Our Downfall

Falls have long been known to be a major problem among older people. Even when they don’t cause chronic disability or death, a single fall can lead to paralyzing anxiety. The medical costs alone, for hospital care, rehab, and post-acute care, are enormous: one estimate is that they reached $50 billion in 2015. But despite significant advances in knowledge about fall prevention, new data indicate that the problem is getting worse. In fact, a short “research letter” in JAMA indicates that age-adjusted mortality from falls among people aged 75 and older roughly doubled between 2000 and 2016. 

The data are shocking. The age-adjusted mortality rate from falls for men over 75 went from 60.7/100,000 in 2000 to 116.4/100,000 in 2016. For women, the numbers are even more dramatic, with age-adjusted mortality for those over 75 going from 46.3/100,000 in 2000 to 105.9/100,000 in 2016. 

To understand just how bad things are, it helps to break down the statistics by both age and gender. The overall crude mortality rate for individuals over 75 (2016 data) was 122.2/100,000. For the youngest cohort, those ages 75 to 79, the age-adjusted rate is 42.1/100,000 (52.3 for men). For the 80 to 84-year-old set, the age-adjusted rate doubles to 88.9/100,000 (105.8 for men). For the oldest old, the numbers are extraordinary: going from 171.2/100,000 for those 85 to 89 to 362.5/100,000 for the 90 to 94-year-olds to 630.8/100,000 for those age 95 or older. And the corresponding age-adjusted rates for men are even worse, ranging from 205.2/100,000 to 762.8/100,000.

With statistics like these, you might think no one has a clue as to how to prevent falls. You would be mistaken. Entering “fall prevention in the elderly” as a search term in Google Scholar for the period 2000-2016 yields 18,000 hits. The articles have titles such as “randomized controlled trial of falls prevention” and “falls and their prevention in elderly people: what does the evidence show?” The American Geriatrics Society and the British Geriatrics Society issued a joint clinical practice guideline for the assessment of fall risk and preventive strategies in 2010. Two years later, the CDC decreed falls in older people a major public health problem issue and released a variety of evidence-based materials to help physicians, patients, and families address the problem. Calling their program STEADI (Stopping Elderly Accidents, Deaths, and Injuries), they offered, at no charge, a provider tool kit, a detailed algorithm and a handy pocket guide for clinicians, and a patient information sheet. 

Strategies to diminish falling in older people continue to proliferate. The American Hospital Association along with two other organizations came out with recommendations for addressing the problem in hospitals, where falls are also a major problem: between 700,000 and one million people fall in US hospitals each year and about one-third suffer injuries from their falls. As many as 11,000 people die as a result of the fall.  

The Centers for Medicare and Medicaid Services concluded that falls are preventable—and decided to penalize hospitals if a patient falls and either dies or sustains a serious injury as a result. Medicare considers such falls to be “never events” and will not reimburse hospitals for any additional costs associated with falls.

And yet, despite the research, the policies, and the programs, fall rates are rising, not falling. The burning question is, why?

Analyses of the obstacles—and successes—encountered when health systems tried to implement STEADI are revealing. When Oregon Health Sciences University introduced the program in their primary care clinics, they found the single most important factor conducive to adoption was the presence of clinical champions at each site. These clinicians spearheaded a team effort to develop a clinical workflow, customized for their site. They were also empowered to commission the development of electronic health record tools to document screening and assessment of falls. Other programs similarly reported that without strong endorsement by clinical leadership and the resources to implement and document fall-related activities, the initiatives were dead on arrival.

But if we examine the STEADI algorithm for fall risk screening, assessment, and intervention, we can identify other barriers. 

Falls often have multiple interacting causes and the most successful interventions tend to be correspondingly multidisciplinary. But medicine is much better at dealing with isolated problems than with messy, multifactorial ones: high blood pressure? Take a pill. Pneumonia? Use an antibiotic. 

Now look at the screening that the clinician is supposed to carry out. If a patient answers yes to any of a few key questions, the clinician is supposed to evaluate gait, strength and balance. That means performing a “timed up and go” test and possibly a 30-second chair stand or 4-stage balance test. How many internists or family physicians know what these tests are, let alone routinely perform them.

Then consider the kinds of interventions that STEADI suggests. For high risk patients, the recommendation is to refer to enhance mobility and improve balance, optimize vision, optimize home safety, and address foot problems. For all practical purposes, that means referring the patient to physical therapy, to ophthalmology, to occupational therapy, and to podiatry. Only rarely will a physician be equipped to do any of these things themselves. What’s left? Educate patients—another activity that physicians often delegate to others. Prescribe vitamin D and calcium—controversial these days. Manage and monitor hypotension and medications—the only activities that fall within the orbit of the typical internist or family physician.

What we see here is a profound educational deficit. What’s worse, few of these deficits are skills that physicians are likely to find interesting to acquire. I would argue that what most physicians are excited about is learning about prescribing new medications and using nifty new technology. As a whole—and of course there are exceptions—physicians are less enamored of low tech, low complexity interventions, especially when they deem them to lie outside the bounds of medicine. Advance care planning, which rests on communication skills, has similarly been an area that physicians have been reluctant to engage in. So, if the problem is largely cultural, then strong leadership and a supportive electronic health record, while necessary, are not going to suffice to fix it.

What is the way out? I think two strategies could make an enormous difference. First, nurse practitioners and physician assistants should educate themselves in fall risk screening, assessment and intervention and medical practices should gratefully turn to them for help. Second, patients and families need to clamor for falls assessment. In this era of consumer pressure, what the customer wants may be the key to change.

A Bone to Pick?

Increasingly, research studies published in major medical journals conclude the same way: with a plea for more studies. The writers say they have found evidence leading them to believe that drug X “may be helpful” or drug Y "did not produce a measurable difference in outcomes" and urge additional testing to confirm (or presumably refute) their results. So, it was interesting to note that a recent study of vitamin D and bone health concludes not only that the authors found no evidence that vitamin D is beneficial in preventing or treating falls, fractures, or osteoporosis, but that also that no further study is warranted. The writers confidently assert that this latest study, a meta-analysis that examines all the well-done studies to date, including 45 recent studies that were not included in previous meta-analyses, should be the last word on the subject. Unless you have rickets or osteomalacia, two relatively rare conditions, the authors conclude that you should not bother to take vitamin D supplements.

In the past, the response to negative studies of vitamin D has been a chorus of “but, but, but.” But what about the effect of the dose of vitamin D—maybe 400 International Units is not enough to do anything but 800 is. The current examination looked at this question and failed to detect any difference in outcomes between people taking high dose or lower dose vitamin D. But what about the importance of age—can vitamin D make a difference in the oldest old, people at the highest risk of fracture? The current examination didn’t find any evidence it does. But what about the thickness of the bones at the time that vitamin D is initiated—maybe it’s too late to matter if there has already been a great deal of bone loss, but can be helpful at an earlier stage. The authors of the new report don’t think so.

Two years ago, I addressed the issue of vitamin D in my blog post, “Make No Bones About It.” I concluded that the evidence supporting vitamin D supplements was weak, but because falls and fractures are so devastating for older people and the cost of vitamin D is so low, with almost non-existent side effects, it wouldn’t hurt to take it—and maybe, just maybe, it might help. What do I advocate today? What will I personally do? Well, I still have a large bottle of vitamin D (1000 IU capsules) in my medicine cabinet. I’ll finish the bottle. Then what? Unless someone comes up with a compelling reason to continue, I’ll probably stop. But I will make sure to drink lots of milk, eat cheese, and get plenty of sunshine to ensure that my non-medicinal intake of vitamin D is sufficient.

The Nurse Will See You Now

           

          Articles in medical journals tend to pay scant attention to the role of nurses in treating illness—or for that matter, to the role of social workers, physical therapists, and many other clinicians. Hence, when JAMA, one of the major American general medical journals, published an article in 2002 entitled, “Hospital Nurse Staffing and Patient Mortality, Nurse Burnout, and Job Dissatisfaction,” it was a bombshell. The lead author, Linda Aiken, is a nurse researcher at the University of Pennsylvania where she is a Professor of Sociology and the founding director of the Center for Health Outcomes and Policy Research. Looking at survey data from 10,000 nurses and administrative data on nearly 250,000 medical and surgical patients hospitalized in Pennsylvania in 1998-1999, she drew some dramatic conclusions: each additional patient per nurse was associated with a 7 percent increase in the likelihood of dying within 30 days of hospitalization, and each additional patient per nurse was associated with a 23 percent increase in the odds of “burnout” and a 15 percent increase in nursing job dissatisfaction. 

          Aiken's analysis, along with other smaller studies, have led to calls for an increase in the nurse to patient staffing ratios in hospitals. In light of general hospital administrative reluctance to make such increases, many nurses have demanded and some state legislatures have proposed mandatory increases in nurse to patient ratios. Massachusetts voters are being asked to vote this November on a referendum that would establish mandatory staffing ratios. To date, the only state to have instituted such a requirement is California—which passed legislation in 1999, before Aiken’s landmark study. California’s experience offers an unparalleled opportunity to ask whether mandatory ratios result in the desired improvements in quality of care and whether they produce a variety of unintended consequences. In principle, it could also shed light on whether nurse to patient ratios are particularly important for older people.

            California’s law specifies different nurse to patient ratios for intensive care units, surgical units, and medical units. Compliance was at first uneven, but gradually hospitals conformed to the requirements. Several studies have attempted to assess the outcomes. They are limited because California did not conduct a randomized, controlled experiment before passing its legislation—it did not impose mandatory minimum ratios on some hospitals and not on others. Moreover, nursing staff ratios are hardly the only factor affecting outcomes that changed in the early years of the mandate: many other federal quality improvement initiatives were undertaken to encourage hospitals to prevent pressure ulcers, falls, catheter-related infections and other major hazards of hospitalization. Hospitals have also experienced major financial pressures: the cost of hiring nurses was only one of many economic challenges. Determining cause and effect is not easy. Nearly twenty years later, what do we know?

            First and foremost, did the mandatory ratios result in improved quality of care? One of the most carefully performed studies was undertaken by the California Health Care Foundation, part of UCSF, in 2009. This report looked at pressure ulcers, pneumonia deaths, and deaths from sepsis (blood-borne infection) and were unable to find any statistically significant change after the law was implemented in 2004 (following a multi-year study period to design the regulations). Another study that focused exclusively on pressure ulcers and falls used data from CalNOC, a large nursing database for the entire state, to conclude there was no change in fall rates. They did note a paradoxical increase in pressure ulcers in patients admitted to “step-down” units, units between an ICU and a general medical or surgical floor in the acuity of their patients, after the requirement of more nurses per patient was introduced (presumably a reflection of sicker patients). A systematic review of the literature, published in the Annals of Internal Medicine in 2013, failed to find any statistically significant effect on a variety of safety measures. Of note, none of the studies I identified looked at either patient or nursing satisfaction.

            If mandatory nurse to patient ratios did result in more face-time with patients but no demonstrable improvement in overall quality of care, might older patients nonetheless be one subgroup that did benefit?  All we can say is that many of the quality measures that were examined—pressure ulcers and falls, for example—are particularly relevant to older people. 

            What about the feared adverse consequences of imposing rigid nursing staff ratios? An analysis in Health Affairs in 2011 found no evidence that hospitals were substituting less well-qualified staff (who still meet the legal requirements) such as LPNs for registered nurses. The California Health Care Foundation did conclude that hospitals were increasingly relying on “travel nurses,” (nurses from out of state or from other countries, hired for short periods of time) and on “float nurses” to move from floor to floor to compensate for lunch breaks by the regular staff. Such changes may result in less continuity of nursing care for patients. They also showed that hospitals across the state experienced shrinking operating margins beginning in 2002, especially in the hospitals that were initially fiscally strongest. However, they emphasize that many other factors could account for this phenomenon. Hospitals of all types did comply with the law, resulting in more hours of nursing care for each patient every day:

          On balance, regulating nurse to patient staff ratios in isolation is not likely to make much of a difference in patient outcomes, nor is it likely to devastate hospitals' finances. Hospitals are complex institutions with many interrelated parts. Just because hospitals with low nurse to patient staffing ratios tend to have poorer outcomes than other hospitals does not mean that if we "fix" the ratio, care will necessarily improve. Assuring that there are enough nurses to provide good care is essential, but that step alone is unlikely to dramatically improve the hospital experience.

             

            

  

Falling Down on the Job

In the sixties, physicians routinely prescribed bed rest for patients who had suffered a heart attack. Then along came the recognition that bed rest led to clot formation in the lower extremities, clots that sometimes broke off and traveled to the lungs, causing potentially life-threatening pulmonary emboli. Bed rest also led to deconditioning—when patients finally were allowed to get up, they found they were often weak and wobbly. And so bed rest was out and early mobilization was in. But now, concurrent with a vigorous attempt to prevent falls among older hospitalized patients, bed rest is back in—and with more complications than ever, as reported in a thoughtful article in JAMA Internal Medicine last week.

In 2008, in response to the observation that “injurious falls” were responsible for increased hospital costs and were clearly bad for patients, the Centers for Medicare and Medicaid Services introduced a program incentivizing hospitals to prevent falls. Currently, a fall resulting in significant injury (such as a fracture) is one of eight hospital-acquired conditions that collectively determine whether hospitals will be penalized for poor performance. To address the CMS initiative, hospitals introduced a variety of techniques designed to keep older patients from falling such as bed alarms and “fall risk” signs on the door. According to Growdon and colleagues, the result has been a “national epidemic of immobility among hospitalized older adults.”

Paradoxically, the means used by hospitals to prevent falls don’t work. Bed (and chair) alarms are ineffective—which is not entirely surprising, as by the time a nurse responds to the buzzer indicating the patient has gotten out of bed (or chair), the person is probably already on the floor. Even a multi-prong study from Australia using a variety of different approaches simultaneously was unsuccessful.

But all those bed alarms and signs on the door do achieve something, and that’s to keep patients at bed rest. And just as bed rest was bad for heart attack patients in the sixties, it’s bad for older patients today. Bed rest promotes the development of confusion (delirium) and worsens mobility, so when patients finally do get out of bed, either late in their hospital stay or after they get home, they are more likely to fall.

Growdon, a resident in internal medicine at a major Boston teaching hospital, and his colleagues at a VA Hospital in Florida and at Hebrew Senior Life, a teaching nursing home, are rightfully indignant. They advocate promoting mobility rather than penalizing falls, arguing that “although hospital falls can lead to harm, treating them as ‘never events’ has led to over implementation of measures with little efficacy for falls [prevention] yet profound contribution to immobility.” They are, no doubt, correct. But why? Why should an incentive program based on outcomes lead to the adoption of a strategy that does not lead to the desired outcome?

If CMS had used a process measure, if it had offered extra payments to hospitals that introduced fall prevention programs, I wouldn't have been surprised that it resulted in hospitals adopting programs for the sake of having something, regardless of efficacy. But instead it opted to penalize hospitals for performing poorly, which should by rights have led to hospitals choosing to take steps that made a difference. What is it about the culture of hospitals or the leadership of hospital CEOs or the knowledge base of physicians and nurses that lets them make such irrational choices?

I wish I knew the answer. In the meantime, perhaps CMS would do well to offer carrots rather than sticks, and to be specific about the kind of carrots that it likes the most. If programs that promote mobility work, directives to get patients out of bed early and to consult physical therapy—both to prevent falls and to maintain function—then it’s those specific programs it should endorse and pay for.

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