Overview

This trial is active, not recruiting.

Condition appendicitis
Treatment appy-cds
Sponsor HealthPartners Institute
Collaborator Kaiser Permanente
Start date March 2016
End date February 2019
Trial size 8200 participants
Trial identifier NCT02633735, 14-025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(No Intervention)
Usual care
(Active Comparator)
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

Primary Outcomes

Measure
Pre and post rates of diagnostic imaging (Change from baseline CT or US use)
time frame: Change from baseline CT or US use at 24 months

Eligibility Criteria

Male or female participants from 5 years up to 19 years old.

Inclusion Criteria: - children and adolescents ages 5-19 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

Additional Information

Official title EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
Principal investigator Elyse O Kharbanda, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by HealthPartners Institute.