn., you’re going to see a lot more mentally ill people through the rest of your practice, no matter what you do, than you are going to see pregnant women.”
Just starting these conversations – with patients, with colleagues, with family and friends – might be the most important change of all. “Even though nobody is above these issues afflicting them, this is still something that is not part of an open dialogue, and this is something that affects our own colleagues,” Dr. Mandal said. “I don’t know how many more trainees jumping out of windows it will take, or colleagues going through depression and feeling that it’s a sign of weakness to even talk about it.
“We need to create safe harbors within our own medical communities and acknowledge that we ourselves can be prone to this,” he said. “Perhaps by doing that, we will develop more empathy and become more comfortable, not just with ourselves and our colleagues but also helping these patients. People get overwhelmed and throw their hands up because it is just such a difficult issue. I don’t want people to give up, both from the medical community and our society as a whole – we can’t give up.”
A med-psych unit pilot project
Med-psych units can be a good model to take on these challenges. At Long Island Jewish Medical Center, they launched a pilot project to see how one would work in their community and summarized the results in an SHM abstract.
The hospital shares a campus with a 200-bed inpatient psych hospital, and doctors were seeing a lot of back and forth between the two institutions, said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “Patients would come into the hospital because they had an active medical issue, but because of their behavioral issues, they’d have to have continuous observation. It would not be uncommon for us to have sometimes close to 30 patients who needed 24-hour continuous observation to make sure they were not hurting themselves.” These PCAs or nurse’s assistants were doing 8-hour shifts, so each patient needed three. “The math is staggering – and with not any better outcomes.”
So the hospital created a 15-bed closed med-psych unit for medically ill patients with behavioral health disorders. They staffed it with a dedicated hospitalist, a nurse practitioner, a psychologist, and a nurse manager.
The number of patients requiring continuous observation fell to single digits. Once in their own unit, these patients caused less disruption and stress on the medical units. They had a lower length of stay compared to their previous admissions in other units, and this became one of the hospital’s highest performing units in terms of patient experience.
The biggest secret of their success, Dr. Karlin-Zysman said, is cohorting. “Instead of them going to the next open bed, wherever it may be, you get the patients all in one place geographically, with a team trained to manage those patients.” Another factor: it’s a hospitalist-run unit. “You can’t have 20 different doctors taking care of the patients; it’s one or two hospitalists running this unit.”
Care models like this can be a true win-win, and her hospital is using them more and more.
“I have a care model that’s a stroke unit; I have a care model that’s an onc unit and one that’s a pulmonary unit,” she said. “We’re creating these true teams, which I think hospitalists really like being part of. What’s that thing that makes them want to come to work every day? Things like this: running a care model, becoming specialized in something.” There are research and abstract opportunities for hospitalists on these units too, which also helps keep them engaged, she said. “I’ve used this care model and things like that to reduce burnout and keep people excited.”
The persistent mortality gap
Patients with mental illness tend to receive worse medical care than people without, studies have shown; they die an average of 25 years earlier, largely from preventable or treatable conditions such as cardiovascular disease and diabetes. The World Health Organization has called the problem “a hidden human rights emergency.”
In one in a series of articles on mental health, Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston, raises the question: Might physician attitudes toward mentally ill people contribute to this mortality gap, and if so, can we change them?
She recognizes the many obstacles physicians face in treating these patients. “The medicines we have are good but not great and can cause obesity and diabetes, which contributes to cardiovascular morbidity and mortality,” Dr. Rosenbaum said. “We have the adherence challenge for the psychiatric medications and for medications for chronic disease. It’s hard enough for anyone to take a medicine every day, and to do that if you’re homeless or you don’t have insight into the need for it, it’s really hard.”
Also, certain behaviors that are more common among people with serious mental illness – smoking, substance abuse, physical inactivity – increase their risk for chronic diseases.
These hurdles may foster a sense of helplessness among hospitalists who have just a small amount of time to spend with a patient, and attitudes may be hard to change.
“Negotiating more effectively about care refusals, more adeptly assessing capacity, and recognizing when our efforts to orchestrate care have been inadequate seem feasible,” Dr. Rosenbaum writes. “Far harder is overcoming any collective belief that what mentally ill people truly need is not something we can offer.” That’s why a truly honest examination of attitudes and biases is a necessary place to start.
She tells the story of one mentally ill patient she learned of in her research, who, after decades as the quintessential frequent flier in the ER, was living stably in the community. “No one could have known how many tries it would take to help him get there,” she writes. His doctor told her, “Let’s say 10 attempts are necessary. Someone needs to be number 2, 3 and 7. You just never know which number you are.”
Education for physicians
A course created by the National Alliance on Mental Illness addresses mental illness issues from a provider perspective.
“Although the description states that the course is intended for mental health professionals, it can be and has been used to educate and inform other healthcare professionals as well,” said Ron Honberg, JD, senior policy advisor for the National Alliance on Mental Illness. The standard course takes 15 hours; there is an abbreviated 4-hour alternative as well. More information can be found at http://www.nami.org/Find-Support/NAMI-Programs/NAMI-Provider-Education.
Sources
1. Szabo L. Cost of Not Caring: Nowhere to Go. USA Today. https://www.usatoday.com/story/news/nation/2014/05/12/mental-health-system-crisis/7746535/. Accessed March 10, 2017.
2. Mental Health America. The State of Mental Health in America. http://www.mentalhealthamerica.net/issues/state-mental-health-america. Accessed March 30, 2017.
3. Karlin-Zysman C, Lerner K, Warner-Cohen J. Creating a Hybrid Medicine and Psychiatric Unit to Manage Medically Ill Patients with Behavioral Health Disorders [abstract]. Journal of Hospital Medicine. 2015; 10 (suppl 2). http://www.shmabstracts.com/abstract/creating-a-hybrid-medicine-and-psychiatric-unit-to-manage-medically-ill-patients-with-behavioral-health-disorders/. Accessed March 19, 2017.
4. Garey J. When Doctors Discriminate. New York Times. http://www.nytimes.com/2013/08/11/opinion/sunday/when-doctors-discriminate.html. August 10, 2013. Accessed March 15, 2017.
5. Rosenbaum L. Closing the Mortality Gap – Mental Illness and Medical Care. N Engl J Med. 2016; 375:1585-1589. doi: 10.1056/NEJMms1610125.
6. Rosenbaum L. Unlearning Our Helplessness – Coexisting Serious Mental and Medical Illness. N Engl J Med. 2016;375:1690-4. doi: 10.1056/NEJMms1610127.
The numbers tell a grim story. Nationwide, 43.7 million adult Americans experienced a mental health condition during 2016 – an increase of 1.2 million over the previous year. Mental health issues send almost 5.5 million people to emergency departments each year; nearly 60% of adults with a mental illness received no treatment at all.
If that massive – and growing – need is one side of the story, shrinking resources are the other. Mental health resources had already been diminishing for decades before the recession hit – and hit them especially hard. Between 2009 and 2012, states cut $5 billion in mental health services; during that time, at least 4,500 public psychiatric hospital beds nationwide disappeared – nearly 10% of the total supply. The bulk of those resources have never been restored.
Provider numbers also are falling. “Psychiatry is probably the top manpower shortage among all specialties,” said Joe Parks, MD, medical director of the National Council for Behavioral Health. “We have about a third the number of psychiatrists that most estimates say we need, and the number per capita is decreasing.” A significant percentage of psychiatrists – more than 50% – only accept cash, bypassing the low reimbursement rates even private insurance typically offers.
Hospitals, of course, feel those financial disincentives too, which discourage them from investments of their own. “It’s a difficult population to manage, and it’s difficult to manage the financial realities of mental health as well,” said John McHugh, PhD, assistant professor of health policy at Columbia University, New York. “If you were a hospital administrator looking to invest your last dollar and you have the option of investing it in a new heart institute or in behavioral health service, more likely than not, you’re going to invest it in the more profitable cardiovascular service line.”
Providers of last resort
But much of the burden of caring for this population ends up falling on hospitals by default. At Denver Health, Melanie Rylander, MD, medical director of the inpatient psychiatric unit, reports seeing this manifest in three categories of patients. First, there is an influx of people coming into the emergency department with primary mental health issues.
“We’re also seeing an influx of people coming in with physical problems, and upon assessment it becomes very clear very quickly that the real issue is an underlying mental health issue,” she said. Then there are the people coming in for the same physical problems over and over – maybe decompensated heart failure or COPD exacerbations – because mental health issues are impeding their ability to take care of themselves.
Some hospitalists say they feel ill equipped to care for these patients. “We don’t have the facility or the resources many times to properly care for their psychiatric needs when they’re in the hospital. It’s not really part of an internist’s training to be familiar with a lot of the medications,” said Atashi Mandal, MD, a hospitalist and pediatrician in Los Angeles. “Sometimes they get improperly medicated because we don’t know what else to do and the patient’s behavioral issues are escalating, so it’s really a difficult position.”
It’s a dispiriting experience for a hospitalist. “It really bothers me when I am trying to care for a patient who has psychiatric needs, and I feel I’m not able to do it, and I can’t find resources, and I feel that this patient’s needs are being neglected – not because we don’t care, and not because of a lack of effort by the staff. It’s just set up to fail,” Dr. Mandal said.
Ending the silo mentality
Encouraging a more holistic view of health across health care would be an important step to begin to address the problem – after all, the mind and the body are not separate.
“We work in silos, and we really have to stop doing that because these are intertwined,” said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “A schizophrenic will become worse when they’re medically ill. That illness will be harder to treat if their psychiatric illness is active.” This is starting to happen in the outpatient setting, evidenced by the expansion of the integrated care model, where a primary care doctor is the lead physician working in combination with psychologists, psychiatrists, and social workers. Communication among providers becomes simpler, and patients don’t fall through the cracks as often while trying to navigate the system.
That idea of integration is also making its way into the hospital setting in various ways. In their efforts to bring the care to the patient, rather than the other way around, Dr. Karlin-Zysman’s hospital embedded two hospitalists in the neighboring inpatient psychiatric hospital; when patients need medical treatment, they can receive it without interrupting their behavioral health treatment. As a result, patients who used to end up in their emergency department don’t anymore, and their 30-day readmission rate has fallen by 50%.
But at its foundation, care integration is more of an attitude than a system; it begins with a mindset.
“We talk so much today about system reform, integrated systems, blah, blah,” said Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston. “I don’t want to make it seem like it’s not going to work, but what does it mean for the patient who is psychotic and has 10 problems, with whom you have 15 minutes? Taking good care of these patients means you have to take a deep breath and put in a lot of time and deal with all these things that have nothing to do with the health system under which you practice. There’s this ‘only so much you can do’ feeling that is a problem in itself, because there’s actually a lot we can do.”
Hospitals and communities
It’s axiomatic to say that a better approach to mental health would be based around prevention and early intervention, rather than the less crisis-oriented system we have now. Some efforts are being made in that direction, and they involve, and require, outreach outside the hospital.
“The best hospitals doing work in mental health are going beyond the hospital walls; they’re really looking at their community,” Dr. Nguyen said. “You have hospitals, like Accountable Care Organizations, who are trying to move earlier and think about mental health from a pediatric standpoint: How can we support parents and children during critical phases of brain growth? How can we provide prevention services?” Ultimately, those efforts should help lower future admission rates to EDs and hospitals.
That forward-looking approach may be necessary, but it’s also a challenge. “As a hospital administrator, I would think that you look out at the community and see this problem is not going away – in fact, it is likely going to get worse,” Dr. McHugh said. “A health system may look at themselves and say we have to take the lead on this.” The difficulty is that thinking of it in a sense of value to the community, and making the requisite investments, will have a very long period of payout; a health system that’s struggling may not be able to do it. “It’s the large [health systems] that tend to be more integrated … that are thinking about this much differently,” he said.
Still, the reality is that’s where the root of the problem lies, Dr. Rylander said – not in the hospital, but in the larger community. “In the absence of very basic needs – stable housing, food, heating – it’s really not reasonable to expect that people are going to take care of their physical needs,” she said. “It’s a much larger social issue: how to get resources so that these people can have stable places to live, they can get to and from appointments, that type of thing.”
Those needs are ongoing, of course. Many of these patients suffer from chronic conditions, meaning people will continue to need services and support, said Ron Honberg, JD, senior policy adviser for the National Alliance on Mental Illness. Often, people need services from different systems. “There are complexities in terms of navigating those systems and getting those systems to work well together. Until we make inroads in solving those things, or at least improving those things, the burdens are going to fall on the providers of last resort, and that includes hospitals,” he said.
A collaborative effort may be needed, but hospitals can still be active participants and even leaders.
“If hospitals really want to address these problems, they need to be part of the discussions taking place in communities among the various systems and providers and advocates,” Mr. Honberg said. “Ultimately, we need to develop a better community-based system of care, and a better way of handing people off from inpatient to community-based treatment, and some accountability in terms of requiring that people get services, so they don’t get rehospitalized quickly. You’re increasingly seeing accountability now with other health conditions; we’re measuring things in Medicare like rehospitalization rates and the like. We need to be doing that with mental health treatment as well.”
What a hospitalist can do
One thing hospitalists might consider is starting that practice at their own hospitals, measuring, recording, and sharing that kind of information.
“Hospitalists should measure systematically, and in a very neutral manner, the total burden and frequency of the problem and report it consistently to management, along with their assessment that this impairs the quality of care and creates patient risk,” Dr. Parks said. That information can help hospitalists lobby for access to psychiatric personnel, be that in person or through telemedicine. “We don’t have to lay hands on you. There’s no excuse for any hospital not having a contract in place for on-demand consultation in the ER and on the floors.”
Track outcomes, too, Dr. Mandal suggests. With access to the right personnel, are you getting patients out of the ED faster? Are you having fewer negative outcomes while these patients are in the hospital, such as having to use restraints or get security involved? “Hopefully you can get some data in terms of how much money you’ve saved by decreasing the length of stays and decreasing inadvertent adverse effects because the patients weren’t receiving the proper care,” he said.
As this challenge seems likely to continue to grow, hospitalists might consider finding more training in mental health issues themselves so they are more comfortable handling these issues, Dr. Parks said. “The average mini-psych rotation from medical school is only 4 weeks,” he noted. “The ob.gyn. is at least 8 weeks and often 12 weeks, and if you don’t go into ob.gyn., you’re going to see a lot more mentally ill people through the rest of your practice, no matter what you do, than you are going to see pregnant women.”
Just starting these conversations – with patients, with colleagues, with family and friends – might be the most important change of all. “Even though nobody is above these issues afflicting them, this is still something that is not part of an open dialogue, and this is something that affects our own colleagues,” Dr. Mandal said. “I don’t know how many more trainees jumping out of windows it will take, or colleagues going through depression and feeling that it’s a sign of weakness to even talk about it.
“We need to create safe harbors within our own medical communities and acknowledge that we ourselves can be prone to this,” he said. “Perhaps by doing that, we will develop more empathy and become more comfortable, not just with ourselves and our colleagues but also helping these patients. People get overwhelmed and throw their hands up because it is just such a difficult issue. I don’t want people to give up, both from the medical community and our society as a whole – we can’t give up.”
A med-psych unit pilot project
Med-psych units can be a good model to take on these challenges. At Long Island Jewish Medical Center, they launched a pilot project to see how one would work in their community and summarized the results in an SHM abstract.
The hospital shares a campus with a 200-bed inpatient psych hospital, and doctors were seeing a lot of back and forth between the two institutions, said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “Patients would come into the hospital because they had an active medical issue, but because of their behavioral issues, they’d have to have continuous observation. It would not be uncommon for us to have sometimes close to 30 patients who needed 24-hour continuous observation to make sure they were not hurting themselves.” These PCAs or nurse’s assistants were doing 8-hour shifts, so each patient needed three. “The math is staggering – and with not any better outcomes.”
So the hospital created a 15-bed closed med-psych unit for medically ill patients with behavioral health disorders. They staffed it with a dedicated hospitalist, a nurse practitioner, a psychologist, and a nurse manager.
The number of patients requiring continuous observation fell to single digits. Once in their own unit, these patients caused less disruption and stress on the medical units. They had a lower length of stay compared to their previous admissions in other units, and this became one of the hospital’s highest performing units in terms of patient experience.
The biggest secret of their success, Dr. Karlin-Zysman said, is cohorting. “Instead of them going to the next open bed, wherever it may be, you get the patients all in one place geographically, with a team trained to manage those patients.” Another factor: it’s a hospitalist-run unit. “You can’t have 20 different doctors taking care of the patients; it’s one or two hospitalists running this unit.”
Care models like this can be a true win-win, and her hospital is using them more and more.
“I have a care model that’s a stroke unit; I have a care model that’s an onc unit and one that’s a pulmonary unit,” she said. “We’re creating these true teams, which I think hospitalists really like being part of. What’s that thing that makes them want to come to work every day? Things like this: running a care model, becoming specialized in something.” There are research and abstract opportunities for hospitalists on these units too, which also helps keep them engaged, she said. “I’ve used this care model and things like that to reduce burnout and keep people excited.”
The persistent mortality gap
Patients with mental illness tend to receive worse medical care than people without, studies have shown; they die an average of 25 years earlier, largely from preventable or treatable conditions such as cardiovascular disease and diabetes. The World Health Organization has called the problem “a hidden human rights emergency.”
In one in a series of articles on mental health, Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston, raises the question: Might physician attitudes toward mentally ill people contribute to this mortality gap, and if so, can we change them?
She recognizes the many obstacles physicians face in treating these patients. “The medicines we have are good but not great and can cause obesity and diabetes, which contributes to cardiovascular morbidity and mortality,” Dr. Rosenbaum said. “We have the adherence challenge for the psychiatric medications and for medications for chronic disease. It’s hard enough for anyone to take a medicine every day, and to do that if you’re homeless or you don’t have insight into the need for it, it’s really hard.”
Also, certain behaviors that are more common among people with serious mental illness – smoking, substance abuse, physical inactivity – increase their risk for chronic diseases.
These hurdles may foster a sense of helplessness among hospitalists who have just a small amount of time to spend with a patient, and attitudes may be hard to change.
“Negotiating more effectively about care refusals, more adeptly assessing capacity, and recognizing when our efforts to orchestrate care have been inadequate seem feasible,” Dr. Rosenbaum writes. “Far harder is overcoming any collective belief that what mentally ill people truly need is not something we can offer.” That’s why a truly honest examination of attitudes and biases is a necessary place to start.
She tells the story of one mentally ill patient she learned of in her research, who, after decades as the quintessential frequent flier in the ER, was living stably in the community. “No one could have known how many tries it would take to help him get there,” she writes. His doctor told her, “Let’s say 10 attempts are necessary. Someone needs to be number 2, 3 and 7. You just never know which number you are.”
Education for physicians
A course created by the National Alliance on Mental Illness addresses mental illness issues from a provider perspective.
“Although the description states that the course is intended for mental health professionals, it can be and has been used to educate and inform other healthcare professionals as well,” said Ron Honberg, JD, senior policy advisor for the National Alliance on Mental Illness. The standard course takes 15 hours; there is an abbreviated 4-hour alternative as well. More information can be found at http://www.nami.org/Find-Support/NAMI-Programs/NAMI-Provider-Education.
Sources
1. Szabo L. Cost of Not Caring: Nowhere to Go. USA Today. https://www.usatoday.com/story/news/nation/2014/05/12/mental-health-system-crisis/7746535/. Accessed March 10, 2017.
2. Mental Health America. The State of Mental Health in America. http://www.mentalhealthamerica.net/issues/state-mental-health-america. Accessed March 30, 2017.
3. Karlin-Zysman C, Lerner K, Warner-Cohen J. Creating a Hybrid Medicine and Psychiatric Unit to Manage Medically Ill Patients with Behavioral Health Disorders [abstract]. Journal of Hospital Medicine. 2015; 10 (suppl 2). http://www.shmabstracts.com/abstract/creating-a-hybrid-medicine-and-psychiatric-unit-to-manage-medically-ill-patients-with-behavioral-health-disorders/. Accessed March 19, 2017.
4. Garey J. When Doctors Discriminate. New York Times. http://www.nytimes.com/2013/08/11/opinion/sunday/when-doctors-discriminate.html. August 10, 2013. Accessed March 15, 2017.
5. Rosenbaum L. Closing the Mortality Gap – Mental Illness and Medical Care. N Engl J Med. 2016; 375:1585-1589. doi: 10.1056/NEJMms1610125.
6. Rosenbaum L. Unlearning Our Helplessness – Coexisting Serious Mental and Medical Illness. N Engl J Med. 2016;375:1690-4. doi: 10.1056/NEJMms1610127.
The numbers tell a grim story. Nationwide, 43.7 million adult Americans experienced a mental health condition during 2016 – an increase of 1.2 million over the previous year. Mental health issues send almost 5.5 million people to emergency departments each year; nearly 60% of adults with a mental illness received no treatment at all.
If that massive – and growing – need is one side of the story, shrinking resources are the other. Mental health resources had already been diminishing for decades before the recession hit – and hit them especially hard. Between 2009 and 2012, states cut $5 billion in mental health services; during that time, at least 4,500 public psychiatric hospital beds nationwide disappeared – nearly 10% of the total supply. The bulk of those resources have never been restored.
Provider numbers also are falling. “Psychiatry is probably the top manpower shortage among all specialties,” said Joe Parks, MD, medical director of the National Council for Behavioral Health. “We have about a third the number of psychiatrists that most estimates say we need, and the number per capita is decreasing.” A significant percentage of psychiatrists – more than 50% – only accept cash, bypassing the low reimbursement rates even private insurance typically offers.
Hospitals, of course, feel those financial disincentives too, which discourage them from investments of their own. “It’s a difficult population to manage, and it’s difficult to manage the financial realities of mental health as well,” said John McHugh, PhD, assistant professor of health policy at Columbia University, New York. “If you were a hospital administrator looking to invest your last dollar and you have the option of investing it in a new heart institute or in behavioral health service, more likely than not, you’re going to invest it in the more profitable cardiovascular service line.”
Providers of last resort
But much of the burden of caring for this population ends up falling on hospitals by default. At Denver Health, Melanie Rylander, MD, medical director of the inpatient psychiatric unit, reports seeing this manifest in three categories of patients. First, there is an influx of people coming into the emergency department with primary mental health issues.
“We’re also seeing an influx of people coming in with physical problems, and upon assessment it becomes very clear very quickly that the real issue is an underlying mental health issue,” she said. Then there are the people coming in for the same physical problems over and over – maybe decompensated heart failure or COPD exacerbations – because mental health issues are impeding their ability to take care of themselves.
Some hospitalists say they feel ill equipped to care for these patients. “We don’t have the facility or the resources many times to properly care for their psychiatric needs when they’re in the hospital. It’s not really part of an internist’s training to be familiar with a lot of the medications,” said Atashi Mandal, MD, a hospitalist and pediatrician in Los Angeles. “Sometimes they get improperly medicated because we don’t know what else to do and the patient’s behavioral issues are escalating, so it’s really a difficult position.”
It’s a dispiriting experience for a hospitalist. “It really bothers me when I am trying to care for a patient who has psychiatric needs, and I feel I’m not able to do it, and I can’t find resources, and I feel that this patient’s needs are being neglected – not because we don’t care, and not because of a lack of effort by the staff. It’s just set up to fail,” Dr. Mandal said.
Ending the silo mentality
Encouraging a more holistic view of health across health care would be an important step to begin to address the problem – after all, the mind and the body are not separate.
“We work in silos, and we really have to stop doing that because these are intertwined,” said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “A schizophrenic will become worse when they’re medically ill. That illness will be harder to treat if their psychiatric illness is active.” This is starting to happen in the outpatient setting, evidenced by the expansion of the integrated care model, where a primary care doctor is the lead physician working in combination with psychologists, psychiatrists, and social workers. Communication among providers becomes simpler, and patients don’t fall through the cracks as often while trying to navigate the system.
That idea of integration is also making its way into the hospital setting in various ways. In their efforts to bring the care to the patient, rather than the other way around, Dr. Karlin-Zysman’s hospital embedded two hospitalists in the neighboring inpatient psychiatric hospital; when patients need medical treatment, they can receive it without interrupting their behavioral health treatment. As a result, patients who used to end up in their emergency department don’t anymore, and their 30-day readmission rate has fallen by 50%.
But at its foundation, care integration is more of an attitude than a system; it begins with a mindset.
“We talk so much today about system reform, integrated systems, blah, blah,” said Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston. “I don’t want to make it seem like it’s not going to work, but what does it mean for the patient who is psychotic and has 10 problems, with whom you have 15 minutes? Taking good care of these patients means you have to take a deep breath and put in a lot of time and deal with all these things that have nothing to do with the health system under which you practice. There’s this ‘only so much you can do’ feeling that is a problem in itself, because there’s actually a lot we can do.”
Hospitals and communities
It’s axiomatic to say that a better approach to mental health would be based around prevention and early intervention, rather than the less crisis-oriented system we have now. Some efforts are being made in that direction, and they involve, and require, outreach outside the hospital.
“The best hospitals doing work in mental health are going beyond the hospital walls; they’re really looking at their community,” Dr. Nguyen said. “You have hospitals, like Accountable Care Organizations, who are trying to move earlier and think about mental health from a pediatric standpoint: How can we support parents and children during critical phases of brain growth? How can we provide prevention services?” Ultimately, those efforts should help lower future admission rates to EDs and hospitals.
That forward-looking approach may be necessary, but it’s also a challenge. “As a hospital administrator, I would think that you look out at the community and see this problem is not going away – in fact, it is likely going to get worse,” Dr. McHugh said. “A health system may look at themselves and say we have to take the lead on this.” The difficulty is that thinking of it in a sense of value to the community, and making the requisite investments, will have a very long period of payout; a health system that’s struggling may not be able to do it. “It’s the large [health systems] that tend to be more integrated … that are thinking about this much differently,” he said.
Still, the reality is that’s where the root of the problem lies, Dr. Rylander said – not in the hospital, but in the larger community. “In the absence of very basic needs – stable housing, food, heating – it’s really not reasonable to expect that people are going to take care of their physical needs,” she said. “It’s a much larger social issue: how to get resources so that these people can have stable places to live, they can get to and from appointments, that type of thing.”
Those needs are ongoing, of course. Many of these patients suffer from chronic conditions, meaning people will continue to need services and support, said Ron Honberg, JD, senior policy adviser for the National Alliance on Mental Illness. Often, people need services from different systems. “There are complexities in terms of navigating those systems and getting those systems to work well together. Until we make inroads in solving those things, or at least improving those things, the burdens are going to fall on the providers of last resort, and that includes hospitals,” he said.
A collaborative effort may be needed, but hospitals can still be active participants and even leaders.
“If hospitals really want to address these problems, they need to be part of the discussions taking place in communities among the various systems and providers and advocates,” Mr. Honberg said. “Ultimately, we need to develop a better community-based system of care, and a better way of handing people off from inpatient to community-based treatment, and some accountability in terms of requiring that people get services, so they don’t get rehospitalized quickly. You’re increasingly seeing accountability now with other health conditions; we’re measuring things in Medicare like rehospitalization rates and the like. We need to be doing that with mental health treatment as well.”
What a hospitalist can do
One thing hospitalists might consider is starting that practice at their own hospitals, measuring, recording, and sharing that kind of information.
“Hospitalists should measure systematically, and in a very neutral manner, the total burden and frequency of the problem and report it consistently to management, along with their assessment that this impairs the quality of care and creates patient risk,” Dr. Parks said. That information can help hospitalists lobby for access to psychiatric personnel, be that in person or through telemedicine. “We don’t have to lay hands on you. There’s no excuse for any hospital not having a contract in place for on-demand consultation in the ER and on the floors.”
Track outcomes, too, Dr. Mandal suggests. With access to the right personnel, are you getting patients out of the ED faster? Are you having fewer negative outcomes while these patients are in the hospital, such as having to use restraints or get security involved? “Hopefully you can get some data in terms of how much money you’ve saved by decreasing the length of stays and decreasing inadvertent adverse effects because the patients weren’t receiving the proper care,” he said.
As this challenge seems likely to continue to grow, hospitalists might consider finding more training in mental health issues themselves so they are more comfortable handling these issues, Dr. Parks said. “The average mini-psych rotation from medical school is only 4 weeks,” he noted. “The ob.gyn. is at least 8 weeks and often 12 weeks, and if you don’t go into ob.gyn., you’re going to see a lot more mentally ill people through the rest of your practice, no matter what you do, than you are going to see pregnant women.”
Just starting these conversations – with patients, with colleagues, with family and friends – might be the most important change of all. “Even though nobody is above these issues afflicting them, this is still something that is not part of an open dialogue, and this is something that affects our own colleagues,” Dr. Mandal said. “I don’t know how many more trainees jumping out of windows it will take, or colleagues going through depression and feeling that it’s a sign of weakness to even talk about it.
“We need to create safe harbors within our own medical communities and acknowledge that we ourselves can be prone to this,” he said. “Perhaps by doing that, we will develop more empathy and become more comfortable, not just with ourselves and our colleagues but also helping these patients. People get overwhelmed and throw their hands up because it is just such a difficult issue. I don’t want people to give up, both from the medical community and our society as a whole – we can’t give up.”
A med-psych unit pilot project
Med-psych units can be a good model to take on these challenges. At Long Island Jewish Medical Center, they launched a pilot project to see how one would work in their community and summarized the results in an SHM abstract.
The hospital shares a campus with a 200-bed inpatient psych hospital, and doctors were seeing a lot of back and forth between the two institutions, said Corey Karlin-Zysman, MD, FHM, FACP, chief of the division of hospital medicine at Northwell Health. “Patients would come into the hospital because they had an active medical issue, but because of their behavioral issues, they’d have to have continuous observation. It would not be uncommon for us to have sometimes close to 30 patients who needed 24-hour continuous observation to make sure they were not hurting themselves.” These PCAs or nurse’s assistants were doing 8-hour shifts, so each patient needed three. “The math is staggering – and with not any better outcomes.”
So the hospital created a 15-bed closed med-psych unit for medically ill patients with behavioral health disorders. They staffed it with a dedicated hospitalist, a nurse practitioner, a psychologist, and a nurse manager.
The number of patients requiring continuous observation fell to single digits. Once in their own unit, these patients caused less disruption and stress on the medical units. They had a lower length of stay compared to their previous admissions in other units, and this became one of the hospital’s highest performing units in terms of patient experience.
The biggest secret of their success, Dr. Karlin-Zysman said, is cohorting. “Instead of them going to the next open bed, wherever it may be, you get the patients all in one place geographically, with a team trained to manage those patients.” Another factor: it’s a hospitalist-run unit. “You can’t have 20 different doctors taking care of the patients; it’s one or two hospitalists running this unit.”
Care models like this can be a true win-win, and her hospital is using them more and more.
“I have a care model that’s a stroke unit; I have a care model that’s an onc unit and one that’s a pulmonary unit,” she said. “We’re creating these true teams, which I think hospitalists really like being part of. What’s that thing that makes them want to come to work every day? Things like this: running a care model, becoming specialized in something.” There are research and abstract opportunities for hospitalists on these units too, which also helps keep them engaged, she said. “I’ve used this care model and things like that to reduce burnout and keep people excited.”
The persistent mortality gap
Patients with mental illness tend to receive worse medical care than people without, studies have shown; they die an average of 25 years earlier, largely from preventable or treatable conditions such as cardiovascular disease and diabetes. The World Health Organization has called the problem “a hidden human rights emergency.”
In one in a series of articles on mental health, Lisa Rosenbaum, MD, a cardiologist at Brigham and Women’s Hospital, Boston, raises the question: Might physician attitudes toward mentally ill people contribute to this mortality gap, and if so, can we change them?
She recognizes the many obstacles physicians face in treating these patients. “The medicines we have are good but not great and can cause obesity and diabetes, which contributes to cardiovascular morbidity and mortality,” Dr. Rosenbaum said. “We have the adherence challenge for the psychiatric medications and for medications for chronic disease. It’s hard enough for anyone to take a medicine every day, and to do that if you’re homeless or you don’t have insight into the need for it, it’s really hard.”
Also, certain behaviors that are more common among people with serious mental illness – smoking, substance abuse, physical inactivity – increase their risk for chronic diseases.
These hurdles may foster a sense of helplessness among hospitalists who have just a small amount of time to spend with a patient, and attitudes may be hard to change.
“Negotiating more effectively about care refusals, more adeptly assessing capacity, and recognizing when our efforts to orchestrate care have been inadequate seem feasible,” Dr. Rosenbaum writes. “Far harder is overcoming any collective belief that what mentally ill people truly need is not something we can offer.” That’s why a truly honest examination of attitudes and biases is a necessary place to start.
She tells the story of one mentally ill patient she learned of in her research, who, after decades as the quintessential frequent flier in the ER, was living stably in the community. “No one could have known how many tries it would take to help him get there,” she writes. His doctor told her, “Let’s say 10 attempts are necessary. Someone needs to be number 2, 3 and 7. You just never know which number you are.”
Education for physicians
A course created by the National Alliance on Mental Illness addresses mental illness issues from a provider perspective.
“Although the description states that the course is intended for mental health professionals, it can be and has been used to educate and inform other healthcare professionals as well,” said Ron Honberg, JD, senior policy advisor for the National Alliance on Mental Illness. The standard course takes 15 hours; there is an abbreviated 4-hour alternative as well. More information can be found at http://www.nami.org/Find-Support/NAMI-Programs/NAMI-Provider-Education.
Sources
1. Szabo L. Cost of Not Caring: Nowhere to Go. USA Today. https://www.usatoday.com/story/news/nation/2014/05/12/mental-health-system-crisis/7746535/. Accessed March 10, 2017.
2. Mental Health America. The State of Mental Health in America. http://www.mentalhealthamerica.net/issues/state-mental-health-america. Accessed March 30, 2017.
3. Karlin-Zysman C, Lerner K, Warner-Cohen J. Creating a Hybrid Medicine and Psychiatric Unit to Manage Medically Ill Patients with Behavioral Health Disorders [abstract]. Journal of Hospital Medicine. 2015; 10 (suppl 2). http://www.shmabstracts.com/abstract/creating-a-hybrid-medicine-and-psychiatric-unit-to-manage-medically-ill-patients-with-behavioral-health-disorders/. Accessed March 19, 2017.
4. Garey J. When Doctors Discriminate. New York Times. http://www.nytimes.com/2013/08/11/opinion/sunday/when-doctors-discriminate.html. August 10, 2013. Accessed March 15, 2017.
5. Rosenbaum L. Closing the Mortality Gap – Mental Illness and Medical Care. N Engl J Med. 2016; 375:1585-1589. doi: 10.1056/NEJMms1610125.
6. Rosenbaum L. Unlearning Our Helplessness – Coexisting Serious Mental and Medical Illness. N Engl J Med. 2016;375:1690-4. doi: 10.1056/NEJMms1610127.
Nonadherence to lupus drugs may play a role in frequent hospitalization
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
SAN DIEGO – New research into factors that predict which systemic lupus erythematosus patients are at high risk for hospitalization is beginning to identify the contribution of medication nonadherence to the problem.
Compared with others hospitalized for systemic lupus erythematosus (SLE), high-risk patients were an adjusted 10 percentage points less likely to show evidence of adherence to prescribed drugs, according to a study presented at the annual meeting of the American College of Rheumatology.
“Medication nonadherence remains an important problem among patients with SLE. It is a major modifiable cause to help decrease hospital admissions and readmissions and decrease risk for morbidity and mortality associated with SLE,” study coauthor Allen P. Anandarajah, MBBS, said in an interview after the ACR meeting.
The researchers found that the average patient required $51,808 in treatment costs annually; the average stay was 8.5 days (Lupus. 2017;26[7]:756-61).
Dr. Anandarajah led another study, released at the 2016 ACR annual meeting, that found patients at high risk of hospitalization were more likely to be younger, have earlier SLE onset, and be African American (abstract 122).
As for medication nonadherence, a systematic review of 11 studies published this year found that “the percentage of nonadherent patients ranged from 43% to 75%, with studies consistently reporting that over half of patients are nonadherent” (Arthritis Care Res [Hoboken]. 2017 Nov;69[11]:1706-13).
Nonadherence is an especially significant issue “among a small group of high-risk, high-need patients,” Dr. Anandarajah said.
For the new study, the researchers aimed to better understand “if medication adherence was a risk factor for hospital admissions among SLE patients,” he said.
They identified a group of 28 high-risk patients out of 171 hospitalized SLE patients who were admitted from 2013 to 2015. Compared with other patients, the high-risk patients, who required three or more annual admissions, were younger (mean age, 39.6 vs. 47.6; P = .03), less likely to be female (82% vs. 92%; P = .09), and more likely to be African American (61% vs. 41%; P = .05).
Why might the young be less adherent? “Younger people are more likely to have difficulty with taking care of themselves when afflicted with chronic diseases due to lack of understanding of the implications of insufficiently treating their illness, poor coping skills, peer pressures about dealing with potential side effects like weight gain with steroids, and financial reasons, including lack of insurance,” he said.
As for African Americans, possible reasons for lower adherence include “cultural reasons such as a taboo about illness and misconceptions about need for continuous use of medications, lower educational levels, lack of trust in their health care providers/health care team, and socioeconomic reasons/financial issues,” he said.
The researchers linked patients to a pharmacy claims database to calculate the medication possession ratio, “an indicator of whether a patient had adequate medication supply in a given time frame,” as the study puts it. A total of 102 patients had complete pharmacy data.
The researchers found that the unadjusted mean medication possession ratio was lower in high-risk patients, compared with the others (73.4% vs. 79.9%; P = .30), and was an estimated 10 percentage points lower in an adjusted analysis that nearly reached statistical significance (P = .06).
“While it was not significant, there was a trend, and one could possibly expect a significant value with larger numbers,” Dr. Anandarajah said.
How can adherence be improved in SLE? In an interview, Michelle Petri, MD, professor of medicine and codirector of the lupus center at Johns Hopkins University, Baltimore, said she saw a major improvement in hydroxychloroquine (Plaquenil) adherence after introducing blood level testing.
“I believe rheumatologists should introduce drug monitoring for all of our important drugs: [hydroxychloroquine] (where it must be a whole blood level and not plasma), azathioprine, methotrexate, and mycophenolate,” said Dr. Petri, who praised the new research as “an excellent first study.”
Going forward, Dr. Anandarajah said his university has started a program designed to help poor, high-risk SLE patients in the Rochester area through a clinic in the inner city, coordinated care with nurses, and a series of focus-group meetings and educational programs for patients and providers. “We hope to improve compliance with outpatient visits, medication adherence, and self-management skills,” he said.
The study authors and Dr. Petri reported no relevant disclosures. No specific study funding was reported.
REPORTING FROM ACR 2017
Key clinical point:
Major finding: Compared with other patients hospitalized with SLE, high-risk patients had 10% lower medication adherence.
Data source: A 2-year analysis of 171 patients (28 deemed high risk) admitted for SLE at a single hospital.
Disclosures: The study authors reported no relevant disclosures. No specific study funding is reported.
Source: C. Thirukuraman et al. ACR 2017 abstract 223.
VIDEO: Dr. Sherene Loi discusses PANACEA trial and implications for pembrolizumab use
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – The phase 1b/2 PANACEA trial of pembrolizumab and trastuzumab in trastuzumab-resistant HER2-positive advanced breast cancer met its primary endpoint, showing an overall response rate of 15.2% in the PD-L1-positive cohort and controlling disease for almost a year without chemotherapy, Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre in Melbourne reported on behalf of the International Breast Cancer Study Group (IBCSG). But level of antitumor immunity was key. In an interview at the San Antonio Breast Cancer Symposium, Dr. Loi discussed the findings and possible implications for use of pembrolizumab earlier in the disease course.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
VIDEO: Meta-analysis lead author Dr. Richard Gray on dose intensity benefit
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Increasing the dose intensity of adjuvant chemotherapy reduced risks of breast cancer recurrence and death by about 15% in an Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis of individual patient data from 25 randomized trials among 34,122 women. Lead author Richard Gray, MSc, professor of medical statistics in the Nuffield Department of Population Health at University of Oxford, England, discussed the findings for various dose-intensification approaches and likely impact on clinical practice in an interview at the San Antonio Breast Cancer Symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
FDA approves injectable diabetes drug that improves A1c scores
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
The Food and Drug Administration has approved semaglutide (OZEMPIC) injections for treatment of type 2 diabetes in adults, according to a press release from Novo Nordisk.
Semaglutide is a once-weekly injection of glucagon-like peptide (GLP-1) receptor agonist that, combined with diet and exercise, can improve glycemic control in adults with type 2 diabetes. Weekly injections are administered by health care providers in a prefilled pen subcutaneously in the stomach, abdomen, thigh, or upper arm as a 0.5-mg or 1-mg formulation. It is important that all doses be administered on the same day each week, according to the OZEMPIC package insert.
“The OZEMPIC (semaglutide) approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
To ensure access to semaglutide, Novo Nordisk is pricing the drug competitively with other GLP-1 receptor agonists and will offer an associated savings card program to reduce copays for insured patients, the company said. Novo Nordisk expects to launch OZEMPIC in the United States in the first quarter of 2018, and is working on contracting solutions with health insurance providers to increase patient access to the drug.
According to the Novo Nordisk statement, clinicians should not consider semaglutide as a first choice option for treating diabetes or as a substitute for insulin in patients with type 1 diabetes and diabetic ketoacidosis. Whether semaglutide can be used by people who have had pancreatitis or is safe in patients under the age of 18 years old remains to be seen.
“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” said Helena Rodbard, MD, past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”
Pulmonary hypertension treatment gets under the skin
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
The development of an implantable therapy for pulmonary hypertension could expand the use of treprostinil, a demonstrated effective treatment for PAH that has been limited in its use because of a range of side effects when given intravenously, orally, subcutaneously, or by inhalation, Joel A. Wirth, MD, FCCP, and Harold I. Palevsky, MD, FCCP, wrote in an editorial.
The use of an intravenous pump and catheter infusion system for stable PAH patients could help them return more quickly to normal activities and curb the risk of catheter-related infections, they said. “Having the potential to remove some of the burden and risk incumbent with an external delivery system may reduce several of the overall barriers to continuous intravenous prostanoid acceptance by both patients and providers,” they noted (Chest. 2017 Dec 6. doi: 10.1016/j.chest.2017.07.006).
Clinicians must be educated to perform the implant procedure itself, and care centers must be trained in identifying patient management issues and refilling the pump reservoir as needed, Dr. Wirth and Dr. Palevsky emphasized. Patients must be educated in what to expect, including how to monitor the pump and track the need for refills, they said. Although the pump is not appropriate for patients with severe PAH, “a planned staged approach of transitioning PAH patients from IV therapy to a less complex system could lend itself to employing prostanoid use earlier and for less severely affected PAH patients,” they said.
Dr. Wirth is affiliated with Tufts University, Boston. Dr. Palevsky is affiliated with the University of Pennsylvania, Philadelphia. Both Dr. Wirth and Dr. Palevsky disclosed serving as consultants and as principal investigators for United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Pulmonary arterial hypertension (PAH) patients with moderate, stable disease can benefit from an implantable drug delivery system, based on data from a review of 60 adults with successful implantations. The findings were published in the December issue of CHEST.
“A fully implanted system offers patients the hope of returning to more normal activities such as bathing, swimming, and reduced risk of infections from externalized central venous catheter contamination or reduced subcutaneous pain from subcutaneous infusion,” wrote Aaron B. Waxman, MD, PhD, of Brigham and Women’s Hospital, Boston, and his colleagues (Chest. 2017 June 3. doi: 10.1016/j.chest.2017.04.188).
In the DelIVery Trial, clinicians at 10 locations in the United States placed a fully implantable delivery system in adults aged 18 years and older with stable PAH who were previously receiving treprostinil via an external pump at an average dose of 71 ng/kg per min.
All 60 patients were successfully implanted with a system consisting of a drug infusion pump placed in an abdominal pocket and an intravascular catheter linking the implanted pump to the superior vena cava.
“The location of the pump pocket was determined in partnership with the patient and was based on consideration of clothing styles, belt line and subcutaneous fat depth,” the researchers noted.
Procedure-related complications deemed clinically significant included one atrial fibrillation, two incidences of pneumothorax, two infections unrelated to catheter placement, and three catheter dislocations (two in the same patient). The most common patient complaints were expected implant site pain in 83% and bruising in 17%.
The findings were limited by the small number of patients, but the researchers identified several factors that contributed to the success of the procedure, including selecting patients who have shown response to treprostinil and are motivated to comply with pump refill visits, performing the procedure at centers with a high volume of PAH patients, keeping the procedure consistent for each patient, and using the same implant team in each case. “The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training,” the researchers added.
Patients reported satisfaction with the implant system at 6 weeks and 6 months, and said they spent an average of 75% less time managing their delivery system, according to previously published data on the patients’ perspective (CHEST 2016;150[1]:27-34).
Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
FROM CHEST
Key clinical point: An implantable drug delivery system was successfully placed in 100% of adult PAH patients with no serious complications.
Major finding: The most common complaints among patients who received an implant system to deliver treprostinil were implant site pain (83%) and bruising (17%).
Data source: A multicenter, prospective study of 60 adults with pulmonary arterial hypertension who received implantable pumps to deliver treprostinil.
Disclosures: Medtronic sponsored the study. The lead author, Dr. Waxman, had no financial conflicts to disclose; several coauthors reported relationships with companies including Medtronic, Actelion, Bayer, Gilead, Merck, and United Therapeutics.
Using post-acute and long-term care quality report cards
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
2. Thompson, MP, Waters, TM, Kaplan et al. Most hospitals received annual penalties for excess readmissions, but some fared better than others. Health Aff (Millwood). 36(5):893-901.
3. Auerbach AD et al. Preventability and causes of readmissions in a national cohort of general medicine patients. JAMA Intern Med. 2016;176(4):484-93.
4. Jack B et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-87.
5. Hansen LO et al. Project BOOST: effectiveness of a multihospital effort to reduce rehospitalization. J Hosp Med. 2013;8(8)421-7.
6. Naylor MD et al. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011;30(4):746-54.
7. Coleman EA. Family caregivers as partners in care transitions: The caregiver advise record and enable act. J Hosp Med. 2016 Dec;11(12):883-5.
8. Leppin AL et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Internal Med. 2014;174(7):1095-107.
9. Mukamel DB et al. Personalizing nursing home compare and the discharge from hospitals to nursing homes. Health Serv Res. 2016;1(6):2076-2094.
10. Werner RM et al. Changes in consumer demand following public reporting of summary quality ratings: An evaluation in nursing homes. Health Serv Res. 2016;51 Suppl 2:1291-309.
11. Boccuti C et al. Reading the stars: nursing home quality star ratings, nationally and by state. Kaiser Family Foundation Issue Brief. May 2015.
12. Centers for Medicare and Medicaid Services. Nursing home compare data archives. May 2017 monthly files. Quality MSR Claims data. https://data.medicare.gov/data/archives/nursing-home-compare. Accessed July 15, 2017.
13. Harrington C et al. The need for higher minimum staffing standards in U.S. nursing homes. Health Serv Insights. 2016;9:13-9.
14. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
2. Thompson, MP, Waters, TM, Kaplan et al. Most hospitals received annual penalties for excess readmissions, but some fared better than others. Health Aff (Millwood). 36(5):893-901.
3. Auerbach AD et al. Preventability and causes of readmissions in a national cohort of general medicine patients. JAMA Intern Med. 2016;176(4):484-93.
4. Jack B et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med. 2009;150(3):178-87.
5. Hansen LO et al. Project BOOST: effectiveness of a multihospital effort to reduce rehospitalization. J Hosp Med. 2013;8(8)421-7.
6. Naylor MD et al. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011;30(4):746-54.
7. Coleman EA. Family caregivers as partners in care transitions: The caregiver advise record and enable act. J Hosp Med. 2016 Dec;11(12):883-5.
8. Leppin AL et al. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Internal Med. 2014;174(7):1095-107.
9. Mukamel DB et al. Personalizing nursing home compare and the discharge from hospitals to nursing homes. Health Serv Res. 2016;1(6):2076-2094.
10. Werner RM et al. Changes in consumer demand following public reporting of summary quality ratings: An evaluation in nursing homes. Health Serv Res. 2016;51 Suppl 2:1291-309.
11. Boccuti C et al. Reading the stars: nursing home quality star ratings, nationally and by state. Kaiser Family Foundation Issue Brief. May 2015.
12. Centers for Medicare and Medicaid Services. Nursing home compare data archives. May 2017 monthly files. Quality MSR Claims data. https://data.medicare.gov/data/archives/nursing-home-compare. Accessed July 15, 2017.
13. Harrington C et al. The need for higher minimum staffing standards in U.S. nursing homes. Health Serv Insights. 2016;9:13-9.
14. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
The challenges of hospital discharge planning are well known and yet have not been adequately addressed by hospitalists and discharge teams. As the complexity of patient care needs has grown, so has the difficulty in developing appropriate discharge goals for post-acute and long term care (LTC), choosing the appropriate setting(s), and selecting appropriate providers. Post-acute and LTC needs may include rehabilitation, nursing care, home health, supportive services, and/or palliative care1 in an institutional setting or at home from a wide array of providers with varying levels of quality.
Even though 52% of U.S. hospitals received penalties for having higher-than-expected readmissions between 2013 and 2017,2 inadequate discharge planning for post-acute and LTC continues to contribute to high rates of all-cause 30-day rehospitalization. The discharge process sometimes is deficient in: discussion of goals; assessment of discharge needs; appropriate choice of discharge locations; and the provision of additional or different home services.3 Discharge decisions are complicated by the stressful circumstances of hospitalization and discharge deadlines.
Hospital discharge planning decisions fall heavily on patients, families, and caregivers, often with inadequate information about choices and options. More than 30 states have passed the Caregiver Advise, Record, and Enable (CARE) Act into law to require hospitals to provide resources for family caregiver education and instruction,7 but hospitals do not have to provide information on all LTC options and provider quality ratings.
Quality report cards about LTC providers – a major innovation for consumer education and choice – are often not used in the discharge process for a number of reasons. A significant concern is that using report cards will extend the length of stay. Rather than extending the decision-making time and the length of stay, the use of report cards can reduce length of stay.9 A focus on identifying the first available nursing home bed or LTC provider often ignores the need to identify the most appropriate high-quality providers.
Hospitals and health plans often have established networks of post-acute and LTC providers and these networks must be taken into account in the discharge process. Most hospital and health plan networks have providers with a wide range of ratings, allowing for choices within networks.
The Centers for Medicare and Medicaid Services (CMS) established a web-based nursing home report card called Nursing Home Compare in 1998 that includes information on facility characteristics, deficiencies, staffing information (since 2000), and resident quality indicators (since 2002). In 2008, the website added a “five-star” rating system for all U.S. nursing homes and all-cause 30-day readmission rates and successful discharge rates from nursing homes were incorporated into the ratings in 2016.
CMS also established a web-based home health website, which provides quality ratings. This website has general information, quality measures, and patient surveys with information on readmission rates from home health agency services.
After establishment of the CMS Nursing Home Compare rating system in 2008, nursing homes improved their scores on certain quality measures and consumer demand significantly increased for the best (5-star) facilities and decreased for 1-star facilities.10 More recently, a clinical trial of the use of a personalized version of Nursing Home Compare in the hospital discharge planning process found greater patient satisfaction, patients being more likely to go to higher ranked nursing homes, patients traveling further to nursing homes, and patients having shorter hospital stays, compared with the control group.9
Quality report cards show wide variations within and across states ranging from one star (poorest quality) to five stars (highest quality). More than one-third of nursing homes had relatively low overall star ratings (1 or 2 stars) serving 39 percent of residents in 2015.11 Federal nursing home regulatory violations range from zero to more than 40 deficiencies (average of 7) with a scope and severity ranging from minor to widespread harm or jeopardy (including deaths).12 Total nurse staffing hours (average, 4.1 hours per resident day) range from less than 3 hours to more than 5.5 hours per resident day and RN hours are 3.5 times higher in some nursing homes than in the lowest staffed homes.13 Hospital readmission rates for short-stay residents from nursing homes also vary widely (4%-52%; average, 21%).12,14
Hospitalists and discharge planners should inform patients, families, and caregivers about the federal and state LTC quality report cards, provide education and choices, and engage and assist them in the decision making process. Hospitals, health plans, and accountable care organizations also need to be more informed about the availability of and benefits of using quality report cards for developing post-acute and LTC provider networks. The use of high quality LTC network providers should be able to reduce hospital length of stay and hospital readmission rates, and improve patient and caregiver satisfaction.
Charlene Harrington, PhD, RN, is professor of sociology and nursing; Leslie Ross, PhD, is a research specialist and principal investigator of the Calqualitycare.org website project; and Jeffrey Newman, MD, MPH, is a professor at the Institute for Health and Aging, all at the University of California, San Francisco.
References
1. Mor V et al. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010;29(1):57-64.
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