Study protocol for The GOAL Trial: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals—a cluster randomised controlled trial

Trials

Study Protocol

EM Aquino¹  E Pascoe¹  E Kalaw¹  LE Hickey¹  C Kiriwandeniya¹  M Matsuyama¹  J Varghese¹  DM Reidlinger¹  AK Viecelli²  CM Hawley²  DW Johnson³  J Bailey⁴  LC Gray⁴  TA Comans⁴  B Logan⁴  M Janda⁴  G Mihala⁵  JD Pole⁶  RE Hubbard⁷  KH Nguyen⁸  MDJose⁹  N Scholes-Robertson^1,10  R Raj^1,11  KR Polkinghorne^1,12  D Pond^1,13  A Jaure^1,14  G Wong^1,15 

[1] Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia;Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia;Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia;Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia;Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia;Centre for Kidney Disease Research, Translational Research Institute, Brisbane, Australia;Centre for Health Services Research, University of Queensland, Brisbane, Australia;Centre for Health Services Research, University of Queensland, Brisbane, Australia;Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia;Centre for Health Services Research, University of Queensland, Brisbane, Australia;Dalla Lana School of Public Health, The University of Toronto, Toronto, Canada;Centre for Health Services Research, University of Queensland, Brisbane, Australia;Department of Geriatric Medicine, Princess Alexandra Hospital, Brisbane, Australia;Centre for Health Services Research, University of Queensland, Brisbane, Australia;Global Brain Health Institute, Trinity College, Dublin, Ireland;Renal Unit, Royal Hobart Hospital, Hobart, Australia;School of Medicine, University of Tasmania, Hobart, Australia;Rural and Remote Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia;School of Medicine, University of Tasmania, Hobart, Australia;Department of Nephrology, Launceston General Hospital, Launceston, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;Department of Medicine, Monash University, Melbourne, Australia;Department of Nephrology, Monash Health, Melbourne, Australia;School of Rural Medicine, University of New England, Armidale, Australia;Wicking Centre, University of Tasmania, Hobart, Australia;School of Medicine, Western Sydney University, Sydney, Australia;Sydney School of Public Health, The University of Sydney, Sydney, Australia;Sydney School of Public Health, The University of Sydney, Sydney, Australia;Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, Australia;Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia;

关键词: Activities of daily living;    Aged;    Assessment;    Chronic kidney disease;    Cost-effectiveness;    Dialysis;    Cluster randomised controlled trial;    Comprehensive geriatric assessment;    Frail elderly;    Frailty;    Functional improvement;    Goal attainment scaling;    Goals;    Goal setting;    Process analysis;    Quality of life;    Reablement;    Recovery of function;    Treatment outcome;   

DOI  :  10.1186/s13063-023-07363-4

 received in 2023-03-22, accepted in 2023-05-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAn increasing number of older people are living with chronic kidney disease (CKD). Many have complex healthcare needs and are at risk of deteriorating health and functional status, which can adversely affect their quality of life. Comprehensive geriatric assessment (CGA) is an effective intervention to improve survival and independence of older people, but its clinical utility and cost-effectiveness in frail older people living with CKD is unknown.MethodsThe GOAL Trial is a pragmatic, multi-centre, open-label, superiority, cluster randomised controlled trial developed by consumers, clinicians, and researchers. It has a two-arm design, CGA compared with standard care, with 1:1 allocation of a total of 16 clusters. Within each cluster, study participants ≥ 65 years of age (or ≥ 55 years if Aboriginal or Torres Strait Islander (First Nations Australians)) with CKD stage 3–5/5D who are frail, measured by a Frailty Index (FI) of > 0.25, are recruited. Participants in intervention clusters receive a CGA by a geriatrician to identify medical, social, and functional needs, optimise medication prescribing, and arrange multidisciplinary referral if required. Those in standard care clusters receive usual care. The primary outcome is attainment of self-identified goals assessed by standardised Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS at 6 and 12 months, quality of life (EQ-5D-5L), frailty (Frailty Index – Short Form), transfer to residential aged care facilities, cost-effectiveness, and safety (cause-specific hospitalisations, mortality). A process evaluation will be conducted in parallel with the trial including whether the intervention was delivered as intended, any issue or local barriers to intervention delivery, and perceptions of the intervention by participants. The trial has 90% power to detect a clinically meaningful mean difference in GAS of 10 units.DiscussionThis trial addresses patient-prioritised outcomes. It will be conducted, disseminated and implemented by clinicians and researchers in partnership with consumers. If CGA is found to have clinical and cost-effectiveness for frail older people with CKD, the intervention framework could be embedded into routine clinical practice. The implementation of the trial’s findings will be supported by presentations at conferences and forums with clinicians and consumers at specifically convened workshops, to enable rapid adoption into practice and policy for both nephrology and geriatric disciplines. It has potential to materially advance patient-centred care and improve clinical and patient-reported outcomes (including quality of life) for frail older people living with CKD.Trial registrationClinicalTrials.gov NCT04538157. Registered on 3 September 2020.

【 授权许可】

CC BY   
© The Author(s) 2023

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