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Anesthesia Charting Fidelity Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179932
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  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

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland 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. ]
    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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospitals Cleveland 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
First Submitted: July 26, 2010
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
Last Verified: July 2010

Keywords provided by University Hospitals Cleveland 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