DRAFT VERSION - 11/7/2010
Introduction Our
approach to long-term replacement of the human kidney, so promising
and patient-centered forty years ago, has evolved into a highly
dysfunctional system. Some of the problems and long-term mistakes
of dialysis care are now well-known and have begun to be addressed.
Some have been rationalized, ignored, or denied. Others are just
beginning to become understood, acknowledged, and defined. |
|
Evident Problems and Mistakes
Survival
Despite improvements in technology and medications, the US has seen only a disappointing 2% decrease in the dialysis patient mortality rate over the last 26 years. Few other medical specialties can claim so little progress. It is presently a matter of debate whether this is due to the patients’ increasing age and comorbidities, or whether it is a failure of medicine, government policy, or financial factors.
Rehabilitation
A far greater percentage of working-age dialysis patients were
employed in the 1970s. Debilitation and disability are now considered
normal and acceptable outcomes. Unbelievably, patient employment and renal
rehabilitation are NOT treatment goals of the two largest corporations
that now treat the majority of the approximately dialysis 350,000 patients.
Not surprisingly, depression is a widespread problem among dialysis patients.
In terms of its original intent, this widespread acceptance and even fostering
of patient disability has been one of the greatest failures of the Medicare
dialysis program. Too many lives and livelihoods have been — and
are being — needlessly lost. This is a human tragedy and a failure
of purpose for this branch of medicine, as well as an economic disaster
for families, local governments, and society.
Professional
hypocrisy
Current professional and business models for dialysis care do not reflect
the personal choices that informed and knowledgeable insiders would make.
When asked what they would choose to stay active and employed, virtually
all professionals say they would choose evening or night treatments and
often insist on double or more dialysis therapy than their typical patient
receives.
There is a growing hypocrisy among dialysis care professionals in that
virtually none of them would accept the standard, thrice-weekly, day-time,
in-center hemodialysis treatments that over 90% of their patients receive.
Few of them fully disclose the mortality information and professional
opinions they would use to make that choice for themselves. Until most
nephrologists insist on providing their patients the kind of therapy that
they would choose for themselves, it is evident that today's system of
care is not patient-centered.
Kt/V (or its
derivative URR) and 3-times-a-week hemodialysis
Using this value as a measure of dialysis adequacy was the biggest
medical mistake of the last thirty years. While Kt/V and urea kinetics
were based on complex mathematics and seemed to represent sophisticated
medicine, they ignored the many benefits of longer and more frequent treatments.
Only within the last two years have leading nephrologists begun to agree
that the original premises on which both the concept and the mathematics
are based are incorrect.
Despite the technological advances, hemodialysis is essentially the same as it was forty years ago. The process is primarily defined by the limitations of diffusion and osmosis within the human body and not by the properties of the artificial kidney or dialysis machines. If the process is rushed with high blood flow rates and treatments times under four hours, patients suffer from insufficient removal of middle molecules, cardiac stunning, and prolonged treatment recovery times.
Kt/V-based treatments
goals are based on two outcomes: death and hospitalization for those patients
receiving thrice-weekly hemodialysis treatments. Treatment based on this
modality unnecessarily increases the medical complications the patients
must bear. It ignores blood volume control issues, the leading cause of
death today for dialysis patients. It has resulted in most patients being
underdialyzed, feeling chronically poisoned or drugged, and unable to
continue many of their normal life activities, especially employment.
As most nephrologists will acknowledge, when patients receive longer and
more frequent hemodialysis treatments, many of their complications - and
their need for medications - significantly decrease. Ironically, much
of the nephrology's expertise in dialysis care has been focused on prescribing
medications for the complications caused too little dialysis — usually
prescribed by computerized Kt/V programs. Unfortunately for patients,
Kt/V remains the standard of care for policymakers and the large dialysis
provider corporations.
After receiving anonymous reports that lab results were being repeated and “gamed” to achieve the desired results, RenalWEB stopped reporting on the URR values on CMS’s Dialysis Facility Compare web site. This measure, derived from Kt/V, is typically only done on one of the thirteen hemodialysis treatments per month. Its validity as a marker of quality dialysis treatments is highly questionable.
Kt/V was supposed
to provide optimal, individualized, hemodialysis treatment prescriptions.
Instead, it brought a single-approach-fits-all standard to prescribing
dialysis care. Instead of a whole-patient approach, many nephrologists
relied almost completely on Kt/V and biochemical markers as a measure
of patient well-being. Some nephrologists even stopped routinely seeing
their dialysis patients, requiring a change in Medicare reimbursement
policies in 2004. Instead of an individualized approach, Kt/V created
a “fix the numbers” mentality in patient care that still drives
unknowing patients to suboptimal care and life outcomes.
Standard Kt/V-based care provides a suboptimal quality of life. This was
especially evident at the recent NxStage Users Conference in Las Vegas
in October 2010. Patients on the NxStage system routinely receive far
more therapy than the standard Kt/V or URR dose provided by standard,
in-center care. This quote is from one of the attendees, Dr. Alan Hull,
and it illustrates the point perfectly:
"A room full of people, 40 of which were patients & not being able to pick out the patients from helpers is something I have been seeking my whole nephrology life."
Medical
problems identified at the 2009 Boston ESRD conference
In April 2009, a twenty-year follow-up meeting to the 1989 Dallas
conference on reducing dialysis patient mortality was held in Boston.
At this meeting (see course
agenda), the course directors bluntly emphasized how little progress
had been made in twenty years.
The conference (RenalWEB's coverage)
finally did identify many problems with the Kt/V concept. These included
its inappropriateness for smaller patients, that increasing "t"
(time) but not Kt/V improves outcomes, and that the traditional renal
diet associated with the Kt/V leaves many patients chronically undernourished.
The conference also identified the need for euvolemia, decreased catheter
use and lowering infection rates, addressing the high morbidity in the
first 90 days of dialysis, preventing sodium overload, increasing rehabilitation,
increasing immunization rates, and decreasing inflammation, and addressing
sleep apnea.
In June 2009, the conference's steering committee sent an open
letter that outlined their recommendations to Dr. Barry Straube, the
Chief Medical Officer of the Centers for Medicare & Medicaid Services
(CMS) and to Nancy-Ann DeParle, Counselor to the President (on healthcare
reform). It should be noted that Ms. DeParle was once sat on the board
of DaVita, a leading dialysis provider in the U.S., and she received significant
compensation from them.
Dr. Straube responded
in August. At best, it offers a long and complicated path to change.
To date, a few changes at CMS have resulted from the Boston conference.
CMS has begun monitoring accessess and access infections, starting in
July 2010. Partially in response to the Boston conference, in March 2010
CMS held Technical Expert Panel meetings on six measures:
- Anemia Management (Target value for Serum Ferritin, Target value for Transferrin Saturation)
- Mineral Metabolism (Target value for Calcium, Target value for Phosphorus)
- Vascular Access Infection Rate (Catheter Infection Rate)
- Pediatric Adequacy (Hemodialysis [HD], Peritoneal Dialysis [PD])
- Pediatric Anemia (Anemia Management)
- Fluid Weight Management
The course directors state that they have had serious discussions with the large dialysis providers about engaging in a collaborative study to assess extracellular volume monitoring, rather than continuing to use subjective techniques of "dry weight." The American Society of Nephrology has invited the participants of the Boston conference to present at the 2010 meeting, at which Dr. Straube will participate. The conference chairs continue to publish and provide presentations of their findings in numerous formats.
Not-So-Evident
Problems and Mistakes
These problems, mistakes, and issues are not routinely
discussed at today's medical conferences, nor are they routinely addressed
in medical journal articles on dialysis care. However, their impact on
patient outcomes and patients' lives is undeniable.
Financial
Counterproductive
financial incentives
The U.S. government now pays the majority of the $40 billion
spent yearly on stage 5 chronic kidney disease (CKD5). The U.S. dialysis
business is dominated by two for-profit corporations, Fresenius Medical
Care and DaVita. Being publicly traded companies, their corporate officers
must focus on maximizing profits from existing reimbursement policies
while delivering an acceptable standard of patient care. Reimbursement
policies set by Medicare and Congress drive nearly all of the patient
care policies of these companies. Unfortunately, several of these reimbursement
policies and practices now work against providing patient-centered care
and against prolonging patients’ lives.
For more than 25 years, the Medicare composite rate – essentially a flat fee for providing a dialysis treatment – has been stagnant. It has forced dialysis providers to lower their dialysis treatment costs and reduce patient services. This led to shortened treatment times, increased patient-to-staff ratios, and widespread consolidation of dialysis providers. It has also decimated the professional staff in dialysis centers, with large reductions in professional nursing staff, psychological services, social workers, and dieticians. In terms of renal rehabilitation and patient employment, virtually no professional expertise remains in the entire industry. Instead of assisting patients to stay employed, many providers routinely encourage patients to apply for disability status.
When Congress and Medicare officials created the composite rate system, they did not create financial incentives that would also maintain patient employment rates, increase rehabilitation, and improve health-related quality-of-life. MedPAC, the Medicare Payment Advisory Commission that recommended composite payment rates, never considered patient life outcomes in its payment recommendations. Today, most dialysis centers that provide standard, in-center treatments have essentially become factories that produce debilitated, disabled, and depressed patients. Unfortunately for patients, the new PPS or “bundle,” which replaces the composite rate system, only continues these perverse financial disincentives.
Another significant reimbursement policy, the Medicare Secondary Payer (MSP) time period, has evolved over many years in terms of its intent, purpose, and effects. What started as a small cost-saving measure for Medicare has now become the economic backbone of the dialysis industry. Almost unnoticed, it also now has the unintended effect of discouraging corporate investments in extending patient lifespans beyond 30 months on dialysis. (What follows is a simplified, but conceptually correct, explanation of MSP policy and policy changes.)
The MSP period was first intended to lower Medicare spending on dialysis treatments. It began by having the patients’ private insurance pay for the first 12 months of dialysis treatments. Then in one evolutionary change, dialysis corporations began charging the private insurance companies fees that far exceeded – sometimes now by enormous amounts – the standard Medicare reimbursement. In another change, the MSP time period has been gradually extended from 12 months to thirty months. In yet another change, its financial purpose evolved into subsidizing the stagnant Medicare composite rate. Today, the MSP period has become the economic foundation of all dialysis centers and the primary source of profits of the two large corporations. Almost every dialysis center requires a few MSP-period patients to stay solvent and subsidize their Medicare patients. Obviously, all dialysis providers want more MSP-period, “private-pay” patients.
In an unintended evolutionary change, the MSP period now functions to discourage corporate investment in the development of products and services that would extend patients’ lives beyond the MSP time period. When MSP-period patients reach 31 months on dialysis, they become Medicare patients and are no longer the source of significant profits, if any at all. From the viewpoint of corporate shareholders and business managers, the perfect patient is one that has private insurance and then is transplanted, dies, or is discharged from their facility 31 months after starting dialysis.
Interestingly, the dialysis industry recently announced a voluntary program (PEAK) that is focused on improving the mortality rate for some patients during their first year on dialysis. There has been no announcement of a similar concerted effort to try to improve the survival rate of longer-term patients. While the 2009 Boston ESRD conference did focus on the lack of improvement in long-term patient survival, its two course directors were two nephrologists outside the two major corporations.
A final financial disincentive for better care is the separation between Medicare Part A and Part B, which does not exist in commercial insurance. It makes it impossible for savings in Part A (inpatient) to offset the higher costs in Part B (outpatient) that are often necessary to achieve improved outcomes and overall savings in the care of dialysis patients. In the future, both the the medical home concept and the accountable care organizations have the potential to address this problem.
Professional
conflicts of interest
The influence of money can no longer be understated in the dialysis
business. It has changed the way patients are seen by many, as they have
become commodities rather than individuals requiring excellent medical
care. When physician-owned clinics are acquired by large for-profit corporations,
the sales are usually based on a "per head” amount. Many of
these nephrologists reap fortunes based on the amount of profit the corporation
believes it will make from treating people with kidney failure.
Medicare and Congress always have and still do expect nephrologists to look out for the best interests of the patients. Some nephrologists continue to function in that role. Unfortunately, CMS and Congress did not foresee the consolidation and expansion of corporate power and that many nephrologists would align their financial interests with these corporations. Nephrologists now receive tens of millions of dollars each year from the large for-profit provider corporations both as employees and in various forms of grants. In terms of negative effects on patients’ lives, this professional conflict of interest has become a major policy mistake.
It can be easily argued that large for-profit corporations have a powerful influence — far greater than most nephrologists — on dialysis patient care. This was especially apparent with the prescribing of anemia drugs before the FDA “black box” warnings in 2007. These drugs had become a major source of profit for the largest corporations. USRDS data has shown that ESA use at DaVita clinics significantly exceeded industry norms. Corporate officers there fended off accusations of excessive use of ESAs by insisting that their physicians had signed the orders and acted in the patients’ best interests. In a striking contrast, USRDS data for that same period showed that DCI nephrologists gave the lowest doses of ESAs, which is striking because DCI is also the only non-profit corporation among the large and medium-sized dialysis provider corporations. DCI also consistently has the best hospitalization and survival rates according to USRDS data.
The monopoly that Amgen has enjoyed in CKD5 care for over twenty years has provided it with tens of billions of dollars in pure profit. For many of those years, many felt that Amgen and some nephrologists ignored the potential dangers of overuse of this medication in the pursuit of profits. Far too many nephrologists also accepted speaking fees and “unrestricted” grant money from Amgen, and far too few were willing to speak out against these practices. Ultimately, this corporate and physician behavior made the ESA “bundle” necessary.
It is now undeniable that dialysis care in the U.S. is a big business. The reality is that the large, for-profit corporations must answer first to shareholders. Thousands of nephrologists now derive a significant portion of their income from these corporations, are their contracted employees, and must also serve these shareholders. Many nephrologists also have a financial interest in utilizing the existing dialysis stations in their facilities, yet most of these nephrologists would not accept the care for themselves that they provide the vast majority of their patients. Even more potential professional conflicts of interest arise when a large dialysis provider also manufactures several of the medications used by its patients .
With large corporations now dominating dialysis care as well as having significant influences over nephrologists, Congress and CMS can no longer rely on most nephrologists to act solely in patients’ best interests. Until new financial incentives are created, policymakers should expect many nephrologists to continue to target suboptimal, and even minimal levels, of overall health and well-being for these vulnerable patients.
Not-So-Evident Problems and Mistakes: Psychosocial
The unpleasant realities of being a dialysis patient in the US
When patients reach CKD5, many find their normal life “falls apart” as they must deal with the many burdens of their illness on a continuous basis. Few human life experiences bring such dramatic health, psychological, and lifestyle changes. Replacing the human kidney requires patients to accept and endure the greatest treatment burden of any chronic disease. Psychosocial services, once considered essential components of successful long-term dialysis care, have been nearly eliminated today. Instead of making patients’ lives easier in living with CKD5, most dialysis centers do not provide the resources that patients need and require to continue living a normal life.
An awful standard of care has evolved over the last thirty years. Today, patients are routinely expected to give up their normal lives when they start dialysis treatments. Social workers routinely encourage their patients to seek disability status when they begin dialysis treatments. Patient employment and renal rehabilitation are no longer valued. While not a direct correlation, Medicare does pay for cardiac and pulmonary rehabilitation, but there are no similar programs for renal rehabilitation. Renal social workers now have unbelievable caseloads of 150 patients or more and spend most of their time on transportation and insurance matters.
For the most part, the patients are expected to shape their lives around the dialysis clinic hours and medical appointments. Most dialysis units do not have shifts starting after 5 pm. Once connected to a dialysis machine in a busy, noisy, and sometimes hostile hemodialysis center, most patients struggle to get their basic needs met. Most patients want to avoid more time in this environment. They often leave the facility feeling washed out and exhausted, making work impossible and normal roles in family life difficult. The amount of dialysis therapy they receive is often minimal, leaving most patients feeling as if they are being constantly poisoned or drugged. The medical and financial models that have evolved today are designed to work best when people with renal failure become professional revenue streams – instead of people trying to lead normal lives.
Most dialysis corporations and their employees create a powerful ‘nocebo’ effect on their patients. Unlike the placebo effect, which produces positive outcomes based on beliefs, the nocebo effect produces negative outcomes. Few dialysis facility employees have had experiences with long-term patients who are successful and empowered. These employees see a system that infantilizes patients and only provides short-time hemodialysis treatments during workday hours as completely normal. By failing to develop any expertise in patient employment or rehabilitation in the CKD5 industry, nearly every contact with a healthcare professional imparts a nocebo effect on patients.
Nearly everyone involved in providing ESRD care is invested – professionally, psychologically, and financially – in the “sick” ESRD patient care model. Two generations of medical professionals have trained and educated who see hemodialysis patients as sick and debilitated. Most professional dialysis care givers have never been involved in the care of thriving, well-dialyzed, hemodialysis patients. All their skills and experiences are based on taking care of minimally-dialyzed patients. Many of the usual medicine and nursing interventions are for symptoms or conditions that only exist when patients are under-dialyzed.
Another example shows how pervasive this effect is. Two new models of CKD5 care appeared in print within the last two years, one in Nephrology News and Issues and the other in Nephrology Nursing Journal. Both were written by groups of leading experts in comprehensive CKD5 care. Neither article mentioned the words ‘employment’ or ‘rehabilitation’ a single time.
It is widely underappreciated that dialysis provider corporations have nearly unlimited power and influence to control and intimidate patients, intentionally or not. Patients must rearrange their lives around dialysis clinic hours and clinic appointments. Few patients have the energy to participate in the change process. Those that demand additional care to support heir employment status or a normal quality of life can be labeled as problem patients. They can be threatened, using documented "behavior" problems, with dismissal or banning from the dialysis facility nearest to their homes
Those patients that
still want to participate in the change process are often buried in excessive
information with little help to sort through fifty years of nephrology
history, medical studies, and federal legislation. When these frustrated
patients are allowed to speak openly in formats such as patient-only support
groups, these meeting often quickly become emotional complaint sessions,
as patients vent long-suppressed anger and frustrations with the quality
of their care.
Patient organizations
rarely, if ever, speak out against the practices at the large dialysis
provider organizations. Most depend on these companies for their financial
existence. Most of the prominent so-called patient-led organizations are
controlled by non-patients, many with connections to Kent Thiry, the CEO
of DaVita.
Patient voices are now several developmental stages behind professional organizations and corporations in terms of being effectively heard in Washington. Corporations have been using the enormous profits they make in dialysis care to “educate” lawmakers and physicians about dialysis financial matters and the best clinical practices for patients. Over the last decade, they have spent millions of dollars for lobbying Congress so as to control policy formation. While this has resulted in billions of profits, as well as eight-digit yearly incomes for a few top executives, it has brought neither optimal health, nor rehabilitation, nor empowerment for the vast majority of dialysis patients.
Lack of data
from patients’ perspectives
In every business, gathering voice-of-the-customer data has become integral
to developing new products and services to best serve the customer. Why
has this not happened in dialysis care?
While there are decades of biochemical markers and treatment parameters in databases, there have been no mechanisms in place to collect and report feedback from patients as to what they find most important about their own care. Neither CMS nor the dialysis providers have records of patients’ experiences to aid them in understanding or quantifying the many factors that help patients survive and thrive on dialysis.
Forty years after the start of routine, long-term dialysis care we still do not have a vocabulary, definitions, or language to quantify the patients’ experiences. The terms illness burden, treatment burden, disease burden, and even patient-centered care remain undefined from the collective patient perspective. If evidence-based medicine is going to perform retrospective studies on the effects of psychosocial factors on patient survival and care, they will find little data with which to work. There have been no studies focused on determining the amount of dialysis therapy that is needed to feel well enough to stay employed. Without this information on patients’ psychosocial needs and illness burdens, the current model of dialysis care has little chance of improving.
Patient voices are
not being heard through the corporations. Despite the caring and benevolent
tones set in their annual corporate reports, the large dialysis provider
corporations do not seek out honest patient opinions and feedback. Instead,
these corporations continue to insist to shareholders that Kt/V and URR
are effective measures of dialysis adequacy and quality care.
Nor are mature patient voices and opinions being developed by CMS. At
the CMS Town Hall Meeting in October 2009, no in-center patients who spoke,
even though they constitute over 90% of the patients. In Sept. 2010, CMS
held an Open Door Forum conference call to educate patients on the proposed
Quality Improvement Program (QIP) and the comment period. Unfortunately,
even though it was sixty-day comment period, CMS held this meeting on
Sept. 21, three days before the comment period ended on Sept. 24th. Only
250 persons listened to the call. Per usual, patients were told of a large
amount of information they had to digest before commenting. CMS staff
members also reiterated the fact that the QIP program would only be based
on existing data they currently had.
Missing and
undefined concepts: illness burden and treatment burden
In the last year, I was able to ask two of the most respected leaders
of the dialysis field, the CEO of the largest dialysis provider and the
top nephrologist/scientist, which dialysis therapy they would choose for
themselves if they faced renal failure. Both answered essentially the
same. Analyzing their selection offers insights not only into what is
likely the best possible care, but also what has gone wrong conceptually
for the vast majority of patients.
Both these gentlemen would continue to work. To do so, both would choose every-other-day, nocturnal, 8-hour, in-center, hemodialysis treatments. This is more than double the amount of dialysis than most patients receive. It is also a therapy that is not offered anywhere in the U.S. at this time (every other night, in-center, no 2-day weekend). It is also interesting to note that this modality would likely not be profitable under Medicare reimbursement and is only possible due to MSP-period reimbursement.
What is especially
conceptually interesting and revealing is that they both would choose
to minimize their illness burden and treatment burden of their kidney
disease. By getting more than double the amount of standard therapy, they
would likely minimize their illness burden, greatly reducing or eliminating
many of the complications that most patients experience. The every-other-day
treatments, with no 2-day weekend, also would greatly reduce their cardiovascular
disease risk.
They would reduce their treatment burden by choosing nocturnal treatments,
as it would combine dialysis treatments with restorative sleep. This dialysis
modality would minimally interfere with normal lives, and most importantly,
leave their days free for work. By choosing in-center treatments, they
would also minimize the treatment burden on themselves, their families,
and their homes.
If they themselves had to go on dialysis, despite the lack of definitive studies, most nephrology professionals would use their professional knowledge to minimize both their illness burden and treatment burden. They would make it a priority to continue their normal life activities. Sadly, few top nephrologists are willing to go on the record as to what treatment modality they would choose for themselves or a family member. Many will state - off the record – that they would find standard, in-center hemodialysis treatments, which over 90% of their patients receive, simply unbearable. Even though patients are educated to some degree about their choice of treatment modalities, they are not informed of the illness and treatment burdens of standard, daytime, in-center treatments. Again, unfortunately for patients, this is a moral failure that even a child can recognize.
Another concept not yet recognized is that decreasing the patient's illness burden with more dialysis therapy can also increase the patient's treatment burden. From a psychosocial point of view, requiring patients to sit in chairs for longer periods of time likely makes dialysis treatments increasingly toxic. Treatment burden is a complex individual issue, involving dozens of factors including life disruptions, inconvenience, and impact on family life. Unfortunately, this issue is not widely recognized by mainstream nephrology at this time and even patient advocates disagree on its definitions. However, common sense suggests that many studies on longer and more frequent dialysis treatments are significantly flawed because they did not consider the psychosocial burdens of each treatment approach.
Without studies that include the impact of psychosocial issues and treatment burden, the best sources of information today are those relatively few patients have experienced both in-center dialysis care and self-managed dialysis care. They know how they feel and how life is experienced both with too little dialysis — often based on a standard Kt/V of 1.2 — and with double this amount of dialysis treatment time. CMS and the corporations must work with these patients to identify and quantify the concepts of illness and treatment burden, especially with the problems that arise from too little dialysis and from the intrusiveness of medical care.
A model of
care has evolved that downplays and ignores the psychosocial needs of
dialysis patients
Since the introduction
of Kt/V and the composite rate, the patients' illness burden — and
the mortality rate — has not significantly decreased. Meanwhile,
the treatment burdens that most patients must bear have significantly
increased. Unfortunately, the cumulative effects of these additional treatment
burdens on patient survival remain essentially unacknowledged and unstudied
by nephrologists. Typically, when nephrologists seek to improve patient
care or the mortality rate, almost all continue to focus on biochemical
markers and medical causes.
Instead of continuing to allow the medical problems defined by the nephrologists to dominate all other concerns in dialysis care, a new model of care is required that elevates the importance of the patients’ psychosocial needs, as well as their insights as to what constitutes good and/or bad care. Caregivers must also realize that if patients’ psychosocial needs are not being addressed or met first, they are far less likely to thrive on dialysis, let alone comply with medical treatment and pursue excellence in their medical care.
While the connection
between depression and survival has been medically established in chronic
dialysis care, it is mostly ignored in today’s care models. Nephrologists
simply do not consider or try to address the often whelming psychological
and lifestyle burdens that patients routinely face. In reality, with little
psychosocial expertise remaining in the industry, there are few professional
tools to quantify it or address these problems. Additionally, nephrologists
receive no renal rehabilitation instruction during their training.
Perhaps it is time to consider that rehabilitation and psychosocial needs
are as important as medical needs for long-time survival with this chronic
disease. Despite the current professional posture, most nephrologists
will acknowledge – off the record - that the mind/body connection
is very important for their patients. I have found prominent nephrologists
willing to agree with these statements:
• A patient’s ‘will to live’ or ‘reason to live’ greatly impacts their continued survival.
• If the patient’s spirit or soul dies, the body will soon follow.
In long-term dialysis
care, it appears essential for patients to maintain connections to a purpose
and the meaningful experiences in their lives. While currently not acknowledged,
maintaining these connections appears to be a necessary component for
successful, long-term dialysis care. Long-term medical care cannot be
a goal in itself.
Recognizing this reality justifies establishing patient employment and
renal rehabilitation as essential goals in this area of medicine. It
is time to rebuild the decimated psychosocial services of today's dialysis
care system. Going forward, in addition to reducing the caseloads of social
workers, there should be far more peer-to-peer support services. More
educated patient mentors and ombudsmen will be required, not only to help
reduce the psychological burdens and provide support, but also to build
and maintain these essential connections in patients’ lives.
No definition
of ‘patient-centered care’
It is time to recognize that the model of care that has evolved over the
last forty years is no longer patient-centered. Scientific terms and language
to describe the patient experiences has not been developed and refined.
In today's system, people with renal failure are valued more as professional
patients (i.e. revenue streams) by most providers than as employed, tax-paying
citizens. In recent decades, dialysis professionals and corporations have
focused almost solely on improving biochemical markers, rather than life
outcomes such as employment, rehabilitation, and health-related quality
of life.
The best definition of patient-centered care may come from the previously mentioned CEO and nephrologist/ scientist. Analyzing their choice of dialysis modalities, it appears that excellence in dialysis care from the patient's perspective should be an unobtrusive as possible and leave each patient feeling well enough to live as much of their normal lives as possible for as long as possible. This means finding the balance that minimizes both the illness burden and the treatment burden for each patient. This could be a new, simple, and individualized definition of excellent dialysis care that far exceeds the capabilities of Kt/V.
Patient empowerment
Some patients thrive on long-term dialysis. Mostly on their own, these
patients have become self-educated, discovered what works best for them,
and now manage their own care. Instead of accepting standard, in-center
hemodialysis treatments, most have found ways of getting much more dialysis
therapy without further disrupting their normal lives. Most of these remarkable
people have been able to minimize both their illness and treatment burdens.
Many have not been hospitalized in years. They are active and many remain
employed and are tax-paying citizens — as was envisioned some forty
years ago when the federal dialysis program began.
What these patients
share is that have become empowered. They know that their understanding
of their condition and problems are superior to anyone else’s. They
have become experts of their own personal care. While they still need
physicians to oversee their overall medical care, they take control of
as much of their dialysis care as they can. They do not accept in-center
care that infantilizes them nor frustrates them in their quest for better
care and a better life. Some of them have been labeled “disruptive”
because they demand more staff time, individual education, and a higher
level of care.
Thirty-five
years after dialysis treatments became widely available, we should have
a medical and professional culture that provides superior medical care,
as well as educates, supports, and empowers patients. Instead we provide
medical care that increases both their illness and treatment burden, as
well as reduces them to being professional patients who are debilitated,
disabled, and depressed. We have created a system that has no memory of
what makes patients successful and empowered.
Not-So-Evident Problems and Mistakes: Medical
Medical technology
is not enough
Since Descartes, most medical expertise has focused on separating the
mind from the body and then dividing humans into further parts. At the
ESRD conference in April 2009 in Boston, it was shown that only 14% of
current morbidity and mortality can be accounted for by assessing the
CMS-mandated clinical performance markers that most dialysis facilities
report (albumin, Ca, P, Kt/V, PTH, cholesterol, etc.). There is obviously
so much more to consider.
Physicians are considered the experts in CKD5 patient care, yet they receive little training in meeting psychosocial needs in CKD5 care, nor do they receive any training in renal rehabilitation. Put bluntly, because they have little expertise in psychosocial aspects of CKD5, they routinely consider it outside the scope of their practices. This was never more evident than at the 2009 Boston ESRD conference. While these well-intentioned physicians at the Boston conference did effectively discredit the use of Kt/V and URR as sole measures of dialysis adequacy, they continued nephrology's mistake of discounting the effects of psychosocial concerns and treatment burdens on mortality. Not a single presentation at this four-day conference centered on the psychosocial needs of the patients, despite the widespread use of the surveys like the KDQOL- SF and KDQOL-36. Only one presentation mentioned depression beyond a single sentence or two.
Despite many recommendations from the 2009 Boston conference for improving patient medical outcomes, patient groups have not embraced the conference’s actions with any sense of urgency or enthusiasm. Yet, patients seem to instinctively know that medical care by itself is not enough. This strange disconnect has been almost unnoticed.
Nephrologists and
scientists must stop their "fix the numbers" approach and thinking
that a single medical measure (Kt/V, URR, hemodialysis product) can represent
good dialysis care. It must be a multi-dimensional approach. Nephrologists
must accept that the pursuit of excellence in dialysis care is almost
futile without aligning the provision of medical care with each patient’s
individual life interests.
Many empowered patients have spoken of the importance of having a strong
personal relationship with their physician. Optimal dialysis care should
be largely driven by relationships that provide full disclosure of scientific
facts and the professionals’ personal opinions to patients. Successfully
treating this chronic illness requires the physician to be more than a
scientific expert. Not unlike the role of a traditional medicine man or
woman, the relationship itself becomes an important component of the overall
treatment and is perceived as highly therapeutic and positive.
CKD5 care
must have a model of its own
If dialysis care professionals are going to make major improvements in
patient survival and quality of life, a dramatically new model of care
is needed. It must greatly differ from care models used for CKD stages
1-4, when patients' lives are not significantly disrupted by their disease.
When patients reach stage 5 and require dialysis treatments to survive,
the model of care must expand to include psychosocial concerns and treatment
burdens, as well as the financial goals of all parties involved.
A whole patient approach is required for CKD5. If new entities such as accountable care organizations (ACOs) or medical homes simply consider CKD5 care an extension of the medical care provided in CKD stages 1 through 4, there will be no improvements in renal rehabilitation, patient employment, or depression. Unlike acute illnesses, medical care alone will never be enough from the patients' perspectives in long-term dialysis care.
EBM alone
is too limiting in a complex chronic disease
For the last twenty years, corporate and
government policies have been increasingly based on evidence-based medicine
(EBM). Unfortunately for patients, EBM has focused almost solely on improving
biochemical markers, rather than life outcomes such as employment, rehabilitation,
and health-related quality of life. While it is true that EBM has excelled
at assessing the efficacy of a new medication or a treatment modification
in CKD5, the current body of EBM has gathered little psychosocial data
for CKD5 patients.
In reality,
no studies are likely to be designed and completed that consider all the
factors that influence the patients’ treatment burdens. At this
time, nephrology simply lacks the language skills to define illness burden
and treatment burden as well as any established system to quantify their
impact on patients’ lives. Even with
a concerted effort for a decade, It is highly unlikely that EBM alone
will be effective — ever —
in addressing all the interweaving psychological
and medical complexities of a whole-patient model that is necessary for
CKD5.
As CKD5 patient activists and advocates know well, this situation is extremely frustrating. Proponents and adherents of EBM usually demand that sufficiently-powered, double-blind, randomized clinical trials be completed before policies are changed. By pursuing this EBM “purity,“ these EBM proponents and adherents have effectively ignored the numerous quality of life improvements enjoyed by self-empowered patients. These patients have used the preponderance of available information — as well as common sense — to prolong their lives and improve their care. In the meantime, most patients are told they must sacrifice their health and lives waiting for these studies to be designed, implemented, and completed, as only then can existing corporate and government policies be “safely” changed. Meanwhile, virtually no dialysis care professionals would choose the care that most of their patients receive. Staying true to EBM purity, we are stuck with a self-defeating model of care.
Most EBM studies in CKD5 are driven by the interests and the money of pharmaceutical, provider, or device companies. Since EBM can only address issues for which it has data, EBM will not be able to effectively address quality-of-life issues in CKD5 care anytime soon. While nephrologists have found much money and help available for pharmaceutical studies, they will likely find little support available of similar quality for studies focused entirely on psychosocial needs and treatment burden.
Under this current model of care based on EBM, nephrologists are limited to a narrow perspective in treating dialysis patients. It is obvious that a new model of care is required that also includes traditional medical wisdom, common sense, and simply listening to successful patients.
In conclusion
A review of the evident and not-so-evident problems and mistakes
in dialysis care paint a depressing and unpromising picture for today's
dialysis patients. Patient survival statistics and rehabilitation rates
are dismal. Financial incentives have evolved to the point where they
are no longer coherent and even harmful. Corporate financial goals are
often aligned against patients' long-term survival and many nephrologists
have aligned their interests with corporations. Important and necessary
psychosocial services have been decimated. Nephrology is stuck in a limiting
and often self-defeating model of medical care.
This is not a patient-centered system of care. In the end, perhaps it
is also time to consider that by downplaying and ignoring psychosocial
concerns and treatment burdens, nephrologists have allowed the wrong dialysis
facilities, the wrong architecture, the wrong technologies, and the wrong
professional skills, and the wrong leaders to dominate dialysis care today.
There are many changes
coming in dialysis care due to the new “bundle.” There
is a growing focus on new entities such as accountable care organizations
and medical homes for dialysis patients. Unfortunately, at this time,
all of these changes and entities build on the past mistakes and existing
problems in dialysis care. Despite the enormous investment of time and
effort, these "medical" solutions continue to stray even further
from the essential foundations of long-term, patient-centered care.
If
CMS, industry leaders, and some nephrologists continue to resist change
based on arguments concerning the lack of EBM, then today's too few successful
and empowered patients should hold publicly confront them for all the
failures of the federal dialysis program — the unnecessary early
deaths, as well as the widespread debilitation, disability, and depression,
and complete lack of renal rehabilitation — as well as for their
professional hypocrisy.
Solutions and corrections to the evident and not-so-evident problems in dialysis care are not likely to be found in more randomized controlled trials, quality improvement programs, state inspections, or in CROWNWeb data. Simply providing gradually improving evidence-based medicine, by itself, is not enough. A new model of care is needed that values patient experiences, input, and suggestions for long-term care and identifies their most important needs. Resources to meet these needs must be built up as quickly as possible. It must also address the dysfunctional financial incentives that have evolved and solutions that can quickly align them with the patients' most basic interest — long-term survival.
Towards these ends,
this paper introduces an all-inclusive, self-balancing model for dialysis
care that is much wider in scope than is commonly considered today. It
views the psychosocial and economic components of dialysis care as important
as the medical care. This
new model acknowledges the spike — even the explosion — of
psychosocial needs that patients experience when they enter CKD5. By design,
it recognizes that EBM alone cannot deliver the best possible care in
this complex chronic disease. While it does include EBM as a significant
part, this new model is also — by design — far more patient-centered
than current models. It also includes all the human, economic, and organizational
factors that can influence patient life outcomes — and society.
A
New Foundation: Four Quadrants
No well-known healthcare model could be found that would address all the problems and mistakes in dialysis care. However, a model from outside healthcare was found that can perform these functions. It is beginning to be utilized for other healthcare disciplines that are turning to a more patient-centered focus. The essential beauty of this basic four-quadrant model design, developed by Ken Wilber, is that it is "all-inclusive" and quickly shows major omissions in any comprehensive approach to complex problems.
In essence, the four
quadrants are: individual patient knowledge/experiences, individual medical
care provided, collective patient knowledge/experiences, and all organizations
involved in dialysis care.
Quadrant I: Individual Internal
This quadrant represents each individual patient’s personal knowledge
and experience with CKD5. Among the components: personal attitudes, thoughts,
actions, beliefs, experiences, needs, culture, and knowledge all contribute
to individual definitions of treatment and illness burdens.
Quadrant 2:
Individual External
This quadrant represents each patient's individual medical care
they are provided. Among the components: dialysis modality, dose, and
frequency duration. Clinicians' expertise and philosophy of care, as well
as financial motivations. Frequency, depth and quality of patient’s
relationship with MDs and caregivers. Patient education and empowerment
programs in clinic.
Quadrant 3:
Collective Internal
This quadrant represents the collective patient knowledge and experiences.
Among the components: collective illness and treatment burdens. Collective
employment issues, psychosocial needs, and health-related quality of life.
Identifies disparities in care. Competency of patient-to-patient mentoring
and advocacy.
Quadrant 4:
Collective External
This quadrant represents all the high-level organizations playing a role
in U.S. dialysis care today. Among the components: evidence-based medicine,
government and corporate policymaking, Financial incentives and goals,
profit or non-profit providers, payers, different societal and cultural
influences.
This model recognizes that chronic disease patients' life goals and psychosocial needs must be considered as important as medical goals in order for them to be fully engaged and participating in their healthcare. In its optimal form, it considers patients with life-altering chronic conditions to be equal partners with physicians and policymakers. In order for the model to work for every patient, the four quadrants must be seen as equally important.
