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
  • Provider training
  • Patient education
  • Both provider training and patient education
  • Usual care
Outcomes

Primary: dialysis session stability (intradialytic hypotension)

Secondary: patient symptoms, fluid adherence, dialysis adherence, quality of life, hospitalizations, mortality

Timeframe 1-year follow-up for primary outcome

Project Information

Tiffany Veinot, MLIS, PhD
University of Michigan
$7,353,575
Enhancing the Cardiovascular Safety of Hemodialysis Care: a Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions

Key Dates

September 2015
August 2023
2015

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Funding Opportunity Type
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022