Follow-Up Strategies for Children With Medical Complexity

(AFTERCARE Trial)

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Seattle Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Children with medical complexity often receive a recommendation to see an outpatient clinician soon after leaving the hospital. It is uncertain whether every child needs this routine visit or whether follow-up can be guided by the family's concerns and the child's recovery. AFTERCARE is a multicenter pilot randomized trial comparing these two follow-up recommendations for children hospitalized with an acute infection.

Families will be assigned by chance to receive either a recommendation to arrange follow-up with their usual outpatient clinician within seven days or a recommendation to seek follow-up if the child is not improving as expected or new concerns arise. Families in both groups may seek medical care whenever needed. The study will assess recruitment, follow-up data collection, delivery of the recommendations and acceptability. Caregiver surveys and medical record review will also describe outpatient visits and hospital returns. This pilot will inform the design of a larger trial, and is not designed to establish that the strategies are equally safe or effective.

Who Is on the Research Team?

NN

Nassr Nama, MD, MSc

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children with complex medical needs who have been hospitalized for infections like respiratory, urinary tract, stomach flu, or skin infections. It focuses on families willing to follow specific follow-up recommendations after hospital discharge.

Inclusion Criteria

Chronic medical conditions affecting at least two body systems
I am between 1 and 16 years old.
Expected discharge home, with an adult parent or legal guardian available to provide consent and complete study activities
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Exclusion Criteria

A new type of medical equipment needed at home, or planned home intravenous nutrition or antibiotics
I have a follow-up visit scheduled soon or my family/doctor prefers a specific care plan.
Enrollment after hospital day 30
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • As-needed follow-up recommendation
  • Automatic follow-up recommendation

Trial Overview

The study compares two approaches: one group is told to schedule a routine doctor visit within seven days after leaving the hospital; the other group is advised to seek follow-up only if their child isn't improving or new issues arise. Families are randomly assigned to each approach.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: As-needed follow-up recommendationExperimental Treatment1 Intervention
Group II: Automatic follow-up recommendationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials
319
Recruited
5,232,000+