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

• Published in: Trials
• Main Authors: B Logan, AK Viecelli, DW Johnson, EM Aquino, J Bailey, TA Comans, LC Gray, CM Hawley, LE Hickey, M Janda, A Jaure, MD Jose, E Kalaw, C Kiriwandeniya, M Matsuyama, G Mihala, KH Nguyen, E Pascoe, JD Pole, KR Polkinghorne, D Pond, R Raj, DM Reidlinger, N Scholes-Robertson, J Varghese, G Wong, RE Hubbard, on behalf of The GOAL Trial Investigators
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2023
• Subjects: Activities of daily living; Aged; Assessment; Chronic kidney disease; Cost-effectiveness; Dialysis; Medicine (General); R5-920; First Nations
• Online Access: https://doi.org/10.1186/s13063-023-07363-4; https://doaj.org/article/c1c854c6ff074e4f8eaf99cc79acb044

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 ...