EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care (Appy-CDS)

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Other: Appy CDS

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.

• Study Type: Interventional
• Enrollment (Actual): 5940
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California
  • Minnesota
    • Minneapolis, Minnesota, United States, 55440
      • HealthPartners Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care
EXPERIMENTAL: Appy CDS; 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 intervention is administered to providers in this arm.	Other: Appy CDS; See description under arm/group section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	pre-intervention of 8 months (average), and post intervention of 23 months

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Kaiser Permanente; Children's Hospitals and Clinics of Minnesota
• Investigators: Principal Investigator: Anupam B Kharbanda, MD, MSc, Children's Hospital and Clinics of Minnesota

Publications and helpful links

General Publications

• Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Dehmer SP, Ekstrom H, Rauchwerger AS, McMichael B, Cotton DM, Kene MV, Simon LE, Zhu J, Warton EM, O'Connor PJ, Kharbanda EO; Clinical Research on Emergency Services and Treatments Network (CREST) and the Critical Care Research Center, HealthPartners Institute. Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036344. doi: 10.1001/jamanetworkopen.2020.36344.
• Cotton DM, Vinson DR, Vazquez-Benitez G, Margaret Warton E, Reed ME, Chettipally UK, Kene MV, Lin JS, Mark DG, Sax DR, McLachlan ID, Rauchwerger AS, Simon LE, Kharbanda AB, Kharbanda EO, Ballard DW; Clinical Research on Emergency Services and Treatments (CREST) Network. Validation of the Pediatric Appendicitis Risk Calculator (pARC) in a Community Emergency Department Setting. Ann Emerg Med. 2019 Oct;74(4):471-480. doi: 10.1016/j.annemergmed.2019.04.023. Epub 2019 Jun 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (ESTIMATE): December 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Clinical Decision Support
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Pain; Neurologic Manifestations; Disease Attributes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Emergencies; Abdominal Pain; Appendicitis; Abdomen, Acute
• Other Study ID Numbers: 14-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No