Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial

Abstract

Background: In the UK, gout management is suboptimum, with only 40% of patients receiving urate-lowering therapy, usually without titration to achieve a target serum urate concentration. Nurses successfully manage many diseases in primary care. We compared nurse-led gout care to usual care led by general practitioners (GPs) for people in the community.

Methods: Research nurses were trained in best practice management of gout, including providing individualised information and engaging patients in shared decision making. Adults who had experienced a gout flare in the previous 12 months were randomly assigned 1:1 to receive nurse-led care or continue with GP-led usual care. We assessed patients at baseline and after 1 and 2 years. The primary outcome was the percentage of participants who achieved serum urate concentrations less than 360 μmol/L (6 mg/dL) at 2 years. Secondary outcomes were flare frequency in year 2, presence of tophi, quality of life, and cost per quality-adjusted life-year (QALY) gained. Risk ratios (RRs) and 95% CIs were calculated based on intention to treat with multiple imputation. This study is registered with www.ClinicalTrials.gov, number NCT01477346.

Findings: 517 patients were enrolled, of whom 255 were assigned nurse-led care and 262 usual care. Nurse-led care was associated with high uptake of and adherence to urate-lowering therapy. More patients receiving nurse-led care had serum urate concentrations less than 360 μmol/L at 2 years than those receiving usual care (95% vs 30%, RR 3·18, 95% CI 2·42-4·18, p<0·0001). At 2 years all secondary outcomes favoured the nurse-led group. The cost per QALY gained for the nurse-led intervention was £5066 at 2 years.

Interpretation: Nurse-led gout care is efficacious and cost-effective compared with usual care. Our findings illustrate the benefits of educating and engaging patients in gout management and reaffirm the importance of a treat-to-target urate-lowering treatment strategy to improve patient-centred outcomes.

Funding: Arthritis Research UK.

Figure 1

Trial profile ITT=intention-to-treat. GP=general practitioner. *Patients with a diagnosis of gout who had had at least one gout flare in the previous 12 months. †Unable to commit time, poor health, gout flare more 12 months previously, advised by surgery not to contact, initial appointment was booked but cancelled and could not be rearranged.

Figure 2

Mean (95% CI) serum urate concentrations throughout the study Data in the usual-care group were only available at baseline, 1 year, and 2 years but serum urate monitoring data recorded in follow-up visits were available in the nurse-led group.

Figure 3

Serum urate concentration, number of flares and presence of tophi at baseline, 1 year, and 2 years (A) Mean (95% CI) serum urate concentration. (B) Mean (95% CI) number of flares. (C) Proportion of patients with any tophi.