Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
In kidney disease, the kidneys don’t work well to remove waste from the blood. Some people with kidney disease have end-stage kidney disease, or kidney failure. These patients have lost their kidney function. People with kidney failure need to have a kidney transplant or dialysis to live. Dialysis is a treatment with a machine that cleans the blood.
Most people in the United States who have kidney failure get dialysis at a clinic three times a week. During dialysis, providers try to keep the sessions stable. This means they try to prevent patients from having complications, such as low blood pressure. Unstable dialysis sessions can lead to negative outcomes like fatigue, hospital stays, or injury to the heart and other organs. Unstable sessions are common in the United States.
In this study, the research team is testing two ways to increase the stability of dialysis sessions. The first way involves training dialysis clinic staff and using a digital checklist. The second way involves educating patients.
Who can this research help?
Results may help dialysis clinics when considering ways to improve dialysis session stability.
What is the research team doing?
The research team is working with 28 dialysis clinics across the United States. The team is assigning each clinic to one of four groups by chance.
In the first group, clinics receive only the training for healthcare providers. Staff at these clinics learn how to prevent unstable dialysis sessions. Staff also have a checklist to help them identify patients who are more likely to have an unstable session.
Patients at clinics in the second group take part in a patient education program. The program includes peer mentoring from trained patients who have dialysis experience. Peer mentors have five meetings with patients using a tablet computer. At these meetings, peer mentors help patients change their behavior to help them have more stable sessions. Patients at clinics in this group also complete interactive online modules on a tablet to reinforce discussions with peer mentors.
Clinics in the third group receive provider training and also offer the patient education program. In the fourth group, clinics offer usual care, without either the provider training or the patient education program.
The research team is looking at medical records and comparing dialysis session stability across the clinics during the 12-week period before the program starts, during the 28-week program, and for 12 weeks after the program ends. Across the 28 clinics, the team is also comparing
- Patient recovery time after dialysis
- Patient symptoms reported at each dialysis session
- Weight gain between dialysis sessions
- Number of minutes of dialysis time, and number of sessions, missed per week
- Patient quality of life
- Whether the patient was hospitalized for any reason
- Whether the patient died of any cause
Dialysis clinics are helping to design, deliver, and test the staff training and patient education program. A project advisory committee includes healthcare providers, nonprofit organizations, and patients; patients are also on the research team.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | All non-vulnerable patients in 28 participating hemodialysis facilities who have not opted out of the study |
| Interventions/ Comparators |
|
| Outcomes |
Primary: dialysis session stability (intradialytic hypotension) Secondary: patient symptoms, fluid adherence, dialysis adherence, quality of life, hospitalizations, mortality |
| 1-year follow-up for primary outcome |