Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

Study Overview
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Brief Summary
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The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

Detailed Description
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When a person's kidneys stop working, he or she has end-stage renal disease (ESRD). Individuals with ESRD cannot live without either dialysis therapy-in which a machine performs the functions of the kidneys-or a kidney transplant. Dialysis must remove fluid as well as toxins in the blood. People with ESRD have a high risk for death, and the usual cause is cardiovascular disease. 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, and decisions by healthcare providers. Presently, the way to best improve the stability of 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, the investigators 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 a checklist. Another intervention, patient activation, focuses on patients. It includes peer mentoring by trained ESRD patients. Mentors will hold with other patients multimedia-aided meetings that include skills instruction and role modeling. These interventions have been successful in hospital care and in chronic disease care, and the investigators will adapt them to dialysis safety. The investigators will then conduct a study in 20 dialysis facilities in different parts of the United States. Five facilities will get the provider education only; five will get the patient activation intervention only; five will get both interventions; and five will get no interventions. The investigators will test whether session stability improves in the facilities that get either intervention over the 48-week study period. This study is expected to clarify whether these interventions can make dialysis safer for ESRD patients. This will inform hemodialysis care providers on whether to pursue provider-focused or patient-focused safety interventions, or both. People on hemodialysis will also have information to help them decide whether to become engaged in their session stability, and the intervention will help them learn how to do so.

Official Title
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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)

Conditions
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Kidney Failure, End Stage Renal Disease, Hypotension, Cardiovascular Diseases, Patient Safety

Intervention / Treatment
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* Behavioral: Patient Activation
* Behavioral: Provider Education


Participation Criteria
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Eligibility Criteria
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Selection is at both the clinic level and individual patient level. Clinic Inclusion Criteria: outpatient hemodialysis facilities at least 70 adult (>21 years old) patients to guarantee sample size Clinic Exclusion Criteria: facilities involved in another study facilities in immediate jeopardy facilities with 1-star quality ratings facilities designated as COVID-19 isolation facilities Individual Patient Exclusion Criteria: individual patients who are currently incarcerated individual patients who have poor cognition or cognitive impairment individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish individual patients who have opted out of data collection

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The study is a 2X2 factorial design, such that five facilities will get the provider education only; five will get the patient activation intervention only; five will get both interventions; and five will get no interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Activation<br>This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling. | Behavioral: Patient Activation<br>* Patients in clinics assigned to this group will be offered peer mentoring and digital resources.<br>|
| Experimental: Provider Education<br>This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. | Behavioral: Provider Education<br>* Staff in clinics assigned to this group will receive team training and a checklist.<br>|
| No Intervention: No Intervention<br>Patients in clinic receive usual care. | |
| Experimental: Patient and Provider<br>This arm includes both Patient Activation and Provider Education interventions | Behavioral: Patient Activation<br>* Patients in clinics assigned to this group will be offered peer mentoring and digital resources.<br>Behavioral: Provider Education<br>* Staff in clinics assigned to this group will receive team training and a checklist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Session Stability | Binary variable whereby session is labeled unstable (=1) or stable (=0). Sessions will be labeled unstable (=1) if: (1) intradialytic hypotension occurs, which is defined as systolic blood pressure falling below 100. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Adherence | Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions. | 48 weeks | 
| Dialysis adherence - minutes missed | Measured as the number of minutes of prescribed dialysis time missed per week (number of prescribed minutes-number of actual minutes). | 48 weeks | 
| Dialysis adherence - sessions missed | Measured as the number of missed sessions per week (number of prescribed sessions-number of actual sessions). | 48 weeks | 
| Patient symptoms - post-dialysis recovery time | Measured at each session as patient recovery time after dialysis, reported on a survey item on an ordinal scale from within minutes to did not recover before the next scheduled dialysis session. | 48 weeks | 
| Patient symptoms - symptom burden | Measured as the total number symptoms reported by the patient at each session (each symptom treated as one, then added to create total symptoms). | 48 weeks | 
| Quality of Life-KDQOL | Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1). | 52 weeks | 
| Hospitalization | Binary variable, measured as whether or not a patient was hospitalized for any reason, where hospitalization=1 and no hospitalization=0 (all-cause hospitalizations). | 48 weeks | 
| Mortality | Binary variable, measured as whether or not a patient died of any cause, where mortality=1 and no mortality=0 (all-cause mortality). | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer Mentoring, Team Training, Checklist