Appendicitis
Conditions
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
See description under arm/group section
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Pre to Post Ratio of Image Use | pre-intervention of 8 months (average), and post intervention of 23 months | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 5,940 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 11.7 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 Participants | 1104 Participants | 1892 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1991 Participants | 2057 Participants | 4048 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 176 Participants | 367 Participants | 543 Participants |
| Race (NIH/OMB) Black or African American | 402 Participants | 473 Participants | 875 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 201 Participants | 262 Participants | 463 Participants |
| Race (NIH/OMB) White | 2000 Participants | 2059 Participants | 4059 Participants |
| Sex: Female, Male Female | 1512 Participants | 1780 Participants | 3292 Participants |
| Sex: Female, Male Male | 1267 Participants | 1381 Participants | 2648 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,161 | 0 / 2,779 |
| other Total, other adverse events | 222 / 3,161 | 224 / 2,779 |
| serious Total, serious adverse events | 96 / 3,161 | 109 / 2,779 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Pre to Post Ratio of Image Use | CT Use | 1.13 ratio of pre-post use |
| Control | Pre to Post Ratio of Image Use | US Use | 1.03 ratio of pre-post use |
| Control | Pre to Post Ratio of Image Use | All Imaging Use | 1.06 ratio of pre-post use |
| Intervention | Pre to Post Ratio of Image Use | CT Use | 1.07 ratio of pre-post use |
| Intervention | Pre to Post Ratio of Image Use | US Use | 1.01 ratio of pre-post use |
| Intervention | Pre to Post Ratio of Image Use | All Imaging Use | 1.02 ratio of pre-post use |