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Enhancing the Cardiovascular Safety of Hemodialysis Care: a Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions ("Dialysafe")

Most people in the United States who have ESRD get hemodialysis therapy in a clinic for four hours at a time, three times a week. The stability of hemodialysis sessions varies, and many sessions become unstable from low blood pressure and other complications. Unstable dialysis sessions can result in negative symptoms, like fatigue.

Dialysis instability is an important problem. Session instability is linked to injury to the heart and other organs. Patients who have unstable dialysis sessions are more likely to end up in the hospital or die than are those who have stable sessions. Session instability is preventable. The main causes of instability are removal of fluid from a patient too fast or removal of too much fluid. Session instability results from many factors: decisions made by patients, decisions by healthcare providers, and dialysis clinic policies.

Presently, the way to best implement care practices to protect the heart and other organs during dialysis is not clear. Dialysis clinics approach this problem differently, and there is variation among clinics in how often hemodialysis sessions become unstable.

In partnership with the National Kidney Foundation and Fresenius Medical Care North America, we will test two interventions designed to increase the stability of patient dialysis. One intervention, multimodal provider education, focuses on dialysis facility care teams. It includes team training, online education, and checklists. Another intervention, patient activation, focuses on patients. It includes peer mentoring by trained ESRD patients and multimedia educational materials. Mentors will hold with other patients on tablet computers while patients at study facilities dialyze.

We will conduct a pragmatic study in 28 dialysis facilities in different parts of the United States. Seven facilities will get the provider education only; seven will get the patient activation intervention only; seven will get both interventions; and seven will get no interventions. We will test whether session stability improves in the facilities that get either intervention over the 28-week intervention period and the 12-week follow-up period. This study is expected to clarify whether these interventions can make dialysis more stable for ESRD patients. This will inform hemodialysis care providers on whether to pursue provider-focused or patient-focused safety interventions to implement care changes, or both. People on hemodialysis will also have information to help them decide whether to become engaged in session stability, and the intervention will help them learn how to do so.

Each of the 28 hemodialysis facilities in this study is a standalone site, but all are owned and administered by Fresenius Medical Care North America. Each facility rolls up under one responsible site, Fresenius Medical Care North America. There is an internal PI at Fresenius Medical Care is Dr. Dinesh Chatoth, Associate Chief Medical Officer. The Project Manager at Fresenius Medical Care is Rebecca Wingard, RN, CNN. We have received confirmation from the IRBMED that University of Michigan will serve as the single IRB for this multi-site research.

Principal Investigator: Tiffany Veinot

Co-investigators: Rajiv Saran, Michael Heung, Brenda Gillespie, Jennifer Bragg-Gresham, Kai Zheng, Dinesh Chatoth

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The amount of the award is $7,353,575 for the project period. The contract is funded by the Patient-Centered Outcomes Research Institute.