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
Authors: Logan B , Viecelli AK , Johnson DW , Aquino EM , Bailey J , Comans TA , Gray LC , Hawley CM , Hickey LE , Janda M , Jaure A , Jose MD , Kalaw E , Kiriwandeniya C , Matsuyama M , Mihala G , Nguyen KH , Pascoe E , Pole JD , Polkinghorne KR , Pond D , Raj R , Reidlinger DM , Scholes-Robertson N , Varghese J , Wong G , Hubbard RE , Buckle Graham , Carswell Phil , Cerni Joanne , Collins Michael G. , Elms Amanda , Fanning John , Fischer Karen , Flavell Adam , Gordon Emily H. , Grainer Natalie , Green Stella , Guha Chandana , Hand Samantha , Hibbs Moira , Hockley Bronwyn , Irvine Rachael , Ismail Ibrahim , Jesudason Shilpanjali , Kan George , Kennedy Debbie , Khelgi Vinod , Kokoszka Shannon , Krishnan Anoushka , Leadbitter Janelle , Leary Diana , Makris Angela , Marquez Khalilah Katherine , McIntyre David , Murie Penelope , Murphy Karina , Peel Nancye , Qiu Xiaodan , Rapisardi Madeleine , Roberts Matthew A. , Roger Simon D. , Saade Mona , Sen Shaundeep , Tataro Gerald , Weaver Brioney , Yates Paul A. , Yip Belinda ,   on behalf of The GOAL Trial Investigators
Published: May 2023

Abstract
Background
An 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.

Methods
The 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.

Discussion
This 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 registration
ClinicalTrials.gov NCT04538157. Registered on 3 September 2020.