Abstract
Women and men on haemodialysis frequently experience symptoms of severe or overwhelming pain, fatigue, nausea, cramping, itching, trouble sleeping, and depression that contribute to poor quality of life. A focus on laboratory biomarkers of lower relevance to patients, may have resulted in missed opportunities to intervene and reduce symptoms and improve health-related quality of life. Recent trials in other clinical settings have shown that active symptom management can improve overall survival. The aim of this trial is to determine whether regular symptom monitoring with feedback to the renal team can improve health-related quality of life and overall survival among adults with end-stage kidney disease (ESKD) managed with facility-haemodialysis. Using a novel ANZDATA registry-based cluster randomised trial design, with adults receiving haemodialysis, the proposed trial will test the hypothesis that: 1) three-monthly symptom monitoring using the IPOS-Renal tool with feedback to clinicians improves health-related quality of life (measured by the EQ-5D), dialysis duration and frequency, and cause-specific mortality compared with usual care; and 2) electronic capture of patient-reported outcomes within a clinical quality registry is cost-effective. A two-arm design of 160 clusters (~3072 individuals) has 90% power to detect a 7% clinically meaningful increase in health-related quality of life (primary endpoint); and 80% power to detect an 11% reduction in deaths from dialysis withdrawal (secondary endpoint). The SWIFT pilot study commencing in December 2018 will assess the feasibility and acceptability of the intervention to patients and clinicians including feedback of how data was used. Funding for the SWIFT pilot study was awarded from Kidney Health Australia in July 2018. Ethics approval was received in August 2018, and the electronic patient reported outcome measures were developed in Qualtrics software, with a novel QR reader interface to link with the ANZDATA registry. Preliminary user testing suggested the recording of quality of life and symptom scores within defined response categories is straight forward, however has identified issues with the touch screen interface on tablet computers for the EQ-5D visual analogue scale. The findings from SWIFT may result in improved quality of life, lower symptom burden (both severity and number of symptoms), and lower rates of dialysis withdrawal with the potential to change practice in haemodialysis care. Of significance, SWIFT provides a template for registry-based randomised trial of health services interventions; ongoing bi-national monitoring of patient-reported outcome measures; and infrastructure for economic evaluation of subsequent interventions.
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