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July 14
WIDOWHOOD

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By Dawn Carr, Ph.D.

College of Social Sciences and Public Policy

 

When I was in college, my mother died during my junior year following a two-year struggle with cancer. As difficult as it was for me to lose her, my dad was in his early 50s and had to face changes in his life that were well beyond my comprehension as a 21-year-old. My mom and dad had been married 31 years when my mom died, and they had been together since the eighth grade. It’s hard to believe anyone could recover from something like that. And the truth is, not everyone fully adjusts to widowhood. So, why do some people do better than others?

 

If we get married and manage to stay married into old age, we can and should expect to become widowed at some point. Only about one in 10 older men report being widowed. This is because they tend to marry women who are younger, they have lower average life expectancy, and, they are more likely to remarry following widowhood.

 

Even though widowhood is more common among women — over 1/3 of older women report being widowed — men, on average, tend not to adjust as well as women.

 

To better understand why some people fair better than others, it is helpful to consider the factors that make widowhood especially difficult. Perhaps most obvious, widowhood is difficult because it makes us feel sad— we miss our spouses after they die, and we feel sad because someone who has been in our lives for a long time are no longer with us. But, the deep sadness that comes with new widowhood can be short-lived. So, we have to consider the range of factors that have a long-term impact.

 

When we lose our spouse, we have to take on all household chores without the help of another person, we no longer have someone to help care for us, and we might lose an important source of income, leaving us without the ability to get help from others if we need it. However, perhaps the most concerning problem relates to social interactions. When a spouse dies, we no longer have someone available to talk with, to share our intimate experiences with on a daily basis.

 

For older people, this is accentuated by the fact that most people over age 65 are retired and do not have a work environment in which to interact with others on a regular basis. As a result, it is common for widows to be fairly socially isolated and subsequently, to become lonely. Persistent loneliness is not only unpleasant, research shows that it has significant effects on our health; in fact, it has a similar effect on mortality risk as smoking!

 

When it comes to aging well, or aging “successfully,” research suggests that those who enjoy the best health and wellbeing in old age avoid getting chronic illnesses, maintain high cognitive and physical functioning, and stay engaged in life. One reason that staying actively engaged, such as in activities like volunteering, is beneficial is that these sorts of activities usually involve interacting with others in ways that are meaningful and productive, which creates a sense of social connectedness. But, even though feeling lonely means that we feel disconnected from others, can engaging in activities that help build a strong sense of connectedness with others be the anecdote when it comes to a time when loneliness persists?

 

In a recently published research study, my colleagues and I explored whether volunteering impacts how well people adjust to widowhood. We found that individuals who started volunteering after they became widowed, and engaged in at least two hours per week experienced no greater loneliness than their continuously married counterparts. In other words, volunteering did seem to provide an anecdote for persistent loneliness following widowhood, but only for those who committed to regular engagement.

 

As noted earlier, research has suggested that men tend to experience greater detrimental effects to their health following widowhood. Some researchers have proposed that one reason men struggle more is because (current cohorts of) older men are less socially embedded than women are in later life. My colleagues and I were interested in exploring what factors were associated with better outcomes for men, and in another recent study, we looked to a common early life experience among current older men — military involvement.

 

About half of all older men today served in the military. We were interested in whether involvement in the military, an institution that creates a ready social network with shared experiences, left a lasting impact on men’s ability to recover from widowhood in later life. We discovered that the military itself did not provide men with better outcomes, and we discovered a counterintuitive finding. The men who had been exposed to death while serving in the military experienced no increase of loneliness following the death of his spouse, a relationship that was unexplained by the social networks that the men engaged in.

 

We hypothesized that having experienced a death earlier in life may have given the men experiences, tools, and potentially emotional resources from which to draw when faced with widowhood later on.

 

Although it is not possible to draw conclusions about the results of our research, and further research is certainly needed to figure out what specific factors set people up to handle the loss of a spouse in our later years, our research does suggest a few things that might help.

 

First, regularly engaging in volunteering is known to be associated with a range of other health and well-being benefits, even in the absence of widowhood. For instance, volunteering on a regular basis is associated with benefits such as decreased depressive symptoms, enhanced functional health, and decreased risks of mortality. As a result, if you become widowed, picking up a new volunteer job and engaging on a regular basis a few hours a week may not take away all of the pain and challenges you will face, but it is unlikely to cause you harm.

 

Second, it may be possible to accumulate emotional or social resources that help us more effectively handle the consequences of experiencing widowhood. Although no one would choose the unlucky path of having a major loss early in life, it may be possible to learn important skills in other ways that help us to be more resilient when we do experience difficult situations like becoming widowed.

 

The findings from our study are limited to men in the military, so we plan to complete further research to help us better understand the unique circumstances that the military provides for handling difficult life events, and also learn how these findings extend to others, including women, who haven’t served in the military.

 

June 23
FSU, an Age-Friendly University

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OLLI — the Osher Lifelong Learning Institute — is an integral part of FSU's commitment to people in all stages of life and learning.


By Neil Charness, Ph.D.
Director, the Institute for Successful Longevity
William G. Chase Professor of Psychology

 

Florida State University was recently awarded the designation of being an Age-Friendly University. The age-friendly university initiative is an international effort, started in Ireland by Dublin City University, and it fits nicely with initiatives such as WHO’s age-friendly city and community effort, being spearheaded locally by Sheila Salyer and the Tallahassee Senior Center. These initiatives represent grassroots efforts to address the challenges of an aging society.

 

The Age-friendly University initiative aims to highlight the role higher education plays in responding to the challenges and opportunities associated with an aging population. It has 10 principles for distinguishing and evaluating age-friendly programs and policies as well as defining opportunities for growth:

 

§  To encourage the participation of older adults in all the core activities of the university, including educational and research programs.

§  To promote personal and career development in the second half of life and to support those who wish to pursue second careers.

§  To recognize the range of educational needs of older adults (from those who were early school-leavers through to those who wish to pursue master’s or Ph.D. qualifications).

§  To promote intergenerational learning to facilitate the reciprocal sharing of expertise between learners of all ages.

§  To widen access to online educational opportunities for older adults to ensure a diversity of routes to participation.

§  To ensure that the university’s research agenda is informed by the needs of an aging society and to promote public discourse on how higher education can better respond to the varied interests and needs of older adults.

§  To increase the understanding of students of the longevity dividend and the increasing complexity and richness that aging brings to our society.

§  To enhance access for older adults to the university’s range of health and wellness programs and its arts and cultural activities.

§  To engage actively with the university’s own retired community.

§  To ensure regular dialogue with organizations representing the interests of the aging population.

When I first heard of this opportunity a few years ago, I realized that FSU met many of the principles already. We have an active non-credit educational program through the Osher Lifelong Learning Institute (OLLI), and FSU, of course, offers credit courses to students, including non-traditional (older) students.  The College of Social Work houses our certificate program in gerontology, open to both undergraduate and graduate students.  FSU’s Career Center provides superb service to students and alumni, and we also specialize in providing education and career guidance to veterans through the Student Veterans Center.

 

We have an active Association of Retired Faculty (ARF). Our Institute for Successful Longevity already works with seniors throughout the region to include them in research through the participant registry. FSU is famous for its arts and cultural programs and provides many free (e.g., student recital) events to the community.

 

It was easy to work with other Center Directors here (e.g., Anne Barrett, Director of the Pepper Institute on Aging and Public Policy, Larry Polivka, Director of the Pepper Center) to structure an application, confer with senior administrators at FSU, and get the go ahead to apply.  Even though we have succeeded in achieving this designation, there are plenty of opportunities to broaden and deepen our commitment.

 

ISL aims to improve the chances for successful longevity by all those who are benefiting from the longevity dividend, the nearly 30-year increase in life expectancy at birth that our nation has enjoyed between the 20th and 21st centuries.  FSU as an age-friendly university can play a leading role in this effort.

 

 

 

May 30
Increase in memory complaints in older adults: Does it reflect age-related memory decline and/or something else?



Department of Psychology

We all often blank on an acquaintance’s name or forget a phone number that we’ve just checked.  When we’re young, we don’t pay much attention to these memory failures, but as we grow older, we become concerned more about what they mean.  According to a new national survey (West Health Institute/NORC Survey on Aging on America: http://www.westhealth.org/press-release/worries-about-aging-loom-large-for-americans-over-30-survey-finds/), memory loss is one of the leading concern for 60+ Americans. Older adults often not only perceive memory failures but also frequently complain about the perceived memory failures.  In fact, increase in memory complaints in older adults can be seen as a “normal” part of aging, which is associated with age-related memory decline.  But memory complaints might be a possible indicator of more serious cognitive and functional deterioration, including dementia and Alzheimer’s disease. Aging researchers have thus been interested in studying memory complaints in older adults. 

Memory complaints and depressive symptoms      

However, early research has shown that subjective memory complaints in older adults are just partly based on actual change in Jong-Sung Yoon.jpg

memory performance.  In fact, research has shown that subjective memory complaints are associated with some other factors, such as depressive symptom and personality traits (e.g. neuroticism and conscientiousness) reflecting
In fact, research has shown that subjective memory complaints are associated with some other factors, such as depressive symptom and personality traits (e.g. neuroticism and conscientiousness) reflecting negative affectivity.  Particularly, the link between subjective memory complaints and depressive symptoms in older adults has intrigued aging researchers for decades.  In general, individuals with more depressive symptoms complaints more about their memory. Recent studies also support the notion that changes in memory complaints over time may be affected by depressive symptoms rather than monitoring of actual age-related memory changes.

This is not surprising because depressive symptoms would lead individuals to interpret a common, everyday memory problem, such as a forgetting incident, more seriously because depressive affect would increase concern for the negative information (i.e. memory problem).  Older adults with depressive symptoms might also be more susceptible to everyday memory problems, perceiving them as an indicator of more serious age-related cognitive decline [1]. 

The type of memory complaints, depressive symptoms, and cognitive factors

However, many of previous studies have mainly relied on very brief and global assessments of subjective memory measured by participants’ responses on a limited number of items (e.g. “Over the past month, have you had difficulty with your memory?”).  This measure may not be sensitive enough to detect subtle changes in memory and would simply reflect older adults’ general beliefs about their memory rather than actual changes in memory [2]. 

To address the limitation, some aging researchers have attempted to assess the relationship between subjective memory complaints and depressive symptoms using a more extensive subjective memory complaint scale, namely, the Memory Functioning Questionnaire (MFQ) [3]. 

The MFQ measures four different types of memory complaints: 1) Frequency of Forgetting (FF; How often do you forget names, faces, appointments, etc.?), 2) Seriousness of Forgetting (SF; When you actually forget those items, how serious of a problem do you consider the memory failure to be?), 3) Retrospective Functioning (RF; How is your memory compared to the way it was 1 year ago, 5 years ago, and so on?), and 4) Mnemonic Usage (MU; How often do you use techniques – e.g. keep an appointment book, make lists of things to do, etc. – to remind yourself about things?). 

Recent study shows that the associations between memory complaints and depressive symptoms can vary with the specific type of memory complaints measured by the MFQ [4].  In particular, among the four different types of memory complaints, reporting more frequent forgetting (FF) is most strongly associated with depressive symptoms. Reporting a greater decline in memory function (RF) is also linked to depressive symptoms. However, seriousness of forgetting (SF) and mnemonic usage (MU) are not associated with depressive symptoms. 

Interestingly, a pattern of relationships between cognitive factors and memory complaints also varies with the type of MFQ measure. In the same study [4], older adults with higher cognitive functioning reported less frequent forgetting incidents (FF), although they tended to report a worse decline in memory (RF) and a more use of mnemonics (MU). The results indicates that older adults with better cognitive functioning might be more likely to notice declines in memory functioning and undertake compensating activities (e.g. use of mnemonics) to cope with the perceived memory problems.


What those findings mean and how we use them

Understanding how people perceive their own memory functioning can have important implications for assessing cognitive and clinical aspects in later life. Previous studies have demonstrated that the investigation of specific patterns between the type of memory complaints and depressive symptoms might allow us to differentiate individuals experiencing mild memory deficit from those with depressive symptoms. It means that investigators and clinicians should carefully examine if and how the associations between memory complaints, depressive symptoms, and cognitive factors vary with the specific type of memory complaints. More specifically, it appears that clinicians need to screen for depression when older clients present with complaints about frequent forgetting.

It is important to investigate where memory complaints come from, how older adults deal with this perceived memory decline, and how these are tied in with the individual’s well-being. Future studies could benefit from exploring activated neural pathways underlying the association between depressive symptoms, cognition, and memory complaints as well as the effect of aging on them.

 

References

[1] Hülür, G., Hertzog, C., Pearman, A., Ram, N., & Gerstorf, D. (2014). Longitudinal associations of subjective memory with memory performance and depressive symptoms: Between-person and within-person perspectives. Psychology and Aging, 29, 814-827.

[2] Pearman, A., Hertzog, C., & Gerstorf, D. (2014). Little evidence for links between memory complaints and memory performance in very old age: Longitudinal analyses from the Berlin Aging Study. Psychology and Aging, 29, 828-842.

[3] Gilewski, M. J., Zelinski, E. M., & Schaie, K. W. (1990). The Memory Functioning Questionnaire for assessment of memory complaints in adulthood and old age. Psychology and Aging, 5, 482–490.

[4] Yoon, J-., Charness, N., Boot, W. R., Czaja, S. J.,  & Rogers, W. A. (in press). Depressive Symptoms as a Predictor of Memory Complaints in the PRISM Sample. The Journals of Gerontology, Series B: Psychological Sciences and Social Sciences.

 

March 30
Longer working years?




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A silk worker in the 1940s works from home in Patterson, New Jersey, as he's no longer part of the factory work force; life for older workers has changed since then, but challenges remain in the 21st century economy.

By Neil Charness, Ph.D.

Director, Institute for Successful Longevity

There is an interesting development in terms of older adult participation in the paid labor force — people are working longer, reversing a decades-long trend toward earlier retirement.

The huge Baby Boom cohort has expressed interest in working past “normal” retirement periods of age 62, with partial pension, and age 65 for full pension. (Retirement with full Social Security benefits comes at age 67 for those born after 1960 and between 66 and 67 for Baby Boomers.)

Of course, not long ago people worked their entire lives, before national governments became rich enough to support the creation of social safety nets such as Social Security here in the United States (instituted in 1935). One of the earliest national plans was established in 1889 in Prussia/Germany by Otto von Bismarck, then chancellor, with entitlement set at age 70 (not the mythical 65 most people have heard of, though the government eventually set the earliest pensionable age to 65 in 1916, years after Bismarck’s death).  There were private pension plans long before public ones, with the first in the United States apparently being that by the American Express Company in 1875. By 1929, nearly 400 retirement plans were in operation. 

This work-longer trend is occurring at a time of dropping participation rates in the labor force.  The participation rate is defined as the proportion of the civilian noninstitutional population that is in the labor force. Non-institutional means those people 16 years of age and older residing in the 50 states and the District of Columbia who are not inmates of institutions (penal, mental facilities, homes for the aged), and who are not on active duty in the Armed Forces.

There are a number of reasons that older adults might be staying longer at work. One factor may be the shift of risk from companies to individuals for private retirement savings, marked by companies dropping defined benefit-pension plans, which pay fixed and predictable pensions, to defined-contribution plans, where the individual is responsible for investing with uncertainty about the payoff on retirement if investments go sour. 

Another is the trend of not having pensions offered at all in some, usually smaller, companies, especially for low-wage workers.  Another is that the centuries-long increases in life expectancy (which may now be reversing) is making people aware of the possibility of outliving their financial resources, so they retire later as a buffer against that uncertainty.

Certainly there are other cost-shifts that have occurred, for instance, in paying for health benefits, that make people more uncertain about whether they have saved enough for increasing health care costs while retired.  (No Virginia, there is no Uncle Sam or Santa Claus to pay for extended skilled nursing home care should you be incapacitated at the end of life, until you exhaust all your financial resources.)  Those are the negatives that may be driving later retirements.

There are also positives.  People in white-collar work environments may want to remain, perhaps at less intensity (part-time) to maintain social networks at work, as well as for the extra income. They may find considerable satisfaction in their work too, as does this blogger. Those trends may not occur in many physically demanding blue-collar work environments: think coal mining, where most everyone retires as early as possible (age 62 in the United States).

So, our work force is going to be increasingly older.  So, an interesting question is: how are we preparing to support an aging work force?  There are some predictable age-related trends that show little sign of changing, such as decreasing perceptual, cognitive, and psychomotor abilities with increased age.  Countering negative trends in many abilities as people age is the increase in knowledge that people continue to acquire until quite late in life.  Obsolescence is probably more of a threat to older worker productivity than loss in abilities.  Given the need to maintain productivity (which has slowed in recent years), we now need to contemplate how to keep all age groups up to date and well-equipped to enhance work force productivity. 

There are still biases against training and promoting older workers, though the literature suggests that an economic case can be made for training older workers.  Training and retraining methods best-suited for older workers are not yet clear cut, at least on the research evidence front, though there are some useful resources that provide guidelines

So, we have some interesting challenges, particularly the desire of Baby Boom workers to stay employed longer, yet we need to allow for those in physically demanding settings or those in poor health to retire earlier and with true social security.  Can we take advantage of the knowledge that older workers have acquired over their increasingly lengthy careers (perhaps through mentor roles)? How can we best compensate for any ability losses (through work-place redesign) and for obsolescence (with new training)?  Now is the time for all of us to get to work on this issue.

Neil Charness, Ph.D., is the William G. Chase Professor of Psychology at Florida State University and director of the Institute for Successful Longevity.

December 01
Osteosarcopenic obesity as a new syndrome in elderly: What are the prevention and management challenges?

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By Jasminka Z. Ilich-Ernst

Nutrition, Food and Exercise Sciences

The triad of bone, muscle and fat tissue deregulation

Recently, a new syndrome was identified and termed osteosarcopenic obesity (OSO), signifying the impairment of bone, muscle and adipose tissues as an ultimate consequence of aging. OSO may also develop due to the initiating presence of overweight/obesity perpetuated by low-grade chronic inflammation, as well as to inadequate diet and lifestyle.

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Additionally, some chronic conditions, like cancers, diabetes and other diseases that cause endocrine imbalance and stem cell lineage disruption may also cause OSO. Although the tight connection between bone and muscle has been recognized and addressed in recent years, the inclusion of fat tissue, either as an overt obesity, or as an age-induced redistribution of fat, or as an infiltrated fat into bone and muscle, is just beginning to gain more attention within the context of bone and muscle impairments.
We realize now that obesity (once thought to be protective of bone and muscle), is increasingly linked to deterioration of these tissues, especially with aging. Therefore, other new terms; osteopenic obesity and sarcopenic obesity, resulting from increased overall body fat and/or fat infiltration into bone and muscle, leading to lower bone and muscle mass, quality, and possibly increased frailty, need to be taken into consideration as well.

Currently, there are no estimates about the number/percentage of older adults suffering from the combined condition of OSO and some preliminary criteria to diagnose it are just being developed. However, at least 54 million Americans currently have osteopenia and/or osteoporosis and one in two American women will experience a bone fracture. Additionally, about 5-13% of adults >65 years old and ~50% of adults >80 years old have sarcopenia. Ironically, hip or any other osteoporotic fracture accelerates the onset of sarcopenia in older adults; and sarcopenia, which impairs overall physical function, increases the risk of falls and fractures. One of the most common health problems in the osteosarcopenic obese population is increased risk of falls and fractures. Fall-related injuries are one of the major causes of mortality and morbidity among the elderly. These injuries could have a significant impact on health-related costs and quality of life. In 2014, one third of fall- related deaths were attributable to osteoporosis and/or sarcopenia.

The economic impact of third component of OSO (overweight/obesity) is especially manifested in healthcare costs and long-term loss of productivity. The annual medical costs for an obese individual are on average $1,429 higher than that of a normal-weight healthy individual. The recent rise in the prevalence of obesity is associated with comorbidities such as type II diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease, stroke, asthma, obstructive sleep apnea, osteoarthritis, renal failure, cancer and others. Aside from all of these complications, obesity has been associated with a 6 to 20-year loss in life expectancy.

Management

            Although chronic disease, drug therapy, genetic predisposition and environmental factors are the main determinants in the etiology of OSO, lifestyle factors such as dietary patterns and physical activity are important as well. The latter two play a substantial role in metabolic homeostasis, determining to what extent an individual is able to preserve bone mass, muscle mass, and overall function, while still preserving an optimal body weight or reducing obesity with age.

Nutrition: Although American adults consume more food and total energy than people of many other cultures worldwide, evidence points to increased malnutrition risk with age and a link between the so called “Western-type Diet” and development of chronic disease, including bone, muscle and fat tissue disorders. Older adults in the United States are potentially at nutritional risk due to three main factors: increased consumption of high-energy and low-nutrient-density types of food; inadequate dietary fiber consumption; and decreased ability to absorb or utilize some essential nutrients with age. The Western Diet being heavily based on processed food, provides increased energy but decreased amount of many essential nutrients, and promotes deregulation of major systems in the body. A typically low dietary fiber intake in older adults is associated with insulin resistance and increased inflammation, especially in the obese. Western diet is also characterized by the high ratio of omega-6 to omega-3 polyunsaturated fatty acids (the latter being eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), which contributes to low-grade chronic inflammation and other unfavorable physiological outcomes. Besides the relatively unwholesome diet, older adults often consume less nutrients secondary to decreased appetite, side effects from medications, dementia or a desire for weight loss. Particularly affected nutrients are protein, calcium, magnesium and vitamin D, all needed to maintain and build bone and muscle. Additionally, dietary absorption of most of vitamins and minerals is also decreased, making it harder for the body to utilize them from the food consumed.           

The combination of low protein, high simple carbohydrates, deficiencies of calcium, magnesium and potassium and excess of phosphorus, sodium and iron may be associated with lower bone mass, sarcopenia and obesity, and therefore OSO syndrome. Overall the nutrient composition of the Western Diet, distribution and amounts, for both macro and micro nutrients may not promote healthy aging and may be contributing to the development of OSO syndrome.

            Physical activity: In general, physical activity is needed for maintenance and improvement of all components of body composition, as well as the physiological and mental health in people of all ages. Specifically for the OSO syndrome, physical activity, even in the form of low intensity or habitual activity, is needed to maintain or improve bone health, muscle strength and quality, improve balance, and reduce adiposity and inflammation, with aging. A comprehensive exercise program for older adults includes aerobic, strength, flexibility, and balance training and could reduce risk for falls, increase functional ability, and improve quality of life. However, recent findings show that although resistance training may increase lean (muscle) mass and weight bearing exercise may result in a reduction of the rate of bone loss (rather than in a significant increase in bone mass), the best exercise is what an older person is able to do. Aside from some medium to high-impact activities, habitual and low-impact physical activity including heavy housework, gardening, do-it-yourself activities, recreational activities and walking have been shown to be beneficial for bone, muscle and overall endurance.

Other alternative exercises such as Tai Chi, Yoga, and Pilates, could be used to support body composition and prevent bone loss and, as it has been shown, these exercises are associated with increased quality of life of older individuals. Overall, older adults may require special considerations such as tailoring progression of exercise intensity and beginning at a lower intensity. However, any type of immobilization, even during illness, should be avoided as much as possible in order for the proper maintenance of bone, muscle and fat tissues.

Conclusions and overall recommendations

OSO syndrome is a multifactorial condition of age-related changes in body composition including bone loss and muscle loss combined with increased adiposity. This complex condition of aging may be aggravated by poor nutrition, lack of physical activity and chronic disease. Treatment for OSO syndrome or its management may require the combination of healthy/optimal nutrition and different modes of physical activity. For the best prevention, efforts should be made to achieve peak bone mass before the age of 30, to gain/maintain muscle mass for all age groups and maintain healthy weight. As discussed above, nutritional interventions include: consumption of foods with high and good quality protein (eggs, fish, meat, dairy) adequate energy intake (to maintain healthy weight), adequate calcium, magnesium and vitamin D intake (dairy foods), consumption of food rich in EPA and DHA (omega-3 polyunsaturated fatty acids; as found in flaxseed oil, fish oil, walnuts, soybeans). Moreover, physical activity including strength training and aerobic exercise supports the maintenance of bone and skeletal muscle mass and thus attenuates osteopenia/osteoporosis as well as sarcopenia and may maintain weight. However, habitual daily activity as well as some alternative types of exercise (Yoga, Pilates) may be more acceptable in older individuals and thus better suited for the prevention and management of OSO syndrome.

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October 24
Where Are the Older Volunteers in Clinical Trials?

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By Zhe He, Ph.D.

Assistant Professor, School of Information

Florida State University

zhe@fsu.edu / ischool.cci.fsu.edu


Clinical trials are conducted for testing the efficacy and safety of a treatment (e.g., medication, device, procedure) for one or more medical conditions. However, older adults are systematically underrepresented in clinical trials, and this creates serious repercussions in the health-care industry.

For example, as early as 1999, a study of Southwest Oncology Group reported that although about 60% of new cases of cancer occur among older adults, they comprise only 25% of participants in cancer clinical trials [1].zhe He.jpg

Besides cancer studies, older adults are also systematically underrepresented in clinical studies on other chronic conditions such as cardiovascular diseases, diabetes, and dementia. In 2004, Schoenmaker and Van Gool reported a wide age gap between the patients enrolled in dementia clinical studies and the patients with dementia in the general patient population
[2]. The dementia patients who are included in clinical research are systematically younger than patients from the general population.

Due to lack of population representativeness, many trials failed to balance the internal validity and the external validity. In the context of clinical research, Internal validity refers to whether the design and execution of the clinical trial leads to valid conclusions about the efficacy and the safety of the treatment.

For example, say you were interested in whether a new drug was effective for headache relief. If you don’t include a control condition, such as a placebo pill, along with the experimental treatment condition, you won’t be able to conclude that the drug is effective. You may be observing a placebo effect, where any treatment would work (e.g., to cure a headache) as long as the patient believed the treatment would relieve pain. So, typically, a trial involves random assignment to a placebo intervention and a treatment intervention as well as trying to keep the patients blind to the intervention that they are in (hence the placebo pill) as well as having the evaluators of the outcome blind to the intervention when they make measurements on the patients (such as for blood glucose levels, HbA1c, in a diabetes trial). If the internal controls are not adequate, then the conclusions about the efficacy of the treatment may not be valid.

External validity refers to the generalizability of the trial. Even when internal validity is strong, if the trial involves just one age group, say college students, would make it difficult to conclude that the treatment effect (assuming it was significant) will generalize to the whole population (e.g., children, seniors).

Often, internal validity and external validity are in conflict as tight internal controls, the inclusion and exclusion criteria for enrolling into a study, systematically bias in the types of sample recruited, making it more difficult to ensure generalizability.  You need internal validity to draw valid conclusions about efficacy.  You need external validity to draw valid conclusions about the range of people for whom the treatment can be expected to have efficacy.

For example, studies are usually designed to minimize confounding factors and adverse events by excluding patients with co-medications/polypharmacy, multiple comorbidities, and cognitive impairment, which disproportionately exclude older adults. The participants in a trial had fewer comorbid conditions and lower overall mortality than the general patient population [3]. Stringent eligibility criteria may explicitly or implicitly limit the inclusion of elderly patients with typical age-related organ impairment and comorbid conditions that may not interact with the treatment under study. Moreover, there is a lack of evidence for assessing quality of care for elderly patients with multiple comorbidities as clinical practice guidelines commonly only focus on a single disease. To provide the evidence for assessing the efficacy and safety of a medication that will be used in elders with multiple comorbidities, these patients should be appropriately represented in clinical trials.

What are the consequences?

What are the consequences of ignoring or excluding older adults in clinical trials? First, older adults who cannot afford the treatment may not have a chance to try the free treatment that may save their lives. More importantly, older adults often have more chronic conditions and take more medications than younger people. When they take the drug that was primarily tested on younger people, they may not find it as effective as stated. Even worse, they have a higher likelihood to encounter serious adverse drug reactions such as toxicity, organ damage, or even death due to complex drug-drug interactions.

 

From 1969 when the drug event reporting system of FDA was initiated till 2002, about 2.3 million case reports of adverse events for the cumulative number of approximately 6,000 marketed drugs were entered in the database [4]. Out of these 2.3 million cases reports, 1.8 millions reports originated from the United States. Among the reports who specified age, 35% referred to those 60 years or older. More than 75 drugs/drug products have been removed from the market due to safety problems. Since 2006, the number of reports gradually increases each year and has exceeded 1 million in 2013 (See the figure below). This phenomenon naturally makes us to rethink about the clinical research enterprise. How can we identify most safety issues during pre-marketing clinical trials instead of asking the entire real-world patients to “test” the drugs?

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Number of adverse event reports received (solid bars) and entered (checked bars) into Adverse Events Reporting System since 2006 through the first quarter of 2015. (Form http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm)


How to improve the representation of older adults in clinical trials?

 

Dissemination of information about clinical trials

ClinicalTrials.gov is the official clinical study and results registry created and maintained by the U.S. National Library of Medicine. Mandated by Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), all the US-based clinical trials of drugs, devices, and biological products other than Phase I trials have to be registered in ClinicalTrials.gov. As of October 6, there were 227,255 studies with sites in 191 countries registered. On September 16, FDA released the final rule for clinical trial registration and results information submission in ClinicalTrials.gov. National Institutes of Health Director Dr. Francis Collins co-authored a viewpoint in the Journal of the American Medical Association about recent NIH efforts on clinical trial reform which aim to enhance the award processes, increase NIH’s ability to better assess applications, improve oversight, and increase sharing of results [5]. Dr. Collins and other senior leaders said: “Investigators and sponsors who fail to comply with the regulation may be subject to civil monetary penalties assessed by FDA. In addition, NIH will withhold clinical trial funding to grantee institutions if the agency is unable to verify adequate registration and results reporting from all trials funded at that institution. The availability of results will promote innovations in clinical trial design and avoid duplication of unsuccessful strategies, thereby avoiding unnecessary risks to research participants.”

 

With improved transparency of clinical trials, clinical investigators should be able to broaden their search for trial participants. Meanwhile, it should be easier for patients to find clinical trials to get screening.

 

Relaxing overly-restrictive eligibility criteria in clinical trials

 

Clinical trial designers should evaluate the population representativeness of eligible patients during the design phase of a new trial. Normally, one could manually identify a set of representative exclusion criteria in a trial and analyze the percentage of real-world patients that would not fulfill each of these criteria. The vast amount of electronic data also presents unprecedented opportunity for improving trial design with big data technologies. A visual analysis tool of quantitative eligibility features named VITTA (http://is.gd/VITTA), which includes processed studies summaries in ClinicalTrials.gov, allows one to flexibly select trials in the same disease domain and then visualize their study populations with a quantitative eligibility feature [6]. For example, VITTA can visualize overly included or systematically excluded value ranges of HbA1c of type 2 diabetes trials. Milians and her colleagues used semantic web technologies to structure eligibility criteria to enhance their reuse and relaxation [7].

The underrepresentation of older adults in clinical trials reduces their generalizability and the cost-effectiveness ratio. Concerted efforts should be made to attract older adults who are safe to be enrolled in the trials on medical conditions often seen in older adults. Clinical trials with optimized balance between internal validity and external validity will give their findings more credibility.

 

References

[1]   Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Jr., Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341(27):2061-7. PMID: 10615079

[2]   Schoenmaker N, Van Gool WA. The age gap between patients in clinical studies and in the general population: a pitfall for dementia research. Lancet Neurol. 2004;3(10):627-30. PMID: 15380160

[3]   van de Water W, Kiderlen M, Bastiaannet E, Siesling S, Westendorp RG, van de Velde CJ, et al. External validity of a trial comprised of elderly patients with hormone receptor-positive breast cancer. J Natl Cancer Inst. 2014;106(4):dju05. PMID: 24647464

[4]   Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165(12):1363-9. PMID: 15983284

[5]   Hudson KL, Lauer MS, Collins FS. Toward a New Era of Trust and Transparency in Clinical Trials. JAMA. 2016;316(13):1353-4

[6]   He Z, Carini S, Sim I, Weng C. Visual aggregate analysis of eligibility features of clinical trials. J Biomed Inform. 2015;54:241-55

[7]   Milian K, Hoekstra R, Bucur A, Ten Teije A, van Harmelen F, Paulissen J. Enhancing reuse of structured eligibility criteria and supporting their relaxation. J Biomed Inform. 2015;56:205-19

 



August 22
Can Telehealth contribute to successful longevity?

 

 

Can telehealth contribute to successful longevity?

 

By Neil Charness

 

Director, Institute for Successful Longevity

 

August 8, 2016

 

 

 

Sputnik_670.jpg

 

 

 When the Soviet Union launched the Sputnik satellite on October 4, 1957, it did more than trigger the Space Race — it also laid the foundation for today’s telehealth, the remote provision of health care and education via communications technology.

As the Space Race rushed forward, from simple radio communications to putting animals and then humans in orbit, scientists and engineers in the USSR and in America wrestled with the need to monitor vital signs of the cosmonauts and astronauts. They took advantage of cutting-edge electronics to transmit heart rates, blood pressure measurements and other data from spacecraft to Earth. This same concept — aided by many evolutions in technology — is at work today as telehealth communications.

Here on the ground, telehealth services were later rolled out (on dog sleds) to people living in Alaska in the last century as a way to provide health care outside the main cities.  Originally remote monitoring drew on television technology and bulky camera systems to beam images of patients and their health conditions (including data from devices such as electronic stethoscopes) from remote clinics to physicians who could diagnose and treat the problem.

Today telehealth involves much more compact devices, including smartphones, but still the most popular format is videoconferencing between a patient and a health care provider.  Services that required a visit to a clinic or an office (or a hospital) can be delivered to the home (or a remote clinic), enabling health care professionals to “see” patients more efficiently and hopefully, more cost effectively.

The verdict on cost effectiveness is still open, particularly after a very large clinical trial in the United Kingdom (the Whole Systems Demonstrator project) failed to find cost effectiveness compared to usual care, though it was “usual care” pitted against usual care plus telehealth.

Given important advances in communication bandwidth, imaging, and even telerobotics, remote provision of care can now include remote operations where a surgeon at one location guides equipment at a different one.  (Hopefully the telecommunications link is sound and doesn’t fail at a critical junction.)  It can also involve having a rehabilitation specialist looking in on a client to be sure that exercises are being performed the right way.  Many forms of telehealth can reduce the costs of interacting, particularly travel costs for patients and provide health care resources in a timely way.

So what has telehealth to do with successful longevity? 

People around the world are living longer than ever before, though there are some worrying indicators that progress may be stalling or even reversing for some groups here in the United States.  Nonetheless, increased age is still strongly associated with costly to treat chronic conditions such as heart disease, cancer, respiratory disorders, diabetes, and dementia.  Some estimates suggest that nearly 90% of health care expenditures in the United States are on behalf of those with chronic conditions.  Thus, managing chronic conditions cost effectively is a major challenge.  Management involves monitoring, detecting negative trends, and intervening before someone reaches a crisis requiring costly emergency care.

The monitoring part is ideally suited to telehealth technology.  Rapidly improving sensor technology can be packaged in wristwatch like devices.  It can be coupled with intelligent software that can detect negative changes and send alerts via text messages and email to health-care providers.  So, it is increasingly feasible to offload monitoring usually done via regular visits to overburdened physicians to telehealth systems.

There are still plenty of issues to resolve before intelligent agents (think Siri) replace or even just supplement usual care practices.  As one example, how reliable are such systems?  Here in Florida, we have regular power interruptions during summer thunderstorm season, not to mention, occasionally experiencing more severe weather events such as hurricanes. One hundred percent reliable electrical transmission systems are not likely to be in place.  A recent study my colleagues and I conducted showed that our telehealth system was pretty reliable, with up time for the network around 93%.  Strikingly, the human components of the system were less reliable, with patients completing around 80% of measurements that we asked them to take daily (such as weight, blood pressure, filling out survey items).  Finding ways to minimize (fallible) human effort by substituting more reliable machine components is going to be a challenge for the field, though monitoring is always going to be a collaborative enterprise between the human and the monitoring system.

Another potential barrier to adoption is knowledge about and attitudes toward telehealth.  Several large surveys (mainly in Europe and Canada) have shown that only about 10% of people know what telehealth is, though most saw potential value once it was defined.  That finding extends even to clinicians in some countries.

Attitudes may be a much tougher nut to crack for aging adults as many seniors are reluctant to embrace new technologies given the greater cost to them of learning new things compared to younger adults.  Perceived usefulness and perceived ease of use dominate as predictors of technology adoption and use, as my colleague Wally Boot and I showed in a recent review chapter.  The cost of new learning contributes negatively to perceived ease of use.  Even health-care professionals such as nurses have shown some concerns about adopting telehealth in their practices, as a study we conducted jointly with colleagues in the Netherlands discovered.

Nonetheless, assuming other important hurdles such as licensure for practitioners (to practice across geographic regions rather than solely in the state in which they are licensed), and payment for telehealth services can be surmounted, it seems inevitable that health-care delivery will migrate from hospitals and clinics to the home.  That process will require better design of telehealth systems and better training for users, both professionals and the people they treat, mainly the growing numbers of seniors with costly to manage chronic conditions.  Telehealth will increasingly be in the spotlight in our quest to reduce health care costs and enhance the prospects for successful longevity.

 

Neil Charness, Ph.D., is the William G. Chase Professor of Psychology at Florida State University and director of the Institute for Successful Longevity.

 

 

 

February 16
Long Term Care in the U.S.: From Community to Corporate Control

Long Term Care in the U.S.: From Community to Corporate Control
Professor Larry Polivka, Claude Pepper Center, Florida State University
 
 
 
The U.S. Long Term Care System
Long term care for impaired younger and older adults has been a major part of the nation’s health care system for several decades, but until now it has not received much attention from the media or policymakers.  With the projected doubling of the 70+ population over the next thirty years, however, it is being looked at with renewed interest.   
 
The current publicly (mostly Medicaid) supported long term care (LTC) system is a mix of nursing home, assisted living and in-home supportive services.  This mix is slowly but steadily shifting in the direction of community-based services.  This shift is largely in response to the proven cost effectiveness of community based alternatives to nursing home care and the overwhelming preference of both older and younger impaired persons for them.
 
Most paid LTC services are funded by the Medicaid program and, to a much lesser extent, Federal Older Americans Act funds.  In most states, these federal funds are administered through the non -profit Aging Network (AN), which consists of over 600 Area Agencies on Aging (AAAs), several thousand mostly non-profit service providers, and many advocates for aging services.  As documented by AARP in recent reports[1], state and local Aging Networks have built an extensive infrastructure of community-based services over the last thirty years and administered them in a comparatively efficient, low-cost manner. 
 
 
The Move to Managed Long Term Care
The relative cost effectiveness of AN has not, however, stopped states from seeking to convert their Medicaid-supported LTC system from non-profit Aging Network administered home and community based systems into managed LTC systems that are largely controlled by for-profit HMO organizations. This transition to HMO-run managed LTC systems is occurring in the absence of much, if any, evidence that these services can be provided as cost effectively by HMOs as they have been for several years through the Aging Network.  In fact, four studies conducted in Florida since 2003[2], have found that the state’s HMO-administered community-based program was consistently less cost effective than the Aging Network run programs.
 
The move toward HMO-administered managed long term care (MLTC) programs has received a boost from the federal government through the recent Dual Eligible Demonstration Project, implemented in over fifteen states.  Most of these projects are administered by HMOs under a merged Medicare/Medicaid capitation rate.
 
 
 
Does the future belong to HMO-administered MLTC? Is the AN on the cusp of becoming a LTC side show over the next decade? Has the MLTC train left the station? In some states the answers would appear to be yes.  In these states the HMO infrastructure for MLTC is established and the AN has either become a limited player in community-based LTC or else it was never a major LTC player to begin with.  In other states, where the AN is established, well-organized, and relatively sophisticated, the train is unlikely to arrive, or, if it does, it would not mean HMOs would displace and marginalize AN organizations (Oregon, Washington, and a few other states).  In the remaining states, mixed models of LTC involving the AN and HMOs, are likely to emerge over the next decade (Massachusetts, Minnesota, and Ohio).  These hybrid models might provide opportunities for extensive partnerships between HMOs and AN organizations, but only if the latter continue to receive sufficient support from policymakers.
 
Preserving the Aging Network Role in Long Term Care
I think it is important for several reasons that the AN role in LTC be preserved and even strengthened in the future.  First, the older population is growing rapidly and the need for LTC services is projected to double over the next twenty years, heightening the need for efficient and low-cost administration of services.  The AN has a 20-year history of managing LTC services with an administrative overhead of around 5% and minimal increases in reimbursement rates.  It is highly doubtful that for-profit HMOs can match this record while meeting shareholder profit expectations.  In order to avoid serious threats to the quality of services or access to care, HMO-administered LTC services could well end up costing substantially more than AN-run services, creating fiscal pressures that could lead to unmet needs and declining quality.  Policymakers and the elderly could, in short, be caught between the escalating need for services, on the one hand, and cost increases that could seriously jeopardize the states’ capacity to meet a minimally acceptable levels of care, on the other.
 
A second reason for maintaining the role of the Aging Networks is the Network’s demonstrated ability to strengthen and maintain informal caregiving networks.  Long term care’s labor intensive and, at its best, depends on close interaction between formal (paid) and informal (unpaid) care from family, friends, neighbors, and volunteers.  The social capital (community trust and support) of non-profit organizations in the AN is essential for building and maintaining the formal-informal caregiving networks and for avoiding a potential crisis in caregiving as described by the President’s Council on Bioethics in 2005:
 
…The danger is that some old people will be abandoned or impoverished, with no one to care for them, no advocate to stand with them, and inadequate resources to provide for themselves.[3]
 
An increasing number of baby boomers will lack children or spouses to help provide care, which means that we as a nation are facing a major caregiver challenge.  An AN-based LTC system deeply embedded in the community is what we need to meet this challenge.  It could become an
 
 
essential part of a more comprehensive, community-based model guided by an “ethic of care” rather than the maximization of shareholder value.  This kind of community-embedded and oriented care could provide a framework for integrating all domains of care from preventative and acute care services to LTC for the huge number of elderly who will need help over the next several years.
 
Why Managed Long Term Care Now?
Since the evidence indicates that the non-profit aging network organizations have long been a cost-effective provider of community-based care with the demonstrated capacity to administer an integrated LTC system, why have for-profit HMOs been enlisted to replace them in several states with the support of the Federal Center for Medicare and Medicaid Services (CMS).   My co-author, Professor Baozhen Luo, and I are now completing a paper that addresses this question by suggesting that this innovation is a product of the public policy driven by the neoliberal political economy, which has been ascendant in the last several years.
 
The neoliberal political economy and policy agenda are based on several ideological assumptions about how the economy and government should work, individuals live, and communities function.  Neoliberalism assumes the supremacy of the free market in determining the value of goods and services and the superiority of market incentives to maximize profits over collective efforts to achieve the common good.  The neoliberal policy agenda prioritizes cuts in spending on public programs and privatizing what remains, cutting and virtually never raising taxes, removing as much public regulation as possible, and maximizing the scope of individual responsibility for every aspect of life from daycare and education to retirement security and long term care.  This economic model denies the value of the public sector and its ability to create the conditions (including substantial government subsidies) necessary for economic growth.
 
What’s At Stake?
Long term care is one of the last remaining domains of the U.S. health care system not dominated by corporate health organizations.  This situation, however, is rapidly changing, as HMOs have become convinced that they can profitably administer LTC programs created by the non-profit AN, and as the neoliberal policy agenda has gained traction at the Federal and state levels for over thirty years.  I seriously doubt that the neoliberal corporate model will be able to achieve the same efficiencies and quality of care outcomes as has the AN in most states for over twenty-five years.  If the AN has been allowed to wither away and the corporate model fails to contain costs or meet quality standards, the critical LTC challenge facing the U.S. will become dire, and, we will have little choice but to either pay the corporate piper anyway or allow the need for LTC services to go unmet.
 
In most states the AN organizations are essential and widely-supported elements of their local communities.  They are well-positioned to serve as hubs for community based, integrated health and LTC systems.  The displacement of these aging network by HMOs would, in my judgment, represent a lost opportunity for further developing such systems of community-based and person-centered systems of care.  The AN is a civic asset whose benefits radiate throughout their local communities and contribute to the creation of strong communities with a sense of control over their own fates. 
 
Even in those states that move toward comprehensive HMO-administered MLTC systems, AN organizations, including services providers, should be given the chance to evolve in a manner conducive to their survival and even to thrive in modified roles.  This eventuality is unlikely, however, in the absence of a serious discussion about LTC policy at the federal and state levels and a renewal of aging advocacy activity.
               


[1] Reinhard, S. C., et al. 2014, AARP, Raising Expectations, Second Edition.
[2] Polivka, L. & Zayac, H. 2008, The Gerontologist, Forum, Vol. 48, No. 5, 564-572
  The Florida Legislature, OPPAGA 2010, Report No. 10-33.
[3] The President’s Council on Bioethics 2005, Taking Care: Ethical Caregiving in Our Aging Society, https://bioethicsarchive.georgetown.edu/pcbe/reports/taking_care/.
January 26
Pay for Performance: Can it Help Improve Nursing Home Care?
Pay for Performance: Can it Help Improve Nursing Home Care?
 
William G. Weissert
Jan. 22, 2016
 
Nursing home quality of care is a chronic problem the country over.  Nearly 95 percent of nursing homes flunk one or more quality measures on regulatory surveys.  A quarter of homes have problems that threaten patients’ lives.  Regulators strive to pull laggards up to the minimal standards required to keep licensure and certifications, but they can go only so far.   A small group of facilities is always at the bottom.  Nothing seems to move them up. 
 
How about paying for performance?  If they improve quality of care, pay them a bonus.  ObamaCare (the ACA) now does that for hospitals.  They get paid a bonus of 1 or 2 percent of their Medicare bill if they meet hard-to-achieve quality markers for certain conditions.  They lose money if they don’t show improvement, readmit too many patients because they failed to fix their problems the first time, or because they fail to control infections in their hospital.   Together these bonuses and fines can add up to substantial new revenues, or substantial losses.
 
But the ACA does not apply to nursing homes.  We wanted to know whether or not it should.  Could Pay for Performance – P4P – help improve nursing home care.  Not replace current regulations.  Just complement them with bonuses for improving care.
 
We reviewed the P4P studies done over a decade in hospitals and nursing homes to see what has been learned about P4P in both nursing homes and hospitals.  Over the years 2002 to 2012, 22 studies were found suitable for inclusion in our analysis.  Six were randomized controlled trials, 10 were not randomized but had a control group, and six were before and after studies with no comparison group.  We calculated “effect sizes” for each study:  That is, how big and in what direction was the effect of receiving P4P on the 150 outcomes studied across all the 22 studies? 
 
The range of effects was large.  Most positive was a 45 percent increase in foot exams when a facility was paid extra to do them.  Tests for kidney disease were positively affected (37 percent increase); 28 percent more patients received perfect asthma care when providers were paid for perfect care; eye exams in diabetic patients went up by more than 25 percent.  A dozen and a half other outcomes went up by double digits.  Several dozen more went up by single digits and more by less than 1 percent increase.
 
Unfortunately, nearly another two-dozen outcomes got worse when paid to get better.  Most of the negative effects were less than a 1 percent decline.  But two were in single digits, and one was a 21 percent decline: the amount of blood being pumped from the heart’s left ventricle.  But it was in a rural hospital, and probably reflects an increase in a small number of patients.
 
Of more concern is the median effect size.  That was less than 3 percent.  Even if we assume that over time P4P would get providers’ attention and cause them to work harder at improvement, to say the 75th percentile (a very generous assumption), P4P promises to improve care by barely over 4.5 percent.
 
If P4P were cheap, easy and pretty certain to deliver improvement, even a 3 or 4.5 percent increase might be worth trying for.  But alas, P4P is anything but cheap, easy or certain.  In point of fact it is likely to be rather expensive for at least two reasons: The cost of bonuses; and The cost of monitoring to make sure that patients have the condition being paid for at the start of a payment period, and that it’s been fixed when payment is due.  With bonuses and potential lawsuits at stake, careful, ideally repeated and validated measurement is necessary.  And bonuses have to be large enough to attract providers’ attention.
 
But these are not the only problems with P4P.  Indeed, the list of potential pitfalls with P4P is quite distressing.  It typically starts with poor design.  For example, what do you pay for?  If you pay for things that are easy, you waste money and produce little improvement.  If you pay for difficult, complex outcomes, you risk demanding that providers prevent or fix problems that may be the result of nature or other causes beyond the providers’ control.  If you pay for only a few things, quality still lags in most areas.  If you pay for many, providers may lose focus or get discouraged. And you can only pay for things that can be measured clearly, and for which there are enough cases to do analysis, and there is a reasonable chance of success.
 
And whom do you pay?  If you pay top management, the money may never trickle down to those whose behavior at the bedside has to change.  But if you pay aides and nurses, management may not cooperate in supporting extra care needed.  And when do you pay?  Monthly to keep providers aware of their potential to benefit, or infrequently so that successes and failures even out so you don’t have to take money back that you gave last month when things went well now that we’re in a month when declines are outnumbering improvements.
 
But these are just design problems.  There is still implementation.  Here is where things can really go wrong, plagued by such problems as:
             “Slippery slope:”  Caving in when providers demand that you pay for almost meeting success criteria; paying for processes of care that don’t guarantee better outcomes; paying for good outcomes that don’t really change patient well-being; paying for outcomes that are similar but not as difficult as the ones you wanted to pay for; paying for improved record keeping rather than real change in care practice; and paying windfalls to facilities that were already going to do it, while the ones you really want to improve are still not meeting outcome goals, not getting bonuses but not getting any better.
            “Distortion effect:”  What you pay for is what you get, but when you don't pay for what you used to get, you may not get it anymore until you add it to the pay list.  Care and attention get drawn away to things that earn bonuses.
            “Cream skimming:”  Facilities quickly figure out that they should admit only patients likely to improve, shun those not likely to improve, and load up on patients with conditions that are lucrative under your P4P system.
            Staff may also not know how to fix the problems you are eager to pay for.  Training may be inadequate even if knowledge is available.  And no one knows whether paying for certain outcomes will cease to be effective over time.  Providers may become inured. Finally, will filthy lucre drive out good will?  Will those who used to work harder out of a sense of mission and duty now cease to volunteer unless they are paid?
            These problems are not made up.  They come from experiences of those who’ve done the studies and those who’ve studied them.  But there are some positive lessons to take home.  Among them are: transparency is important – providers must know what’s being measured and where the baseline from which they’re expected to improve started; providers have to be involved in choosing outcome performance targets and agree that they are achievable; and P4P is more likely to succeed if it’s coupled with other reforms, like web-based quality ratings.
            In the paper we’re summarizing here[1] we did report one large and very successful randomized controlled trial of nursing home P4P which was done decades before any of the other less successful studies.  Alas it was conducted by the present author and colleagues at what is now called the US Agency for Healthcare Research and Quality.  It resulted in: (1) admission of more complex cases to the treatment group nursing homes (cases they normally shun); (2) longer life expectancy; (3) increased discharges; (4) reduced hospitalizations; and (4) and higher patient satisfaction.   So it can be done.  The problem is that it’s easy to go wrong, hard to get P4P right, it’s likely to have only small effect sizes, it’s expensive, and no one knows whether short term P4P improvements will last over the decades that we want nursing homes to deliver good quality.
            On the other hand, it’s an approach that can be broadly applied to many nursing homes, which most reforms can’t.  Those few celebrated nursing home success stories tend to focus on star performers, which is not helping the average Medicaid patient.  And Congress really likes P4P and is likely to demand broader application of it.  We’d be best served by trying to improve our design and implementation efforts rather than giving up on it even though, frankly, it’s not clear that the juice is worth the squeeze.
            Dr. Weissert is director of the FSU Public Health degree program, professor of political science at FSU, and professor emeritus of public health at the University of Michigan.
           

 
[1] Weissert, William G. and Lucy Faye Frederick. 2013. Pay for Performance: Can It Help Improve Nursing Home Quality?  Public Administration Review 73:S1, (S140–S151) October.
December 08
Nursing Home Culture Change: Legal Apprehensions and Opportunities

Nursing Home Culture Change:  Legal Apprehensions and Opportunities

Marshall B. Kapp, J.D., M.P.H
Director, Florida State University Center for Innovative Collaboration in Medicine and Law
 
            Despite significant improvements over the past quarter century, problems persist in nursing home quality of care and quality of life in nursing homes.  They persist despite an atmosphere of extensive regulation and litigation.  The Culture Change Movement is an attempt to improve quality of life by making nursing homes less institutional and more homelike.  The movement officially originated in 1997, has been spearheaded by the Pioneer Network, and is currently embodied in such projects as the Eden Alternative, Wellspring Program, Green House Project, and Advancing Excellence in America’s Nursing Homes campaign.
 
One example of a Culture Change initiative was the August 2011 publication of “New Dining Practice Standards” written by the Pioneer Network and the Food and Dining Clinical Standards Task Force, with its emphasis on individualized diets.  Building on that effort and broadening it, the Rothschild Person-Centered Care Planning Task Force published “A Process for Care Planning for Resident Choice” in February 2015.  
           
            An area of interest for me is the extent to which legal apprehensions held by nursing home providers serve as an impediment to changes in facility practices that could promote Culture Change.  Many providers are concerned that resident choices regarding their daily lives may be inconsistent with professional custom and/or recommendations, and therefore respecting those choices may expose the provider to adverse legal consequences in the event of bad health outcomes.  Providers also are concerned that current regulations, by focusing sharply on medical outcomes, may be inconsistent with a forceful enhancement of quality of life for residents.  Because health care providers on the whole generally have low to no tolerance when they perceive their own legal risks, it is important to study the extent (if any) that perceived defensive, risk management-oriented behavior drives out positive, resident autonomy-enhancing opportunities.   
 
            What might be done to ameliorate some of the provider anxiety about regulatory repercussions that effectively stand in the way of more vigorous commitment to Culture Change?  For one thing, we must emphasize the consistency between person-centered care and resident rights regulations.  Additionally, we should amend applicable regulations and subregulations (such as Guidances, Opinions, and Advisory Letters), for example, incorporating by reference New Dining Practice Standards into the Centers for Medicare/Medicaid Services (CMS) Long-Term Care Interpretive Guidelines for surveyors.  We need to closely examine proposed federal Medicare/Medicaid Conditions of Participation now under consideration for their compatibility or incompatibility with the Culture Change philosophy and practice.  We should endeavor to make the Medicare/Medicaid Survey & Certification process more transparent and consistent, less punitive (“Gotcha”), and more collaborative with good facilities honestly working to improve resident quality of life.  Providers need to engage in proactive communication and collaboration with resident advocacy groups and ombudsmen. 
 
            Valuable strides have been made in making nursing homes better places to live, but much more remains to be accomplished.  Research and education regarding the interplay of law and practice will be an essential part of this effort.
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