Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of Utah
About this trial
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
As-needed follow up
BehavioralAt 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.
Automatic follow-up
BehavioralAt 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.
Treatment groups
2,674 Participants
are divided into 2 treatment groupsGroup A: As-needed (PRN) post-hospitalization follow-upExperimental treatment 1 intervention
Group B: Automatic post-hospitalization follow-upActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 dischargeSecondary outcomes
1
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 discharge2
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 dischargeOther outcomes
1
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 discharge2
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 discharge3
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 discharge4
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 dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov