Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT01179932
Status:
WITHDRAWN
Last Update Posted:
2022-04-18
First Post:
2010-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthesia Charting Fidelity Study
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Acute Anesthesia Charting Fidelity Quality Assessment Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: