Children With Medical ComplexityAFTERCARENCT07864636
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
A study testing Automatic follow-up recommendation and As-needed follow-up recommendation in people with Children With Medical Complexity and Respiratory Tract Infections (RTI), run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Children With Medical Complexity, Respiratory Tract Infections (RTI), Urinary Tract Infection (UTI)
- What is being tested?
- Automatic follow-up recommendation and As-needed follow-up recommendation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Selected complicated infections or infection-specific high-risk conditions.
- Foster care, hospice care or discharge to an institutional care setting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: AFTERCARE: Automatic Versus Family-directed Transition Follow-up After Hospitalization: Evaluating Randomization, Caregiver Acceptability, and Recruitment fEasibility
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.
- Conditions
- Children With Medical Complexity, Respiratory Tract Infections (RTI), Urinary Tract Infection (UTI), Acute Gastroenteritis, Skin and Soft Tissue Infection
- Being tested
- Automatic follow-up recommendation, As-needed follow-up recommendation
- Keywords
- Pediatric hospitalization, Postdischarge follow-up, Caregiver-directed care, Feasibility trial
- Medical subject headings
- Respiratory Tract Infections, Urinary Tract Infections, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic follow-up recommendationBehavioural
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 recommendationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Automatic follow-up recommendation | Active comparator | Families are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge. Receives: Behavioral: Automatic follow-up recommendation |
| As-needed follow-up recommendation | Experimental | Families are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise. Receives: Behavioral: As-needed follow-up recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During recruitment, anticipated to last approximately 2 years.
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.
Measured: During the initial hospitalization, before randomization or the end of recruitment for that patient (up to hospital day 30).
Family consent rate
Percentage of initially eligible families offered study participation who provide consent.
Measured: During recruitment in the initial hospitalization (up to hospital day 30).
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.
Measured: Within 7 days after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Medical ComplexityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter external pilot trial with individual 1:1 randomization, stratified by site, to automatic or as-needed postdischarge follow-up recommendations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassr Nama, Seattle Children's Hospital
- Investigators
- Nassr Nama, MD, MSc, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864636
- Sponsor's protocol ID
- STUDY00005858
- Acronym
- AFTERCARE
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AFTERCARE: Automatic Versus Family-directed Transition Follow-up After Hospitalization: Evaluating Randomization, Caregiver Acceptability, and Recruitment fEasibility
- ClinicalTrials.gov ID
- NCT07864636
- Acronym / sponsor ID
- AFTERCARE / STUDY00005858
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter external pilot trial with individual 1:1 randomization, stratified by site, to automatic or as-needed postdischarge follow-up recommendations.
| Arm | Type | Receives |
|---|---|---|
| Automatic follow-up recommendation | Active comparator | Behavioral: Automatic follow-up recommendationFamilies are instructed to arrange follow-up with their usual outpatient clinician within seven days after hospital discharge. |
| As-needed follow-up recommendation | Experimental | Behavioral: As-needed follow-up recommendationFamilies are instructed that follow-up is recommended if the child is not improving as expected or new concerns arise. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Selected complicated infections or infection-specific high-risk conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic follow-up recommendationFamilies 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. | Behavioural | Automatic follow-up recommendation |
| As-needed follow-up recommendationFamilies 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. | Behavioural | As-needed follow-up recommendation |
Primary outcome
Eligible hospitalizations per site per month
Time frame: During recruitment, anticipated to last approximately 2 years.
Number of hospitalizations confirmed as initially eligible through study screening per month that a study site is open to recruitment.
Clinician acceptance rate
Time frame: During the initial hospitalization, before randomization or the end of recruitment for that patient (up to hospital day 30).
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.
Family consent rate
Time frame: During recruitment in the initial hospitalization (up to hospital day 30).
Percentage of initially eligible families offered study participation who provide consent.
Difference in seven-day primary care follow-up between study arms
Time frame: Within 7 days after hospital discharge.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nassr Nama, MD, MSc principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic follow-up recommendation and As-needed follow-up recommendation in people with Children With Medical Complexity and Respiratory Tract Infections (RTI), run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligible hospitalizations per site per month (time frame: During recruitment, anticipated to last approximately 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.