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 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.
Interventions
BEHAVIORALClinical Decision Support
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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Pittsburgh Medical Center
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Six months to \<18 years of age 2. Radiographic evidence of pneumonia in ED 3. Provider-confirmed diagnosis of pneumonia
Exclusion criteria
1. Children with tracheostomy, cystic fibrosis, immunosuppression 2. Inter-hospital transfers 3. Hospitalization within preceding 7 days 4. Previously enrolled within preceding 28 days 5. Provider preference for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate Disposition | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalizations (7 Days) | 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. |
| Overall Site-of-care Disposition | ED 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. |
| ED Revisits (7 Days) | 7 days | This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge. |
| Rehospitalizations (72 Hours) | 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. |
| ED Revisits (72 Hours) | 72 hours | This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 days | This outcome reports the number of participants who died as a result of their pneumonia-related illness within 30 days discharge from the index encounter. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control 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. | 269 |
| CDS Intervention 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.
Clinical Decision Support: 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. | 267 |
| Total | 536 |
Baseline characteristics
| Characteristic | CDS Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 4.3 years | 4.4 years | 4.4 years |
| Comorbidity Complex chronic | 83 Participants | 80 Participants | 163 Participants |
| Comorbidity Non-chronic | 132 Participants | 150 Participants | 282 Participants |
| Comorbidity Non-complex chronic | 25 Participants | 26 Participants | 51 Participants |
| Insurance Multiple | 20 Participants | 16 Participants | 36 Participants |
| Insurance None | 4 Participants | 5 Participants | 9 Participants |
| Insurance Private | 101 Participants | 95 Participants | 196 Participants |
| Insurance Public | 142 Participants | 153 Participants | 295 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 50 Participants | 36 Participants | 86 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 15 Participants | 22 Participants |
| Race/Ethnicity, Customized Unknown | 31 Participants | 30 Participants | 61 Participants |
| Race/Ethnicity, Customized White | 177 Participants | 184 Participants | 361 Participants |
| Sex: Female, Male Female | 141 Participants | 126 Participants | 267 Participants |
| Sex: Female, Male Male | 126 Participants | 143 Participants | 269 Participants |
| SpO2:FiO2 ratio | 457.1 ratio | 457.1 ratio | 457.1 ratio |
| Triage heart rate | 135.0 beats per minute | 138.5 beats per minute | 136.0 beats per minute |
| Triage respiratory rate | 32.0 respirations per minute | 30.0 respirations per minute | 31.0 respirations per minute |
| Triage systolic blood pressure | 108.0 mmHg | 108.0 mmHg | 108.0 mmHg |
| Triage temperature | 37.2 degrees Celsius | 37.5 degrees Celsius | 37.3 degrees Celsius |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 269 | 4 / 267 |
| other Total, other adverse events | 0 / 269 | 0 / 267 |
| serious Total, serious adverse events | 0 / 269 | 0 / 267 |
Outcome results
Primary
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. 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.
Time frame: 24 Hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Inappropriate Disposition | 7 Participants |
| CDS Intervention | Inappropriate Disposition | 6 Participants |
95% CI: [0.32, 2.95]
Secondary
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.
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | ED Revisits (72 Hours) | 10 Participants |
| CDS Intervention | ED Revisits (72 Hours) | 6 Participants |
95% CI: [0.3, 2.37]
Secondary
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.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | ED Revisits (7 Days) | 15 Participants |
| CDS Intervention | ED Revisits (7 Days) | 9 Participants |
95% CI: [0.32, 1.82]
Secondary
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.
Time frame: ED Disposition
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Overall Site-of-care Disposition | ED | 107 Participants |
| Control | Overall Site-of-care Disposition | Inpatient | 113 Participants |
| Control | Overall Site-of-care Disposition | ICU | 49 Participants |
| CDS Intervention | Overall Site-of-care Disposition | ED | 109 Participants |
| CDS Intervention | Overall Site-of-care Disposition | Inpatient | 96 Participants |
| CDS Intervention | Overall Site-of-care Disposition | ICU | 62 Participants |
p-value: 0.233Fisher Exact
Secondary
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.
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Rehospitalizations (72 Hours) | 2 Participants |
| CDS Intervention | Rehospitalizations (72 Hours) | 9 Participants |
95% CI: [0.34, 7.51]
Secondary
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.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Rehospitalizations (7 Days) | 8 Participants |
| CDS Intervention | Rehospitalizations (7 Days) | 5 Participants |
95% CI: [0.13, 1.42]
Other Pre-specified
Death
This outcome reports the number of participants who died as a result of their pneumonia-related illness within 30 days discharge from the index encounter.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Death | 3 Participants |
| CDS Intervention | Death | 4 Participants |
95% CI: [0.41, 7.9]