Nurse-Led versus Usual (General Practitioner-Led) Care of People with Gout: A UK Community-Based, Two Year, Randomised Controlled Trial
31 Pages Posted: 14 Sep 2018More...
Background: In the UK gout management is suboptimal, only 40% of patients receiving urate-lowering therapy (ULT), usually without titration to a target serum urate (SU) level. Nurses successfully manage many diseases in primary care. This trial compared nurse-led care to ongoing usual (general practitioner-led) care for people with gout.
Methods: Research nurses were trained in best practice management of gout, including full individualised patient information and engagement in shared decision-making. Adults with acute gout in the previous year were randomised (1:1) to nurse-led or continuing usual care in the community. Assessments were at baseline, one and two years. The primary outcome was percentage of participants achieving SUA<360μmol/L at two years. Secondary outcomes were attack frequency in year two, presence of tophi, quality of life (SF-36) and cost per quality-adjusted life year (QALY) gained. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated based on intention to treat with multiple imputation.
Findings: Of 517 participants, 255 were assigned nurse-led care and 262 usual care. Comparing nurse-led to usual care groups at two years: 96% versus 56% were on ULT with 79% versus 10% taking allopurinol >300mg/day (all p<0•001); 95% versus 30% had SU<360μmol/L (RR 3•18, 95%CI 2•42 to 4•18); 3% versus 11% had tophi (RR 0•09, 0•02-0•36); and mean (SD) SF-36 physical component scores were 41•31(16•76) versus 37•87(14•31) (p<0•05). During year two, 8% versus 24% had >2 gout attacks respectively (RR 0•33, 0•19-0•57). The cost per QALY gained for the nurse-led intervention was £5066 at two years, and modelled to be £286 at three years and cost-saving at five years.
Interpretation: Nurse-led gout care is clinically effective and also cost-effective compared to usual care. These findings illustrate the benefits of patient education and engagement in gout management, and reaffirm the importance of a treat-to-target ULT strategy to improve patient-centred outcomes.
Trial Registration Number: National Clinical Trials Registry (www.clinicaltrials.gov ref: NCT01477346).
Funding: Arthritis Research UK fully funded the study (Award 19703).
Declaration of Interest: MD and AA have received research funding from AstraZeneca for a PI-led “sons of gout” study; MD has received consultation fees from AstraZeneca, Grunenthal and Mallinckrodt; WZ has received consultation fees from AstraZeneca and Grunenthal. Other authors have no conflict of interest.
Ethical Approval: It was approved by East Midlands Nottingham Research Ethics Committee (12/EM/0044) and registered with the National Clinical Trials Registry.
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