A multicenter randomized trial to compare automatic versus as-needed follow-up for children hospitalized with common infections: The FAAN-C trial protocol.

ABSTRACT

INTRODUCTION: Physicians commonly recommend automatic primary care follow-up visits to children being discharged from the hospital. While automatic follow-up provides an opportunity to address postdischarge needs, the alternative is as-needed follow-up. With this strategy, families monitor their child's symptoms and decide if they need a follow-up visit in the days after discharge. In addition to being family centered, as-needed follow-up has the potential to reduce time and financial burdens on both families and the healthcare system. As-needed follow-up has been shown to be safe and effective for children hospitalized with bronchiolitis, but the extent to which hospitalized children with other common conditions might benefit from as-needed follow-up is unclear. METHODS: The Follow-up Automatically versus As-Needed Comparison (FAAN-C, or "fancy") trial is a multicenter randomized controlled trial. Children who are hospitalized for pneumonia, urinary tract infection, skin and soft tissue infection, or acute gastroenteritis are eligible to participate. Participants are randomized to an as-needed versus automatic posthospitalization follow-up recommendation. The sample size estimate is 2674 participants and the primary outcome is all-cause hospital readmission within 14 days of discharge. Secondary outcomes are medical interventions and child health-related quality of life. Analyses will be conducted in an intention-to-treat manner, testing noninferiority of as-needed follow-up compared with automatic follow-up. DISCUSSION: FAAN-C will elucidate the relative benefits of an as-needed versus automatic follow-up recommendation, informing one of the most common decisions faced by families of hospitalized children and their medical providers. Findings from FAAN-C will also have implications for national quality metrics and guidelines.