Pneumonia Childhood
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | 18 months | 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). |
| Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | 18 months | This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter. |
| Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | 18 months | This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 1,027 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Control Arm |
|---|---|---|---|
| Age, Continuous | 4.0 years | 4.2 years | 4.8 years |
| Comorbidity Complex Chronic | 120 Participants | 255 Participants | 135 Participants |
| Comorbidity Non-Chronic | 359 Participants | 641 Participants | 282 Participants |
| Comorbidity Non-complex Chronic | 70 Participants | 131 Participants | 61 Participants |
| ED Disposition Home | 219 Participants | 431 Participants | 212 Participants |
| ED Disposition Inpatient | 215 Participants | 404 Participants | 189 Participants |
| ED Disposition Intensive Care | 115 Participants | 192 Participants | 77 Participants |
| Enrolling Site Site A | 214 Participants | 535 Participants | 321 Participants |
| Enrolling Site Site B | 335 Participants | 492 Participants | 157 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 96 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 472 Participants | 862 Participants | 390 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants | 69 Participants | 28 Participants |
| Heart rate | 139 bpm | 136 bpm | 134 bpm |
| Insurance Private | 246 Participants | 422 Participants | 176 Participants |
| Insurance Public | 280 Participants | 561 Participants | 281 Participants |
| Insurance Self-Pay | 23 Participants | 41 Participants | 18 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 31 Participants | 14 Participants |
| Race/Ethnicity, Customized Black | 79 Participants | 196 Participants | 117 Participants |
| Race/Ethnicity, Customized Mixed | 12 Participants | 22 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 44 Participants | 24 Participants |
| Race/Ethnicity, Customized Unknown | 22 Participants | 41 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 399 Participants | 693 Participants | 294 Participants |
| Respiratory rate | 34 respirations per minute | 32 respirations per minute | 30 respirations per minute |
| Sex: Female, Male Female | 246 Participants | 463 Participants | 217 Participants |
| Sex: Female, Male Male | 303 Participants | 564 Participants | 261 Participants |
| SpO2:FiO2 ratio | 457 ratio | 457 ratio | 462 ratio |
| Systolic BP | 108 mmHg | 108 mmHg | 108 mmHg |
| Temperature | 37.5 degrees Celsius | 37.4 degrees Celsius | 37.3 degrees Celsius |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 478 | 1 / 549 |
| other Total, other adverse events | 0 / 478 | 0 / 549 |
| serious Total, serious adverse events | 83 / 478 | 74 / 549 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Site A | 174 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | ICU | 22 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Outpatient | 140 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Age < 6 years | 163 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Site B | 81 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Age >/= 6 years | 92 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Inpatient | 93 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Receiving Antibiotics | 147 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Overall | 255 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Receiving Antibiotics | 192 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Overall | 284 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Site A | 120 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Site B | 164 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Outpatient | 164 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Inpatient | 99 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | ICU | 21 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Age < 6 years | 192 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours | Age >/= 6 years | 92 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site A | 200 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | ICU | 41 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Outpatient | 145 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age <6 years | 195 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site B | 105 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age >/= 6 years | 110 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Inpatient | 119 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Receiving Antibiotics | 200 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Overall | 305 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Receiving Antibiotics | 297 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Overall | 383 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site A | 146 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site B | 237 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Outpatient | 168 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Inpatient | 154 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | ICU | 61 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age <6 years | 256 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age >/= 6 years | 127 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Site A | 198 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | ICU | 35 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Outpatient | 145 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Age <6 years | 189 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Site B | 99 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Age >/= 6 years | 108 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Inpatient | 117 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Receiving Antibiotics | 189 Participants |
| Control Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Overall | 297 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Receiving Antibiotics | 266 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Overall | 358 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Site A | 144 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Site B | 214 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Outpatient | 168 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Inpatient | 145 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | ICU | 45 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Age <6 years | 242 Participants |
| Intervention Arm | Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours | Age >/= 6 years | 116 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site A | 163 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | ICU | 17 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Outpatient | 140 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age <6 years | 156 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site B | 77 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age >/= 6 years | 84 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Inpatient | 83 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Receiving Antibiotics | 135 Participants |
| Control Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Overall | 240 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Receiving Antibiotics | 175 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Overall | 261 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site A | 111 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Site B | 150 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Outpatient | 164 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Inpatient | 85 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | ICU | 12 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age <6 years | 175 Participants |
| Intervention Arm | Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode | Age >/= 6 years | 86 Participants |