Comparing automatic vs. as-needed follow-up care for children after hospitalization
The Follow-up Automatically vs. As-Needed Comparison Trial
This study tests whether regular follow-up visits for kids after being in the hospital can help them stay healthy and avoid going back to the hospital, compared to only seeing a doctor when needed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2674 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 14 sites (Phoenix, Arizona and 13 other locations) |
| Trial ID | NCT05471908 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of automatic follow-up visits versus as-needed (PRN) follow-up for children discharged from the hospital after treatment for common infections like pneumonia and urinary tract infections. The study aims to determine if automatic follow-ups reduce hospital readmissions and improve continuity of care, while also considering the potential burdens on families such as missed work and transportation costs. Children under 18 years old who have been hospitalized for specific infections will be randomly assigned to either follow-up approach, with outcomes measured in terms of readmission rates and child health-related quality of life.
Who should consider this trial
Good fit: Ideal candidates are children under 18 who have been hospitalized for pneumonia, urinary tract infections, soft tissue infections, or gastroenteritis.
Not a fit: Patients with complex chronic diseases, those requiring surgical intervention, or who have a scheduled follow-up visit within 7 days will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more patient-centered follow-up care that reduces unnecessary hospital visits and associated costs for families.
How similar studies have performed: Other studies have explored follow-up care strategies, but this specific comparison of automatic versus PRN follow-up is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \<18 years at the time of randomization * Hospitalization due to a primary diagnosis of pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection. * Parent speaks English or Spanish. Exclusion Criteria: * Presence of a comorbid disease that is both chronic and complex * Principal disease required surgical intervention (beyond superficial incision and drainage) * Immunodeficiency * A well-child check-up or post-hospitalization follow-up visit is already scheduled within 7 days of hospital discharge * Parent or participant strongly prefers PRN or automatic follow-up * A medical provider feels strongly that a post-hospitalization follow-up visit is needed within 7 days of hospital discharge * Sibling concurrently hospitalized * Unable to identify a clinic where the participant would receive any needed post-hospitalization follow-up * Diagnosis of pneumonia complicated by: o Receiving a chest tube * Diagnosis of urinary tract infection complicated by: * History of neurogenic bladder or urologic surgery * Renal imaging anticipated within 7 days of hospital discharge * Renal abscess * Diagnosis of skin and soft tissue infection complicated by: * Chronic wound * Postoperative infection * Predisposition to poor wound healing * Discharging with a drain in place * Complicated by necrotizing fasciitis or toxic shock syndrome * Diagnosis of gastroenteritis complicated by: * Hemolytic uremic syndrome
Where this trial is running
Phoenix, Arizona and 13 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Recruiting)
- Packard at El Camino Hospital — Mountain View, California, United States (Recruiting)
- Lucile Packard Children's Hospital — Palo Alto, California, United States (Recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Recruiting)
- Penn Medicine Princeton Medical Center — Plainsboro, New Jersey, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center - Main Campus — Cincinnati, Ohio, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center - Liberty Campus — Liberty Township, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Texas Children's Main — Houston, Texas, United States (Recruiting)
- Texas Children's West — Houston, Texas, United States (Recruiting)
- Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus — Lehi, Utah, United States (Recruiting)
- Riverton Hospital — Riverton, Utah, United States (Completed)
- Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Eric Coon, MD — University of Utah
- Study coordinator: Eric Coon, MD, MS
- Email: Eric.Coon@hsc.utah.edu
- Phone: 801-587-2160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.