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Not yet recruitingNCT07864636AFTERCAREUpdated Oct 8, 2026

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

An interventional study of Automatic follow-up recommendation and As-needed follow-up recommendation in Children With Medical Complexity, Respiratory Tract Infections (RTI) and Urinary Tract Infection (UTI), sponsored by Seattle Children's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

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

Keywords

  • Pediatric hospitalization
  • Postdischarge follow-up
  • Caregiver-directed care
  • Feasibility trial
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 160 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 211 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Children aged 1 to younger than 17 years at hospital admission.
  2. Chronic medical conditions affecting at least two body systems.
  3. Hospitalized on a general pediatric, complex care or equivalent service for a respiratory infection, urinary tract infection, skin or soft-tissue infection, or infectious gastroenteritis.
  4. Expected discharge home, with an adult parent or legal guardian available to provide consent and complete study activities.

Exclusion criteria

Exclusion Criteria

  1. Enrollment after hospital day 30.
  2. Primary care follow-up already scheduled or recommended within seven days after discharge, or a strong family or clinician preference that makes randomization unacceptable.
  3. History of cancer or organ, bone marrow or stem-cell transplantation.
  4. A new type of medical equipment needed at home, or planned home intravenous nutrition or antibiotics.
  5. Selected complicated infections or infection-specific high-risk conditions.
  6. Foster care, hospice care or discharge to an institutional care setting.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study 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.

    Behavioral: Automatic follow-up recommendation

  • 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.

    Behavioral: As-needed follow-up recommendation

Interventions

  • BehavioralAutomatic follow-up recommendation

    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.

  • BehavioralAs-needed follow-up recommendation

    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.

06

What researchers measure

Primary outcomes

  1. Eligible hospitalizations per site per month

    Number of hospitalizations confirmed as initially eligible through study screening per month that a study site is open to recruitment.

    Time frame: During recruitment, anticipated to last approximately 2 years.

  2. Clinician acceptance rate

    Percentage of consented patients with known objection status for whom no clinician objected to randomization, including no reply after clinician notification and the response period.

    Time frame: During the initial hospitalization, before randomization or the end of recruitment for that patient (up to hospital day 30).

  3. Family consent rate

    Percentage of initially eligible families offered study participation who provide consent.

    Time frame: During recruitment in the initial hospitalization (up to hospital day 30).

  4. Difference in seven-day primary care follow-up between study arms

    Automatic minus as-needed difference in the percentage of patients with known follow-up status who have a clinical visit or call with their regular doctor or usual care team within seven days after discharge.

    Time frame: Within 7 days after hospital discharge.

07

Study locations

1 site
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864636
Lead sponsor
Seattle Children's Hospital
Responsible party
Nassr Nama (Assistant Professor, Seattle Children's Hospital) — Principal investigator
First posted
Oct 8, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Nassr Nama, MD, MSc
principal investigator · Seattle Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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