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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI125642 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| University of Pittsburgh Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
Encounters NOT meeting these criteria were defined as Inappropriate. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ED Disposition |
| ED Revisits (72 Hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek J Williams, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38797872 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CDS Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
Encounters NOT meeting these criteria were defined as Inappropriate. | Posted | Count of Participants | Participants | 24 Hours |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Derek J. Williams, MD, MPH | Vanderbilt University Medical Center | 615-322-2744 | derek.williams@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2022 | Aug 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2022 | Aug 23, 2023 | SAP_001.pdf |
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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.
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This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
| 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. | 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. | 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. | 7 days |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Comorbidity | Data for this measure not available for all patients. | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Triage temperature | Median | Inter-Quartile Range | degrees Celsius |
|
| Triage heart rate | Median | Inter-Quartile Range | beats per minute |
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| Triage respiratory rate | Median | Inter-Quartile Range | respirations per minute |
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| Triage systolic blood pressure | Median | Inter-Quartile Range | mmHg |
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| SpO2:FiO2 ratio | Data for this measure not available for all patients. | Median | Inter-Quartile Range | ratio |
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| OG001 | 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. |
|
|
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| 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. | Posted | Count of Participants | Participants | ED Disposition |
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|
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| 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. | Posted | Count of Participants | Participants | 72 hours |
|
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| 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. | Posted | Count of Participants | Participants | 7 days |
|
|
|
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| 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. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 7 days |
|
|
|
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| 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| 3 |
| 269 |
| 0 |
| 269 |
| 0 |
| 269 |
| EG001 | 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. | 4 | 267 | 0 | 267 | 0 | 267 |
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| Complex chronic |
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| Multiple |
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| None |
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| ICU |
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