Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
FAAN-C
The Follow-up Automatically vs. As-Needed Comparison Trial
1 other identifier
interventional
2,674
1 country
14
Brief Summary
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
December 10, 2025
December 1, 2025
4.4 years
July 21, 2022
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital readmission
The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
Within 14 days of hospital discharge
Secondary Outcomes (2)
Medical interventions
Within 14 days of hospital discharge
Child health-related quality of life
7 days after hospital discharge
Other Outcomes (16)
Cost burden
Within 14 days of hospital discharge
Child time
Within 14 days of hospital discharge
Parent time
Within 14 days of hospital discharge
- +13 more other outcomes
Study Arms (2)
As-needed (PRN) post-hospitalization follow-up
EXPERIMENTALAt 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 post-hospitalization follow-up
ACTIVE COMPARATORAt 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (14)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Packard at El Camino Hospital
Mountain View, California, 94040, United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey, 08536, United States
Cincinnati Children's Hospital Medical Center - Main Campus
Cincinnati, Ohio, 45229, United States
Cincinnati Children's Hospital Medical Center - Liberty Campus
Liberty Township, Ohio, 45044, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Main
Houston, Texas, 77030, United States
Texas Children's West
Houston, Texas, 77094, United States
Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
Lehi, Utah, 84043, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Coon, MD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Owing to the nature of the comparators, blinding of participants and their medical providers is not possible. However, outcomes that require adjudication will be adjudicated by persons blinded to the subject's randomized group. Outcomes requiring adjudication in FAAN-C are the safety outcomes (hospital readmissions related to the index infection and medical errors). Specifically, a clinician will determine if the readmission was related to the index infection and a separate clinician will score parent-reported medical errors in terms of severity (as described in the Safety Reporting section of the protocol). The clinicians performing adjudication of these outcomes will be blinded to the subject's randomized group.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start
August 22, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share