The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. This will be the first study, internationally, to evaluate the clinical and cost effectiveness of Comprehensive Geriatric Assessment (CGA), a highly promising intervention for improving patient-important health outcomes in frail older people with Chronic Kidney Disease (CKD).
There is an increasing number of frail patients with CKD, and multiple morbidities. Many of them face rapid deterioration of health, referral to residential aged care facilities and loss of independence. This substantively impairs their quality of life and has societal ramifications, including very high costs of care. Patients and carers are often overwhelmed by the multitude of decisions they have to make and may follow a care path that is in contrast to their goals. The GOAL trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. The primary objective is to test the hypothesis that in frail older people with stages 3-5 CKD, Comprehensive Geriatric Assessment (compared with usual care) will increase attainment of patient-identified goals at 3 months follow up. The secondary objectives are to test the hypotheses that the Comprehensive Geriatric Assessment will increase attainment of patient-identified goals at 6 and 12 months follow up, improve their quality of life and reduce frailty, hospital and residential aged care facility admissions while being safe and cost-effective. In this multicentre cluster randomised controlled trial, a total of 500 adult CKD stage 3-5 patients will be recruited. Sites will be randomly allocated to either provide a Comprehensive Geriatric Assessment to participants or usual care. The primary outcome measure is goal attainment scaling at 3 months follow up. The secondary outcome measures will be goal attainment scaling at 6 and 12 months, quality of life EQ-5D-5L, frailty index, mortality, hospital and residential aged care facility admissions and cost-utility analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
A CGA is a diagnostic and therapeutic intervention which initially identifies an older person's medical, functional, psychosocial problems and then tailors coordinated management plans to address them.
Blacktown Hospital
Blacktown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Renal Research Gosford
Gosford, New South Wales, Australia
Goal Attainment Scaling at 3 months
To determine whether CGA in frail older people with stages 3-5 CKD improves attainment of patients' own goals of care at three months.
Time frame: 3 months
Goal Attainment Scaling at 6 and 12 months
To determine whether CGA improves attainments of patients' own goals of care at six and 12 months.
Time frame: 6 and 12 months
Quality of life using EQ-5D-5L
To determine whether CGA improved patient's quality of life at three, six and 12 months.Quality of life will be assessed using the EQ-5D-5L
Time frame: 3, 6 and 12 months
Frailty status
To determine whether CGA favourably affects the trajectory of frailty status at three, six and 12 months. Frailty will be assessed using the Frailty Index CKD.
Time frame: 3, 6 and 12 months
Mortality
To determine whether CGA reduces mortality during the 12 months follow-up.
Time frame: 12 months
Duration of hospital admissions
To determine whether CGA reduces the duration of hospital admissions during the 12 months follow-up.
Time frame: 12 months
Number of hospital admissions
To determine whether CGA reduces the number of hospital admissions during the 12 months follow-up.
Time frame: 12 months
Number of residential aged care facility admissions
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Masking
SINGLE
Enrollment
240
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Logan Hospital
Logan City, Queensland, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
...and 5 more locations
To determine whether CGA reduces admissions to residential aged care facilities at 12 months follow-up.
Time frame: 12 months
Cost-effectiveness
Difference in the incremental cost per Quality Adjusted Life Year gained between treatment arms
Time frame: 12 months