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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorSeattle Children's Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 1 to younger than 17 years at hospital admission.

Chronic medical conditions affecting at least two body systems.

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.

Expected discharge home, with an adult parent or legal guardian available to provide consent and complete study activities.

Disqualifiers

Enrollment after hospital day 30.

Primary care follow-up already scheduled or recommended within seven days after discharge, or a strong family or clinician preference that makes randomization unacceptable.

History of cancer or organ, bone marrow or stem-cell transplantation.

A new type of medical equipment needed at home, or planned home intravenous nutrition or antibiotics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Automatic follow-up recommendationActive comparator 1 intervention
Group B: As-needed follow-up recommendationExperimental treatment 1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: