Prevalence and Characterization of Diagnostic Error Among Patients With Bacteremia

NCT03577366 | Completed

• 1 other identifier: 7099
• Study Type: observational
• Target: 1,570
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diagnostic error is an important but often under-recognized source of adverse events in the hospital. This study is focused on the delayed or missed diagnosis of sepsis associated with bacteremia among patients admitted to The Ottawa Hospital. The aim of this study is to determine the prevalence and characterization of diagnostic error among patients admitted to the at The Ottawa Hospital with sepsis associated with a positive blood culture. This study will consist of a retrospective chart review of all patients who are greater than 18 years with positive blood culture taken within 12 hours of presenting to the Emergency Department of Ottawa Hospital Civic and General Campus between January 2016 to August 13th 2017. For charts that are eligible for review for diagnostic errors, the qSOFA (Quick Sequential \[Sepsis-related\] Organ Failure Assessment) score at time at admission will be used to identify those patients who were at risk of serious harm because of a missed diagnosis of sepsis and lack of treatment. Patient variables will be collected and compared between the following three groups: (1) patients who received antibiotics within 24 hours, (2) patients who did not receive antibiotics within 24 hours and who did not meet qSOFA criteria, and (3) patients who did not receive antibiotic within 24 hours and who met qSOFA criteria. Variables to be studied include age, gender, hospital campus, admitting service, day of admission (weekend vs. weekday), time of admission (night vs. day), length of stay, disposition and Elixhauser Comorbidity Index. For charts eligible for review for diagnostic error, the DEER (Diagnostic Error Evaluation Research) Taxonomy tool will be used to classify cases per the location and type of error that occurred in the diagnostic process.

Conditions

Bacteremia Sepsis

Keywords

Bacteremia; Sepsis; Diagnostic Error

Outcome Measures

Primary Outcomes (1)

• Diagnostic Error

  Prevalence and Characterization of Diagnostic Error

  January 2016-August 13th, 2017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in this study will be \>18 years old with a positive blood culture taken in the Emergency Department or on admission to the hospital between January 2016-August 13th,2017. No data entered into the medical chart before or after the specified dates will be collected. Among these patients, we will only review charts for those patients who did not receive treatment for sepsis on presentation by an Emergency Room physician or consultant.

You may qualify if:

• \>18 years old with a positive blood culture taken in the Emergency Department or on admission to the hospital between January 2016-August 13th,2017. No data entered into the medical chart before or after the specified dates will be collected.

Sponsors & Collaborators

• Aimee Li: lead

MeSH Terms

Conditions

Bacteremia; Sepsis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scholar

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 5, 2018
• Study Start: January 1, 2016
• Primary Completion: August 13, 2017
• Study Completion: August 13, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07