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Automatic vs. As-Needed Follow-Up for Infections (FAAN-C Trial)

N/A
Recruiting
Led By Eric Coon, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalization due to a primary diagnosis of pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection
Age <18 years at the time of randomization
Must not have
Diagnosis of pneumonia complicated by: Receiving a chest tube
Presence of a comorbid disease that is both chronic and complex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after hospital discharge
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether automatic follow-up after being hospitalized for an infection is more effective than as-needed follow-up.

Who is the study for?
Children under 18 hospitalized for pneumonia, skin infections, gastroenteritis, or urinary tract infection can join. They must speak English or Spanish. Kids with chronic diseases, needing surgery beyond minor procedures, with immune issues, or scheduled follow-ups within a week of discharge cannot participate.
What is being tested?
The trial is testing if automatic follow-up appointments after hospitalization are better than scheduling them only as needed for children recovering from common infections like pneumonia and UTIs.
What are the potential side effects?
Since this trial involves follow-up methods rather than medication, there aren't direct side effects. However, the frequency of doctor visits could affect recovery comfort and convenience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was hospitalized for pneumonia, skin infection, stomach flu, or a UTI.
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I am under 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have pneumonia and am receiving treatment with a chest tube.
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I have a long-term, complex health condition.
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My condition needed surgery beyond a simple cut and clean.
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I have gastroenteritis with complications from hemolytic uremic syndrome.
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I have a weakened immune system.
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I don't have a clinic for follow-up after hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital readmission
Secondary study objectives
Child health-related quality of life
Medical interventions
Other study objectives
Child time
Viral Load result
Communicable Diseases
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed (PRN) post-hospitalization follow-upExperimental Treatment1 Intervention
At hospital discharge, participant receives a recommendation for PRN follow-up. Recommendation informs participant that scheduling a follow-up visit is not needed at discharge and suggests that participant follow symptoms after discharge to decide if a visit is ultimately needed or not.
Group II: Automatic post-hospitalization follow-upActive Control1 Intervention
At hospital discharge, participant receives a recommendation for automatic follow-up. Recommendation instructs participant to schedule a follow-up visit and attend the visit even if symptoms get better.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,695,120 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,076,285 Total Patients Enrolled
Eric Coon, MDPrincipal InvestigatorUniversity of Utah

Media Library

As-needed follow up Clinical Trial Eligibility Overview. Trial Name: NCT05471908 — N/A
Soft Tissue Infections Research Study Groups: As-needed (PRN) post-hospitalization follow-up, Automatic post-hospitalization follow-up
Soft Tissue Infections Clinical Trial 2023: As-needed follow up Highlights & Side Effects. Trial Name: NCT05471908 — N/A
As-needed follow up 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471908 — N/A
~1312 spots leftby Feb 2027