Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients, With Results Notification to Teams. A Cluster Randomised Controlled Trial Nested in a National Registry F-SWIFT (French Symptom Monitoring WIth Feedback Trial)
In France, end-stage renal disease (ESRD) affects almost 170 people per million inhabitants every year, and 92,500 people are treated by dialysis or kidney transplantation (0.14% of the French population). The treatment of chronic renal failure is extremely costly: 4 billion euros in 2021, i.e. 2% of health insurance expenditure, and an annual cost of 42,000 euros per patient. The health-related quality of life (HRQoL) of dialysis patients is low, with reports of patients at 40%-60% of full health. In France, there has been a significant decrease in physical (-15.4 points) and mental (-6.9 points) component scores compared with the general population. Dialysis patients often present severe or overwhelming symptoms, which contribute to this poor HRQoL. However, in nephrology, studies have focused on survival and laboratory biomarkers, and very few interventions have been aimed at improving what was a priority for patients, i.e. treating their symptoms and improving their HRQoL. Opportunities to intervene and improve symptom management and overall HRQoL may therefore have been missed. Ignoring patients' symptoms is an important omission. Of 28 randomized trials in primary care and oncology that measured the impact of communicating patient-reported outcomes to clinicians, 65% showed improved care processes and 47% improved health outcomes. The results of two recent randomized trials in oncology suggest that symptom monitoring can improve HRQoL and overall survival. There is no evidence for dialysis patients, although therapeutic solutions are available in most cases. Nephrology teams do not sufficiently recognize the prevalence, severity and negative effects of symptoms in their patients, and patients under-report their symptoms. With systematic symptom screening and automatic transmission of symptoms in the form of alerts, dialysis staff will be able to react and implement routine management to alleviate patients' symptoms. The F-SWIFT study evaluates the hypothesis that regular symptom monitoring and feedback to hemodialysis patients and their dialysis staff improves patient HRQoL at 18 months. In addition, the trial aims to determine whether electronic capture of patient-reported outcomes within a national dialysis patient registry is feasible and cost-effective, evaluated using consumption data from the Système National des données de Santé (SNDS) medico-administrative database. F-SWIFT is the French part of an international project (SWIFT) initiated in Australia in 2021: Australian New Zealand Clinical Trials Registry #ACTRN12620001061921. This French part is funded by Inserm's AAP MESSIDORE 2022. F-SWIFT is also the continuation of the pilot study n° 2021-A00776-35 accepted by the CPP EST II on 19/10/2021 and financed by the Agence de la Biomédecine (AOR 2021) in the RIPH3 category.
⁃ Symptom collection phase
⁃ The inclusion criteria for patients are as follows:
• Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data.
• Adults aged 18 and over
• Patients with end-stage renal disease treated by dialysis in participating dialysis units
• Patients able to answer questionnaires
⁃ Process evaluation phase
⁃ The inclusion criteria for healthcare professionals are as follows:
• Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data.
• Patients with end-stage renal disease treated by dialysis in participating dialysis units.
• Doctors and nurses working in the dialysis unit taking part in the study.