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

Official title

The Follow-up Automatically vs. As-Needed Comparison Trial

Overview

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.

Interventions

• Behavioral 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.
• Behavioral 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

• Hospital readmission [Time frame: Within 14 days of hospital discharge]

Secondary outcome measures (2)

• Medical interventions [Time frame: Within 14 days of hospital discharge]
• Child health-related quality of life [Time frame: 7 days after hospital discharge]

Eligibility criteria

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 14 centers

• Phoenix Children's Hospital — Phoenix
• Packard at El Camino Hospital — Mountain View
• Lucile Packard Children's Hospital — Palo Alto
• St. Louis Children's Hospital — St Louis
• Penn Medicine Princeton Medical Center — Plainsboro
• Cincinnati Children's Hospital Medical Center - Main Campus — Cincinnati
• Cincinnati Children's Hospital Medical Center - Liberty Campus — Liberty Township
• Children's Hospital of Philadelphia — Philadelphia
• … and 6 more centers

Identifiers

NCT: NCT05471908 · IHS-2021C1-22388

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗