SAT0679 EFFICACY OF A NURSE-LED PATIENT EDUCATIONINTERVENTION IN PROMOTING SAFETY KNOWLEDGE AND SKILLS OF PATIENTS WITH INFLAMMATORY ARTHRITIS (IA) TREATED WITH BIOLOGICS: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Biologic disease modifying drugs (bDMARDs) are highly effective treatments of IA such as rheumatoid arthritis (RA) and axial or peripheral spondyloarthritis (SpA). However, they lead to risks of infections and other side effects. Some of these adverse events may be prevented by patient education (PE) aimed at promoting patients’ safety skills. Objectives: To investigate the effect of a nurse-led PE on safety skills of patients with IA at the introduction of a first subcutaneous bDMARD. Methods: Multicentric randomized controlled trial comparing an intervention group (IG) to usual care (UC) at the time of the introduction of a first bDMARD. Inclusion criteria: patients with RA or SpA, biologic naive, eligible for a subcutaneous bDMARD according to the rheumatologist’s opinion. Intervention: a face-to-face nurse-led PE at baseline (BL) and 3 months later, ie, assessment by the nurse of the patients’ health beliefs and educational needs, education focused on safety skills, self-injections and motivation. The primary outcome was the acquisition of safety skills at 6 months measured by the Biosecure Questionnaire (0-100 scale), a 55 item validated questionnaire assessing competences to deal with fever, infections, vaccination, and other daily life situations (ref). The secondary outcomes were quality of life, severe infections rate, coping, psychological well-being and disease activity. Data were anaysed as intent-to-treat using multiple imputations. Results: 128 patients were included from 9 rheumatology departments between January 2017 and April 2018, 39 (30.7%) with RA, 72 (56.7%) with axial SpA, 16 (12.6%) with peripheral SpA; mean age 47.0 ±12.8 years, mean disease duration 6.1 ±7.5 years, 120 (94%) completed the study. BL mean self- reported information on RA treatments (0-10 numeric scale) was similar: 7.1±2.0 in IG; 6.8±2.1 in CG. The mean duration of the intervention was 65.5 ±17.9 minutes. The primary outcome was met: the Biosecure score at 6 months was 81.2 ±13.1 versus 75.6±13.0 in the IG and CG respectively (p =0.016), showing better skills in the IG. Secondary outcomes were also favorable. Conclusion: Safety is an important issue in the management of IA treated with bDMARDs. In this trial, a nurse-led patient education was shown for the first time to be effective in teaching patients the essential safety skills.