MARCH 2016 • VOL. 17, NO. 3 www.CaringfortheAges.com for the Ag es for the Ag es A Monthly Newspaper for Long-Term Care Practitioners ™ In This Issue Caring AN OFFICIAL PUBLICATION OF AMDA – THE SOCIETY FOR POST-ACUTE AND LONG-TERM CARE MEDICINE Help for the Dying Karl Steinberg, MD, CMD, discusses California’s new End of Life Options Act. ............... 2 Where There’s a Will When the courts intervene, ensuring your deceased resident’s final wishes are carried out is a valuable final service you can provide. ........ 5 Good Fats, Bad Fats It’s never too late to strive for the right balance of fats to improve your residents’ heart health. ........................12 Care for Pressure Ulcers When healing isn’t expected, aim for minimum pain and maximum comfort, says Jeffrey Levine, MD, CMD. ...............19 T he frontier of palliative care is out- side of hospitals and hospice, said Diane Meier, MD, FACP, director of the national Center to Advance Pallia- tive Care (CAPC) and Anne-Marie Filkin lecturer at AMDA’s 2016 annual confer- ence in Orlando, FL. Settings such as home care, post-acute facilities, and nurs- ing homes are the greatest opportunity for innovative, effective palliative care. Palliative care is not limited to end-of- life or care of the dying, and it should be provided at the same time as all other appropriate medical therapies. “Compared with 10 years ago, we’ve come a long way,” said Dr. Meier. “We’re at a point where two-thirds of hospitals with more than 50 beds have palliative care. That’s huge progress.” However, “We don’t really know how many patients in these hospitals receive ser- vices, or how well the teams are staffed or trained to provide them,” she said. “More importantly, for people living in the community — at home or in facilities — palliative care is not reliably accessible, despite the obvious need. The next step will be to ensure that patients get and benefit from the highest possible quality of palliative care in all care settings.” Making the Grade Dr. Meier cited CAPC’s 2015 America’s Care of Serious Illness report as proof of the progress made to date, at least in hospitals. It shows that the number of 50-plus-bed U.S. hospitals with palliative care teams is 67%, up from 63% in 2011 and 53% in 2008. The number of states with “A” grades, defined as those with 80% of their hospitals reporting a pallia- tive care team, also increased from 3% in 2008 to 17% percent in 2015. Also nota- ble, for the first time, no states received an “F” grade (fewer than 20% of hospi- tals reporting a palliative care program.) However, as Dr. Meier noted, gaps still exist, and the report bears this out. One- third of U.S. hospitals with 50 or more beds still report having no palliative care services, and one-third of states received a grade of “C” or “D.” CAPC concluded that the report “demonstrates that access to palliative care remains inadequate for millions of Americans living with serious illness, such as cancer, heart disease, kid- ney disease and dementia… .” And these data don’t even begin to address the gaps in access to palliative care for individuals who are not dying and are therefore not hospice-eligible but who need expert pal- liative care in the communities and facili- ties where they live. Beyond Hospitals Even when hospitals are making the grade with palliative care, it’s not enough. “The great majority of older and seri- ously ill patients in need of palliative care services — attention to pain and symptoms, expert communication about what to expect and what matters most to patients in that context, and reliable continuity and coordination of care over time and across settings — aren’t in the hospital. Instead, they are receiving care at home or in long-term care facilities. These settings represent an important future priority for integration of palliative care knowledge and skills,” said Dr. Meier. She shared a story demonstrating what is at stake. She had a patient several years ago who had outlived her spouse, sib- lings, and friends. Her children lived in another state. As much as she wanted to stay in her home, the elderly woman eventually had to go into an assisted liv- ing facility, then a nursing home. “I documented a conversation we had in which she expressed a wish for Filkin Lecturer Urges Practitioners to Trek Forward on Palliative Care Frontier BY JOANNE KALDY I owa is the latest state to launch a unique strategy that aims to reduce medi- cal malpractice lawsuits and bolster doctor-patient commu- nication after poor outcomes, while encouraging swift reso- lution. The Communication and Optimal Resolution (CAN- DOR) law, which took effect in July 2015, permits privileged discussions between Iowa physicians and patients after medical errors and allows for compensation offers, when ap- propriate. After years of failing to enact traditional tort reform, the alternative method is hoped to decrease litigation costs and keep doctors and patients out of a flawed court system, said Michael McCoy, MD, chair of the Iowa Medical Society Ad Hoc Tort Reform Task Force. “If there’s an untoward out- come, the current system cre- ates isolation,” he said. “The patients get alienated, and the doctors get stressed. That’s the exact opposite of what should happen. You should be able to talk to patients and feel protec- tion. That’s what this law does.” About 36 states have so-called “apology laws” that prohibit BY ALICIA GALLEGOS Candor Laws Growing, but Are They Effective? See Palliative Care • page 16 See Candor Laws • page 18 O R L A N D O AMDA 2016 ANNUAL CONFERENCE MARCH 17-20, 2016 Gaylord Palms Resort & Convention Center • Orlando, FL ™ Pre-Registration Closes 2/26 (save up to $100) Registration Available On-Site • www.PALTCmedicine.org SEE YOU IN Most elderly and seriously ill patients who need palliative care are at home, in PA facilities, and in nursing homes, according to Diane Meier, MD, FACP. PHOTO COURTESY OF DIANE MEIER, MD, FACP
Transcript
MARCH 2016 • VOL. 17, NO. 3www.CaringfortheAges.com
for the Agesfor the Ages A Monthly Newspaper for Long-Term Care Practitioners
™
In This Issue
Caring AN OFFICIAL PUBLICATION OFAMDA – THE SOCIETY FOR POST-ACUTE AND LONG-TERM CARE MEDICINE
Help for the DyingKarl Steinberg, MD, CMD, discusses California’s new End of Life Options Act. ...............2
Where There’s a WillWhen the courts intervene, ensuring your deceased resident’s final wishes are carried out is a valuable final service you can provide. ........5
Good Fats, Bad FatsIt’s never too late to strive for the right balance of fats to improve your residents’ heart health. ........................12
Care for Pressure UlcersWhen healing isn’t expected, aim for minimum pain and maximum comfort, says Jeffrey Levine, MD, CMD. ...............19
The frontier of palliative care is out-side of hospitals and hospice, said Diane Meier, MD, FACP, director
of the national Center to Advance Pallia-tive Care (CAPC) and Anne-Marie Filkin lecturer at AMDA’s 2016 annual confer-ence in Orlando, FL. Settings such as home care, post-acute facilities, and nurs-ing homes are the greatest opportunity for innovative, eff ective palliative care. Palliative care is not limited to end-of-life or care of the dying, and it should be provided at the same time as all other appropriate medical therapies.
“Compared with 10 years ago, we’ve come a long way,” said Dr. Meier. “We’re at a point where two-thirds of hospitals with more than 50 beds have palliative care. That’s huge progress.” However, “We don’t really know how many patients in these hospitals receive ser-vices, or how well the teams are staffed or trained to provide them,” she said. “More importantly, for people living in the community — at home or in facilities — palliative care is not reliably accessible, despite the obvious need. The next step will be to ensure that patients get and benefit from the highest possible quality of palliative care in all care settings.”
Making the Grade Dr. Meier cited CAPC’s 2015 America’s Care of Serious Illness report as proof of the progress made to date, at least in hospitals. It shows that the number of
50-plus-bed U.S. hospitals with palliative care teams is 67%, up from 63% in 2011 and 53% in 2008. The number of states with “A” grades, defined as those with 80% of their hospitals reporting a pallia-tive care team, also increased from 3% in 2008 to 17% percent in 2015. Also nota-ble, for the first time, no states received an “F” grade (fewer than 20% of hospi-tals reporting a palliative care program.)
However, as Dr. Meier noted, gaps still exist, and the report bears this out. One-third of U.S. hospitals with 50 or more beds still report having no palliative care services, and one-third of states received a grade of “C” or “D.” CAPC concluded that the report “demonstrates that access to palliative care remains inadequate for millions of Americans living with serious illness, such as cancer, heart disease, kid-ney disease and dementia… .” And these data don’t even begin to address the gaps in access to palliative care for individuals who are not dying and are therefore not hospice-eligible but who need expert pal-liative care in the communities and facili-ties where they live.
Beyond Hospitals Even when hospitals are making the grade with palliative care, it’s not enough.
“The great majority of older and seri-ously ill patients in need of palliative care services — attention to pain and symptoms, expert communication about what to expect and what matters most to patients in that context, and reliable continuity and coordination of care over
time and across settings — aren’t in the hospital. Instead, they are receiving care at home or in long-term care facilities. These settings represent an important future priority for integration of palliative care knowledge and skills,” said Dr. Meier.
She shared a story demonstrating what is at stake. She had a patient several years ago who had outlived her spouse, sib-lings, and friends. Her children lived in another state. As much as she wanted to stay in her home, the elderly woman eventually had to go into an assisted liv-ing facility, then a nursing home.
“I documented a conversation we had in which she expressed a wish for
Filkin Lecturer Urges Practitioners to Trek Forward on Palliative Care Frontier
BY JOANNE KALDY
Iowa is the latest state to launch a unique strategy that aims to reduce medi-
cal malpractice lawsuits and bolster doctor-patient commu-nication after poor outcomes,
while encouraging swift reso-lution. The Communication and Optimal Resolution (CAN-DOR) law, which took eff ect in July 2015, permits privileged discussions between Iowa physicians and patients after medical errors and allows for
compensation off ers, when ap-propriate.
After years of failing to enact traditional tort reform, the alternative method is hoped to decrease litigation costs and keep doctors and patients out of a flawed court system, said
Michael McCoy, MD, chair of the Iowa Medical Society Ad Hoc Tort Reform Task Force.
“If there’s an untoward out-come, the current system cre-ates isolation,” he said. “The patients get alienated, and the doctors get stressed. That’s the
exact opposite of what should happen. You should be able to talk to patients and feel protec-tion. That’s what this law does.”
About 36 states have so-called “apology laws” that prohibit
BY ALICIA GALLEGOS
Candor Laws Growing, but Are They Effective?
See Palliative Care • page 16
See Candor Laws • page 18
ORLANDOAMDA 2016 ANNUAL CONFERENCE
M A R C H 1 7 - 2 0 , 2 0 1 6 Gaylord Palms Resort & Convention Center • Orlando, FL
™
Pre-Registration Closes 2/26 (save up to $100) Registration Available On-Site • www.PALTCmedicine.org
SEE YOU IN
Most elderly and seriously ill patients who need palliative care are at home, in PA facilities, and in nursing homes, according to Diane Meier, MD, FACP.
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2 • CARING FOR THE AGES MARCH 2016
On My Mind
Within the next few months, Cali-fornia’s AB X2-15, the End-of-Life Options Act will go into
eff ect in my state, bringing the number of Americans who will live in a state where physician-assisted dying (PAD) is allowed to some 50 million, or about one-sixth of the U.S. population. This highly conten-tious subject has been the topic of debate for many years, and no doubt will con-tinue to be, as physicians have very strong feelings about it. The level of controversy is highlighted by the variety of names tied to this practice, ranging from “physician-assisted suicide” to “death with dignity.”
Personally, I am ambivalent about PAD. At its most basic level, I feel that this is not part of my job description as a physician. Our duties are to prolong life and alleviate suffering, although sometimes we cannot do both. The principle of double effect (e.g., we are giving morphine to alleviate air hunger — not to hasten death — but sometimes death is hastened as a result of symptom control) is a well-established and comforting bioethics tenet. That feels very different from giving someone a pre-scription they can take that will result in their death as the primary goal.
In reality, PAD has been around in Oregon for almost 20 years, and fewer than 1,000 people have actually taken the lethal prescription — most of them well-educated, wealthy white men. A sub-stantial minority of patients who get the prescription never take it, but feel that it is reassuring to know they have it if they need it. Like many in the palliative
care community, I believe the campaign by Compassion and Choices (formerly known as the Hemlock Society) is a huge distraction from the real issue. That is, unlike the tiny sliver of a per-cent of all people who wind up availing themselves of PAD, there is an enor-mous number of people who do not get access to basic palliative care, much less more aggressive interventions like palliative sedation. We can certainly hold out hope that both the public at large and Compassion and Choices will push for improved and widespread access to broader palliative care information and services because of the increased atten-tion on a “dignified” death — and not just continue to concentrate on those desiring “self-deliverance.”
Brittany Maynard, the young woman suffering from glioblastoma multiforme who moved to Oregon so she could avail herself of this option, made a compel-ling and widely publicized case for PAD, to such an extent that California’s Gov. Edmund G. “Jerry” Brown, a Catholic and former seminarian, decided not to veto this bill despite the end-run its spon-sors made around the usual legislative process: “In the end, I was left to reflect on what I would want in the face of my own death. I do not know what I would do if I were dying in prolonged and excruciating pain. I am certain, how-ever, that it would be a comfort to be able to consider the options afforded by the bill. And I wouldn’t deny that right to others.” In bioethics, we make
much of autonomy, and Gov. Brown’s heartfelt signing message speaks right to that point.
There are safeguards in California’s law, including the requirement that the patient have decision-making capacity and be able to self-administer the medication, and that two physicians certify a 6-month-or-less life expectancy. Also, no health care provider will be required to participate in any way with the prescribing or adminis-tration of lethal medications, and in fact the California law does not even obligate a physician to discuss the option or make a referral to a doctor who is willing to write the prescription. In Oregon and Washington, less than 1% of completed PAD procedures have occurred in LTC settings, so I doubt it will become a real-life issue in most of our homes.
I recently attended a dinner with fel-low medical directors of local hospices. An informal poll indicated that a large majority of these physicians would not hesitate to provide the lethal prescription if they were asked, which surprised me. For myself, I would perhaps consider it in an extreme situation, but it would be a distant last resort. Many hospices in Oregon and Washington have elected not to participate with patients who desire PAD, whereas others take a less militant approach by not participating directly in the procurement or administration of the medications, but showing up after the medication has been self-administered to attend the death — which usually occurs within an hour or two.
There are so many nuances that make me nervous about PAD becoming part of our day-to-day reality, including “slippery slope” arguments (e.g., in The Netherlands, where people can request PAD just because they don’t like life any-more, or more ominous sci-fi scenarios where old people are euthanized), and concerns about undue influence (like the patient who is pressured by her family to take this option instead of spending the kids’ inheritance on medical bills and custodial care).
Most of us who work in nursing homes have been asked many times by our patients, “Can’t you just give me some-thing to end it?” or “You would do this for your dog, wouldn’t you?” It’s always a great opportunity to explore what has brought them to the point of making such a request — a springboard to explore goals of care and how best to manage troubling symptoms and existential dis-tress. But it used to be somewhat reas-suring, to me at least, to be able to just categorically answer that question with a simple, “No. I am not allowed to do that.” In this brave new world, the answer will be considerably more complex.
For information about California’s new law, see: www.cmanet.org/resource-library/detail/?item=the-cali-fornia-end-of-life-option-act. CfA
Dr. Steinberg, editor in chief of Caring for the Ages, is a multi-facility and hospice medical director, as well as chair of AMDA’s Public Policy committee.
Coming Soon to a State Near You? Physician-Assisted Dying
By Karl Steinberg, MD, CMD
Caring for the Ages ™
Editor in Chief Karl Steinberg, MD, CMD
EDITORIAL ADVISORY BOARD
Chair: Karl Steinberg, MD, CMD, California
Robin Arnicar, RN, West Virginia
Nicole Brandt, PharmD, CGP, BCPP, FASCP, Maryland
Ian L. Cordes, MBA, NHA, Florida
Jonathan Evans, MD, CMD, Virginia
Janet Feldkamp, RN, JD, BSN, Ohio
Robert M. Gibson, PhD, JD, California
Daniel Haimowitz, MD, FACP, CMD, Pennsylvania
Phyllis Famularo, DCN, RD, New Jersey
Jennifer Heffernan, MD, CMD, Texas
Bill Kubat, MS, LNHA, South Dakota
Jeffrey Nichols, MD, New York
Dan Osterweil, MD, CMD, California
Barbara Resnick, PhD, CRNP, FAAN, FAANP, Maryland
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CARING FOR THE AGES is the official newspaper of AMDA – The Society for
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professionals with timely and relevant news and commentary about
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SNOWMASS, CO — It’s time to elimi-nate the practice of prescribing aspirin for stroke prevention in patients with atrial fibrillation and a CHA2DS2-VASc score of 1, two eminent cardiologists agreed at the Annual Cardiovascular Conference at Snowmass.
“The European guidelines have done away with aspirin for stroke prevention in atrial fibrillation. It barely made it into our current U.S. guidelines. I don’t think aspirin should be in there and I don’t think it will be there in the next guidelines. The role of aspirin will fall away,” predicted Bernard J. Gersh, MB, ChB, DPhil, professor of medicine at the Mayo Clinic in Rochester, MN.
“It’s not that aspirin is less effective than the oral anticoagulants, it’s that there’s no role for it. There are no good data to sup-port aspirin in the prevention of stroke in atrial fibrillation,” he declared.
N.A. Mark Estes III, MD, agreed the aspirin evidence is seriously flawed.
“The use of aspirin has probably been misguided, based upon a single trial which showed a profound effect and was prob-ably just an anomaly,” according to Dr. Estes, professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts University, Boston.
The sole positive clinical trial of aspirin versus placebo, the 25-year-old Stroke Prevention in Atrial Fibrillation (SPAF) study (Circulation 1991;84:527–39), found an unrealistically high stroke protection benefit for aspirin, a result made implausible by multiple other ran-domized trials showing no benefit, the cardiologists agreed.
“In our current guidelines for atrial fibrillation (Circulation 2014;130:2071–104), aspirin can be considered as a Class IIb level of evidence C recommenda-tion in patients with a CHA2DS2-VASc of 1. But I would just take it off of your clinical armamentarium because the best available data indicates that it doesn’t prevent strokes. Increasingly in my patients with a CHA2DS2-VASc of 1, I’m discussing the risks and benefits of a NOAC [novel oral anticoagulant],” Dr. Estes said.
Dr. Gersh was also critical of another common practice in stroke prevention in atrial fibrillation: concomitant use of aspirin with an oral anticoagulant.
“We use too much aspirin in patients on oral anticoagulation. Aspirin is per-haps the major cause of bleeding in patients on an oral anticoagulant. Other than in people with a drug-eluting stent, there’s no role at all for aspirin in stroke prevention,” he asserted.
He was coauthor of an analysis of 7,347 participants in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) who were on an oral anticoagulant. Fully 35% of them were also on aspirin. In a multi-variate analysis, concomitant aspirin and oral anticoagulation was independently associated with a 53% increased risk of major bleeding and a 52% increase in hospitalization for bleeding, compared
with atrial fibrillation patients on an oral anticoagulant alone (Circulation 2013;128:721–8).
Moreover, the widespread use of dual therapy in this real-world registry didn’t appear to be rational. Thirty-nine per-cent of those on aspirin plus an oral anticoagulant had no history of athero-sclerotic disease, the presence of which would be an indication for consider-ing aspirin. And 17% of dual therapy patients had an elevated Anticoagulation
and Risk Factors in Atrial Fibrillation risk score of 5 or more, making dual therapy particularly risky.
This clinically important interaction between aspirin and oral anticoagulation was recently underscored in an analy-sis of rivaroxaban-treated patients in the ROCKET AF trial, Dr. Gersh observed. Long-term use of aspirin at entry into this pivotal randomized trial of rivaroxa-ban vs. warfarin in patients with atrial fibrillation proved to be an independent
predictor of a 47% increase in the risk of gastrointestinal bleeding, compared with patients on rivaroxaban alone ( J Am Coll Cardiol 2015;66:2271–81). He added that there is no evidence that combin-ing aspirin and oral anticoagulation enhances stroke prevention beyond the benefit achieved with oral anticoagula-tion alone. CfA
Bruce Jancin is with the Denver bureau of Frontline Medical News.
Experts Say Abandon Aspirin for Stroke Prevention in AFibBY BRUCE JANCIN
Aerobic exercise has been shown to have a positive eff ect on heart health and overall fi tness across
all age groups. Now, researchers from Wake Forest University have found that aerobic exercise may slow the eff ects of Alzheimer’s disease in the brain.
Alzheimer’s is a multifactorial disease, said Laura Baker, PhD, associate profes-sor of internal medicine, neurology and public health sciences at the Wake Forest School of Medicine, Winston-Salem, NC. Aerobic exercise has many health restoring effects that address multiple physiological pathways and systems. So, Dr. Baker and her colleagues set out to determine if exercise can meaningfully restore health to these systems that are compromised by aging and AD.
Dr. Baker recently presented research results during the 2015 webinar series “What’s Happening in Alzheimer’s Research?” presented by the Administration for Community Living, the Centers for Disease Control & Prevention, and the National Institute on Aging.
She noted several unhealthy trends in the United States: low cost, low quality food; sedentary behavior; too little sleep; too much work; and too much TV view-ing. “Sitting is the new smoking, with similar effects on health,” she said. If aerobic exercise can be an effective inter-vention to change the health outcomes trajectory of these behaviors, why not for the progression of AD?
She pointed to a host of animal studies that previously set the stage for research
in humans. Exercise in animals has shown positive results of even short amounts of exercise on brain cells, inflammation, blood vessels, and resistance to stress, and it may reduce Alzheimer pathology. And in humans, in the last 15 years, a few studies have shown positive results that exercise protects the brain, she said.
In a study conducted at Wake Forest, 71 sedentary adults with mild cogni-tive impairment (mean age, 66 years) were randomly assigned to participate in either high-intensity aerobic training or a stretching and balance program for 6 months.
Researchers tested memory and thinking skills and collected cerebro-spinal fluid (CSF) via lumbar puncture to “more directly look at the brain’s recycling of brain fluid, which gives us a much better picture than blood ever would of what this intervention might be doing in the brain,” Dr. Baker said.
Participants also completed brain imaging using MRI to show resting blood flow and brain structure before and after the interventions.
The exercise intervention consisted of 45-minutes sessions, 4 days per week, at local YMCAs. In the first 6 weeks, exercise was gradually increased in duration and intensity. Participants were supervised by a trainer for the first eight sessions, then one time per week thereafter. Participants completed daily activity logs and received weekly calls from gym staff. The inter-vention had a 91% attendance level.
In the aerobic group, participants had to reach a target heart rate of 70%–80% of maximum, using a treadmill,
stationary bike, elliptical trainer, or approved classes. In the stretching group, participants had to reach a target heart rate of less than 35% of maximum while performing a series of stretching and balance exercises, gentle yoga, and participating in other approved classes.
Three Findings The researchers noted three essential findings at the end of the 6-month study. First, they looked at the effects of aerobic exercise on phosphorylated tau protein (p-tau) levels in CSF — one of the first AD biomarkers that increases with aging — in adults older than 70. Compared with stretching exercises, in these adults, the aerobic exercise program lowered the levels of p-tau in CSF. However, in those who were younger than 70, researchers didn’t find the same effects.
“What we learned about these people over 70 is the levels of this protein in their CSF at baseline, before the exercise, were higher than all the other adults,” Dr. Baker said. “So perhaps these over 70-year-olds had higher levels to begin with and with exercise, they had more room for improvement.”
Secondly, for the brain overall, blood flow at rest was increased for those who completed the high intensity aerobic exercise program, particularly in the posterior parietal cortex, which is typi-cally most significantly affected by AD, she said.
“It’s a remarkable difference in blood flow between people who participated in the higher intensity vs. the lower inten-sity exercise,” she said.
Finally, the researchers also tested participants’ short-term memory and executive function after the exercise interventions. Although they found no improvement in short-term memory in the high-intensity exercise group, there was a dramatic change in execu-tive function and participants’ ability to plan, organize, and focus. “These tasks — in this area of the brain — may be more immediately sensitive to exercise, and it may require even more aerobic exercise to have an effect on short-term memory,” she suggested.
Greater Effort=Greater Rewards Dr. Baker concluded that moderate to high intensity aerobic exercise “appears to be worth the sweat,” and may slow the effects of aging and Alzheimer’s in the brain. However, she cautioned that this is a “high-dose” lifestyle intervention.
“This isn’t just casual walking. You have to exercise with exertion to place a physiological challenge on the body. These high-dose lifestyle interventions, like exercise or diet, have numerous health restoring effects that may prevent or slow the disease.”
The researchers are now conducting a large, 18-month study across the coun-try to determine whether this alterna-tive, non-pharmacologic intervention can meaningfully slow disease and improve cognitive function in people who are at high risk for Alzheimer’s dementia. CfA
Carey Cowles is the managing editor of Caring for the Ages.
Sweatin’ for the Oldies: Aerobic Exercise Improves Brain Function in Alzheimer’s
Increasing weight loss between midlife and late life is a marker for mild cog-nitive impairment, according to a re-
port published online Feb. 1 in JAMA Neurology.
“While weight loss may not be causally related to MCI [mild cognitive impair-ment], we hypothesize that weight loss may represent a prodromal stage or an early manifestation of MCI,” wrote Rabe E. Alhurani, MD, of the department of neurology, Mayo Clinic, Rochester, MN, and his associates. Some recent studies have reported a link between weight loss and dementia, “but overall, the findings of different studies have been inconclu-sive,” they noted.
To examine any association between weight loss over time and incident MCI, the investigators analyzed information in the population-based Mayo Clinic Study of Aging database, which cov-ered approximately 10,000 residents of Olmsted County, MN, who were 70–89 years at the beginning of the study in 2004. They focused on 1,895 partici-pants who were cognitively normal at entry into the study and whose medical
records included data on weight and height from midlife (age 40–65 years) onward. All these study subjects under-went physical examination and extensive neuropsychological evaluation every 15 months for a mean of 4.4 years.
A total of 524 study participants developed MCI during follow-up. The mean weight loss since midlife was sig-nificantly greater for people who devel-oped MCI (−2.0 kg) than for those who remained cognitively normal (−1.2 kg). After the data were adjusted to account for patient sex, education level, and apolipoprotein E ε4 allele status, loss of weight after midlife was robustly associated with incident MCI, so that a loss of 5 kg per decade corresponded to a 24% increase in risk of MCI, Dr. Alhurani and his associates reported [JAMA Neurol 2016 Feb 1. doi: 10.1001/jamaneurol.2015.4756].
These findings remained consistent across all categories of baseline weight, regardless of whether the participants were underweight, normal weight, overweight, or obese at enrollment. The effect sizes of the associations were greater in men than in women but were significant in both sexes.
This study could not establish causal-ity, but the researchers speculated that the association between weight loss and MCI could be due to three possible mechanisms. First, the weight loss could stem from the “anorexia of aging,” meaning that dysfunctional production of certain hormones — such as chole-cystokinin, leptin, cytokines, dynorphin, neuropeptide Y, and serotonin — or dys-functional dietary intakes and energy metabolism could lead patients to eat less, which could in turn raise MCI risk.
Second, “neuropsychiatric symptoms such as depression and apathy, which are prodromal and predictors of MCI and dementia, may contribute to decreased appetite and weight loss prior to the diagnosis of these conditions,” they suggested.
Third, weight loss and MCI could share an etiology. Researchers have reported finding protein deposits, including deposits of Lewy bodies, tau, or amyloid, in the olfactory bulb and central olfactory pathways before the onset of dementia, and olfactory dysfunction is a marker for cognitive impairment and dementia. “Impairment in smell with related changes in taste
may contribute to decreased appetite, reduced dietary intake, and the weight loss observed with MCI, Alzheimer dementia, and other neurodegenera-tive conditions,” Dr. Alhurani and his associates wrote. CfA
Mary Ann Moon is a Frontline Medical News freelance writer based in Clarksburg, MD.
Later-Life Weight Loss Signals Mild Cognitive Impairment BY MARY ANN MOON
Editor’s NoteThis is one more reason that we should fear weight loss in our population — although in the nursing home, the etiologies may be far more ominous than incident MCI. And obviously, many patients lose virtually all interest in eating and drinking by the time their dementia becomes severe. New excuse for not exercising and eating right: “Hey, I’d love to take off 5 kg, but I don’t think it’s worth it to sacrifice a 24% increase in risk of MCI.”
Dear Dr. Jeff: A patient of mine died a few months ago. I was notified by her lawyer that her will may be disputed and that he expects me to testify regarding her mental status and her competence to write a will. Do I have to tes-tify? Will her medical records be revealed in court? How will my diagnosis in her chart of “probable MCI” (mild cognitive impairment) affect all this? Do you have any suggestions?
Dr. Jeff responds: Interactions between the world of medi-cine and the legal system always seem problematic. Our categorizations and ways of thinking rarely translate easily into theirs. At the same time, physicians worry that their words will be misinter-preted, or even twisted, potentially injur-ing patients, families, or the testifying practitioner. Unless you are experienced offering testimony, this whole process may seem like a looming ordeal and an unre-imbursed drain on your time and energy.
If you had an established relationship with your deceased patient, ensuring that her wishes are carried out may be the final service you can provide for her. Many practitioners who care for the elderly are outraged that advanced age alone is often treated as a demonstra-tion of incapacity regardless of actual performance. The thought that grasp-ing relatives might try to slander your patient’s name as a route to acquiring money or assets that he or she never wanted them to have is genuinely infu-riating. The possibility that mentally frail seniors might unintentionally fail to pro-vide adequately for family members — of whom they are truly fond — or even forget the names of children not seen recently, is real.
Unfortunately, care providers can unduly influence some forgetful or con-fused individuals near the end of life, exploiting them for personal gain. On the other hand, it is not unreasonable to wish to reward a second spouse or a devoted caregiver for kindness near the end of life. “What have you done for me lately?” is different from memory loss. It is not totally unreasonable for the court system to investigate the validity of wills drawn up when an individual has advanced illness, is receiving multiple medications, and is highly dependent on others for her care.
Paper Trails Health care professionals are familiar with many of the problems associated with advance directives for health care. A will is simply a financial advance direc-tive, instructing others what to do with property when the deceased individual is
unable to direct the distribution of their assets personally. And, as with medical advance directives, changing circum-stances and vague language can make interpretation difficult. Advance direc-tives such as DNR or POLST orders are typically reviewed periodically, some-times quarterly or annually, whereas wills are typically drawn up at a par-ticular point in time with no schedule for review and confirmation. They may be abruptly altered without necessarily revisiting an impulsive decision based on transitory anger or affection.
The Last SayA durable power of attorney for health care (a health care proxy or agent, depending on the language of particu-lar states) has the power to interpret advance directives in accordance with their best understanding of the patient’s wishes under current circumstances. But the executor of a will, who is similarly charged to carry out instructions, can do so only if all the parties to the will agree.
Disappointed parties can use the courts to enforce their interpretation of the dead person’s wishes or to overturn documented bequests. In many states, it is extremely difficult to disinherit close relatives, particularly children. Wills that are not drawn up with sufficient preci-sion and necessary language are likely to be challenged. These challenges are typi-cally based on or reinforced by claims that the deceased person had insufficient mental faculties and understanding to create a valid will. Such claims will, in turn, draw in the medical practitioner.
Families often struggle over relatively minor amounts of money or posses-sions. At times, legal costs may equal or exceed the actual value of the items being disputed. Which child actually inherits grandma’s china is not simply a question of possession of aged crock-ery; it is often perceived as a measure of who was favored or even who was most loved. Some of my cousins fought for years over a single used car that had belonged to their father. At issue was not the value of the car, which could have been sold and evenly divided, but rather, that on different occasions he had verbally promised it to each child “because he really wanted them to have it.” Only one daughter received it in the will — along with more grief than the car’s value.
When called upon to declare a medical opinion, the professional is not expected to pronounce on whether the patient met legal definitions for testamentary capacity, that is, the capacity to execute a legally valid will. This standard for
capacity is, of course, interpreted by the court. It is generally a lower stan-dard than expected for complex medical decisions, since complex risk and benefit analyses are not required, nor is the indi-vidual drawing up the will required to review or to choose among alternatives. The simple act of signing a will implies that the individual knows that they can’t take it with them. Generally, they are expected to know what they are giving away and to whom.
These are not questions typically asked in a mental status examination — most patients would be startled and likely suspicious if a doctor asked them to list their financial assets. Ability to draw a clock face or remember three objects in 5 minutes does not define testamentary capacity. BIMS or MMSE or SLUMS tests, even if done close to the time the will was executed, do not by themselves determine capacity for this or for other purposes. Certainly a medical determination that a patient’s cognitive function was below expected levels for age, but not sufficiently low to impair life functions (the definition of mild cognitive impairment), would not imply a lack of capacity in this functional sphere. Being at increased risk for the development of dementia, even if based on determinations of poor memory and poor judgment, does not automatically lead to a determination of incapacity.
Conversely, a good score on test-ing does not guarantee capacity, since many patients have wide swings in cog-nitive capacity during the day. Some patients are quite alert and sharp in the morning but sundown as the day progresses, becoming more confused or even agitated and delusional. The exact functional level at the time the will was drawn up and signed might be significant. Also, given the high level of depression among elderly patients, a patient who was emotionally stable at one visit might be despondent and angry a week later when the attorney is present. Medication changes and acute infections are among many factors that can affect cognitive performance as well.
Protecting the Resident A geropsychiatrist colleague, Michael Goldstein, MD, has proposed that when a will is executed under circumstances that might be suspect (in a nursing home, for a person with diagnosed men-tal illness or dementia, in the face of very advanced age or dependency, and so on), that special safeguards be insti-tuted. They would include videotaping the proceedings and employing a trained mental health professional asking
specific relevant questions to document cognitive functioning and emotional sta-tus at the time the will is signed. This might, of course, involve considerable expense for the videographer, plus doc-tor’s fees. Still, if the estate is relatively large, the costs might be much less than an extended court case.
The Health Insurance Portability and Accountability Act determines who is allowed access to a patient’s private medi-cal information. After death, these deci-sions typically transfer to the executor of the estate. When a will is in dispute, this might be in dispute as well. Even if faced with a subpoena for medical records, you should be cautious regarding their release. I would suggest confirming the release with attorneys for the facility, if that is where the patient was examined, or even with the judge if you have any doubts.
In theory, your testimony can be forced through a subpoena. However, courts are generally respectful of physi-cian time, and both sides are likely to accept a deposition done at a conve-nient time and in the location where relevant medical records are present, as well as provide compensation as an expert, rather than a fact witness. If you have no useful information to pro-vide, particularly when a patient had only been seen once or twice or your memory and documentation of men-tal status is scanty or absent, you may be excused. Attorneys often subpoena office records for patients only seen in the nursing home under the mistaken belief that LTC doctors might maintain separate files. A simple call stating that no such records exist may result in the cancellation of the subpoena. Judges are reluctant to authorize a fishing expe-dition through a medical chart which might violate the privacy of the dead. An annoyed or angry physician is not likely to be a helpful witness for whoever has forced their attendance or wasted their time.
We care for the old and frail. Death is not a stranger in the nursing home. And when our patients still have assets at the time of death, struggles over inheritance are not rare. Issues regarding wills and inheritance simply come with the terri-tory; it might behoove long-term care practitioners to familiarize themselves with the landscape. CfA
Dr. Nichols is president of the New York Medical Directors Association and a member of the Caring for the Ages Editorial Advisory Board. Read this and other columns at www.caringfortheages.com under “Columns.”
Where There’s a Will, There’s Much To Weigh
Dear Dr. Jeff By Jeffrey Nichols, MD, CMD
6 • CARING FOR THE AGES MARCH 2016
Unnecessary ED Visits About one out of every five transfers from skilled nursing facilities to hospi-tal emergency departments are poten-tially preventable, according to a study of root cause analysis, or RCA, a tool the researchers said can provide impor-tant insights leading to care process improvements.
Led by Joseph G. Ouslander, MD, of Florida Atlantic University, Boca Raton, researchers evaluated data from more than 4,800 hospital transfers from 64 skilled nursing facilities enrolled in a ran-domized, controlled implementation trial of the INTERACT (Interventions to Reduce Acute Care Transfers) qual-ity improvement program.
“We believe that RCA is a funda-mental process necessary for quality improvement,” Dr. Ouslander, a mem-ber of the AMDA Foundation board of directors, told Caring for the Ages. “RCA will uncover factors that are unique to individual facilities as well as factors that are common across facilities that can inform educational and care process improvements to improve outcomes, such as reducing unnecessary transfers.”
Among the findings: ▶ Some 69% of transfers to an ED
involved two or more signs and symp-toms, the most common being abnor-mal vital signs, altered mental status, shortness of breath, pain, functional decline, behavioral symptoms, fever, decreased food or fluid intake, and unresponsiveness.
▶ Nearly two-thirds of the transfers were ordered via telephone rather than by an onsite evaluation by a physician, nurse practitioner, or physician assistant. Nursing home staff performed blood tests, X-rays, urinalysis, and cultures before transfer in 15%, 9%, and 6% of cases, respectively, and provided an inter-vention, such as oxygen or a new medi-cation in one-third of cases.
▶ About one in five transfers occurred less than 1 week after admission to the SNF.
▶ Seventy-eight percent of the transfers resulted in inpatient hospital admission.
The study also dispelled some com-monly held notions that transfers often occurred during the evening and week-end shifts and that family members often insisted on the transfer. In this study, transfers were equally distributed among
days of the week; 29% occurred on the night or evening shift; and patient and/or family preference or insistence played a role in 16% of the transfers. A new advance directive or order was placed before transfer in only 2% of cases, and the lack of an advance directive was noted as a factor in 6% of the transfers.
Perhaps the most significant finding: In 1,044 of 4,527 analyses (23%), nursing home staff indicated that the transfer might have been prevented.
“RCAs can help to dispel some think-ing that is subjective, like all our trans-fers occur on nights and weekends, or our problem is mainly that families insist
on transfers,” Dr. Ouslander said. “They also demonstrate that SNF staff, when performing retrospective RCAs on hos-pital transfers, recognize that they may have been able to prevent about one in five transfers for a variety of reasons, all of which can be addressed through edu-cation and care process improvements.”
Perhaps the most significant finding: In 1,044 of 4,527 analyses (23%), nursing home staff indicated that the transfer might have been prevented.
A secondary endpoint of the study was the occurrence of culture-confi rmed infl uenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modifi ed Centers for Disease Control and Prevention–defi ned infl uenza-like illness.1,2
51.1%
SECONDARY ENDPOINT
MORE EFFICACIOUS compared with Fluzone vaccine against flu caused by antigenically similar viral strains1,2
Primary endpoint of the study was the occurrence of laboratory-confi rmed, protocol-defi ned, infl uenza-like illness caused by viral strains regardless of their antigenic similarity to vaccine strains.1,2
PRIMARY ENDPOINT
24.2%MORE EFFICACIOUS compared with Fluzone vaccinein preventing flu caused by viral strains regardless of antigenic similarity1,2
▶ Source: Root Cause Analyses of Transfers of Skilled Nursing Facility Patients to Acute Hospitals: Lessons Learned for Reducing Unnecessary Hospitalizations — Ouslander JG, et al.
Frailty Intervention A comprehensive approach is needed to identify frailty and implement pre-ventive interventions against this and other age-related conditions. This was the consensus of a panel of global experts established by the World Health Organization (WHO) and the International Association of
Gerontology and Geriatrics (IAGG) in 2014.
The WHO-IAGG Frailty Network, combining information from an exten-sive literature search and the final meet-ing of the experts in Geneva Switzerland, produced an article that looked at these four areas concerning frailty:
▶ Prevalence. The panel found an average prevalence of 9.9% for frailty and 44.2% for prefrailty. Prevalence increases with age and is higher in women, Hispanics, and blacks; it is also associated with unfavorable socioeco-nomic conditions.
▶ Course and outcomes. Although the course of frailty varies from person to person, individuals generally are at increased risk of falls, hospitalizations, disability, institutionalization, and mor-tality. Increasingly, researchers use the concept of resilience — the individual’s ability to adapt in the face of stresses and adversities — to explore the stage at which an individual’s ability to limit injury declines.
▶ Interventions. Frailty is a syndrome, most likely with more than one under-lying cause. Comprehensive geriatric assessment-driven models of care that
involve collaborations among various medical specialties have shown benefits across different settings.
▶ Health systems. Early intervention is necessary to prevent disability, although disability can be reduced or its progres-sion slowed. One step toward accom-plishing this, the panel concluded, is to raise awareness of frailty among policy-makers, public health authorities, prac-titioners, and the general population.
▶ Source: Frailty: An Emerging Public Health Priority — Cesari M, et al.
Comprehensive Care Care based on a comprehensive geriatric evaluation may lead to longer survival and shorter hospital stays without sig-nificantly higher costs. This is according to results of the Ambulatory Geriatric Assessment – A Frailty Intervention Trial (Age-FIT), a 3-year randomized, controlled, assessor-blinded trial in Sweden.
Led by Anne W. Ekdahl, MD, PhD, researchers randomized 837 patients 75 and older to an intervention group that received care based on comprehen-sive geriatric assessment and follow-up ambulatory geriatric assessment, or a control group that received the usual social and health care. In comprehen-sive geriatric assessment, providers from multiple specialties determine a frail per-son’s psychological and functional capa-bility and develop a long-term follow-up and treatment plan.
Mean survival time was 69 days longer in the intervention group than in the control group. Within 3 years, 58 patients in the intervention group (27.9%) and 67 patients in the control group (38.5%) had died. Also, 30 patients (14.4%) in the intervention group and 32 in the control group moved to nursing homes during the 3-year follow-up period.
The number of hospitalizations did not differ significantly between the groups, but patients in the intervention group had a mean 15 inpatient days vs. 21 days for the control group.
Finally, mean costs during the study were $71,905 for the intervention group vs. $65,626 for the control group. Patients in the intervention group had more visits to physicians and other staff and fewer costs for hospital care vs. the control group.
▶ Source: Long-Term Evaluation of the Ambulatory Geriatric Assessment: A Frailty Intervention Trial (AGe-FIT): Clinical Outcomes and Total Costs After 36 Months — Ekdahl AW, et al. CfA
Jeffrey S. Eisenberg, a freelance writer in the Philadelphia area, compiled this report.
Comprehensive geriatric assessment and follow-up ambulatory geriatric assessment led to longer survival, compared with a control group that received usual care.
To order Fluzone High-Dose vaccine, go to VaccineShoppe.com®
or call 1-800-VACCINE (1-800-822-2463).
IMPORTANT SAFETY INFORMATION
INDICATIONFluzone High-Dose vaccine is indicated for active immunization for the prevention of infl uenza disease caused by infl uenza A subtype viruses and type B virus contained in the vaccine.
Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older.
SAFETY INFORMATIONThe most common local and systemic adverse reactions to Fluzone High-Dose vaccine include pain, erythema, and swelling at the injection site; myalgia, malaise, headache, and fever. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any infl uenza vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks following previous infl uenza vaccination, the decision to give Fluzone High-Dose vaccine should be based on careful consideration of the potential benefi ts and risks. Vaccination with Fluzone High-Dose vaccine may not protect all individuals.
Before administering Fluzone High-Dose vaccine, please see brief summary of full Prescribing Information on next page.
Fluzone High-Dose and Fluzone vaccines are manufactured and distributed by Sanofi Pasteur Inc.
Fluzone High-Dose vaccine (CPT®a code 90662) is a covered benefi t under Medicare Part B.
a CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.
Kimmel M, et al. Effi cacy of high-dose versus standard-dose infl uenza vaccine in older adults. N Engl J Med. 2014;371:635-645.
Fluzone® High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection2015-2016 Formula
BRIEF SUMMARY: Please consult package insert for full prescribing information.
INDICATIONS AND USAGEFluzone High-Dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose is approved for use in persons 65 years of age and older.
DOSAGE AND ADMINISTRATIONFor intramuscular use onlyDose and ScheduleFluzone High-Dose should be administered as a single 0.5 mL injection by the intramuscular route in adults 65 years of age and older.
AdministrationInspect Fluzone High-Dose visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered. Before administering a dose of vaccine, shake the prefilled syringe. The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Do not administer this product intravenously or subcutaneously. Fluzone High-Dose should not be combined through reconstitution or mixed with any other vaccine.
DOSAGE FORMS AND STRENGTHSFluzone High-Dose is a suspension for injection. Fluzone High-Dose is supplied in prefilled syringes (gray syringe plunger rod), 0.5 mL, for adults 65 years of age and older.
CONTRAINDICATIONSA severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of Fluzone High-Dose.
WARNINGS AND PRECAUTIONSGuillain-Barré SyndromeIf Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.1,2
Preventing and Managing Allergic ReactionsAppropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Altered ImmunocompetenceIf Fluzone High-Dose is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
Limitations of Vaccine EffectivenessVaccination with Fluzone High-Dose may not protect all recipients.
ADVERSE REACTIONSClinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. Two clinical studies have evaluated the safety of Fluzone High-Dose. Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.
Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.
Table 1: Study 1a: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone
High-Dose or Fluzone, Adults 65 Years of Age and Older
a NCT00391053b N is the number of vaccinated participants with available data for the events listedc Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site
swelling: ≥2.5 cm to <5 cm; Fever: >100.4°F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activitiesd Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever:
>102.2°F; Myalgia, Malaise, and Headache: prevents daily activitiese Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluzone
High-Dose; and 98.6% and 1.4%, respectively, for Fluzone
Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29–180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.
Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients.
Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluzone High-Dose recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluzone High-Dose recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluzone High-Dose recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluzone High-Dose recipients and 0 (0%) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.
Post-Marketing ExperienceThe following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluzone High-Dose.
Events Reported During Post-Approval Use of Fluzone.• Blood and Lymphatic System Disorders : Thrombocytopenia, lymphadenopathy• Immune System Disorders : Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)• Eye Disorders : Ocular hyperemia• Nervous System Disorders : Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse
myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia• Vascular Disorders : Vasculitis, vasodilatation/flushing• Respiratory, Thoracic and Mediastinal Disorders : Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness• Skin and Subcutaneous Tissue Disorders : Stevens-Johnson syndrome• General Disorders and Administration Site Conditions : Pruritus, asthenia/fatigue, pain in extremities, chest pain• Gastrointestinal Disorders : Vomiting
Other Events Reported During Post-Approval Use of Fluzone High-Dose.• Gastrointestinal Disorders : Nausea, diarrhea• General Disorders and Administration Site Conditions : Chills
DRUG INTERACTIONSData evaluating the concomitant administration of Fluzone High-Dose with other vaccines are not available.
USE IN SPECIFIC POPULATIONSPregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone High-Dose. It is also not known whether Fluzone High-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone High-Dose should be given to a pregnant woman only if clearly needed.
Pediatric Use: Safety and effectiveness of Fluzone High-Dose in persons <65 years of age have not been established.
Geriatric Use: Safety, immunogenicity, and efficacy of Fluzone High-Dose have been evaluated in adults 65 years of age and older.
CLINICAL STUDIESImmunogenicity of Fluzone High-Dose in Adults 65 Years of Age and OlderStudy 1 (NCT00391053) was a multi-center, double-blind pre-licensure trial conducted in the US in which adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. For immunogenicity analyses, 2576 participants were randomized to Fluzone High-Dose and 1275 participants were randomized to Fluzone. Females accounted for 51.3% of participants in the Fluzone High-Dose group and 54.7% of participants in the Fluzone group. In both groups, the mean age was 72.9 years (ranged from 65 through 97 years in the Fluzone High-Dose group and 65 through 94 years in the Fluzone group); 35% of participants in the Fluzone High-Dose group and 36% of participants in the Fluzone group were 75 years of age or older. Most participants in the Fluzone High-Dose and Fluzone groups, respectively, were White (91.7% and 92.9%), followed by Hispanic (4.8% and 3.7%), and Black (2.7% and 2.7%).
The primary endpoints of the study were hemagglutination inhibition (HI) GMTs and seroconversion rates 28 days after vaccination. Pre-specified statistical superiority criteria required that the lower limit (LL) of the 2-sided 95% CI of the GMT ratio (Fluzone High-Dose/Fluzone) be greater than 1.50 for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>0.67), and that the lower limit of the 2-sided 95% CI of the seroconversion rate difference (Fluzone High-Dose minus Fluzone) be greater than 10% for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>-10%). As shown in Table 2, statistically superior HI GMTs and seroconversion rates after vaccination with Fluzone High-Dose compared to Fluzone were demonstrated for influenza A subtypes, A (H1N1) and A (H3N2), but not for influenza type B. For strain B, non-inferiority of Fluzone High-Dose compared to Fluzone was demonstrated for both the HI GMTs and seroconversion rates.
Table 2: Study 1a: Post-Vaccination HI Antibody GMTs and Seroconversion Rates and Analyses of Superiority of Fluzone High-Dose Relative to Fluzone, Adults 65 Years of Age and Older
B 69.1 52.3 1.3 (1.2; 1.4) 41.8 29.9 11.8 (8.6; 15.0) No
a NCT00391053b Seroconversion: Paired samples with pre-vaccination HI titer <1:10 and post-vaccination (day 28) titer ≥1:40 or a minimum 4-fold increase for
participants with pre-vaccination titer ≥1:10c N is the number of vaccinated participants with available data for the immunologic endpoint listedd Predefined superiority criterion for seroconversion: the lower limit of the two-sided 95% CI of the difference of the seroconversion rates
(Fluzone High-Dose minus Fluzone) is >10%. Predefined superiority criterion for the GMT ratio: the lower limit of the 95% CI of the GMT ratio (Fluzone High-Dose divided by Fluzone) is >1.5
Efficacy of Fluzone High-Dose in Adults 65 Years of Age and OlderStudy 2 (NCT01427309) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluzone High-Dose or Fluzone. The study was conducted over two influenza seasons (2011-2012 and 2012-2013); 53% of participants enrolled in the first year of the study were re-enrolled and re-randomized in the second year. The per-protocol analysis set for efficacy assessments included 15,892 Fluzone High-Dose recipients and 15,911 Fluzone recipients. The majority (67%) of participants in the per-protocol analysis set for efficacy had one or more high-risk chronic comorbid conditions.
In the per-protocol analysis set, females accounted for 57.2% of participants in the Fluzone High-Dose group and 56.1% of participants in the Fluzone group. In both groups, the median age was 72.2 years (range 65 through 100 years). Overall, most participants in the study were White (95%); approximately 4% of study participants were Black, and approximately 6% reported Hispanic ethnicity.
The primary endpoint of the study was the occurrence of laboratory-confirmed influenza (as determined by culture or polymerase chain reaction) caused by any influenza viral type/subtype in association with influenza-like illness (ILI), defined as the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgia. Participants were monitored for the occurrence of a respiratory illness by both active and passive surveillance, starting 2 weeks post-vaccination for approximately 7 months. After an episode of respiratory illness, nasopharyngeal swab samples were collected for analysis; attack rates and vaccine efficacy were calculated (see Table 3).
Table 3: Study 2a: Relative Efficacy Against Laboratory-Confirmed Influenzab Regardless of Similarity to the Vaccine Components, Associated with Influenza-Like Illnessc, Adults 65 Years of Age and Older
Fluzone High-Dose Nd=15,892
ne (%)
Fluzone Nd=15,911
ne (%)
Relative Efficacy % (95% CI)
Any type/subtypef 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5)g
Influenza A 190 (1.20) 249 (1.56) 23.6 (7.4; 37.1)
a NCT01427309b Laboratory-confirmed: culture- or polymerase-chain-reaction-confirmed c Occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing;
concurrent with at least one of the following systemic signs or symptoms: temperature >99.0°F, chills, tiredness, headaches or myalgiad N is the number of vaccinated participants in the per-protocol analysis set for efficacy assessmentse n is the number of participants with protocol-defined influenza-like illness with laboratory confirmationf Primary endpointg The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of Fluzone
High-Dose relative to Fluzone >9.1%) was met.h In the first year of the study the influenza B component of the vaccine and the majority of influenza B cases were of the Victoria lineage; in the
second year the influenza B component of the vaccine and the majority of influenza B cases were of the Yamagata lineage
A secondary endpoint of the study was the occurrence of culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations in association with a modified CDC-defined ILI, defined as the occurrence of a temperature >99.0°F (>37.2°C) with cough or sore throat. The efficacy of Fluzone High-Dose relative to Fluzone for this endpoint was 51.1% (95% CI: 16.8; 72.0).
REFERENCES1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med
1998;339:1797-802.
2. Baxter, R, et al. Lack of Association of Guillain-Barré Syndrome with Vaccinations. Clin Infect Dis 2013;57(2):197-204.
HOW SUPPLIED/STORAGE AND HANDLING How SuppliedSingle-dose, prefilled syringe, without needle, 0.5 mL (NDC 49281-397-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-397-65).
Storage and HandlingStore Fluzone High-Dose refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Do not use after the expiration date shown on the label.
PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). • Inform the patient or caregiver that Fluzone High-Dose contains killed viruses and cannot cause influenza.• Among persons aged 65 years and older, Fluzone High-Dose stimulates the immune system to produce antibodies that help protect against
influenza.• Among persons aged 65 years and older, Fluzone High-Dose offers better protection against influenza as compared to Fluzone.• Annual influenza vaccination is recommended.• Instruct vaccine recipients and caregivers to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting
System (VAERS).
Fluzone is a registered trademark of Sanofi Pasteur Inc.
Manufactured by:Sanofi Pasteur Inc.Swiftwater PA 18370 USAMKT29937-1
Product information as of June 2015.
Printed in USA
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Few adults who reported subjec-tive memory complaints discussed such issues with a health care
provider, according to results from a telephone study involving more than 10,276 people.
Just under a quarter (22.9%) of the respondents reported discussing their memory problems with a health care professional. Even those who reported having a routine check-up within a year of the date they were surveyed were only slightly more likely to discuss their memory problem with a health care professional, compared with those who had not seen a doctor within the past year. Specifically, 25.2% of those in the former group reported taking such an action, reported Mary L. Adams, MPH, MS, of On Target Health Data.
The respondents were 45 or older and lived in 21 states. Those who reported subjective memory complaints were more likely to live in California and iden-tify as Hispanic. They also were more likely to be 75 or older and currently smoke than respondents not reporting subjective memory complaints.
Respondents with functional difficul-ties were significantly more likely to have engaged in a conversation about their memory issues with a health care professional than those who had not reported functional difficulties, with 34.4% of the former group having dis-cussed their memory problems with a health care professional. A similar percentage of survey respondents who had been diagnosed with depression
reported having talked to a health care professional about memory problems (33.2%).
Among the respondents who said memory complaints interfere with work-ing, volunteering, or engaging in social activities sometimes, usually, or always, the rates were 33.8%, 38.9%, and 51.3%, respectively. Another study finding was that as age increased, the likelihood of
discussing memory problems with a health care professional decreased.
The study findings suggest that “rou-tine check-ups are a missed opportunity for assessing and discussing memory problems for the majority of adults aged 45 or older with [subjective mem-ory problems],” Ms. Adams wrote. The results “highlight the need for the cognitive assessment required in the
Affordable Care Act for Medicare recipi-ents, and also suggest the need and potential benefit of cognitive assess-ment among adults younger than 65.”
Read the study in Preventing Chronic Disease (Prev Chronic Dis2016;13:150471). CfA
Katie Wagner Lennon is a web content editor with Frontline Medical News.
As Adults Age, Odds of Discussing Memory Problems With Doctors Decline
BY KATIE WAGNER LENNON
Editor’s NoteThese results shouldn’t surprise any-one, considering the embarrassment, anxiety, and denial around issues of memory loss and possible dementias. While the U.S. Preventive Services Task Force still believes there is insuf-ficient evidence to support routine screening for memory loss in the elderly — perhaps in part due to the lack of effective treatments — many of us feel that such screening can be useful. Especially in light of some of the recent studies demonstrating the efficacy of dietary changes such as the modified DASH, MIND, or MedDiet (see Caring for the Ages, February 2016: “Is Diet the Best Prevention Strategy for Dementia?”; online at www.caringfortheages.com/article/S1526-4114(16)00003-2/fulltext) in pre-venting and even improving cognitive loss, it seems reasonable to consider screening. And in our nursing homes, of course, everybody gets the Brief Inventory of Mental Status at least quarterly. It’s not the most sensitive instrument to pick up early dementia, but it’s something.
My last column (see Caring for the Ages, December 2015, “So You Give Great Care; Do You Have
Data To Back That Up?”; online at www.caringfortheages.com/article/S1526-4114(15)00433-3/fulltext) focused on the overwhelming importance of data in all future Centers for Medicare & Medicaid Services payment schemes. That article left one question unanswered: where does all that data come from?
Here’s the practical problem: When CMS and The Office of the National Coordinator for Health Information Technology (ONC) developed the pro-grams that are now the Physician Quality Reporting System (PQRS) and Electronic Health Record (EHR) meaningful use, the assumptions were that the physician worked in a fixed location (clinic or insti-tution) with a dedicated support staff. Patients arriving for treatment were cogni-tively intact, or accompanied by a respon-sible party. Set-up data were captured by a combination of office professionals and allied health staff; the physician’s role was limited to documenting assessments, plans, and treatments. Other team mem-bers completed the balance of the activi-ties needed for operations.
In contrast, the typical PA/LTC med-ical group comprises physicians who spend their days treating patients in the field at multiple LTC facilities. There is usually a small central office with a core administrative support staff. More often than not, the billing for the practice is managed from a different location.
This arrangement is effective at keep-ing overhead low but requires the medi-cal professionals working in the field to be the primary source for data entry.
What made sense for PQRS and mean-ingful use data capture in a clinic or hospital setting is woefully misguided for PA/LTC medicine. The workload on the physician becomes overwhelming; necessary data are skipped, productivity drops, and burnout begins. Often we see all three of these negative results occurring simultaneously.
PQRS+EHR Connectivity NecessaryWhile that physician is struggling to mimic all the roles of the missing clinic staff, the nursing facility is capturing much of these data for their own facil-ity’s EHR. Reusing these nursing facility data in the physician’s EHR and practice management software allows the facil-ity staff to become virtual staff mem-bers of the medical practice.
For readers who may wonder why the need for EHR connectivity is so impor-tant to some of us, let me remind you: 2016 is the first year that the force of penalties for not reporting PQRS reaches all the way down to the very smallest medical groups. Failure to report PQRS is an automatic 2% penalty, along with an additional 2% or 4% value-based purchasing penalty. That means small groups that fail to participate will suffer a combined 4% cut in Medicare Part B pay-ments; larger groups (10 or more prac-titioners) receive an automatic 6% cut.
What is the link between PQRS and EHR connectivity? Plenty! There are 198 individual PQRS measures and 26 measures groups. In addition, there are 64 ambulatory EHR clinical quality mea-sures (eCQMs) that can serve as PQRS measures.
Did you know a significant num-ber of those PQRS measures focus on tasks already being done by the staff in the SNF/NF? Further, those quality activities are documented in the facil-ity’s EHR. In many cases, it is perfectly legitimate for a physician to use patient data from the facility’s record to answer PQRS questions about the same patient. The challenge is transferring that infor-mation into the physicians’ recordkeep-ing system so it can be reused.
The IMPACT act (Improving Medicare Post-Acute Care Transformation Act) for PA/LTC health providers, and MACRA (Medicare Access and CHIP Reauthorization Act) for medical groups, support the alignment of quality measures and reporting across facility locations and with physician groups. At the same time, the complexity and quantity of quality measures are increasing. The only way providers can successfully manage these complex quality activities is through col-laboration, and sharing the data is required to document that quality — which brings me to this year’s AMDA annual conference.
Conference ConnectionThere are three major opportunities at the conference to explore the ways your practice or facility can benefit from data integration:
▶ On Thursday, March 17, a full-day educational track entitled Models of Care will explore the changing system of reimbursement (bundled payments, ACOs, CJR) and the Health Information Technology (HIT) infrastructure needed to support those programs. In the after-noon, a panel discussion will describe the technologies that exist, and those that are on the horizon to support these new patient-centered payment models.
▶ The exhibit hall will be open on Thursday, March 17, and Friday, March 18. More facility EHR vendors are exhib-iting on the exhibit floor than ever before (there are currently three, and possibly a few more). We’ll also have repeat visits from SNF/NF-focused data analytics ven-dors who specialize in Minimum Data Set analysis; those vendors can be an invalu-able source of a facility’s quality data for medical practices. Each of the vendors already registered is exhibiting new and sophisticated physician interfaces. These can be simple, such as providing a patient list and enabling e-signing of orders, or sophisticated enough to e-prescribe con-trolled substances.
▶ On Saturday, March 19, AMDA lead-ers will provide an update on the top policy issues of 2016, including legisla-tive advocacy, communications with gov-ernment agencies, updates on health care
reform implementation efforts, and on proposed changes to PA/LTC facilities requirements for participation.
I encourage readers to attend these events and get involved. If you don’t have the opportunity to participate in the AMDA annual conference, the next best
alternative is to talk with your facilities or medical practices, depending on your role. Sharing data takes time, effort, and probably some expense. Each facility or practice should identify a leader who supports the need for data exchange. Identify the EHR and practice manage-ment systems used by other partnering entities, then contact those vendors and ask for help with connectivity.
PA/LTC HIT SummitIf you are in a larger organization that has the benefit of any kind of HIT infrastruc-ture, you should strongly consider attend-ing the PA/LTC Health Information Technology Summit, in Reston, VA, June 26–28 (www.ahima.org/ltpacsummit). This meeting is devoted to promoting the free flow of clinical data between PA/LTC providers and the balance of the health care continuum. It brings together staff from CMS, ONC, pharmacy, facili-ties, medical groups, vendors, and their various professional groups (AMDA is a member of the steering committee).
This may be a pivotal year to move the interoperability conversation forward. Provider data entry workload may be greatly reduced if more providers partici-pate and lead the conversation. We may look back on 2016 as the year when the first true interoperability began — when we began to use data exchange for enhanced patient safety and care coordination.
The Vision Group will present its orga-nizations’ innovative ideas for exchanging/integrating physician data with their custom-ers’ software systems on Wednesday night, March 16, before the AMDA annual conference begins. CfA
Mr. Baird is president of Geriatric Practice Management, Asheville, NC. Read this and other columns at www.caringfortheages.com under “Columns.”
Is 2016 the Year for PA/LTC EHR Connectivity?
By Rod Baird
Apply Now for EHR Meaningful Use Hardship Exemption
Identify the EHR and practice management systems used by other partnering entities, then contact those vendors and ask for help with connectivity.
BY GREGORY TWACHTMAN
The Centers for Medicare & Medicaid Services has released the applications for meaningful use hardship exemptions.
Physicians who qualify for a hardship exemption must apply by March 15; hospitals must apply by April 1 to avoid being penalized in 2017. Exemptions may be granted for those facing infrastructure-related problems, unforeseen circum-stances, lack of face-to-face interactions, or lack of available certified electronic health record systems.
As part of the Patient Access and Medicare Protection Act, passed in December 2015, CMS will be able to process blocks of applications instead of processing them on a case-by-case basis, as CMS was required to do prior to the new law.
Applications and instructions are available at www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/paymentadj_hardship.html. CfA
Gregory Twachtman is a reporter with Frontline Medical News.
Insuffi cient omega-6 polyunsaturated fatty acids (n-6 PUFA), excess trans fat and, to a lesser extent, excess saturat-
ed fat, are signifi cant causes of coronary heart disease, suggests a global study recently published online.
“Our analysis provides, for the first time, a rigorous comparison of global CHD burdens attributable to insufficient n-6 PUFA versus higher saturated fat. In 80% of nations, n-6 PUFA–attribut-able CHD burdens were at least twofold
higher than saturated fat-attributable burdens. This suggests that focus on increasing healthful n-6 rich vegetable oils may provide important public health benefits,” Qianyi Wang, ScD, and her colleagues said.
The researchers estimated national intakes of saturated fat, n-6 PUFA, and trans fat based on country-specific dietary surveys, food availability data, and for trans fat, industry reports on fats/oils and packaged foods. The effects of dietary fats on CHD mortal-ity were derived from meta-analyses of
prospective cohorts, and CHD mortality rates were derived from the 2010 Global Burden of Diseases Study. Absolute and proportional attributable CHD mortal-ity were computed using a comparative risk assessment framework.
The researchers estimated insufficient n-6 PUFA consumption having been replaced by carbohydrate or saturated fat consumption was responsible for 711,800 CHD deaths per year, account-ing for 10% of total global CHD mor-tality and for 187 CHD deaths per year per 1 million adults. The most absolute CHD deaths per year — 547 per 1 mil-lion adults — attributable to insufficient n-6 PUFA occurred in Eastern Europe, while Oceania had the highest propor-tion of n-6 PUFA–attributable CHD deaths. East Asia had both the fewest absolute — 74 per 1 million adults — and lowest proportion — 6.7% — of CHD deaths attributable to inadequate consumption of n-6 PUFA.
Excess consumption of saturated fat as a replacement for n-6 PUFA caused an estimated 250,900 CHD deaths per year, accounting for 3.6% of CHD deaths and 66 CHD deaths per year per 1 million adults.
The researchers estimated that excess trans fat consumption caused 537,200 CHD deaths per year, representing 7.7% of global CHD mortality and 141 CHD deaths per year per 1 million adults. High-income nations generally had higher trans fat–attributable CHD mortality than lower-income nations. The highest trans fat–attributable abso-lute CHD mortality occurred in Egypt, with 1,120 deaths per year per 1 million adults. Canada, Pakistan, and the United States all had more than 475 deaths per year per 1 million adults because of excess consumption of trans fat. Such deaths accounted for more than 17% of corresponding national CHD mortality.
Sub-Saharan Africa and the Caribbean had the lowest estimated trans fat–attrib-utable CHD mortality.
Additional findings of this study included mean global changes in dietary intakes of saturated fat, n-6 PUFA, and trans fat, and corresponding changes in CHD deaths occurring between 1990
and 2010. Specifically, global propor-tional CHD mortality attributable to insufficient n-6 PUFA and higher satu-rated fat consumption decreased by 9% and 21%, respectively. Such decreases occurred in concert with a 0.5% increase in consumption of n-6 PUFA and a 0.2% decrease in consumption of saturated fat. In high-income countries, trans fat consumption declined in parallel with policy strategies to reduce industrial trans fat production. In contrast, global proportional CHD deaths attributable to higher trans fat increased by 4% as global mean dietary intakes of trans fat increased by 0.1%.
“Growing evidence indicates that lowering saturated fat provides convinc-ing cardiovascular benefits only when replaced by PUFA, whereas cardiovas-cular benefits of n-6 PUFA are similar whether replacing saturated fat or total carbohydrates,” said Dr. Wang of the Harvard T.H. Chan School of Public Health, Boston.
Read the study in the Journal of the American Heart Association [doi:10.1161/JAHA.115.002891]. CfA
Katie Wagner Lennon is a web content editor for Frontline Medical News.
Replacing Saturated Fat, Refined Carbs With Healthy Fats Could Ease Global CHD Burden
Expert PerspectiveIn this study, researchers investigated the impact of various dietary fats on the global burden of coronary heart disease at two specific time periods, 1990 and 2010. Food intake data from a variety of databases were used to determine intakes of saturated (SAT), n-6 PUFA (or omega-6 fatty acids) and trans fats.
Not surprisingly, trans fats were associated with significant CHD burden, with North America having a high trans fats–attributable CHD mortality rate. The good news is that trans fat intakes decreased in the United States from 1990–2010. And by 2018, no foods produced in the United States will contain manufactured trans fats, as they have been banned by the Food and Drug Administration. Many food producers have already removed trans fats; however, some foods contain naturally occurring trans fats, which do not appear to have the same negative impact.
Although it has been firmly established that trans fats have a harmful effect on cardiovascular (CV) health, the attention-grabbing results of this study were that insufficient intake of n-6 PUFAs in many countries can increase the CHD burden. This type of fatty acid is contained in vegetable oils including sun-flower, safflower, corn, soy, and sesame oils, and is known as the essential fatty acid linoleic acid. Of the cardiac deaths that were recorded, 45% occurred pre-maturely in adults younger than 70, clearly pointing to the impact of diet on CHD. Intake of n-6 PUFA can be inadequate if saturated fat intake is greater than 10% of calories and intake of refined carbohydrates is high. A diet high in fatty meats, sugary beverages, and snacks, but low in whole grains, fruits, and vegetables serves as a good example of a diet potentially low in n-6 PUFA.
Omega-3 fatty acid intakes were not included in this study, as the investigators stated that there is “no convincing evidence for causal effects on CHD,” despite promising evidence for the Mediterranean diet pattern. Optimal intake levels for the fats studied were determined to be 12% of energy intakes from n-6 PUFA, 10% from saturated fat and 0.5% for trans fatty acids. Although the intake of trans fats is decreasing due to changes in food production, this study supports that a balance of saturated and n-6 PUFA can reduce the burden of CHD. A diet low in saturated fats not to exceed 10% along with the consumption of n-6 PUFA and omega-3 fatty acids (olive and canola oils, salmon, walnuts, and flax-seed) not to exceed total fat intake of 30%, along with whole grains, fruits, and vegetables may prove to be the healthiest diet for cardiovascular health.
—Phyllis J. Famularo, DCN, RDSodexo Nutrition Services
Howell, NJ
Meaningful use is on its way out.
Andy Slavitt, acting admin-istrator of the Centers for Medicare & Medicaid Services, told investors attend-ing the annual J.P. Morgan Healthcare Conference that CMS is pulling back from the health care IT incentive pro-gram in the coming months.
“The meaningful use program as it has existed will now be effectively over and replaced with something better,” Mr. Slavitt said. Without providing full
details, he said that March 25 would be an important date as concerns the rollout of the new health IT initiatives.
“We have to get the hearts and minds of physi-cians back. I think we’ve lost them,”
Mr. Slavitt said. He noted that, when the meaningful use incentive program began, few physicians and practices used
electronic health records and concerns were that many would not willingly embrace information technology. Now that “virtually everywhere care is deliv-ered has a computer,” it’s time to make health care technology serve beneficia-ries and the physicians who serve them, Mr. Slavitt said.
The cost, however, was too high, Mr. Slavitt said. “As any physician will tell you, physician burden and frustration levels are real. Programs that are designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add
to the cynicism that the people who build these programs just don’t get it.”
Soon, CMS will no longer reward health care providers for using technol-ogy but will instead focus on patient outcomes through the merit-based incentive pay systems created by last year’s Medicare Access and CHIP Reauthorization Act (MACRA) legisla-tion. In addition to asking physicians to work with health care IT innovators to create systems that work best accord-ing to their practice’s respective needs, CMS is calling on the private sector to create apps and analytic tools that will
End of Meaningful Use Imminent in 2016 BY WHITNEY MCKNIGHT
Andy Slavitt
BY KATIE WAGNER LENNON
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keep data secure while fostering true and widespread interoperability.
Anyone seeking to block data trans-fer will find CMS is not their friend. Mr. Slavitt said. “We’re deadly serious about interoperability. Technology companies that look for ways to prac-tice data blocking in opposition to new regulations will find that it will not be tolerated.”
James L. Madara, MD, CEO of the American Medical Association, echoed Mr. Slavitt’s comments on the current, negative impact of EHRs on physicians’ practices. He noted that many physi-cians are spending at least 2 hours each workday using their EHR and may click up to 4,000 times per 8-hour shift.
Dr. Madara outlined three AMA goals to help restore the physician-patient relationship. The first is to restructure the medical school cur-riculum, which he said essentially is the same as it has been for 100 years.
New generations of physicians should be taught how to deliver collabora-tive care that includes telemedicine, more ambulatory care, and home care. Community-based partnerships, he said, would become key to treat-ing chronic diseases like diabetes and would have to be factored into reim-bursement models. The AMA also seeks to improve health outcomes and ensure thriving physician practices.
With MACRA set to go into full effect in 2019, Dr. Madara said that a “daunt-ing” level of change is about to take place. Citing the successful shift to ICD-10, he
said he was optimistic there would be positive changes, largely brought about through incentives to the private market-place and by dropping meaningful use.
Although having metrics in health care delivery is important, Dr. Madara said that, up to this point, “We kinda got it wrong” with quality measures that are more process-based, rather than evi-dence-based. “It was really great to hear about the move from meaningful use to a more aggregated program.” CfA
Whitney McKnight is a reporter with Frontline Medical News.
Expert Perspective
The king is dead, long live the king!Recently, Andy Slavitt, acting
administrator of the Centers for Medicare & Medicaid Services, gave a presentation at the annual invi-tation-only J.P. Morgan Healthcare Conference. In a lengthy talk, he said, “Now that we effectively have technology into virtually every place care is provided, we are now in the process of ending meaningful use and moving to a new regime cul-minating with the MACRA imple-mentation. The meaningful use program as it has existed, will now be effectively over and replaced with something better.”
The tweeters in the audience went wild, and a new meme was born: MU is dead. A week later, Mr. Slavitt and Karen B. DeSalvo, MD, MPH (the acting assistant secretary of the Department of Health and Human Services) issued a new blog post that reframed Mr. Slavitt’s comments.
Meaningful use (MU) is over as a standalone program. When the origi-nal legislation establishing the MU program was enacted, there was a provision for up to 5 years of hard-ship exemptions. The MU penalty program began in 2014; if the legisla-tive language prevails (which I antici-pate), exemptions will run through 2018. How that gets incorporated into MACRA/MIPS (Medicare and CHIP Reform Act, which created the Merit-Based Incentive Payment System) is unknown.
MIPS has four components: qual-ity, meaningful use, cost effective-ness, and practice improvement. Meaningful use counts for 25% of the program.
So in one fell swoop, Congress simultaneously killed meaningful use and reincarnated it within MIPS.
— Rod BairdGeriatric Practice Management
Asheville, NC
‘We’re deadly serious about interoperability. Technology companies that look for ways to practice data blocking in opposition to new regulations will find that it will not be tolerated.’
14 • CARING FOR THE AGES MARCH 2016
Legal Issues
The traditional long-term care mod-el is fraught with inconsistencies in the care continuum, which helped
spur the nursing home negligence litiga-tion cottage industry that has sprung up in many states. Typically, a resident would be discharged from an acute care facility to a skilled nursing facility, and then he or she would only be seen by an attending physician within a few days of admission (although in some states, there is no requirement for timing on the initial visit, so it could be as long as 30 days), and then once every 30 days for the fi rst 90 days, depending on payer status and health status.
This “low service” model generally results in higher 30-day readmission rates to acute care facilities and longer SNF stays because there is no incentive to discharge residents sooner rather than later. However, the low service model is changing to a “high service” model, which has the dual benefit of provid-ing the resident with more physician or nurse practitioner face time and may be more lucrative for the SNF.
Benefits of High Service The high service vs. low service debate requires a discussion of the financial ramifications of hiring more clinicians — a move that directly affects the bot-tom line of a facility’s balance sheet. It may seem counterintuitive, but the added cost of the physician or physi-cian/nurse practitioner team is offset by maintaining a full census and keeping utilization costs down. Plaintiffs’ attor-neys have made financial considerations appear taboo when discussing how best to operate an SNF.
A high service model fosters a united front when the facility knows it can rely upon the clinicians to be an ally rather than a disinterested bystander, or at worst, a direct foe in litigation.
In practice, one argument we regularly encounter is that a facility placed profits over people; the high service model dis-putes that theory. This model assists in defending against nursing home negli-gence claims and also directly impacts residents in a positive way in real time. For example, no reasonable person can say that a clinician attended to a resident too much (although it is possible that scrutiny from payers, if they are being billed for services, may look askance at models where a reasonably stable patient is being seen three to five times a week by a doctor or nurse practitioner).
The high service model assists the defense during litigation because the cli-nicians, in deposition, can speak to exactly how many times they saw and examined
the resident. Furthermore, when changes of condition arise that concern the nursing staff, the high service model will ensure that a physician or nurse practitioner is in the facility at the time of the event, and will reduce the medical response time.
Case Study A resident, Mrs. P, was admitted to an SNF from an acute care facility with multiple comorbidities including diabe-tes mellitus type 2, history of uterine cancer and radiation to her sacral area, osteomyelitis, sick sinus syndrome, cor-onary disease with history of myocar-dial infarction and stenting, anemia, and chronic urinary tract infections. Upon admission, Mrs. P had superficial skin breakdown to her coccyx, which was treated with hydrogel. The specific rea-son for admission to the SNF was osteo-myelitis of her left fifth metatarsal head, and ongoing intravenous administration of piperacillin and tazobactam (Zosyn, Pfizer), due to a diabetic foot ulcer.
Mrs. P’s residency was fairly unevent-ful and consisted mainly of issues related to her nutritional status. Mrs. P was seen regularly by a dietician whose recom-mendations were ordered by the physi-cian and implemented by the SNF staff. Mrs. P’s coccyx wound broke down dur-ing the course of her residency despite nutritional interventions, regular turn-ing and repositioning, and regular visits from a board-certified wound physician.
On Mrs. P’s 27th day of residency, she developed left-sided weakness and altered mentation that manifested as increased sleepiness. This change of condition was reported during an occupational therapy session. The nursing supervisor assessed Mrs. P, who was able to answer questions and was otherwise alert and oriented. The nursing supervisor placed two calls to the attending physician who did not return the calls until approximately 45 minutes after the change of condition was discovered and reported to the nurs-ing supervisor. Because Mrs. P was last noted to have been sleeping prior to her OT session, the last-known “well” time was not clear. Once the attending physi-cian returned the call, he ordered Mrs. P sent to the emergency department due to suspected stroke. Emergency response was called, and she was transferred out within 15 minutes of receiving the physi-cian’s return call.
The plaintiff contended, among other things, that the transfer to the acute care facility was unduly delayed, which prevented Mrs. P from receiving tissue plasminogen activator (TPA) to reverse the stroke. Had the facility been using the high service model of care, the
timeliness of transfer in this situation would not be as much of an issue.
The defense experts opined that the timeliness of transfer was not an issue due to the fact that her stroke symptoms were mild, she recovered within 3 days, and she had Stevens-Johnson syndrome due to an allergic reaction to the Zosyn, which presented the distinct possibility that she would have bled out had TPA been administered. However, the point here is that plaintiff had a foothold on the timeliness issue because there was almost an hour gap between when the stroke symptoms were discovered and when the nursing staff spoke to the physician about the symptoms. With TPA, every minute counts, and the hour gap gave the plain-tiff ammunition against the facility.
Case Study 2 In another example, a resident with altered level of consciousness was trans-ferred emergently from an SNF to an acute care facility and found to have a subdural hematoma. The facility chart revealed that the resident had fallen when transferring from her bed to the bedside commode. The resident told the staff that she did not use the call light for assistance because she felt that she could make the short transfer safely on her own. The resident denied hit-ting her head on the ground. The staff returned her to her bed, conducted a head-to-toe examination and instituted neuro-checks, all of which were within normal limits.
Approximately 1 week later, the resi-dent began exhibiting signs of altered mentation and was sent to the acute care facility. The resident’s CT scan revealed a massive subdural hematoma. The resi-dent died shortly thereafter.
In the complaint against the facility, the resident’s family alleged that the resi-dent suffered a fall that went unreported by the staff. Initially, the allegation did not seem to hold water because she had been on warfarin for an extended time, which could have caused a spontaneous bleed.
However, the resident may have had a slow bleed from a fall 2 months before being transferred out. After the prior fall, her CT was negative for subdural hema-toma. The defense initially thought they could argue that the radiologist missed a slow bleed when interpreting the prior CT. However, the length of time between the prior fall and the current fall was too great to support the slow bleed theory.
The defense expert neurologist explained that the resident had a sub-dural hematoma and intracranial bleed-ing which, to a reasonable degree of
medical probability, did not happen in the absence of trauma. Looking back at the chart, the resident had experienced a string of small events that pointed toward evidence of a head injury in the week before her transfer, which might have been caught by a physician or nurse practitioner had the facility used the high service model. Furthermore, had physi-cians and nurse practitioners been in the facility on a daily basis, either the unre-ported fall might have been reported or the symptoms could have been caught and managed sooner.
If the facility in this case had used the high service model of managed care, it most likely would have reduced the settlement value of this case. In the facts as they currently stand, there was no other information the facility could rely upon to state, to a reasonable degree of medical probability, the resident did not suffer an undocumented fall. That type of uncertainty resulted in the facility (or its insurer) paying more money than they might have paid, had more clini-cians been on-site regularly.
The financial cost of employing cli-nicians in-house or partnering with physician groups is generally offset by the savings found in lesser settlement amounts and, in the case of hospitals, decreased penalties for readmissions.
Ideally, the high service model evis-cerates the claim that the facility placed profits over people, was not properly staffed to handle acute situations, or sim-ply ignored their residents. The high ser-vice model fosters a relationship among the caregivers (physician and SNF staff ) and the resident and their families. Some programs even incorporate home visits so the clinicians can see every potential barrier to the resident’s recovery. The resident is treated holistically, which pro-tects against claims. If the resident or responsible party feels respected and well-treated, the risk of a claim decreases.
The benefits of increasing clinician rounding do not just manifest them-selves in cost savings. The residents directly benefit from increased attention from a physician or nurse practitioner. The clinicians develop a rapport with the resident and his or her involved family members. High service post-acute care is a win-win for everyone involved. CfA
This column is not to be substituted for legal advice. Mr. Wilson is a partner in the law firm Wilson Getty LLP, which represents all types of long-term care facilities against civil claims. He also represents facilities in administrative hearings and advises long-term care clients on risk management and corporate compliance.
Views From a High Service Model of Medical Care Management
By William C. Wilson, Esq.
16 • CARING FOR THE AGES MARCH 2016
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Palliative Carefrom page 1
strictly comfort care if her mental status rendered her incapable of making or expressing decisions. She received pal-liative care supports right in her nurs-ing home until her illness progressed to the point where she became hospice-eligible. As a result of her clear expres-sion of her preferences, and the capacity of her nursing home to honor them, she did not undergo a single hospitalization in her last 2 years of life, just as she wished. She died there peacefully with her pain and shortness of breath well managed,” said Dr. Meier.
“This is how advance care planning can make a difference,” she noted. However, she said that finding a nursing home that has the resources and capacity to deliver palliative care, and later on, hospice, is still challenging. “Lots of factors” are involved in ensuring that patients receive the quality, ongoing palliative care neces-sary to honor their wishes.
“This is a level of ‘hovering’ we can’t expect from understaffed, overwhelmed, and overextended practitioners,” Dr. Meier said, suggesting the need for a national commitment to the resources needed to deliver reliably high quality pal-liative care to all nursing home residents who need it.
Recently approved Medicare reim-bursement for advance care planning services, such as the explanation and discussion of advance directives by phy-sicians or other qualified health care pro-fessionals, is a start. However, she noted, “Practitioners need to know how to have these conversations, document them, and share them as appropriate. Finally, it doesn’t matter if we know the person’s wishes if we don’t have the resources necessary to honor them — and that usu-ally means having the capacity to address the broad range of palliative care needs where the person lives.”
Comfort and ConversationsMost physicians and nurses, Dr. Meier said, “have had little to no training on palliative care. Once out of training and in clinical practice, they often don’t know how to do it.” They may not have had any training in safe and effective pain and symptom management, nor be proficient in the assessment and identification of depression, she said.
They also need to be skilled at “hav-ing conversations with residents and their families about what mattered most to the person,” she said. “They need to know who the patients were when they were fully themselves and what they considered to constitute a good life. Then, practitioners need to use this information to support decision-making that honors each person’s inner life and spirit.”
Anticipatory care decision conversa-tions can be challenging for many clinical practitioners, as clinicians are trained to value treatment and cure above all else. “If they can’t treat, it feels like they’re abandoning the patient,” she said. “So they keep treating.” She cited a poll from The Regence Foundation — the
nonprofit arm of the Regence health insurance company — showing that physicians think it is difficult to talk to patients about future medical decisions and preferences. Although nearly all of physicians questioned said that pain relief and enhanced quality of life are more important than using every pos-sible medical intervention to prolong life, few share that perspective with their patients.
At the same time, about one in four physicians surveyed expressed misplaced concerns that emphasizing palliative care could interfere with efforts to pro-long life.
“Physicians fear that planning for future end-of-life decisions might be misinterpreted by patients or families as the physician giving up on them or their loved one. When the physician has his or her own conflicted feelings, this further complicates matters and leads doctors to avoid offering crucial information nec-essary for shared decision-making,” Dr. Meier said.
A Balancing Act It is important to have honest conversa-tions with patients and families about the best and worst case scenarios associ-ated with treatment options, Dr. Meier said. Decisions about care “need to be contextualized to who the person is and what he or she cares most about,” she said. For example, a younger per-son with heart failure may be willing to do anything to stay alive to see his or her children reach adulthood, whereas an elderly person with multiple ill-nesses may prefer to avoid hospitals and procedures. It also is important, said Dr. Meier, not to confuse palliative care with end-of-life care.
“People who get palliative care at the same time as regular disease treat-ment actually live longer, at least in part because they are spared the very real risks and hazards of hospitaliza-tion. Palliative care focused on quality of life needs to be delivered from the point of diagnosis of a serious illness,” she said.
It is time for action on this issue and not just more research. “I feel like a call for more research is a call to do noth-ing. There is a huge body of research already about the value of palliative care,” Dr. Meier said. “We can’t wait years for more data.” At the same time, she added, “Business as usual isn’t an option. We need a range of innovative models of palliative care delivery that fit in home and nursing home settings and ways to address quality of life.”
“Palliative Care in the Mainstream: Stepping up to the Plate” is the topic for Dr. Meier’s presentation, which is set for Sunday, March 20. She will discuss the case for integrated geriatric care strategies and describe what works to improve quality care and reduce costs for vulnerable adults. She also will discuss how to address future needs of patients, their families, policy makers, payers, and health system leadership. CfA
Senior contributing writer Joanne Kaldy is a freelance writer in Harrisburg, PA, and a communications consultant for AMDA and other organizations.
CARINGFORTHEAGES.COM CARING FOR THE AGES • 17
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Electroconvulsive Therapy May Be Effective Treatment for Major Depression
BY KATIE WAGNER LENNON
A long recovery from disorientation following electroconvulsive ther-apy seems to be a sign that the
therapy has eff ectively treated an elderly patient who has major depression, sug-gests a longitudinal cohort study con-ducted in Norway.
The study comprised 57 Norwegian-speaking inpatients, age 60–85, who had major depressive disorders. To enter the study, a patient needed to have a mini-mum baseline score of 18 on the 17-item Hamilton Rating Scale for Depression (HRSD17). Among the study’s exclusion criteria were a diagnosis of dementia, Parkinson’s disease, schizophrenia, or schizoaffective disorder, and any use of ECT during the previous 6 months. All study participants received the seizure-inducing ECT twice a week. The inten-sity of therapy varied per patient and session, and age and sex of a patient were among the criteria used to determine the
intensity of each stimulus administered. Treatments continued until a patient achieved remission or the patient’s ben-efits plateaued. The maximum number of sessions was 16.
Two assessors used the questions included in the HRSD17 to assess the decline in depression symptom sever-ity for each patient every Wednesday between every second ECT session. A patient who achieved an HRSD17 score of 7 or less was considered to be in remission. The patient’s postictal reori-entation time (PRT) following ECT ther-apy was recorded at the first and third treatments. “Assessments of the PRTs were timed relative to the assessments of depressive symptoms during the ECT course. Hence, the PRT at the third treatment was recorded 2 days after the second assessment of symptom sever-ity,” wrote Tor Magne Bjølseth, MD, and colleagues. The PRT was defined as the minutes that passed until the patients were able to correctly answer four of five questions about themselves, their location, and the time. A maximum PRT score of 50 minutes was assigned to any patient who took more than 40 minutes to recover from disorientation.
Although the researchers did not see a significant association between the mean PRT and the outcome of ECT, they observed that the patients with lon-ger PRTs during early ECT sessions were
likely to experience greater declines in depression symptoms.
The researchers also found that “a greater increment in [ECT] dosage ren-dered a smaller absolute and relative decline in PRT.”
An additional finding suggesting that ECT is beneficial for elderly patients with major depressive disorder was that the study participants’ HRSD17 scores, on average, declined by 14.7 points from baseline to the end of their ECT sessions.
“Our results indicate that a longer PRT reflects a more efficacious seizure and that the speed of recovery from disori-entation may supplement [EEG] char-acteristics in tailoring stimulus dosing for elderly patients, at least early in the treatment course of formula-based ECT. It remains to be established whether our findings are generalizable beyond the elderly population. Further research is also warranted to clarify how the PRT may be utilized to guide stimulus dos-ing,” the researchers wrote ( J Affect Disord 2016;190:178–86). CfA
Katie Wagner Lennon is a web content editor with Frontline Medical News.
Editor’s NoteMost of us who have been around for awhile have had the opportunity to observe the very effective results of ECT on depressive symptoms, especially the kind of catatonic symp-toms where patients stop eating and getting out of bed. However, we also observe the negative cognitive impact on these patients, often with disori-entation and new deficits that can become enduring. ECT is expensive and cannot be given in the nursing home setting; it requires anesthe-sia, and must be considered fairly burdensome. Taking into account these combined burdens of treat-ment — cognitive deterioration and the other factors — we need to be transparent when discussing risks vs. benefits with patients and their fami-lies, and we need to help them make informed decisions based on their overall goals of care.
In my experience, if the patient is at a point where ECT is being seri-ously considered, then probably from a quality of life standpoint, the ben-efits outweigh the risks. These are patients who are truly miserable and involuting, often on a sharp trajectory toward death with a failure to thrive picture, rapid weight loss, and so on. Sometimes a little loss of mental sharp-ness is a small price to play for the sub-stantial improvement in mood and the ability to feel reasonably cheerful.
—Karl Steinberg, MD, CMDEditor in Chief
Patients with longer postictal reorientation times during early ECT sessions were likely to experience greater declines in depression symptoms.
18 • CARING FOR THE AGES MARCH 2016
certain statements, expressions, or other evidence from being admissible in a mal-practice lawsuit, according to data from Sorry Works!, an advocacy group that tracks apology statutes. Most apology laws cover expressions of empathy or sympathy, while some statutes protect admissions of fault. At least three states — including Iowa — go a step farther, laying the foundation for early disclo-sure of errors, communication between physicians and patients, and negotia-tion of potential resolutions. Oregon’s Early Discussion and Resolution (EDR) law, which passed in 2013, allows both providers and patients to initiate con-versations after adverse events, discuss what happened, and resolve the issue outside of court. Massachusetts’ 2012 disclosure, apology, and offer legisla-tion includes a 182-day waiting period before lawsuits can be filed to allow for the process. Other states, including Washington, Texas, California, and Utah have expressed interest in enacting simi-lar laws.
Efforts in Iowa, Oregon, and Massachusetts were driven by the successes of similar programs at the University of Illinois Hospital and Health Sciences System, Chicago and at the University of Michigan Health System, Ann Arbor, among others. Since the University of Michigan began its CANDOR program in 2001, average legal expenses per case have been cut in half, according to UM data. The health system’s pre-suit claims have gone from 260 annually to about 100 per year. Pilot efforts by the University of Illinois (Chicago) Hospital and Health Sciences System since 2006 have increased adverse event reports from 1,500 per year to 10,000 while decreasing mal-practice premiums by $15 million since 2010.
But questions remain as to whether such approaches are successful when implemented on a state level. So far, the majority of data on early discussion, apology, and offer programs have come from closed systems, such as academic medical centers.
“We’re starting to look at how this works in an open system when you try to disseminate it across a state,” said Alan
C. Woodward, MD, chair of the Massachusetts Medical Society Committee on P r o f e s s i o n a l Liability and cofounder of the Massachusetts Alliance for Communication and Resolution f o l l o w i n g
Medical Injury (MACRMI). “If we can show this is an effective model in a statewide distribution, the hope is that multiple other states will follow suit, because this is clearly a better alternative for patients and providers and for patient safety improvement efforts.”
Massachusetts Shows Promise In Massachusetts, the state’s CANDOR law enabled MACRMI to roll out its Communication, Apology, and Resolution (CARe) model at six hos-pital pilot sites. MACRMI was formed as part of a research initiative led by Beth Israel Deaconess Medical Center, Boston, and the Massachusetts Medical Society, Waltham, and funded by a 2010 grant from the Agency for Health Care Research and Quality.
Under the CARe model, participat-ing health providers communicate with patients and families after an unan-ticipated adverse outcome, investigate and explain what happened and, where appropriate, apologize and offer fair financial compensation. Data collection in the 3-year study closed in December 2015, and the alliance plans to publish its findings in spring 2016. The model has greatly expedited case resolutions, Dr. Woodward said. A case in the CARe program can be resolved in 6 months or less, compared with a lawsuit that can take up to 5 years to resolve. By April 2015, the alliance had screened 856 cases. In three-quarters of cases, the care provided was deemed appropriate, Dr. Woodward said. Of these cases, 615 were closed after full-disclosure meet-ings with patients. Of the total cases screened, 122 cases were referred to an insurer for resolution, and 93 cases were awaiting further evaluation.
“It’s doing extraordinarily well,” Dr. Woodward said. “We’re resolving cases very efficiently in a short period of time, rather than using litigation.”
Outside the pilot program, health pro-viders in Massachusetts are benefiting from the state’s 182-day waiting period before malpractice lawsuits can be filed, said Elizabeth A. Cushing, Esq., vice president of claims for CRICO, a medical
liability insurer for the Harvard University medi-cal community. The law allows physicians and insurers the opportunity to review a case and decide whether the complaint requires com-
pensation. In cases that are not con-sidered malpractice, explaining the underlying reasoning to patients or plaintiffs’ attorneys prevents some law-suits from being filed, she said.
However, Ms. Cushing noted that not every case fits smoothly into the alter-native model. Cases in which a poor outcome is immediately known, such as a surgical mishap, lend themselves to quicker investigation, disclosure, and remedy, she said. Claims of misdiagnosed cancer for instance, where the alleged mistake occurred years before, are more challenging.
“A lot of what we are seeing are alleged failures to diagnose things sooner, so it’s 2 years later and someone says, ‘You should have picked up on the fact that I had lung cancer 2 years ago,’ ” Ms. Cushing said. “Those situations get tricky. What did you know, when? Those
cases are not as easily amenable to this process.”
Oregon Program Gaining Speed Meanwhile, Oregon officials are hop-ing that more doctors will soon par-ticipate in the state’s Early Discussion and Resolution program. In 2014 — its first year in operation — no individual physicians initiated participation in the program. Because EDR is voluntary, both parties must agree to participate for EDR to begin and either party can choose to stop participating at any time.
In 2014, Oregon patients and health providers filed 29 EDR requests to par-ticipate in the program, according to data from the Oregon Patient Safety Commission. Patients filed 21 notices and health care professionals filed eight notices. A majority of the eight notices filed by health professionals were issued by hospital representatives. No requests were filed by individual health provid-ers. In 9 of the 21 patient-filed notices, at least one involved health professional accepted the patient’s request to par-ticipate in EDR. In the remaining 12 patient-filed notices, the involved health provider(s) declined the request. Data is not yet available on resolution time or case outcomes.
EDR leaders are hopeful that more health professionals and patients will participate in the coming years, said Melissa Parkerton, director of the Early Discussion and Resolution program for the Oregon Patient Safety Commission.
“Widespread adoption of a new approach like EDR requires not just a
new process, but a new mindset,” she said. “This kind of cultural shift takes time. In Oregon, our fervent hope is that EDR will be embraced by every health care organization and professional.”
Efforts to raise awareness about the program are ongo-ing, added Robert Dannenhoffer, MD, a Roseburg, OR, pediatrician and past pres-ident of the Oregon Medical Association.
“It’s a little hard to get the word out,” he said in an interview. “Most [doctors] are not going to be dealing with this
on a regular basis. It’s a slow uptake. We’re working on better educating physicians.”
Model for Independent Docs Questions remain about whether dis-closure, apology, and offer models work for independent physicians in small practices.
Thad L. Anderson, MD, an obstetri-cian/gynecologist in private practice in Dubuque, IA, strongly supports his state’s law, but he does not foresee the process having much impact on his
practice. Larger health systems are generally more situated to utilize the pro-cess, he said.
“A hospital system that employs physi-cians is probably better suited to take advantage of this law,” he
said. Independent doctors “don’t have the infrastructure. You don’t have the in-house lawyer. It’s probably a little more problematic for an individual to take advantage of the process compared to a bigger system.”
With this issue in mind, MACRMI in Massachusetts recently added an 800-physician, multispecialty outpatient group to its program analysis. The goal is to evaluate how the process oper-ates within this type of setting and identify challenges and impediments, Dr. Woodward said. In addition, the alli-ance is encouraging commercial insur-ers to assist independent physicians in participating in the CARe model.
“The independent or small practice all benefit from the statute we passed — they have the [182-day] waiting period — but if they don’t have an internal risk management structure, than we’ve been working with insurers to set up a support structure,” he said. That way, “when a patient is unhappy with their care, there is a process that can support even a small practice in going through this and working through it with a patient.” CfA
Alicia Gallegos is a Frontline Medical News freelance writer based in Chicago.
Candor Lawsfrom page 1
Expert PerspectiveProtection from admissibility of apologies, statements of sympathy, and such can do much to allow a physician to maintain the benevolence with which we should do our jobs. EDR has the potential to provide compensation to injured parties when they need it most, and to reduce anger and depression that worsen out-comes greatly. Consider that an injured party has a powerful subliminal incentive to not rehabilitate or improve when a pending litigation’s outcome depends on compensation of damages. I have seen a number of patients with what should have been transitory harm develop chronic life changing disability for this reason.
Additionally, more admitted errors with fair though smaller financial com-pensation should incentivize quality improvement much more than a rare, large amount award to a plaintiff. A hospital administrator is not likely to have a common error that may or may not ever result in a six-figure lawsuit on their radar, but if that common error results in frequent losses of a few thousand dollars, they will be on the problem like cocoa butter on a spring breaker.
—Dave Smith, MD, CMDGeriatric Consultants of Central Texas, Brownwood
Elizabeth Cushing
Melissa Parkerton
Thad Anderson, MD
Alan Woodward, MD
CARINGFORTHEAGES.COM CARING FOR THE AGES • 19
Who will care for them? By the year 2030, nearly 20% of the U.S. population will be over the age of 65. Help us meet the high demand for post-acute and long-term care (PA/LTC) professionals.
The AMDA Foundation advances the quality of life for persons in PA/LTC through inspiring, educating and recognizing future and current health care professionals.
Please support the AMDA Foundation and be sure someone’s there to care for them.
Make a donation today!
www.amdafoundation.org
Our Futures Program helps build a better workforce by exposing participants to the numerous career opportunities available in PA/LTC medicine.
Our Awards Program recognizes the outstanding contributions by our members to PA/LTC medicine.
Who will care for them? By the year 2030, nearly 20% of the U.S. population will be over the age of 65. Help us meet the high demand for post-acute and long-term care (PA/LTC) professionals.
The AMDA Foundation advances the quality of life for persons in PA/LTC through inspiring, educating and recognizing future and current health care professionals.
Please support the AMDA Foundation and be sure someone’s there to care for them.
Make a donation today!
www.amdafoundation.org
Our Futures Program helps build a better workforce by exposing participants to the numerous career opportunities available in PA/LTC medicine.
Our Awards Program recognizes the outstanding contributions by our members to PA/LTC medicine.
Palliative Care Plays Important Role in Wound Care
Pressure ulcer management calls for more than just treating the wound. Palliative care can help
address pain and discomfort, and it can improve quality of life. Yet patients and practitioners alike often avoid important conversations because they think pallia-tive care means giving up or giving in.
Especially when it isn’t likely that the wound will heal, said Jeffrey Levine, MD, CMD, “The toughest thing is the conver-sation. You’re handing over the bad news that healing isn’t expected, and we need to set aside hopes that the wound will heal and the patient will go home and get back to their old life. That is usually not only because of the wound but also from other comorbid conditions as well. Nonetheless, we have to help the patient function at the highest possible level and live with minimum pain and maximum comfort.
“When you examine wounds, you don’t look at the hole in the patient; you look at the whole patient,“ he said, a quote he attributed to Elizabeth Ayello, RN, PhD. “That is so wise. We need goals of care that address the whole, individual patient within an ethical and spiritual framework.”
Some family members may resist palliative care for their loved one and insist on aggressive treatments instead.
“Some want everything possible done. They construe anything else as negative and unacceptable,” Dr. Levine said. At least one study has suggested that unin-formed relatives are more likely to insist on aggressive interventions — such as feeding tubes or hospital admission for antibiotic or other treatment — than those who have knowledge about risks and benefits.
When patients have pressure ulcers and other conditions due to serious or termi-nal illness and increasing frailty, there is a point at which comfort rather than cure is an appropriate goal. Open communica-tion with patients and families can help them understand this.
“Particularly when death is approach-ing, people may panic and question them-selves and their decisions,” he said. “We need to provide patients and families with reinforcement to initiate the best, most effective palliative care and help see them through stormy times.
“When there is a wound and we don’t expect it to heal, we have decisions to make. There are expensive, advanced, heroic, complex treatments. But if we know the wound won’t heal and that these interventions aren’t likely to be safe or effective, there is no sense in subjecting the patient to them,” said Dr. Levine. He shared a story: “I recently saw a patient in her 90s who had a
malodorous eschar and was in severe pain. In a younger, healthier person, I would say ‘debride it right away.’ But just turning her over caused her terrible pain. We reached the decision with her family to use a topical antiseptic to mini-mize pain and prevent infection.”
Individualizing palliative care is espe-cially key for non-pharmacologic inter-ventions to address issues such as pain, anxiety, or depression, he said.
“You have to know each patient and what interventions and activities are most likely to be beneficial. For exam-ple, I was just on a hospice floor where musicians were going from floor to floor playing classical music. For those who enjoy this, it can be very comforting and enjoyable. Other people really respond to pet therapy, although I wouldn’t advise bringing animals around some-one with a wound.” For these individu-als, staff should consider alternatives such as plush toy animals or movies or picture books featuring animals.
“We need to keep in mind that quality of life is subjective based on the patient’s perspective. To you or me, a person who has dementia and is bed-bound and uncommunicative may seem to have a poor quality of life. But he or she may have close family relationships and get immense pleasure from their children and grandchildren. Or they may listen to
music via headphones and get enjoyment from that,” Dr. Levine said. “We need to keep this in mind when we consider what is best for each person.” CfA
Dr. Levine is one of the speakers on “Overview of the New AMDA Clinical Practice Guideline for Pressure Ulcers,” set for Friday, March 18, 1:30–3:00 pm, during AMDA’s 2016 annual conference in Orlando, FL. He will participate in a panel with Art Stone, DPM, Paul Takahashi, MD, CMD, Janet McKee, RD, MS, Nancy Overstreet, DNP, GNP, Gary Brandeis MD, and Karl Steinberg, MD, CMD.
Senior contributing writer Joanne Kaldy is a freelance writer in Harrisburg, PA, and a communications consultant for AMDA and other organizations.
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Jeffrey Levine, MD, CMD, and Winslow
20 • CARING FOR THE AGES MARCH 2016
Palliative care activities and interventions aimed at providing comfort shouldn’t only happen at the end of life or when a person is terminally ill. Palliative care is something anyone with a serious illness or chronic conditions can benefit from.
Everyone deserves relief from the complications, symptoms, pain, discomfort, and emotional/mental stress of illnesses and diseases. This is where palliative care comes in; it involves a balance of drug and non-drug treatments and care such as pain management, spiritual counseling, psychosocial assessment and counseling, and music or art therapy. Palliative care involves a team that may include social workers, mental health professionals, recreational therapists, pharmacists, and dietitians, as well as nurses and doctors. This team works with the patient and family members to tackle the physical, emotional, spiritual, and social concerns and issues that often come with advanced illnesses, including advance care planning. Palliative care should be tailored to each person’s needs, interests, wishes, diagnoses, and cultural or ethnic background. And palliative care can be given in conjunction with life-prolonging care such as chemotherapy.
Pain and other symptom management is a com-mon part of palliative care. In addition to medi-cations, palliative care may include the use of massage, meditation and relaxation techniques, or topical treatments such as patches or gel packs. Emotional or mental health care may involve depression/anxiety treatment; psychotherapy; art, music, or pet therapy; and aromatherapy. Spiritual care may include attendance at religious services, ecumenical counseling, and/or access to spiritual/religious literature. Social care may involve family meals, group outings, visits with pets or children, and/or participation in activities such as dances, club meetings, and holiday celebrations.
People often think that hospice and palliative care are the same thing. However, hospice is
just one small facet of palliative care. Hospice is a specific benefit under Medicare and some other insurers. Generally, patients qualify for a hospice program when they have a prognosis of 6 months or less to live, if their illness runs its normal course. Care is provided by a specialized hospice team. To be on hospice, a patient must give up curative or life-prolonging treatment for their illness.
Your physician can help you or a loved one identify what palliative care interventions may be likely to provide the best results. Then, he or she will work with the rest of the care team to put the palliative care plan in place. Remember that you don’t have to face illness or disease alone.
▶ Questions To Ask Your Practitioner• How do we see palliative care goals that are realistic and can be achieved?• How do we know what non-drug treatments/activities might be useful?• How do we make sure that the palliative care we want and need will be provided?• How often should we review palliative care plans and goals?
▶ What You Can Do• Talk with your family if you think palliative care might help you. Involve a practitioner in these discussions when possible.• Tell a caregiver or practitioner right away if you are in pain or if treatments for pain aren’t working.• Tell a caregiver or practitioner if you are feeling sad, especially if it goes on for more than a few days.• Be honest about activities that will bring you joy, satisfaction, and comfort.
▶ For More Information:• What Is Palliative Care?: mayocl.in/1WgQBzk• About Palliative Care: bit.ly/1Kexw01
Caring for consumers
Palliative Care Isn’t Just for Terminally Ill Karl Steinberg, MD, CMD, editor-in-chief of Caring for the Ages, talks about palliative
care, what it is, and how it works to improve comfort and quality of life.
CARING FOR THE AGES is the official newspaper of AMDA – The Society for Post-Acute and Long-Term Care Medicine and provides
post-acute and long-term care professionals with timely and relevant news and commentary about clinical developments and about
the impact of health care policy on long-term care. Content for CARING FOR THE AGES is provided in part by Frontline Medical News
and by writers, reporters, columnists, and editorial advisory board members under the editorial direction of Elsevier and AMDA.
The ideas and opinions expressed in CARING FOR THE AGES do not necessarily reflect those of the Association or the Publisher.
AMDA – The Society for Post-Acute and Long-Term Care Medicine and Elsevier Inc., will not assume responsibility for damages,
loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related
to the products, drugs, or services mentioned herein.
Baux Cutoff Points Predict Geriatric Burn OutcomesBY M. ALEXANDER OTTO
SAN ANTONIO — Geriatric burn patients have a less than 50% chance of returning home with a Baux score of about 85, and the risk of death begins to climb steadily above a score of 93, approaching 50% at 110 points and almost 100% at 130 points, according to a review of 8,001 elderly patients in the National Burn Repository. The investi-gators are developing the findings into
a decision-making tool to help coun-sel families and caregivers about their options when elderly loved ones are seri-ously burned.
“There’s just not a lot of data out there on prognosis after burn injury in the geriatric population. We thought a simple decision aid for discussion with key stakeholders would provide significant assistance,” said investiga-tor Erica Hodgman, MD, a surgery research resident at the University of
Texas Southwestern Medical Center, Dallas.
The hope is that families and caregiv-ers will be able to better judge if the patient would want to press on with treatment given the odds of return-ing home, being discharged to a skilled nursing or rehab facility, or dying. “I think it will help people” feel less guilty if they decide to withdraw care or not send patients far away to a burn cen-ter, she said at the Eastern Association
for the Surgery of Trauma scientific assembly.
The Baux score, a well-known met-ric in the burn community, adds the patient’s age to the percentage of surface area burned, so a 70-year-old
woman burned over 23% of her body, for instance, would have a score of 93. A modified Baux score adds points for inhalation injuries, but because the data didn’t include inhalation injury severity, the investigators found it more useful to stick with the original formula.
They queried the repository for patients 65 or older with second- or third-degree burns from 2002–2011. They excluded patients with a length of stay of a day or less, along with elective admissions, non-burn injuries, and trans-fers to other burn centers. Next, they calculated Baux scores for each of their 8,001 subjects and noted if the patients were discharged home or to an alternate facility, or if they died.
Most patients had moderate scores of 70–100, and almost half were sent home. Of the 1,509 who died in the hospital, 264 (17.5%) had care withdrawn at a median of 3 days. Flames were the most common cause of injury, followed by scalding.
A receiver operating curve analysis found that a Baux score at or below 86.15 predicted discharge home (AUC 0.698, 75.28% sensitivity, 54.64% speci-ficity); a score above 77.12 predicted discharge to an alternate setting (AUC 0.539, 74.91% sensitivity, 34.38% speci-ficity); and a score above 93.3 predicted mortality (AUC 0.779, 57.46% sensitivity, 87.08% specificity).
Dr. Hodgman said she thinks the cutoff points will remain useful even as burn care improves with new grafting tech-niques that require smaller donor sites. Such innovation will apply mostly to moderately injured patients; for the more severely injured, the predictive power of the findings should still hold. CfA
M. Alexander Otto is with the Seattle bureau of Frontline Medical News.
Researchers are using Baux score outcomes to develop a prognostic tool for elderly burn victims.
The Annual Conference Program Planning Committee invites you to submit abstract proposals for AMDA – The Society for Post-Acute and Long-Term Care Medicine Annual Conference 2017, March 16-19, 2017 in Phoenix, Arizona.
AMDA’S ANNUAL CONFERENCE 2017 THE SOCIETY FOR POST-ACUTE AND LONG-TERM CARE MEDICINE
Submit online at https://amda2017.abstractcentral.com.
Call for Abstracts
T A R G E T A U D I E N C EThe program is designed for medical directors, attending physicians, nurses, administrators, consultant pharmacists and other professionals practicing in the post-acute/long-term care continuum. Medical students, interns, residents and fellows planning a career in geriatrics are also encouraged to attend.
S U G G E S T E D T O P I C SAMDA welcomes submissions on all topics pertinent to post-acute/long-term care medicine and medical direction. Emerging clinical information, best practices in management and medical direction, research, innovations in non-pharmaceutical modification of challenging behaviors, and updates on approaches to regulatory compliance, are areas of interest. AMDA also seeks proposals that emphasize strategies for successful cooperation with consultant pharmacists and administrators as well as the entire interdisciplinary team.
H O W T O S U B M I TTo submit an oral proposal or abstract for the 2017 annual conference or for more information, please go to https://amda2017.abstractcentral.com. All abstracts must be submitted via the abstract submission site.
Q U E S T I O N S ?Contact AMDA’s Professional Development/Meetings Department at [email protected].
M A R C H 1 6 - 1 9 , 2 0 1 7 Phoenix Convention Center • Phoenix, AZ
New VTE Guidelines Favor NOACs Over Warfarin
Updated guidelines regarding the treatment of patients with ve-nous thromboembolism advise
abandoning the routine use of com-pression stockings for prevention of postthrombotic syndrome in patients who have had an acute deep vein thrombosis, according to Clive Kearon, PhD, lead author of the American Col-lege of Chest Physicians’ 10th edition of “Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report” (Chest 2016;149:315–52).
The VTE guidelines include 12 rec-ommendations. Two other key changes from the previous guidelines include new treatment recommendations that advise which patients with isolated subsegmental pulmonary embolism should, and should not, receive anti-coagulant therapy; and a recommen-dation for the use of non–vitamin K antagonist (novel) oral anticoagulants (NOACs) instead of warfarin for ini-tial and long-term treatment of VTE in patients without cancer.
Best Evidence The update is another of the group’s “living guidelines,” intended to be flex-ible, easy-to-update recommendations “based on the best available evidence, and to identify gaps in our knowl-edge and areas for future research,” Dr. Kearon of McMaster University, Hamilton, Ontario, said in an interview.
“Clinicians and guideline developers would like clinician decisions to be sup-ported by very strong, or almost irrefut-able, evidence,” he said. “It’s difficult to do studies that provide irrefutable evidence, however,” and most of the updated recommendations are not based on the highest level of study evidence — large, randomized controlled trials.
Nevertheless, “the quality of evidence that supports guidelines and clinical deci-sion-making is much better now than it was 20 or 30 years ago,” Dr. Kearon said, mainly because more recent studies are considerably larger and involve multiple clinical centers. Plus, “we’re continually improving our skills at doing high-qual-ity studies and studies that have a low potential for bias.”
The old recommendation to use grad-uated compression stockings for 2 years after DVT to reduce the risk of post-thrombotic syndrome was mainly based on findings of two small single-center randomized trials, published in the Lancet and Annals of Internal Medicine, in which patients and study personnel were not blinded to stocking use. Since then, a much larger multicenter, pla-cebo-controlled trial found that routine use of graduated compression stock-ings did not reduce postthrombotic syn-drome or have other important benefits in 410 patients with a first proximal DVT randomized to receive either active or placebo compression stockings. The incidence of postthrombotic syndrome
was 14% in the active group and 13% in the placebo group, a nonsignificant dif-ference. The same study also found that routine use of graduated compression stockings did not reduce leg pain during the 3 months after a DVT — although the stockings were still able to reduce acute symptoms of DVT, and chronic symptoms in patients with postthrom-botic syndrome.
Warfarin on the Way Out The recommendation to replace warfa-rin with NOACs is based on new data suggesting that the agents are associ-ated with a lower risk of bleeding, and on observations that NOACs are much easier for patients and clinicians to use. Several of the studies upon which earlier guidelines were based have been rean-alyzed, Dr. Kearon and his coauthors wrote. There are also now extensive data on the comparative safety of NOACs and warfarin.
“Based on less bleeding with NOACs and greater convenience for patients and health care providers, we now suggest that a NOAC is used in preference to VKA [vitamin K antagonist] for the ini-tial and long-term treatment of VTE in patients without cancer,” they wrote.
The recommendation to employ watchful waiting over anticoagulation in some patients with subsegmental PE is based on a compendium of clinical evidence rather than on large studies. A true subsegmental PE is unlikely to need anticoagulation because it will have arisen from a small clot and thus carry a small risk of progression or recurrence.
“There is, however, high-quality evi-dence for the efficacy and safety of anti-coagulant therapy in patients with larger PE, and this is expected to apply similarly to patients with subsegmental PE,” the authors wrote. “Whether the risk of pro-gressive or recurrent VTE is high enough to justify anticoagulation in patients with subsegmental PE is uncertain.”
If clinical assessment suggests that anticoagulation isn’t appropriate, these patients should have a confirmatory bilateral ultrasound to rule out proxi-mal DVTs, especially in high-risk loca-tions. If a DVT is detected, clinicians may choose to conduct subsequent ultrasounds to identify and treat any evolving proximal clots.
The guideline has been endorsed by the American College of Clinical Pharmacy, the International Society for Thrombosis and Haemostasis, and the American Society of Health-System Pharmacists.
Dr. Kearon has been compensated for speaking engagements sponsored by Boehringer Ingelheim and Bayer Healthcare related to VTE therapy. Some of the other guideline authors also disclosed relationships with phar-maceutical companies. CfA
Michele G. Sullivan is with the Mid-Atlantic bureau of Frontline Medical News.
BY MICHELE G. SULLIVAN
22 • CARING FOR THE AGES MARCH 2016
Much has been written about person- or patient-centered care in health care. Google
the words and you’ll get close to 4 mil-lion hits. They are the watchwords in virtually every health care venue and setting, including community long-term care. The Institute of Medicine defi nition is familiar: “Providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions.”
Other words and paradigms have also emerged over the years. In health care, the term “culture change” emerged in the early ’90s, starting with a focus on nursing homes and then broadening to
include the entire LTC continuum. One well-known manifestation of culture change in long-term care is the Eden Alternative founded by Bill Thomas, MD, whom many consider a prophet, while others see him as a pariah.
What’s the overarching paradigm in community- or facility-based long-term care: person-centered care or culture change? What’s the relationship between the two? Now the discussion has become even fuzzier with a heightened focus on palliative care. Is it person-centered care, culture change or palliative care?
In the fall of 2015, the Institute for Healthcare Improvement (IHI) con-ducted an Expedition series, Advancing Palliative Care in the Era of Value-Based Care. It consisted of six webinars with a worldwide audience and notable, credible presenters. For session five, “Building Collaboration between Geriatrics and Palliative Care,” the presenter was Kate Lally, MD, director of palliative care at Care New England Health System. Dr. Lally referenced the work of James Pacala, MD, and an article he wrote that appeared in the Journal of the American Geriatrics Society in 2014, “Is Palliative Care the ‘New’ Geriatrics? Wrong Question — We’re Better Together.”
I spoke with Dr. Pacala, who helped connect the dots among person-cen-tered care, culture change, palliative care, and geriatrics, as well as their relevance to community long-term care. Dr. Pacala is professor and asso-ciate head of the department of fam-ily medicine and community health at the University of Minnesota Medical School. A board-certified family physi-cian and geriatrician, he is a past presi-dent and board chair of the American Geriatrics Society, and in 2013–14 was a Health and Aging Policy fellow.
The Wrong QuestionConsidering palliative care vis-à-vis geri-atrics, Dr. Pacala maintained, “Is pal-liative care the ‘new’ geriatrics?” is the wrong question. It’s wrong because of the connotation that the two are mutu-ally exclusive or even adversarial. Rather, he suggested, the focus should be to identify mutual strengths, recognize dif-ferences, and leverage shared strengths to promote better health care for older adults, whatever the care setting.
Dr. Pacala said that palliative care and geriatrics are two good examples of per-son-centered care. The focus of all health care is to be person-centered, with the individual at the center of care and the care team, rather than the individual’s disease(s) or condition(s). No single field — including geriatrics and palliative care — has a corner on the person-centered care market. They each have a different focus; some are curative, some are not. But the best of both involves care that is targeted to the individual.
Dr. Pacala’s perspective reflects his area of practice. He is quick to point out that he is a geriatrician who does pal-liative care, not vice versa. His practice is in all settings, and he recognizes the nuances of clinic (outpatient) practice, facility-based, and home- and commu-nity-based care settings. For example, he described the differences between work-ing with home care nurses and hospital nurses, and the need for the physician to be fluent in the language and culture of the different settings.
In home care, understanding of the person is driven by intense, 1–2 hour visits that are regular but usually not daily, with goals that may or may not be curative. In the hospital, patient stays are episodic and staff interactions are less longitudinal and characterized by intensive, frequent involvement for short periods of time usually with a clearly curative goal, he said. Nurses in long-term, facility-based settings would pro-vide a hybrid of care — less episodic and intense, more longitudinal, less curative
and more focused on quality of life. What matters, Dr. Pacala said, is to recognize the differences in care environments.
What then about person-centered care and culture change?
Dr. Pacala said that culture change, in its various manifestations, operational-izes person-centered care. This is critically important because nothing in today’s health care environment is pure. We all aspire to and invoke person-centered care, but the realities of life in today’s era of value-based care demand that the efficiencies and constraints of health care delivery systems be acknowledged and addressed. The tension may not be as great or dramatic as the person-centered vs. provider-centered care dynamic that gave birth to the culture change move-ment in the ’90s, but it still exists.
Long Way To Go Dr. Pacala believes we have a long way to go to optimize person-centered care. He cited the current state of most elec-tronic health records as an example. Although EHRs are more prevalent and interoperability is a key requirement, important elements to support person-centered approaches are not there or are hard to find:
▶ What does the patient want from the care team?
▶ What are the patient’s goals of care? ▶ Who is care proxy? ▶ What is the social or environmental
setting for the patient?
But progress is being made. Consider the emergence and evolution of the fields of geriatrics and palliative care. Consider also the emergence of inno-vative, exemplary primary care models across the country. There are common themes that run through these emerging models: person-centered approaches; coordinated continuity of care; delivery of care in teams; and innovative primary
care clinics. Obviously, community LTC and these emerging primary care mod-
els occupy com-mon ground.
Dr. Pacala noted several primary care models that have informed the approaches of the University of Minnesota’s clinics. The Veterans Health Administration’s H o m e - B a s e d
Primary Care model is one (see “For Veterans, Good Health Care Begins at Home,” Caring for the Ages, January 2016). Another is the “care by design” approach of the University of Utah’s Health Care Community Clinics, a model that inte-grates acute, chronic, and preventive care into a comprehensive system for treating patients. The GRACE Team Care model developed at Indiana University is a third (see the May 2016 issue of Caring for the Ages). This model integrates primary care with geriatrics and social services for low income seniors. Each of these models rep-resents some facet of the evolution and future of health care delivery.
No, palliative care is not the new person-centered care. As Dr. Pacala suggested, and other presenters in the IHI Expedition affirmed, palliative care is one example of person-centered care, not the totality of it. One presenter, Diane Meier, MD said it this way: “The salient difference is that palliative care is focused on being person-centered for people with serious and complex illness, while person-centered care applies to everyone seeking and receiv-ing health care.”
It’s not a replacement of one model of care with another. Palliative care and person-centered care are not mutually exclusive and, as Dr. Pacala affirmed, to ask if one is the new iteration of the other is the wrong question. It’s more productive, he said, “to identify mutual strengths, recognize their differences — and the relationship between the two — and leverage shared strengths to pro-mote better health care for older adults, whatever the setting of care.” CfA
Mr. Kubat is director of mission integration for the Evangelical Lutheran Good Samaritan Society. He is an editorial adviser for Caring for the Ages and coordinates the work of various authors for this column. Read this and other columns at www.caringfortheages.com under “Columns.”
Community LTC By Bill Kubat, LNHA
Palliative Care: Just One Facet of Person-Centered Care
The focus of all health care is to be person-centered, with the individual at the center of care and the care team, rather than the individual’s disease(s) or condition(s).
‘The salient difference is that palliative care is focused on being person-centered for people with serious and complex illness, while person-centered care applies to everyone seeking and receiving health care.’
James Pacala, MD
CARINGFORTHEAGES.COM CARING FOR THE AGES • 23
N E W S F R O M T H E S O C I E T Y
Join your AMDA friends and col-leagues on Saturday, March 19, at
5:45 p.m. in the Convention Center’s Osceola Ballroom A for a free screen-ing of Alive Inside, an award-winning fi lm featuring annual conference closing keynote speaker Dan Cohen, MSW, found-er of Music & Memory. This docu-mentary is an exploration of music’s capacity to reawaken souls and un-cover the deepest parts of our human-ity. It shows Mr. Cohen in action as he demonstrates music’s ability to combat memory loss and restore a deep sense
of self to those suff ering from it. The fi lm also includes interviews with family members who have witnessed
the eff ect that person-alized music has on their loved ones, as well as insights from best-selling author Oliver Sacks, MD, and musician Bobby McFerrin. Seating is
on a fi rst-come, fi rst-served basis. Following the screening, join 2016–
2017 AMDA president Susan Levy, MD, CMD, and other conference attendees at the President’s Reception in the St. Augustine Atrium from 7:00–9:30 p.m. CfA
Conference Features Free Screening of Alive Inside
in action
Top Tips for C.A.S.T.-ers
Calendar Cover Dog Evokes Happy Memories
Two years ago, AMDA member Aaron Shives, MD, CMD, was the
fi rst registrant for the annual confer-ence, and his wife, Deanna, shares his enthusiasm for the event. “Every year I look forward to the opportunities the C.A.S.T. program provides for us to tour the city where the meeting is being held and to visit local attrac-tions,” she said. “It gives us a real feel for the area — the history, culture, food, and people. The tours are always my favorite part, and sharing the experience with other C.A.S.T. members is terrifi c!”
This year the C.A.S.T. program features several optional tours (many tours may be sold out in advance; check at the AMDA registration desk for available opportunities). These include the Winter Park Cultural Tour, historic Bok Gardens Tour, and an Airboat and Wildlife Park Tour. Thursday’s premium tour, Disney’s Keys to the Kingdom Backstage Tour, highlights the fascinating his-tory of Walt Disney World Resorts and provides backstage access to the theme park. Participants will hear
the story of Walt Disney and learn how his innovative ideas, revolution-ary vision, creative philosophies, and amazing accomplishments brought the park to life. Most signifi cantly, the tour includes an amazing trip below Magic Kingdom into the service tun-nels known as “utilidors,” where par-ticipants get a unique, unforgettable peek into the park’s daily operations.
Mrs. Shives shared one favorite story. “I remember a C.A.S.T. tour of Catalina Island when the confer-ence was in Long Beach, CA. After riding the ferry to the island, another C.A.S.T. member and I rented a golf cart and toured around on our own. She was from New York, and I’m from South Dakota. We haven’t seen each other since, but we had a great time!”
Like AMDA members, who say the conference is a homecoming, Mrs. Shives sees the C.A.S.T. program as a friendly reunion. “I encounter people I’ve met at previous conferences. We don’t always remember names, but we recognize each other’s faces; and our smiles say, ‘Hey, I know you. Good to see you here again!’ ” CfA
Parsley was special. For several years, he accompanied his owner,
Jeff rey Levine, MD, CMD, to the 300-bed nursing home in Queens, NY, where he served as medical di-rector. The Norfolk terrier had the run of the facility and freely inter-acted with residents. They loved the little dog with the big soulful eyes, and, in turn, he relished the atten-tion — especially the hugs and kiss-es. Parsley touched many lives and made hundreds of friends during his many years as a therapy dog. When he died nearly 3 years ago at age 17, it was a great loss to many — but none more than Dr. Levine.
So when he saw the cover of the 2016 AMDA Foundation Caring Canines calendar, which features a photo he took of Parsley and one of his residents, he was thrilled. “It brought a tear to my eye — my wife and I loved him so much,” he said.
The Caring Canines calendar, now in its sixth and fi nal year, has told the stories of many pets that have made a diff erence in the lives of PA/LTC facility residents, staff , and visi-tors. This year’s calendar features the most popular pets from past years, including Abby, the service dog drop-out who lived briefl y with singer Willie Nelson before fi nding a home with a Hawaii-based physician, and Dolly and Domo, rescue dogs who became local TV stars when they were featured on the calendar’s cover 2 years ago.
Proceeds from calendar sales sup-port AMDA Foundation programs, including the Futures Program and its Quality Improvement Awards Program. Your purchase of the calen-dar also goes to support excellence awards, including Medical Director of the Year. To order, visit www.caring-caninescalendar.com. CfA
What do Floridians have to say about Orlando? David LeVine,
MD, CMD, AMDA member and medical director of Menorah Manor in St. Petersburg, said, “Other than the obvious Disney and Universal at-tractions, some lesser known sites, such as WonderWorks [especially for families with kids 6–16 years old] and Medieval Times Dinner and Tourna-ment, are fun for those with limited time. Disney and Universal are excellent — better rides at Universal,
but better family experience at Disney — but they really require a full day or more to experience them adequately.” Dr. LeVine recommended the parks’ “fastpass” options.
Other Orlando attractions for visi-tors include Gatorland, Wet ’n Wild, Charles Hosmer Morse Museum of American Art, Florida EcoSafaris at Forever Florida (see black bears, gators, and even the rare Florida pan-ther), and the Orlando Magic basket-ball team. CfA
Insider’s Tips to Orlando
March 17–20, 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine Annual Conference 2016 Orlando, FL Contact: AMDA Registrar Phone: 410-992-3116 Email: [email protected] Website: www.paltcmedicine.org
April 4–May 1, 2016 AMDA Online Core Curriculum Part I Contact: AMDA Registrar Phone: 410-992-3116 Email: [email protected] Website: www.amda.com/cmedirect/core-part-1.cfm
April 22, 2016 Colorado Medical Directors Association Annual Conference Denver, CO Website: http://cmda.us/annual-cmda-conference/
April 29–30, 2016 California Association of Long-Term Care Medicine Annual Meeting Los Angeles, CA Website: www.caltcm.org/annual-meeting
May 18–21, 2016 Society for Healthcare Epidemiology of America Spring 2016 Conference Atlanta, GA Website: http://sheaspring.org/
July 28–31, 2016 AMDA Core Curriculum on Medical Direction in Long-Term Care: Part II Indianapolis, IN Contact: AMDA Registrar Phone: 410-992-3116 Email: [email protected] Website: www.amda.com/education/core/index.cfm
August 1–September 26, 2016 AMDA Online Core Curriculum on Medical Direction in Long-Term Care: Part I Contact: AMDA Registrar Phone: 410-992-3116 Email: [email protected] Website: www.amda.com/cmedirect/core-part-1.cfm
August 19–20, 201626th Annual Caring for the Frail Elderly ConferenceColumbia, MOEmail: [email protected]: http://medicine.missouri.edu/cfe/
September 30–October 2, 2016 AMDA Advanced Curriculum on Medical Direction in Long-Term Care Arlington, VA Contact: AMDA Registrar Phone: 410-992-3116 Email: [email protected] Website: www.amda.com/education/advanced/index.cfm
