Clinical Trial: Pediatric Appendicitis Pathway Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Pediatric Appendicitis Pathway Study

Brief Summary: The purpose of this study is to test a standardized approach for children being evaluated for appendicitis in the emergency department. This means that all doctors would use the same approach to diagnose appendicitis in children in the emergency department. This pathway uses two scoring systems to identify patients who are at high and low risks of appendicitis. These scoring systems are based on the patient's symptoms, signs the doctor finds when examining the patient, and their blood tests. The goal of this part of the study is to determine if the investigators' pathway accurately identifies patients who have appendicitis.

Detailed Summary:

Methods:

Overview:

This study will consent and enroll a prospective cohort as well as incorporate a retrospective before and after chart review based on a HIPAA waiver of informed consent.

The prospective portion will study pediatric patients ages 3-18 being evaluated for acute appendicitis in the OHSU/Doernbecher ED. Patients will be prospectively consented and enrolled by the CRISP program. The treating physician will document specific clinical predictors of acute appendicitis using a paper form. These criteria will be combined with routine laboratory measurements to identify patients at high and low risk for acute appendicitis based on two published and validated scoring systems.

High risk patients will be directly admitted to the pediatric surgery service. Low risk patients will be observed further in the ED or discharged home with close outpatient follow-up based on the ED attending physician's judgment. Low risk patients will not be routinely consulted by pediatric surgery unless by the discretion of the ED attending. Patients at intermediate risk based on the scoring systems will continue evaluation in the ED at the discretion of the attending physician. Patients who are not definitively diagnosed with acute appendicitis by operative findings will be contacted by telephone at two weeks by a trained research assistant to assess for missed outcomes, the same follow up method used by Schneider et al. in another validation study of prediction rules for pediatric appendicitis.

As this clinical protocol is being introduced in the OHSU/Doernbecher ED independently of the research study, patients not participating will likely also be treated according to a similar algorithm. T
Sponsor: Oregon Health and Science University

Current Primary Outcome: Sensitivity and specificity of criteria [ Time Frame: 2 Weeks after visit ]

Sensitivity and specificity of criteria for diagnosing and excluding appendicitis


Original Primary Outcome:

Current Secondary Outcome:

  • Length of stay [ Time Frame: At completion of visit ]
    Length of ED length of stay before and after institution of pathway
  • Rates of CT and ultrasound [ Time Frame: After visit ]
    Rates of CT and ultrasound use before and after the pathway
  • Admission rate [ Time Frame: After visit ]
    Admission rate before and after institution of pathway


Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: August 30, 2010
Date Started: October 2010
Date Completion: September 2012
Last Updated: May 1, 2012
Last Verified: May 2012