Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2) (ICE-CAP2)

• ClinicalTrials.gov Identifier: NCT06033079
• Recruitment Status: Completed
• First Posted: September 13, 2023
• Results First Posted: December 5, 2023
• Last Update Posted: December 5, 2023
• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Pittsburgh Medical Center
• Information provided by (Responsible Party): Derek Williams, Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pneumonia Childhood	Behavioral: Clinical Decision Support	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 536 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support
• Actual Study Start Date: November 20, 2020
• Actual Primary Completion Date: November 30, 2022
• Actual Study Completion Date: November 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Inappropriate Disposition [ Time Frame: 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 Outcome Measures :

1. Overall Site-of-care Disposition [ Time Frame: 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.
2. ED Revisits (72 Hours) [ Time Frame: 72 hours ]
   This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
3. ED Revisits (7 Days) [ Time Frame: 7 days ]
   This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
4. Rehospitalizations (72 Hours) [ Time Frame: 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.
5. Rehospitalizations (7 Days) [ Time Frame: 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.

Other Outcome Measures:

1. Death [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Tennessee

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

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

National Institute of Allergy and Infectious Diseases (NIAID)

University of Pittsburgh Medical Center

Investigators

• Principal Investigator: Derek J Williams, MD, MPH; Vanderbilt University Medical Center

  Study Documents (Full-Text)

Documents provided by Derek Williams, Vanderbilt University Medical Center:

Study Protocol  [PDF] October 26, 2022

Statistical Analysis Plan  [PDF] October 26, 2022

More Information

• Responsible Party: Derek Williams, Associate Professor of Pediatrics, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT06033079
• Other Study ID Numbers: R01AI125642pt2; R01AI125642 ( U.S. NIH Grant/Contract )
• First Posted: September 13, 2023
• Results First Posted: December 5, 2023
• Last Update Posted: December 5, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases