Project Summary

What is the research about? Most people with kidney failure, a condition that occurs when the kidneys are no longer able to meet the body’s day-to-day needs, are treated three times a week with hemodialysis to remove harmful wastes and excess fluid from the body. Hemodialysis is a life-saving treatment but often causes distressing symptoms. People treated with hemodialysis frequently report symptoms such as muscle cramps, itching, and fatigue, and these symptoms contribute to poor quality of life and hospitalizations. Research in patients with other chronic diseases show that frequently asking patients to report their symptoms using standardized questionnaires (patient-reported outcome measures) and helping medical providers follow up on reported symptoms can improve symptoms, quality of life, and health care use. In current hemodialysis practice in the United States, patients formally report their symptoms once a year on a quality of life survey, and there is no system to help medical providers follow up on the reported symptoms.

This study is comparing two approaches for monitoring and addressing symptoms among adult patients with kidney failure who are treated with hemodialysis. For the first approach patients use an electronic system twice a month to report their symptoms. The system sends alerts to their medical team at the dialysis clinic about the reported symptoms and gives suggestions about how to manage them. The system also provides reports that show patients and their medical team the reported symptoms over time. For the second approach patients complete a quality of life questionnaire that includes questions about symptoms once a year. The questionnaire does not have follow-up support like alerts, symptom management guidance, or reports. In addition, researchers will talk to patients, dialysis clinic personnel, and medical providers about their experiences using the electronic symptom monitoring system to learn about how to best use patient-reported outcome measures in dialysis care.

Who can this research help? Dialysis system and health insurance (Medicare) administrators can use findings from this study to learn about the best way to monitor and address hemodialysis patient symptoms. In addition, dialysis system administrators can learn about best practices for using patient-reported outcome measures in routine dialysis care.

What is the research team doing? The research team is working with 30 hemodialysis clinics across the country to enroll 2400 adults with kidney failure who are treated with hemodialysis. Patients must receive hemodialysis at one of the participating clinics and be willing to share their clinical information with the research team to participate in the study. The team is assigning each clinic to either the twice a month electronic symptom monitoring system or the once a year quality of life questionnaire. Every patient receiving hemodialysis at the clinic will receive the symptom monitoring approach to which their clinic has been assigned.

Over 12 months, the research team will measure changes in patients’ symptom severity; quality of life; specific symptoms such as fatigue, pain, anxiety, and depression; and healthcare use, to see if one approach has more benefit than the other. The researchers will also interview and survey patients, clinic personnel, and medical providers about their experiences with symptom reporting to learn about how to incorporate patient-reported outcome measures into routine dialysis care.

The research team is working with patients, healthcare providers, and representatives from dialysis delivery organizations and CMS as well as representatives from patient and professional organizations to design and conduct this study.

Design: Clinic-randomized controlled trial

Population: Adults with kidney failure receiving hemodialysis at the participating dialysis clinics who are willing to share their clinical information with the research team

Comparators: 1) twice a month electronic symptom monitoring system with supported medical provider follow-up and 2) once a year symptom monitoring via a quality of life survey without supported medical provider follow-up

Outcomes: Primary: symptom severity; Secondary: quality of life; specific symptoms such as fatigue, pain, anxiety, and depression; patient activation; hospitalizations; missed hemodialysis treatments; shortened hemodialysis treatments

Timeframe: 12-month follow-up for all outcomes

Project Information

Jennifer Flythe, MD, MPH
Laura Dember, MD
The University of North Carolina at Chapel Hill
$5,711,565 *

Key Dates

60 months *
March 2022
2022

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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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
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Last updated: March 8, 2022