R MORTON1, L M GREENHAM2, A K VIECELLI3, P N BENNETT4, S JESUDASON2,5,6, C BROWN1, W A HANDKE7, R MISTER1, P WESTALL1, J R SIMES1, M D JOSE8, R RAJ9, P CHOI10, P MOUNT11, L LARANJO12, S C PALMER13, A SALMON14, A TONG15, D C HARRIS12,16, C HAWLEY3, D W JOHNSON3, S P MCDONALD2,5,6
1University Of Sydney, NHMRC Trials Centre, Camperdown, Australia, 2Australia and New Zealand Dialysis and Transplant Registry and SA Health and Medical Research Institute, Adelaide, Australia, 3Princess Alexandra Hospital , Woolloongabba, Brisbane, Australia, 4Satellite Healthcare, San Jose, United States, 5Royal Adelaide Hospital, Adelaide, Australia, 6Adelaide Medical School, University of Adelaide, Adelaide, Australia, 7Private Citizen, Kambah, Australia, 8University of Tasmania, Hobart, Australia, 9University of Launceston, Launceston, Australia, 10John Hunter Hospital, New Lambton Heights, Australia, 11Austin Health, Heidelberg, Australia, 12University of Sydney, Camperdown, Australia , 13University of Otago , Christchurch, New Zealand, 14Waitematā District Health Board, , New Zealand, 15Centre for Kidney Research, Westmead hospital, Westmead, Australia, 16Westmead Hospital , Westmead, Australia
Aim: To determine whether symptom monitoring with feedback to patients and clinicians improves health-related quality of life (HR-QoL) and cause-specific mortality in adults treated with haemodialysis (HD); and whether electronic capture of patient-reported outcome measures (PROMs) within ANZDATA is cost-effective.
Background: Adults treated with HD for kidney failure experience high burden of symptoms, including fatigue, itching and pain, and have reduced health-related quality of life (HR-QoL). Two trials in oncology have shown active symptom management improves survival and HR-QoL.
Methods: This abstract reports the protocol of an NHMRC-funded, ANZDATA registry-based, cluster randomised trial with 1:1 allocation, developed by clinicians, researchers and consumers. Symptom monitoring in the intervention clusters will use the Integrated Palliative Outcome Scale-Renal (IPOS-Renal) 3-monthly, with results fed back to patients and treating clinicians. Clinicians will also receive evidence-based symptom management guidance. HR-QoL (primary endpoint) will be measured by the EQ-5D-5L at baseline, 6 and 12 months. A two-arm design of 160 clusters (~3072 individuals) is estimated to have 90% power to detect a 7% (clinically meaningful) change in HR-QoL; and 80% power to detect an 11% reduction in death following dialysis withdrawal (secondary endpoint). Other secondary outcomes include symptom management practices, symptom burden, the Standardised Outcomes in Nephrology (SONG-HD) Fatigue score and cost-effectiveness determined via linkage to administrative data.
Results: CALHN Ethics approval granted 28/08/20; site feasibility indicates willingness to participate from private and public sector satellite units in Australia and New Zealand.
Conclusions: Symptom monitoring with feedback is hypothesised to improve HR-QoL and decrease symptom burden and death following dialysis withdrawal. SWIFT provides an evidence base for ANZDATA collection of PROMs and registry infrastructure for economic evaluation in future registry-based trials.
Professor Rachael Morton (PhD, MSc(Clin Epi)(Hons)) is a senior health economist. She is Director of Health Economics at the NHMRC Clinical Trials Centre and Professor in the Faculty of Medicine and Health, University of Sydney where she leads a specialised team of economists and economic modellers. She has published >150 research articles, and won >$50M in competitive research grants. Professor Morton is Chair of the patient reported outcome measures (PROMs) working group for ANZDATA, and the lead health economist for many kidney research projects including CARSK, MODUS and SWIFT.