The Follow-up Automatically vs. As-Needed Comparison Trial (FAAN-C)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2028
  • participants needed
    2674
  • sponsor
    University of Utah
Updated on 27 October 2022
pneumonia
acute gastroenteritis

Summary

Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.

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.

Details
Condition Pneumonia, Urinary Tract Infections, Soft Tissue Infections, Gastroenteritis
Treatment As-needed follow up, Automatic follow-up
Clinical Study IdentifierNCT05471908
SponsorUniversity of Utah
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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