Anesthesia Charting Fidelity Study
|ClinicalTrials.gov Identifier: NCT01179932|
Recruitment Status : Unknown
Verified July 2010 by University Hospitals Cleveland Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
|Condition or disease||Intervention/treatment|
|Anesthesia||Other: No Intervention Used|
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Primary Objective: Conduct a prospective, observational pilot study that assesses the frequency and severity of anesthesia charting fidelity weaknesses in three separate clinical environments (Cardiac surgical operating room, cardiac surgical intensive care unit, and electrophysiology laboratory) as assessed by a customized error scoring system that focuses on the magnitude of errors among multiple continuous, categorical and dichotomous variables. The errors are being assessed in order to identify the most common charting inaccuracies so that target areas appropriate for testing of improvement strategies may be isolated.
- Cardiac surgical operating room: Any cardiac surgical procedure that involves the use of cardiopulmonary bypass and planned postoperative intensive care unit admission in an electronic supplemented anesthesia charting environment
- Cardiac surgical intensive care unit: The cardiac surgical intensive care unit environment during the first 2-3 hours following procedures referenced in section I,A,1
- Electrophysiology laboratory: select electrophysiology laboratory based procedures that employ a paper anesthesia chart
Secondary and Exploratory Objectives:
- Identify environmental variables that contribute significantly to medical record errors.
- Identify clinical role of individual responsible for charting
- Investigate time of day/patterns that charting errors occur
- Relationship of clinical acuity and event occurrences
- Role of equipment malfunction and event frequency
- Role of social distracters and event frequency
- Role of monitor infidelity and event frequency
- Role of delayed charting of event and frequency of errors
- Identify/quantify the awareness of clinicians to their execution of medical record errors through use of simple, multiple choice 4 question survey that clinicians will be asked to fill out following a case study
- Examine the relationship between the assessed environments and the frequency of medical charting errors
- Identify the areas of anesthesia charting most in need of improvement in order to address designing ways to potentially improve these weaknesses.
Error scoring system:
The degree of charting fidelity error in this study will be converted via a classification system to make data analysis more efficient. All types of errors that involve continuous variables will be assessed with mean, median and standard deviation as well as range. Numerical data points related to time will be classified into four separate categories.
- Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from actual time of event/observation.
- Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation from actual time of event/observation.
- Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation from actual time of event/observation.
- Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from actual time of event/observation.
The degree of charting fidelity error observed with respect to hemodynamic parameters will be classified as follows:
- Class Ih: accurate hemodynamic data with less than 3% deviation from the representative value recorded by the scribe.
- Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the representative value recorded by the scribe.
- Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the representative value recorded by the scribe.
- Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the representative value recorded by the scribe.
- The degree of charting fidelity error observed with respect to whether a procedure which was performed by anesthesia provider was charted will be assessed as a dichotomous variable, Yes or No.
- The degree of charting fidelity error observed with respect to whether a significant intraoperative event, or intra-procedural event for the electrophysiology laboratory, was charted will be assessed as a dichotomous variable, Yes or No.
- The degree of charting fidelity error observed with respect to drug dosing will be assessed as a dichotomous variable, Yes or No.
- The degree of charting fidelity error as related to procedural details will be assessed as a dichotomous variable, Yes or No.
- Full statistical analysis making all possible comparisons of collected data will be performed with the assistance of a trained statistician.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Acute Anesthesia Charting Fidelity Quality Assessment Pilot Study|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||August 2011|
The nursing and anesthesia records will be examined for accuracy and completeness
Other: No Intervention Used
Our study is observational; therefore, there is no type of intervention being used.
- Frequency/severity of anesthesia charting fidelity weaknesses in cardiac care based clinical environments as assessed by an error scoring system. [ Time Frame: A total of thirty separate anesthesia records will be inidividually assessed and compared to the data prospectively collected during each corresponding anesthetic (lasting an average of 5 hours in the OR and 45 min in the EP lab. ]A single dedicated observer with focused clinical education will continually scribe observations made with close attention to detail (e.g., time of event, drug administered, dose of drug, route of administration of drug) using a prospectively designed data collection tool. This record of events will then be compared to the clinician charted anesthesia record in order to assess the frequency and severity of errors ocurring within the anesthesia record. A customized scoring system will be employed to grade the observed errors noted in the anesthesia record.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179932
|Contact: Edwin G Avery, MD||216-844-7334||Edwin.Avery@uhhospitals.org|
|United States, Ohio|
|University Hospitals Case Medical Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Edwin G Avery, MD 216-844-7334 Edwin.Avery@uhhospitals.org|
|Sub-Investigator: James Rowbottom, MD|
|Sub-Investigator: John C Klick, MD|
|Sub-Investigator: James Reynolds, PhD|
|Sub-Investigator: Howard Nearman, MD|
|Sub-Investigator: Alan Markowitz, MD|
|Principal Investigator:||Edwin G Avery, MD||UH Case Medical Center|