Impact of a hybrid medical care model in the rheumatoid arthritis patient-reported outcomes: A non-inferiority crossover randomized study

Abstract

Objective Patients and physicians can naturally adopt hybrid healthcare models that combine face-to-face consultations with telemedicine. The study's objective was to compare the impact of two healthcare interventions, hybrid care modality and face-to-face consultation, on the patient-reported outcomes of rheumatoid arthritis patients, during the COVID-19 pandemic. Methods Consecutive outpatients reincorporated to a clinic previously in lockdown were invited to a non-inferiority, randomized study (October 2020–-May 2022). Patients were randomized to 6 months of face-to-face consultation or hybrid care modality (intervention period-1) and then the converse modality (intervention period-2). The primary outcome was disease activity/severity behavior (Routine Assessment of Patient Index Data 3). Additional patient-reported outcomes were disability (Health Assessment Questionnaire Disability Index), quality-of-life (World Health Organization quality of life questionnaire-brief version), adherence and satisfaction with medical care, and treatment recommendation. Sample size calculation established 55 patients/healthcare interventions. Results There were 138 patients invited to participate, 130 agreed and 121 completed their study participation. Sixty-one and 60 patients respectively, received face-to-face consultation and hybrid care modality over intervention period-1. Patients were primarily middle-aged females (90.1%), with (median, IQR) 12 (9–16) years of education, long-standing disease, working (62.8%), receiving disease-modifying anti-rheumatic drugs (96.7%), and corticosteroids (61.2%). Patients had low disease activity (median Routine Assessment of Patient Index Data 3: 2.7) and Health Assessment Questionnaire Disability Index score that translated into the absence of disability, while quality of life was compromised. Baseline characteristics were similar between patients assigned to each healthcare intervention. Differences in Routine Assessment of Patient Index Data 3 behavior were below the non-inferiority margin. Results considered the order in which patients received the intervention and baselines scores, and extended to the patient-reported outcomes left. Conclusions Hybrid care modality was non-inferior to in-person consultations in achieving patient-reported outcomes during the COVID-19 pandemic in rheumatoid arthritis patients.