. 2023 May 30;24(1):365.

doi: 10.1186/s13063-023-07363-4.

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

B Logan¹, A K Viecelli^{2

3}, D W Johnson^{2

3

4}, E M Aquino², J Bailey⁵, T A Comans⁵, L C Gray⁵, C M Hawley^{2

3}, L E Hickey², M Janda⁵, A Jaure⁶, M D Jose^{7

8}, E Kalaw², C Kiriwandeniya², M Matsuyama², G Mihala^{5

2}, K H Nguyen^{5

9}, E Pascoe², J D Pole^{5

10}, K R Polkinghorne^{11

12

13}, D Pond^{14

15

16}, R Raj^{8

17}, D M Reidlinger², N Scholes-Robertson¹⁸, J Varghese², G Wong^{6

19

20}, R E Hubbard^{5

21}; GOAL Trial Investigators

Collaborators, Affiliations

Collaborators

GOAL Trial Investigators:
Graham Buckle, Phil Carswell, Joanne Cerni, Michael G Collins, Amanda Elms, John Fanning, Karen Fischer, Adam Flavell, Emily H Gordon, Natalie Grainer, Stella Green, Chandana Guha, Samantha Hand, Moira Hibbs, Bronwyn Hockley, Rachael Irvine, Ibrahim Ismail, Shilpanjali Jesudason, George Kan, Debbie Kennedy, Vinod Khelgi, Shannon Kokoszka, Anoushka Krishnan, Janelle Leadbitter, Diana Leary, Angela Makris, Khalilah Katherine Marquez, David McIntyre, Penelope Murie, Karina Murphy, Nancye Peel, Xiaodan Qiu, Madeleine Rapisardi, Matthew A Roberts, Simon D Roger, Mona Saade, Shaundeep Sen, Gerald Tataro, Brioney Weaver, Paul A Yates, Belinda Yip

Affiliations

¹ Centre for Health Services Research, University of Queensland, Brisbane, Australia. benignus.logan@uq.edu.au.
² Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
³ Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia.
⁴ Centre for Kidney Disease Research, Translational Research Institute, Brisbane, Australia.
⁵ Centre for Health Services Research, University of Queensland, Brisbane, Australia.
⁶ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
⁷ Renal Unit, Royal Hobart Hospital, Hobart, Australia.
⁸ School of Medicine, University of Tasmania, Hobart, Australia.
⁹ Global Brain Health Institute, Trinity College, Dublin, Ireland.
¹⁰ Dalla Lana School of Public Health, The University of Toronto, Toronto, Canada.
¹¹ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
¹² Department of Medicine, Monash University, Melbourne, Australia.
¹³ Department of Nephrology, Monash Health, Melbourne, Australia.
¹⁴ School of Rural Medicine, University of New England, Armidale, Australia.
¹⁵ Wicking Centre, University of Tasmania, Hobart, Australia.
¹⁶ School of Medicine, Western Sydney University, Sydney, Australia.
¹⁷ Department of Nephrology, Launceston General Hospital, Launceston, Australia.
¹⁸ Rural and Remote Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
¹⁹ Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
²⁰ Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.
²¹ Department of Geriatric Medicine, Princess Alexandra Hospital, Brisbane, Australia.

PMID: 37254217
PMCID: PMC10227800
DOI: 10.1186/s13063-023-07363-4

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

B Logan et al. Trials. 2023.

. 2023 May 30;24(1):365.

doi: 10.1186/s13063-023-07363-4.

Authors

Collaborators

GOAL Trial Investigators:
Graham Buckle, Phil Carswell, Joanne Cerni, Michael G Collins, Amanda Elms, John Fanning, Karen Fischer, Adam Flavell, Emily H Gordon, Natalie Grainer, Stella Green, Chandana Guha, Samantha Hand, Moira Hibbs, Bronwyn Hockley, Rachael Irvine, Ibrahim Ismail, Shilpanjali Jesudason, George Kan, Debbie Kennedy, Vinod Khelgi, Shannon Kokoszka, Anoushka Krishnan, Janelle Leadbitter, Diana Leary, Angela Makris, Khalilah Katherine Marquez, David McIntyre, Penelope Murie, Karina Murphy, Nancye Peel, Xiaodan Qiu, Madeleine Rapisardi, Matthew A Roberts, Simon D Roger, Mona Saade, Shaundeep Sen, Gerald Tataro, Brioney Weaver, Paul A Yates, Belinda Yip

Affiliations

¹ Centre for Health Services Research, University of Queensland, Brisbane, Australia. benignus.logan@uq.edu.au.
² Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
³ Department of Kidney and Transplant Services, Princess Alexandra Hospital, Brisbane, Australia.
⁴ Centre for Kidney Disease Research, Translational Research Institute, Brisbane, Australia.
⁵ Centre for Health Services Research, University of Queensland, Brisbane, Australia.
⁶ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
⁷ Renal Unit, Royal Hobart Hospital, Hobart, Australia.
⁸ School of Medicine, University of Tasmania, Hobart, Australia.
⁹ Global Brain Health Institute, Trinity College, Dublin, Ireland.
¹⁰ Dalla Lana School of Public Health, The University of Toronto, Toronto, Canada.
¹¹ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
¹² Department of Medicine, Monash University, Melbourne, Australia.
¹³ Department of Nephrology, Monash Health, Melbourne, Australia.
¹⁴ School of Rural Medicine, University of New England, Armidale, Australia.
¹⁵ Wicking Centre, University of Tasmania, Hobart, Australia.
¹⁶ School of Medicine, Western Sydney University, Sydney, Australia.
¹⁷ Department of Nephrology, Launceston General Hospital, Launceston, Australia.
¹⁸ Rural and Remote Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
¹⁹ Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
²⁰ Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.
²¹ Department of Geriatric Medicine, Princess Alexandra Hospital, Brisbane, Australia.

PMID: 37254217
PMCID: PMC10227800
DOI: 10.1186/s13063-023-07363-4

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.

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

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Conflict of interest statement

DWJ has received consultancy fees, research grants, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care, consultancy fees from Astra Zeneca, Bayer, and AWAK, speaker’s honoraria from ONO and Boehringer Ingelheim & Lilly, and travel sponsorships from Ono and Amgen. None of these are related to the current study.

CMH has received fees paid to her institution from Janssen and GlaxoSmithKline; Advisory Board fees paid to her from Otsuka; Research Grants to her institution from Otsuka, Shire, Fresenius, and Baxter. In addition, she has received grants paid to her institution from the Polycystic Kidney Disease Foundation of Australia. None of these are related to the current study.

Figures

**Fig. 1**
SPIRIT Figure [1, 2] showing the study schedule for enrolment, intervention and assessments

See this image and copyright information in PMC

References

1. Chan AW, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 10.1136/bmj.e7586. - PMC - PubMed
1. Chan AW, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583. - DOI - PMC - PubMed
1. Webster ACAP, et al. Chronic Kidney Disease. Lancet. 2016;389(10075):1238–1252. doi: 10.1016/S0140-6736(16)32064-5. - DOI - PubMed
1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Inter Suppl. 2013;3(1):19–62.
1. Bikbov B, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709–733. doi: 10.1016/S0140-6736(20)30045-3. - DOI - PMC - PubMed

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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

Collaborators

Affiliations

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

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials