In the United States, 421,349 patients—64% of all people with end-stage renal disease (ESRD)—are receiving hemodialysis therapy in an outpatient facility.1 The annual mortality rate for hemodialysis patients is 17.2%, with half from cardiovascular causes.1 Sudden cardiac death, the leading cause of death in hemodialysis patients, accounts for death in up to one-quarter of hemodialysis patients.2

Most hemodialysis patients receive therapy sessions three times a week, typically for 12 hours per week. Conventional, thrice weekly hemodialysis therapy delivered over a short period of time has been referred to as an “industrialized process,” one with potential for harm. Large volumes of fluid (e.g., 2-3 liters or more) are often removed at rapid rates during a typical hemodialysis session. In the face of pre-existing diminished cardiovascular reserves among patients, this often results in hemodynamic instability and “myocardial stunning”. Myocardial stunning is a form of cardiovascular harm that happens when there is repeated loss of fluid in the muscles of the heart (“myocardial hypoperfusion”). This results in abnormalities in the motion of the walls of the heart.3-5

In this article, we discuss the problem of hemodialysis session stability as a driver of cardiovascular harm, and outline barriers facing efforts to reduce cardiovascular complications of dialysis care. We then outline a promising new study that attempts to tackle these barriers and reduce hemodialysis-associated cardiovascular complications.

Hemodialysis session stability: A critical focus

Related to the potential for cardiovascular harm from hemodialysis, the stability of sessions varies, with an average of 20% becoming unstable—most commonly from low blood pressure during dialysis (“intradialytic hypotension”).6-8 Half of all hemodialysis patients experience intradialytic hypotension.6-8 Intradialytic hypotension often makes patients feel miserable as well; it may prompt muscle cramping, dizziness, vomiting, fainting, and fatigue.9-11 Highly unstable sessions may even require cardiopulmonary resuscitation or lead to hospitalization or rarely, even death during or immediately after a hemodialysis session. Hemodialysis session instability is a serious patient safety problem that is associated with repetitive and cumulative injury to the cardiovascular system and other organ systems.3-5

Why are so many patients experiencing unstable hemodialysis sessions? One of the key, potentially modifiable causes of unstable hemodialysis sessions is rapid removal of large amounts of fluid. Yet how often dialysis session instability happens varies across facilities and patients. The variation in the prevalence of session instability is driven by decisions made by multiple players: 1) self-care decisions made by patients; 2) care decisions made by hemodialysis care providers; and 3) facility-level policies.12,13

Read also: Prioritizing fluid management for the renal community

This suggests that it is possible for patients to receive hemodialysis care that is more stable and therefore safer. In recognition of this, the medical directors of 14 of the largest hemodialysis providers in the U.S. issued a statement for a paradigm shift in hemodialysis care towards a greater focus on fluid intake and volume control, an approach that they have called “volume first.”14 Unfortunately, adoption of safer fluid removal practices has not yet become widespread, and intradialytic hypotension remains the most common complication of hemodialysis therapy.

Barriers to changing routine practice

There are many barriers to providing more stable hemodialysis sessions for patients. First, thus far, no measures related to dialysis session instability are included in the Centers for Medicare & Medicaid Services’ End-stage Renal Disease Quality Incentive Program. CMS measures related to safety and dialysis adequacy do not include intradialytic hypotension and session stability more broadly. Related to this, hemodialysis facilities currently have varied approaches and capacity to track and evaluate fluid management goals.

Second, and most importantly, changing the standard of care in the U.S. requires changing the behavior of people: patients, renal care providers, and facility policy makers. Virtually no one involved in hemodialysis care will be unaffected by expanded and focused efforts to prevent dialysis session instability. For this reason, there is a need to develop intervention approaches that aim to improve care using approaches from the field of implementation science.

As a scholarly field, implementation science first emerged to address the fact that evidence-based interventions often have little immediate impact on health care practices. Thus, implementation science focuses on how best to facilitate the integration of new, evidence-based interventions into routine health care delivery. It is about finding the best ways to change care once clinical evidence has been established. Thus it is not about whether a clinical intervention (e.g., ultrafiltration rate (UFR) kept at <10 ml/hour for a complete hemodialysis session) is effective, but rather how to promote changes in routine care so that a UFR is typically kept at <10 ml/hour as part of routine care. At the same time, the field of implementation science has its own body of evidence, which focuses on methods of organizational change, workflow reengineering, knowledge translation, education, incentives, and behavior modification. Patient safety is one of the major domains of interest in implementation science.

A new initiative to improve the cardiovascular safety of hemodialysis care

With funding from the Patient-Centered Outcomes Research Institute (PCORI)’s Improving Healthcare Systems program, our research team is now embarking on a five-year implementation science-based trial that will evaluate two promising approaches to changing routine hemodialysis care.  The study is called “Enhancing the cardiovascular safety of hemodialysis care: a cluster-randomized, comparative effectiveness trial of multimodal provider education and patient activation interventions.” As part of the project, we will conduct a trial in 28 hemodialysis facilities that compares two approaches to reducing rates of hemodialysis dialysis session instability: 1) provider education and checklists, and 2) patient peer mentoring and multimedia education. Of importance, our project will also involve the development and monitoring of a measure of dialysis session instability, with a goal of making this measure an accepted indicator of hemodialysis care quality.

Read also: Why a fluid manager makes sense in your dialysis clinic

The project is a partnership between the University of Michigan, patient partners, the National Kidney Foundation (NKF), Fresenius Medical Care North America and the 5-Diamond Patient Safety Program, which involves nine ESRD Networks in the U.S. A national Advisory Committee will also be established that will incorporate an even wider range of stakeholders, including additional patient-driven organizations and dialysis facility providers. The project was funded as a result of PCORI’s independent, rigorous peer merit review process, which involves highly qualified and experienced scientists, patients, and stakeholders.

As part of this project, our research team and partners will translate interventions that have been successfully applied in other contexts, such as patient peer mentoring and use of checklists, to help hemodialysis patients and health care providers prevent session instability.

With regard to peer mentoring, our intervention builds upon a national, telephone-based patient peer mentoring program offered by study partner, the NKF. The content and format of the intervention will be determined by a team of patients, caregivers, health care providers, and scientists, as a result of extensive consultation processes that will include interviews and participatory design sessions. The NKF’s peer mentors will be trained in both patient education and behavior change techniques to deliver the specific intervention in a structured format. Based on clinical expertise, the content will include topics such as how to manage one’s fluid intake, the role of frequency and duration of dialysis therapy in session instability, and the potential risk of greater session instability early in the week after the longer gap in dialysis over the weekend. In keeping with the behavior change focus of the intervention, the content will include strategies that patients, in partnership with their care providers, can use to address these risks.

Similarly, the checklist will be based on a detailed review of the published clinical evidence on fluid management, as well as information gathered to assist in successful design and implementation of checklists. This information will be collected via interviews with health care providers, participatory design sessions, and a panel review process involving the national Advisory Committee. Staff in the participating facilities will also provide input into how to best implement the checklists so that they fit seamlessly within their workflow.

To test the results of the interventions, we will conduct a pragmatic cluster-randomized controlled trial (CRCT). A pragmatic trial is one that tests a new intervention in the actual environment in which it will be used. Participants will be the patients and staff at 28 facilities with at least 1,400 patients in several US regions.

Outpatient hemodialysis facilities will be randomized in a 2×2 factorial design. Hemodialysis facilities will be randomized to receive 1) both provider education and patient activation interventions, 2) provider education only, 3) patient activation intervention only or 4) no intervention. Each of the four groups will include seven facilities with at least 350 patients. The intervention will include an intensive period of six months and then a maintenance phase of six months.

Following this, we will conduct analyses of the main effect of the interventions on dialysis session stability. We will also conduct secondary analyses of the impact of the interventions on quality of life, fluid and dialysis adherence, symptoms, hospitalization, and mortality.

The contributions of this research include translating evidence-based interventions into the context of hemodialysis session safety, and generating critical comparative effectiveness information regarding hemodialysis safety interventions.

Study results will inform hemodialysis facilities regarding whether to pursue provider-focused or patient-focused safety interventions, or both. Results will also inform patients who want to become more engaged in safety-related decisions and activities. Ultimately, we believe that by engaging patients and providers, our efforts hold promise for effectively changing routine practice and reducing hemodialysis complications.

References

  1. Saran R, Li Y, Robinson B, et al. US Renal Data System 2015 Annual Data Report: epidemiology of kidney disease in the United States. Am J Kidney Dis 2016;67(3)(suppl 1):S1-S434
  2. Green D, Roberts PR, New DI, Kalra PA. Sudden cardiac death in hemodialysis patients: an in-depth review. Am J Kidney Dis. 2011;57(6):921-929.
  3. McIntyre CW. Haemodialysis-induced myocardial stunning in chronic kidney disease – a new aspect of cardiovascular disease. Blood Purif. 2010;29(2):105-110.
  4. Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced repetitive myocardial injury results in global and segmental reduction in systolic cardiac function. Clinical Journal of The American Society of Nephrology: CJASN. 2009;4(12):1925-1931.
  5. Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced cardiac injury: determinants and associated outcomes. Clinical Journal of The American Society of Nephrology: CJASN. 2009;4(5):914-920.
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  7. Kooman JP, Moret K, van der Sande FM, Gerlag PG, van den Wall Bake AW, Leunissen KM. Preventing dialysis hypotension: a comparison of usual protective maneuvers. Kidney Int. 2001;60(2):802-803.
  8. Sandberg F, Bailon R, Hernando D, et al. Prediction of hypotension in hemodialysis patients. Physiological measurement. 2014;35(9):1885-1898.
  9. Caplin B, Kumar S, Davenport A. Patients’ perspective of haemodialysis-associated symptoms. Nephrol Dial Transplant. 2011;26(8):2656-2663.
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  11. Twardowski ZJ. Treatment time and ultrafiltration rate are more important in dialysis prescription than small molecule clearance. Blood Purif. 2007;25(1):90-98.
  12. Sands JJ, Usvyat LA, Sullivan T, et al. Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome. Hemodial Int. 2014;18(2):415-422.
  13. Usyvat L, Sullivan T, Zabetakis P, Kotanko P, Maddux FW, Diaz-Buxo J. Intradialytic Hypotension (IH): Variation in Dialysis Facilities. 33rd Annual Dialysis Conference; March 10-12, 2013, 2013; Seattle, WA.
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About the authors

Dr. Veinot is associate professor, School of Information and School of Public Health, Dept. of Health Behavior and Health Education, University of Michigan. She is co-principal investigator of the study described in this article.

Mr. Bash is a peer mentor for the National Kidney Foundation and a patient advocate at the University of Michigan Health System. He is a patient partner on the study.

Dr. Bragg-Gresham is assistant research scientist at the Kidney Epidemiology and Cost Center, University of Michigan. She is a co-investigator for the study.

Mr. Dant is a peer mentor and Member of the National Alliance for Home Dialysis Innovation and Accountability Committee and of the WeKan patient activist national organization. He also served as a Member of the Medical Review board and Board of Directors, as well as the chairman of the Patient Committee for ESRD Network 15 in Denver Colorado from 1988-2012. He is a patient partner on the study.

Dr. Gillespie is associate research professor of statistics and associate director of the Center for Statistical Consultation and Research (CSCAR), University of Michigan. She is a co-investigator for the study.

Dr. Heung is clinical associate professor of internal medicine and director, Inpatient Dialysis Programs, University of Michigan. He is a co-investigator for the study.

Dr. Krein is a research health science specialist at the VA Ann Arbor Center for Clinical Management Research and research associate professor of Internal Medicine at the University of Michigan. She is a co-investigator for the study.

Dr. Saran is professor, internal medicine and associate director, Kidney Epidemiology and Cost Center, University of Michigan. He is co-principal investigator of the study.

Dr. Zheng is associate professor of informatics at the University of California-Irvine. He is a co-Investigator for the study.