Trial Outcomes & Findings for EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care (NCT NCT02633735)
NCT ID: NCT02633735
Last Updated: 2020-07-09
Results Overview
First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5940 participants
Primary outcome timeframe
pre-intervention of 8 months (average), and post intervention of 23 months
Results posted on
2020-07-09
Participant Flow
ED Sites were randomized to the AppyCDS intervention or usual care (UC). Sites were stratified by health system and then grouped on patterns of pediatric referral and provider cross coverage. EDs or groups of EDs were sorted into pairs by estimated pediatric patient volume. Study phases were consistent but date ranges varied by health system.
Participant milestones
| Measure |
Control
Usual care
|
Intervention
The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.
appy-cds: See description under arm/group section
|
|---|---|---|
|
Pre-implementation Phase
STARTED
|
788
|
1011
|
|
Pre-implementation Phase
COMPLETED
|
788
|
1011
|
|
Pre-implementation Phase
NOT COMPLETED
|
0
|
0
|
|
Implementation Phase
STARTED
|
1991
|
2150
|
|
Implementation Phase
COMPLETED
|
1991
|
2150
|
|
Implementation Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
Baseline characteristics by cohort
| Measure |
Control
n=2779 Participants
Usual care
|
Intervention
n=3161 Participants
The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.
appy-cds: See description under arm/group section
|
Total
n=5940 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
11.8 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1512 Participants
n=5 Participants
|
1780 Participants
n=7 Participants
|
3292 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1267 Participants
n=5 Participants
|
1381 Participants
n=7 Participants
|
2648 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
788 Participants
n=5 Participants
|
1104 Participants
n=7 Participants
|
1892 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1991 Participants
n=5 Participants
|
2057 Participants
n=7 Participants
|
4048 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
176 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
402 Participants
n=5 Participants
|
473 Participants
n=7 Participants
|
875 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2000 Participants
n=5 Participants
|
2059 Participants
n=7 Participants
|
4059 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
201 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
463 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-intervention of 8 months (average), and post intervention of 23 monthsPopulation: Numbers are sum of subjects in pre-implementation and implementation phases.
First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.
Outcome measures
| Measure |
Control
n=2779 Participants
Usual care
|
Intervention
n=3161 Participants
The appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.
appy-cds: See description under arm/group section
|
|---|---|---|
|
Pre to Post Ratio of Image Use
CT Use
|
1.13 ratio of pre-post use
Interval 0.92 to 1.4
|
1.07 ratio of pre-post use
Interval 0.97 to 1.17
|
|
Pre to Post Ratio of Image Use
US Use
|
1.03 ratio of pre-post use
Interval 0.92 to 1.16
|
1.01 ratio of pre-post use
Interval 0.91 to 1.12
|
|
Pre to Post Ratio of Image Use
All Imaging Use
|
1.06 ratio of pre-post use
Interval 0.98 to 1.14
|
1.02 ratio of pre-post use
Interval 0.94 to 1.11
|
Adverse Events
Appy CDS Intervention
Serious events: 96 serious events
Other events: 222 other events
Deaths: 0 deaths
Control
Serious events: 109 serious events
Other events: 224 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Appy CDS Intervention
n=3161 participants at risk
The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The Appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.
Post Appy Clinical Decision Support: The Appy CDS is a point of care clinical decision support system that provides the provider with 1) risk for appendicitis based on EHR data, 2) recommendations on actions to take based on risk, 3) advises on imaging use.
|
Control
n=2779 participants at risk
People in the control arm receive usual care.
|
|---|---|---|
|
Gastrointestinal disorders
Appendiceal perforation
|
15.7%
63/402 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
19.6%
67/341 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
|
Surgical and medical procedures
Negative appendicitis
|
4.8%
20/421 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
7.4%
27/365 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
|
General disorders
Missed appendicitis
|
0.41%
13/3161 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
0.54%
15/2779 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
Other adverse events
| Measure |
Appy CDS Intervention
n=3161 participants at risk
The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The Appy-cds has multiple components, 1) presents risk prediction/stratification to provider, 2) provides recommendations consistent with standardized appendicitis care, 3) alerts for unnecessary exposure to ionizing radiation via a best practice alert. The intervention is administered to providers in this arm.
Post Appy Clinical Decision Support: The Appy CDS is a point of care clinical decision support system that provides the provider with 1) risk for appendicitis based on EHR data, 2) recommendations on actions to take based on risk, 3) advises on imaging use.
|
Control
n=2779 participants at risk
People in the control arm receive usual care.
|
|---|---|---|
|
General disorders
Return to ED within 7 days of index
|
7.0%
222/3161 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
8.1%
224/2779 • Within 7 days of index ED visit.
The number analyzed are the sum of participants who completed the pre-implementation and implementation phase in both study arms. Negative appendicitis and appendiceal perforation were monitored for the subset of participants that had a surgical procedure following exposure to the clinical decision support intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place