Pneumonia ChildhoodICE-CAP2NCT06033079
Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)
A study testing Clinical Decision Support in people with Pneumonia Childhood, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially eligible for study. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pneumonia Childhood
- What is being tested?
- Clinical Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Six months to <18 years of age
- Radiographic evidence of pneumonia in ED
- Provider-confirmed diagnosis of pneumonia
Who cannot join
- Children with tracheostomy, cystic fibrosis, immunosuppression
- Inter-hospital transfers
- Hospitalization within preceding 7 days
- Previously enrolled within preceding 28 days
- Provider preference for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support
Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially eligible for study. During intervention periods, providers caring for enrolled children will be presented with a detailed decision support strategy that emphasizes management in accordance with national guideline recommendations. The anticipated study duration is 24 months and, as this study does not include direct contact with enrolled subjects, there is no anticipated follow up.
Read the detailed description
Pneumonia is the most common serious infection in childhood. In the United States (US), pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per 1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization with >100,000 hospitalizations per year (15-22 per 100,000 US children per year). Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any other condition.
Emergency care for childhood pneumonia, including hospitalization rates, varies widely across the nation. A study examining hospital admission rates at 35 US children's hospitals from 2009-12 showed marked differences in severity-adjusted pneumonia hospital admission rates (median 31%; range 19-69%). Provider preferences and inaccurate risk perceptions contribute to these differences in hospitalization rates. Within the Intermountain Healthcare System in Utah, Dean et al. exposed large differences in admission rates (range 38-79%) among 18 individual ED providers providing care for >2,000 adults with pneumonia. Differences were not explained by patient characteristics or illness severity and higher rates of hospitalization did not reduce hospital readmissions or mortality. In another multicenter study of 472 adults with pneumonia at <4% risk of 30-day mortality estimated using objective severity scores, providers overestimated the risk of mortality in 5% of outpatients (range across institutions 0-12%) and 41% of inpatients (range across institutions 36-48%). These studies suggest that risk perceptions are often inaccurate, and potentially lead to unnecessary or prolonged hospitalizations and intensive therapies. Similar studies have not been performed in children because no valid prognostic tools exist to reliably predict pediatric pneumonia severity.
- Conditions
- Pneumonia Childhood
- Being tested
- Clinical Decision Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision SupportBehavioural
For enrolled subjects assigned to the decision support arm, providers will receive prognostic information derived using our previously validated and best performing model. The decision support application will automatically calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. Outcome probabilities will be integrated into the decision support application and displayed within the EHR.
| Study group | Role | What they receive |
|---|---|---|
| CDS Intervention | Experimental | The prognostic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way. Receives: Behavioral: Clinical Decision Support |
| Control | No intervention | No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate Disposition
Number of participants who were disposed from the ED and experienced a change in level of care within 24 hours unless objective criteria present. Appropriate dispositions were defined as follows.
- Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h
- Disposition: Inpatient Ward, Appropriate if hospital length of stay (LOS) ≥ 24h OR hospital LOS < 24h with objective criteria for admission present (eg, need for supplemental oxygen) PLUS no transfer to intensive care (ICU) within 24h
- Disposition: ICU, ICU LOS ≥ 24h OR ICU LOS < 24h with objective criteria for ICU admission present (eg, respiratory failure)
Encounters NOT meeting these criteria were defined as Inappropriate.
Measured: 24 Hours
Secondary outcomes (5)
Overall Site-of-care Disposition
This outcome reports the total number of participants who were initially discharged from the ED, admitted to the inpatient ward, or admitted to the ICU.
Measured: ED Disposition
ED Revisits (72 Hours)
This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
Measured: 72 hours
ED Revisits (7 Days)
This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
Measured: 7 days
Rehospitalizations (72 Hours)
This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.
Measured: 72 hours
Rehospitalizations (7 Days)
This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start20 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a randomized controlled trial comparing our prognostic tool (intervention arm) to usual care (control arm) over a period of 24 months. Randomization will occur at the patient level. Allocation to intervention or control will be based on medical record number (even vs. odd) or similar strategy and will be assigned automatically once a provider confirms the diagnosis of pneumonia. Importantly, all standard of care treatment options will be available and decision-making will not be restricted in any way in either group.
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Derek Williams, Vanderbilt University Medical Center
- Investigators
- Derek J Williams, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033079
- Sponsor's protocol ID
- R01AI125642pt2
- Other IDs
- R01AI125642
- Acronym
- ICE-CAP2
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2023
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams DJ, Nian H, Suresh S, Slagle J, Gradwohl S, Johnson J, Stassun J, Reale C, Just SL, Rixe NS, Beebe R, Arnold DH, Turer RW, Antoon JW, Sartori LF, Freundlich RE, Grijalva CG, Smith JC, Weitkamp AO, Weinger MB, Zhu Y, Martin JM. Prognostic clinical decision support for pneumonia in the emergency department: A randomized trial. J Hosp Med. 2024 Sep;19(9):802-811. doi: 10.1002/jhm.13391. Epub 2024 May 26.
PubMed 38797872
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support
- ClinicalTrials.gov ID
- NCT06033079
- Acronym / sponsor ID
- ICE-CAP2 / R01AI125642pt2
- Conditions
- Pneumonia Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Pittsburgh Medical Center
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially eligible for study. During intervention periods, providers caring for enrolled children will be presented with a detailed decision support strategy that emphasizes management in accordance with national guideline recommendations. The anticipated study duration is 24 months and, as this study does not include direct contact with enrolled subjects, there is no anticipated follow up.
Detailed description
Pneumonia is the most common serious infection in childhood. In the United States (US), pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per 1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization with >100,000 hospitalizations per year (15-22 per 100,000 US children per year). Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any other condition.
Emergency care for childhood pneumonia, including hospitalization rates, varies widely across the nation. A study examining hospital admission rates at 35 US children's hospitals from 2009-12 showed marked differences in severity-adjusted pneumonia hospital admission rates (median 31%; range 19-69%). Provider preferences and inaccurate risk perceptions contribute to these differences in hospitalization rates. Within the Intermountain Healthcare System in Utah, Dean et al. exposed large differences in admission rates (range 38-79%) among 18 individual ED providers providing care for >2,000 adults with pneumonia. Differences were not explained by patient characteristics or illness severity and higher rates of hospitalization did not reduce hospital readmissions or mortality. In another multicenter study of 472 adults with pneumonia at <4% risk of 30-day mortality estimated using objective severity scores, providers overestimated the risk of mortality in 5% of outpatients (range across institutions 0-12%) and 41% of inpatients (range across institutions 36-48%). These studies suggest that risk perceptions are often inaccurate, and potentially lead to unnecessary or prolonged hospitalizations and intensive therapies. Similar studies have not been performed in children because no valid prognostic tools exist to reliably predict pediatric pneumonia severity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a randomized controlled trial comparing our prognostic tool (intervention arm) to usual care (control arm) over a period of 24 months. Randomization will occur at the patient level. Allocation to intervention or control will be based on medical record number (even vs. odd) or similar strategy and will be assigned automatically once a provider confirms the diagnosis of pneumonia. Importantly, all standard of care treatment options will be available and decision-making will not be restricted in any way in either group.
| Arm | Type | Receives |
|---|---|---|
| CDS Intervention | Experimental | Behavioral: Clinical Decision SupportThe prognostic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way. |
| Control | No intervention | –No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Six months to <18 years of age
- Radiographic evidence of pneumonia in ED
- Provider-confirmed diagnosis of pneumonia
Key exclusion criteria (5 listed)
- Children with tracheostomy, cystic fibrosis, immunosuppression
- Inter-hospital transfers
- Hospitalization within preceding 7 days
- Previously enrolled within preceding 28 days
- Provider preference for any reason
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 |
|---|---|---|
| Clinical Decision SupportFor enrolled subjects assigned to the decision support arm, providers will receive prognostic information derived using our previously validated and best performing model. The decision support application will automatically calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. Outcome probabilities will be integrated into the decision support application and displayed within the EHR. | Behavioural | CDS Intervention |
Primary outcome
Inappropriate Disposition
Time frame: 24 Hours
Number of participants who were disposed from the ED and experienced a change in level of care within 24 hours unless objective criteria present. Appropriate dispositions were defined as follows. 1. Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h 2. Disposition: Inpatient Ward, Appropriate if hospital length of stay (LOS) ≥ 24h OR hospital LOS < 24h with objective criteria for admission present (eg, need for supplemental oxygen) PLUS no transfer to intensive care (ICU) within 24h 3. Disposition: ICU, ICU LOS ≥ 24h OR ICU LOS < 24h with objective criteria for ICU admission present (eg, respiratory failure) Encounters NOT meeting these criteria were defined as Inappropriate.
5 secondary outcomes
Overall Site-of-care Disposition
Time frame: ED Disposition
ED Revisits (72 Hours)
Time frame: 72 hours
ED Revisits (7 Days)
Time frame: 7 days
Rehospitalizations (72 Hours)
Time frame: 72 hours
Rehospitalizations (7 Days)
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38797872Williams DJ, Nian H, Suresh S, Slagle J, Gradwohl S, Johnson J, Stassun J, Reale C, Just SL, Rixe NS, Beebe R, Arnold DH, Turer RW, Antoon JW, Sartori LF, Freundlich RE, Grijalva CG, Smith JC, Weitkamp AO, Weinger MB, Zhu Y, Martin JM. Prognostic clinical decision support for pneumonia in the emergency department: A randomized trial. J Hosp Med. 2024 Sep;19(9):802-811. doi: 10.1002/jhm.13391. Epub 2024 May 26.
- 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. This study is not recruiting at the moment.
Derek J Williams, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support in people with Pneumonia Childhood, run by Vanderbilt University Medical Center 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inappropriate Disposition (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033079, which also lists 1 linked publication.
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 5 Dec 2023.