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EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care

EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02633735
Acronym
Appy-CDS
Enrollment
5940
Registered
2015-12-17
Start date
2017-06-01
Completion date
2019-07-31
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Keywords

Clinical Decision Support

Brief summary

Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes. The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.

Detailed description

Abdominal pain is one of the most common reasons for children and adolescents to seek care in the emergency department (ED). Computed tomography (CT) has been promoted as a method to improve diagnostic accuracy when evaluating patients with acute abdominal pain. In the past 20 years, CT use has increased dramatically, especially for children receiving care in general ED settings. Although in some adult cohorts, increased CT use has been associated with decreased rates of negative appendectomies, similar improvements in health outcomes among children with acute abdominal pain have not occurred. Negative consequences of CT include increased costs and substantial exposure to ionizing radiation. Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. This cluster randomized trial builds on more than 10 years of work on derivation and validation of ED-based clinical decision rules, previous successful outpatient and emergency department clinical decision support interventions, and complex economic and statistical analyses of risk assessment and ED resource use. In this project, the investigators aim to extend the benefits of previous efforts by developing and implementing an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain. The results of this project will extend the understanding of how to maximize the clinical return on massive public and private sector investments being made in sophisticated EHR systems. If successful, this flexible decision support tool could be adapted and implemented broadly in a range of acute care settings to both standardize and personalize care delivered to pediatric patients.

Interventions

OTHERAppy CDS

See description under arm/group section

Sponsors

Kaiser Permanente
CollaboratorOTHER
Children's Hospitals and Clinics of Minnesota
CollaboratorOTHER
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Parallel cluster-randomized clinical trial at 14 general EDs in two large care system to evaluate the impact of appy-CDS intervention with a pre and post intervention phases

Eligibility

Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* children and adolescents ages 5-20 years with abdominal pain * internal med, family med, or emergency med trained providers at participating EDs

Exclusion criteria

* select comorbid conditions * previous abdominal surgery * treated for select comorbid conditions

Design outcomes

Primary

MeasureTime frameDescription
Pre to Post Ratio of Image Usepre-intervention of 8 months (average), and post intervention of 23 monthsFirst, 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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Control
Usual care
2,779
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
3,161
Total5,940

Baseline characteristics

CharacteristicControlInterventionTotal
Age, Continuous11.7 years
STANDARD_DEVIATION 4.5
11.9 years
STANDARD_DEVIATION 4.6
11.8 years
STANDARD_DEVIATION 4.5
Ethnicity (NIH/OMB)
Hispanic or Latino
788 Participants1104 Participants1892 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1991 Participants2057 Participants4048 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
176 Participants367 Participants543 Participants
Race (NIH/OMB)
Black or African American
402 Participants473 Participants875 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
201 Participants262 Participants463 Participants
Race (NIH/OMB)
White
2000 Participants2059 Participants4059 Participants
Sex: Female, Male
Female
1512 Participants1780 Participants3292 Participants
Sex: Female, Male
Male
1267 Participants1381 Participants2648 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3,1610 / 2,779
other
Total, other adverse events
222 / 3,161224 / 2,779
serious
Total, serious adverse events
96 / 3,161109 / 2,779

Outcome results

Primary

Pre to Post Ratio of Image Use

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.

Time frame: pre-intervention of 8 months (average), and post intervention of 23 months

Population: Numbers are sum of subjects in pre-implementation and implementation phases.

ArmMeasureGroupValue (MEAN)
ControlPre to Post Ratio of Image UseCT Use1.13 ratio of pre-post use
ControlPre to Post Ratio of Image UseUS Use1.03 ratio of pre-post use
ControlPre to Post Ratio of Image UseAll Imaging Use1.06 ratio of pre-post use
InterventionPre to Post Ratio of Image UseCT Use1.07 ratio of pre-post use
InterventionPre to Post Ratio of Image UseUS Use1.01 ratio of pre-post use
InterventionPre to Post Ratio of Image UseAll Imaging Use1.02 ratio of pre-post use

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026