Eric R Coon1, Lauren A Destino2, Tom H Greene3, Elizabeth Vukin1, Greg Stoddard3, Alan R Schroeder2. 1. Department of Pediatrics, Primary Children's Hospital, University of Utah School of Medicine, Salt Lake City. 2. Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California. 3. Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City.
Abstract
Importance: Posthospitalization follow-up visits are prescribed frequently for children with bronchiolitis. The rationale for this practice is unclear, but prior work has indicated that families value these visits for the reassurance provided. The overall risks and benefits of scheduled visits have not been evaluated. Objective: To assess whether an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing anxiety among parents of children hospitalized for bronchiolitis. Design, Setting, and Participants: This open-label, noninferiority randomized clinical trial, performed between January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California). Data analysis was performed in an intention-to-treat manner. Interventions: Randomization (1:1) to a scheduled (n = 151) vs an as-needed (n = 153) posthospitalization follow-up visit. Main Outcome and Measures: The primary outcome was parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale, which ranged from 0 to 28 points, with higher scores indicating greater anxiety. Fourteen prespecified secondary outcomes were assessed. Results: Among 304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88%). A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%). The mean (SD) 7-day parental anxiety score was 3.9 (3.5) among the as-needed posthospitalization follow-up group and 4.2 (3.5) among the scheduled group (absolute difference, -0.3 points; 95% CI, -1.0 to 0.4 points), with the upper bound of the 95% CI within the prespecified noninferiority margin of 1.1 points. Aside from a decreased mean number of clinic visits (absolute difference, -0.6 visits per patient; 95% CI, -0.4 to -0.8 visits per patient) among the as-needed group, there were no significant between-group differences in secondary outcomes, including readmissions (any hospital readmission before symptom resolution: absolute difference, -1.6%; 95% CI, -5.7% to 2.5%) and symptom duration (time from discharge to cough resolution: absolute difference, -0.6 days; 95% CI, -2.4 to 1.2 days; time from discharge to child reported "back to normal": absolute difference, -0.8 days; 95% CI, -2.7 to 1.0 days; and time from discharge to symptom resolution: absolute difference, -0.6 days; 95% CI, -2.5 to 1.3 days). Conclusions and Relevance: Among parents of children hospitalized for bronchiolitis, an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing parental anxiety. These findings support as-needed follow-up as an effective posthospitalization follow-up strategy. Trial Registration: ClinicalTrials.gov Identifier: NCT03354325.
RCT Entities:
Importance: Posthospitalization follow-up visits are prescribed frequently for children with bronchiolitis. The rationale for this practice is unclear, but prior work has indicated that families value these visits for the reassurance provided. The overall risks and benefits of scheduled visits have not been evaluated. Objective: To assess whether an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing anxiety among parents of children hospitalized for bronchiolitis. Design, Setting, and Participants: This open-label, noninferiority randomized clinical trial, performed between January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California). Data analysis was performed in an intention-to-treat manner. Interventions: Randomization (1:1) to a scheduled (n = 151) vs an as-needed (n = 153) posthospitalization follow-up visit. Main Outcome and Measures: The primary outcome was parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale, which ranged from 0 to 28 points, with higher scores indicating greater anxiety. Fourteen prespecified secondary outcomes were assessed. Results: Among 304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88%). A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%). The mean (SD) 7-day parental anxiety score was 3.9 (3.5) among the as-needed posthospitalization follow-up group and 4.2 (3.5) among the scheduled group (absolute difference, -0.3 points; 95% CI, -1.0 to 0.4 points), with the upper bound of the 95% CI within the prespecified noninferiority margin of 1.1 points. Aside from a decreased mean number of clinic visits (absolute difference, -0.6 visits per patient; 95% CI, -0.4 to -0.8 visits per patient) among the as-needed group, there were no significant between-group differences in secondary outcomes, including readmissions (any hospital readmission before symptom resolution: absolute difference, -1.6%; 95% CI, -5.7% to 2.5%) and symptom duration (time from discharge to cough resolution: absolute difference, -0.6 days; 95% CI, -2.4 to 1.2 days; time from discharge to child reported "back to normal": absolute difference, -0.8 days; 95% CI, -2.7 to 1.0 days; and time from discharge to symptom resolution: absolute difference, -0.6 days; 95% CI, -2.5 to 1.3 days). Conclusions and Relevance: Among parents of children hospitalized for bronchiolitis, an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing parental anxiety. These findings support as-needed follow-up as an effective posthospitalization follow-up strategy. Trial Registration: ClinicalTrials.gov Identifier: NCT03354325.
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