Actively Recruiting
The Follow-up Automatically vs. As-Needed Comparison Trial for Children Hospitalized with Common Infections
Led by University of Utah · Updated on 2025-12-10
2674
Participants Needed
14
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two different approaches to post-hospitalization follow-up care for children hospitalized with common infections such as pneumonia, skin and soft tissue infections, acute gastroenteritis, or urinary tract infections. The study evaluates whether automatic follow-up visits scheduled at discharge or a more flexible as-needed (PRN) follow-up approach, where parents monitor symptoms and decide on visits, impact hospital readmission rates and other health outcomes. Participants are randomly assigned to one of two groups. One group receives a recommendation for automatic follow-up, instructing them to schedule and attend a follow-up visit regardless of symptom improvement. The other group receives a recommendation for PRN follow-up, where scheduling a visit at discharge is not required, and parents decide if a visit is necessary based on their child's symptoms. Both groups are monitored to compare outcomes over time. During the study, researchers will track hospital readmissions within 14 days of discharge as the primary outcome. Secondary outcomes include medical interventions and the child's health-related quality of life measured seven days after discharge. Additional factors like healthcare use, parent anxiety, satisfaction, and costs will also be assessed. The study includes follow-up through communications with healthcare providers and monitoring of immunizations and well-child visits. Participation lasts at least through the 14-day post-discharge period to capture these outcomes.
CONDITIONS
Brief Title
Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is younger than 18 years at the time of randomization
- Hospitalized for pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection
- Parent or guardian speaks English or Spanish
You will not qualify if you...
- Has a chronic and complex medical condition
- Illness required surgery beyond simple incision and drainage
- Has immunodeficiency
- Already has a scheduled well-child check-up or follow-up visit within 7 days of discharge
- Parent or participant strongly prefers one follow-up method
- Medical provider strongly recommends a follow-up visit within 7 days
- Has a sibling hospitalized at the same time
- No clinic identified for follow-up care
- Pneumonia complicated by chest tube use
- Urinary tract infection complicated by neurogenic bladder, urologic surgery, planned renal imaging within 7 days, or renal abscess
- Skin or soft tissue infection complicated by chronic wound, postoperative infection, poor wound healing, drain in place, necrotizing fasciitis, or toxic shock syndrome
- Gastroenteritis complicated by hemolytic uremic syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 14 days after hospital discharge
Participants receive a recommendation for either automatic or as-needed (PRN) follow-up after hospital discharge and monitor their child's symptoms accordingly.
1 follow-up visit recommended for automatic group; as-needed follow-up visits for PRN group
Trial Site Locations
Total: 14 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Packard at El Camino Hospital
Mountain View, California, United States, 94040
Actively Recruiting
3
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
4
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey, United States, 08536
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center - Main Campus
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Cincinnati Children's Hospital Medical Center - Liberty Campus
Liberty Township, Ohio, United States, 45044
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Texas Children's Main
Houston, Texas, United States, 77030
Actively Recruiting
10
Texas Children's West
Houston, Texas, United States, 77094
Actively Recruiting
11
Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
Lehi, Utah, United States, 84043
Actively Recruiting
12
Riverton Hospital
Riverton, Utah, United States, 84065
Completed
13
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
14
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
E
Eric Coon, MD, MS
L
Liz Rodriquez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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