Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT07864636
Status
Not Yet Recruiting

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Conditions

  • Acute Gastroenteritis
  • Children With Medical Complexity
  • Respiratory Tract Infections (RTI)
  • Skin and Soft Tissue Infection
  • Urinary Tract Infection (UTI)

Eligibility Criteria

Sex
ALL
Age
1 Year - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Automatic follow-up recommendation — BEHAVIORAL
    Families are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge. This is the clinician or team the family usually contacts first for health concerns and may be a generalist, complex-care clinician or specialist. Other specialist care continues as usual.
  • As-needed follow-up recommendation — BEHAVIORAL
    Families are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise. This recommendation concerns follow-up with the clinician or team the family usually contacts first for health concerns, which may be a generalist, complex-care clinician or specialist. Other specialist care continues as usual.

Study Details

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.

Key Dates

First listed
Oct 8, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Automatic follow-up recommendation
    Families are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge.
  • Experimental: As-needed follow-up recommendation
    Families are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise.

Primary Outcome Measure

Eligible hospitalizations per site per month [ Time Frame: During recruitment, anticipated to last approximately 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105-

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