Without doubt the people who have commented that we need to
do more frequent and/or longer dialysis to improve the lives of patients are
right.
Some have suggested that nephrologists should have made it happen – implying that we have been too timid in doing what is right. I don’t agree. As I have already discussed, to have change in dialysis practice at the national level needs more than just pointing the finger at nephrologists
and saying “do it”. Nor will it fly, in my view, to say "nephrologists are not leading change
because they are greedy or have conflicts of interest." Sorry folks, while these
arguments might resonate with some; in my mind, they won't change dialysis practice.
The leadership and change management guru, John Kotter,
a professor at Harvard Business School provides one way to think about tactics that, he suggests, drive change (see his book from
1996: “Leading Change”). Here I've applied this to dialysis practice:
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Source: http://www.ideachampions.com
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1. Creating Urgency
For there to be a change in dialysis practice, such that the mantra "more-dialysis-is-better" results in widespread modification in the dialysis prescription, there needs to be consensus among providers and patients. One way to make this happen is to gather evidence that supports more dialysis. We have some
evidence (discussed here),
but we need more: bigger trials, harder and cleaner endpoints, and formal demonstration of cost-effectiveness. By showing mortality benefit that could be generalizable to the dialysis population as a whole there becomes an urgency to change what we currently do.
2. Forming a Powerful
Coalition
Key organizations have to re-align. Instead of the current coalition of professional,
patient advocacy, dialysis provider and pharma companies aligning under the
Kidney Care Partners (KCP) umbrella, a new
coalition of nephrology professional and patient advocacy organizations needs
to form. The current coalition represents the spectrum of nephrology interests, but it mixes up commercial interests with patient interests. We need a coalition aligned with patient interests for better outcome. For example, it may be more expensive to have every-other-day dialysis compared to the current regimen. The benefits of every-other-day dialysis -- particularly financial - may not be seen by the dialysis providers. Forming a new powerful coalition that focuses on the long-term interests of patients is in the interest of both patients and nephrology professionals, but as callous as it may sound, may not be in the commercial interest of dialysis providers.
3. Creating a Vision
for Change
A clear vision is needed. What do the patient and nephrology
community want to do? Is the goal quotidian (or daily) dialysis? Or is it every other
day (EOD) therapy? Is the vision for nocturnal dialysis or short daily dialysis? Coalescing around a singular goal with an associated vision would be good.
4. Communicating the
Vision
The vision needs to be communicated via key opinion leaders
speaking and writing about this issue. Having national or international
societies embrace the vision woudn’t do much harm either. The media needs to
get involved to promote the vision, highlighting that it is based on evidence from well conducted trials.
5. Removing Obstacles
Getting Medicare to reimburse "more dialysis" would clearly be a powerful driver for change. After all, Medicare (CMS actually) is the principal payer for dialysis in the US. Before this happens, CMS has to agree that there is evidence to change the current reimbursement for dialysis. Establishing consensus over the evidence requires writing to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)
and asking them to fomally review the evidence. They would probably set up a technical review. Another option could involve lobbying for
the FDA to start regulating dialysis itself (as I have argued elsewhere, link 1,
link 2). In Europe - UK as an example - getting the NHS to buy-in would be critical. Lastly, one could lobby political leaders in Congress and the Senate who could then pressure CMS.
6. Creating Short-term
Wins
Demonstrating that more dialysis is technically and practically
possible for some patients has already been done. Demonstrating the feasibility of every other
day in-center dialysis as an option for everyone can be done but requires a demonstration project(s) or pilot programs.
7. Building on the
Change
Expanding more dialysis to include all patients – elderly
and the disabled - rather than in select patient populations would be
important. Getting professional societies on board would make a difference. Showing the benefits of "more-dialysis" on outcomes such as rehabilitation potential, depression, physical and mental domains of quality of life, hospitalization rates, etc would build on the agenda for change.
8. Anchoring the Changes
Developing guidelines that anchor evolving clinical practice would be important. Creating performance measures through the National Quality Forum and other like bodies to monitor whether providers are complying with changes in practice. Rewarding providers through incentives would also help anchor changes.


Another great article, thank you Dr. Singh.
ReplyDeleteIt does seem that the urgency is already there but that some catalyst is needed to create the powerful coalition.
Reading a lot of the current "Patient Organization Websites" I feel bombarded with advertising from LDO's about dialysis travel or other great solutions that will improve my life. This makes me feel like the organization has forgotten its roots.
It also seems counter-productive to what a "real" patient organization should be focused on. I.e. working and lobbying towards care providers and companies in order to get better care and more resources.
Simply pointing fingers at doctors or companies will not improve lives. Only patients have the real power to create strong unity and thus improve their situation.
If you think about it makes sense in the same way (although very different in other) as that only women could bring about universal suffrage.
The person who has the most vested in the change occurring is the one who has to fight the hardest for it to actually happen.
It has always amazed me how so many have fought for improved care that truly me ets the patient's needs, but yet we still have not moved an inch. Well, we see the QIP which is focused on numbers, soon to be focused on other important aspects e.g. infection. But, in reality, why can't anyone realize that there are patients who want to return to work. If those on worker's compensation can receive rehabilitation to find a new employment position, why can't one who requires dialysis be offered the same.
DeleteAnonymous mentioned 'real' patient organizations - Most, if not all, of the patient organizations are, in some way, connected to the industry. Hence, how can these groups remain completely objective when discussing goals, if they have ties to the LDO, etc. Certainly seems like a conflict of interest, to some degree.
As a non-connected-to-the-industry Dialysis Patient Safety Advocate, I have, in fact, attempted at having legislation passed to improve care, providing valid information for supporting date (ESRD Network annual reports, CDC's MMWR reports, dialysis facility surveys/inspections).
Within the units, there is a degree of retaliation, either overt or covert, that often keeps a patient from speaking out, or becoming involved in trying to change and improve the situation that 'anonymous' mentions. What CMS calls 'bullying', at a meeting they had, some time ago, is 'retaliation'. CMS is aware of this, but again, the fear to speak up is ever-present, unfortunnately.
The first step is for providers to realize that staff, in many of their units, (just take a look at the facility inspection reports) do not follow physician orders, or facility policies and procedures. Several years ago, providers identified various problems in units but I am not sure these have been corrected. We continue, even knowing that infection is the number two killer of this vulnerable population, to have a significant number of infection control deficiencies cited. What is wrong? (1) Lack of training/education with rationale for compliance which includes patient negative outcomes when there is no compliance, (2)A new preceptor program for new staff so that they learn the correct way and not shortcuts, or wrong practices from staff who don't have time to precept, (3) Charge nurses who are well familiarized with dialysis and able to identify problems and act/intervene, and who are not afraid to address such with staff and (4) a medical director who will put his/her foot down so that his/her patients receive safe care....
The lack of unit-level supervision is greatly lacking as evidenced in the survey findings. Each survey (inspection report)should be posted in the faciity so that every patient can see how their faciity is doing. When a patient asks to see the survey, and a staff refuses, one only has to wonder why
OPINIONS OF
Roberta Mikles BA RN
Dialysis Patient Safety Advocate
uncompensated advocates striving for improved care incenter
www.qualitysafepatientcare.com
Only in America could we have higher licensing standards for hairdressers than we do for dialysis technicians in the majority of states. Only in America.
DeleteA simple change to would be the following modifications to bundled payment rules:
ReplyDelete1. Any treatment less than 4 hours will not be compensated, but grant an exception to this rule when it can be demonstrated that the patient was dialyzed a fourth time in any given week,
2. If 4x/week sessions of 3-4 hours becomes acceptable, but ONLY if total hours dialyzed remains at 12 or higher.
Given what we know, less than this is "improper" delivery of dialysis, and should not be compensated.
An alternative discussed elsewhere by Agar and others would be to use a multiplier including both hours and sessions, so that the same number of hours divided in more sessions is more "valuable" to a provider.
However, requiring that "cost effectiveness" be demonstrated in some "pilot program" before proceeding places the needs of government bureaucracy higher than patients, and would only serve as yet another delay tactic and roadblock to change. It's not just about saving money, it's about saving LIVES. EVEN if this costs marginally more (which much evidence says it would not), it is still the RIGHT thing to do.
Saying we need yet more and larger RCT's for purpose of "creating urgency" actually works the opposite way. It UNDERMINES and discredits the body of evidence we already have. Monday's kill. We don't need more RCT's to demonstrate this. It is time to do something, and it is long past time for groups such as ASN and RPA to either put up or shut up.
Indeed ----
DeleteI am assuming that 'anonymous' is someone who works in the industry, has been fighting for quality safe care for a long time, but can not provide his/her real name due to various aspects e.g. possibly being criticized by his/her peers, fear of losing his/her job, or just does not want to give their name. I often wonder about those who post anonymously, especially, when they provide valuable information, but having, at one time, posted anonymously myself, I do understand.
I have never know the ASN or the RPA or any other similar groups e.g.AAKP, etc. to truly act to ensure that incenter patients receive the care that they should.
There are many good units out there, however, I am hearing more and more of problems that patients are encountering.
I agree completely with 'anonymous' that we are talking about LIVES and saving LIVES... I often wonder how some of these dialysis so-called professionals can sleep at night when they know they are taking shortcuts, not implementing correct practices and not ensuring safe care is happening.,, safe care meaning perhaps doing EOD to prevent complications, including death,
OPINIONS OF --- Roberta Mikles BA RN, Dialysis Patient Safety Advocate
Director, Advocates4QualitySafePatientCare
www.qualitysafepatientcare.com
I often wonder why the leading professional and patient organizations have failed to take a position which is actually consistent with nephrology professionals' own personal beliefs.
ReplyDeleteIs it because these organizations depend on industry funding? Are we thus mere "lap dogs" so willing to betray our beliefs lest we bite the proverbial hand that feeds us? Why have we not held our own leading organizations *accountable* for their failure to act in the best interests of patients, even when this is allegedly the core mission of these organizations?
Any systemic problem has many concurrent causes, and we can argue all day about which one is the greater, or "root" cause. But in the current debate, with respect to these organizations, the real sin is not greed, but rather cowardice, which unfortunately is far more difficult to overcome.
As a very first step, ALL leading renal organizations can and should make a statement in favor of EOD. People are dying who don't have to. Hundreds every day. How much more "urgent" do we need?
Enough already. Get off your duffs and justify your existence.
Anonymous, perfectly stated.....
DeleteIt is apparent that a deterrant is present that keeps these organizations from acting in the best interest of patients. I wonder how many stockholders have loved ones on dialysis and what there experiences have been. I would guess we will never see improvement in care in dialysis units... There has been NO significant change in the types of deficiencies cited, even since the newly revised Conditions have been in effect.. Hence, with seeing this, what is one to expect.
I had a dialysis technician contact me the other day. She quit her job after six weeks because she could not get the training she needed to ensure safety...
Roberta Mikles BA RN
Advocates4QualitySafePatientCare
www.qualitysafepatientcare.com
Wait a minute...are the ESRD networks affiliated with "the industry"?
DeleteI'm not a "professional advocate" or a politician or a CEO...I'm just a mere patient; perhaps the buildup of toxins in my brain prevent me from understanding why this has to be so complicated. I would say re: your comment no. 3, the "goal" should be whatever the neph and the patient agree it should be. You don't have to be a rocket scientist to understand that since normal kidneys work 24/7/365, the more dialysis you get is going to be better for you. What form that more frequent dialysis will take should be up to the patient since it is s/he that has to live with it.
ReplyDeleteI very much disagree with the first of the anonymi who said that it has to be patients that lead the vanguard in the same way that women were the "only ones" who could bring about universal suffrage. There were enough men who saw through the injustice and voted for a constitutional amendment. There were many white people who fought for desegregation because their color did not blind them to injustice. So, there has to be many more people than just sick dialysis patient who must show that current dialysis practice in the US is immoral and cruel. I choose to believe that nephrologists became physicians because they want to end suffering. They should be at the head of this brigade, standing arm in arm with their vulnerable patients. In other social battles, it has been power that was the prize. In the dialysis war, the prize is profit, and that prize is the most valued of all.
The fundamental truth is that money is at the root of all such battles. I don't believe that any nephrologist thinks that standard inclinic dialysis, administered only thrice weekly (and, so, with the killer weekend embedded in this particular modality) is the best treatment for any patient. I'm sure that there are patients who would refuse to do more, but the point is that most patients either don't have a choice or are not even told of those choices.
So, that leaves us with the fact that the true obstacle is money. Who stands to gain the most financially. Don't tart it up and start blathering about how we don't know if more dialysis is truly any better. Of course we know it's true.
Dr. Singh, let me ask you another direct question. You remember the sobbing patient you told us about in a previous blog entry? What did you tell her about how dialysis works? Did you tell her that more dialysis is better dialysis? Did you educate her in this regard, or did you just sort of leave her to flap about in ignorance? When you post blog entries such as this one, how much of your advocacy do you apply to your own patients?
Don't think that the readership has not noticed that Dr. Singh has dodged your question three times now.
DeleteIt seems that either Dr. Singh did not have an answer for his distraught patient, or that he is ashamed of what the answer was.
If this is not the case, he has had, and still has, the opportunity to prove otherwise by actually answering.
Many do not realize that the Boston group has already done what Dr. Singh currently recommends here (writing to CMS/MEDPAC etc), as part of an "Action Plan" coming out of the 2009 meeting.
ReplyDeleteDr. Barry Straube's response largely dismissed the group's recommendations as mere "opinion" stating that CMS cannot make changes without "evidence" as well as the usual excuses about prioritizing finite resources: http://www.renalweb.org/press/CMSFinalResponse081409.htm
So, has anything changed? Do we now have enough "evidence"? (http://www.thekidneydoctor.org/2011/09/editorial-wait-wait-dont-tell-me-is.html)
Will we ever have "enough"?
People and especially organizations can always choose to ignore inconvenient evidence, or demand "overwhelming" evidence despite that nearly everywhere else in medicine treatment is guided by the preponderance of the best AVAILABLE evidence.
What does the preponderance of the AVAILABLE evidence say?
Equipoise has been lost. The era of conducting yet more RCT's (in an ethical manner) on this question is over. Patients refuse to be randomized to inferior care.
If there is a widespread belief that more frequent dialysis hasn't been proven to be of benefit, let's look at this from another perpective. We all know about the NEJM's 2011 study on the "killer weekend". Now we have a widely acclaimed study showing that standard, thrice weekly inclinic dialysis kills people.
ReplyDelete"First do no harm."
I submit that any nephrologist who prescribes only thrice weekly inclinic is doing harm and raising the mortality risk to their patients.
This is unethical, and the studies prove it.
End of debate. See, it's just not that hard, people.
Steps 1-8 above are all nice "generalizations" or "strategies"- but are not grounded in the reality of an individual medical decision at a specific moment in time. Actual practice patterns emerge from thousands of individual decisions made on a daily basis.
ReplyDeleteIn deciding what to do for the individual patient in front of you, if you were hypothetically to prescribe a 4th treatment (or EOD or SDD or whatever) for this patient who requests it, what are the consequences?
--For fear of these consequences is clearly the only true "barrier" that nephrologists find insurmountable on a daily basis. What if, you were to start prescribing that 4th treatment for even the majority of your patients?
So what *would* be the consequences? Having to fight for payment? Having to provide written medical justification and a letter to CMS? Having to fill out more paperwork? Having to learn and become certified in HHD equipment and techniques? Passing excess costs directly to the patient? (Not everyone can afford it, but there are many who would perhaps be more than willing to spend $300/week extra out of pocket to stay alive.) Fearing the wrath of your provider for breaching the protocols? How many of your patients do you ask each visit, how are you feeling? Would you be willing to dialyize longer and see if you feel better? Some may refuse, but NOT ALL. How many of your patients have you even asked these questions?
Now compare this to the consequences faced by this same patient in terms of QOL, diet, disability, and survival. How can any of these "inconveniences" to the nephrologist be anything other than trivial in comparison? Do you spend 12 hours per week fighting for that patient to live BETTER, the way that same patient fights to stay alive? Do you spend even one?
The reason nephrology won't honestly confront this critical moment in time, where the actual decision is made, where the litmus test of "What would *I* PERSONALLY choose and WANT?" fails repeatedly--should be called what it is: plain old-fashioned shame.
So Dr. Singh, if it were you, or your wife, or your child, as the one facing the chair. What would you ARRANGE? What would you DEMAND? What "strings" would you have to pull to protect your loved one? (Not what could you "afford"-- but rather what would you WANT?)
Now, is the treatment being received by patients similar to your loved one comparable? Is it?
Anything short of this standard has let the patient in front of you down.
We need a Golden Rule of Dialysis: "Dialyze unto others as you would want to be dialyzed yourself." No, understanding this is not hard.
Accepting responsibility to do what's right, even when there will be repercussions, is what's so hard.
Oh, I'd love to know the answers to these very thought-provoking questions! To repeat, I am quite certain that the vast majority of nephs KNOW that more dialysis is better, so what would happen if all nephs prescribed EOD for all of their patients?
ReplyDeleteHow many people (outside of business schools and avid readers) have even heard of John Kotter? Now, how many people have heard of Ghandi?
ReplyDeleteKotter's ideas are sound, well written, and popular--but writing books doesn't cause change.
Demonstrating courage to behave differently causes change.
What would happen if suddenly 1000 people demanded an extra treatment per week?
ReplyDeleteWhat if it was 10,000?
What if it was 100,000?
Doctors fighting for patients is important but Ghandi knew, as did MLK that strength lies in numbers.
If? Gone are the days when the profession and industry can just "screen" patients from obtaining the exact same information they have access to. They don't have to go to Boston to know what was discussed and recommended.
ReplyDeleteWAKE UP people. Your patients are going to be demanding answers, not excuses. Are you ready? Game over. Just stop already.
So, nephrologists of America, ASN, and RPA - that's nearly 8000 signatures right there.
DeleteHow many patients collectively do you have access to? (dialysis and CKD)--how many MILLIONS of signatures is that? What if 8000 nephrologists all wrote to their Congressional representatives with the same message? What if this message were also signed by the several hundred patients in each average sized practice?
Don't think that you're in a position where you can't have any influence.
Change in American dialysis practices cannot come to pas until the American nephrology community resolves the 40 year "how much dialysis is enough" debate. The body of literature from observational studies over the last 50 years is clear. The information from two RCT's is clear, more is better. One RCT, the nocturnal FHN failed in its recruitment, failed to keep the original protocol and in so doing failed to provide any usable information rendering it null and void of usable content. Many continue to call for further RCT's to define the mortality of alternative dialysis modalities even though the FHN revealed the truth that patients no longer have equipoise. They continue to call for further RCT's despite the fact that the number of patients needed to meet the power requirements of a mortality outcome study is prohibitive. The one issue settled by the nocturnal FHN study is that patients refuse randomization to standard in-center options when compared to the various home modalities. Equipoise for patients no longer exists.
ReplyDeleteIt is only their nephrologists that wonder which is the best way to go. In such, the person who is supposed to be the team leader, the nephrologist instead is not leading on these issues for the majority of patients and appear to sit in the cloud of waiting for a study that logistically will be impossible to accomplish with the 3500 patients estimated by Dr. Chertow several years ago. Certainly, there are many nephrologists who support optimal dialysis practices and understand the "unphysiology" of conventional in-center dialysis that has produced our high mortality. But as a unified professional voice, there is no unified voice at all from nephrology themselves.
Nephrologists are the only people that can prescribe dialysis and the only professionals who can establish the standard of care. With no agreed upon optimal dialysis dosage 50 years after it was a practical treatment option, settling that issue must be the first step in bringing about change. Ignoring the physiology of dialysis is how we have reached this sad state of affairs in the first place. We can talk about political strategies, but without going to the root problem, politics and political action will not render the change that the nephrologist has at the power of his pen right now. We can blame CMS for their reimbursement structural deficiencies, but indeed, the nephrology community continues to press forth with thrice weekly, 3-4 hour dialysis as the standard of care. Until that changes, I see nothing of substance that any other action will bring to pass. I believe that is the target.
So, does your personal nephrologist actually have the power to change the dialysis prescription? What special powers does he have? How did he accomplish this magical feat?
DeleteActually, yes, I plan to write about what he has accomplished as an individual nephrologist simply by applying what we know about improving dialysis mortality to his practice. It is a joint FMC/Kaiser venture where he took a population of patients who were frequent fliers in the hospital and ER and reduced admissions, reduced mortality, improved nutrition through a non-profit organization he founded to give his patients nephro supplements and he is now a supporter of home hemodialysis and has a large proportion of his patients on home hemodialysis and PD. However, his first action was increasing every patient from 3 to 4 hour sessions unless they refused or had some sort of issue that prevented that. That was his first step that so many nephrologists fail to consider.
ReplyDeleteQuite a remarkable transformation in just 10 short years that has had a profound impact on his patients lives. Yes, it CAN be done by an individual nephrologist, I have seen it up front and personal as a patient and as his colleague. However, many of the nephrologists in the same area he works appear to care more about the bottom line than patient outcomes and still have short 3 hour sessions as their standard.
So, yes, nothing magical about what he has accomplished. I am planning to get together with him soon to review all that he has done in the last 10 years and give an update on it soon. Nothing magical about it at all, the literature already has much information on reducing mortality in dialysis units that is seldom applied, at least while I was still practicing and admitting these sickly patients who were underdialyzed and malnourished. Sadly, I thought at the time that was expected, and my colleague turned that upside down with actual clinical outcomes. Thank you for asking and reminding me I need to call him soon.
Why would other Kaiser nephrologists care more about the bottom line than outcomes? Why should it be any skin off their backs?
DeleteGood question. Kaiser has several joint ventures with FMC where the medical director of the FMC unit is a Kaiser physician. By contractual agreement, Kaiser physicians in Southern CA are not allowed to accept any outside income as a physician. In such, I can personal attest that my nephrologist turned his salary for running the FMC unit back to Kaiser. Just part of our contract of employment. Thus, the Kaiser physician has NO financial interest in the dialysis unit that they are running.
ReplyDeleteHowever, the Kaiser physician may receive incentives from Kaiser for reducing hospital utilization and other patient matrices that save Kaiser money. This is an alignment of patient outcomes and patient expenditure. With the non-profit status of Kaiser, it works well. Until dialysis is incentivized for patient outcomes, reduced hospitalizations, etc. I expect no change will take place in America. Should someone figure out what Kaiser has already accomplished for years with FMC, then the bottom line becomes the benefit of the patient. Many leaders in the dialysis industry have noted the perverse incentives in most dialysis units today as one of the leading causes for our high mortality rates. That is a problem that only CMS can fix system wide. Why CMS has yet to put into practice what Kaiser has already accomplished with FMC is a mystery beyond my comprehension.
Perhaps because RPA fought so hard in court to gain an effective exemption to the Stark anti-kickback law, (and, despite technically losing on appeal), successfully arm-twisted CMS into dropping safe-harbor language altogether from the adopted payment rules.)
DeleteCMS listened to RPA's interests, rather than those of taxpayers and patients. RPA pats themselves on the back on what a great job of protecting members' interests from undue government hindrance, while squandering resources that could have better been used lobbying for CMS and Congressional support for more resources devoted to better care.
Kaiser, unlike the US government, probably still believes that such payments from outside companies to their contracted physicians is a conflict of interest, unlikely to be in Kaiser's best interests, and maybe even unethical.
There is a reason such vested interests by physicians are illegal in most EU countries.
(However, unlike Europe, American medicine is not so susceptible to financial pressures influencing care decisions, so regulatory oversight of how the taxpayer's money is utilized is completely unnecessary.)