In a recent JAMA Internal Medicine article,1 standardization of medical care was debated as an approach to improving the quality and safety of patient care. The article’s authors, physicians Lara Goitein and Brent James, ended the debate agreeing to a list of principles that characterize successful and “responsible” standardization programs. The topic is important, and the authors, whose perspective is the acute-care hospital setting, voice a lively and engaging point-and-counterpoint on the uses and downsides of standardization.

The use of workflows and protocols can prove extremely beneficial for patients. However, protocols must be designed so they empower, and not alienate, physicians. That said, two of the principles mentioned above warrant special attention, given their potential to benefit the dialysis industry.

DM tools to manage the ESRD population

First, it’s important to note that disease management tools for physicians caring for dialysis patients are far more robust, mature, and extensive than may be true for most other patient populations, including those cared for by providers in hospital settings. Many factors contribute to this distinction, including:

  • the magnitude and complexity of the disease burden in the dialysis patient population
  • the physical presence of the patient in the facility for several hours three days or more each week, often for years
  • the high risk potential of the dialysis procedure itself
  • the need for structured surveillance of a wide range of physiologic, biologic, and laboratory markers
  • the availability of national and international clinical practice guidelines and recommendations against which to measure clinical performance
  • the embedding of many of these guidelines and recommendations in Conditions for Coverage of end-stage renal disease facilities
  • the public reporting of a range of patient outcomes for each facility
  • the explicit requirement for care to be continuous, coordinated, and interdisciplinary.

While there are some exceptions, it’s fair to say dialysis care has developed high levels of standardization because of the nature of the patients, the dialysis procedure, and the breadth of agreement among physicians in the clinical nephrology community about what reflects safe, reliable, effective and patient-centric care.

Understanding physician practice to understand variation

Within the modern dialysis care delivery paradigm, protocols, clinical pathways, and physician workflow solutions each present opportunities for improving quality and safety through standardization, while optimizing the use of physician time for high-level decision-making. However, none of these approaches can be successful if they don’t meet physicians’ needs.

That brings us to the authors’ first principle for responsible standardization in health care.

Encourage and understand the reasons for variation from protocols.

Regardless of the guidelines, recommendations or population-based evidence available to inform decision-making, it is the physician who must make the decisions that collectively constitute the care prescription for the individual patient. The imperative to understand the sources of variation in decision making is, at its core, an invitation to understand the richness and complexity of the physician-patient relationship. And there are few, if any, physician-patient relationships in medicine that match in depth, longevity, and intensity of those that develop between the nephrologist and the dialysis patient.

Chronic diseases requiring regular surveillance, monitoring, and adjustment of treatment orders are good candidates for protocols. Protocols are physician orders that cover most conditions the physician can foresee in managing the disease condition. Protocols can range from fairly simple, like semiannual Hepatitis C testing, to complex, like anemia management with ESAs and IV iron. Physicians can order protocols if they choose. Not-per-protocol decisions, as needed, can be based on medical judgment and based on individual patient circumstances. The closer the protocol fits physician practice, the richer the foreseeable conditions it covers. The more reliable the outcomes obtained by per-protocol management, the more the protocol is ordered and used by physicians.

Thus, the arc of protocol development in the dialysis setting in general, and at DaVita Kidney Care specifically, reflects a continuous improvement process that requires constant evaluation of physician preference and evidence of patient outcomes, with intermittent iterations to align with changes in science, regulation, or policy. The ability to distinguish per-protocol from not-per-protocol decision making, and to link those distinct patterns of decision-making to patient outcomes, is central to guiding an evidence-based continuous improvement effort. When there is insufficient evidence to gain sufficient support for one common practice preference over another (for example, holding ESA or not for a Hb > 11 g/dL; or, holding IV iron or not for ferritin > 500 ng/mL), we offer protocol choices that satisfy each choice. Again, practice variation is not only expected, it is sought and analyzed and becomes a resource for continuous innovation and improvement.

Seeking input from frontline physicians

The authors’ second recommendation was:

Provide the necessary resources to make it easy for frontline clinicians to contribute to the development and rapid modification of protocols.

Because nephrologists are pressed for time, and because we have 8,000 physicians who round in our 2,000+ clinics across the country, the task of seeking out physician preferences to guide protocol development and revision requires a significant investment of time and resources. One strategy was creating what we call the “Think Tank,” a group of 170 engaged physicians on whom we can rely to provide comments on key elements of practice preference. For more in-depth input and discussion, we turn to the 10 members of the DaVita Physician Council, and to our nine group medical directors. When we have potential new or major updates of protocols at DaVita in mind, we preview the proposed changes with all credentialed physicians by email and invite comments and suggestions. Facility nurses, of course, are important sources of information about physician practice preferences because they work directly with physicians as the individual patient orders are discussed and communicated. So part of our continuous improvement effort involves listening to and talking with nurses who are assigned to work in specific disease management areas, including anemia, access, adequacy, fluid and infection. And, before any new protocol or protocol update is released widely, we first evaluate it in a small group of facilities in order to get direct, real-time feedback from physicians, nurses and medical directors.

Clinical pathways, physician workflow solutions, and standard orders

To take things a step further, protocols are hardly the only tools in dialysis facilities that improve quality and safety through the use of standardization. A clinical pathway is more flexible than a protocol and is a better match for practice when the physician’s evaluation and decision making is part of a sequenced, stepwise process that requires participation by others in the interdisciplinary team. FluidWise is a DaVita fluid management clinical pathway that aims to reduce fluid-related hospitalizations by decreasing interdialytic weight gain and improving intradialytic hemodynamic stability. Dietitians and nurses provide assessments and counselling, and physicians are turned to when prescription changes need to be considered.

Clinical pathways are part of a broader category of workflow solutions. They capture best practice at each step and alert the next member of the interdisciplinary team (including the physician and patient) when his or her input is needed. Ideally, clinical pathways operate in real time. Accordingly, multiplatform software solutions may be required so that the physician can review information and execute needed decisions from a smart phone, iPad, laptop or desktop remote from the facility without waiting until physically rounding in the facility. Improving physician workflow while rounding, on the other hand, is a key design feature for the DaVita dialysis EMR software, which provides the right information to the physician in the right format and flow to assist in making the best decision. Again, the approach is not to standardize care, but to optimize decision making by understanding how physicians work and by incorporating best practices into decision support tools.

Standard facility orders are another tool in wide use within the dialysis industry but are less common in hospital practice. Standard facility orders apply to any component of the dialysis prescription, most commonly those associated with dialysate composition. Most patients in a facility will have physician orders for the facility-standard choice, and individualization is reserved for patients with specific indications. Standard facility orders (dialysate sodium and dialysate calcium are specific examples) are set by the facility governing body and serve to improve population outcomes while reducing the potential for medical error.

The future

As the focus of dialysis industry quality improvement efforts shift from managing the fundamentals alone (adequacy, access, anemia, and metabolic bone disorder, for example) to also improving patient health in more direct and complex dimensions (managing fluid, reducing infection, avoiding hospitalization, improving patient experience), the imperative to understand, capture, and extend best practice will be yet more important and will demand better evidence and more resources.2  We will need new tools to manage pharmaceutical agents and other new therapies, and because change will likely accelerate rather than slow, we will need to be much more agile. Protocols, pathways, and EMRs will need to extend beyond the physical limits of the dialysis facility to better integrate care with non-nephrology providers, including hospitals. As we move to a more integrated world, with more robust sharing of health information, managing the signal-to-noise ratio will be an increasing challenge.

In facing these challenges, there is some reassurance in knowing that, for the dialysis industry, there has long been consensus on the need for standardization tools and an achieved widespread use of these tools in improving quality and safety. The good news is: We are already making progress in this new world. Physicians are implementing “meaningful use” of electronic medical records. In addition, integrated care is a main goal of a new initiative from the federal government, which is partnering with groups of health care providers and suppliers to test and evaluate a new model of payment and care delivery specific to Medicare beneficiaries with end-stage renal disease. The goals of the model are to improve beneficiary health outcomes and reduce per capita Medicare expenditures. New legislation named the Dialysis PATIENT Demonstration Act (bills H.R. 5506 and S. 3090) that has been introduced in Congress would expand this model and is designed to achieve similar goals.

These improvements require a new way of thinking, new ways of managing of care and likely a great deal of trial and error. However, continuing to standardize and understand deviations from protocol, to analyze our processes and outcomes and to dedicate ourselves to continual improvement is no more than what our patients require and deserve.

References

  1. Goitein L, James, B. Standardized best practices and individual craft-based medicine: A conversation about quality. JAMA (online publication) May 16, 2016.
  2. Nissenson AR. Improving outcomes for ESRD Patients: Shifting the quality paradigm. Clin J Am Soc Nephrol 2014; 9:430-4.