Clinical trial NCT05471908: Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial
Official title: The Follow-up Automatically vs. As-Needed Comparison Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia
Urinary Tract Infections
Soft Tissue Infections
Gastroenteritis
Keywords: post-hospitalization
follow-up care
patient centered care
randomized control trial
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-07-25
Enrollment: 2674
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Hospital readmission
timeFrame: Within 14 days of hospital discharge
Secondary outcomes:
measure: Medical interventions
timeFrame: Within 14 days of hospital discharge
measure: Child health-related quality of life
timeFrame: 7 days after hospital discharge
Other outcomes:
measure: Cost burden
timeFrame: Within 14 days of hospital discharge
measure: Child time
timeFrame: Within 14 days of hospital discharge
measure: Parent time
timeFrame: Within 14 days of hospital discharge
measure: Symptom duration
timeFrame: Within 7 days of hospital discharge
measure: Total additional ambulatory visits
timeFrame: Within 30 days of hospital discharge
measure: Non-primary care ambulatory visits
timeFrame: Within 30 days of hospital discharge
measure: Parent self-efficacy
timeFrame: 7 days after hospital discharge
measure: Parent anxiety
timeFrame: 7 days after hospital discharge
measure: Satisfaction with care
timeFrame: 7 days after hospital discharge
measure: Telephone and electronic communications with medical providers
timeFrame: Within 14 days of hospital discharge
measure: Well-child visits
timeFrame: Within 6 months of hospital discharge
measure: Immunizations
timeFrame: Within 6 months of hospital discharge
measure: Usual place of medical care
timeFrame: Within 6 months of hospital discharge
measure: Medical interventions related to the index infection
timeFrame: Within 14 days of hospital discharge
measure: Medical errors
timeFrame: Within 14 days of hospital discharge
measure: Hospital readmissions related to the index infection
timeFrame: Within 14 days of hospital discharge
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Mountain View
country: United States
facility: Packard at El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Plainsboro
country: United States
facility: Penn Medicine Princeton Medical Center
state: New Jersey
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - Main Campus
state: Ohio
city: Liberty Township
country: United States
facility: Cincinnati Children's Hospital Medical Center - Liberty Campus
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Main
state: Texas
city: Houston
country: United States
facility: Texas Children's West
state: Texas
city: Lehi
country: United States
facility: Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Utah
name: Eric Coon, MD
role: PRINCIPAL_INVESTIGATOR
References: