Dialysis at a Crossroads—Part II: A Call for Action

Clinical Metrics and the Political and Regulatory Environment

The US healthcare system spends more per capita on healthcare than any other country in the world, but the quality is often no better than and sometimes inferior to other developed nations (3,4). The US healthcare political and regulatory environment in 2012 demands improved quality in all areas, notably including the dialysis sector. Table 1 lists some recent initiatives intended to enhance quality of care in dialysis.

The dialysis industry along with organizations such as the National Kidney Foundation (NKF) and Renal Physicians Association have been at the forefront of developing clinical metrics for patients with complex chronic illnesses, but only limited quality improvement initiatives have emerged that resulted in meaningful changes in outcomes. Our proposed actions are not contingent on the application of payment reform processes, such as the Accountable Care Organization model, and will work with or without it.

Clinical metrics in dialysis can be described to embrace three categories. Those metrics in category 1 are the most rigorous, because they relate to public reporting of aggregate outcomes and reimbursement from government funds for services rendered that meet or exceed a predetermined level of quality (e.g., Clinical Performance Measures [CPMs]). These metrics have tended to be evidence-based, might be time-limited, and may be subject to review and endorsement by oversight organizations such as the National Quality Forum (NQF). They also primarily address populations rather than individual patients. Category 2 metrics, often called Clinical Practice Guidelines, are overall somewhat less rigorous, because they are often developed internally by specialty organizations or providers themselves; examples are the NKF and the International Society of Nephrology (i.e., Kidney Disease Improving Global Outcomes or Large Dialysis Organizations [LDOs]). Although using best-available evidence, they also embrace expert opinion and best-practice philosophies. The Institute of Medicine phrases it as “systematically developed statements to assist practitioners and patient decisions about appropriate health care for specific circumstances” (8). Clinical Practice Guidelines are intended to define minimum targets or suggestions for the care of individuals rather than for an exclusive course of management for populations of patients; however, experience has shown that these minimum targets can morph into CPMs defining average outcomes for populations of patients. Category 3 metrics are those metrics used to ensure safe practices, and they come under the aegis of the public health and safety provisions of state and federal administrative law and regulations. These metrics serve as a minimally acceptable floor, below which no practice or care system should be allowed to consistently fall.

Despite the strengths afforded by this trilevel system for quality assurance and improvement, we posit that the composite of these efforts to date has been minimally effective in the necessary and feasible improvement in patient outcomes advocated in this commentary.

The process-dominated ESRD network, state/federal surveys, and certification inspections (largely directed at category 3 metrics) have been relatively ineffective because of (1) inadequate funding, (2) infrequent surveys, and (3) importantly, a focus on the minimally acceptable floor rather than exemplary care. Although such oversight and certification processes are a necessary component of overall monitoring and quality of care improvement plans, they do not currently function in the manner to address issues posed by this essay, namely fostering a dramatic decrease in mortality, hospitalizations, and cost. In our view, it is not prudent to use them for this purpose given their other responsibilities. We suggest that patient-centered outcomes will not materially improve simply by increasing such oversight and regulation. Fundamental change will occur when physicians and providers alter how they measure their practice and processes/outcomes of care by creating aspirational standards instead of minimal performance criteria of acceptable care (the safety imperative) and incorporate the basic concepts of continuous quality improvement process.

Development and implementation of category 1 metrics are expensive and often contentious and cumbersome processes; they respond poorly to the ever-changing dynamics of ESRD care. Considering the positions of CMS and the NQF, dialysis quality metrics in category 1 still lack patient-centered clinical relevance. These metrics are largely directed to population-based measures and not at the individual patient. It is noteworthy that ESRD, despite its prevalence and high costs, is not generally recognized as having high importance by legislators, healthcare policy makers, payers, and the general public (4).

A dilemma surrounding the need for new metrics and the potential unintended consequences of advocacy of unproven metrics is apparent. Safety is paramount. A recent investigative journalist’s article arguably charged that the dialysis system in the United States has major patient safety and quality lapses, with lack of will or ability to address the concerns (6). Nevertheless, achieving the desired patient-centered outcomes within an imperative of optimum safety must not incapacitate the agents who provide the care. Changes in the clinical metrics and care that they measure must provide positive results: patients living longer with improved quality of life and preventable hospitalizations/rehospitalizations avoided. The political, regulatory, and financial environment begs for leadership and action in the dialysis world. As healthcare givers, we need to be proactive in this worthwhile endeavor.

Gaps between Current Clinical Metrics and Better Dialysis Care

Medical practice based on clinical evidence is intended to enhance both patient safety and outcomes of care. The metrics describing such practices can be used for (1) continuously improving quality, (2) comparing performance among physicians (both publicly and privately), (3) informing patients so that they can choose providers who best meet their needs, (4) advocacy of quality incentive payments linked to meaningful outcomes, and (5) monitoring the safety of the treatment setting (7,9,10). All of these metrics should ideally be valid, reliable, and reproducible, and they should undergo periodic review/revision and adjustment for patient characteristics that confound the outcome in question.

The work by Lowrie (11) has shown that achieving target values for the usual process-based metrics is necessary but insufficient to drive optimal mortality, morbidity, and quality of life outcomes—the critical objectives of any quality assurance program. Current process-based clinical metrics, both categories 1 and 2, do not make enough of a difference, accounting for only 14%–30% of the variability in patient-centered outcomes across the spectrum of providers (11,12). Recent attempts by Center for Medicare and Medicaid Services (CMS) through Technical Expert Panels have, in large part, failed to develop those measures that might make the kind of differences in outcomes, because the NQF rejected the recommendations, largely because of the lack of large randomized clinical trials (RCTs) ostensibly needed for a category 1 metric. An NQF endorsement requires rigorous scientific and evidence-based reviews, with the major (but not the only) determinant being the RCT (13). The paucity of evidence from high-quality RCTs in nephrology has led to a delay in the development and implementation of potentially life-saving/altering therapies, because CKD and ESRD are frequently exclusion criteria in large RCTs (unless focused directly on these issues). However, should the evidentiary standards be placed so high that they stifle innovative approaches to the problem in a field with relatively stagnant outcomes? We answer this question unequivocally no. Complimenting and perhaps preceding the RCT should be a preponderance of evidence methodology from large observational trials driving the needed changes (14). We believe the changes can be achieved quickly through the comparative effectiveness research provision of the Affordable Care Act and implemented on a time-limited basis to assess validity.

The gaps between the quality of the evidence and the need for change in treatment pathways create a dilemma for providers of care. In this setting, the advice of the Institute for Health Policy is germane (15): “Measurement of physician clinical performance in quality improvement activities need not be precise, but only sufficiently accurate to reassure physicians of the validity of the data and to engage them in redesigning the processes of care and micro-systems to improve patient outcomes.”

Basic Elements of an Action Plan

There are medical interventions that can significantly improve survival in our patients, but these interventions require a coordinated effort among physicians, staff, providers, regulatory agencies, and patients—the entire ESRD community. A collaborative action plan can be implemented and sustained.

Perspectives and Implementation

In this work, we opine that, despite slow incremental improvements in patient outcomes and admirable intentions by all stakeholders, the dialysis field still struggles to identify those processes and metrics that will significantly improve survival, decrease hospitalizations, and enhance the quality of life of kidney patients. Herein, we propose the basic tenets of a new pathway for care and its oversight. Standing at the crossroad is no longer acceptable. The conundrum, of course, is how to do it. Admittedly, there are no RCTs that support many of the proposed measures. Although RCTs are desirable, they take years to organize and execute (if they can be done at all). Do we need an RCT to confirm that the use of catheters is harmful and expensive? We believe that control of and reducing excessive ECV by the most efficient means possible, with avoidance of LVH, is better for the patient. Longer dialysis sessions (4 hours each or more) or more frequent treatments (daily or nocturnal) offer great promise for better patient outcomes, especially in the vulnerable period shortly after initiating treatment. An LDO recently recommended to all attending nephrologists that these treatment strategies be implemented, despite the lack of RCT evidence. However, medical practice cannot be dictated or enforced by an LDO. Changes in practice need to occur by consensus-based initiatives from a preponderance of evidence, such as we advocate in this commentary, while waiting for an RCT (which may or may not be done).

Nephrologists and dialysis providers can and will make a difference. We believe that these two mutually interconnected entities, with support from the federal government (CMS), can catalyze a move to implementing needed changes in the treatment paradigm. We cannot await only new CPM development but must move to less traditional means, asking nephrologists and dialysis providers to step up to the plate and catalyze needed change in practice patterns.

As a starting position, we suggest a Consensus Development Program of key stakeholders expertly facilitated around specific, actionable items. Maintaining the integrity of the Consensus Development Program is a high priority of the NQF (13). Such a conference, composed of chief medical officers, providers, and other stakeholders, would be charged to examine how to address the issues that we raise. This process is translational clinical research, with a cycle of innovative ideas, pilot testing, and wider implementation along with a high prospect for success.

The goal will be to determine if the preponderance of evidence is sufficient to implement changes as suggested above within the current framework of reimbursement. The financial implications of what we propose will be the topic of another manuscript.

For too long, we have been engaged in adherence to process-dominated metrics of limited value. Change needs to incorporate programs and metrics that are likely to have the greatest promise for monitoring and improving patient care and outcomes. Linking superior patient-centered outcomes to better payment for services could be a benefit to incentivize the processes that we outline.

This commentary will hopefully provoke a spirited dialogue among caregivers and providers directly responsible for patient care to begin an evolution to a new pathway of care. We anticipate that a collaborative effort among all caregivers will transform the crossroads analogy into a new dynamic exercise that improves the value of our care. The patients entrusted to our care deserve nothing less and must receive more.

Disclosures

None.