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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

1. 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. 1. 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 2. 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 3. Electrophysiology laboratory: select electrophysiology laboratory based procedures that employ a paper anesthesia chart 2. Secondary and Exploratory Objectives: 1. Identify environmental variables that contribute significantly to medical record errors. 2. Identify clinical role of individual responsible for charting 3. Investigate time of day/patterns that charting errors occur 4. Relationship of clinical acuity and event occurrences 5. Role of equipment malfunction and event frequency 6. Role of social distracters and event frequency 7. Role of monitor infidelity and event frequency 8. Role of delayed charting of event and frequency of errors 9. 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 10. Examine the relationship between the assessed environments and the frequency of medical charting errors 11. 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: 1. 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. 1. Class It: temporally accurate data will less than 2 minutes or 3.3% deviation from actual time of event/observation. 2. Class IIt: temporally inaccurate data with between 2-3 minutes or 3.3-5% deviation from actual time of event/observation. 3. Class IIIt: temporally inaccurate data with between 3-6 minutes or 5-10% deviation from actual time of event/observation. 4. Class IVt: temporally inaccurate data with greater than 10% deviation (6 min) from actual time of event/observation. 2. The degree of charting fidelity error observed with respect to hemodynamic parameters will be classified as follows: 1. Class Ih: accurate hemodynamic data with less than 3% deviation from the representative value recorded by the scribe. 2. Class IIh: inaccurate hemodynamic data with between 3-5% deviation from the representative value recorded by the scribe. 3. Class IIIh: inaccurate hemodynamic data with between 5-10% deviation from the representative value recorded by the scribe. 4. Class IVh: inaccurate hemodynamic data with greater than 10% deviation from the representative value recorded by the scribe. 3. 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. 4. 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. 5. The degree of charting fidelity error observed with respect to drug dosing will be assessed as a dichotomous variable, Yes or No. 6. The degree of charting fidelity error as related to procedural details will be assessed as a dichotomous variable, Yes or No. 7. Full statistical analysis making all possible comparisons of collected data will be performed with the assistance of a trained statistician.


Criteria:

a. Inclusion criteria: 1. Male or female patients ≥ 18 years of age 2. Patients and the hospital staff that are caring for them, scheduled to undergo any cardiac surgical procedure that involves the use of both general anesthesia (with planned computer assisted charting using the PISCES system) and cardiopulmonary bypass, including postoperative intensive care unit monitoring -or- Patients and the hospital staff caring for them scheduled to undergo select electrophysiologic procedures (detailed below 1 - 3) involving the administration of general anesthesia in the electrophysiology laboratory with planned manual paper charting 1. Defibrillation threshold testing using non-invasive programmed stimulation of an implantable cardiovertor defibrillator (ICD) 2. Transesophageal echocardiography guided electrical cardioversion of patients with supraventricular arrhythmias 3. Electrical cardioversion of patients with supraventricular arrhythmias


NCT ID:

NCT01179932


Primary Contact:

Principal Investigator
Edwin G Avery, MD
UH Case Medical Center

Edwin G Avery, MD
Phone: 216-844-7334
Email: Edwin.Avery@uhhospitals.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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