An interventional study of As-needed follow up and Automatic follow-up in Pneumonia, Urinary Tract Infections and Soft Tissue Infections, sponsored by University of Utah. Recruiting at 14 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University of Utah · Not applicable, Interventional, and Health services research
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
BACKGROUND:
Automatic post-hospitalization follow-up visits are commonly recommended by hospital-based pediatricians. The intuitive appeal of automatic follow-up visits is that they might decrease hospital readmissions and promote continuity of care. However, automatic follow-up visits result in missed work for parents, missed school for children, and expenses like co-pays and transportation costs. The principal alternative strategy to automatic follow-up is PRN (pro re nata, "as-needed") follow-up, a patient and family-centered approach that empowers parents to monitor their child's symptoms and decide if a follow-up visit is necessary.
OBJECTIVE:
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
DESIGN:
The Follow-up Automatically vs As-Needed Comparison (FAAN-C, or "fancy") trial is a multicenter randomized controlled trial
POPULATION:
Children hospitalized for pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection will be eligible for enrollment.
EXPERIMENTAL INTERVENTION:
Randomization to a recommendation for PRN post-hospitalization follow-up
CONTROL INTERVENTION:
Randomization to a recommendation for automatic post-hospitalization follow-up
OUTCOMES:
The primary outcome is hospital readmission within 14 days of discharge. Secondary outcomes are medical interventions and child health-related quality of life. Exploratory outcomes are cost burden, child time, parent time, symptom duration, total additional ambulatory visits, non-primary care ambulatory visits, parent self-efficacy, parent anxiety, satisfaction with care, telephone and electronic communications with medical providers, well-child visits, immunizations, usual place of medical care, and medical interventions related to the index infection. Safety outcomes are medical errors and hospital readmissions related to the index infection.
TRIAL SIZE:
A total of 2,674 patients (1,337 patients in each group) will be randomized, providing 90% power to demonstrate non-inferiority of a recommendation for PRN follow-up compared to a recommendation for automatic follow-up.
Exclusion Criteria:
Diagnosis of pneumonia complicated by:
o Receiving a chest tube
Diagnosis of urinary tract infection complicated by:
Diagnosis of skin and soft tissue infection complicated by:
Diagnosis of gastroenteritis complicated by:
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.
Behavioral: As-needed follow up
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.
Behavioral: Automatic follow-up
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.
Also known as: PRN (pro re nata)
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.
Hospital readmission
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
Time frame: Within 14 days of hospital discharge
Medical interventions
The proportion of participants who receive either a laboratory test, imaging test, or a new medication within 14 days of hospital discharge
Time frame: Within 14 days of hospital discharge
Child health-related quality of life
Mean health-related quality of life score 7 days after hospital discharge, measured by the Impact on Activities and Routines instrument.
Time frame: 7 days after hospital discharge
Cost burden
Mean total costs to parents (missed income and expenses) related to the participant's illness within 14 days of hospital discharge, measured by the cost burden survey.
Time frame: Within 14 days of hospital discharge
Child time
Mean number of hours of school or daycare missed by the participant within 14 days of hospital discharge as a result of their medical needs
Time frame: Within 14 days of hospital discharge
Parent time
Mean number of hours spent away from responsibilities (work or non-work related) by parents within 14 days of hospital discharge as a result of their child's medical needs
Time frame: Within 14 days of hospital discharge
Symptom duration
Proportion of participants who have completely recovered from their infection at 7 days after hospital discharge
Time frame: Within 7 days of hospital discharge
Total additional ambulatory visits
Mean number of ambulatory visits (in-person or via telehealth) that a participant attends, apart from the post-hospitalization follow-up visit, within 30 days of hospital discharge; Ambulatory visits include clinic, urgent care, and emergency department (not resulting in hospital admission) visits.
Time frame: Within 30 days of hospital discharge
Non-primary care ambulatory visits
Mean number of ambulatory visits (in-person or via telehealth) to non-primary care providers, within 30 days of hospital discharge; Non-primary care providers will include all providers outside of the clinic that families identify as their primary care clinic.
Time frame: Within 30 days of hospital discharge
Parent self-efficacy
Mean self-efficacy score 7 days after hospital discharge, measured by the PROMIS self-efficacy short form.
Time frame: 7 days after hospital discharge
Parent anxiety
Mean anxiety score 7 days after hospital discharge, measured by the PROMIS anxiety short form.
Time frame: 7 days after hospital discharge
Satisfaction with care
Proportion of participants who report agreeing or strongly agreeing with the statement, "I am satisfied with the medical care my child has received since hospital discharge," 7 days after hospital discharge
Time frame: 7 days after hospital discharge
Telephone and electronic communications with medical providers
Mean number of telephone and electronic (excluding telehealth visits) communications with a medical provider within 14 days of hospital discharge
Time frame: Within 14 days of hospital discharge
Well-child visits
Proportion of participants who attend a well-child visit within Proportion of participants who attend a well-child visit within 6 months of hospital discharge
Time frame: Within 6 months of hospital discharge
Immunizations
Proportion of participants who receive an immunization within 6 months of hospital discharge
Time frame: Within 6 months of hospital discharge
Usual place of medical care
Proportion of participants who report having a usual place of medical care 6 months after hospital discharge
Time frame: Within 6 months of hospital discharge
Medical interventions related to the index infection
Proportion of participants who receive either a laboratory test, imaging test, or a new medication related to the index infection within 14 days of hospital discharge
Time frame: Within 14 days of hospital discharge
Medical errors
Proportion of parents who report that their child experienced a medical error within 14 days of hospital discharge, measured by the Family Safety Interview
Time frame: Within 14 days of hospital discharge
Hospital readmissions related to the index infection
Proportion of participants who experience a hospital readmission related to the index infection within 14 days of hospital discharge
Time frame: Within 14 days of hospital discharge
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