Trial Outcomes & Findings for Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2) (NCT NCT06033079)
NCT ID: NCT06033079
Last Updated: 2023-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
536 participants
Primary outcome timeframe
24 Hours
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
269
|
267
|
|
Overall Study
COMPLETED
|
269
|
267
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data for this measure not available for all patients.
Baseline characteristics by cohort
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
Total
n=536 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.4 years
n=269 Participants
|
4.3 years
n=267 Participants
|
4.4 years
n=536 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=269 Participants
|
141 Participants
n=267 Participants
|
267 Participants
n=536 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=269 Participants
|
126 Participants
n=267 Participants
|
269 Participants
n=536 Participants
|
|
Race/Ethnicity, Customized
White
|
184 Participants
n=269 Participants
|
177 Participants
n=267 Participants
|
361 Participants
n=536 Participants
|
|
Race/Ethnicity, Customized
Black
|
36 Participants
n=269 Participants
|
50 Participants
n=267 Participants
|
86 Participants
n=536 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=269 Participants
|
2 Participants
n=267 Participants
|
6 Participants
n=536 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=269 Participants
|
7 Participants
n=267 Participants
|
22 Participants
n=536 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
30 Participants
n=269 Participants
|
31 Participants
n=267 Participants
|
61 Participants
n=536 Participants
|
|
Comorbidity
Non-chronic
|
150 Participants
n=256 Participants • Data for this measure not available for all patients.
|
132 Participants
n=240 Participants • Data for this measure not available for all patients.
|
282 Participants
n=496 Participants • Data for this measure not available for all patients.
|
|
Comorbidity
Non-complex chronic
|
26 Participants
n=256 Participants • Data for this measure not available for all patients.
|
25 Participants
n=240 Participants • Data for this measure not available for all patients.
|
51 Participants
n=496 Participants • Data for this measure not available for all patients.
|
|
Comorbidity
Complex chronic
|
80 Participants
n=256 Participants • Data for this measure not available for all patients.
|
83 Participants
n=240 Participants • Data for this measure not available for all patients.
|
163 Participants
n=496 Participants • Data for this measure not available for all patients.
|
|
Insurance
Public
|
153 Participants
n=269 Participants
|
142 Participants
n=267 Participants
|
295 Participants
n=536 Participants
|
|
Insurance
Private
|
95 Participants
n=269 Participants
|
101 Participants
n=267 Participants
|
196 Participants
n=536 Participants
|
|
Insurance
Multiple
|
16 Participants
n=269 Participants
|
20 Participants
n=267 Participants
|
36 Participants
n=536 Participants
|
|
Insurance
None
|
5 Participants
n=269 Participants
|
4 Participants
n=267 Participants
|
9 Participants
n=536 Participants
|
|
Triage temperature
|
37.5 degrees Celsius
n=269 Participants
|
37.2 degrees Celsius
n=267 Participants
|
37.3 degrees Celsius
n=536 Participants
|
|
Triage heart rate
|
138.5 beats per minute
n=269 Participants
|
135.0 beats per minute
n=267 Participants
|
136.0 beats per minute
n=536 Participants
|
|
Triage respiratory rate
|
30.0 respirations per minute
n=269 Participants
|
32.0 respirations per minute
n=267 Participants
|
31.0 respirations per minute
n=536 Participants
|
|
Triage systolic blood pressure
|
108.0 mmHg
n=269 Participants
|
108.0 mmHg
n=267 Participants
|
108.0 mmHg
n=536 Participants
|
|
SpO2:FiO2 ratio
|
457.1 ratio
n=220 Participants • Data for this measure not available for all patients.
|
457.1 ratio
n=227 Participants • Data for this measure not available for all patients.
|
457.1 ratio
n=447 Participants • Data for this measure not available for all patients.
|
PRIMARY outcome
Timeframe: 24 HoursNumber 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.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
Inappropriate Disposition
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: ED DispositionThis outcome reports the total number of participants who were initially discharged from the ED, admitted to the inpatient ward, or admitted to the ICU.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
Overall Site-of-care Disposition
ED
|
107 Participants
|
109 Participants
|
|
Overall Site-of-care Disposition
Inpatient
|
113 Participants
|
96 Participants
|
|
Overall Site-of-care Disposition
ICU
|
49 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 72 hoursThis outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
ED Revisits (72 Hours)
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7 daysThis outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
ED Revisits (7 Days)
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 72 hoursThis outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
Rehospitalizations (72 Hours)
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 7 daysThis outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
Rehospitalizations (7 Days)
|
8 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThis outcome reports the number of participants who died as a result of their pneumonia-related illness within 30 days discharge from the index encounter.
Outcome measures
| Measure |
Control
n=269 Participants
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.
|
CDS Intervention
n=267 Participants
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.
|
|---|---|---|
|
Death
|
3 Participants
|
4 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
CDS Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Derek J. Williams, MD, MPH
Vanderbilt University Medical Center
Phone: 615-322-2744
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place