Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial. Issue 1 (16th March 2022)

• Record Type: Journal Article
• Authors: Beauvais, Catherine; Fayet, Françoise; Rousseau, Alexandra; Sordet, Christelle; Pouplin, Sophie; Maugars, Yves; Poilverd, Rose Marie; Savel, Carine; Ségard, Véronique; Godon, Béatrice; L'amour, Christian; Perdriger, Aleth; Brin, Fabienne; Peyrard, Patricia; Chalier, Fabienne; Pallot-Prades, Béatrice; Tuffet, Sophie; Griffoul, Isabelle; Gossec, Laure
• Is Part Of: RMD open. Volume 8:Issue 1(2022)
• Publication Date: 2022-03-16
• Subjects: arthritis -- biological therapy -- patient care team -- nursing; Musculoskeletal system -- Diseases -- Periodicals; Rheumatism -- Periodicals; 616.7005
• DOI: 10.1136/rmdopen-2021-001828
• Languages: English
• ISSNs: 2056-5933

Abstract

Abstract : Objective: To evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs). Methods: This is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0–100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate. Results: 129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65 min at baseline and 44 min at 3 months). The primary outcome was met: the BioSecure score was 81.2±13.1 and 75.6±13.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference. Conclusions: Educating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues. Trial registration number: NCT02855320 .