## Protocol Section
### Identification Module
**NCT ID:** NCT06033079

**Acronym:** ICE-CAP2

**Brief Title:** Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)

**Official Title:** Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support

#### Organization Study ID Info
**ID:** R01AI125642pt2
#### Organization
**Class:** OTHER
**Full Name:** Vanderbilt University Medical Center
#### Secondary ID Infos
**ID:** R01AI125642
**Link:** https://reporter.nih.gov/quickSearch/R01AI125642
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2022-11-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-11-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-12-05

**Type:** ACTUAL

**Results First Submit Date:** 2023-10-19

**Results First Submit QC Date:** 2023-11-13

#### Start Date
**Date:** 2020-11-20

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-09-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-23
**Study First Submit QC Date:** 2023-09-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

**Class:** OTHER

**Name:** University of Pittsburgh Medical Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Vanderbilt University Medical Center

#### Responsible Party

**Investigator Affiliation:** Vanderbilt University Medical Center

**Investigator Full Name:** Derek Williams

**Investigator Title:** Associate Professor of Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pneumonia Childhood

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 536

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Clinical Decision Support

**Label:** CDS Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CDS Intervention

**Description:** 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.

**Name:** Clinical Decision Support

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Death

**Time Frame:** 30 days

#### Primary Outcomes

**Description:** 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.

**Measure:** Inappropriate Disposition

**Time Frame:** 24 Hours

#### Secondary Outcomes

**Description:** 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.

**Measure:** Overall Site-of-care Disposition

**Time Frame:** ED Disposition

**Description:** This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.

**Measure:** ED Revisits (72 Hours)

**Time Frame:** 72 hours

**Description:** This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.

**Measure:** ED Revisits (7 Days)

**Time Frame:** 7 days

**Description:** This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.

**Measure:** Rehospitalizations (72 Hours)

**Time Frame:** 72 hours

**Description:** This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.

**Measure:** Rehospitalizations (7 Days)

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 18 Years

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nashville

**Country:** United States

**Facility:** Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37232

#### Overall Officials

**Official 1:**

**Affiliation:** Vanderbilt University Medical Center

**Name:** Derek J Williams, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-10-26

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 353554

- Type Abbrev: Prot

- Upload Date: 2023-08-23T15:01

- Date: 2022-10-26

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 356050

- Type Abbrev: SAP

- Upload Date: 2023-08-23T15:02

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13904

- Name: Pneumonia

- Relevance: HIGH

- As Found: Pneumonia

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3897

- Name: Muckle-Wells Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011014

- Term: Pneumonia

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Control

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 269

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 269

**Serious Number At Risk:** 269

**Title:** Control

**Group ID:** EG001

**Title:** CDS Intervention

**Deaths Num Affected:** 4

**Deaths Num At Risk:** 267

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 267

**Serious Number At Risk:** 267

**Title:** CDS Intervention

**Frequency Threshold:** 0

**Time Frame:** 30 days

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Units:** Participants

### Group

**ID:** BG000

**Title:** Control

**Description:** 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.

### Group

**ID:** BG001

**Title:** CDS Intervention

**Description:** 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 2.1

**Upper Limit:** 7.0

**Value:** 4.4

#### Measurement

**Group ID:** BG001

**Lower Limit:** 2.1

**Upper Limit:** 7.2

**Value:** 4.3

#### Measurement

**Group ID:** BG002

**Lower Limit:** 2.1

**Upper Limit:** 7.4

**Value:** 4.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 126

#### Measurement

**Group ID:** BG001

**Value:** 141

#### Measurement

**Group ID:** BG002

**Value:** 267

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 143

#### Measurement

**Group ID:** BG001

**Value:** 126

#### Measurement

**Group ID:** BG002

**Value:** 269

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 184

#### Measurement

**Group ID:** BG001

**Value:** 177

#### Measurement

**Group ID:** BG002

**Value:** 361

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 86

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 22

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 31

#### Measurement

**Group ID:** BG002

**Value:** 61

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** Unknown

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 150

#### Measurement

**Group ID:** BG001

**Value:** 132

#### Measurement

**Group ID:** BG002

**Value:** 282

**Category Title:** Non-chronic

#### Measurement

**Group ID:** BG000

**Value:** 26

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 51

**Category Title:** Non-complex chronic

#### Measurement

**Group ID:** BG000

**Value:** 80

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 163

**Category Title:** Complex chronic

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 256

**Group ID:** BG001

**Value:** 240

**Group ID:** BG002

**Value:** 496

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 153

#### Measurement

**Group ID:** BG001

**Value:** 142

#### Measurement

**Group ID:** BG002

**Value:** 295

**Category Title:** Public

#### Measurement

**Group ID:** BG000

**Value:** 95

#### Measurement

**Group ID:** BG001

**Value:** 101

#### Measurement

**Group ID:** BG002

**Value:** 196

**Category Title:** Private

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Multiple

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 9

**Category Title:** None

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 36.9

**Upper Limit:** 38.2

**Value:** 37.5

#### Measurement

**Group ID:** BG001

**Lower Limit:** 36.8

**Upper Limit:** 38.08

**Value:** 37.2

#### Measurement

**Group ID:** BG002

**Lower Limit:** 36.8

**Upper Limit:** 38.1

**Value:** 37.3

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 121.0

**Upper Limit:** 154.0

**Value:** 138.5

#### Measurement

**Group ID:** BG001

**Lower Limit:** 117.0

**Upper Limit:** 155.0

**Value:** 135.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 118.0

**Upper Limit:** 155.0

**Value:** 136.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 24.0

**Upper Limit:** 40.0

**Value:** 30.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 24.0

**Upper Limit:** 40.5

**Value:** 32.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 24.0

**Upper Limit:** 40.0

**Value:** 31.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 99.0

**Upper Limit:** 117.0

**Value:** 108.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 100.0

**Upper Limit:** 117.0

**Value:** 108.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 100.0

**Upper Limit:** 117.0

**Value:** 108.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 269

**Group ID:** BG001

**Value:** 267

**Group ID:** BG002

**Value:** 536

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 442.9

**Upper Limit:** 466.7

**Value:** 457.1

#### Measurement

**Group ID:** BG001

**Lower Limit:** 447.6

**Upper Limit:** 466.7

**Value:** 457.1

#### Measurement

**Group ID:** BG002

**Lower Limit:** 447.6

**Upper Limit:** 466.7

**Value:** 457.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 220

**Group ID:** BG001

**Value:** 227

**Group ID:** BG002

**Value:** 447

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Data for this measure not available for all patients.
**Title:** Comorbidity
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Insurance
**Unit of Measure:** Participants
### Measure 6
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triage temperature
**Unit of Measure:** degrees Celsius
### Measure 7
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triage heart rate
**Unit of Measure:** beats per minute
### Measure 8
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triage respiratory rate
**Unit of Measure:** respirations per minute
### Measure 9
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triage systolic blood pressure
**Unit of Measure:** mmHg
### Measure 10
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Population Description:** Data for this measure not available for all patients.
**Title:** SpO2:FiO2 ratio
**Unit of Measure:** ratio
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** derek.williams@vumc.org
**Organization:** Vanderbilt University Medical Center
**Phone:** 615-322-2744
**Title:** Derek J. Williams, MD, MPH
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.95
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.99
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.233
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Fisher Exact
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.30
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.37
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.86
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.82
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.78
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.34
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.51
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.42
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.13
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.42
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.46
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.41
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.90
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.72
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 107
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 109
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 24 Hours
**Title:** Inappropriate Disposition
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** ED Disposition
**Title:** Overall Site-of-care Disposition
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 3
**Description:** This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 72 hours
**Title:** ED Revisits (72 Hours)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 4
**Description:** This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 7 days
**Title:** ED Revisits (7 Days)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 5
**Description:** This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 72 hours
**Title:** Rehospitalizations (72 Hours)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 6
**Description:** This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 7 days
**Title:** Rehospitalizations (7 Days)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
#### Outcome Measure 7
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 30 days
**Title:** Death
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Control
##### Group
**Description:** 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.
**ID:** OG001
**Title:** CDS Intervention
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Control
#### Group
**Description:** 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.
**ID:** FG001
**Title:** CDS Intervention
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 269
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 267
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 269
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 267
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True