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Not Yet Recruiting NCT07864636

Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity

Conditions: Children With Medical Complexity, Respiratory Tract Infections (RTI), Urinary Tract Infection (UTI), Acute Gastroenteritis, Skin and Soft Tissue Infection

Sex: All
Ages: 1 Year – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Seattle Children's Hospital

Location: Seattle Children's Hospital Seattle Washington

Summary

Children with medical complexity often receive a recommendation to see an outpatient clinician soon after leaving the hospital. It is uncertain whether every child needs this routine visit or whether follow-up can be guided by the family's concerns and the child's recovery. AFTERCARE is a multicenter pilot randomized trial comparing these two follow-up recommendations for children hospitalized with an acute infection. Families will be assigned by chance to receive either a recommendation to arrange follow-up with their usual outpatient clinician within seven days or a recommendation to seek follow-up if the child is not improving as expected or new concerns arise. Families in both groups may seek medical care whenever needed. The study will assess recruitment, follow-up data collection, delivery of the recommendations and acceptability. Caregiver surveys and medical record review will also describe outpatient visits and hospital returns. This pilot will inform the design of a larger trial, and is not designed to establish that the strategies are equally safe or effective.

Eligibility Criteria

Inclusion Criteria 1. Children aged 1 to younger than 17 years at hospital admission. 2. Chronic medical conditions affecting at least two body systems. 3. Hospitalized on a general pediatric, complex care or equivalent service for a respiratory infection, urinary tract infection, skin or soft-tissue infection, or infectious gastroenteritis. 4. Expected discharge home, with an adult parent or legal guardian available to provide consent and complete study activities. Exclusion Criteria 1. Enrollment after hospital day 30. 2. Primary care follow-up already scheduled or recommended within seven days after discharge, or a strong family or clinician preference that makes randomization unacceptable. 3. History of cancer or organ, bone marrow or stem-cell transplantation. 4. A new type of medical equipment needed at home, or planned home intravenous nutrition or antibiotics. 5. Selected complicated infections or infection-specific high-risk conditions. 6. Foster care, hospice care or discharge to an institutional care setting.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07864636). StuddyBuddy aggregates publicly available trial information.