Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2) (ICE-CAP2)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06033079 |
Recruitment Status :
Completed
First Posted : September 13, 2023
Results First Posted : December 5, 2023
Last Update Posted : December 5, 2023
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia Childhood | Behavioral: Clinical Decision Support | Not Applicable |
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 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 |
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.
|
- 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.
- Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Six months to <18 years of age
- Radiographic evidence of pneumonia in ED
- Provider-confirmed diagnosis of pneumonia
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033079
United States, Tennessee | |
Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Derek J Williams, MD, MPH | Vanderbilt University Medical Center |
Documents provided by Derek Williams, Vanderbilt University Medical Center:
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 Key Record Dates |
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 |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |