Feasibility of Symptom monitoring WIth Feedback Trial (SWIFT) for adults on hemodialysis: a registry-based cluster randomized pilot trial.

Autor: Agarwal N; NHMRC Clinical Trials Centre, University of Sydney, Level 6, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia. neeru.agarwal@sydney.edu.au., Shah KK; NHMRC Clinical Trials Centre, University of Sydney, Level 6, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia., Dansie K; Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia., Bennett PN; Medical and Clinical Affairs, Satellite Healthcare, San Jose, USA.; Clinical & Health Sciences, University of South Australia, Adelaide, Australia., Greenham L; Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia., Brown C; NHMRC Clinical Trials Centre, University of Sydney, Level 6, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia., Smyth B; NHMRC Clinical Trials Centre, University of Sydney, Level 6, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia.; Department of Renal Medicine, St George Hospital, Kogarah, Australia., McDonald S; Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia.; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.; Central Northern Adelaide Renal and Transplantation Service, Adelaide, Australia., Jesudason S; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.; Central Northern Adelaide Renal and Transplantation Service, Adelaide, Australia., Viecelli AK; Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.; Faculty of Medicine, University of Queensland, Brisbane, Australia., Morton RL; NHMRC Clinical Trials Centre, University of Sydney, Level 6, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia.
Jazyk: angličtina
Zdroj: BMC nephrology [BMC Nephrol] 2023 Nov 22; Vol. 24 (1), pp. 345. Date of Electronic Publication: 2023 Nov 22.
DOI: 10.1186/s12882-023-03399-5
Abstrakt: Background: Patients with kidney failure on hemodialysis (HD) experience considerable symptom burden and poor health-related quality of life (HRQoL). There is limited use of patient reported outcome measures (PROMs) in facility HD units to direct immediate care, with response rates in other studies between 36 to 70%. The aim of this pilot study was to evaluate feasibility of electronic PROMs (e-PROMs) in HD participants, with feedback 3-monthly to the participants' treating team, for severe or worsening symptoms as identified by the Integrated Palliative Outcome Scale (IPOS-Renal), with linkage to the Australian and New Zealand Dialysis and Transplant (ANZDATA) registry, compared with usual care.
Methods: This is a registry-based cluster-randomized controlled pilot trial involving all adults receiving HD in 4 satellite units in Australia over a 6-month period. HD units were cluster randomized 1:1 to the control (HRQoL data collection only) or intervention arm (symptom monitoring with feedback to treating team every 3 months). Feasibility was assessed by participant response rate (percentage of eligible HD participants, including new incident participants, who completed the questionnaire at each time point); retention rate (percentage of participants who completed the baseline questionnaire and all subsequent measures); and completion time. HRQoL and symptom burden scores are described.
Results: There were 226 unique participants who completed the e-PROMs (mean age 62 years, 69% males, 78% White-European, median dialysis vintage 1.62 years). At 6 months, response rate and retention rate for the intervention arm were 54% and 68%, respectively, and 89% and 97% in the control arm. Median time to complete IPOS-Renal was 6.6 min (5.3, 10.1) at 3 months, and when combined with the outcome measure (EQ-5D-5L), the median time was 9.4 min (6.9, 13.6) at 6 months.
Conclusions: Electronic symptom monitoring among HD participants with feedback to clinicians is feasible. Variations in response and retention rates could be potentially explained by the lengthier questionnaire, and higher frequency of data collection time points for participants in the intervention arm. A definitive national RCT is underway.
Trial Registration: ACTRN12618001976279 (07/12/2018).
(© 2023. The Author(s).)
Databáze: MEDLINE
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