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

The authors acknowledge the contributions of the following individuals to The GOAL Trial and this manuscript: Nisha Anthony (Royal Perth Hospital), Ricky Arenson (Royal Perth Hospital), Bhadran Bose (Department of Renal Medicine, Nepean Hospital), Sabine Braat (The University of Melbourne), Sreenath Bukkapatnam (Logan Hosptial), Katrina Campbell (Australasian Kidney Trials Network, The University of Queensland), Elissa Campbell (Sir Charles Gairdner Hospital), Hayley B Candler (Australasian Kidney Trials Network, The University of Queensland), Simon Carter (The Royal Children’s Hospital, Melbourne), Hicham Cheikh Hassan (Renal Unit, Wollongong Hospital), Yeoungjee Cho (Department of Kidney and Transplant Services, Princess Alexandra Hospital), Philip Clayton (Royal Adelaide Hospital), Jonathan C Craig (Flinders University), Vanessa Cullen (Consumer Advocate), Jessica Dawson (NHMRC Clinical Trial Centre, The University of Sydney), Leon Flicker (University of Western Australia), Celine Foote (Concord Repatriation General Hospital), Sarah Fox (The University of Queensland), Ross Francis (Princess Alexandra Hospital), Kirsten Howard (Menzies Centre for Health Policy and Economics, Sydney School of Public Health, The Sydney University), Andrew Huynh (Department of Geriatric Medicine, Austin Health), Nicole Isbel (Department of Nephrology, Princess Alexandra Hospital), Dev K Jegatheesan (Princess Alexandra Hospital), Danelle Kenny (The University of Queensland), Khadija Khatry (Logan Hospital), Angeline Khoo (Townsville Hospital), Rathika Krishnasamy (Sunshine Coast University Hospital), Rathika Krishnasamy (Australasian Kidney Trials Network, The University of Queensland), Dickson Lam (Concord Repatriation General Hospital), Nicholas Larkins (Department of Nephrology, Perth Children’s Hospital), Kathryn Lee (Austin Health), Alice Lee (Toowoomba Hospital), Andrea Lees (Royal Hobart Hospital), Claire Long (Western Health), Peter F Mount (Department of Nephrology, Austin Health), David Mudge (Princess Alexandra Hospital), Samantha Ng (Princess Alexandra Hospital), Danielle Ni Chroinin (Liverpool Hospital), Suetonia C Palmer (The University of Otago, Christchurch, New Zealand), Bonnie Pimm (The University of Queensland), Stephanie Polley (Blacktown Hospital), Daniela Potter (Renal Department, South Western Sydney Local Health District, Liverpool), Tracey Putt (University of Otago, Dunedin, New Zealand), Kannaiyan Rabindranath (Waikato Hospital, Hamilton, New Zealand), Gowri Raman (Concord Repatriation General Hospital), Angus G Ritchie (Concord Repatriation General Hospital), Ken-Soon Tan (Logan Hospital), Armando Teixeira-Pinto (Sydney School of Public Health, The University of Sydney), Andrea Valks (Australasian Kidney Trials Network, The University of Queensland), Paul Varghese (Princess Alexandra Hospital), Louise Waite (Concord Repatriation General Hospital), Robert Walker (University of Otago, Dunedin, New Zealand), Rachael C Walker (Te Pukenga / Eastern Institute of Technology, Hamilton, New Zealand), Amanda Y Wang (Department of Renal Medicine, Concord Clinical School, The University of Sydney), Vidu Wijeratne (Renal Research Gosford), Daniel Wong (Renal Research Gosford)

The authors acknowledge the following committees who have contributed to the trial’s development and operation: The GOAL Trial Steering Committee, The GOAL Trial Management Committee, The GOAL Trial Consumer Advisory Board, The GOAL Trial Chief and Associate Investigators for the NHMRC Grant, The GOAL Trial Data and Safety Monitoring Board, AKTN Executive Operations Secretariat, AKTN Leadership Team, AKTN Project Management Team, and AKTN Scientific Committee.

The support of the following study sites has been integral to this trial, and they are acknowledged with thanks: Austin Health, Blacktown Hospital, Cairns Hospital, Concord Repatriation General Hospital, Gold Coast University Hospital, Liverpool Hospital, Logan Hospital, Princess Alexandra Hospital, Renal Research Gosford, Royal Adelaide Hospital, Royal Perth Hospital, Sir Charles Gairdner Hospital, Toowoomba Hospital, Townsville Hospital, and Western Health.

McCloud Consulting Group Pty Ltd provided statistical support to the trial, with particular thanks to Fiona Telfer for DSMB statistical support.

The trial investigators acknowledge the provision of the EQ-5D-5L questionnaires used in the study by The EuroQol Research Foundation, Rotterdam, The Netherlands.

Study data were collected and managed using REDCap electronic data capture tools hosted at The University of Queensland [39, 68]. REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.

Collaborators: The GOAL Trial Investigators

Graham Buckle (Consumer Representative), Phil Carswell OAM (Consumer Representative), Joanne Cerni (Gold Coast University Hospital), Michael G Collins (Royal Adelaide Hospital), Amanda Elms (Logan Hospital), John Fanning (Toowoomba Hospital), Karen Fischer (Royal Adelaide Hospital), Adam Flavell (Western Health), Emily H Gordon (Centre for Health Services Research, The University of Queensland), Natalie Grainer (Cairns Hospital), Stella Green (Cairns Hospital), Chandana Guha (Sydney School of Public Health, The University of Sydney), Samantha Hand (Concord Repatriation General Hospital), Moira Hibbs (Royal Perth Hospital), Bronwyn Hockley (Royal Adelaide Hospital), Rachael Irvine (Kidney Trials Unit, Princess Alexandra Hospital), Ibrahim Ismail (Department of Renal Medicine, Cairns Hospital), Shilpanjali Jesudason (Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital), George Kan (Townsville Hospital), Debbie Kennedy (Gold Coast University Hospital), Vinod Khelgi (Logan Hospital), Shannon Kokoszka (Western Health), Anoushka Krishnan (Royal Perth Hospital), Janelle Leadbitter (Sir Charles Gairdner Hospital), Diana Leary (Princess Alexandra Hospital), Angela Makris (Liverpool Hospital), Khalilah Katherine Marquez (Concord Repatriation General Hospital), David McIntyre (Townsville University Hospital and Health Service), Penelope Murie (Westmead Hospital), Karina Murphy (Logan Hospital), Nancye Peel (The University of Queensland), Xiaodan Qiu (Western Health), Madeleine Rapisardi (Consumer Representative), Matthew A Roberts (Eastern Health Clinical School, Monash University), Simon D Roger (Renal Research Gosford), Mona Saade (Austin Health), Shaundeep Sen (Concord Repatriation General Hospital), Gerald Tataro (Medical & Cognitive Research Unit, Austin Health), Brioney Weaver (Logan Hospital), Paul A Yates (Department of Geriatric Medicine, Austin Health), Belinda Yip (Liverpool Hospital).

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