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

NCT02633735 | Completed Results DMC

• 1 other identifier: 14-025
• Study Type: interventional
• Target: 5,940
• Locations: 1 country
• Sites: 2

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.

Conditions

Appendicitis

Keywords

Clinical Decision Support

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Appy CDS

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Interventions

Appy CDS OTHER

See description under arm/group section

Appy CDS

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HealthPartners Institute: lead
• Kaiser Permanente: collaborator
• Children's Hospitals and Clinics of Minnesota: collaborator

Study Sites (2)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

HealthPartners Medical Group

Minneapolis, Minnesota, 55440, United States

Location

Related Publications (2)

• 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.

  PMID: 33560426 DERIVED

• 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.

  PMID: 31229394 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Results Point of Contact

• Title: Elyse Kharbanda
• Organization: HealthPartners Institute

elyse.o.kharbanda@healthpartners.com

952-967-5038

Study Officials

• Elyse O Kharbanda, MD, MPH

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Anupam B Kharbanda, MD, MSc

  Children's Hospital and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 17, 2015
• Study Start: June 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: July 9, 2020
• Results First Posted: July 9, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)