Summary

for people ages 18 years and up (full criteria)
study started
estimated completion

Description

Summary

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.

Official Title

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

Details

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 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. The investigators will test whether session stability improves in the facilities that get either intervention over the one-year 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.

Keywords

Kidney Failure End Stage Renal Disease Hypotension Cardiovascular Diseases Patient Safety Peer Mentoring Team Training Checklist Kidney Failure, Chronic Renal Insufficiency Patient Activation Provider Education

Eligibility

For people ages 18 years and up

Selection is at the clinic level, not at the individual level.

Inclusion Criteria:

  • outpatient hemodialysis facilities
  • at least 50 adult (>18 years old) patients to guarantee sample size
  • at least four other facilities within a 70 mile radius

Exclusion Criteria:

  • facilities involved in another study
  • facilities in immediate jeopardy
  • facilities participating in ESRD Seamless Care Organization (ESCO) program
  • facilities with 1-star quality ratings
  • facilities with WiFi speeds less than 10,000 kbs upload/download

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
Links
Veinot T., Bash N., Bragg-Gresham JL. et al. Changing Routine Practice to Enhance the Cardiovascular Safety of Hemodialysis Care Nephrology News & Issues. 5/23/2016
ID
NCT03171545
Study Type
Interventional
Last Updated