Skip to content

Improving CarE for Community Acquired Pneumonia 1

Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Antibiotic Decision Support

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03760419
Acronym
ICE-CAP1
Enrollment
1027
Registered
2018-11-30
Start date
2018-12-17
Completion date
2020-09-30
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia Childhood

Brief 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. 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.

Interventions

BEHAVIORALClinical Decision Support

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.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of Pittsburgh Medical Center
CollaboratorOTHER
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Six months to \<18 years of age * Radiographic evidence of pneumonia in ED * Provider-confirmed diagnosis of pneumonia (via Clinical Decision Support \[CDS\])

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours18 monthsThe primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.

Secondary

MeasureTime frameDescription
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode18 monthsThis 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).
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours18 monthsThis secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode18 monthsThis secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).

Countries

United States

Participant flow

Participants by arm

ArmCount
Control Arm
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.
478
Intervention Arm
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. Clinical Decision Support: 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.
549
Total1,027

Baseline characteristics

CharacteristicIntervention ArmTotalControl Arm
Age, Continuous4.0 years4.2 years4.8 years
Comorbidity
Complex Chronic
120 Participants255 Participants135 Participants
Comorbidity
Non-Chronic
359 Participants641 Participants282 Participants
Comorbidity
Non-complex Chronic
70 Participants131 Participants61 Participants
ED Disposition
Home
219 Participants431 Participants212 Participants
ED Disposition
Inpatient
215 Participants404 Participants189 Participants
ED Disposition
Intensive Care
115 Participants192 Participants77 Participants
Enrolling Site
Site A
214 Participants535 Participants321 Participants
Enrolling Site
Site B
335 Participants492 Participants157 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
36 Participants96 Participants60 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
472 Participants862 Participants390 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
41 Participants69 Participants28 Participants
Heart rate139 bpm136 bpm134 bpm
Insurance
Private
246 Participants422 Participants176 Participants
Insurance
Public
280 Participants561 Participants281 Participants
Insurance
Self-Pay
23 Participants41 Participants18 Participants
Race/Ethnicity, Customized
Asian
17 Participants31 Participants14 Participants
Race/Ethnicity, Customized
Black
79 Participants196 Participants117 Participants
Race/Ethnicity, Customized
Mixed
12 Participants22 Participants10 Participants
Race/Ethnicity, Customized
Other
20 Participants44 Participants24 Participants
Race/Ethnicity, Customized
Unknown
22 Participants41 Participants19 Participants
Race/Ethnicity, Customized
White
399 Participants693 Participants294 Participants
Respiratory rate34 respirations per minute32 respirations per minute30 respirations per minute
Sex: Female, Male
Female
246 Participants463 Participants217 Participants
Sex: Female, Male
Male
303 Participants564 Participants261 Participants
SpO2:FiO2 ratio457 ratio457 ratio462 ratio
Systolic BP108 mmHg108 mmHg108 mmHg
Temperature37.5 degrees Celsius37.4 degrees Celsius37.3 degrees Celsius

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 4781 / 549
other
Total, other adverse events
0 / 4780 / 549
serious
Total, serious adverse events
83 / 47874 / 549

Outcome results

Primary

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.

Time frame: 18 months

Population: All categories except Overall are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursSite A174 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursICU22 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursOutpatient140 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursAge < 6 years163 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursSite B81 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursAge >/= 6 years92 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursInpatient93 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursReceiving Antibiotics147 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursOverall255 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursReceiving Antibiotics192 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursOverall284 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursSite A120 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursSite B164 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursOutpatient164 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursInpatient99 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursICU21 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursAge < 6 years192 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Therapy, First 24 HoursAge >/= 6 years92 Participants
Secondary

Any Guideline-Concordant Antibiotic Prescribing, Entire Episode

This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).

Time frame: 18 months

Population: All categories except Overall are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite A200 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeICU41 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOutpatient145 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge <6 years195 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite B105 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge >/= 6 years110 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeInpatient119 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeReceiving Antibiotics200 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOverall305 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeReceiving Antibiotics297 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOverall383 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite A146 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite B237 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOutpatient168 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeInpatient154 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeICU61 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge <6 years256 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge >/= 6 years127 Participants
Secondary

Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours

This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.

Time frame: 18 months

Population: All categories except Overall are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursSite A198 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursICU35 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursOutpatient145 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursAge <6 years189 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursSite B99 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursAge >/= 6 years108 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursInpatient117 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursReceiving Antibiotics189 Participants
Control ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursOverall297 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursReceiving Antibiotics266 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursOverall358 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursSite A144 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursSite B214 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursOutpatient168 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursInpatient145 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursICU45 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursAge <6 years242 Participants
Intervention ArmAny Guideline-Concordant Antibiotic Prescribing, First 24 HoursAge >/= 6 years116 Participants
Secondary

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).

Time frame: 18 months

Population: All categories except Overall are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite A163 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeICU17 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOutpatient140 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge <6 years156 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite B77 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge >/= 6 years84 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeInpatient83 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeReceiving Antibiotics135 Participants
Control ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOverall240 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeReceiving Antibiotics175 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOverall261 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite A111 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeSite B150 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeOutpatient164 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeInpatient85 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeICU12 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge <6 years175 Participants
Intervention ArmExclusive Guideline-Concordant Antibiotic Prescribing, Entire EpisodeAge >/= 6 years86 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026