Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
- Conditions
- Soft Tissue InfectionsPneumoniaUrinary Tract InfectionsGastroenteritis
- Interventions
- Behavioral: As-needed follow upBehavioral: Automatic follow-up
- Registration Number
- NCT05471908
- Lead Sponsor
- University of Utah
- Brief Summary
Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2674
- 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.
-
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:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description As-needed (PRN) post-hospitalization follow-up 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 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.
- Primary Outcome Measures
Name Time Method Hospital readmission Within 14 days of hospital discharge The proportion of participants who experience a hospital readmission within 14 days of their index hospital discharge.
- Secondary Outcome Measures
Name Time Method Medical interventions Within 14 days of hospital discharge The proportion of participants who receive either a laboratory test, imaging test, or a new medication within 14 days of hospital discharge
Child health-related quality of life 7 days after hospital discharge Mean health-related quality of life score 7 days after hospital discharge, measured by the Impact on Activities and Routines instrument.
Trial Locations
- Locations (14)
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
🇺🇸Saint 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