Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
NCT ID: NCT05471908
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2674 participants
INTERVENTIONAL
2022-08-22
2028-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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As-needed (PRN) post-hospitalization 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.
As-needed 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.
Automatic post-hospitalization 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.
Automatic 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.
Interventions
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As-needed 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.
Automatic 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hospitalization due to a primary diagnosis of pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection.
* Parent speaks English or Spanish.
Exclusion Criteria
* 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:
* Chronic wound
* Postoperative infection
* Predisposition to poor wound healing
* Discharging with a drain in place
* Complicated by necrotizing fasciitis or toxic shock syndrome
* Diagnosis of gastroenteritis complicated by:
* Hemolytic uremic syndrome
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Utah
OTHER
Responsible Party
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Eric Coon
Professor
Principal Investigators
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Eric Coon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Packard at El Camino Hospital
Mountain View, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey, United States
Cincinnati Children's Hospital Medical Center - Main Campus
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center - Liberty Campus
Liberty Township, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Main
Houston, Texas, United States
Texas Children's West
Houston, Texas, United States
Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
Lehi, Utah, United States
Riverton Hospital
Riverton, Utah, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Brittany Wold, MD
Role: primary
Lauren Destino, MD
Role: primary
Alan Schroeder, MD
Role: primary
Sarah Bram, MD
Role: primary
Julianne Prasto, MD
Role: primary
Patrick Brady, MD
Role: primary
Patrick Brady, MD
Role: primary
Chris Bonafide, MD
Role: primary
Sowdhamini Wallace, MD
Role: primary
Katie Ban, MD
Role: primary
Kristina McKinley, MD
Role: primary
Kristina McKinley
Role: primary
Eric Coon, MD, MS
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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IHS-2021C1-22388
Identifier Type: -
Identifier Source: org_study_id
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