Recruiting

Follow-up vs. As-Needed

Sponsor:

University of Utah

Code:

NCT05471908

Conditions

Pneumonia

Urinary Tract Infections

Soft Tissue Infections

Gastroenteritis

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

As-needed follow up

Automatic follow-up

Study Details

Brief summary:

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

Conditions

Pneumonia

Urinary Tract Infections

Soft Tissue Infections

Gastroenteritis

Study ID

NCT05471908

Start date

Aug 22, 2022

Status verified date

Dec, 2025

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2674 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: As-needed (PRN) post-hospitalization 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.

active comparator: Automatic post-hospitalization 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.

Interventions

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 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 measure

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

Central Contacts and Locations

Central contacts

Eric Coon, MD, MS

801-587-2160Eric.Coon@hsc.utah.edu

Liz Rodriquez

liz.rodriguez@hsc.utah.edu

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Packard at El Camino Hospital

Recruiting

Mountain View, California, United States, 94040

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Penn Medicine Princeton Medical Center

Recruiting

Plainsboro, New Jersey, United States, 08536

Cincinnati Children's Hospital Medical Center - Main Campus

Recruiting

Cincinnati, Ohio, United States, 45229

Cincinnati Children's Hospital Medical Center - Liberty Campus

Recruiting

Liberty Township, Ohio, United States, 45044

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Texas Children's Main

Recruiting

Houston, Texas, United States, 77030

Texas Children's West

Recruiting

Houston, Texas, United States, 77094

Intermountain Primary Children's Hospital Larry H. and Gail Miller Family Campus

Recruiting

Lehi, Utah, United States, 84043

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

University of Utah

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • post-hospitalization
  • follow-up care
  • patient centered care
  • randomized control trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Utah on 2025-12-10.