Importance Generic pediatric patient-reported outcome measures (P-PROMs) have the potential to enhance care and patient-clinician interactions in specialty hospital settings. However, evidence about their feasibility and acceptability is lacking. Objective To identify the feasibility and acceptability of a P-PROM at the point of care among children receiving outpatient care from selected specialty clinics. Design, Setting, and Participants This nonblinded, pilot feasibility and acceptability randomized clinical trial was conducted from February to June 2024 across 4 pediatric specialty clinics (asthma, sleep, encopresis, and chronic constipation) at The Royal Children’s Hospital in Melbourne, Victoria, Australia. Children aged 4 to 17 years (and their caregivers) were eligible for inclusion if they had an appointment at one of the participating clinics during the trial period. Patients and their caregivers were randomly assigned to the intervention or control group. Clinicians (physicians, nurses, and allied health staff) providing specialty care services to eligible patients were also invited to participate. Intervention Children and/or their caregivers assigned to the intervention arm were asked to complete a generic P-PROM—the EuroQoL 5-Dimensional Questionnaire for Youth, 5 Levels (EQ-5D-Y-5L)—7 days before their appointment and to indicate which EQ-5D-Y-5L items they would like to discuss with their clinician during their appointment. Responses to the completed P-PROM were displayed to clinicians in the electronic medical record, and children and their caregivers received information to act on the P-PROM items. Clinicians received training, clinical decision support, and resources to support patient actions. Patients assigned to the control arm received standard outpatient care, which excluded completing a P-PROM. Main Outcomes and Measures Primary outcomes were feasibility and acceptability of the P-PROM. Results Of 170 eligible patients, 87 children (51.2%) and their caregivers were randomly assigned to the intervention arm (n = 43) or control arm (n = 44). Patients included 44 females (50.6%) with a mean (SD) age of 8.8 (3.2) years, and caregivers included 82 females (94.3%) with a mean (SD) age of 41.8 (6.9) years. Of the 17 eligible clinicians, 14 were included in the study; they reported working in a specialty clinic for a mean (SD) of 9.7 (8.4) years. Thirty-three of 37 caregivers (89.2%) in the intervention arm and 9 of 14 clinicians (64.3%) reported that the P-PROM was acceptable. A P-PROM completion rate of 93.0% (40 of 43 patients) was achieved, indicating feasibility. Conclusions and Relevance In this pilot randomized clinical trial, the collection and use of the EQ-5D-Y-5L was feasible and acceptable in routine outpatient specialty pediatric care. Further study should examine the quantitative impacts of the intervention on quality of care and outcomes as well as the impacts over time. Trial Registration ISRCTN Identifier: ISRCTN16030620
Jones et al. (Thu,) studied this question.