JMIR Publications

ABSTRACT

Background:

End-stage kidney disease (ESKD) is treated by dialysis or a kidney transplant, with the majority of ESKD patients receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular/hemodynamic instability, with the most common form being low blood pressure during the dialysis treatment (“intradialytic hypotension,” or “IDH”). IDH is a complication of hemodialysis that can involve symptoms such as fatigue, nausea, cramping, and loss of consciousness. IDH increases risks of cardiovascular disease, and ultimately hospitalizations and mortality. Provider-level and patient-level decisions influence the occurrence of IDH; thus, IDH may be preventable in routine hemodialysis care.

Objective:

This study has a primary objective of evaluating the independent and comparative effectiveness of two interventions—one directed at hemodialysis providers and another for patients—in reducing the rate of IDH at hemodialysis facilities. Additionally, the study will assess the interventions’ effects on secondary patient-centered clinical outcomes and examine factors associated with successful implementation of the interventions.

Methods:

This study is a pragmatic, cluster-randomized trial to be conducted in 20 hemodialysis facilities in the United States. Hemodialysis facilities will be randomized using a 2x2 factorial design, such that 5 sites will receive a multimodal provider education intervention, 5 sites will receive a patient activation intervention, 5 sites will receive both interventions, and 5 sites will receive neither. The multimodal provider education intervention involves theory-informed team training and the use of a digital, tablet-based checklist to heighten attention to patient clinical factors associated with increased IDH risk. The patient activation intervention involves tablet-based, theory-informed patient education and peer mentoring. Patient outcomes will be monitored during a 12-week baseline period, followed by a 24-week intervention period and a 12-week post-intervention follow-up period. The study’s primary outcome is the proportion of treatments with IDH, which will be aggregated at the facility level. Secondary outcomes include patient symptoms, fluid adherence, hemodialysis adherence, quality of life, hospitalizations, and mortality.

Results:

This study is funded by the Patient-Centered Outcomes Research Institute (PCORI) and approved by the University of Michigan Medical School’s Institutional Review Board (IRBMED). The study began enrolling patients in January 2023. Initial feasibility data will be available in May 2023. Data collection will conclude in November 2024.

Conclusions:

The effects of provider and patient education on reducing the proportion of sessions with IDH and improving other patient-centered clinical outcomes will be evaluated, and the findings used to inform further improvements in patient care. Improving the stability of hemodialysis sessions is a critical concern for clinicians and ESKD patients; the interventions targeted to providers and patients are predicted to lead to improvements in patient health and quality of life. Clinical Trial: clinicaltrials.gov ID NCT03171545; https://clinicaltrials.gov/ct2/show/NCT03171545