The GOAL trial protocol: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals– A cluster randomised controlled trial
Logan, B and Johnson, DW and Tong, A and Comans, T and Janda, M and Pond, C and Pascoe, E and Peel, NM and Gray, L and Pole, J and Polkinghorne, K and Jose, M and Gordon, EH and Scholes-Robertson, N and Bailey, J and Robison, L and Hawley, C and Varghese, J and Kiriwandeniya, C and Reidlinger, D and Hubbard, RE, The GOAL trial protocol: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals- A cluster randomised controlled trial ISSN 1320-5358 (2020) [Conference Extract]
Aim: To determine if a Comprehensive Geriatric Assessment (CGA) will allow frail older patients with chronic kidney disease (CKD) to better attain their treatment goals and improve their frailty and quality of life, while being cost-effective.
Background: There is an increasing number of frail older patients with CKD. Many of them face deteriorating health and functional status, which adversely affects their quality of life. CGA is an effective intervention to improve survival and independence of older people but its effect in people with CKD remains unknown.
Methods: GOAL is a NHMRC-funded cluster randomised controlled trial developed by consumers, clinicians and researchers. It will recruit patients from January 2021 aged ≥65 with CKD stage 3–5/5D and a Frailty Index >0.25. The intervention clusters will receive a CGA by a geriatrician to identify medical, social and functional needs, optimise medication prescribing and arrange multidisciplinary referral if required. The primary outcome is attainment of patient determined goals assessed by standardised Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS scores 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) at 12 months.
Results: A two-arm design of 16 clusters with 1:1 allocation (~500 participants) has 90% power to detect a clinically meaningful mean difference in GAS score of 10 units.
Conclusions: The GOAL trial addresses patient-prioritised outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This is the first study, internationally, to evaluate the clinical and cost effectiveness of CGA in improving patient-important health outcomes in frail older people with CKD.