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

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Urinary Tract Infections; Gastroenteritis; Soft Tissue Infections; Pneumonia

Treatments: Behavioral: As-needed follow up; Behavioral: Automatic follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT05471908

IHS-2021C1-22388

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,674 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,674 participants in 2 patient groups

As-needed (PRN) post-hospitalization follow-up

Experimental group

Description:

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.

Treatment:

Behavioral: As-needed follow up

Automatic post-hospitalization follow-up

Active Comparator group

Description:

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.

Treatment:

Behavioral: Automatic follow-up