Anesthesia Charting Fidelity Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital Case Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01179932
First received: July 26, 2010
Last updated: August 10, 2010
Last verified: July 2010
  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.


Condition Intervention
Anesthesia
Other: No Intervention Used

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Anesthesia Charting Fidelity Quality Assessment Pilot Study

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anesthesia Record
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.

  Hide Detailed Description

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Deidentified patients undergoing a cardiac surgical procedure or undergoing select electrophysiologic procedures as well as the corresponding clinical staff caring for them.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179932

Contacts
Contact: Edwin G Avery, MD 216-844-7334 Edwin.Avery@uhhospitals.org

Locations
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         
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Edwin G Avery, MD UH Case Medical Center
  More Information

Publications:
Responsible Party: Edwin Avery, Principle Investigator, University Hospitals
ClinicalTrials.gov Identifier: NCT01179932     History of Changes
Other Study ID Numbers: Charting Pilot
Study First Received: July 26, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Pilot
Charting
Anesthesia Record
Cardiac surgical operating room
Cardiac surgical intensive care unit
Electrophysiology lab

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014