A randomized study comparing regular care with a nurse‐led clinic based on tight disease activity control and person‐centred care in patients with rheumatoid arthritis with moderate/high disease activity: A 6‐month evaluation

Abstract

IntroductionA recent survey showed that 27% of rheumatoid arthritis (RA) patients had inadequately controlled disease activity. Hence, there is a need for new strategies aiming at improving patient outcomes. The aim of the present study was to evaluate the effect of a nurse‐led clinic with frequent visits, treat‐to‐target and person‐centred care of patients with established RA and moderate‐to‐high disease activity compared with patients receiving regular care.MethodsThe study was a randomized, controlled trial over 26 weeks, with a nonrandomized extension to week 50. Patients were randomized to an intervention group (IG; nurse‐led clinic) based on person‐centred care, frequent visits and “treat to target”, or to a control group (CG) which visited the clinic according to care as usual. The primary outcome was the difference in the DAS28 change between the IG and the CG groups.ResultsA total of 332 patients were screened for eligibility, of which 70 were randomly assigned to either the IG (n = 36) or the CG (n = 34) group. The primary outcome was not met, although patients in the IG group tended to improve more than those in the CG group (difference: 0.43 (95% confidence interval [CI] –0.27, 1.13). In both the IG and CG groups, delta‐DAS28 improved significantly. The European League Against Rheumatology moderate or good response was achieved by 76% (95% CI 58, 89) in the IG and 49% (95% CI 32, 65) in the CG group.ConclusionsDisease activity tended to improve more with the nurse‐led intervention compared with regular care, although the difference was not significant, probably partly due to the lack of statistical power.

Learning from Gothenburg model of person centred healthcare

“…Outcomes from these trials were increased self-efficacy1319252627; improved experience of health111720; improved satisfaction with care10; improved symptom control1720222829; improved physical function/capacity11172021; improved activities of daily living24; fewer chronic heart failure/chronic obstructive pulmonary disease related deteriorations13; improved discharge planning30; shorter length of hospital stay232431; and cost saving 32. In six trials results were not significant in the ITT analysis (no data on PP available) 91112141516…”

Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial

“…The current EULAR recommendations for the treatment of RA include the involvement of specialist nurses in the follow-up of patients with RA. 8 Nurse-led care (NLC) has already been successfully established in some countries (eg, the UK, the Netherlands, Denmark and Sweden), [9][10][11][12][13][14] showing evidence of non-inferiority of NLC in comparison to RLC in different clinical settings. 11 Furthermore, evidence suggests an added value of a holistic perspective and an increased focus on individual patients needs, and this has been shown to be appreciated by patients.…”

Treat-to-Target Strategies in Rheumatoid Arthritis: a Systematic Review and Cost-Effectiveness Analysis

“…The Fransen trial [27] (two groups, established RA, 6month treatment) only reported LDA; significantly more patients achieved LDA with intensive than conventional treatment (31% vs 16%, p = 0.028). Similarly, the Bergsten trial [28] reported a greater proportion of patients achieved LDA with intensive (48%) than conventional treatment (24%). The van Hulst trial [22] (two groups, early and established RA, 18month treatment) reported more EULAR good responders (which includes LDA) with intensive (22%) than conventional treatment (18%) (significance unreported).…”

“…Eight trials (1977 patients) compared TTT with usual care [22][23][24][25][26][27][28][29]; seven trials (2418 patients) compared different treatment protocols [30][31][32][33][34][35][36]; six trials (1758 patients) compared different treatment targets [24,26,35,[37][38][39]; four trials (1143 patients) made other comparisons of conventional with intensive therapy [14,17,19,20]. Thirteen trials studied early RA patients [17,24,25,[30][31][32][33][34][35][36][37][38][39]; five studied established RA patients [19,[26][27][28]40]; and four studied early and established RA [20,22,23,29]. Fifteen trials involved controls receiving less intensive treatment…”

“…Twelve RCTs were judged at overall high risk of bias [17,19,20,24,28,31,33,[35][36][37][38][39], five at overall unclear risk of bias [25,30,32,34,40] and one at overall low risk of bias [23]. None were judged at high risk of bias for random sequence generation or allocation concealment; 13 had high risk of bias for blinding of participants and personnel [17, 19, 20, 23-25, 31-34, 38-40]; eight for blinding of outcome assessment [19,20,24,31,33,[37][38][39]; eight from reporting withdrawals > 10% [17,19,24,28,35,36,39,40]; and five had high risk of bias as some outcomes reported in either the protocol [20,25,28,32] or the methods section [35] were omitted from the results (Supplement 3).…”