Pneumonia ChildhoodICE-CAP1NCT03760419
Improving CarE for Community Acquired Pneumonia 1
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
- 1,027 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 30 Sep 2020
- 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 (via Clinical Decision Support [CDS])
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): Antibiotic 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 18 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)2-5. Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any other condition.
Safely reducing inappropriate antibiotic use is critical to slow the progression of antimicrobial resistance, and childhood pneumonia is a key area where substantial improvements can be made. In the 2011 Pediatric Infectious Diseases Society/Infectious Diseases Society of America (PIDS/IDSA) pneumonia guideline, appropriate use of antibiotics was an important area of emphasis. For presumed bacterial pneumonia, recommendations emphasize the use of a single, narrow-spectrum antibiotic (i.e. amoxicillin or ampicillin). In children <6 years of age treated in the outpatient setting, the guideline recommended considering withholding antibiotics, recognizing that pneumonia in this population is most often caused by viruses. Both of these recommendations were graded as strong and supported by high-quality evidence. Nonetheless, in a large database study we conducted just prior to release of the 2011 guideline, use of broad-spectrum antibiotics was very common among children hospitalized with pneumonia, with substantial differences in antibiotic selection patterns among the various hospitals. In that study, use of narrow-spectrum ampicillin was rare (<5%). High rates of broad-spectrum antibiotic use were also noted in a study of children with pneumonia treated and released from US EDs, with <30% of children receiving narrow-spectrum therapy.
Study Aim: To test the hypothesis that electronic antibiotic decision support increases guideline-concordant antibiotic use compared with usual care in the emergency department.
The primary outcome is the proportion of children exclusively receiving guideline-concordant first line antibiotic therapy during the first 24 hours of care. Secondary outcomes include exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant antibiotic therapy during the first 24 hours of care and for the entire episode, and emergency department revisits and hospitalizations within 72 hours and 7 days of the index discharge.
In this study, conducted at two experienced academic centers, the investigator will implement and evaluate an electronic health record based clinical decision support application to promote antibiotic use in concordance with the 2011 PIDS/IDSA guideline in a pragmatic, cluster randomized trial. Decisions regarding management, including antibiotic selection and site of care, will be at the discretion of the treating provider and will not be restricted or altered in any way. Thus, this study poses no greater than minimal risks to participants. Due to the nature of the research, waiver of informed consent has been provided, as it has been done in similar pragmatic studies at the institutions.
- 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The antibiotic 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 Arm | 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.
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.
Measured: 18 months
Secondary outcomes (3)
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).
Measured: 18 months
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.
Measured: 18 months
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start17 Dec 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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.
- 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
- Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).
- Masking
- None (open label)
- Enrolment
- 1,027 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
- NCT03760419
- Sponsor's protocol ID
- R01AI125642
- Other IDs
- R01AI125642
- Acronym
- ICE-CAP1
- Status last verified
- Nov 2022
- First submitted
- 15 Sep 2018
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Antibiotic Decision Support
- ClinicalTrials.gov ID
- NCT03760419
- Acronym / sponsor ID
- ICE-CAP1 / R01AI125642
- Conditions
- Pneumonia Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 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
- 17 Dec 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Posted 8 Dec 2022
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 18 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)2-5. Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any other condition.
Safely reducing inappropriate antibiotic use is critical to slow the progression of antimicrobial resistance, and childhood pneumonia is a key area where substantial improvements can be made. In the 2011 Pediatric Infectious Diseases Society/Infectious Diseases Society of America (PIDS/IDSA) pneumonia guideline, appropriate use of antibiotics was an important area of emphasis. For presumed bacterial pneumonia, recommendations emphasize the use of a single, narrow-spectrum antibiotic (i.e. amoxicillin or ampicillin). In children <6 years of age treated in the outpatient setting, the guideline recommended considering withholding antibiotics, recognizing that pneumonia in this population is most often caused by viruses. Both of these recommendations were graded as strong and supported by high-quality evidence. Nonetheless, in a large database study we conducted just prior to release of the 2011 guideline, use of broad-spectrum antibiotics was very common among children hospitalized with pneumonia, with substantial differences in antibiotic selection patterns among the various hospitals. In that study, use of narrow-spectrum ampicillin was rare (<5%). High rates of broad-spectrum antibiotic use were also noted in a study of children with pneumonia treated and released from US EDs, with <30% of children receiving narrow-spectrum therapy.
Study Aim: To test the hypothesis that electronic antibiotic decision support increases guideline-concordant antibiotic use compared with usual care in the emergency department.
The primary outcome is the proportion of children exclusively receiving guideline-concordant first line antibiotic therapy during the first 24 hours of care. Secondary outcomes include exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant antibiotic therapy during the first 24 hours of care and for the entire episode, and emergency department revisits and hospitalizations within 72 hours and 7 days of the index discharge.
In this study, conducted at two experienced academic centers, the investigator will implement and evaluate an electronic health record based clinical decision support application to promote antibiotic use in concordance with the 2011 PIDS/IDSA guideline in a pragmatic, cluster randomized trial. Decisions regarding management, including antibiotic selection and site of care, will be at the discretion of the treating provider and will not be restricted or altered in any way. Thus, this study poses no greater than minimal risks to participants. Due to the nature of the research, waiver of informed consent has been provided, as it has been done in similar pragmatic studies at the institutions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Clinical Decision SupportThe antibiotic 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 Arm | 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 (via Clinical Decision Support [CDS])
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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan. | Behavioural | Intervention Arm |
Primary outcome
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Time frame: 18 months
The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.
3 secondary outcomes
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Time frame: 18 months
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Time frame: 18 months
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 8 Dec 2022. 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 8 Dec 2022). 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?
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours (time frame: 18 months). 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 Dec 2022.