Trial Outcomes & Findings for Improving CarE for Community Acquired Pneumonia 1 (NCT NCT03760419)
NCT ID: NCT03760419
Last Updated: 2022-12-08
Results Overview
The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1027 participants
Primary outcome timeframe
18 months
Results posted on
2022-12-08
Participant Flow
Participant milestones
| Measure |
Monroe Carell Jr Children's Hospital at Vanderbilt
Children with pneumonia presenting to the ED at Monroe Carell Jr. Children's Hospital at Vanderbilt. Encounters were randomized to control or intervention.
Control: Standard of care will be provided to those randomized to the control arm.
Intervention: The antibiotic decision support application will be provided to those randomized to the intervention arm.
|
Children's Hospital of Pittsburgh
Children with pneumonia presenting to the ED at Monroe Carell Jr. Children's Hospital at Vanderbilt. Encounters were randomized to control or intervention.
Control: Standard of care will be provided to those randomized to the control arm.
Intervention: The antibiotic decision support application will be provided to those randomized to the intervention arm.
|
|---|---|---|
|
Overall Study
STARTED
|
535
|
492
|
|
Overall Study
Received Intervention
|
214
|
335
|
|
Overall Study
Received Contol
|
321
|
157
|
|
Overall Study
COMPLETED
|
535
|
492
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This measurement was not able to be assessed for 3 patients.
Baseline characteristics by cohort
| Measure |
Control Arm
n=478 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.
|
Intervention Arm
n=549 Participants
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
Total
n=1027 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.8 years
n=478 Participants
|
4.0 years
n=549 Participants
|
4.2 years
n=1027 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=478 Participants
|
246 Participants
n=549 Participants
|
463 Participants
n=1027 Participants
|
|
Sex: Female, Male
Male
|
261 Participants
n=478 Participants
|
303 Participants
n=549 Participants
|
564 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=478 Participants
|
36 Participants
n=549 Participants
|
96 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
390 Participants
n=478 Participants
|
472 Participants
n=549 Participants
|
862 Participants
n=1027 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=478 Participants
|
41 Participants
n=549 Participants
|
69 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
White
|
294 Participants
n=478 Participants
|
399 Participants
n=549 Participants
|
693 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
Black
|
117 Participants
n=478 Participants
|
79 Participants
n=549 Participants
|
196 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=478 Participants
|
17 Participants
n=549 Participants
|
31 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
10 Participants
n=478 Participants
|
12 Participants
n=549 Participants
|
22 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
Other
|
24 Participants
n=478 Participants
|
20 Participants
n=549 Participants
|
44 Participants
n=1027 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
19 Participants
n=478 Participants
|
22 Participants
n=549 Participants
|
41 Participants
n=1027 Participants
|
|
Comorbidity
Non-Chronic
|
282 Participants
n=478 Participants
|
359 Participants
n=549 Participants
|
641 Participants
n=1027 Participants
|
|
Comorbidity
Non-complex Chronic
|
61 Participants
n=478 Participants
|
70 Participants
n=549 Participants
|
131 Participants
n=1027 Participants
|
|
Comorbidity
Complex Chronic
|
135 Participants
n=478 Participants
|
120 Participants
n=549 Participants
|
255 Participants
n=1027 Participants
|
|
Insurance
Public
|
281 Participants
n=475 Participants • This measurement was not able to be assessed for 3 patients.
|
280 Participants
n=549 Participants • This measurement was not able to be assessed for 3 patients.
|
561 Participants
n=1024 Participants • This measurement was not able to be assessed for 3 patients.
|
|
Insurance
Private
|
176 Participants
n=475 Participants • This measurement was not able to be assessed for 3 patients.
|
246 Participants
n=549 Participants • This measurement was not able to be assessed for 3 patients.
|
422 Participants
n=1024 Participants • This measurement was not able to be assessed for 3 patients.
|
|
Insurance
Self-Pay
|
18 Participants
n=475 Participants • This measurement was not able to be assessed for 3 patients.
|
23 Participants
n=549 Participants • This measurement was not able to be assessed for 3 patients.
|
41 Participants
n=1024 Participants • This measurement was not able to be assessed for 3 patients.
|
|
Temperature
|
37.3 degrees Celsius
n=478 Participants
|
37.5 degrees Celsius
n=549 Participants
|
37.4 degrees Celsius
n=1027 Participants
|
|
Heart rate
|
134 bpm
n=478 Participants
|
139 bpm
n=549 Participants
|
136 bpm
n=1027 Participants
|
|
Respiratory rate
|
30 respirations per minute
n=478 Participants
|
34 respirations per minute
n=549 Participants
|
32 respirations per minute
n=1027 Participants
|
|
Systolic BP
|
108 mmHg
n=478 Participants
|
108 mmHg
n=549 Participants
|
108 mmHg
n=1027 Participants
|
|
SpO2:FiO2 ratio
|
462 ratio
n=478 Participants
|
457 ratio
n=549 Participants
|
457 ratio
n=1027 Participants
|
|
ED Disposition
Home
|
212 Participants
n=478 Participants
|
219 Participants
n=549 Participants
|
431 Participants
n=1027 Participants
|
|
ED Disposition
Inpatient
|
189 Participants
n=478 Participants
|
215 Participants
n=549 Participants
|
404 Participants
n=1027 Participants
|
|
ED Disposition
Intensive Care
|
77 Participants
n=478 Participants
|
115 Participants
n=549 Participants
|
192 Participants
n=1027 Participants
|
|
Enrolling Site
Site A
|
321 Participants
n=478 Participants
|
214 Participants
n=549 Participants
|
535 Participants
n=1027 Participants
|
|
Enrolling Site
Site B
|
157 Participants
n=478 Participants
|
335 Participants
n=549 Participants
|
492 Participants
n=1027 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All categories except "Overall" are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.
The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.
Outcome measures
| Measure |
Control Arm
n=478 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.
|
Intervention Arm
n=549 Participants
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
|---|---|---|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Overall
|
255 Participants
|
284 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Site A
|
174 Participants
|
120 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Site B
|
81 Participants
|
164 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Outpatient
|
140 Participants
|
164 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Inpatient
|
93 Participants
|
99 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
ICU
|
22 Participants
|
21 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Age < 6 years
|
163 Participants
|
192 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Age >/= 6 years
|
92 Participants
|
92 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
Receiving Antibiotics
|
147 Participants
|
192 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All categories except "Overall" are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.
This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).
Outcome measures
| Measure |
Control Arm
n=478 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.
|
Intervention Arm
n=549 Participants
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
|---|---|---|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Overall
|
240 Participants
|
261 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Site A
|
163 Participants
|
111 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Site B
|
77 Participants
|
150 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Outpatient
|
140 Participants
|
164 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Inpatient
|
83 Participants
|
85 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
ICU
|
17 Participants
|
12 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Age <6 years
|
156 Participants
|
175 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Age >/= 6 years
|
84 Participants
|
86 Participants
|
|
Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
Receiving Antibiotics
|
135 Participants
|
175 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All categories except "Overall" are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.
This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.
Outcome measures
| Measure |
Control Arm
n=478 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.
|
Intervention Arm
n=549 Participants
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
|---|---|---|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Overall
|
297 Participants
|
358 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Site A
|
198 Participants
|
144 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Site B
|
99 Participants
|
214 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Outpatient
|
145 Participants
|
168 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Inpatient
|
117 Participants
|
145 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
ICU
|
35 Participants
|
45 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Age <6 years
|
189 Participants
|
242 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Age >/= 6 years
|
108 Participants
|
116 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
Receiving Antibiotics
|
189 Participants
|
266 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All categories except "Overall" are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.
This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).
Outcome measures
| Measure |
Control Arm
n=478 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.
|
Intervention Arm
n=549 Participants
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
|---|---|---|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Overall
|
305 Participants
|
383 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Site A
|
200 Participants
|
146 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Site B
|
105 Participants
|
237 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Outpatient
|
145 Participants
|
168 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Inpatient
|
119 Participants
|
154 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
ICU
|
41 Participants
|
61 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Age <6 years
|
195 Participants
|
256 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Age >/= 6 years
|
110 Participants
|
127 Participants
|
|
Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
Receiving Antibiotics
|
200 Participants
|
297 Participants
|
Adverse Events
Control Arm
Serious events: 83 serious events
Other events: 0 other events
Deaths: 2 deaths
Intervention Arm
Serious events: 74 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control Arm
n=478 participants at risk
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.
|
Intervention Arm
n=549 participants at risk
The antibiotic 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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ED revisit within 72 hours
|
4.0%
19/478 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
4.0%
22/549 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
ED revisit within 7 days
|
6.7%
32/478 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
5.5%
30/549 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
Re-hospitalization within 72 hours
|
1.9%
9/478 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
1.3%
7/549 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
Re-hospitalization within 7 days
|
4.8%
23/478 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
2.7%
15/549 • 18 months
Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
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